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With nearly 1,250 Benicar lawsuits pending in the federal court system, each involving similar allegations that side effects of the hypertension drug caused plaintiffs to suffer chronic diarrhea and other digestive problems, case specific discovery will soon begin for a small group of claims that will be eligible for early test trials.
Since April 2015, complaints filed throughout the federal court system over failure to adequately warn about the potential side effects of Benicar have been consolidated before U.S. District Judge Robert Kugler in the District of New Jersey for coordinated pretrial proceedings as part of an MDL, or multi-district litigation.
Each of the complaints allege that users of Benicar or other blood pressure drugs containing the active ingredient olmesartan suffered a medical condition known as sprue-like enteropathy, which is associated with chronic diarrhea and sudden weight loss that may develop months or even years after first use of the drug.
While the Benicar diarrhea symptoms typically resolve when the medication is no longer used, many plaintiffs allege that they have been left with long-term gastrointestinal damage due to the side effects, since doctors did not know the problems were linked to the use of their blood pressure drug.
The cases are centralized as part of a federal MDL before Judge Kugler to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the judicial system.
As part of the coordinated pretrial proceedings, a bellwether program for the Benicar litigation has been established, where a group of 30 cases were selected by the court last month for an initial bellwether pool. Following the voluntary dismissal of a handful of cases, Judge Kugler identified three replacement cases in a letter (PDF) sent to attorneys involved in the litigation last week.
It is expected that the current group of 30 bellwether cases will be reduced to a total of 20 claims for case-specific discovery this week, as parties were able to each strike five cases by January 22.
Following depositions and other discovery that will occur over the next year and a half, the first Benicar trials are expected to begin by late 2017.
Benicar Diarrhea Risks
The Benicar claims 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, doctors were previously unaware of the link between Benicar and diarrhea. 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.