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As discovery continues to move forward in hundreds of Benicar lawsuits pending throughout the federal court system, each involving allegations that inadequate warnings were provided about the risk of chronic diarrhea associated with the drug, plaintiffs indicate that they intend to ask the court for a partial summary judgment in the case, based on evidence turned up so far.
There are currently more than 1,700 product liability lawsuits pending against Daiichi Sankyo and Forest Laboratories in a federal MDL, or Multidistrict Litigation, which is centralized for pretrial proceedings before U.S. District Judge Robert Kugler in the District of New Jersey, since each claim involves similar allegations that side effects of Benicar caused users to suffer chronic and uncontrollable diarrhea, often leaving them with permanent gastrointestinal injury.
Plaintiffs claim that the drug makers knew or should have known for years about the link between Benicar and diarrhea, yet withheld warnings from consumers and the medical community, causing many individuals to continue using the medication.
The Benicar litigation emerged after the FDA required the drug makers to update the warning label in July 2013, indicating for the first time that the drug may cause severe diarrhea problems to develop months or even years after first use of the drug.
Since most doctors were unaware of the link many users were misdiagnosed with celiac disease or other gastrointestinal problems, and continued to use Benicar, increasing the risk of permanent damage to their intestines, known as villous atrophy.
In a joint report (PDF) submitted by parties involved in the MDL on August 29, plaintiffs’ attorneys indicate that they plan to bring several motions for partial summary judgment in the near future. One will ask the court to rule in the plaintiffs’ favor on the issue of general causation, establishing that Benicar causes severe diarrhea and other symptoms associated with a medical condition known as sprue-like enteropathy. The other indicates that plaintiffs “intend to file a motion for partial summary judgment establishing the inadequacy of the [Benicar] prescribing information as a matter of law.”
Benicar (olmesartan medoxomil) is part of a family of blood pressure medications, which also include Benicar HCT, Azor and Tribenzor. The drugs have been on the market for more than a decade, and previously contained no warnings about the risk that users may suddenly develop uncontrollable diarrhea and weigh loss, which often resolves when the medications are no longer used.
When the FDA required new warnings in July 2013, the agency indicated that there was “clear evidence” that Benicar may cause sprue-like enteropathy, even if an individual has used the medication for a long period of time with no prior issues. Reports suggested that users experiencing chronic diarrhea on Benicar had symptoms resolve when the medication was discontinued, but it returned when the medication was used again.
According to allegations presented in cases filed by individuals nationwide, the drug makers’ failure to warn users and the medical community prevented individuals from avoiding severe gastrointestinal problems, indicating that they would have discontinued the medication when symptoms first appeared if they had known Benicar was the cause.
Given the similar questions of law and fact raised in complaints filed in U.S. District Courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings for the cases last year, centralizing the lawsuits before Judge Kugler to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the judicial system.
As part of the Benicare MDL proceedings, the parties have been preparing a number of cases for early trial dates, known as “bellwether” lawsuits, which are designed to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.
The motions for partial summary judgment may impact what elements plaintiffs must establish at trial to be successful with their claim. Even if the issues of general causation and adequacy of warnings are resolved by the pretrial motions, each plaintiff will still have to establish that their individual injury was caused by Benicar.
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.