Benicar Cases Selected by Court for Bellwether Trial Process in MDL

The U.S. District Judge presiding over all federal Benicar cases has selected the 30 lawsuits that will be part of a bellwether pool, which will go through case-specific discovery and be eligible for early test trials that will be scheduled in the growing litigation.

There are currently more than 1,100 product liability cases pending throughout the federal court system that involve allegations that Daiichi Sankyo and Forest Laboratories failed to adequately warn about the side effects of Benicar and other blood pressure medications containing the active ingredient olmesartan, such as Benicar HCT, Azor and Tribenzor.

Plaintiffs indicate that they developed severe and chronic diarrhea and other symptoms of a medical condition known as sprue-like enteropathy, which often resulted in the need for repeated hospitalization due to the lack of warnings indicating there was a connection between Benicar and diarrhea. As a result, many of the plaintiffs were left with permanent gastrointestinal damage, dehydration, malnutrition and other problems caused by Benicar.

Since April 2015, the federal Benicar injury cases have been consolidated for pretrial proceedings in the federal court system as part of a an MDL, or Multidistrict Litigation, which is centralized before U.S. District Judge Robert Kugler in the District of New Jersey to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts. Similar centralized proceedings were recently established in New Jersey state court as well, where about 100 additional Benicar cases are pending.

As part of the coordinated management of the Benicar litigation in the federal MDL, Judge Kugler has previously indicated that a small group of cases will be prepared for early trial dates, which will likely not begin until late 2017. Known as a “bellwether” process, focusing case-specific discovery on a small pool of cases and holding a series of test trials is 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 other Benicar cases.

In advance of a status conference held on December 16, Judge Kugler sent a letter (PDF) to all counsel involved in the Benicar litigation last week, identifying the 30 cases that were randomly selected by the Court for the bellwether bool.

By January 22, plaintiffs and defendants will each be allowed to strike five cases each from the bellwether pool, leaving a total of 20 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 risk of Benicar problems for years, yet placed their desire for profits before consumers safety by withholding the information.

Following the bellwether trial process, if the drug makers fail to reach Benicar 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.