Benicar MDL Opposed by Drug Makers, Despite Mounting Lawsuits Nationwide

The makers of the hypertension drug Benicar are opposing the creation of a federal multidistrict litigation (MDL) for the growing number of product liability lawsuits being filed nationwide by individuals who allege that side effects of Benicar caused them to suffer chronic diarrhea, malnutrition and other symptoms associated with the development of sprue-like enteropathy.

In late December, a motion was filed with the U.S. Judicial Panel on Multidistrict litigation, seeking to establish a Benicar MDL in the federal court system, centralizing all of the lawsuits before one judge for coordinated pretrial proceedings to reduce duplicative discovery into common issues in the cases, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the courts.

In a response (PDF) filed on Friday, Daiichi Sankyo and Forest Laboratories, which jointly manufacture and market Benicar and other related blood pressure drugs that contain olmesartan, opposed the consolidation of the cases, arguing that the lawsuits are already in various different stages of litigation, and that centralization could hamper progress.

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Side Effects of Benicar May Cause Diarrhea, Villous Atrophy and Sprue-Like Enteropathy

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“The olmesartan litigation involving Benicar, Benicar HCT and Azor is driven by a small number of Plaintiffs’ counsel before a few courts, and involves cases that will turn on highly individualized, case-specific legal and factual issues that are not susceptible to common proof,” according to the response and opposition filed by the drug makers. “Defense counsel is already informally coordinating common discovery in these actions before a handful of courts to maximize efficiencies. Creating an MDL proceeding will only add to the burden, expense and uncertainty of this litigation, and would prejudice Defendants as these actions would have to start anew before a different court.”

There are currently at least 23 Benicar lawsuits filed in at least a dozen different U.S. District Courts nationwide.

All of the Benicar cases over sprue-like enteropathy involve nearly identical allegations, claiming that Daiichi Sankyo and Forest Laboratories failed to adequately warn users of their popular blood pressure drugs about the risk that symptoms like chronic diarrhea, weight loss and other gastrointestinal problems may be caused Benicar.

A number of different plaintiffs with cases over Benicar pending against Daiichi Sankyo and Forest have filed briefs in support of the creation of an MDL, indicating that the size of the litigation is expected to continue to grow substantially as Benicar injury lawyers continue to review potential claims for individuals who have experienced complications.

“The overwhelming majority of federal cases do not have any protective orders entered, they do not have any case management conference schedules entered, and they do not have any preliminary discovery court orders entered,” according to a response brief (PDF) filed on behalf of eight plaintiffs with Benicar lawsuits filed in Ohio. “With the vast number of different plaintiff law firms involved across numerous federal jurisdictions and with the overwhelming majority of federal cases at the starting point of the litigation process, transfer and consolidation is essential in order to avoid conflicting rulings across numerous federal courts and for judicial efficiency.

Benicar Sprue-Like Enteropathy Risks

The Benicar litigation has arisen since the FDA required Daiichi Sankyo and Forest Laboratories to update the drug warning label in July 2013, providing information for the first time that users of the blood pressure drug may face an increased risk of sprue-like enteropathy.

The FDA warnings indicated that there is clear evidence that use of the medication may cause users to suffer chronic diarrhea, abdominal pain, weight loss and other symptoms, which may surface months or even years after the medication is started.

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.

Although the medication has been on the market for more than 10 years, information about the link between Benicar and diarrhea problems were not recognized within the medical community until the FDA warnings, resulting in many former users experiencing complications from the medication for years.

In many cases, users have repeatedly been hospitalizations because 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.

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