Benicar Enteropathy Lawsuits Transferred to MDL in New Jersey

The U.S. Judicial Panel on Multidistrict Litigation has decided to consolidate and centralize all Benicar lawsuits pending throughout the federal court system that involve claims brought by former users who experienced chronic diarrhea, or other symptoms of a condition known as sprue-like enteropathy.

According to a transfer order (PDF) on April 3, cases currently pending nationwide will be transferred to U.S. District Judge Robert Kugler for coordinated handling as part of a multidistrict litigation, or MDL, in the District of New Jersey.

There are currently more than 35 enteropathy lawsuits over Benicar pending in 23 different U.S. District Courts, which will all be centralized before Judge Kugler to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different judges and to serve the convenience of witnesses, the parties and the courts.

As Benicar enteropathy lawyers continue to review and file additional cases throughout the federal court system, those complaints will also be transferred into the MDL.

Given the widespread use of Benicar and other blood pressure drugs that contain the active incredient olmesartan, including Benicar HCT, Azor and Tribenzor, it is ultimately expected that several thousand lawsuits will be brought on behalf of individuals who have experienced sprue-like enteropathy, lymphocytic colitis, microscopic colitis, collagenous colitis and other serious gastrointestinal injuries.

These enteropathy problems from Benicar typically result in severe and chronic diarrhea, malnutrition and weight loss, which can surface months or even years after first use of the medication.

Centralized Management of Benicar Litigation

All of the cases involved in the enteropathy litigation raise similar allegations, claiming that Daiichi Sankyo and Forest Laboratories failed to adequately warn consumers and the medical community that the problems may be caused by side effects of Benicar, resulting in many users to experiencing chronic and long-term symptoms that have left them with debilitating intestinal damage.

The drug makers opposed the creation of the Benicar MDL, arguing that there was not a sufficient number of claims and that informal coordination among the attorneys involved could achieve the same purposes. However, the JPML disagreed.

“In opposing centralization, defendants argue that each of the involved cases will turn on unique, plaintiff-specific issues, including, for example, the subject plaintiff’s medical history and the treatment decisions made by that plaintiff’s physician,” the judges noted. “This argument is not convincing.”

The judges said that even without the additional expected cases, the present number of Benicar complaints is sufficient to warrant centralization, “especially given the complexity of the issues involved and the likelihood of at least some foreign discovery.”

Daiichi Sankyo is based in Japan.

Benicar Enteropathy Risks

Although Benicar has been on the market for more than a decade, the first warnings about the potential enteropathy risks were not issued until July 2013, when the FDA required a Benicar label change to indicate that users may experience symptoms of sprue-like enteropathy long after they start using the medication.

Based on adverse event data that has been available to the drug makers for years, FDA officials concluded that there is “clear evidence” that Benicar may cause users to suffer chronic diarrhea, abdominal pain, weight loss and other gastrointestinal symptoms, which typically resolve when the medication is no longer used.

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.

As a result of the lack of warnings prior to July 2013, many users have repeatedly been hospitalized with severe diarrhea, as doctors were unaware that the symptoms may be caused by their blood pressure medication. The Benicar problems have often been misdiagnosed as Celiac disease or unclassified sprue, resulting in continued use of the medication, which could leave users with long-term intestinal damage.

Although the diarrhea symptoms associated with sprue-like enteropathy typically resolve when the medication is no longer used, the problems can cause permanent damage to the intestines, known as villous atrophy from Benicar.

As part of the centralized pretrial proceedings in the MDL, Judge Kugler will coordinate discovery into generic issues that impact all cases. In addition, it is expected that a small group of lawsuits will be prepared for early trial dates, known as “bellwether” cases because the outcomes will help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

Following coordinated discovery and a series of bellwether trials in the MDL, if the drug makers fail to reach Benicar settlements that resolve the litigation, each individual case may be remanded back to the U.S. District Court where it was originally filed for a separate trial date.