Benicar Injury Claims to be Selected by Court for Bellwether Discovery Pool in MDL

A group of thirty Benicar injury lawsuits will be selected by the U.S. District Judge presiding over the litigation to go through case-specific discovery, as part of a bellwether trial process for cases involving allegations that the popular blood pressure drug caused users to suffer chronic diarrhea and other gastrointestinal problems.

Since April 2015, all Benicar claims filed throughout the federal court system have been consolidated for pretrial proceedings as part of an MDL, or Multidistrict Litigation, with the cases centralized before U.S. District Judge Robert Kugler in the District of New Jersey to reduce duplicative discovery into common issues in the cases, avoid the risk of conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

There are currently more than 1,000 claims pending in the MDL, each raising similar allegations that Daiichi Sankyo and Forest Laboratories failed to adequately warn about the side effects of Benicar, which have been linked a serious medical condition known as sprue-like enteropathy. This may cause users to experience chronic and severe diarrhea problems, which may surface months or even years after first use of the medication.

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Side Effects of Benicar May Cause Diarrhea, Villous Atrophy and Sprue-Like Enteropathy

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As part of the coordinated management of the Benicar litigation, Judge Kugler has indicated that a small group of cases will be prepared or early trial dates, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout a number of similar injury claims.

In a case management order (PDF) issued on Monday, Judge Kugler announced that the court will randomly select 30 cases by January 8, 2016, which will be part of an initial bellwether discovery pool. The selections will come from cases filed on or before December 31.

By January 22, plaintiffs and defendants will each be allowed to strike five cases each from the pool, leaving a total of 20 bellwether claims that will go through case-specific discovery in preparation for the first test trials.

Benicar Health Risks

The Benicar claims have emerged since the FDA required Daiichi Sankyo and Forest to update the warning labels for the popular family of blood pressure drugs in July 2013.

At that time, the drug makers were required to update the Benicar warning label to alert users about the risk of chronic diarrhea and sprue-like enteropathy.

Although the medication had been on the market for more than ten years, this was the first notice provided to consumers or the medical community that diarrhea symptoms may be caused by Benicar. As a result of inadequate warnings previously provided by Daiichi Sankyo and Forest, plaintiffs allege that doctors could not recognize that the blood pressure medication may be the cause of severe symptoms experienced by patients.

Based on adverse event data that has been available to the drug makers for years, FDA officials now indicate that they believe there is “clear evidence” that Benicar causes some users to suffer chronic diarrhea, abdominal pain, weight loss and other gastrointestinal symptoms, which typically resolve when the medication is no longer used. However, after experiencing these problems over long-periods of time, users may face a risk of suffering villous atrophy from Benicar, which results in permanent gastrointestinal problems and reduced digestive capability, leading to chronic malnourishment and dehydration.

Plaintiffs in the lawsuits allege that Daiichi Sankyo and Forest Laboratories knew or should have known about the link between Benicar and diarrhea problems for years, yet placed their desire for profits before consumers safety by withholding the information.

In addition to cases pending in the federal MDL, there are also a growing number of complaints filed at the state level in New Jersey, where the drug maker is based. According to a request filed on May 26, which seeks to establish similar centralized management for Benicar cases in New Jersey, there were at least 59 cases pending in the state court system.

Following the bellwether trial process, if the drug makers fail to reach Benicar injury settlements or otherwise resolve the litigation, hundreds of individual cases may be remanded back to U.S. District Courts nationwide for separate trial dates to determine whether a failure to warn about the Benicar risks caused the plaintiff’s injury.


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