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The U.S. District Judge presiding over all federal Benicar lawsuits has denied a request by plaintiffs to obtain partial summary judgment on the issue of whether it is an established medical fact that the hypertension drug may cause users to suffer chronic diarrhea and other symptoms of a medical condition known as sprue-like enteropathy.
There are currently more than 1,700 product liability lawsuits pending against Daiichi Sankyo and Forest Laboratories in the federal court system, each involving allegations that the drug makers failed to adequately warn about the potential side effects of Benicar, indicating that users suffered severe and sometimes permanent gastrointestinal injuries after experiencing diarrhea problems from the drug.
Plaintiffs claim that the drug makers knew or should have known for years about the link between Benicar and diarrhea, which can surface months or even years after first use of the drug. As a result of the failure to warn consumers and the medical community, plaintiffs indicate that doctors often continued patients on the drug, increasing the risk of severe intestinal damage, known as villous atrophy.
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.
Given the similar questions of fact and law raised, the cases are centralized for pretrial proceedings before U.S. District Judge Robert Kugler in the District of New Jersey, as part of an MDL, or multidistrict litigation.
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.
In August, plaintiffs petitioned the court to skip a process known as general causation, which is requires proof that the drug could cause the types of injuries claimed by plaintiffs. They argued that the link between Benicar and chronic diarrhea is established science at this point, and that there was no need for it to be re-argued at trial.
Plaintiffs asked Judge Kugler to grant a partial summary judgment on the issue, which he denied in an opinion (PDF) released on November 9.
“None of the exhibits proffered by plaintiffs either singly or in combination evidences in a clear, unambiguous, and concrete way the mechanism by which the olmesartan-containing drugs at issue may generally cause the complained injuries,” Judge Kugler ruled. “No exhibit or combination can resolve the inevitable jury speculation as to the complex biochemical, biological, and epidemiological information that underpins the general causation questions here.”
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.
Following Judge Kugler’s recent order, each plaintiff will still have to establish at trial that the drug Benicar causes sprue-like enteropathy, as well as establishing that the failure to warn about the risk caused the plaintiffs’ specific injury.
While the outcomes of the upcoming early bellwether trials will not be binding in other lawsuits, they will be closely watched by lawyers involved in the litigation, and may help facilitate Benicar settlements that would avoid the need for hundreds of individual trials to be scheduled in courts throughout the country.