Benicar Bellwether Lawsuits Narrowed to Ten Cases Being Prepared for Trial

With hundreds of Benicar lawsuits moving forward through the federal court system, each involving similar allegations that the hypertension drug caused individuals to suffer severe and debilitating diarrhea, and other symptoms of a condition known as sprue-like enteropathy, the U.S. District Judge presiding over the litigation has selected a group of 10 cases that will be prepared for a series of early “bellwether” trials.

There are currently about 1,250 product liability lawsuits pending in a federal multidistrict litigation (MDL), with dozens of additional cases pending in state court systems, each claiming that the drug makers Daiichi Sankyo and Forest Laboratories failed to adequately warn consumers and the medical community about the potential side effects of Benicar.

Benicar (olmesartan medoxomil) is part of a family of blood pressure medications, which also include Benicar HCT, Azor and Tribenzor. In recent years, studies have confirmed that the medications may cause chronic diarrhea and sudden weight loss to develop months, or even years, after first years of the medications.

According to allegations presented in cases filed by individuals nationwide, the drug makers knew or should have known about the link between Benicar and diarrhea symptoms for years, yet withheld information and provided misleading warnings. As a result, many individuals experienced long-term gastrointestinal problems from Benicar, without ever realizing the medication was causing their symptoms, often resulting in chronic malnutrition and other severe health complications.

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 U.S. District Judge Robert Kugler in the District of New Jersey 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.

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.

In a case management order (PDF) issued on April 20, Judge Kugler selected the 10 cases from this bellwether discovery group that will move forward be part of a trial pool. In doing so, Judge Kugler rejected a call by the defendants to allow the drug makers to strike more of the plaintiffs’ choices for potential bellwether trials.

The drug makers had argued that about 44% of the initial plaintiffs’ bellwether pool cases have been dismissed, suggesting that the plaintiffs were manipulating which cases would be the first to go to trial, in hopes of getting the most favorable claims before a jury to influence possible settlement negotiations. However, plaintiffs rejected that argument, noting that the individual reasons for the dismissal of each case had been well explained to the court and that the defense has made the claims repeatedly.

Following a status conference on April 18, Judge Kugler denied the Defendant’s motion to allow additional strikes of bellwether trial candidates, and identified cases ten cases that will be prepared for trial.

Case-specific discovery on the remaining trial pool cases is expected to be completed over the coming months, with final schedules for Daiichi Japan depositions due earlier this week. Fact depositions are expected to commence on June 20 for bellwether plaintiffs.

A discovery conference call with the court is scheduled for today, and the next monthly status conference before Judge Kugler is set for May 26.

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.