Benicar Diarrhea Lawsuits Continue to Mount as MDL Centralization Considered

With a panel of judges scheduled to meet next week to decide whether all federal Benicar lawsuits should be centralized for pretrial proceedings, a growing number of complaints continue to be filed that allege side effects of the hypertension drug caused users to suffer chronic diarrhea and other symptoms of sprue-like enteropathy.

There are currently at least 31 product liability lawsuits filed in U.S. District Courts nationwide that raise similar allegations, indicating that Daiichi Sankyo and Forest Laboratories failed to adequately warn about the potential diarrhea side effects from Benicar. Since the problems may surface months or even years after first use of the drug, many plaintiffs indicate that they have suffered from chronic diarrhea for long periods of time, which doctors never knew may be caused by use of their blood pressure medication.

The U.S. Judicial Panel on Multidistrict Litigation is scheduled to hear oral arguments on March 26 in a motion filed to coordinate all Benicar diarrhea lawsuits pending throughout the federal court system, centralizing the cases before one judge to reduce the risk of duplicative discovery into common issues, avoid conflicting rulings and serve the convenience of the parties, witnesses and the courts.

Daiichi Sankyo and Forest Laboratory have opposed the creation of a federal multidistrict litigation (MDL) for the Benicar cases, arguing that there are an insufficient number of claims and that informal coordination among the attorneys involved can achieve the same purposes. However, it appears that the litigation is growing at such a quick rate that it would be impractical to coordinate proceedings without a formal MDL established.

When the motion was originally filed to establish a Benicar MDL in December, there were 15 cases pending nationwide. However, a brief in support of consolidation (PDF) filed earlier this month indicates that the number of claims have more than doubled, and are now spread out among 18 different federal district courts, with 26 different law firms representing plaintiffs. In addition, as Benicar injury lawyers continue to review and file cases, it is ultimately expected that several hundred, if not thousands of lawsuits will be filed nationwide.

Following oral arguments next week, the U.S. JPML is expected to decide whether MDL proceedings are warranted in the Benicar litigation and determine the most appropriate transfer forum for the cases.

Benicar Diarrhea Risks

All of the cases raise nearly identical allegations, indicating that Daiichi Sankyo and Forest Laboratories knew or should have known about the link between Benicar and diarrhea symptoms for years, yet withheld information from consumers and the medical community about the fact that the medication may be the cause of severe and debilitating problems.

The first official warnings about the issue were not provided 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.

Benicar (olmesartan medoxomil) is part of a family of Daiichi Sankyo hypertension drugs, which also includes Benicar HCT, Azor and Tribenzor. All of the blood pressure drugs include the active ingredient olmesartan, which has been linked to the development sprue-like enteropathy.

As a result of the lack of warnings provided by the drug makers, 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.