Tuesday, October 16, 2012

New England Compounding Center Meningitis Outbreak Update

As of October 16, 2012, the CDC is now reporting 233 cases of meningitis and 15 deaths associated with New England Compounding Center's methylprednisolone acetate steroid injection. Tennessee remains the hardest hit state, but the numbers are climbing in Michigan,Virginia, and Indiana. In addition to the Aspergillus fungus, the Exserohilum fungus has also been identified as the causal organism in many cases.

Now the FDA is investigating reports of fungal infections associated with some of NECC's other products. One patient has developed meningitis symptoms after receiving a back injection with a different steroid, triamcinolone acetone. Two heart transplant patients have suffered fungal infections after receiving cardioplegic solution from NECC during open heart surgery. The FDA is also concerned about NECC products used during eye surgery, and is investigating NECC's ophthalmic drugs.

If you or a loved one has been injured as a result of receiving a contaminated pharmaceutical product, contact the attorneys at Schlichter, Bogard & Denton for a free evaluation.

posted by Beth Wilkins at 3:02 PM

Tuesday, October 9, 2012

105 injured and 8 dead as a result of contaminated steroid injections. Up to 13,000 people at risk.

The Centers for Disease Control and Prevention (CDC) has reported an outbreak of fungal meningitis in patients who have received epidural steroid injections. So far, 105 cases of meningitis have been identified and eight people have died. Several people have suffered strokes related to the meningitis. Thousands more may be affected, as 13,000 patients may have received the recalled product.

The meningitis outbreak has been linked to three contaminated lots of a steroid injection called Preservative-Free Methylprednisolone Acetate. Methylprednisolone Acetate is an injectable steroid medication generally given in hospital or outpatient settings. It is used to relieve chronic back pain and inflammation.

The contaminated steroids are manufactured by the New England Compounding Center (NECC), a pharmacy located in Framingham, Massachusetts. Outbreaks have occurred across  the country, as the contaminated steroid injections were distributed in 23 states, including California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, and West Virginia. A list of the clinics, hospitals, and healthcare facilities that have received the recalled Methylprednisolone Acetate PF is available on the CDC's website, http://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html , and is also provided below.

Meningitis is a serious infection which causes an inflammation of the protective membranes that surround the brain and spinal cord. Usually, meningitis is caused by a bacteria or a virus. This meningitis outbreak initially baffled doctors when affected patients did not respond to antibiotics that are usually used to treat meningitis. The antibiotics failed because this meningitis outbreak is caused by Aspergillus, a fungus, and not a bacteria.
Fungal meningitis is very rare, and usually only occurs in patients who have compromised immune systems. However, this outbreak has occurred in otherwise healthy patients. Doctors soon realized that these patients shared a commonality--- they had recently received epidural steroid injections. The infections were then traced to the steroids, which were contaminated with Aspergillus.

Unlike more common cases of meningitis, this meningitis is not contagious. However, if you have recently received a spinal steroid injection and are suffering meningitis symptoms, the CDC recommends that you seek medical care quickly. Symptoms include headache, fever, nausea, stiff neck, confusion, dizziness, and aversion to bright lights.

If you or a loved one has been injured as a result of receiving a contaminated steroid injection, contact the pharmaceutical attorneys at Schlichter, Bogard & Denton for a free evaluation of your potential claim. 

FACILITIES THAT RECEIVED RECALLED CONTAMINATED STEROIDS


FACILITY CITY STATE
CYPRESS SURGERY CENTER DBA VISALIA CA
ENCINO OUTPATIENT SURGICENTER ENCINO  CA
UKIAH VALLEY MEDICAL CENTER UKIAH CA
UNIVERSAL PAIN MANAGEMENAT PALMDALE CA
INTERVENTIONAL SPINE AND SPORTS MED MIDDLEBURY CT
FLORIDA PAIN CLINIC OCALA FL
INTERVENTIONAL REHAB CENTER PENSACOLA FL
MARION PAIN MANAGEMENT CENTER OCALA FL
NORTH COUNTY SURGICENTER PALM BEACH GARDENS FL
ORLANDO CENTER FOR OUTPATIENT SURGERY ORLANDO FL
PAIN CONSULTANTS OF WEST FLORIDA PENSACOLA FL
SURGERY CENTER OF OCALA OCALA FL
SURGICAL PARK CENTER MIAMI FL
FORSYTH STREET AMBULATORY SURG. CTR. MACON GA
PAIN SPECIALISTS OF IDAHO IDAHO FALLS ID
WALTER KNOX MEMORIAL HOSPITAL EMMETT ID
APAC CENTERS FOR PAIN MANAGEMENT WESTCHESTER IL
APAC CENTERS FOR PAIN MANAGEMENT- CHICAGO IL
THOREK MEMORIAL HOSPITAL CHICAGO IL
AMBULATORY CARE CENTER LLC EVANSVILLE IN
FORT WAYNE PHYSICAL MEDICINE FORT WAYNE IN
OSMC OUTPATIENT SURGERY CENTER ELKHART IN
SOUTH BEND CLINIC SOUTH BEND IN
UNION HOSPITAL-- TERRE HAUTE IN
WELLSPRING COLUMBUS IN
BALTIMORE PAIN MANAGEMENT BALTIMORE MD
BERLIN INTERVENTIONAL PAIN MANAGEMENT BERLIN MD
BOX HILL SURGERY CENTER ABINGDON MD
GREENSPRING SURGERY CENTER BALTIMORE MD
HARFORD COUNTY ASC, LLC EDGEWOOD MD
PAIN MEDICINE SPECIALISTS TOWSON MD
SURGCENTER OF BEL AIR BEL AIR MD
MICHIGAN NEUROSURGICAL INST. GRAND BLANC MI
MICHIGAN PAIN SPECIALISTS BRIGHTON MI
NEUROMUSCULAR & REHABILITATION TRAVERSE CITY MI
SOUTHEAST MICHIGAN SURGICAL HOSPITAL WARREN MI
MAPS-EDINA MEDICAL PAIN CLINIC MINNEAPOLIS MN
MAPS-MEDICAL ADVANCED PAIN FRIDLEY MN
MEDICAL ADVANCED PAIN SPECIALISTS* SHAKOPEE MN
MEDICAL ADVANCED PAIN SPECIALISTS. MAPLE GROVE MN
MINNESOTA SURGERY CENTER EDINA MN
MINNESOTA SURGERY CENTER- MAPLE GROVE MN
HIGH POINT SURGERY HIGH POINT NC
NORTH CAROLINA ORTHOPAEDIC CLINIC DURHAM NC
SURGERY CENTER OF WILSON WILSON NC
DR. O'CONNELL'S PAIN CARE CTR MERRIMACK NH
DR. O'CONNELL'S PAINCARE CENTERS, INC SOMERSWORTH NH
CENTRAL JERSEY ORTHOPEDICS SPECIALISTS PC SOUTH PLAINFIELD NJ
EDISON SURGICAL CENTER EDISON NJ
IF PAIN ASSOCIATES / ISAIAH FLORENCE TEANECK NJ
PREMIER ORTHOPEDICS SURG. ASSOC., LLC VINELAND NJ
Comprehensive Pain Management SPARTA NJ
SOUTH JERSEY HEALTH CARE ELMER NJ
SOUTH JERSEY HEALTHCARE VINELAND NJ
SAHARA SURGERY CENTER LAS VEGAS NV
BUTANI, SUNIL H. PHYSICIAN PC MINEOLA NY
OBOSA MEDICAL SERVICES MOUNT VERNON NY
ROCHESTER BRAIN AND SPINE ROCHESTER NY
BKC PAIN SPECIALISTS,LLC MARION OH
CINCINNATI PAIN MANAGEMENT CINCINNATI OH
MARION PAIN CLINIC MARION OH
ORTHO-SPINE REHAB. CENTER, INC. DUBLIN OH
ALLEGHENY PAIN MANAGEMENT ALTOONA PA
SOUTH HILLS PAIN & REHAB ASSOC. JEFFERSON HILLS PA
NEW ENGLAND ANESTHESIOLOGY (NEA) WARWICK RI
OCEAN STATE PAIN MANAGEMENT WOONSOCKET RI
OCEAN STATE PAIN MANAGEMENT- EAST GREENWICH RI
INTERVENE MD MOUNT PLEASANT SC
PCA PAIN CARE CENTER- OAK RIDGE TN
SPECIALTY SURGERY CENTER CROSSVILLE TN
ST. THOMAS OUTPATIENT NEUROSURGIACL NASHVILLE TN
DALLAS BACK PAIN MANAGEMENT DALLAS TX
HARRIS METHODIST SOUTHLAKE CENTER SOUTHLAKE TX
INSIGHT IMAGING-ROANOKE ROANOKE VA
NEW RIVER VALLEY SURGERY CENTER CHRISTIANSBURG VA
PARS INTERVENTIONAL PAIN PARKERSBURG WV







posted by Beth Wilkins at 2:05 PM

Friday, September 28, 2012

Roger Denton Appointed by Federal Judge Herndon to serve as Co-Lead of the Pradaxa Litigation

In an order dated September 27, 2012, Schlichter Bogard and Denton’s partner Roger Denton has been appointed to serve as the Plaintiffs’ Co-Lead Counsel for In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation (MDL 2385). The Pradaxa MDL was created by the U.S. Judicial Panel on Multidistrict Litigation on August 18, 2012. The MDL Panel consolidated all actions which share common factual questions arising out of allegations that plaintiffs suffered severe bleeding or other injuries as a result of taking the drug Pradaxa and that defendants did not adequately warn prescribing physicians of the risks associated with Pradaxa, including the potential for severe or fatal bleeding, and that there is no reversal agent to counteract the Pradaxa’s anticoagulation effects.

As Plaintiffs’ Co-Lead Counsel, Roger is charged with responsibilities including (but not limited to) initiating, coordinating and conducting all pretrial discovery on behalf of all plaintiffs, negotiating and entering into stipulations with defendants regarding the Pradaxa litigation, and acting as a spokesperson for all plaintiffs at pretrial proceedings and in response to any inquires by the Court.

Along with his duties as Co-Lead Counsel, Roger represents individuals who have been injured by Pradaxa. If you or someone you know has been injured by Pradaxa please contact the attorneys at Schlichter, Bogard & Denton to discuss your case.

Labels: , , , , , ,

posted by Megan M. McBride at 4:14 PM

Friday, August 17, 2012

Pradaxa Orders Issued in MDL 2385

Judge Herndon, of the Southern District of Illinois, has issued three case management orders relating to In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL number 2385.

The Initial Conference Order and Procedural Matters (CMO #1), Confidentiality Order (CMO #2), and Order Governing the Format of Production (CMO #3), were entered less than ten days after the JPML transferred the MDL to Judge Herndon. The Panel transferred the cases to Judge Herndon because of his "willingness" and "ability" to handle this litigation. These orders, and the speed in which they were entered, highlight Judge Herndon's committment to the "expeditious resolution of this litigation". See MDL 2385 CMO #1.

Judge Herndon set the Initial Conference for October 3, 2012 at 1:30 p.m. in Courtroom 7 in the United States Courthouse for the Southern District of Illinois. Prior to the Conference, Judge Herndon expects Counsel for the Parties to meet and discuss a number of issues including a timetable for dispositive motions, issues relating to the preservation of discoverable information, and issues relating to privileges, to name a few. Roger Denton, of Schlichter Bogard and Denton has been coordinating with Counsel for Defendant Boehringer Ingelheim Pharmaceuticals, Inc. ("BIPI")(the manufacturer of Pradaxa) since cases were originally filed in the Southern District of Illinois.

These orders, and all other CMOs filed in the MDL relate to all cases filed in the Southern District of Illinois and any "tag along actions" later filed in, removed to, or transferred to Judge Herndon's court.


Labels: , , , , , , ,

posted by Megan M. McBride at 3:28 PM

Thursday, August 9, 2012

Judge Herndon Denies BIPI's Motions to Dismiss

Defendant Boehringer Ingelheim Pharmaceutials, Inc. ("BIPI") filed Motions to Dismiss in every case filed against the company. BIPI argued that the Plaintiffs failed to allege a cause of action in the Complaints against the company. BIPI argued in their Motions that the Pradaxa label properly warned against severe gastrointestinal bleeding, hemorrhagic stroke, and death (as a result of severe or excessive bleeding). In response, Schlichter Bogard and Denton, and a handful of firms located around the country, filed Oppositions to the Motions to Dismiss. Judge Herndon, of the Southern District of Illinois ruled in favor of the Plaintiffs on all counts. This means Plaintiffs are permitted to pursue their claims against BIPI.

By way of background, Pradaxa is a blood thinning(anticoagulant) prescription medication used to lower the chance of stroke in individuals with atrial fibrillation. Pradaxa was approved by the FDA in October 2010 and is manufactured by the Germany-based pharmaceutical company Boehringer Ingelheim. BIPI is the U.S. division of Boehringer Ingelheim responsible for the marketing and sales of Pradaxa.

Since approval, some studies have indicated the risk of gastrointestinal bleeding and hemorrhagic stroke is greater than what was reported in Boehringer Ingelheim's label. Consequently, attorneys at Schlichter, Bogard & Denton represent individuals in the Pradaxa litigation. If you or someone you know has been injured by Pradaxa please contact the attorneys at Schlichter, Bogard & Denton to discuss your case.

posted by Megan M. McBride at 7:23 AM

Wednesday, August 8, 2012

Pradaxa MDL Transferred to Judge Herndon (Southern District of Illinois)

Due to the large number of Pradaxa cases and likely hundreds more which we anticipate will be filed, a process has been established for consolidating the cases filed in the federal court system before a single judge for purposes of pre-trial discovery.

Attorneys from around the country, including Schlichter Bogard and Denton's Roger Denton, presented oral argument before the Judicial Panel on Multi-District Litigation (“JPML”) in July. Roger Denton requested that these cases be filed or transferred to Southern District of Illinois before Chief Judge David Herndon. The Judicial Panel on Multi-District Litigation (“JPML”) entered an Order on August 8, 2012 agreeing with our firm's request and assigned the cases to Judge Herndon. Judge Herndon will now be responsible for overseeing and coordinating all pre-trial discovery issues.

Attorneys at Schlichter, Bogard & Denton represent individuals in the Pradaxa litigation. If you or someone you know has been injured by Pradaxa please contact the attorneys at Schlichter, Bogard & Denton to discuss your case.

Typical injuries include the following:


•gastrointestinal bleeding
•kidney failure
•hemorrhagic stroke; and
•death (as a result of severe or excessive bleeding)


Please contact our experienced pharmaceutical drug attorneys for a free consultation.

posted by Megan M. McBride at 4:20 PM

Wednesday, May 23, 2012

VTE RISK IN NUVARING (UPDATED)

On May 10, 2012, the British Medical Journal published a new follow-up study by Dr. Øjvind Lidegaard entitled “Venous Thrombosis in Users of Non-Oral Hormonal Contraception: Follow-Up Study, Denmark 2001-10.” Øjvind Lidegaard et al., Venous Thrombosis in Users of Non-Oral Hormonal Contraception: Follow-Up Study, Denmark 2001-10, 344 BRIT. MED. J. 2990 (2012), available at http://www.bmj.com/highwire/filestream/583967/field_highwire_article_pdf/0.pdf. The study analyzed the relative risk of venous thrombosis events (VTE) in 1,626,158 women from 2001 to 2010. It concluded that the relative risk of VTE in users of vaginal rings was 6.5 times higher than non-users of hormonal contraception, and 1.9 times higher than users of combined oral contraceptives.

NuvaRing is a vaginal contraceptive product of the kind referenced in this study. It was approved by the Food and Drug Administration (FDA) in 2001, and is composed of two active components: the progestin etonogestrel, and the estrogen ethinyl estradiol. Drug Approval Package: NuvaRing, U.S. FOOD & DRUG ADMIN. (Nov. 8, 2001), available at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-187_NuvaRing.cfm.

Dr. Lidegaard’s conclusions are not new as “[a] recent study reported a…higher risk of [VTE] in women using a vaginal ring.” See OFFICE OF SURVEILLANCE & EPIDEMIOLOGY, U.S. FOOD & DRUG ADMIN., CHC-CVD-111022, COMBINED HORMONAL CONTRACEPTIVES (CHCS) AND THE RISK OF CARDIOVASCULAR DISEASE ENDPOINTS (2011), available at http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf. Dr. Lidegaard’s study, therefore, further clarified the existing statistics linking the NuvaRing to VTE. Taking these statistics in collectively, there is ample evidence demonstrating the potential adverse effects the NuvaRing may have on women.

Rapid responses to Dr. Lidegaard’s article were published by Dr. Samuel Shapiro, Dr. Jane Skov, Dr. Anne Szarewski, Dr. Julie M. Chandler, and Dr. Mary E. Gaffield. Some of these authors have been affiliated with the pharmaceutical industry. It is unclear whether the critics of Dr. Lidegaard’s article reviewed the study or its data in detail prior to posting their “rapid responses,” all of which were posted only days after Dr. Lidegaard’s study was published.

At this time, despite this study, the NuvaRing label states “[i]t is unknown if NuvaRing has a different risk of venous thromboembolism than second generation oral contraceptives.” It is unclear whether the manufacturer of NuvaRing intends to update its label in accordance with this study’s findings in the near future.

Attorneys at Schlichter, Bogard & Denton have extensive knowledge in the NuvaRing litigation as they are members of the Multidistrict Litigation (MDL) Executive Committee, and represent clients from around the country. Attorneys at Schlichter, Bogard & Denton also represent women in the YAZ birth control pill litigation, and have represented women in the Ortho Evra birth control patch litigation. If you or someone you know has been injured by NuvaRing or any other form of birth control, please contact the attorneys at Schlichter, Bogard & Denton to discuss your case.

posted by Megan M. McBride at 7:23 AM

Tuesday, May 22, 2012

Pradaxa Study RE-LY Not So Reliable

Recent journal articles have questioned the reliability of the Randomized Evaluation of Long-Term Anticoagulant Therapy (“RE-LY”) study, which gave dabigatran, also known as Pradaxa, its footing in the Atrial Fibrillation (“AF” or “A. Fib”) market. Coleman et al., Effect of Pharmacological Therapies for Stroke Prevention on Major Gastrointestinal Bleeding in Patients with Atrial Fibrillation, 66 INT. J. CLIN. PRAC. 53 (2012), available at http://onlinelibrary.wiley.com/doi/10.1111/j.1742-1241.2011.02809.x/pdf; Dabigatran for Atrial Fibrillation: Why We Can Not Rely on RE-LY, 80 THERAPEUTICS INITIATIVE (Mar. 2011), available at http://www.ti.ubc.ca/letter80; and Mitchel L. Zoler, Dabigatran Outperforms Warfarin in AF Patients, FAMILY PRACTICE NEWS (2009), available at http://www.familypracticenews.com/news/more-top-news/single-view/dabigatran-outperforms-warfarin-in-af-patients/4ad2891e9f152480694b7f1f0defbb34.html. The RE-LY study was a global, phase III, randomized trial of 18,113 patients designed to compare the safety and efficacy of two dosages of Pradaxa against warfarin in AF patients. Boehringer Ingelheim Pharmaceuticals funded the RE-LY study while developing Pradaxa.

PRADAXA’S HIGH RATE OF GASTROINTESTINAL BLEEDING IN CHALLENGED RE-LY STUDY
A 2012 study in Internal Journal of Clinical Practice, “Effect of Pharmacological Therapies for Stroke Prevention on Major Gastrointestinal Bleeding in Patients with Atrial Fibrillation,” questioned both the RE-LY study’s reliability and Pradaxa’s safety. This study searched research databases for randomized and controlled studies evaluating adults with AF in order to assess Pradaxa’s safety. This paper questioned whether RE-LY was subject to surveillance bias, bias which occurs when one group is followed more closely than another. Additionally, the paper noted that in RE-LY, Pradaxa showed increased rates of major gastrointestinal bleeding compared with warfarin, a serious concern. Whatever questions there might be about the reliability of the RE-LY study, the fact is that current data suggests that Pradaxa is associated with one of the highest rates of major gastrointestinal bleeding.

ALONG WITH PRADAXA’S SAFETY CONCERNS, RE-LY STUDY METHODS QUESTIONABLE
A 2011 letter in Therapeutics, “Dabigatran for AF: Why We Cannot Rely on RE-LY”, challenged both the RE-LY study’s data and its methods. Not only was the 150 mg dose of Pradaxa more harmful in that it caused a 1.1% absolute increase in bleeding leading to hospitalization, but warfarin outperformed Pradaxa in almost every outcomes category looked at in the study. Recent trials suggest the RE-LY data concerning Pradaxa’s superiority to warfarin with regard to intracranial hemorrhaging is questionable. Multiple comparable studies have shown significantly lower incidences of intracranial hemorrhaging than what was found in the RE-LY study. That’s not the only questionable data in the RE-LY study. The FDA clinical reviewer found that some investigator sites inadequately monitored warfarin, which lead the study to a false conclusion that warfarin had an increased mortality trend. When warfarin monitoring was actually within the therapeutic range suggested for warfarin usage, relative mortality risks favored warfarin over Pradaxa a majority of the time.

The RE-LY study’s methods have also been questioned. The study was not blinded between the Pradaxa and warfarin protocols, meaning both the investigator and the trial participant knew which drug the participant was taking. The fact that the study was not entirely blinded subjects the study to performance bias, which is the “differential treatment of patients during the study period”, and ascertainment bias, which is the failure to equally represent all classes of cases supposed to be represented in a sample. In fact, the FDA found these biases sufficient to invalidate RE-LY’s claim that the 150 mg dose of Pradaxa was superior in reducing the risk of stroke as compared with warfarin. These types of bias are not just theoretically damaging to a drug’s claimed benefits because empirical evidence demonstrates these types of bias have affected drug trial results. A similar drug, ximelagatran, manufactured by AstraZeneca was shown to have significantly lower risk factors in an unblinded study than it had in a follow-up double blinded trial. Furthermore, participants in the RE-LY study used other drugs which affect the incidence of major bleeding during the trial, creating even more questions about the reliability of the study.

RE-LY’S SUPPORTERS CONFLICTED
While an older article published in Family Practice News, “Dabigatran Outperforms Warfarin in AF Patients,” discusses Pradaxa’s performance in the RE-LY study in a more favorable light, one cannot overlook the fact that all of the doctors praising Pradaxa have ties to the pharmaceutical industry. Specifically, three of the five doctors, Dr. Connelly, Dr. Camm and Dr. Wallentin, received funds from Boehringer Ingelheim Pharmaceuticals, the company which developed Pradaxa. The only doctor, Dr. Yancy, cited in the article without ties to the pharmaceutical industry was the doctor who discussed the concerns with Pradaxa. Dr. Yancy also pointed out the increased risk of gastrointestinal bleeding, as highlighted in the 2012 article.

These more recent studies highlight the questionable methods and suspect data that makes the RE-LY study unreliable. They also call attention to the Pradaxa risks not fully analyzed in its pioneer study.

Attorneys at Schlichter Bogard and Denton are investigating whether Pradaxa is associated with an increase in severe bleeding compared to warfarin. If you or someone you know has been injured by Pradaxa, please contact the product liability lawyers of Schlichter, Bogard & Denton today to discuss your case.

posted by Megan M. McBride at 11:10 AM

Monday, May 14, 2012

PRADAXA CASES FILED

Eight cases have been filed by individuals for personal injuries against Defendants Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Corporation, Boehringer Ingelheim USA Corporation, and Boehringer Ingelheim Vetmedica, Inc., the manufacturers of Pradaxa. Pradaxa is a direct thrombin inhibitor that is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The complaints allege there is an increased risk in severe bleeding for users of Pradaxa compared to Warfarin. Boehringer Ingelheim Corporation marketed Pradaxa® as being more effective than warfarin in preventing stroke and systemic embolism, providing a convenient alternative to warfarin therapy because it does not require blood monitoring or dose adjustments, and does not require any dietary restrictions. The complaints also allege the Defendants failed to warn emergency room doctors, surgeons and other critical care medical professionals that unlike generally-known measures taken to treat and stabilize bleeding in users of warfarin, there is no effective agent to reverse the anticoagulation effects of Pradaxa, and therefore no effective means to treat and stabilize patients who experience uncontrolled bleeding while taking Pradaxa. Attorneys at Schlichter, Bogard and Denton, LLP are investigating claims associated with Pradaxa for individuals who have experienced brain hemorrhage, severe bleeding, and for families who have lost a loved one after taking Pradaxa. If you or someone you know has been injured by Pradaxa please contact the product liability lawyers of Schlichter, Bogard & Denton today to discuss your case.

posted by Megan M. McBride at 1:47 PM

Thursday, May 10, 2012

VTE RISK IN NUVARING

On May 10, 2012 the British Medical Journal published Dr. Lidegaard's "Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10" which concludes "use of transdermal patches and vaginal rings conferred incidence rates of 9.7 and 7.8 confirmed venous thromboses per 10 000 exposure years, and relative risks of 7.9 and 6.5 compared with non-use of hormonal contraception, respectively." Lidegaard Ø, et al "Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10" BMJ 2012; DOI:10.1136/bmj.e2990. In addition to comparing users of NuvaRing to non-users of birthcontrol, Dr. Lidegaard's study compares NuvaRing to users of combined oral contraceptives containing levonorgestrel and found the adjusted relative risk of venous thrombosis in users the vaginal ring was 1.9 (1.3 to 2.7). At this time, the NuvaRing label states: "It is unknown if NuvaRing® has a different risk of venous thromboembolismt han second generation oral contraceptives." It is unclear whether the company will update their label in order to include this study's findings.

posted by Megan M. McBride at 4:36 PM

Tuesday, May 1, 2012

PRADAXA INJURIES

Pradaxa® (dabigatran) was approved by the FDA in 2010 as an anticoagulant for reducing the risk of stroke in patients with non-valvular Atrial fibrillation (AF or A-fib). Since approval, Pradaxa has been linked to several deaths and reports of severe bleeding. In December 2011, the FDA began a formal investigation into reports of Pradaxa injuries resulting in death. There has been over 260 reports of fatalities while on Pradaxa and several other injuries associated with the anticoagulant including severe bleeding. The FDA is investigating whether the incidence of bleeding among patients prescribed Pradaxa is higher than what would be expected based on the Pradaxa clinical trials. The most serious side effects associated with Pradaxa include internal bleeding that can lead to death. Patients taking Pradaxa sould be aware of the signs and symptoms of internal bleeding. Pradaxa is manufactured by the German based pharmaceutical company Boehringer Ingelheim GmbH. The company reported last week that it expects sales to rise by a high-single-digit percentage this year as a partial result of its sales of Pradaxa. Boehringer said its sales grew 5% to EUR 13.2 billion. Attorneys at Schlichter, Bogard and Denton, LLP are investigating claims associated with Pradaxa for individuals who have experienced brain hemorrhage, severe bleeding, and for families who have lost a loved one after taking Pradaxa. If you or someone you know has been injured by Pradaxa please contact the product liability lawyers of Schlichter, Bogard & Denton today to discuss your case.

posted by Megan M. McBride at 9:36 AM

Tuesday, October 19, 2010

New Tylenol Recall

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.


posted by Nathan Graber at 1:33 PM

Monday, October 11, 2010

Diet Drug Meridia Pulled from US Market

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 15th 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.

posted by Nathan Graber at 4:52 PM

Wednesday, October 6, 2010

Novartis Agrees to $422.5 Million Settlement

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.

posted by Nathan Graber at 1:31 PM

Tuesday, October 5, 2010

FDA Places Harsh Restrictions on Avandia

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 23rd 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.

posted by Nathan Graber at 3:45 PM

Archives

Drug Injury and Recall Blog

Dangerous and Defective Pharmaceutical Products

1.800.873.5297 Email Us

Welcome to the dangerous prescription drugs website of Schlichter, Bogard & Denton,
please upgrade your Flash Plugin and enable JavaScript to see our pharmaceutical injury video.