Plaintiffs Ask Department of Justice to Investigate Johnson & Johnson’s Destruction of Pelvic Mesh Documents

Posted in Transvaginal Mesh

As we have previously reported, plaintiffs have alleged that employees of Johnson & Johnson’s Ethicon unit, manufacturers of the Gynecare Prolift implant, mishandled documents related to the device. Plaintiffs recently asked the Department of Justice to launch an investigation into Ethicon’s handling of thousands of documents related to the device.

The consumer advocacy group, Corporate Action Network, wrote Attorney General Eric Holder to investigate whether Johnson & Johnson, based in New Brunswick, N.J., and CEO Alex Gorsky, committed the crimes of obstructing justice and destroying records in a federal probe. The Corporate Action Network said it plans to bring injured patients to speak at Johnson & Johnson’s annual shareholder meeting in late April.

If you or a loved one has experienced any injury from the use of a vaginal mesh implant, please contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Johnson & Johnson.

Court Orders Boehringer Ingelheim to Unseal Confidential Documents

Posted in Pradaxa®

The use of Pradaxa has been linked to serious injury. There are nearly 2,000 cases currently pending in federal court in the Southern District of Illinois. Pradaxa is a blood thinner that was marketed to replace warfarin, a commonly used anticoagulant. Unfortunately, there is no readily-available antidote for the internal bleeding that can sometimes occur in patients treated with Pradaxa.

As we have previously reported, Judge David R. Herndon, Chief Judge of United States District Court, presiding over the litigation, recently sanctioned the manufacturer of Pradaxa, Boehringer Ingelheim Pharmaceuticals, Inc., over $931,000 for failing to preserve documents. Plaintiffs’ attorneys were concerned that the German-based drug maker continued to improperly withhold other documents related to the drug. Judge Herndon agreed and on January 29, 2014, ordered Boehringer Ingelheim to unseal 85 documents which had previously been marked as confidential. Plaintiffs will continue to request information related to the safety and marketing of Pradaxa.

If you or a loved one has experienced serious side effects after taking Pradaxa, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Boehringer Ingelheim Pharmaceuticals, Inc.

C.R. Bard Pelvic Mesh Internal Memoranda Show Company Knew of Risks

Posted in Transvaginal Mesh

The litigation against manufacturers of pelvic mesh devices continues to increase nationwide. A pelvic mesh implant is a synthetic material implanted and tied to ligaments or bone to lift and support internal organs. The implants were introduced over a decade ago, and can serve as an alternative to a hysterectomy. Thousands of women, who were allegedly uninformed about the dangers involved with the mesh implants, have since complained of injuries, including severe pain, infections and bleeding that often require follow-up surgeries.

C.R. Bard, maker of the Avaulta pelvic mesh device, was recently involved in a dispute concerning the admissibility of several internal memoranda created by Bobby Orr, head of Bard’s Advanced Surgical Concepts Division. Back in 2008 and 2009, Orr drafted memoranda discussing various options and materials that could be used to make new pelvic mesh products safer. Plaintiff sought to introduce the memos in the jury trial of Carolyn Jones v. C.R. Bard to support her claim for design defect. The manufacturer argued the memos discussed hypothetical design changes that were discussed after the Avaulta device had been designed, shipped, and implanted in plaintiff. As such, the manufacturer argued the memos were not helpful to the issue of design defect and should be inadmissible.

The Court disagreed with these arguments and allowed plaintiff to introduce the memos at trial. The Court wrote that “While the Orr memoranda post-dated that critical point in time, each piece of scientific literature found in the memoranda was published prior to it. The pre-launch, peer-reviewed body of literature referenced by Mr. Orr, and his comments respecting it, may thus relate to what Bard should have known prior to launch and the feasibility of a then-safer alternative.” Accordingly, the memoranda were found to be admissible before the jury at trial.

If you or a loved one has experienced any injury from the use of a vaginal mesh implant, please contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against a manufacturer of the vaginal mesh device.

FDA Announces New Safety Assessment for Pradaxa

Posted in Pradaxa®

The dangers associated with Pradaxa use are well known. Since reaching the United States’ market in 2010, Pradaxa has been linked to hundreds of deaths. The Food and Drug Administration (FDA) has received numerous adverse event reports for injuries and complications from Pradaxa use.

Physicians and analysts have commented that the health risks associated with Pradaxa are significant. As Forbes reports, the FDA plans to address these lingering concerns. The FDA posted a request for public comment on a study it plans to conduct regarding the safety of Pradaxa. The study will “assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation.” The major purpose of the study is to identify groups of patients who are at high risk for major bleeding events with Pradaxa.

If you or a loved one has experienced serious side effects after taking Pradaxa, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Boehringer Ingelheim Pharmaceuticals, Inc.

New Study Confirms Januvia/Janumet, Byetta and Victoza Linked to Pancreatic Injuries

Posted in Byetta®, Januvia®/Janumet® and Victoza®

As we have previously reported, the American Diabetes Association (ADA) has asked all pharmaceutical companies involved in the development or marketing of incretin-based medications (Januvia/Janumet/Byetta/Victoza) to make patient level data on their products available for an independent review. Research into the safety of these incretin medications continues across the globe.

A recent study published in the medical journal, Expert Opinion on Drug Safety, confirms other U.S. studies that link incretin mimetic medications to pancreatic damage. The researchers from Ferrara, Italy, looked at 1,169 adverse drug reaction reports that concerned incretin mimetics and found 90 instances of pancreatitis and elevated pancreatic enzymes, with more than a third of those cases serious. This raises concerns that cases of chronic pancreatitis may lead to pancreatic cancer among some users.

If you or a loved one have suffered from pancreatitis or pancreatic cancer after taking Januvia/Janumet, Byetta or Victoza, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any potential claims.

Boehringer Ingelheim Sanctioned $931,000 for Destroying Documents

Posted in Pradaxa®

The use of Pradaxa has been linked to serious injury. There are nearly 2,000 cases currently pending in federal court in the Southern District of Illinois. Pradaxa is a blood thinner that was marketed to replace warfarin, a commonly used anticoagulant. Unfortunately, there is no readily-available antidote for the internal bleeding that can sometimes occur in patients treated with Pradaxa.

Judge David R. Herndon, Chief Judge United States District Court, presiding over the litigation, recently decided that Boehringer Ingelheim, maker of Pradaxa, had acted “in bad faith” by failing to preserve documents related to the drug’s development and marketing. Judge Herndon reportedly found that Boehringer’s behavior was “egregious” and “grossly inadequate” and justified a sanction of more than $931,000. Plaintiffs’ attorneys argued that Boehringer marketed Pradaxa knowing it could cause bleed-out deaths. It is alleged that Pradaxa is linked to more than 500 bleeding-related deaths over a two year period. In addition to the monetary penalties, Judge Herndon ordered Boehringer executives to turn over files and respond to additional document requests.

If you or a loved one has experienced serious side effects after taking Pradaxa, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Boehringer Ingelheim Pharmaceuticals, Inc.

Johnson & Johnson Accused of Destroying Critical Vaginal Mesh Documents

Posted in Transvaginal Mesh

As the vaginal mesh implant multidistrict litigation continues in West Virginia, attorneys for one of the bellwether plaintiffs recently filed a motion alleging that officials of Johnson & Johnson’s Ethicon unit, manufacturers of the Gynecare Prolift implant, lost or disposed of potentially hundreds of thousands of documents over the past decade despite orders to preserve the information. The filing was made as the parties gear up for trial, currently set for February 10, 2014 in Charleston, West Virginia federal court. The motion alleges that Ethicon employees admitted to the destroying documents. The motion asks the court to limit Ethicon’s ability to rely on various defenses in the bellwether and other trials.

If you or a loved one has experienced any injury from the use of a vaginal mesh implant, please contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Johnson & Johnson.

Vaginal Mesh Bellwether Dates Announced

Posted in Transvaginal Mesh

As we have previously advised, the vaginal mesh implant litigation continues to move forward nationwide. The next trial in the federal court litigation is scheduled for early December 2013, against C.R. Bard, Inc., one of the manufacturers of the mesh device. There are four other bellwether cases set for trial in 2014. A lawsuit involving Johnson & Johnson’s subsidiary Ethicon is also set for trial on February 10, 2014. Additionally, trials against Boston Scientific Corp. and American Medical Systems are set for March and April 2014. There are currently more than 30,000 pending lawsuits.

If you or a loved one has experienced any injury from the use of a vaginal mesh implant, please contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against a manufacturer of the vaginal mesh device.

Parties Preparing Consolidated Pleadings in Byetta, Januvia/Janumet and Victoza Litigation

Posted in Byetta®, Januvia®/Janumet® and Victoza®

As we have previously reported, the United States Judicial Panel on Multidistrict Litigation (JPML) granted multidistrict litigation (MDL) treatment to the incretin mimetic litigation, meaning that all federal lawsuits filed across the United States are now centralized in one judicial district. The incretin mimetic litigation, which includes the medications Byetta, Januvia/Janumet and Victoza, was centralized in the Southern District of California. This consolidation streamlines the pretrial discovery process, allowing the parties to avoid duplicative discovery and inconsistent rulings from different judges.

The Honorable Anthony J. Battaglia is presiding over the litigation in the Southern District of California. Judge Battaglia recently set deadlines for the parties regarding the composition of the Master Consolidated Answer. The court tentatively set December 31, 2013, as the deadline for when Defendants must file the Master Consolidated Answer.

If you or a loved one has suffered from pancreatic cancer after taking Byetta, Januvia/Janumet or Victoza, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any potential claims.

Court to Select Bellwether Cases in Pradaxa Federal MDL

Posted in Pradaxa®

As we have previously reported, the use of Pradaxa has been linked to serious injury.  There are nearly 600 cases currently pending in federal court in the Southern District of Illinois. Pradaxa is a blood thinner that was marketed to replace warfarin, a commonly used anticoagulant.  Unfortunately, there is no readily-available antidote for the internal bleeding that can sometimes occur in patients treated with Pradaxa.

Judge David R. Herndon, Chief Judge United States District Court, presiding over the litigation, recently signed Case Management Order 48. Judge Herndon ordered the parties to “designate up to three cases for inclusion as an early trial case” by December 16, 2013. The Court will select four cases for trial by January 23, 2014. The current trial dates for these cases are set for February 16, 2014; August 11, 2014; November 3, 2014 and January 5, 2015.

If you or a loved one has experienced serious side effects after taking Pradaxa, you can contact Stark & Stark and speak to one of the Mass Tort attorneys, free of charge, who can help assess any claims that you might have against Boehringer Ingelheim Pharmaceuticals, Inc.