Benicar Settlement to Result in $300M Payment By Drug Maker for Gastrointestinal Injuries

Daiichi Sankyo and Forest Laboratories have agreed to pay $300 million in financial compensation to individuals who suffered chronic diarrhea and other gastrointestinal injuries after using Benicar, Azor or Tribenzor, settling allegations that inadequate warnings were provided about risks associated with the popular olmesartan-based blood pressure drugs.

The agreement is intended to resolve about 2,000 filed Benicar lawsuits, Azor lawsuits and Tribenzor lawsuits filed throughout the U.S. court system, but also provides additional time for individuals who have not yet hired a lawyer to participate in the Benicar settlement.

For the past two years, all federal litigation over the side effects of Benicar has been centralized before U.S. District Judge Robert Kugler in the District of New Jersey, as part of an MDL or multidistrict litigation. The cases have been consolidated to reduce duplicative discovery, avoid conflicting pretrial rulings and facilitate the management of the lawsuits.

In a case management order (PDF) issued today, Judge Kugler indicated that the parties have reached a Master Settlement Agreement to resolve claims for certain injuries that resulted from the use of Benicar, Benicar HCT, Azor or Tribenzor prior to May 2015. Details of the $300 million settlement have been made available on an Olmesartan Products Resolution Program website.

Judge Kugler has ordered that a census of all claims be filed by August 25, including both filed and unfiled cases. For individuals who have not yet filed a lawsuit, they must have an executed retainer agreement signed with a lawyer by August 23 to be eligible for the settlement.

Each of the claims involve similar allegations that the drug makers knew or should have known about the link between Benicar and diarrhea for years before information was added to the warning label.

These gastrointestinal problems from Benicar (olmesartan) may surface months, or even years, after first use of the drug. Therefore, many doctors did not take their patients off of the drug when symptoms appeared, increasing the risk of permanent intestinal damage, known as villous atrophy.

The Benicar litigation emerged after the FDA required the drug makers to update the warnings in July 2013, indicating for the first time that the there was clear evidence the drug may cause severe diarrhea problems.

Terms of the Benicar agreement require that plaintiffs file an “Opt In Package” by September 15, 2017, with the drug makers bound to the settlement if at least 95% of eligible claimants participate.

For individuals who elect not to accept the offer to settle their Benicar case, Judge Kugler issued a separate order (PDF), requiring that certain information to support their claims be filed within 60 days after the Opt-In Deadline, including evidence of usage, injury and a report from a medical expert indicate that the injury was caused by Benicar or one of the other olmesartan-based drugs.