Initial Conference Scheduled in Benicar Injury Litigation

The U.S. District Judge presiding over all Benicar injury lawsuits has scheduled an initial status conference in the recently established multidistrict litigation (MDL) for cases filed throughout the federal court system.

Earlier this month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered that all product liability lawsuits involving gastrointestinal side effects of Benicar will be centralized before U.S. District Judge Robert Kugler in the District of New Jersey to coordinate discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

In a case management order (PDF) issued on April 16, Judge Kugler scheduled an initial status conference for April 29 at 2:00 p.m., which will be the first meeting for lawyers involved in the various cases pending throughout the federal court system.

The organizational structure of the litigation will be discussed during the conference, including the appointment of various attorneys to serve in leadership positions, summaries of the current status of discovery and whether any progress has been made by the parties before the establishment of the MDL toward settling the cases.

At the time the U.S. JPML centralized the Benicar injury litigation, there were at least 35 product liability lawsuits pending in 23 different U.S. District Courts involving claims that the maker of the blood pressure drug failed to adequately warn about the risk of chronic diarrhea, weight loss and other symptoms of a gastrointestinal condition known as sprue-like enteropathy.

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 hundreds, if not thousands, of 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.

Benicar Risks

All of the cases involved in the Benicar 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.

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.