The Blog of Schlichter, Bogard & Denton

New Tylenol Recall

2010-10-19T13:33:00.001-07:00

Johnson & Johnson has announced yet another recall, this time affecting 50-count packages of Tylenol 8HR. Tylenol 8HR 50-count packages with lot number BCM155 have been recalled for trace contamination with 2,4,6-tribromoanisole, which gives off a musty, moldy smell. The chemical is not known to be toxic and no adverse effects caused by 2,4,6-tribromoanisole have been reported.

This latest Tylenol recall is the fourth recall of Tylenol products this year, raising serious questions about the manufacturing practices of J&J subsidiary McNeil Consumer Healthcare. McNeil has made news recently after a House Committee on Oversight and Government Reform investigation into the company's "phantom recall" of Motrin in 2009.

Contamination of McNeil's products with 2,4,6-tribromoanisole is not new, either. In January of this year, Johnson & Johnson also recalled 53 million bottles of over-the-counter medicines—including Tylenol, Motrin, Benadryl, and Rolaids—nearly two years after receiving consumer complaints regarding a moldy smell in bottles of Tylenol Arthritis Relief medicine.

Just a few months later, April 30 of this year, 40 more products were recalled after FDA inspectors discovered thick dust and grime on equipment, along with other problems, at a J&J factory in Pennsylvania. Then again, in May, McNeil was forced to recall Children's Tylenol after discovering the medicine was contaminated with the drug-resistant bacteria Burkholderia cepacia.

With all these over-the-counter drug recalls, plus the widely publicized DePuy hip implant recall, Johnson & Johnson's safety record has been severely damaged in the past year. The company is now vulnerable to thousands of potential defective product lawsuits stemming from its many recalls.

To be fair, 2,4,6-tribromoanisole is not known to cause medical problems, which makes this latest recall unlikely to generate many pharmaceutical injury lawsuits. In fact, there is probably a greater risk from the medicine in Tylenol itself than from the contaminant as acetaminophen is the most common cause of acute liver failure in the US.

Nonetheless, the damage to the safety records of Johnson & Johnson subsidiaries like McNeil is unlikely to diminish, and questions about the companies' practices will lend serious credibility to defective product injury claims regarding other products, such as DePuy's ASR hip implants. The pharmaceutical injury lawyers of Schlichter, Bogard & Denton are ready to defend the rights of anyone injured by a defective Johnson & Johnson product.

If you or someone you know has been sickened or injured by Tylenol, Benadryl, Motrin, or another recalled or defective drug, please contact the product liability lawyers of Schlichter, Bogard & Denton today to discuss your case.

Diet Drug Meridia Pulled from US Market

2010-10-11T16:52:00.000-07:00

WASHINGTON, DC – Under strong pressure from the Food and Drug Administration (FDA), pharmaceutical manufacturer Abbott Laboratories submitted to a voluntary recall of its weight-loss drug Meridia. The FDA's John Jenkins, M.D., said in a firm statement Friday that "Meridia's continued availability is not justified," given the minimal weight-loss benefits of the drug and the increased risk of heart attack and stroke.

The FDA has advised the approximately 100,000 US patients taking Meridia to stop using the diet drug and speak to their doctors. The decision by the FDA to ask for a drug recall of Meridia resulted from clinical trial results published in late 2009.

In this study of more than ten thousand patients, 11.4% of patients taking Meridia suffered a heart attack, stroke, or serious cardiac event. Only 10% of patient taking a placebo suffered these events. Statistically, this represents a 16% increase in the relative risk of a heart attack, stroke, or cardiac problem for Meridia users. In addition, the trial found that Meridia only increased weight loss by about 2.5% of body weight compared to placebo, a modest result at best.

Abbot disputes the results of this trial, which was done at the request of European regulators, who subsequently removed Meridia from the European market in January of this year. While only half of the members of an FDA committee on September 15^th recommended a defective drug recall, the FDA decided Friday to withdraw Meridia because "there was no identifiable population of patients for whom the benefits of Meridia outweighed its risks."

Meridia is not the first weight-loss drug to be recalled for safety concerns as it is preceded by recalls of Phen-Phen and Hydroxycut®.

While the FDA recall of Meridia is will probably not have a severe impact on Abbott's profitability, it will certainly increase the pharmaceutical company's vulnerability to prescription drug injury lawsuits by raising awareness of Meridia's dangers and lending legitimacy to Meridia pharmaceutical injury lawsuits.

As experienced pharmaceutical injury lawyers, we at Schlichter, Bogard & Denton expect an increase in Meridia heart attack lawsuits just as the recall of Avandia has sparked an increase in Avandia heart attack lawsuits.

If you or a loved one has suffered a heart attack, stroke, or serious cardiac problem after taking Meridia, please contact the pharmaceutical injury attorneys of Schlichter, Bogard & Denton today for a complimentary case evaluation.

Novartis Agrees to $422.5 Million Settlement

2010-10-06T13:31:00.001-07:00

PHILADELPHIA – The US Attorney's office in Philadelphia announced last Thursday that Swiss pharmaceutical company Novartis has agreed to a $422.5 million settlement resolving civil and criminal investigations by the Department of Justice into off-label and illegal marketing of its anti-seizure drug Trileptal and several medications.

The federal government had accused Novartis Pharmaceuticals Inc. of marketing Trileptal, Diovan, Exforge, Tekturna, Zelnorm, and Sandostatin for uses not approved by the Food and Drug Administration (FDA). While physicians are allowed to prescribe a drug for any medical reason, drug makers and marketers are only allowed to promote the drug for FDA-approved uses. However, Novartis specifically targeted physicians and psychiatrists who were known to prescribe Trileptal and compensated off-label prescribers with illegal kickbacks in the form of paid speaking engagements, trips, and meals.

This off-label marketing and illegal kickbacks are costly to taxpayers and potentially dangerous to patients. The US government is one of the world's largest purchasers of prescription drugs through Medicaid, Medicare, TRICARE, and other government-funded healthcare programs. Whistleblowers within Novartis reported the off-label marketing, acting under the False Claims Act, which empowers the whistleblowers to file suit on behalf of the government when illegal activity results in improper or "false" claims paid by these government programs.

One reason off-label is so risky to patients is because it raises the risk of pharmaceutical injury from defective or improperly prescribed drugs. Illegal kickbacks to physicians further harm the doctor-patient relationship by offering incentives for doctors to prescribe off-label. This results in more patients being treated with drugs that are not approved by the FDA for that purpose, greatly increasing the risk of dangerous prescription drug side effects like heart disease and stroke.

Doctors who accept kickbacks or cause injury to a patient by prescribing off-label are not only vulnerable to criminal charges, but may also increase their exposure to medical malpractice lawsuits.

If you have become ill or been injured by a pharmaceutical drug prescribed off-label, please contact the experienced prescription drug injury lawyers of Schlichter, Bogard & Denton today for an evaluation of your case.

FDA Places Harsh Restrictions on Avandia

2010-10-05T15:45:00.001-07:00

WASHINGTON, DC – The US Food and Drug Administration (FDA) announced new, severe restrictions on GlaxoSmithKline's heavily scrutinized diabetes medication Avandia on Thursday, September 23. The European Medicines Agency announced the same day that Avandia was to be completely removed from the market in Europe.

FDA's decision has raised the profile of Avandia's health risks, which have been in the news for months. So far, Avandia has been linked to an increased risk of:

•Heart disease
•Heart failure and heart attacks
•Bladder cancer
•Pulmonary embolism
•Stroke
•Bone fractures

If you or someone you know has developed any of the above conditions after taking Avandia, you may have grounds for an Avandia defective drug lawsuit. The pharmaceutical injury law firm of Schlichter, Bogard & Denton has a strong record in pharmaceutical injury litigation and is ready to help you build your case and seek fair financial compensation.

Suppressing Risks and Scratching Backs

In fact, there is evidence that GSK knew about the risk of heart attacks even before Avandia was approved by the FDA in 2000, but hid the evidence from regulators. In addition, some members of FDA panels that issued earlier regulatory decisions on Avandia have in the past received payments from GSK for speaking engagements. These shady practices and conflicts of interest in the FDA's approval process and regulatory process are likely to be factors in Avandia defective drug lawsuits nationwide.

Even before the FDA's September 23^rd decision to allow only patients who do not respond to any other diabetes medication access to Avandia, plaintiffs across the United States had already been bringing defective drug lawsuits for Avandia-related heart attacks. Reuters reported in July that GSK had agreed to $460 million in Avandia settlements to about 10,000 plaintiffs.

Now that the FDA has severely restricted Avandia, judges and juries will likely find Avandia pharmaceutical injury claims against GSK more credible.

If you or a loved one has developed heart problems or had a heart attack or stroke after taking Avandia, please contact the defective drug injury attorneys of Schlichter, Bogard & Denton today to discuss your legal options.

Yaz® Birth Control Side Effects

2010-09-30T12:13:00.000-07:00

For many years, Yaz® has been prescribed to women for birth control. Recently, there have been very serious side effects from using Yaz® birth control reported in many women throughout the United States. These include higher risks of blood clots such as pulmonary emboli, deep vein thrombosis (DVT), gallbladder problems and even sudden death.

In October 2008, the FDA issued a warning letter to Bayer Healthcare, citing them for violations of certain Federal Food, Drug, and Cosmetic Act provisions in connection with certain television ads. These ads were found to be misleading and lacked significant warning information.

Even women without any history of blood clots or gallbladder issues have experienced these health conditions as side effects of Yaz®. The blood clots most often develop in the legs, however, blood clots could also develop in different areas of the body, including the eyes, pelvis, arms, head, and lungs. Typical symptoms of severe blood clots are include a sudden severe headache; crushing or very sharp chest pains; unusual pains or swelling in the arms or legs; pain in the back of the lower legs or blurry or doubled vision.

And the more risk factors you have, the more likely you will experience some of these side effects. Women who are over 35 who smoke, are overweight, are diabetic, or who have high levels cholesterol are at an increased risk for developing serious health issues.

If taking Yaz® has caused you health problems, please contact the attorneys at Schlichter, Bogard & Denton for a free case evaluation and consultation.

When to Bring Legal Action

2010-09-28T12:12:00.000-07:00

Today’s world has become incredibly litigious, which may make some people uncomfortable, even when faced with what to do when disaster strikes. But there are many factors to consider if you genuinely feel that you are the victim of a faulty or dangerous product.

For example, according to the Consumer Product Safety Commission (CPSC) website, baby-related product recalls are on the rise. Cribs and bassinets, toys, medicines and formulas…we trust the FDA and other consumer protection agencies to weed out the dangers, but sometimes things go wrong. If we don’t speak up, other parents may not be made aware of the secret risks they are taking when using the same products. Filing a defective product lawsuit will help get the word out and can give the manufacturer a chance to pull the product and fix the problem.

If something has happened to your child as a result of using a defective product or drug, you are probably facing additional medical expenses as a result of your child's injury, quite possibly for the rest of his or her life. You may also need to take time off from work as a result, which will only add to your financial and emotional stresses.

Equally important is that your lawsuit may be an important step in protecting someone else's baby. If nothing else, manufacturing companies and distributors are in the business of making money, and if a defective or dangerous product is costing them money either through legal proceedings or loss of revenue, changes will be made.

To learn more about the law firm of Schlichter, Bogard & Denton and how we can help you, please contact us today for a free consultation.

Class Action vs. Multidistrict Litigation (MDL)

2010-09-22T12:11:00.000-07:00

A class action lawsuit is where multiple parties have the same dispute against the same defendants and ask the court to join their causes of action into a single case, resulting in a single trial. Typically, there are at least 100 plaintiffs with the exact same claim and right to compensation and action. Individuals can start a class action suit, but they only have about 6 months to gather the remaining participants, all of whom claim similar damages and legal grounds for the suit. Afterward, the award is typically divided equally between members of the class action.

In an MDL, there is not a single trial that resolves all of the cases. For this type of lawsuit, the case is consolidated under one federal judge who handles all of the discovery matters common to all of the defendants with each case standing on its own merits. All pending civil cases of a similar type are collected and assigned to a single federal judge, a process designed to speed up the handling of complex cases such as the BP Oil Spill.

In complex lawsuits, millions of documents will be used in evidence. The MDL allows all documents and evidence to be collected once and used by any of the plaintiffs as necessary. It remains the burden of the individual lawyers to prove that the defendant’s negligence caused the plaintiff’s injuries.

If you would like more information on becoming part of a class action lawsuit or multidistrict litigation, please contact the attorneys at Schlichter, Bogard & Denton for a free consultation.

What is a “Medical Device”?

2010-09-20T12:11:00.001-07:00

A medical device is a product used by patients for medical purposes. This includes diagnosis, therapy or surgery. When used, the effect of the medical device is primarily physical, as opposed to pharmaceutical drugs, which have a chemical effect.

Medical devices include a wide range of products, from the most basic item like a tongue depressor to the complex such as an artificial heart. Each year ,hundreds of new and different medical devices, including joint replacement components (knees, elbows, hips, ankles), cosmetic implants (chin, breast, buttocks, calf), and surgical instruments are placed on the market by medical device manufacturers.

The Food & Drug Administration (FDA) is supposed to be responsible for testing and approving each and every medical device for safety and efficacy. However, the truth is that the FDA is unable to carefully test and screen all such devices. In recent years, the approval process for medical devices has been accelerated.

According to the FDA, their mission is based on "…taking a balanced public health approach – to protect and promote public health – by assuring that medical devices on the market are safe and effective while also facilitating innovation." But, even with the best intentions, there have been several circumstances when the FDA simply approves a new medical device on the basis of its "substantial similarity" to an already existing device.

If you or a loved one has been injured due to exposure to a defective medical device, please contact the defective medical device attorneys at Schlichter, Bogard & Denton for a free consultation today.

Generic vs. Name Brand Drugs

2010-09-16T12:07:00.000-07:00

What exactly is a generic drug? Generic drugs are copies of brand-name drugs. They have exactly the same dosage, uses, effects, side-effects, risks, safety, and strength as the original drug. The FDA (Food and Drug Administration) requires that generic drugs be as safe and effective as brand-name drugs.

Once a brand-name drug is approved by the FDA, a patent is granted that gives the company that developed the drug the exclusive right to sell the drug as long as the patent is in effect. When that patent expires, manufacturers of generic drugs will get their products on the market as quickly as possible. The main reason generics are less expensive is because the generic drug manufacturers have not had the expenses of developing and marketing a new drug.

Sometimes, generic versions of a drug have different colors, flavors, or combinations of inactive ingredients than the original medications. Trademark laws in the United States do not allow the generic drugs to look exactly like the brand-name version, but the active ingredients must be the same in both preparations, ensuring that both have the same medicinal effects.

For our purposes, in the eyes of the law, it doesn't matter whether you used a name-brand or generic prescription drug, the manufacturer can still be held responsible in the case of injury or death for patients taking their medications.

If you have been injured by a dangerous prescription drug, please contact the prescription drug liability lawyers at Schlichter, Bogard & Denton today, for a free initial consultation.

The Case against Ortho Evra®

2010-09-14T08:42:00.001-07:00

Ortho Evra® is a tiny skin patch with the same hormones as in many birth control pills.

This contraceptive patch prevents pregnancy by delivering a continuous amount of two hormones, estrogen and progestin, through the skin and into the blood stream.

Approved by the U.S. Food and Drug Administration (FDA) in November 2001, it wasn't until November 2005 that Ortho McNeil, the makers of the Ortho Evra® patch, issued a set of revised warnings. In fact, revisions were still being made to the warning label as recently as 2008, when the FDA approved label changes to include the results of a new study that found that users of the birth control patch were at higher risk of developing serious blood clots, (also known as venous thromboembolism) than women using birth control pills.

Like birth control pills, Ortho Evra® is most effective when used as directed. But several studies have shown that Ortho Evra® can be significantly more dangerous than standard birth control pills because it delivers more estrogen than a comparable birth control pill - as much as 60 % more.

With increased estrogen exposure, the risks of blood clots, heart attacks, strokes, and other dangerous outcomes increase as well, particularly in women over 35 or women who smoke. And despite being aware of the risks, this product was still sold to the public, and now thousands of women have suffered adverse outcomes, and dozens have been killed by this dangerous drug.

If you live in Missouri and you or a loved one has suffered from the negative side effects of the Ortho Evra® contraceptive patch, please contact the law offices of Schlichter, Bogard & Denton today to speak with a drug recall lawyer.

FDA Drug Approval Process

2010-09-09T12:04:00.000-07:00

As you might imagine, there are several phases to the process of getting a drug approved by the FDA (Food and Drug Administration) for sale to the public.

Pre-Clinical Testing: In this initial phase, the drug is developed, animal tests are performed, and an institutional review board studies the product. If the recommendations are positive, then an application to the FDA is submitted and clinical drug trials begin.

Phase 1: This is the first time that a new drug is tested on humans. The purpose of these studies is to learn more about how the drug works in humans, how effective it may be and what potential side effects may exist.

Phase 2: This stage is to determine the effectiveness of a drug in treating patients with a specific disease or condition, and to closely examine and assess common short-term side effects or risks.

Phase 3: At this point, large scale clinical trials are performed to provide more information about the effects and safety of the drug, allowing scientists to better gauge their findings in a larger test population.

Once a drug is approved by the FDA, it goes on the market as soon as the manufacturing company can get its production and distribution systems in place.

The FDA estimates that it takes a little over 8 years for a drug manufacturer to acquire FDA approval for a new product. There are, however, circumstances such as terminal illness in which investigational drugs may be administered to the public even before they are approved for marketing.

Despite their best efforts, however, some drugs can have very dangerous side effects that may not have been clearly understood during the testing processes. If you or a loved one has suffered an injury from a defective or recalled drug, please contact the drug litigation attorneys at Schlichter, Bogard & Denton today, for a free initial consultation.

FDA Conflict of Interest in Avandia Panel

2010-09-07T14:18:00.001-07:00

The Food and Drug Administration has completed its investigation of a potential conflict of interest regarding the advisory committee that decided on new labeling requirements for the dangerous drug Avandia.

Despite proven links between Avandia and heart disease, the FDA has left Avandia on the market with a black box warning informing consumers that Avandia increases their risk for heart attack, heart failure, and death.

However, this decision was not unanimous. Three committee members voted against the new labeling requirements, essentially giving Avandia manufacturer GlaxoSmithKline a free pass despite mounting evidence against the drug.

One of these three, endocrinologist David Capuzzi, has been under investigation for a conflict of interest involving his work as a paid speaker for GlaxoSmithKline. While Capuzzi did not directly promote Avandia, he was paid by GSK to promote its dietary supplement Lovaza.

The FDA is not legally allowed to release Capuzzi's financial disclosure form, so it is currently unclear whether these paid speaking engagements were disclosed prior to his work on the Avandia advisory panel. FDA completed its investigation and referred the matter to the Office of the Inspector General for the Department of Health and Human Services a few weeks ago in August.

Conflicts of interest remain an ongoing problem within the FDA. In fact, advisory panel member Abraham Thomas revealed that he had previously done paid speaking engagements for Takeda Pharmaceuticals, which makes Avandia's largest rival diabetes drug Actos, which has also been linked to similar heart problems.

However, Thomas ended his professional relationship with Takeda in 2008 and FDA rules only require panel members to report financial relationships within the last year. Thomas actually voted for Avandia to be recalled, which would have been a boon to Takeda.

Dangerous and defective drugs are a serious problem nationwide, and some industry watchdog groups suspect that the pharmaceutical industry intentionally uses this type of paid speaking engagement to influence future or current FDA panel members without breaking the law.

This type of legalized bribery could potentially lead to more defective drug injuries and even wrongful death in states like Missouri, Arkansas, Illinois, Indiana, Kansas, Wisconsin, Iowa, and nationwide.

If you or a family member has been injured by a prescription drug, over-the-counter drug, or dietary supplement, please contact the drug injury attorneys of Schlichter, Bogard & Denton today for a free evaluation of your case.

What is a Drug Recall?

2010-08-30T15:20:00.001-07:00

Simply put, a drug recall is when a prescription or over-the-counter drug is removed from the market. Consumers and patients are asked to stop using and destroy or return a drug. Drug recalls happen when the FDA determines that the product violates the law. Drugs may be recalled due to problems with packaging, manufacturing, or contamination.

There are three classes of drug recalls: Class I, Class II, and Class III. Class I recalls are the most serious and usually occur because the use of or exposure to a drug will cause serious adverse health effects or death. Class II recalls involve drugs that may cause temporary or medically reversible side effects. Class III recalls have a low chance of causing adverse health consequences, but are being recalled because there is still a chance.

In urgent situations, the FDA may request a recall of a drug. Typically, these requests are reserved for when drugs pose a Class I threat, and will only be requested after adequate evidence has been gathered to classify the drug as a dangerous drug.

Defective drugs can cause serious injury or death, so it is important to choose a qualified drug litigation attorney to help you. Please contact Schlichter, Bogard & Denton today to speak with a drug recall lawyer in Missouri about any drugs that you may have been taking that were recalled.

Heparin Overdose Kills Toddler

2010-08-17T09:38:00.000-07:00

A 2-year-old Dallas girl appears to have died of a Heparin overdose after she was treated in an Omaha hospital for an infection. Heparin is a blood thinner (anti-coagulant) that is used to decrease the clotting ability of the blood. The drug is referred to as a blood thinner though it does not actually thin your blood. The drug cannot dissolve clots that have already formed but it can prevent clots from forming or becoming larger. The larger the blood clot, the greater the potential for serious harm.

Almariah Duque, 23 months, was born with birth defect and had survived transplants of her small intestines, liver, and pancreas in December 2009. The little girl survived the surgeries but died at the Omaha hospital when she was given too strong a dose of the anti-coagulant, Heparin. The hospital has apologized to the parents and has agreed to pay medical and funeral expenses.

This is certainly the first Heparin-related death. Almost four years ago, three preemie infants died from a fatal dose of Heparin in Indianapolis when the hospital erroneously used the adult vials on the babies. The maker of Heparin, Baxter, sent warning letters to hospitals across the country warning them to have their staff members carefully read Heparin labels before administering the drug.

Heparin is the drug that actor Dennis Quaid’s newborn twins were overdosed with last year. The babies were given 1,000 times the normal dosage. Quaid and his wife filed a product liability lawsuit against Baxter alleging the product was "unreasonably dangerous because the company packaged adult and pediatric version…in vials of the same size…"

If you or a loved one has been harmed by a dangerous drug, please contact the pharmaceutical liability attorneys at Schlichter, Bogard & Denton today.

Avandia’s Safety Still in Question? Not According to Glaxo

2010-08-13T04:34:00.000-07:00

It seems like the general public is the only group that fully understands the dangers the Type 2 diabetes drug, Avandia, presents to those taking it. For years now, we have been reading about the significant increase in cardiac events in diabetics taking the drug versus those taking a placebo or no drug at all. Why is this drug still on the market? Why are doctors still prescribing Avandia? Is the FDA really protecting consumers or protecting the drug companies’ wallets?

The safety of Avandia (generic rosiglitazone) has been in question since 1999 when Dr. John Buse of the University of North Carolina at Chapel Hill, a diabetes expert, performed a study in which he concluded that Avandia users experienced a "more than fourfold rise in cholesterol compared with those taking a placebo. Because elevated cholesterol levels are a risk factor for heart disease…Avandia could cause adverse cardiac outcomes." When the maker of Avandia, GlaxoSmithKline, received a copy of this report, reps called Dr. Buse’s boss, accused him of lying and stated he needed to be "muzzled." GSK then threatened to sue for $4 billion, which was the loss of the company’s valuation. After receiving Dr. Buse’s compelling evidence that Avandia did, indeed, increase cardiac events in users of the drug, GSK continued marketing the drug and even went so far as to find a doctor who reported that the drug actually reduced cardiovascular risk factors in laboratory animals.

By 2004, Avandia was making over $1.5 billion a year for Glaxo in the United States alone. In May of 2006, GSK provided the FDA with research indicating that Avandia use did cause a jump in adverse cardiac events, but the FDA did not release this information to the public. Why? Dr. Janet Woodcock, head of the FDA Center for Drug Evaluation and Research, “didn’t necessarily agree with some of the methodology used.”

Three years later, in May of 2007, Cleveland Clinic cardiologist, Dr. Steven Nissan analyzed 42 Avandia trials and submitted a report to the New England Journal of Medicine that there was a 43% higher rate of cardiac events among Avandia patients compared with those taking other drugs or placebos. It is now August 2010, and Avandia is still on the market and still being prescribed to millions of people who may not know how dangerous this drug is. GSK continues to insist its diabetes drug is safe and effective, and in July 2010, the FDA advisory group voted to not pull Avandia off the market, citing lack of strong evidence that it should be taken off the market.

Statistics regarding Avandia and cardiac events and death are not exact for several reasons, but Dr. David Graham, the lead author of the study that prompted the FDA to hold the hearing regarding the safety of the drug, asserts that 100,000 heart attacks, strokes, cases of heart failure, and deaths have occurred due to Avandia since it came on the market in 1999. How many more people have to suffer before the FDA recalls this drug?

If you or a loved one has taken Avandia and suffered any adverse side effect, please contact the experienced pharmaceutical liability attorneys at Schlichter, Bogard & Denton. We are currently taking Avandia cases and would like to help you if you have been harmed by this very dangerous drug.

Levaquin

2010-08-11T08:00:00.000-07:00

Treating life-threatening illnesses with antibiotics has been a common practice since the discovery of penicillin. All too frequently wounded soldiers and patients would die from infected wounds until antibiotics joined the physician's arsenal. Since that time, bacteria have evolved, making them more resistant to traditional antibiotics.

Drug companies are continually manufacturing powerful antibiotics to defeat antibiotic-resistant bacteria. Unfortunately, when used improperly these antibiotics may also be considered dangerous drugs. Levaquin, made by Ortho-McNeil, a subsidiary of Johnson and Johnson, is one of the most popular antibiotics on the market today.

Levaquin Treats Bacterial Infections

In the past, many physicians treated anything that looked like it might be an infection with a course of penicillin or other antibiotic, regardless of whether it was a bacterial infection or not. Antibiotics do not work against viral infections. It was thought that it was better to be safe than sorry, but the more frequently antibiotics were used, the faster bacteria adapted to it.

Levaquin is approved by the FDA to treat the following common infections:

• Respiratory tract infections
• Genitourinary tract infections
• Bacterial skin infections

Man-made antibiotics like Levaquin should only be used when the infection is certain to be bacterial. This will ensure that the bacteria will be killed by the Levaquin treatment but minimize the potentially dangerous side effects that occur with Levaquin.

If you or a loved one has suffered ill effects of improperly-prescribed Levaquin, please contact the pharmaceutical litigation attorneys at Schlichter, Bogard & Denton, serving clients nationwide, to schedule an initial consultation.

Xenical and Alli

2010-08-10T12:44:00.000-07:00

Obesity is an epidemic in America, leading to numerous long-term health problems such as high blood pressure, diabetes, and high cholesterol. In an attempt to help those suffering from obesity, drugs have been developed that can help accelerate weight loss.

Unfortunately one of these drugs, orlistat, the main ingredient in Xenical and Alli, is now under FDA investigation for possibly causing liver damage in some users.

What are Xenical and Alli?

Approved by the FDA in 1999, orlistat is marketed under two names. Xenical, marketed by Hoffmann La Roche Ltd., is a prescription drug. In 2007, orlistat was approved for over the counter use, and is marketed over the counter as Alli by GlaxoSmithKline.

Orlistat works in the digestive system, preventing the body from absorbing about one-quarter of the fat ingested. This can lead to uncomfortable GI issues in many users, but these side effects are considered by most to be acceptable.

Serious Side Effects of Xenical and Alli

Other side effects, however, are not considered acceptable. Between 1999 and 2008, over thirty orlistat users experienced liver injury. Six of these experienced liver failure, and most were hospitalized.

Symptoms of liver failure include:

• Jaundice (yellowing of the skin and the whites of the eyes)
• Brown urine
• Stomach pain
• Overall feeling of weakness

Any of these symptoms should be reported immediately to your doctor as well as to the FDA to help establish the connection between liver failure and orlistat.

If you have experienced symptoms of liver failure while using Xenical or Alli, please contact the pharmaceutical injury attorneys at Schlichter, Bogard & Denton for more information and to schedule a free consultation. Schlichter, Bogard & Denton serves pharmaceutical injury clients nationwide.

Accutane Maker Receives Verdict Reversal

2010-08-09T07:49:00.000-07:00

The acne drug, Accutane, manufactured by Roche Holding AG, came on the market in 1982 and has been linked to very serious medical problems such as IBD (inflammatory bowel disease or disorder). IBD is a painful, inflammatory condition of the colon and small intestine. Since 2007, Roche has lost all seven cases against the acne drug and has paid plaintiffs well over $45 million in damages.

Roche recently won a verdict reversal with appellate judges stating "Roche was unduly impeded at this trial from adducing and advocating numerical proofs that could have potentially and reasonably led a jury to reach a different verdict." The verdict was $10.5 million awarded to Kamie Kendall, a Utah resident who blamed Accutane for her IBD.

Accutane has been Roche’s second biggest-selling drug since it came on the market over twenty-five years ago; an estimated 13 million people have taken the drug. The drug has also been linked to depression and birth defects of babies born to mothers taking the drug.

If you or a loved one has been harmed by a dangerous drug, please contact the pharmaceutical litigation attorneys at Schlichter, Bogard & Denton today to schedule a confidential, no-cost consultation.

Drug Trials Have Positive Outcomes when Funded by Drug Maker

2010-08-03T07:44:00.000-07:00

It’s no surprise, really, that a study regarding the efficacy of a certain drug is going to be more positive if it's funded by the drug's manufacturer rather than some other entity that does not stand to profit from sale of the drug. According to a recent study, researchers found this shocking assertion to be true after reviewing 546 drug trials and finding that industry-funded trials reported positive results 85% of the time compared to 50% of the time in government-funded trials.

In trials funded by non-federal organizations or nonprofits, a positive outcome was reported 72% of the time; among those that received contributions from the drug maker, reviews were more likely to be positive (85%) compared to those without industry support (61%).

This report was published Monday, August 2, 2010 in the Annals of Internal Medicine.
If you or a loved one has been harmed by a dangerous or defective drug anywhere in the United States, please contact the pharmaceutical litigation attorneys at Schlichter, Bogard & Denton today.

Seroquel Manufacturer to Keep Settlements Confidential

2010-08-02T08:40:00.000-07:00

Drug manufacturer, AstraZeneca Plc, the maker of Seroquel, has tentatively settled approximately 4,000 product liability cases involving the anti-psychotic but claims it will keep the terms of the agreements confidential. Astra Zeneca is a London-based company and the U.K.’s biggest drug maker. By the end of March 2010, Astra Zeneca said it was in the process of defending 10,000 Seroquel cases involving over 20,000 plaintiff groups. Most of the allegations are that Seroquel causes diabetes.

The company made about $32.8 billion in sales last year but had spent about $688 million in defending the Seroquel cases. In the first ever Seroquel case, the drug company won a jury verdict that the company properly warned doctors of a Vietnam war veteran of the drug’s diabetes risk.

If you or a loved one has been harmed by a dangerous drug, please contact the pharmaceutical liability attorneys at Schlichter, Bogard & Denton today.

Yaz® and Yasmin® Dangers

2010-07-26T11:37:00.000-07:00

Yaz and Yasmin are both popular birth control pills made by Bayer. While widely prescribed for pregnancy prevention as well as other hormonally related issues, such as PMS, acne, and bloating, these pills have only been FDA approved for pregnancy prevention and treatment of PMDD.

Unfortunately, Yaz and Yasmin also carry possible dangers. One of their major ingredients, known as drospirenone, can cause an increase in potassium levels in the bloodstream. In some cases, this can lead to serious side effects, and can even be fatal.

Who Should Avoid Yaz and Yasmin?
Particularly susceptible to these side effects are people who have existing problems with their kidneys, liver, or adrenal glands. Increases in potassium levels can be very dangerous in these cases. In addition, some other common medications can also increase potassium levels in the bloodstream. Combined with Yaz or Yasmin, the effects can be extremely serious.

What are the Possible Side Effects?
Some possible side effects of Yaz or Yasmin include:

• Deep vein thrombosis
• Heart attack
• Stroke
• Sudden death
• Pulmonary embolism
• Damage to the kidneys

If you have any concerns about using Yaz or Yasmin and how they might interact with drugs you’re already taking or how they might affect existing medical conditions, consult with your doctor. Your doctor can check your blood potassium levels after you’ve taken Yasmin to determine if the levels are abnormal.

If you or a loved one have suffered from any of the above side effects and suspect Yaz or Yasmin might be the cause, please contact one of the experienced, nationwide pharmaceutical injury attorneys at Schlichter, Bogard & Denton. If you’ve been hurt by dangerous pharmaceutical side effects, we want to help.

Nebraska Lawsuit Claims NuvaRing Caused Woman’s Death

2010-07-23T07:11:00.000-07:00

The estate of a woman who died while using the birth control NuvaRing is suing the manufacturer, claiming the contraceptive caused the woman’s deadly blood clot. The lawsuit was filed in U.S. District Court in Omaha, Nebraska on July 19, 2010 and claims that 43-year-old Ann Tompkins died in February 2009 after using NuvaRing for five months.

The suit seeks damages from pharmaceutical companies who at one or another manufactured the birth control device. Named in the suit are Merck & Co, which acquired former maker Schering-Plough; Organon BioSciences NV, and Akzo Nobel NV. The lawsuit alleges that the manufacturer did not provide enough warning about the risks of blood clots to users of NuvaRing. The amount of damages being sought is not known; this is the first NuvaRing case is Nebraska to date.

Ms. Tomkins, a mother of two, was found dead in her home on February 23, 2009; an autopsy revealed the cause of death as a blood clot in one of her lungs. NuvaRing has been on the market since 2002 and is inserted into the vagina and left there for three weeks each month slowly releasing hormones into the vaginal wall to prevent pregnancy.

If you or a loved one has been harmed by a defective drug anywhere in the United States, please contact the experienced pharmaceutical liability attorneys at Schlichter, Bogard & Denton today to schedule a confidential, no-cost consultation so we may hear the details of your case.

Chanitx’s Link to Suicide

2010-07-22T06:46:00.000-07:00

Reports of erratic behavior and suicide have been associated with the use of Chantix, a drug that was designed to help people stop smoking and was approved by the Food and Drug Administration over two years ago. In November 2007, the FDA issued a statement that they are reviewing the possible Chantix suicide side effects and that there have been over 100 reports received of suicidal thoughts and severe behavioral changes within just a few weeks of taking the drug.

Since its approval by the FDA, over 4 million Americans have received a prescription for the drug. Smoking is the leading preventable cause of disease and premature death in the United States and accounts for more than 400,000 deaths every year.

Because of these reports, personal injury and dangerous drug attorneys are evaluating the potential of Chantix lawsuits on behalf of people who have committed suicide or suffered severe injury as a result of the drug’s adverse side effects.

Chantix (generic varenicline tartrate) was approved by the FDA in May 2006 as part of a review that drastically shortened the time required for the drug maker to begin selling the medication. Chantix helps people to quit smoking by easing the withdrawal symptoms of nicotine cessation and by blocking some of the effects of nicotine from cigarettes, which helps to promote long-term smoking cessation.

Label Update

When the FDA issued its November 2007 statement regarding Chantix and suicide, it requested data from the drug’s manufacturer, Pfizer, about reported problems involving suicide and aggressive or erratic behavior associated with the medication. On November 20, 2007, Pfizer updated Chantix’s label to indicate that the drug’s side effects include the following: "reports of depressed mood, agitation, changes in behavior, suicidal ideation and suicide in patients attempting to quit smoking while taking Chantix."

Additionally, the FDA is reviewing reports that the drug could cause problems while driving or operating heavy machinery. While the number of these incidents is very small, the FDA pointed out that they all describe similar situations with symptoms of drowsiness leading to difficulty operating a vehicle.

Other reported side effects of Chantix include:

• Nausea
• Stomach pain
• Vomiting
• Indigestion
• Weakness
• Lethargy
• Increased appetite
• Unpleasant taste in your mouth
• Headache
• Insomnia
• Unusual dreams

If you or a loved one has taken Chantix and experienced suicidal thoughts or behavior, you may have valid legal claim. Please contact the pharmaceutical litigation attorneys at Schlichter, Bogard & Denton today to schedule a confidential consultation.

Maker of Paxil Settles Some Lawsuits

2010-07-21T07:23:00.000-07:00

GlaxoSmithKline, the maker of the anti-depressant Paxil, announced yesterday that it has settled certain lawsuits claiming Paxil (generic paroxetine) caused birth defects in babies of certain women who took the drug while pregnant. GSK stated in a companywide email that it has agreed to pay over $1 billion to resolve over 800 claims. This settlement provides each family affected by the dangerous drug approximately $1.2 million. At this time, there are still well over 100 Paxil cases pending.

Paxil is a drug that is in the class of SSRIs (selective serotonin reuptake inhibitors), and when taken during the first three months of pregnancy, may cause serious birth defects. Two potentially serious forms of birth complications that have been linked to Paxil are heart defects and PPHN (persistent pulmonary hypertension of the newborn).

The experienced pharmaceutical liability attorneys at Schlichter, Bogard & Denton have been handling Paxil cases. If you or a loved one has been injured by a defective drug, please contact our office today. We serve clients nationwide.

Nasal Spray Can Lead to Loss of Sense of Smell

2010-07-20T07:33:00.000-07:00

A researcher has found scientific evidence to back up the claim that nose sprays containing zinc might cause loss of sense of smell, known medically as anosmmia. About a year ago, the Food and Drug Administration warned consumers to stop using these nasal spray cold remedies that contained zinc:

• Zicam Cole Remedy Nasal Gel
• Zicam Cold Remedy Swabs
• Zicam Cold Remedy Swabs for Kids

The FDA had received approximately 130 reports regarding loss of sense of smell after using these products. Though the manufacturer of these products, Matrixx Initiatives, pulled the products from store shelves, the company denied any link between the nasal sprays and anosmia.

A study of 25 patients at the University of California, San Diego Nasal Dysfunction Clinic was performed. These people said they used zinc-containing nasal sprays, experienced intense pain and lost their sense of smell within several hours.

Though Matrixx maintains there is no link between the two, the company settled a lawsuit brought by 340 Zicam users for $12 million in 2006.

If you or a loved one has been harmed by a defective drug, please contact the pharmaceutical liability attorneys at Schlichter, Bogard & Denton today.

Hydroxycut and Liver Damage

2010-07-19T10:13:00.000-07:00

The Food and Drug Administration (FDA) issued a public health advisory about the danger of liver damage from Hydroxycut use after compiling a total of 23 reports of liver injury associated with Hydroxycut use, including one death from liver failure. According to a letter to the editor published in the April 14, 2009 issue of the World Journal of Gastroenterology, current reports of liver damage from Hydroxycut may underestimate the actual numbers by "several orders of magnitude."

If you took Hydroxycut, you may have been made ill by this defective drug; if so, you may be entitled to compensation. Some common adverse effects of this drug include:

Yellowing of the skin and/or whites of the eyes (jaundice)
Brown or dark-colored urine
Pale stool
Nausea, vomiting, or loss of appetite
Pain or sensitivity in the stomach or abdomen
Excessive fatigue or shortness of breath
Weakness or muscle pain
Itching
General feeling of being unwell

If you are currently taking Hydroxycut and are experiencing these symptoms, you may have suffered liver damage. If you experienced these symptoms in the past, but stopped using Hydroxycut and the symptoms cleared, you may have suffered liver damage. If you were diagnosed with hepatitis while or after using Hydroxycut, your liver damage may also have been associated with Hydroxycut.

If you believe you or a loved one may have suffered liver damage as a result of taking Hydroxycut, please schedule a Hydroxycut injury consultation with the product liability lawyers at Schlichter, Bogard & Denton today.

FDA Holds Hearings to Pull Avandia

2010-07-13T09:58:00.000-07:00

The US Food and Drug Administration just opened two days of hearings into the safety of Avanida, a once-popular type 2 diabetes drug manufactured by drug giant, GlaxoSmithKline. Avandia has been on the market for years and is still being prescribed despite an FDA-issued black box warning (the most stern warning a drug can receive) that the drug leads to serious cardiac issues in patients taking the drug for their diabetes. It has been estimated that 100,000 heart attacks have been linked to the drug. In the last part of 2009, it is estimated that 300 people died due to Avandia complications. US Senate reports indicate that Glaxo may have been well aware of the increased risk of heart attacks associated with the drug but sought to suppress that information. Now thousands of lives have been affected.

As early as tomorrow, the panel, made up of 33 people, could vote on whether or not to remove the drug from the market altogether. Glaxo insists the drug is safe despite the evidence showing it is not.

According to Montana Senator Max Baucus, "Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust."

If you or a loved one has suffered from a dangerous drug, please contact the pharmaceutical liability attorneys at Schlichter, Bogard & Denton today to schedule a confidential, no-cost consultation.

Yaz® and Yasmin®

2010-06-29T12:01:00.000-07:00

Yaz and Yasmin are both popular birth control pills made by Bayer. While widely prescribed for pregnancy prevention as well as other hormonally related issues such as PMS, acne, and bloating, these pills have only been approved by the FDA for pregnancy prevention and treatment of PMDD.

Unfortunately, Yaz and Yasmin also carry possible dangers. One of their major ingredients, known as drospirenone, can cause an increase in potassium levels in the bloodstream. In some cases, this can lead to serious side effects and even be fatal.

Who Should Avoid Yaz and Yasmin?

People who have existing problems with their kidneys, liver, or adrenal glands are particularly susceptible to these side effects. Increases in potassium levels can be very dangerous for these patients. In addition, some other common medications can also increase potassium levels in the bloodstream. Combined with Yaz or Yasmin, the effects can be extremely serious.

Possible Side Effects of Yaz and Yasmin

Some possible side effects of Yaz or Yasmin include:

• Deep vein thrombosis
• Heart attack
• Stroke
• Sudden death
• Pulmonary embolism
• Damage to the kidneys

If you have any concerns about using Yaz or Yasmin and how they might interact with drugs you're already taking or how they might affect existing medical conditions, consult with your doctor. Your doctor can check your blood potassium levels after you’ve taken Yasmin to determine if they are abnormal.

If you or a loved one has suffered from any of the above side effects and suspect Yaz or Yasmin might be the cause, please contact one of the experienced, nationwide pharmaceutical injury attorneys at Schlichter, Bogard & Denton. If you’ve been hurt by dangerous pharmaceutical side effects, we can help you receive the compensation you deserve.

"Female Viagra" Not Quite Ready for Prime Time

2010-06-21T09:22:00.000-07:00

What has been dubbed the "Female Viagra" does not show signs of being effective according to the Food and Drug Administration (FDA). An advisory committee for the FDA advised the drug’s manufacturer, Boehringer Ingelheim, to "go back to the drawing board" and provide more conclusive data. The little pink pill's name is flibanserin and has been touted as the answer to low sex drive in women. The drug's manufacturer used some interesting wording to describe the drug’s effect: "It’s better at increasing a woman’s global desire rather than the intensity of acute episodes of desire." HUH? I think that’s bureaucratic speak for the drug is "iffy" at best. Global desire? Acute episodes of desire? Is that orgasm? Get to the point, Boehringer Ingelheim!

Original designed to help battle depression, the drug's side effects were significant in that 15% of the women in the clinical trial experienced the effects to such a degree that they stopped the trial due to dizziness, anxiety, insomnia, and nausea.

At the time of this writing, there is not one FDA-approved drug on the market designed to improve women's sexual dysfunction or to help overcome a lack of sexual desire.

However, we all know how many options men have these days. Viagra, Cialis, Levitra…
If you have taken a drug that has caused harmful side effects, please contact the pharmaceutical litigation attorneys at Schlichter, Bogard & Denton today to schedule a confidential consultation.

$64 Million Paxil Class Action Settlement

2010-06-21T08:01:00.000-07:00

One of the world's largest drug manufacturers, GlaxoSmithKline of Great Britain, is feeling the effects of its dangerous anti-depressants, Paxil and Paxil CR, the controlled-release version of the drug. Still dealing with cases involving Avandia, the diabetes drugs that causes life-threatening cardiac problems, GlaxoSmithKline has been paying out settlements to the parents of teens who killed themselves while (or after) taking the popular drug, Paxil.

The lawsuit alleged that GlaxoSmithKline promoted Paxil for use in children yet failed to provide pertinent information regarding the harmful side effects, including increased suicidal behavior. A United States spokesperson for GlaxoSmithKline did take responsibility on behalf of the drug company but refused to admit any wrongdoing.

Of the $64 million in the settlement fund, plaintiffs' attorneys can claim over $16 million in fees, and the remaining money will be paid out to victims and their families. Any money left over after all victims have been reimbursed will be returned to GlaxoSmithKline. In addition to this class action lawsuit, the parents of teenagers who killed themselves while taking Paxil can still sue GlaxoSmithKline as can government agencies and insurance companies.

If you or someone you love has been harmed by a dangerous drug, please contact the defective product attorneys at Schlichter, Bogard & Denton today to schedule a confidential consultation.

Dangerous Drug, Chantix

2010-06-17T14:11:00.000-07:00

Reports of erratic behavior and suicide have been associated with the use of Chantix, a drug that was designed to help people stop smoking and was approved by the Food and Drug Administration just under two years ago. In November 2007, the FDA issued a statement that they are reviewing the possible Chantix suicide side effects and that there have been over 100 reports received of suicidal thoughts and severe behavioral changes within just a few weeks of taking the drug.

Since its approval by the FDA, over 4 million Americans have received a prescription for the drug. Smoking is the leading preventable cause of disease and premature death in the United States and accounts for more than 400,000 deaths every year.

Because of these reports, defective product and dangerous drug attorneys are evaluating the potential of Chantix lawsuits on behalf of people who have committed suicide or suffered severe injury as a result of the drug's adverse side effects.

Chantix (generic varenicline tartrate) was approved by the FDA in May 2006 as part of a review that drastically shortened the time required for the drug maker to begin selling the medication. Chantix helps people to quit smoking by easing the withdrawal symptoms of nicotine cessation and by blocking some of the effects of nicotine from cigarettes, which helps to promote long-term smoking cessation.

Label Update

When the FDA issued its November 2007 statement regarding Chantix and suicide, it requested data from the drug’s manufacturer, Pfizer, about reported problems involving suicide and aggressive or erratic behavior associated with the medication. On November 20, 2007, Pfizer updated Chantix’s label to indicate that the drug’s side effects include the following: "reports of depressed mood, agitation, changes in behavior, suicidal ideation and suicide in patients attempting to quit smoking while taking Chantix."

Additionally, the FDA is reviewing reports that the drug could cause problems while driving or operating heavy machinery. While the number of these incidents is very small, the FDA pointed out that they all describe similar situations with symptoms of drowsiness leading to difficulty operating a vehicle.

Other reported side effects of Chantix include:

• Nausea
• Stomach pain
• Vomiting
• Indigestion
• Weakness
• Lethargy
• Increased appetite
• Unpleasant taste in your mouth
• Headache
• Insomnia
• Unusual dreams

If you or a loved one has taken Chantix and experienced suicidal thoughts or behavior, you may have valid legal claim. Please contact Schlichter, Bogard & Denton today to schedule a confidential consultation.

Yaz Dangers

2010-06-16T06:50:00.000-07:00

The defective/dangerous drug attorneys at Schlichter, Bogard & Denton have been representing clients in Yaz/Yasmin cases for quite some time now. These birth control pills, along with OCella, cause some very serious side effects in some women and have been associated with over 50 deaths. Bayer, the maker of Yaz and Yasmin, has been hit with several federal lawsuits according to the National Law Journal.

Yaz and Yasmin, approved by the FDA in 2006 and 2001, respectively, are a different type of birth control pill and are referred to as "fourth generation" birth control. They contain a new type of hormone known as drospirenone, which can cause raised potassium levels. High potassium levels can lead to serious health problems, especially in those who already have kidney or liver disease.

Yaz, Yasmin and Ocella (a form manufactured by Barr Laboratories, Inc.) have been linked to:

• Stroke
• Heart attack
• DVT (deep vein thrombosis—blood clots)
• Kidney problems
• Pulmonary embolism
• Death

If you are currently taking Yaz, Yasmin or Ocella, you should contact your doctor immediately to find out if you should stop taking the drug.

The defective drug attorneys at Schlichter, Bogard & Denton are currently victims of these dangerous drugs from all over the country. Please contact us today if you have taken Yaz or Yasmin and have experienced serious health problems.

Congress Reacts to Medicine Recall

2010-06-01T11:08:00.000-07:00

The House Committee on Oversight and Government Reform has opened an investigation into the recent recall of children's over-the-counter defective medicines, according to media reports.

Recently, a division of Johnson & Johnson issued a product recall for more than 40 types of children's and infants' medicines. The Food and Drug Administration, or FDA, subsequently cited deficiencies at the division's Pennsylvania plant that could have caused bacterial contamination of raw materials in the recalled pharmaceutical products.

An FDA report listed more than 20 manufacturing problems at the plant. Including not properly testing for contamination. The FDA also said that the Johnson & Johnson unit received 46 consumer complaints from June 2009 up to April about foreign materials in the drugs, but failed to take corrective action.

The circumstances behind this recall certainly justify congressional interest. Unfortunately, no congressional probe can restore the health of a child who may have suffered personal injury from defective medicine.

At Schlichter, Bogard & Denton, we know that consumers of defective medicine are at risk, and children even more so. It is simply basic justice to hold the maker of faulty medical products responsible for any injury they may cause. If you or a family member has been the victim of such faulty products, we urge you to contact us for a confidential, no-cost discussion of your case at any of our nationwide offices.

Medical Malpractice Suit Names Denver Facility

2010-06-01T11:01:00.000-07:00

A medical malpractice suit filed against a Denver, Colorado, hospital holds it responsible for the negligent actions of an employee who reportedly caused thousands of patients to be infected with hepatitis C.

The suit charges that in January 2009 scrub technician Kristen Parker substituted a tainted needle for a syringe of Fetanyl, a surgical pain reliever, prepared by an anesthesiologist at Rose Medical Center, according to media reports. The syringe was to be used on a woman undergoing surgery.

Parker is now serving a 30-year prison sentence for repeatedly stealing syringes of Fetanyl and replacing them with used saline-filled syringes. In so doing, the reports say, she caused thousands of patients to contract hepatitis C. This suit is the first from any of the infected patients, according to the reports.

The attorney for plaintiff Antoinette Fleisher says that Rose Medical Center is responsible for her injuries, as she was on its premises when she contracted the disease. The suit contains a complaint under which the medical center could be held responsible for the negligent actions of an employee and alleges medical negligence on the part of anesthesiologist Dr. Shawn Roth.

"Rose knew or should have known that the public could suffer foreseeable harm if its employees, agents, independent contractors and/or servants, including Kristen Parker, failed to perform their assigned duties in a safe, skillful, and competent manner," the suit contends.

Any case of medical malpractice or negligence may result in irreparable damage to a patient. Willful disregard of patient well-being cannot be tolerated. At Schlichter, Bogard & Denton, if you have suffered such an injury we will pursue your claim to adequate compensation. Please contact us for a free, no-obligation consultation at any of our nationwide offices.

Drug Recall Probe Goes Nationwide

2010-05-19T06:43:00.000-07:00

The Food and Drug Administration, or FDA, said Monday it is expanding nationwide its investigation of a Johnson & Johnson unit linked to the recall of some 50 children’s versions of Tylenol, Motrin, Benadryl and other defective drugs.

On May 6, five days after the recall, the FDA issued a report identifying 20 violations at the unit's Pennsylvania plant that produced the drugs. According to one violation, the division, McNeil Consumer Healthcare, had received 46 consumer complaints on the recalled products but had taken no action. The FDA urged all parents to stop using the recalled products and to use generics instead.

Now the agency will investigate McNeil's manufacturing practices across the country "to determine whether similar problems exist throughout the company," according to a statement posted on the FDA Website Monday. The statement did not say how many facilities will be targeted in the expanded probe.

In announcing the May 1 recall, McNeil said some of the products may have contained an incorrect ingredient concentration, ingredients that failed to meet testing requirements, or tiny metal particles.

The House Committee on Oversight and Government Reform has scheduled a May 27 hearing on the recall. William Weldon, chief executive of Johnson & Johnson, has been invited to testify.

If the expanded probe uncovers new problems with the company's drug manufacturing process, the health of more children could be at risk. At Schlichter, Bogard & Denton, we have the resources and the expertise to litigate in all circumstances. If you fear that you or a family member has suffered injury from defective drugs, contact us for a free consultation at any of our nationwide offices.

Recalled Drugs Contaminated By Bacteria, FDA Says

2010-05-10T10:58:00.000-07:00

Some of the 40 varieties of children’s cold medicines recalled by Johnson & Johnson last week were contaminated with bacteria, according to the Food and Drug Administration, or FDA.

The FDA report, posted online, lists more than 20 manufacturing problems found at the Pennsylvania plant where the products were made. The recalled products include children’s formulations of Tylenol, Motrin, Zyrtec, and Benadryl.

The FDA said it is considering a range of actions that may include criminal penalties. FDA Commissioner Margaret Hamburg said parents should immediately start using generic versions of the recalled drugs.

“We have no higher concern than providing parents with the highest-quality products for their children,” Johnson & Johnson said in a statement. The company’s McNeil-PPC division, which made the recalled products, said it is taking “corrective actions” at the Pennsylvania plant as a “precautionary measure.”

As posted on this blog, earlier this year McNeil-PPC issued a product recall for containers of Tylenol, Motrin and other over-the-counter drugs after consumers complained of feeling sick from an unusual odor.

Defective drugs are a threat to anyone. When problems with the manufacturing process cause personal injury, the consumer is entitled to vigorous legal action to protect his interests and obtain redress.

At Schlichter, Bogard & Denton we have extensive experience in handling pharmaceutical litigation. No after-the-fact “corrective actions” can make up for injury to you or a family member from faulty drugs. If you believe this has happened, we urge you to contact us for a confidential, no-cost case review at any of our nationwide offices.

Infusion Pump Recalled After FDA Toughens Rules

2010-05-06T12:38:00.000-07:00

This blog has run many posts about the dangers that defective medical devices present to the general public. On April 28 we reported that the Food and Drug Administration, or FDA, was issuing preliminary rules toughening the rules for approving the commercial sale of infusion pumps.

Now there is a new development: the main U.S. subsidiary of Baxter International has announced the recall of its Colleague infusion pump from the American market. The recall may involve up to 200,000 pumps already in use, and the model will be phased out, according to a company spokeswoman.

Spokeswoman Erin Gardner also said that Baxter will offer to replace recalled units of the Colleague pump with its Sigma Spectrum model.

In a related development, Hospira announced recently that it would stop shipments of its Symbiq pump following reports that the alarm on the device was not working properly.

Infusion pumps are intended to improve control and accuracy with drug delivery and to reduce medication errors. They are used for such serious cases as patients who are in comas or are receiving cancer treatment. There is no room for use of dangerous medical devices in such cases, and in medicine, defects mean danger.

If you are wondering about the dangers of other defective products to you or your family, there's one thing you can do: get advice from people who know the subject. The pharmaceutical attorneys at Schlichter, Bogard & Denton are ready to work with you to determine if you have a possible case. We urge you to contact us for a confidential discussion at any of our nationwide offices.

FDA Toughening Rules For Infusion Pumps

2010-04-28T09:03:00.000-07:00

Following a number of complaints, the Food and Drug Administration is issuing preliminary guidelines requiring that manufacturers of infusion pumps provide adequate test data before it will approve commercial sale of the devices.

The dangers of defective medical devices are extreme. Their purpose is to improve patient health, not to cause injury or death. When these machines malfunction, we have won substantial settlements for our clients.

Consumer Complaints

The FDA has received "more than 56,000 reports of adverse effects associated with the use of infusion pumps," including more than 500 deaths and other serious injuries, according to a recent press release.

The problems include:

• Failures of built-in safety alarms and other software defects.
• User interface issues, such as unclear instructions leading to dosage errors.
• Mechanical or electrical failures that could spark battery failures or pump fires.

"These pumps often provide critical fluids to high-risk patients, so failures have significant implications," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. "It is time for a more comprehensive approach than we’ve taken to date."

Infusion pumps are widely used in hospitals, clinics, and homes to improve control, accuracy, and precision in drug delivery and to reduce medication errors. There is little room for error with such devices, yet the release says 87 infusion pump recalls were conducted between 2005 and 2009 to address identified safety concerns.

The pharmaceutical injury attorneys at Schlichter, Bogard & Denton look forward to hearing from you. If you or family members have suffered injury from defective medical devices, please contact us for a free review of your case at any of our nationwide offices.

New Setback for Pfizer On Sutent Drug Study

2010-04-26T13:25:00.000-07:00

The pharmaceutical behemoth Pfizer has found yet another problem with a drug that it is testing against a wide range of cancers, following a review by the independent Data Monitoring Committee.

The company recently announced that it was discontinuing a late-stage Phase III study of its drug Sutent for use in treating liver cancer.

"The disappointing outcome of this trial challenges all of us to work harder to understand the complex biology of this disease," Mace Rothenberg, head of clinical development for Pfizer’s oncology unit, said in a statement. "We are committed to patient safety."

This action, however, is not the first of its kind for Sutent, which had worldwide sales of $964 million in 2009. In March, Pfizer said that two late-stage breast cancer tests involving Sutent failed to meet their goals. Last year, a late-stage trial of Sutent, also known as sunitinib, as a treatment for advanced colon cancer was stopped after it was found to be no more effective than standard chemotherapy.

The drug maker continues to test Sutent against non-small cell lung cancer, prostate cancer, and for kidney cancer following surgery, according to media reports. Its use for treating advanced kidney cancer and gastrointestinal stromal tumors is approved already.

According to one report, the liver cancer study was discontinued because of a high incidence of serious adverse effects suffered by patients taking the medicine. The layman may wonder how this drug, or any other, can be an effective treatment for certain diseases if its effects in other uses are negative.

We know that sometimes pharmaceutical companies can influence the research published on drugs. Where defective drugs are concerned, the well-being of the public must be the chief concern.

If you or a loved one have been injured by a dangerous drug, or think that you may have been, the experienced pharmaceutical injury attorneys at Schlichter, Bogard & Denton are eager to talk with you. Please contact us for a confidential case review at any of our nationwide offices.

Two Antibiotics Recalled by Drug Maker

2010-04-19T08:50:00.000-07:00

Two antibiotics have been voluntarily recalled by their manufacturer, Ranbaxy Laboratories Inc., in Jacksonville, Florida due to a small number of complaints received concerning the powdered form of the drugs changing colors when mixed with water. The two drugs, Amoxicillin and Clavulanate Potassium for Oral Suspension (Lot No. 1910779 and 1910782) are currently available in the United States.

While no injuries or deaths have been reported, Ranbaxy reps state the company’s strong commitment to consumer safety has prompted the recall. The FDA is aware of the recall. In July 2009, the FDA recommended the company recall a single lot of acne treatment, Sotret Isotretinoin capsules. The drug had been known to cause side effects similar to that of Accutane, another acne medication, such as Inflammatory Bowel Disease (IBD), Crohn’s Disease, and Ulcerative Colitis.

If you have taken a drug and have suffered serious side effects or if a loved one died due to a defective drug, you may have a valid legal claim. Please contact the defective drug attorneys at Schlichter, Bogard & Denton today to schedule a confidential consultation; we serve clients in Little Rock, Arkansas and all over the United States.

Avandia Given Positive Reviews Due to $$$$$?

2010-04-15T09:40:00.000-07:00

And so the Avandia saga continues. A recent analysis of articles and reviews about the type 2 diabetes drug manufactured by drug giant, GlaxoSmithKline, indicates that experts who were paid by Glaxo consistently gave more positive reviews concerning the drug’s efficacy and safety than those not paid by Glaxo. Hundreds of studies have been performed in the last three years, many arriving at very different conclusions regarding this very popular drug.

The New England Journal of Medicine, in 2007, published an article indicating that the use of Avandia was "associated with a significant increase in the risk of heart attack." Shortly after the publication of this article, the FDA issued a black box warning and recommended that Glaxo take the dangerous drug off the market.

In response to the allegation that Avandia is receiving positive reviews based on money being paid to those reviewing the drug, Mary Anne Rhyne, Glaxo spokeswoman, said GSK "will disclose research payments made to health care professionals and their institutions" beginning next year; the disclosures will cover all research studies that began on January 1, 2010.

If you or a loved one has taken Avandia and has suffered adverse cardiac events because of it, please contact the defective drug attorneys at Schlichter, Bogard & Denton, serving Little Rock, Arkansas and all of the U.S., today to schedule a confidential consultation.

The FDA and Drug Approval

2010-04-15T08:37:00.000-07:00

The United States Food and Drug Administration (FDA) is charged with ensuring the efficacy and safety of many different products, many of which are drugs and medical devices. Once a drug is approved by the FDA, consumers like to believe the drug is safe. Unfortunately, however, that is not always the case. You will often hear news reports about drugs being recalled or being issued a "black box warning," (the most serious warning a drug can be given by the FDA before being recalled) even after receiving FDA approval. What many people may not realize is that the FDA is not responsible for conducting its own trials of the drugs it approves for sale.

In legal speak, the FDA was given legal authority by the Federal Food and Drug Act of 1938 to "review and approve new drugs for sale in the United States based on scientific support provided by the drug manufacturer as to the safety and efficacy of the drug or medical device."

After testing a drug, the drug manufacturer sends the FDA an application known as a "New Drug Application." If a review by the FDA's physicians indicates the drug’s benefits outweigh the known risks, the drug is approved and marketed. When the FDA discovers that a drug maker has violated FDA regulations, the FDA will send a warning letter to the drug company identifying the violation(s) and orders the company to correct the problems. The FDA then follows up to make sure the corrections were made. If they were not, the drug could be recalled or be issued a black box warning.

The FDA is not responsible for creating the warning labels on medications; the pharmaceutical companies have this responsibility. The problem lies in the fact that sometimes, drug manufacturers do not fully comply with their obligations to ensure the products they put on shelves are safe and effective. When this responsibility is shirked, people can get very sick and die due to adverse effects from the drugs they were prescribed. When lives are lost or people are made seriously ill from dangerous drugs, lawsuits can be filed against the drug manufacturer and other parties involved in providing the drug to the victim.

Many claim there are problems with the FDA-approval process of drugs and medical devices. One major claim against the approval process is that drugs are often approved after only short clinical trials, which means that long-term effects of the drug cannot be detected. Drug companies are supposed to perform studies after the drug hits the market, but many of these companies simply do not follow through with these studies because the FDA has little power after a drug is approved.

The FDA approval process for drugs and medical devices is a complicated one that cannot possibly be explained fully here. To learn more about this process, please read our page FDA Approval Process & the Pharmaceutical Manufacturers.

If you or a loved one has been harmed by a dangerous drug, an experienced defective drug attorney can review your case and advise you of how to proceed. Please contact Schlichter, Bogard & Denton today to schedule a confidential consultation.

J&J Planned Profit from Risky, Unapproved Uses of Risperdal

2010-04-08T13:43:00.000-07:00

According to documents unsealed in relation to a lawsuit over off-label marketing of a dangerous drug, Johnson and Johnson planned to improve its market share for drugs used to control elderly dementia, a use not approved by the FDA. The plan was made just months after the company had already been criticized for marketing materials that overstated the benefits and minimized the risks of Risperdal for elderly patients.

Johnson & Johnson spokesman says the lawsuit "does not cite any evidence that Janssen [a division of Johnson & Johnson] made misrepresentations or engaged in off-label promotion of Risperdal and does not identify any connection between defendants' alleged conduct and Louisiana doctors' decisions to prescribe Risperdal rather than other drugs." Instead, according to the United States Department of Justice, Johnson & Johnson paid illegal kickbacks to the nation's largest nursing home pharmacy, Omnicare, Inc. to promote the drug and increase its market share.

In order to protect nursing home residents from medication abuse, a supposedly independent and impartial pharmacist reviews every resident's medication regimen at least once a month, and has the power to recommend changes. According to a complaint filed in United States District Court in Massachusetts, Johnson & Johnson paid Omnicare to have its physicians to recommend that doctors move patients onto Risperdal, and, in exchange Omnicare got kickback money as the sales increased. In its defense, Johnson & Johnson describes its practice as a "rebate program."

The use of Risperdal is potentially very risky, and should never be undertaken for mere profit. In addition to being illegal, these charges, if true, represent an egregious example of immoral conduct on the part of a drug company.

If you or a loved one has been hurt by an illegally promoted dangerous drug, please contact the pharmaceutical litigation lawyers at Schlichter, Bogard, & Denton to learn about your legal options.

What Are the Different Classes of Drug Recalls?

2010-03-26T08:27:00.000-07:00

A "recalled drug" is any prescription or over-the-counter medication that has been removed from the market. The recall may be voluntarily issued by the drug manufacturing company, or required by the Food and Drug Administration (FDA).

The FDA is responsible for making sure that foods, drugs and medical devices are safe for public use. When it has been proven that a medication has severe adverse side effects and the drug has not been recalled by the drug manufacturer, the FDA will issue a massive recall.

The caring and aggressive defective drug lawyers at Schlichter, Bogard & Denton know how difficult it is to deal with the adverse side effects of a dangerous drug. Our aggressive attorneys can get you the money you deserve.

Categories of Drug Recalls

A drug recall may fall into one of several categories:

Class I Recall: These are issued when there is a reasonable probability that the use or exposure to a given product will cause severe adverse health consequences or death.

Class II Recall: This recall is issued when the use or exposure to a product or drug can cause temporary or medically-reversible adverse health consequences. This is also issued when there is a moderate probability of serious adverse health effects.

Class III Recall: This recall is issued when a product violates FDA labeling or manufacturing regulations but is not likely to cause adverse health consequences.

If you your or a loved one has suffered because of a dangerous drug or is taking a medication that has been recalled, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton. Our firm serves clients nationwide.

What Is the Difference Between Class Action and Multidistrict Lawsuits?

2010-03-25T08:23:00.000-07:00

Multidistrict litigation (MDL) is a way for the courts to collectively handle multiple lawsuits involving the same plaintiff, such as a drug manufacturer. MDL cases are civil cases that involve the same questions of fact, such as whether a drug manufacturer was negligent in manufacturing dangerous pharmaceuticals.

The experienced attorneys at Schlichter, Bogard & Denton understand the frustration of a large civil case and will fight to get you the compensation you deserve for your pain and suffering.

Multidistrict Litigation vs. Class Action

MDL is not a type of class action. Class action suits are large-scale proceedings, usually brought about in product liability cases, on the behalf of multiple clients who have a shared interest in the case. Class actions, however, may be transferred to an MDL consolidation in the same way single-plaintiff cases are.

The Judicial Panel on Multidistrict Litigation decides whether cases should be consolidated under MDL, based on one or more questions of fact. Since commonality is also a requirement for class action suits, these cases are often litigated in MDL proceedings.

Common MDL Cases

The most common types of MDL cases are:

Torts involving disaster (most often airplane crashes)
Complex product liability cases
Trademark and patent infringement
Securities violations
Antitrust issues

If you would like more information on multidistrict litigation, please contact the experienced pharmaceutical litigation attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

First Lawsuit for Avandia Filed In Santa Clara County

2010-03-24T08:21:00.000-07:00

Produced by GlaxoSmithKline, Avandia is an oral medication prescribed for type-2 (adult onset) diabetes. It works by improving your blood sugar levels by making your cells more receptive to insulin.

But despite its effectiveness at regulating type-2 diabetes, studies have revealed that this medication can lead to serious and potentially deadly side effects.

The dangerous drug lawyers at Schlichter, Bogard & Denton know the difficulty of dealing with a dangerous, recalled medication. We will help your family get the money you deserve during this trying time.

Santa Clara, California

The county of Santa Clara, California has filed a lawsuit against Avandia’s manufacturer on behalf of both diabetes patients and health care providers. The county claims that GlaxoSmithKline falsely advertised this diabetes drug and concealed the increased risk of heart attacks and other dangerous side effects. Filed in the U.S. District Court in San Jose, this case is believed to be the first government lawsuit against the company over the drug Avandia.

Santa Clara County has been especially affected by Avandia problems. Their county-run hospital spent $2 million on Avandia between 1999 and 2007 for its patients. It also treated numerous patients who suffered heart attacks and other side effects as a result of Avandia use.

If you your or a loved one has been injured by Avandia, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton. Our firm represents clients nationwide.

Our Involvement in the Yaz®/Yasmin® Litigation

2010-03-23T08:17:00.000-07:00

The birth control pills Yaz® and Yasmin® contain a new kind of progestin hormone known as drsp or drospirenone. But this hormone has been shown to increase the user’s potassium levels, which can lead to adverse health problems such as:

Blood clots
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Stroke and heart attack
Gallbladder disease and removal
Kidney and renal failure
Pancreatitis
Death

The defective drug attorneys at Schlichter, Bogard & Denton empathize with patients who are suffering the adverse health effects of Yaz® and Yasmin®. With experience and perseverance, our lawyers will win you the money you deserve for your suffering.

A Growing Concern

More than 30 lawsuits have been recently filed in states throughout the U.S. against Bayer Pharmaceuticals Corporation and other Bayer-related companies. The allegations include the accusation that Bayer did not provide sufficient warnings against the dangerous side effects of Yasmin®/Yaz®, potentially increasing the risk of serious health complications for users.

Schlichter, Bogard & Denton are investigating these cases, and are working to get injured women the compensation they deserve for their injuries. Our attorneys are also investigating cases involving the generic drug Ocella that is manufactured by Barr Laboratories.

If you your or a loved one has been injured by Yaz®/Yasmin®/Ocella, please contact the effective dangerous drug attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

What Is An FDA Black Box Warning?

2010-03-22T08:14:00.000-07:00

A black box warning is the strongest warning that a medication can carry and still remain on the market. Certain medications are safe for some patients and severely dangerous for others. When a given drug has been shown to cause harmful side effects, the Food and Drug Administration (FDA) will issue a "black box warning" for the product.

The defective drug attorneys at Schlichter, Bogard & Denton are caring and determined lawyers who will fight to get you the money you deserve for your injuries and emotional anguish.

The Black Box

This warning is named after the bold black border drawn around the text. The border is created to draw attention to the warning, and to differentiate it from other labeling information. A black box warning must be printed on all materials, both inside the packaging and on the documents received by doctors who will prescribe the medication.

A black box warning must include any important information about:

Safety concerns
Serious side effects
Life-threatening risks

How a Drug Receives This Warning

A drug is issued a black box warning when studies performed on the drug suggest that it may cause dangerous side effects. Unfortunately, many of these warnings are issued after the drug has been on the market and used by countless consumers.

If your medication has received a black box warning, you should discuss with your doctor the potential side effects and any alternatives. Then decide whether the benefit of the drug is worth the potentially harmful consequences.

If you or someone you love has suffered adverse side effects from a defective drug, or your medication has been recalled, please contact the knowledgeable defective drug attorneys at Schlichter, Bogard & Denton. We serve clients nationwide.

What Is a Drug Recall?

2010-03-20T15:48:00.000-07:00

If you watch TV, surf the Internet or browse through magazines, you have seen ads for medications that depict healthy, active people. Prescription and over-the-counter medications are used by millions of people each day for a variety of ailments, diseases, and medical conditions.

Overall, medications provide relief and health benefits. But sometimes a serious side effect or adverse health consequence is revealed after a drug is introduced into the marketplace. When these undesired results are extreme, the Food and Drug Administration (FDA) or drug manufacturer will issue a drug recall.

The compassionate defective drug attorneys at Schlichter, Bogard & Denton understand the difficulty of dealing with a drug recall and any adverse side effects you have experienced as a result of a dangerous drug.

Sometimes a defective or dangerous prescription drug is voluntarily recalled by the drug manufacturer. If the FDA becomes involved, it can request a recall, which is the fastest way to remove a harmful drug from the market.

The FDA’s Jurisdiction

The FDA has jurisdiction over recalls involving the following:

Drugs
Vaccines
Medical devices
Blood and plasma products
Veterinary products
Other biologics

Once the FDA requests a drug recall, the manufacturing company is responsible for making sure that the recall is successful. Companies must tell the FDA when the prescription recall has begun, and file progress reports. When the recall is completed, the FDA oversees the destruction of the dangerous prescription drug, and then investigates what made the drug harmful.

If you your or a loved one has been injured by a dangerous drug or is taking a medication that has been recalled, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

First Lawsuit for Avandia Filed In Santa Clara County

2010-03-16T15:38:00.000-07:00

Produced by GlaxoSmithKline, Avandia is an oral medication prescribed for type-2 (adult onset) diabetes. It works by improving your blood sugar levels by making your cells more receptive to insulin.

But despite its effectiveness at regulating type-2 diabetes, studies have revealed that this medication can lead to serious and potentially deadly side effects.

The dangerous drug lawyers at Schlichter, Bogard & Denton know the difficulty of dealing with a dangerous, recalled medication. We will help your family get the money you deserve during this trying time.

Santa Clara, California

The county of Santa Clara, California has filed a lawsuit against Avandia’s manufacturer on behalf of both diabetes patients and health care providers. The county claims that GlaxoSmithKline falsely advertised this diabetes drug and concealed the increased risk of heart attacks and other dangerous side effects. Filed in the U.S. District Court in San Jose, this case is believed to be the first government lawsuit against the company over the drug Avandia.

Santa Clara County has been especially affected by Avandia problems. Their county-run hospital spent $2 million on Avandia between 1999 and 2007 for its patients. It also treated numerous patients who suffered heart attacks and other side effects as a result of Avandia use.

If you your or a loved one has been injured by Avandia, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton. Our firm represents clients nationwide.

Hazelnut Recall

2010-03-15T16:06:00.000-07:00

On December 17, 2009 a recall of all shelled hazelnuts processed by Willamette Shelling from October 12, 2009 through November 25, 2009 was announced. The recall is due to possible contamination with Salmonella. Hazelnuts still in their shells are not affected by the recall.

The nuts listed in the Willamette Shelling recall were labeled under the following brand names:

Kunze Farms
Evonuk Oregon Hazelnuts
Canadian Hazelnuts
Firestone Farms

Willamette Shelling, located in Newberg, Oregon, shells hazelnuts for other hazelnut processors. The recall has trickled down, producing recalls of several brands of packaged hazelnuts, recalls of products containing the shelled hazelnuts, and recalls by several retailers of shelled hazelnuts sold in bulk. The recall affects organic and non-organic, raw and roasted nuts.

In addition to the Willamette Shelling announcement, recalls have been issued by Whole Foods Market, Mountain Man Fruit & Nut Company, Market of Choice, Janzen Farms, and others.

Consumers seeking a refund or replacement should contact the retailers from which they purchased the nuts, rather than Willamette Shelling.

The recall was launched as a precautionary measure after one production lot of the shelled hazelnuts tested positive for Salmonella contamination. Willamette Shelling processed over 600,000 pounds of shelled hazelnuts during the affected time period, but only about 114,350 pounds of the of the nuts left the facility.

Salmonella infection can be fatal in young children, the elderly, and people with weakened immune systems. Even those who are not at high risk can experience sever symptoms including nausea, vomiting, diarrhea, abdominal pains, and fever. Although rare, there is always the chance of salmonella entering the bloodstream and leading to more serious health problems.

If you believe that you have become ill from eating recalled hazelnuts or any other product that was discovered to be defective or dangerous in any way, please contact the experienced defective products attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

Tylenol Ez-Open Cap Recall

2010-03-11T15:55:00.000-08:00

On December 18, 2009 McNeil consumer Healthcare announced an expansion of its recall of Tylenol Arthritis Pain Caplets 100 count bottles with EZ-OPEN CAP to include all available lots. It had previously recalled only five lots of the defective drug. The recalled bottles have a red cap.

The recall was issued due to complaints from consumers of an unpleasant odor and gastrointestinal symptoms. The odor is described as musty, mildew-like, or moldy. Symptoms associated with taking the recalled drug include:

Nausea
Vomiting
Diarrhea
Stomach pain

Contamination by a chemical called 2,4,6-tribromoanisole (TBA) causes the odor. TBA is also one of the substances responsible for cork taint, a common problem in the wine industry.

TBA is byproduct of interaction between fungi or bacteria with a substance called 2,4,6- tribromophenol (TBP). TBP is used as a fungicide, antiseptic, wood preservative, and fire retardant. Materials used to package the recalled Tylenol are stored and transported on wooden pallets. These wooden pallets and the substance they were treated with are believed to be the source of the problem.

The health effects of TBA are not well-known. McNeil says reports it has received of illness caused by the recalled medication have not been serious and the effects were temporary.

If you have Tylenol Arthritis Pain Caplets affected by the recall, please do not use them even if they do not seem to have a strange odor. Individuals’ sense of smell is not a reliable indicator of contamination with TBA.

If you have taken the recalled Tylenol or any other product that was later discovered to be defective or dangerous in any way, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton. We have offices in Missouri, Arkansas, Illinois, Indiana, Kansas, Wisconsin and Iowa.

Parkers Farm, Inc. Recalls Several Products

2010-03-10T15:46:00.000-08:00

Parker Farms, Inc. has recalled several of its products which are sold under various brand names. The recall was announced on January 8, 2010, after sampling by the states of Wisconsin and Minnesota detected Listeria monocytogenes in some of its finished product. Listeriosis is a potentially serious and even fatal infection. No illnesses have been reported in connection with the recall.

Recalled Parkers Farm Products

The recall includes several varieties of peanut butter, cold pack cheeses, salsa, dips, and spreads. They were sold under the brand names:

Parkers Farm
Parkers
Happy Farms
Kroger
Central Markets
Dutch Farms

The recalled foods were sold in 15 different retail chains across the U.S. Stores where the recalled products were sold include, but are not limited to:

Sam’s Club
Costco
Jewel
Target
Whole Foods

What You Should Do

If you have any of the recalled products in your possession, do not eat them. Listeriosis does not usually pose a serious threat to healthy adults with normal immune systems, but it can be very dangerous or fatal to the elderly, children, and people with weakened immune systems. Additionally, pregnant women are at an elevated risk for becoming infected if they eat food contaminated with listeria and it can cause miscarriage, stillbirth, or newborn death.

You can return the recalled product to the place from which you purchased it for a full refund.

If you believe that you have become infected with listeriosis from eating recalled Parkers Farm Products or any other product that was discovered to be contaminated, please contact the experienced defective products attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

Avandia linked to heart attacks

2010-03-09T10:20:00.000-08:00

The Senate Finance Committee conducted an investigation of the diabetes drug, Avandia which links the drug to an increased risk of heart attacks. It is estimated that by July 2007, Avandia was associated with approximately 83,000 heart attacks since the drug came to market. The Senate's Committee reports that GlaxoSmithKline, the manufacturer of Avandia, knew of the risks for years.

The report states: "Had GSK considered Avandia's potential increased cardiovascular risk more seriously when the issue was first raised in 1999 some of these heart attacks may have been avoided."

GlaxoSmithKline counters that the Senate report relies on outdated information.

Click this LINK for the report.

Nurture, Inc. Issues Voluntary Recall

2010-03-02T15:40:00.000-08:00

Nurture, Inc. has voluntarily recalled HappyTot and HappyBaby pouch meals due to defective packaging. The recall is a precautionary measure. No illnesses have been reported. Recalled packages may swell or leak and could be contaminated with bacteria. Nurture is offering a full refund or exchange for the recalled product or any package that is swollen or leaking.

About 215 to 250 units of HappyTot and HappyBaby pouches were affected by the manufacturing error that caused the defect. The recalled products are HAPPYTOT Stage 4 and HAPPYBABY Stage 1 and Stage 2. They are have expiration dates between November 2010 and January 2011. They and were sold in late December, 2009 and early January, 2010 in Target and Whole Foods stores in several states.

Nurture has tested some of its affected pouches and did find bacteria that should not be in the food, but that should also be harmless if consumed. Even so, those who have the affected pouches of HappyBaby and HappyTot are advised not to consume the food or feed it to their children. It can be returned to the place of purchase for a refund or consumers can contact Nurture directly for a refund or exchange.

Nurture says it has identified the resolved the problem with the packaging.

Flavors included in the recall are:

Green bean, pear & peas
Sweet potato, carrot, apple & cinnamon
Spinach, mango & pear
Butternut squash & apple
Banana, peach, coconut & prunes
Banana, peach & mango
Mango
Spinach Mango Pear
Apricot Sweet Potato

If you believe that your child has become ill from eating recalled Nurture products or any other product that was discovered to be defective or dangerous in any way, please contact the experienced defective products attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products

2010-03-01T15:24:00.000-08:00

You may have heard about the November and December, 2009 recalls of Tylenol Arthritis Pain medication due to contamination with a substance that causes a moldy odor and gastrointestinal problems. Well, now McNeil Consumer Healthcare is recalling a much wider range of products for the same reason. The January 15, 2010 recall includes over-the-counter (OTC) drugs including Benadryl, Tylenol, Rolaids, and more. Some are children’s medications.

McNeil Slow To Act

The recent McNeil recall affects OTC medications sold in the Americas, the United Arab Emirates (UAE), and Fiji. It is due to contamination with 2,4,6-tribromoanisole (TBA). The recall was announced on the same day that the Food and Drug Administration (FDA) issued a warning letter to McNeil regarding the way it handled its knowledge of the TBA problem in its products.

According to the FDA, McNeil was aware of the contamination as early as August, 2008.

Consumer Complaints

Consumers who have complained about the product reported a musty, moldy, or mildew-like odor and experienced stomach pain, diarrhea, nausea, and vomiting after taking the suspicious smelling medications.

McNeil says the adverse events were “temporary and non-serious.”

McNeil says the contamination came from the packaging materials which were stored and shipped on wooden pallets treated with 2,4,6- tribromophenol (TBP). TBP breaks down into TBA when it interacts with microbes.

The list of products affected by the recall is extensive. You can view the full recalled product list here. If you have any of the recalled products, do not use them, even if you cannot smell the unusual odor.

If you believe that you have become ill from taking recalled OTC medications or any other product that was discovered to be defective or dangerous in any way, please contact the experienced defective products attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

Heluva Good Recalls Cold Pack Cheese Product

2010-02-28T15:19:00.000-08:00

HP Hood has recalled two flavors of Heluva Good Cold Pack Cheese Food. During sampling by the state of Wisconsin, Listeria monocytogenes was found in some of the finished product. Listeria infection can be serious or fatal to those at high risk, such as those with compromised immune systems, and is particularly dangerous to pregnant women and their babies.

Heluva Good Recalled Cheese Products

The products affected by the recall, announced on January 11, 2010, are:

Heluva Good Port Wine Cold Pack Cheese Food, packaged in 8oz plastic cup containers, with a sell by date between 11/15/2010, and UPC 73570 55503
Heluva Good Sharp Cheddar Cold Pack Cheese Food, packaged in 8oz plastic cup containers, with a sell by date between 11/15/2010, and UPC 73570 55501

Listeria Can Cause Miscarriage, Stillbirth, and Infant Death

While the elderly, young children, and people with compromised immune systems are at risk for serious listeria infection, healthy adults with normal immune systems rarely become infected with listeria. The exception is pregnant women. Women who are pregnant are more likely to become infected when exposed to listeria and the bacteria can be fatal to both fetuses and newborns to whom the mother can pass the infection.

People with certain diseases, including AIDS and cancer are also at an elevated risk for listeria infection.

Listeria Sources

Listeria is often found in raw foods, and cooking kills the bacteria. However, food can be re-contaminated after it is cooked and before it is packaged. Soft cheeses, and pre-cooked meats such as hotdogs, are common sources of listeria food poisoning.

If you believe that you have contracted listeriosis from eating recalled Heluva Good cheese products or any other product that was discovered to be contaminated, please contact the experienced defective products attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

Harry London Candies, Inc. Announces a Voluntary Recall

2010-02-27T15:13:00.000-08:00

Harry London Candies, Inc. has recalled its Chocolate Pecan Caramel Stars due to undeclared allergens. The unlisted ingredients in the candy can pose a serious health risk to people with wheat allergy or intolerance, celiac disease, and food dye allergy or intolerance. All of the recalled product carries lot code number 9238-1 and was sold on or before December 28, 2009.

Some Ingredients in Chocolate Pecan Caramel Stars Not Listed On Label

The ingredients list on the label of the recalled Chocolate Pecan Caramel Stars does not include the following ingredients which are contained in the candy:

Wheat
FD&C Yellow #5
FD&C Red # 40
FD&C Blue #1

The label does state that the product was manufactured on equipment shared with wheat, peanuts, tree nuts, soybeans, milk, and eggs.

Potentially Fatal Error

For those who are allergic to the unlisted ingredient, consuming the candy can cause a fatal allergic reaction. A true allergy, such as wheat allergy or allergy to FD&C Yellow #5, can lead to anaphylaxis and death.

Even those who have an intolerance, rather than a true allergy, to the ingredients can become very ill or experience other unpleasant symptoms. People with celiac disease, although different to wheat allergy, can also be adversely affected by consuming wheat products.

An adverse reaction to wheat products can cause both gastrointestinal and non-gastrointestinal symptoms.

If you have had an adverse reaction to a food product or any other product due to inadequate labeling please contact the experienced defective products attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals – Recall

2010-02-26T15:07:00.000-08:00

HappyTot and HappyBaby pouch meals produced by Nurture, Inc. have been recalled due to a packaging defect. The affected packages may swell or leak, indicating possible contamination with bacteria. No illnesses have been associated with the recalled products.

The recall applies to HAPPYTOT Stage 4 and HAPPYBABY Stage 1 and Stage 2 pouches with expiration dates from November, 2010 through January, 2011. They were sold in late December, 2009 and early January, 2010 at Target and Whole Foods stores. About 215 to 250 units were affected by the defect.

If you have one or more of the recalled pouches, or if you have a pouch that is swollen or leaking, do not feed the food to your child. You can return the item to the retailer for a full refund or contact Nurture for a full refund or exchange.

Nurture has conducted its own testing on some of the defective pouches and found no harmful bacteria. It did find food spoilage bacteria called Lactobacillus brevis (L. brevis). This bacteria should not cause any health problems, but is not desirable in the food.

Of course, anytime you discover food packaging that is swollen or leaking, it can mean that the food is contaminated with bacteria. You should never consume or feed your child any food with a packaging defect.

If you believe that your child has become ill from consuming recalled food or any other product that was discovered to be defective or dangerous in any way, please contact the experienced defective products attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

FDA Health Alert for Merrick Beef Filet Squares Dog Treats

2010-02-25T14:57:00.000-08:00

The Food and Drug Administration (FDA) issued a health alert for Merrick Beef Filet Squares Dog Treats on January 14, 2010. Merrick voluntarily withdrew the treats from the market on January 11, but as of January 15 there were 20 cases of the affected dog treats still unaccounted for and possibly in people’s homes. The treats may be contaminated with Salmonella poses a health risk to pets who consume them as well as people who handle or come in contact with them.

Salmonella Detected in December, 2009

During routine testing, the FDA found Salmonella bacteria in Merrick Beef Filet Squares Dog Treats in December, 2009. A follow-up inspection on December 28, 2009 found deficiencies in the manufacturing and packages processes.

Treats Affected by the Health Alert

The defective dog treats are marked "9323 best by 111911". This is printed on the part of the bag that is discarded when the package is opened. The treats were packaged in 10oz, red, green, and tan, re-sealable, plastic bags.

If you have or suspect that you may have the potentially contaminated treats, do not feed them to your dog and do not handle them. Dispose of the treats in a sealed container. Wash your hands and thoroughly clean any containers, dishes, and surfaces that the treats may have come into contact with.

Salmonella poisoning can be fatal to you, your children, and your pets.

If you believe that you, your dog, or a loved one has become ill from eating or coming into contact with recalled dog treats or any other product that was discovered to be defective or dangerous in any way, please contact the experienced defective products attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

Parkers Farm, Inc. Expands Recall to Include All Products

2010-02-05T15:32:00.000-08:00

On January 15, 2010, Parkers Farm, Inc. expanded its existing recall to include a much wider range of food products. Products affected by the recall may be contaminated with Listeria monocytogenes. One reason that the recall was expanded was to prevent confusion and possible consumption of affected products. The expanded recall affects all Parkers Farm products and all recall dates.

Parkers Farm products include many brands and many varieties of ready-to-eat foods, sold in about 15 different retail chains throughout the country. The full list of the recalled Parkers Food products can be found on the Food and Drug Administration (FDA) website. Peanut butter, dips, spreads, cheese food, cheese balls, and salsa are among the products recalled.

Listeria Risk

Listeria can be serious or fatal to some people. It is not a big risk for healthy adults, but those with weakened immune systems are not only more likely to become infected if they consume food contaminated with listeria, they are more likely to suffer serious consequences or die if they become infected. Those at high risk for listeria infection include:

Pregnant women
Children
The elderly
People taking glucocorticosteroid medications
People with certain medical conditions including AIDS, cancer, diabetes, and kidney disease

If you have the recalled product you should not consume it. The products are being recalled due to possible contamination, and some of the finished product tested positive for Listeria monocytogenes in sample by the states of Minnesota and Wisconsin.

If you believe that you have become ill from eating recalled food that was contaminated with listeria, please contact the experienced defective products attorneys at Schlichter, Bogard & Denton, serving clients nationwide.

Rico Queso Recall

2010-02-04T15:30:00.000-08:00

Limeno LLC. has announced a recall of white, hard cheese sold under the brand name Rico Queso. The Florida Department of Agriculture and Consumer Services (FDACS) detected Salmonella in the product during routine testing, prompting the recall and temporary suspension of production of the cheese. So far, no illnesses have been reported. You can return the recalled cheese to the place of purchase for a full refund.

An Unusual Source of Salmonella
Although there have been some large recalls of various types of nuts and nut products associated with Salmonella contamination, we typically think of Salmonella poisoning as a problem caused by undercooked poultry and eggs.

Cheese can be contaminated with Salmonella, but it is most often found in soft cheese. Raw milk can be a source of Salmonella bacteria in both hard and soft cheese, but cheese made from pasteurized milk can become contaminated during processing, packaging, or handling.

In 2008, one person died and nearly 90 others became ill in Quebec from eating hard cheese that was contaminated with Salmonella. About 40% of the people who were infected had to spend at least one day in the hospital.

Salmonella Infection is Serious and Can Be Fatal
Most healthy adults fully recover after a very unpleasant bout with gastrointestinal symptoms caused by Salmonella poisoning. However, even in healthy adults there are rare complications that can be fatal. Salmonella can be very dangerous and even fatal to infants, young children, the elderly, and people with weakened immune systems.

If you believe that you have become ill from consuming recalled cheese or any other product that was later discovered to be contaminated with Salmonella, please contact the experienced defective products attorneys of Schlichter, Bogard & Denton serving clients nationwide.

Nutty Guys Issues Public Notice on Voluntary Recall of Butter Toffee Peanuts and Yogurt Covered Peanuts

2010-02-03T15:26:00.000-08:00

Butter Toffee Peanuts and Yogurt Covered Peanuts are being recalled by Nutty Guys after live insects and larvae were found in some of the products. Thousands of peanut products and products containing peanuts, including human and pet foods, have been recalled in recent months sue to possible Salmonella contamination. The Nutty Guys recall is not linked to those recalls and this problem is not thought to pose a serious health risk.

Recalled Nutty Guys Peanut Products
The Recalled Butter Toffee Peanuts and Yogurt Covered Peanuts have sell by dates of March 15, 2010 and earlier. They are packaged in one pound, plastic see-through bags. Affected Butter Toffee Peanuts have the UPC code 8 31852 00261 0. Affected Yogurt Peanuts have the UPC code 8 31852 00279 5. About 2,000lbs of the recalled peanut products were sold.

The recalled Nutty Guys peanut products were distributed to the following states:

Arizona
California
Colorado
Idaho
Montana
Nevada
Texas
Utah
Washington
Wyoming

If you have either of these recalled peanut products you should contact Nutty Guys for instructions on how to obtain a refund.

Controlling Pests in Nuts
Live bugs are a common problem in nuts and some other foods. While there are some methods used to control and get rid of pests in nuts, many people find food treated with those methods even more undesirable than the bugs themselves. For instance, ionizing radiation can be used to sterilize or kill pests by damaging their DNA, but it is not always effective and the safety of irradiation technology is questionable at best.

If you have taken a product that was later discovered to be defective or dangerous in any way, please contact the experienced defective product attorneys of Schlichter, Bogard & Denton serving clients nationwide.

MuscleMaster.com Conducts a Voluntary Nationwide Recall of Certain Body Building Products

2010-02-02T15:23:00.000-08:00

In cooperation with the Food and Drug Administration (FDA) MuscleMaster.com, Inc announced a recall of 17 dietary supplements, on January 15, 2010. The FDA says the supplements contain ingredients that are or should be classified as steroids. MuscleMaster.com says that it cannot independently confirm the FDA's claims and that the recall should not be construed as an admission of selling illegal products, but is a precautionary measure.

Undeclared Anabolic Steroids in Dietary Supplements
Dietary supplements marketed to bodybuilders sometimes contain undeclared anabolic steroids because they are effective in helping build muscle mass. Anabolic steroids are Schedule III controlled substances and including them in over-the-counter supplements is illegal. However, the process of classifying specific ingredients as anabolic steroids is a complicated process and the FDA does not have the authority to do so. That is the responsibility of the Drug Enforcement Administration (DEA).

Of the five suspect ingredients that are or may be contained in the recalled dietary supplements, only two, androstenedione and Turinabol are technically classified as anabolic steroids. The other three, Superdrol, Madol, and Tren are substances that the FDA believes should be classified as steroids.

Why Undeclared Steroids Are Dangerous
Anabolic steroids can have dangerous and even fatal side effects. People who take them knowingly and willingly at least have the opportunity to be informed of the risks and look out for signs of the side effects. Those who take products with undeclared steroids do not have that advantage and can incur serious harm before discovering the source of the problem.

Acute liver damage is among the many potential side effects of steroid use.

If you have taken a dietary supplement or any other product that was later discovered to be defective or dangerous in any way, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton serving clients in Missouri, Arkansas, Illinois, Indiana, Kansas, Wisconsin and Iowa.

Hines Nut Company Announces Recall of Pine Nuts

2010-01-30T15:21:00.000-08:00

Pine nuts are usually sold raw for use in many tasty dishes. They are one of the main ingredients in most pesto sauce recipes. Adding to the list of nuts and nut products recently recalled for possible Salmonella contamination, Hines Nut Company is recalling its Harris Teeter Farmers Market pine nuts.

The recalled pine nuts were sold between December 30, 2009 and January 14, 2010, and only in Harris Teeter Markets in North Carolina. 270 packages have been recalled. The recalled nuts were packaged in 8oz, cellophane wrapped, foam trays. They are labeled with the UPC code 0 72036 88121 0.

The possible contamination was discovered by Red River Foods, in California, during routine sampling. Red River sold the nuts to Hines Nut Company of Dallas, Texas. Hines Nut Company then distributed the nuts to Harris Teeter Markets in North Carolina.

Do Not Consume the Recalled Pine Nuts
If you have the recalled pine nuts in your possession you can contact Hines Nut Company to find out how to return them for a full refund.

Although some people do snack on raw pine nuts, they are more often used as an ingredient in foods and sauces. Cooking to a high enough temperature will kill Salmonella, but it is not recommended that you eat the recalled nuts, even if you use them in a cooked dish.

Contaminated nuts can also lead to cross-contamination of other foods. If you have used the nuts, be sure to thoroughly clean any containers, surfaces, and utensils that may have come into contact with the nuts.

If believe that you or a loved one has become ill from consuming contaminated pine nuts or if you have taken a product that was later discovered to be defective or dangerous in any way, please contact the experienced defective products attorneys of Bogard & serving clients nationwide.

ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall

2010-01-27T15:19:00.000-08:00

Food and Drug Administration (FDA) and e3 Endovascular, Inc. have announced a Class I Recall of the Trailblazer Support Catheter. So far, no deaths have been linked to the defective catheters, but this is the most serious classification of recalls, and was issued in connect with reported adverse events. So far, no deaths have been linked to the recalled, defective catheters. A class I recall means that the product carries a reasonable possibility of causing a serious adverse health event or death.

Recalled Catheters
The recalled catheters were used in endovascular applications. That means that they were inserted in veins or arteries, rather than being used in other types of applications such as for bladder evacuation.

The recalled Trailblazer Support Catheters may crack near the radioplaque marker band resulting in serious complications including:

Insufficient oxygen supply to tissues
Damage to blood vessels
Heart attack
Limb amputation
Unplanned surgery
Death

No deaths have been reported in connection with the recalled medical devices, but adverse health events have occurred. According to the press release, all of the recalled devices have been returned to ev3, Inc.

If You Have Been Injured By a Defective Medical Device
Injury by a defective medical device can have severe health consequences and can be fatal. If you have been injured by a defective medical device or a defective drug, you may be entitled to compensation for your medical bills and more.

If you believe that you or a loved one has been injured by a medical device that was discovered to be defective or dangerous in any way, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton serving clients nationwide.

Thermoflect Recall

2010-01-25T15:14:00.000-08:00

Thermoflect blankets and other Thermoflect products are used to treat and prevent hypothermia. Preventing hypothermia reduces the risk of surgical site infections and other medical problems and complications. The Thermoflect products are being recalled for re-labeling after a report of an injury to a patient who was using a Thermoflect blanket during Magnetic Resonance Imaging (MRI).

At this point the recall and relabeling is a precaution and it is not known for sure if the Thermoflect product caused the injury. However, Encompass Group the company that sells Thermoflect products, is relabeling the products and has sent letters to hospital, doctors, and other customers asking them not to use Thermoflect products in the MR environment until the American Society for Testing and Materials (ASTM) establishes a standard for testing the safety of the products in that environment.

Thermoflect blankets and other Thermoflect products are still considered to be safe and effective for prevention and treatment of hypothermia outside of the MR environment.

How Thermoflect Works
Thermoflect products include blankets, pants, vests, transport cocoons, caps, and other products. They prevent heat loss due to airflow in the same way that other blankets and clothing items would, but they also reflect the heat radiating off of a patient's body back to them, helping to maintain core body temperature. The science behind Thermoflect products was pioneered by NASA as an alternative to electric heat as a way to maintain body temperature.

If you have been injured by a defective medical device or defective drug, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton serving clients nationwide.

FDA to Re-evaluate BPA Safety

2010-01-19T13:39:00.000-08:00

Bisphenol A, more commonly known as BPA, is a chemical that has been used for more than 40 years in the manufacture of many hard plastic food containers such as baby bottles and reusable cups and the lining of metal food and beverage cans, including canned liquid infant formula. According to the FDA, trace amounts of BPA can be found in some foods packaged in these containers.

In 2008, the FDA judged food-related materials containing BPA on the market to be safe, however, recent studies showing health effects of low doses of BPA in laboratory animals have lead the FDA to express some concern about the safety of BPA. Because of this, the Department of Health and Human Services is investing in new studies for both animals and humans to determine and evaluate the potential health effects of BPA exposure.

In the meantime, the FDA is recommending the following step in reducing exposure to BPA, especially to parents:

Plastic containers that contain BPA are usually marked with the number 3 or 7 on the bottom.

Discard scratched containers, especially baby bottles and infant feeding cups because the chemical can seep through any scratches.

Do not put boiling or very hot water or other liquids in a BPA-container. Traces of BPA are transferred when hot or boiling liquids or food comes in contact with a BPA-container.

Use only containers marked “dishwasher safe” or “microwave safe”.

For general information regarding BPA go to www.fda.gov. For information on ways to prevent BPA exposure to children, go to www.hhs.gov.

Houston Company Issues Recall of Flour Tortillas

2010-01-10T08:02:00.000-08:00

La Espiga de Oro, Inc. is recalling its Fiesta brand Flour Burrito Tortillas. This product is packaged in 12 count bags with a UPC code of 51022 00060 and the packages bear dates of 30, 2009 through December 20, 2009. The recalled products fail to list whey as an ingredient, which is a milk product that can be an allergen to certain people.

Milk allergies are a common food allergy triggered by one or more of the proteins found in milk. Some of the systems affected by reaction to milk allergens include:

Gastrointestinal – nausea, vomiting, diarrhea, and stomach ache
Dermatological – hives, rashes, and itching skin
Respiratory – wheezing, shortness of breath, and respiratory arrest

The primary defense of people suffering from any food allergy is avoidance. They rely on accurate ingredient labels to know what foods to avoid. When food labels do not properly list allergenic ingredients, these people may inadvertently consume something dangerous.

The recall of the flour tortillas was initiated by the discovery that the labels did not indicate the presence of whey. Apparently, the production and packaging department of La Espiga De Oro, Inc. made this critical mistake, resulting in this voluntary recall of this potentially dangerous product. So far, no illnesses are reported. Consumers may call the company at 713-861-4200 to find out more information.

If you or a loved one suffered an allergic reaction to this product, you may be eligible to seek monetary damages from the responsible party. To find out more about the legal options available to injured persons, please contact the knowledgeable personal injury attorneys at Schlichter, Bogard & Denton, LLP.

Majesty Label Cantaloupes Recalled Due To Possible Salmonella Contamination

2010-01-06T07:57:00.000-08:00

Five Crowns Marketing is issuing a voluntary recall of cantaloupes distributed under the Majesty Label due to confirmed salmonella contamination discovered on November 4, 2009. As a cautionary measure, all cantaloupes in the same lot are included in the recall. The lot numbers included in the recall are 198 1 and 198 3. The cantaloupe lots in question were distributed to the following states:

California
Illinois
Michigan
Minnesota
New York
Ohio
Oregon
Pennsylvania
Tennessee

The cantaloupes may be individually marked with the Majesty Label, but all containers are marked. IConsumers who want to find out if their fruit is included in the recall are asked to contact the company at 760-344-1930.

Salmonella is a enterobacteria that causes salmonellosis in individuals who are infected. Some of the symptoms of salmonellosis include:

Diarrhea
Fever
Vomiting
Abdominal cramps

Many people who suffer from the above symptoms may become severely dehydrated and need intravenous fluids. In severe cases, salmonellosis may spread into the bloodstream and may even prove to be fatal. Children, elderly, and immune compromised individuals are most susceptible to severe cases of salmonella infection. Tainted fruits and vegetables are among the leading agents of infection.

If you or a loved one suffered any of the above symptoms due to consumption of the listed products, you may be able to seek damages. To find out more about your legal options, please contact the knowledgeable product liability attorneys at Schlichter, Bogard & Denton, LLP.

Class 1 recall of the Trailblazer Support Catheter

2010-01-05T12:35:00.000-08:00

On January 5, 2010, The FDA issued a MedWatch safety and information report including information about a Class 1 recall of the Trailblazer Support Catheter device.

The recalled catheter is a medical device used to help with the delivery of solutions in the veins or arteries for the treatment of patients.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Specifically, this device may crack near the radiopaque marker band which may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death.

Ev3 Endovascular, Inc., has sent a letter to all of its consumers summarizing the problem with the device and requesting the product be returned to their company.

Model Numbers recalled include: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150.

Unilever Issues Nationwide Allergy Alert

2010-01-05T07:57:00.000-08:00

The maker of Shedd's Country Crock chilled side-dish products is recalling two of its side dishes because they contain undeclared sulfites in the ingredients. The recall was initiated after a report of four family members who suffered adverse effects associated with the side-dish products. The products in question include:

Deluxe Cheddar Broccoli Rice, best by dates 11/29/09 through 1/16/10, upc code 027400218316.
Deluxe Four Cheese Pasta, best by dates 12/05/09 through 1/16/10, upc code 027400230875.

No other Shedd's Country Crock side dishes are affected by the recall.

Sulfites are frequently used as food preservatives, but are also allergens for many susceptible people. People with sulfite allergies may suffer the following symptoms:

Sneezing
Swelling of the throat
Hives
Death

People who suffer from sulfite allergies rely on proper labeling of food products to avoid suffering adverse reactions. When food products are mislabeled allergy suffers may experience needlessly.

If you or a loved one suffered a reaction as a result of consuming one of these products, you may have legal recourse to collect damages. To find out more about your legal options, please contact the product liability litigators at Schlichter, Bogard & Denton, LLP.

Recall of contaminated products

2010-01-04T11:19:00.000-08:00

McNeil Consumer Healthcare has voluntarily recalled all available product lots of Tylenol Arthritis Pain Caplet 100 count bottles. In November 2009, five lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the presence of a chemical believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.
But consumers beware: this phenomenon is not unusual. Packaging not only acts as a barrier against contamination but it is also a source of contamination. In most cases, it is not a question of whether packaging components will leach into a product, it’s a question of how much. And pharmaceutical products are not immune to leaching. As a result, regulatory agencies collect information in order to document the safety margins of these food and drug “leachables”. Still, there is no set guideline among the governmental agencies. For instance, last year, the Canadian government banned the use of BPA in baby bottles as a precautionary measure against the risk that its presence could cause endocrine disruption in children--the FDA and other foreign agencies dispute the Canadian’s safety margins.
Still, scientists are trying to come up with a packaging material that prevents leaching of products. While a fool proof solution is yet to be found, the most successful anti-leaching products are available, at a price--the containers sometime cost several times the price of the components they replace.
In the meantime, pharmaceutical companies like McNeil Consumer Healthcare will continue to voluntarily recall their contaminated products. For all contaminated products, the consumer should stop using the product and contact the manufacturer for instructions on a refund or replacement.

Antidepressant Norpramin Warning

2010-01-04T09:32:00.000-08:00

The FDA announced today that Norpramin (desipramine), an antidepressant made by Sanofi Aventis can cause disturbances in the heartbeat, including sudden cardiac death in people who have a family history of this or other heart rhythm disturbances. Also known as arrhythmia, the FDA says that this problem is often preceded by seizure in those taking Norpramin. MedWatch, the safety information arm of the FDA and the Sanofi Aventis sent this new warming to healthcare professionals. The new warning stated, if you take this drug, be sure to mention this warning to your doctor. Both Sanofi Aventis and the FDA said that Norpramin overdose is more likely to result in death than other tricyclic antidepressants.

According to the FDA, antidepressants are one of the most widely prescribed class of medications and many have side effects which include worsening depression, other mental or mood symptoms, suicidal thoughts or attempts and sometimes new or worsening anxiety, panic attacks, trouble sleeping, irritability, hostile or angry feelings, impulsive actions, severe restlessness, and very rapid speech. But, the heart rhythm disturbance at this time is unique to Norpramin and not associated with other antidepressants.

For more information regarding adverse events and deaths related to desipramine, contact: MedWatch at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or online at http://www.fda.gov/medwatch..

Smoked Nova Salmon Recalled for Possible Health Risk

2010-01-04T07:55:00.000-08:00

The Service Smoked Fish Corporation is recalling specific lots and "use by" dates of Brooklyn's Best brand Smoked Nova Salmon because of bacterial contamination. The recall came after the FDA took some samples and discovered the presence of listeria monocytogenes an organism that causes illness and even fatalities in children and adults with immune deficiencies.

Listeria monocytogenes is a bacterial infection that causes listerosis. The symptoms of listerosis last from 7 to 10 days and if left untreated may result in bacterial meningitis. Pregnant women are more susceptible to the disease, which as been known to cause premature birth and even stillborn babies.

Healthy individuals who ingest listeria may suffer from the following symptoms:

Diarrhea
High fever
Severe headaches
Nausea
Abdominal pain

The Smoked Nova Salmon recall is limited to the lots numbered 060 through 043 with a use by date range from 12/03/09 to 12/19/09. The fish is packaged in the following sizes:

3 oz.
4 oz.
8 oz.
12 oz.
16 oz.

No other date ranges or lots are being recalled, but the underlying problem is still being investigated by the company and the FDA. To find out more about the recall and request a refund of the product, please contact the company at 718-388-4067.

If you or a loved one suffered any illness or injury after consuming this product, you may have legal recourse to seek damages. To find out more about your legal options, please contact the knowledgeable personal injury attorneys at Schlichter, Bogard & Denton, LLP.

Pumpkin Cheesecake Pies Recalled Due to Mislabeling

2010-01-03T07:55:00.000-08:00

Fresh & Easy Neighborhood Market initiated a voluntary recall of its Pumpkin Cheesecake Pies due to improper labeling. Some of the pies were marked with labels for regular Pumpkin Pies and that failed to mention pecans as an ingredient. Pumpkin Cheesecake Pies that have proper labels are not affected by the recall.

Tree nut allergies, including pecans, are one of the more common food allergies next to peanut allergies. Tree nut allergies occur most commonly in children. Medical problems that occur with tree nut allergies include:

Hives
Rash
Shortness of breath
Anaphylaxis

Prevention, i.e. avoiding allergens, is the best treatment for allergies. People with allergies rely on proper labeling to avoid ingesting dangerous food products.

The mislabeled pies with an "Enjoy By" date of November 21st have been removed from all retail locations. Customers may return any unused product or empty product container for a refund from the company, which is trying to limit dangerous product liability. To find out more about this recall, contact Fresh & Early at 1-800-648-8622.

If you or a loved one suffered from any physical ailments due to the mislabeling of these pies, you may have legal options for redress. To find out more, please contact the knowledgeable personal injury attorneys at Schlichter, Bogard & Denton, LLP. Nationwide legal consulting is available to help you get compensation for your injuries.

Proctor and Gamble Recalls Vicks Nasal Spray

2010-01-02T07:54:00.000-08:00

P&G has announced a recall of three lots of Vicks Sinex Nasal Spray when it discovered the bacteria B. cepacia in small amounts of product manufactured in Germany. The bacterium was discovered during routine quality control testing at the plant. The lot numbers included in the recall are:

9239028831 sold in the United States
9224028832 sold in the United Kingdom
9224028833 sold in Germany

The contamination was found in the lot distributed in the U.S. and is testing the other lots, which were made in the same factory.

The bacterium, B. cepacia is a human pathogen that causes pneumonia in immunocompromised people with an underlying lung disease. Healthy people should not be affected by this bacterium.

People with this particular item can safely dispose of it in a normal manner. To obtain a refund or replacement product in the United States, please call 1-877-876-7881.

Adverse events associated with these contaminated drugs should be reported to the FDA's MedWatch Program online at, www.fda.gov/medwatch.

If you or a loved one suffered illness after using this product, you may be able to seek damages in a personal injury claim. To find out more about your legal options, please contact the knowledgeable medical negligence attorneys at Schlichter, Bogard & Denton, LLP.

Tasty Dish Snack Tubs Undergo Allergy Alert

2010-01-01T07:53:00.000-08:00

Nassau Candy Distributors issued a recall for unlabeled snack tubs that do not properly list ingredients linked to severe allergies. The Tasty Dish Snack tubs were sold nationwide at Bed Bath & Beyond retail stores throughout the country. The specific products included in the recall are:

Chocolate Almonds
Chocolate Raisins
Sour Neon Worms

Apparently, the problem occurred when one of the labeling machines failed to apply the appropriate label to the packages. The retailers have been notified and all packages that are missing labels were removed from the shelves. So far, no illnesses are reported in relation to the missing labels. As a precaution to mitigate potential medical negligence, the company issued its voluntary recall.

People with food allergies must avoid those ingredients that cause allergic reactions. Some of the most common are:

Tree Nuts
Peanuts
Milk
Soy

Improperly labeled products put people in danger of suffering mild to severe allergic reactions, even death. People who purchased this product without a label on the back of the package are urged to return the product to Bed Bath & Beyond for a full refund.

If you or a loved one suffered any level of allergic reaction due to this labeling error, you should contact an attorney to discuss your legal options. Please contact an experienced product liability attorney at Schlichter, Bogard & Denton, LLP to find out more.

Gourmet Snack Line Recalled for Undeclared Allergies

2009-12-31T07:52:00.000-08:00

Snacks On Racks Inc. is recalling dozens of products from its retail locations due to the lack of adequate warnings for a number of potential food allergens. These products are only sold in food service establishments throughout the continental United States, and all bear a blue Snacks on Racks label. They are not sold at convenience or grocery stores, but are retailed at hospital gift stores, universities, and kiosks.

The recall was initiated upon discovery of a discrepancy with the labels on chocolate raisins. Further investigation showed several inadequacies with the company's production and packaging lines, which have since been corrected.

Some of the allergies that may be triggered by the product are related to:

Tree nuts
Peanuts
Milk
Soy
Egg
Wheat
Sulfites

In most cases, people with these types of allergies rely on proper labeling in order to avoid foods that may pose a danger. Inadequate labeling is a serious issue for people suffering from food allergies.

To find out which products are subject to the recall, please visit http://www.fda.gov/Safety/Recalls/ucm191010.htm. To return a product, please go to the retailer to get a refund, or call the company at 1-816-505-9131.

If you or someone you love experienced an allergic reaction because of improper labeling, you should know your legal options. Please contact the knowledgeable personal injury attorneys at Schlichter, Bogard & Denton, LLP.

Recall Issued for Undeclared Allergies on Fish Product

2009-12-30T07:51:00.000-08:00

Superior Foods Company of Grand Rapids Michigan issued a recall for its Lemon Pepper Marinated Catfish and Cajun Style Catfish because of missing information on potential allergens. The lemon pepper catfish contains undeclared soy and FD&C Yellow #5 (also known as Tartrazine). The Cajun catfish has undeclared soy products. The presence of these products may trigger severe allergies to susceptible consumers.

Tartrazine is an azo class dye used for food coloring. It appears to cause the most allergic reactions of all that class of dye, especially among people with asthma and those intolerant of aspirin products. Some of the reactions people with allergies may experience include:

Anxiety
Migraines
Depression
Blurry vision
Shortness of breath

The only real defense against Tartrazine is to avoid ingestion and even contact with the product. Mislabeled products can lead to adverse medical conditions.

Soy allergies are one of the top eight food allergies in children and adults and labeling requirements mandate that the presence of soy must be declared. The most severe reactions may lead to anaphylactic shock and even death. Other typical reactions, such as:

Hives
Shortness of breath
Itching

Like Tartrazine, avoidance is the best way to prevent adverse reactions to soy, making proper labeling a life or death issue for some people. Contact the company at 616-541-2137 to find out how to return the product for a refund.

If you or a loved one suffered any adverse or allergic reactions due to the mislabeling of either of these fish products, please contact the experienced product liability attorneys at Schlichter, Bogard & Denton, LLP.

Vita Food Products Recalls Herring Dish for Improper Labeling

2009-12-29T08:01:00.000-08:00

A Chicago food company, Vita Food Products, has issued a voluntary recall on November 24 of its Elf Branded Herring in Sour Cream product for failure to disclose the presents of wheat in the ingredients. The failure to disclose this ingredient may put people who suffer from wheat allergies, or who are following a gluten free diet at risk for illness or severe allergic reactions.

Vita Food Products issued this recall in order to protect itself from dangerous product liability. The product comes in 8 oz. and 12 oz. sizes with the following UPC codes:

8 oz., 0-73302-23111-3
12 oz., 0-73302-22111-4

Both sizes have a use by date of April 12, 2010 or earlier.

People who suffer from wheat allergies, or who are following a strict gluten-free diet rely on food labels to ensure that dangerous ingredients are avoided. When a company fails to provide that information, it puts those people at risk. People who suffer from wheat allergies may experience the following reactions when inadvertently ingesting wheat or wheat gluten:

Nausea
Hives
Itchiness

More severe cases may result in anaphylactic shock and even death. So far, no illnesses are reported in relation to this recall. People who are allergic to wheat or are on a gluten free diet are encouraged to avoid this product. To find out more about this recall, please contact the company at 1-800-989-VITA.

If you or a loved one suffered adversely after ingesting this product, you may be able to collect additional damages from the responsible party. To find out more about your legal options, please contact the experienced personal injury attorneys at Schlichter, Bogard & Denton, LLP today.

Cardiovascular Systems Initiates Recall of Defective Catheter Introducer

2009-12-29T07:51:00.000-08:00

On November 16, 2009, Cardiovascular Systems announced a recall of all lots of its ViperSheath catheter sheath introducer based on reports of stretching or fracturing of the product. The ViperSheath is a coil-reinforced catheter introducer of percutaneous entry of intravascular devices. If a fracture occurs, there is a potential for a segment to break off and travel through the blood stream, requiring surgery to remove. Since the catheter is reinforced by an interior coil, damage may occur if the end of the coil snags on the blood vessel.

The recall pertains to ViperSheath products distributed from March 25, 2009 to October 21, 2009. The following lot and catalog numbers included in the recall are:

Lot range: S28117 through S29174
Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45

Three instances of the failure of this medical device were recorded and all patients affected underwent successful surgery to remove the segment. Once a catheter is successfully in place, not further action is required as the conditions that cause breakage will no longer occur.

To report any adverse events with this product, contact the FDA's MedWatch program at www.fda.gov/medwatch.

If you or a loved one has suffered any medical problems as a result of a failed ViperSheath introducer, please contact the skilled product liability attorneys at Schlichter, Bogard & Denton, LLP to learn more about your legal options.

Stryker Issues a Class I Recall of Surgical Navigation Systems

2009-12-28T08:00:00.000-08:00

Stryker Corporation, a leading medical technology company, is recalling 23 of its navigation systems because of a potential issue for a component to stop working. The failure may cause the navigation screen to freeze, a delay in system updates, or failure to respond to input. These types of delays can have devastating effects in the middle of a computer-guided surgery. Some of the potential hazards of these dangerous medical devices include:

Delay in surgery
Rescheduled surgery
Additional surgery
Risk of infection
Increased morbitity
Neurological defects
Injury or death due to failure to navigate properly

Class I Recalls are the most serious classification of a recalled product, indicating a potentially dangerous, even life threatening product defect. So far, there are no reports of injury related to the recalled products.

The specific items affected by this recall include:

Navigation System II Cart; catalog number 7700-100-000; serial number range, 100715-100735
PC SPC-1 Assembly; catalog number 7799-101-201; lot number, K7P00F600

Hospitals using this system should quarantine it and discontinue use. Customers should contact Stryker immediately at 1-800-253-3210 and arrange for a repair. Adverse events related to this product should also be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm.

If you or a loved one suffered an injury or fatality related to the failure of this device, you may have legal recourse to collect damages from the company. To find out more about your legal options, please contact the experienced dangerous medical device litigators at Schlichter, Bogard & Denton, LLP.

Automated External Defibrillators Subject to Voluntary Field Correction

2009-12-28T07:50:00.001-08:00

Cardiac Science, makers of several types of automated external defibrillators, AED, issued a call for a field correction of some of its devices. A problem was discovered that might hinder a resuscitation event, which could lead to severe medical issues including death. The affected models include:

CardioVive 92531, 92532, and 92533 devices
Powerheart 9300A, 9300C, 9300D, 9300E, 9390A, and 9390E devices

The notice comes after Cardiac Sciences received 64 complaints concerning four resistors linked to this potential medical device failure. Approximately one out of every 75,000 devices manufactured between August 2003 and August of 2009 are predicted. AEDs manufactured after August 2009 do not have this defect. A software correction will be available in May 2010. Until that time, patients using AED should continue using them and follow the recommended maintenance schedule.

An automated external defibrillators, or AED, are a portable devices used to detect and treat life threatening ventricular fibrillation or ventricular tachycardia in patients. An electrical shock is sent to the heart to stop the event. Obviously, a failure occurring in one of these devices would be life threatening.

Cardiac Science recommends that until the May 2010 software update that patients using these devices continue with their regular use and maintenance. To find out more information on the correction and to register for email follow-ups go online to www.cardiacscience.com/AED175.

If you or a loved one has suffered from a failure of this device to diagnose and treat the cardiac problem, please contact the knowledgeable defective medical device litigators at Schlichter, Bogard & Denton, LLP.

Allergy Alert on Toi Sauce Thai Red Curry Issued by Redmond Washington Company

2009-12-27T07:59:00.000-08:00

Rikki USA, Inc. is re-issuing a recall on its Toi Sauce Thai Red Curry (Panang) for undeclared shrimp in one of the sub ingredients. According to the company, a label made by an outsourced company, SIAMRICA Co, failed to warn of shrimp ingredients in the red curry paste. People with severe allergies to shrimp may consume this product and suffer a severe allergic or even fatal reaction.

Shellfish allergies are a comparatively common food allergy. People with shellfish allergies may experience severe allergic reactions to shrimp and other shellfish products. The primary defense for people with common food allergies is avoidance of allergens. Failure to disclose allergen information in ingredient labels may lead to personal injury and even death.

The sauce being recalled was distributed in and around the following locations:

Whole Foods, Redmond WA
Food Emporium, WA
Bridgeport Village, OR
New Seasons Market, OR
Other retail markets through Mile Post 65 in Washington

Toi Sauce Thai Red Curry is packaged in a 12 oz. glass bottle with a bright orange label. The lot number for the bottles is 940509. Consumers who purchased this product are urged to return it to where they bought it for a full refund. To find out more about this recall issued in order to protect itself from dangerous product liability, please call SIAMRICA Co. at 1-866-707-4554.

If you or a loved one was physically affected by the mislabeling of this product, you may have legal recourse to collect damages. To find out more about your legal options, please contact the learned personal injury attorneys at Schlichter, Bogard & Denton, LLP.

Large Seedless Watermelons Recalled for Salmonella Contamination

2009-12-26T07:58:00.000-08:00

Timco Worldwide Inc. is recalling "MelonUp" large seedless watermelons that were distributed to select grocers, wholesalers, and processors in Texas and California. Salmonella bacteria were discovered during the course of routine testing of a randomly selected melon. No illnesses have yet been reported in connection with this product.

The recall involves large seedless watermelons labeled with "MelonUP" stickers with a price look up number of 4032 and universal price code of 0 33383 40240 6.

Salmonella bacteria can cause serious and possibly fatal infections in small children, the elderly, and people with suppressed immune systems. Even healthy people can suffer adverse reactions to infection including:

Nausea
Vomiting
Diarrhea
Abdominal pain

In rare instances, the infection can spread into the bloodstream and cause serious illnesses such as:

Arterial infections
Endocartitis
Arthritis

Consumers, who purchased large seedless watermelons with the "MelonUp" label in Texas and California, are asked to return the product to the place of purchase for a full refund. For more information about this recall, please contact Timco Worldwide at 1-530-757-1000 and press 4 for Food Safety. As a reminder, all fruits and vegetables should be thoroughly washed before cutting into them as bacteria residing on the outside of the product may be transferred.

If you or a loved one suffered serious injury or illness in relation to consuming this product, you may be able to collect damages from those responsible. To find out more about your legal options nationwide, please contact the skilled product liability attorneys at Schlichter, Bogard & Denton, LLP today.

Mislabeled Margarine Leads to ConAgra Recall

2009-12-26T07:49:00.000-08:00

ConAgra foods notified the FDA on November 13 about a report of mislabeled tubs of Blue Bonnet Spread. The tubs and lids indicated that the product was Blue Bonnet Light Spread, when in reality; it was regular Blue Bonnet Spread. This poses a problem because the ingredients do not list milk (whey), which is a potential allergen. The recall affects 1,120 cases of a single lot of Blue Bonnet Margarine. ConAgra was notified of the error when the tub did not match the lid and the case in which it was delivered.

People with milk allergies can suffer health problems including life-threatening allergic reactions. According to the Food Allergy and Anaphylaxis Network, FAAN, approximately 2.5 % of children younger than three are allergic to milk. Products must indicate the presence of milk on the label. Milk allergy symptoms include:

Skin rash
Hives
Vomiting
Diarrhea
Constipation
Anaphylactic shock

Even more people are lactose intolerant, because they lack the enzyme lactase which breaks down milk in the digestive system. Lactose intolerant people also try to ensure the absence of milk in the products they consume.

To find out more about the recall, issued in order to protect the company from dangerous product liability, and how to return unused tubs to the store, contact 866-518-4177 or visit their website at www.bluebonnet.com.

If you or a loved one has suffered personal injury due to consuming this recalled product, please contact the knowledgeable personal injury attorneys at Schlichter, Bogard & Denton, LLP.

Class I Recall of Vertebral Replacement by Synthes USA

2009-12-25T07:48:00.000-08:00

The FDA and Synthes USA have declared a class I recall of the Ti Synex II Vertebral Body Replacement (VBR) product. This device is used to replace damaged T1 – L5 vertebral material during replacement surgery. The FDA received six adverse event reports that lead to the recall. The reports indicated a failure of the medical device from 6 to 15 months after placement. The failure is described as a moderate to severe loss of vertebral height. Loss of height in the device may potentially lead to the following medical issues:

Neural injury
Increased pain
Spinal kyphosis
Reoperation or revision surgery

Synthes advises hospitals and physicians currently in possession of all lots of part numbers 04.808.001-011, Synex II Central Body, Titanium to stop implanting immediately. To find out more about returning this product, please contact Synthes USA at 1 (800) 620-7025, ext. 5375.

Patients who received Synex II implants manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009, should be closely monitored using x-rays and pain assessments to ensure no loss of vertebral height. Changes in the level of pain or loss of height may indicate a potential failure of the device.

To mitigate its liability for a defective medical device, the manufacturer issued this recall. Class I recalls are the most serious type of recall, indicating potentially serious medical problems may occur with the use of the product. Undesirable events related to this product should be reported to the FDA's MedWatch Adverse Events Reporting program online at http://www.fda.gov/medwatch/report.htm.

If you or a loved one has suffered from a failure of this device after surgery, please contact the qualified product liability attorneys at Schlichter, Bogard & Denton, LLP to discuss your legal options.

IDS Issues Recall for Products Containing Steroids

2009-12-24T07:45:00.000-08:00

IDS is a leading distributor of liquid protein supplements. On November 12, 2009, they initiated a voluntary recall of several products when the FDA discovered several ingredients considered to be steroids, which are classified as dangerous drugs. The undeclared substances include:

Madol
Turinabol
Androstenedione

These three ingredients are anabolic steroids known as designer steroids. They were marketed to athletes as performance-enhancing drugs before being banned by the FDA.

Anabolic steroids cause many serious medical problems including:

Acute liver injury
Shrinkage of testes
Male infertility
Masculinization of women
Stunted growth in children

There are several IDS products affected by the recall, namely:

Bromodrol
Dual Action Grow Tabs
Grow Tabs
Mass Tabs
Ripped Tabs TR

The recalled products were distributed in black boxes containing 60 count blister packs or white bottles with black labels containing 30 or 60 capsules.

So far, no illnesses or adverse reactions have been reported to IDS or the FDA regarding these products. Any adverse event should be reported to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch/report.htm.

If you or a loved one has suffered any adverse events after taking any of the products listed in greater detail at http://www.fda.gov/Safety/Recalls/ucm190446.htm, please contact the experienced dangerous drug litigators at Schlichter, Bogard & Denton. They represent clients nationwide in product liability and personal injury cases.

GMP Herbal Products Issues Recall for Weight Loss Supplement

2009-12-23T15:03:00.001-08:00

According to the FDA, the weight loss supplement Pai You Guo contains undeclared drug components. The FDA lab test showed sibutramine, an FDA-approved appetite suppressant. Tests also show that phenolphthalein, which is a solution used for experimentation and is a suspected carcinogen, is also present in the product. Since the product is not listed as a drug, but a dietary supplement, Pai You Guo is not known to be safe or effective as a weight loss agent.

The FDA advises that sibutramine is a dangerous substance that is known to increase blood pressure and pulse rate of some patients. Sibutramine poses a significant risk to people with a history of heart issues, such as:

Coronary artery disease
Congestive heart failure
Arrhythmias
Stroke

So far, no injuries or illnesses related to Pai You Guo have been reported to the company. To report adverse effects related to this product, please contact the FDA's MedWatch Program at 1-800-FDA-1088. Any unused product should be destroyed or returned to the company at 1-866-995-8585.

If you or a loved one has suffered any adverse affects from Pai You Guo, please contact the knowledgeable product liability attorneys at Schlichter, Bogard & Denton, LLP to understand your legal options. Schlichter, Bogard & Denton consults with customers nationwide.

FDA Investigates Vytorin

2009-12-22T15:15:00.000-08:00

Vytorin is a combination of simvastatin (Zocor) and ezetimibe (Zetia). Vytorin reduces the amount of cholesterol (a type of fat) absorbed by the body and block the production of cholesterol in the body.

In August 2008, the U.S. Food and Drug Administration (FDA) issued an Early Communication describing a possible association between the use of Vytorin and an increased risk of cancer and cancer-related death compared to placebo. The Early Communication was based on preliminary results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. FDA has now completed its review of the data from the SEAS trial as well as a review of recent data from two large-scale ongoing cardiovascular trials with Vytorin. Based on the currently available information, FDA believes it is unlikely that Vytorin increases the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out.

FDA is not advising healthcare professionals or consumers to stop using these medications, but to continue to evaluate the clinical benefits and potential risks of Vytorin or Zetia compared to other FDA-approved cholesterol lowering medications. Consumers should talk to their healthcare professional if they have any questions about Vytorin, Zetia, Zocor or the SEAS trial.

For more information about the FDA’s report, click here.

Cleviprex Lot Recall

2009-12-22T15:06:00.000-08:00

There has been a nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension. The recall is due to the potential presence of particulate matter found to be inert stainless steel particles. The particles could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.

Click here for the Medicines Company recall notice.

Class I Recall Initiated for Aortic Catheter

2009-12-22T15:02:00.000-08:00

Edwards Lifesciences Corporation notified its customers about a class I recall of its CardioVations EndoClamp Aortic Catheter. The devices involved in the recall were distributed from November 2008 through September 2009. The model numbers included in the recall are:

EC1001
EC65

The EndoClamp catheter is an important piece of equipment used during heart bypass surgery. The device blocks the aortic artery, delivers the solution that stops the heart during surgery, and monitors the aortic blood pressure. The problem is identified as a potential for the balloon catheters to burst spontaneously causing catastrophic and life threatening emergencies.

Obviously, heart bypass surgery is risky enough without introducing a life-threatening defect to one of the key components. Due to the severe nature of the defect and the potentially grave situation that may develop, the recall is classified as a Class I, the most serious type of recall on dangerous medical devices.

Healthcare facilities that use this product should isolate the remaining devices and contact Edwards Lifescience Corporation immediately to find out how to return the product. The customer phone number is, at 1-800-424-3278.

If you lost a loved one during a heart bypass surgery, it may be a result of a defective product like the CardiVations EndoClamp Aortic Catheter. If you suspect that this device contributed to the death of your loved one, please contact the experienced product liability attorneys at Schlichter, Bogard & Denton, LLP who work with clients nationwide.

RockHard Laboratories Initiates Recall of Dietary Supplement

2009-12-21T15:01:00.000-08:00

After conducting a voluntary lab test of its products, the FDA notified RockHard Laboratories that some of its products contained sulfoaildenfil, the main ingredient in many drugs used to treat erectile dysfunction. As a food supplement, this product is not approved by the FDA to manufacture drugs.

The presence of this agent makes the products sold under the name, RockHard Weekend, illegal drugs. After being notified of the lab results, RockHard Laborites initiated the voluntary recall of the following products:

Blister Pack: T12 705 08 (exp: 10/11) / T12 705 09 (exp: 3/12, 8/12)
3ct Bottle: R417 0509 (exp: 09/12)
8ct Bottle: T237-0509 (exp: 06/12)

Sulfoaildenfil may interact with other prescription drugs that contain nitrites and may dangerously lower blood pressure. People with the following problems often take prescriptions with nitrites and should avoid RockHard Weekend:

Diabetes
Heart disease
High cholesterol

RockHard identified the source of the banned component came from a one of the raw ingredients that came from China. Any adverse reaction to RockHard Weekend should be reported to the FDA's MedWatch Adverse Event reporting program at www.fda.gov/MedWatch/report.htm.

To get a refund or find out more about the recall, call the customer service line at 1-800-562-0543.

If you or a loved one suffered an adverse reaction from consuming RockHard Weekend, you should also contact a qualified pharmaceutical litigation attorney as soon as possible. Please contact Schlichter, Bogard & Denton, LLP to schedule an initial legal consultation.

Voluntary Recall of Liposyn and Propofol Issued

2009-12-20T14:57:00.000-08:00

Hospira, a global specialty pharmaceutical company, has notified the FDA of a voluntary recall of some of its products due to a manufacturing defect. Some of the vials of the following products may contain particulates matter from some of the stainless steel equipment used in the manufacturing process. The presence of these particulates may turn these into defective drugs. The specific products affected by the recall include 85 lots of the following:

Liposyn II 10%
Liposyn II 20%
Liposyn III 10%
Liposyn III 20%
Liposyn III 30%
Propofol Injectible Emulsion 1%

The affected lots were distributed between July 2009 and October 2009. There are no other products affected by this recall.

Liposyn is an intravenous fat emulsion used to increase fat levels for people who are unable to process fat due to illness. Lyposin provides calories and nutrients for patients who are unable to eat and must be fed through an IV.

Propofol is a short acting sedation agent that is administered intravenously. It is used for mechanically ventilated patients and general anesthesia.

The body is unable to dissolve the particulates found in the recalled products. Contaminated product may cause the following health problems:

Embolism
Thrombosis
Systemic Inflammatory Response Syndrome (SIRS)

The resultant restrictions in blood supply may lead to:

Stroke
Respiratory failure
Kidney failure
Liver failure
Heart attach
Death

Any adverse reactions resulting from these recalled products should be reported to the FDAs MedWatch Program at 1-800-FDA-1088. To find out more about this recall, and how to return products, please contact Hospira Customer Care at 1-877-946-7747.

If you or a loved one has suffered personal injury or died because of contaminated Liposyn, please contact the experienced drug litigation attorneys at Schlichter, Bogard & Denton, LLP.

More Pet Carousel Products may Contain Salmonella

2009-12-20T14:56:00.000-08:00

The Food and Drug Administration has issued a health alert for pig ear and beef hoof products manufactured by Pet Carousel. During routine inspection by the FDA, salmonella was discovered in these products. So far, no illnesses related to these products have been reported, but the FDA urges people not to use these potentially dangerous products as both human and animals may suffer from infection from these bacteria.

The affected products are known by the following brand names:

Doggie Delight
Pet Carousel
Choo Hooves
Dentley's
Doggie Delight

All sizes and lot numbers of these products are included in the health alert.

People who handle these products can become infected especially if they do not wash their hands thoroughly after contact with the treats. Healthy people who become infected may suffer some of the following signs and symptoms:

Nausea
Vomiting
Diarrhea
Abdominal cramps
Fever

In rare cases, more severe health issues may be related to salmonella infections, such as:

Endocarditis
Arterial infection
Muscle pain
Urinary tract symptoms

Your pets may also experience some of the same symptoms and may appear lethargic and have a decreased appetite.

To report complaints associated with these potentially dangerous products, please contact the FDA by calling a consumer complaint coordinator in your area. To find the contact information, please visit http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm

If you or a loved one has suffered illness after handling these products, please contact the skilled product liability attorneys at Schlichter, Bogard & Denton who handle cases nationwide.

Recalled Jelly Bellys Fail to List Peanut Ingredients

2009-12-19T14:55:00.000-08:00

On November 4, 2009 Jelly Belly Candy Company issued a recall of its 7.5 ounce packages of 49 Flavors Jelly Belly jellybeans. These packages failed to indicate that peanuts butter and peanut flour in the ingredients. This particular package is packaged in an acetate cylinder and has covers the following lot codes,

090925
090928
090929
091001

The UPC code for the product is 071567989398

People who suffer from peanut allergies need to be aware of all ingredients made from peanuts. Mild allergic reactions to peanuts may include hives, red itching skin, and digestive problems. Severe allergic reaction, called anaphylaxis, may occur in people with severe allergies, which may lead to death.

In order to mitigate liability for food containing dangerous ingredients, the company issued this voluntary recall. Consumers with peanut allergies who have purchased the 49 Flavors Jelly Belly jellybeans should return them to the company at the following address.

Jelly Belly Candy Company
One Jelly Belly Lane
Fairfield, CA 94533

You can also contact them through their customer hotline at 800-522-3267 Monday-Friday 7 am to 5 pm PST.

If you or someone you love has suffered injury or death related to this particular recalled product, please contact the experienced personal injury litigators at Schlichter, Bogard & Denton. They represent clients throughout the country.

Pediatric Tracheal Tubes Subject to Recall

2009-12-18T14:54:00.000-08:00

Centurion Medical Products and the FDA announced a recall of two types of pediatric tracheal tubes. The Premie Pack and Meconium Pack internal tube diameters are smaller than indicated on the label, which would cause problems when sizing the correct tube to use in life-threatening situations. The small diameter could may result in the airway being blocked by secretions and make it more difficult to ventilate the patient.

Tracheal tubes are used by emergency medical personnel to open restricted airways in patients with trauma or severe respiratory distress. The tracheal tubes help maintain an open airway and ensure adequate oxygen reaches the lungs.

The company has issued a voluntary recall of this potentially dangerous medical device. This particular recall is a class 1 recall, which is the most serious type. Continued use of the product may result in serious injury or even death. The recalled products were distributed between January 1, 2007 and September 22, 2009. Please visit the official FDA recall site, http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm188972.htm for more details on the specific lot and serial numbers.

To contact the company, please call them at 1-800-248-4058 Eastern Time.

Centurion Medical Products
301 Catrell Drive
Howell, Michigan 48843-1703

If your child suffered injury or died because of the improper use of this type of tracheal tube, or similar product, please contact the practiced personal injury attorneys at Schlichter, Bogard & Denton, LLP, a national leader in product defect litigation.

PetSmart Products Recalled for Potential Salmonella Contamination

2009-12-17T14:44:00.000-08:00

PetSmart is conducting a voluntary recall of two beef hoof products that may be contaminated with salmonella. The products that are being recalled were manufactured by Pet Carousel, Inc in Sanger California called Dentley's Beef Hooves. The specific products included in the recall are:

Dentley's Bulk Cattle Hoof UPC# 73725703323
Dentley's 10 Pack Beef Hooves UPC# 73725736055

The products covered are those purchased between October 2, 2009 and November 3, 2009. There are no other products included in this recall.

Salmonella is a bacterium that causes an infection called salmonellosis. Although these are pet products, people can become infected from handling the contaminated product or secondary to a pet's infection. People who are infected with salmonella develop the following health problems:

Diarrhea
Fever
Abdominal cramps

In some cases, the condition may warrant hospitalization. Elderly, people with immune deficiencies, and children are more susceptible to contracting salmonellosis than healthy adults are. Dogs may also be exposed to salmonella through contaminated products, which may then be transferred to their owner and family.

In order to protect itself from dangerous product liability PetSmart has issued this voluntary recall. To find out more about the recalled products, request a refund, or replacement for the above products, please contact PetSmart customer service at 1-888-839-9638.

If you have suffered from salmonella infection due to exposure to either of these products, please contact legal counsel from product liability attorneys, Schlichter, Bogard & Denton, LLP.

Ketorolac Tromethamine Injection Recalled by American Regent

2009-12-17T14:42:00.000-08:00

American Regent is conducting a voluntary recall on all lots of Ketorolac Tromethamine Injection, NDC# 0517-0601-25 15 mg/mL 1mL Single Dose Vial. This is an extension of a voluntary recall of all unexpired lots initiated in October of 2009.

Ketorolac Tromethamine Injection is a non-steroidal anti-inflammatory drug, NSAID, used to control moderate to severe pain in adults. The voluntary recall comes due to particulates that may be present as a result of crystallization. The company is concerned with the potentially dangerous side effects that may result if a contaminated dose is administered. Some of the dangers include:

Obstructed blood vessels leading to pulmonary embolism or thrombosis
Anaphylactic reactions
Granulomas
Local irritation

To find out how to return or get credit for recalled vials, please contact American Regent at 1-800-645-1706. To report any adverse reactions with the product, email pv@luitpold.com or send a fax to 610-650-7781, 610-650-0170, or call 1-800-734-9236. Adverse reactions should also be reported to the FDA's MedWatch Adverse Events Reporting program.

If you or someone you love has suffered a negative event related to the use of ketoralac tromethamine injection or another dangerous drug, please contact the product liability attorneys at Schlichter, Bogard & Denton who serve clients nationwide.