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Litigation in 1,250 Lawsuits Over Benicar Diarrhea Problems Moving Forward

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Discovery and other pretrial proceedings are continuing in more than 1,250 Benicar lawsuits filed in the federal court system, involving allegations that the popular blood pressure drug caused individuals to suffer chronic diarrhea, malnutrition and other side effects of a serious medical condition known as sprue-like enteropathy.

Since April 2015, complaints filed in U.S. District Courts nationwide have been consolidated for pretrial proceedings in the District of New Jersey as part of an MDL, or multidistrict litigation. The cases are centralized before U.S. District Judge Robert Kugler to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the judicial system.

Each of the lawsuits involve similar allegations that Daiichi Sankyo and Forest Laboratories failed to adequately warn consumers and the medical community about the risk that side effects of Benicar may cause chronic diarrhea and weight loss, often occurring months or even years after first use of the drug.

Plaintiffs claim that because doctors were unaware that the severe symptoms were being caused by the blood pressure drug, they have suffered severe and long-term gastrointestinal problems from Benicar.

Lawyers involved in the litigation are scheduled to meet with Judge Kugler today for a status conference, to update the court on the coordinated pretrial proceedings and the preparations for a small group of “bellwether” trials, as well as other issues that have come up during discovery.

According to a joint report (PDF) submitted by the parties in advance of the meeting, at least 1,242 complaints have been filed in the Benicar MDL as of March 1, with an additional 67 cases pending in New Jersey state court.

As the Benicar litigation continues to grow, the parties also outlined in the report various issues that have come up during pretrial, including access to plaintiffs’ doctors, maintaining a pool of 30 potential “bellwether” cases, and disputes involving production of documents, completing plaintiff fact sheets and other discovery matters.

Benicar Diarrhea Risks

The mounting lawsuits over Benicar diarrhea problems have emerged since the FDA required Daiichi Sankyo and Forest to update the warning labels for their popular family of blood pressure drugs in July 2013. At that time, the drug makers were required to provide information for the first time to alert consumers and the medical community that Benicar may cause users to suffer chronic diarrhea and sprue-like enteropathy.

Although the medication had been on the market for more than ten years, most doctors were previously unaware of the potential link between Benicar and diarrhea.

Based on adverse event data that has been available to the drug makers for years, FDA officials determined that 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.

As part of the coordinated pretrial proceedings, the parties are preparing a group of lawsuits for early trial dates, known as “bellwether” cases, which are designed to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation. While the outcomes of these early trial dates will not be binding in other lawsuits, they may help the parties reach Benicar settlements to avoid the need for hundreds of individual trials to be scheduled in courts throughout the country.

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