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.

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.

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.

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:

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.