Depositions in Benicar Lawsuits to Commence in January 2016

As a growing number of Benicar lawsuits continue to be filed throughout the federal court system by individuals who have suffered chronic diarrhea and other gastrointestinal problems, depositions of the drug makers’ sales representatives and others with knowledge about the development and design of the blood pressure medication are expected to begin early next year.

Since April 2015, centralized pretrial proceedings have been established for all federal lawsuits filed against Daiichi Sankyo and Forest Laboratories over the drug makers’ failure to adequately warn about the risk that chronic diarrhea and other symptoms of sprue-like enteropathy may be caused by side effects of Benicar.

There are currently at least 1,000 complaints consolidated as part of a federal MDL, or multidistrict litigation, which are 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.

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

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In an order (PDF) issued October 30, U.S. Magistrate Judge Joel Schneider laid out the time line for early discovery in the Benicar litigation, indicating that plaintiffs’ depositions of key representatives of the drug makers will begin the week of January 18, 2016. At least two depositions will be taken per week between January 18 and February 26, with the court expected to address an increased pace for depositions at upcoming conferences.

Defense attorneys for Daiichi Sankyo and Forest Laboratories have previously suggested that it would take 16 months to develop and produce the required documents for the Benicar claims, in part because of the large amount of information sought by the plaintiffs, but also because documents are in both Japanese and English, which will require nearly 300 custodians on both sides of the Pacific.

The parties have been directed to submit simultaneous letter briefs next week, regarding the deposition protocol, including whether Japanese deponents of the drug maker should be compelled to appear in the U.S., whether depositions may be video-conferenced and other remaining issues.

Benicar Litigation Status

The Benicar litigation has 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, Daiichi Sankyo and Forest Laboratories 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 that diarrhea symptoms may be caused by Benicar. The problems may surface months or even years after first use of the medication, previously causing many doctors not to recognize that the blood pressure medication may be the cause of the symptoms..

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.

As part of the coordinated pretrial proceedings, the parties will complete discovery into issues that apply to all claims. It is then expected that a small group of “bellwether” cases will be selected to go through case-specific discovery in preparation for a series of early trial dates, which will be designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

If the drug makers fail to reach Benicar settlements or otherwise resolve the litigation after the bellwether trials, 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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