Daiichi Sankyo settles U.S. lawsuits for $300 million over blood pressure drug Benicar in Multidistrict Litigation No. 2606
Daiichi Sankyo on Tuesday said it has agreed to pay up to $300 million to settle 2,300 U.S. cases (see Benicar MDL 2606 Settlement Order of August 1, 2017) accusing the Japanese drugmaker of failing to warn that its blood pressure medication Benicar can cause gastrointestinal illness, that were being heard in MDL 2606 Benicar US District Court of New Jersey see Benicar MDL No. 2606 Mass Tort Nexus Link.
The four olmesartan products at issue in this litigation are: Benicar®, Benicar HCT®, Azor®, and Tribenzor®. With respect to each of these products, Defendants exaggerated their benefits and understated, omitted and/or failed to adequately warn patients and physicians about the risks associated with such products.
The settlement will become finalized if at least 95 percent of all claimants agree, or opt in, Daiichi Sankyo said in a statement. The company said the settlement fund was capped at $300 million. Daiichi Sankyo said it was not admitting liability by settling and that it continues to believe that the Benicar claims were without merit. The settlement relates to the federal actions in US district court, and excludes a separate Benicar litigation, where another 76 cases in New Jersey State Court, see multicounty litigation in Atlantic County, New Jersey.
“We believe a settlement is in the best interest of all, and will allow us to continue our focus on bringing to market innovative medicines that help people live healthy and meaningful lives,” Glenn Gormley, the group’s executive chairman, said in a statement.
The first lawsuits over Benicar were filed in 2014 and the cases were eventually consolidated in a multidistrict litigation in federal court in New Jersey under MDL 2606 before US District Judge Robert B. Kugler.
The Tokyo-based drugmaker said the agreement would not have a material impact on its financial position, as the settlement is expected to be funded by several of the group’s insurance companies. As far back as 2012, doctors wrote a total of approximately 10.6 million prescriptions for Benicar, and approximately 1.9 million patients received a dispensed prescription for olmesartan-containing products from U.S. outpatient retail pharmacies in a year, reflecting Benicar as a significant source of income for the company..
Plaintiffs alleged that the company’s blood pressure medication Benicar, along with its sister drugs Benicar HCT, Azor and Tribenzor, did not carry labels that warned of gastrointestinal side effects, such as sprue-like enteropathy, until a decade after it was introduced.
The U.S. Food and Drug Administration approved olmesartan medoxomil, Benicar’s active ingredient, in 2002. But, the agency required Daiichi Sankyo to change its label to include the warning in 2013, when studies showed the drug to be linked to intestinal problems and the FDA issued a warning in July 2013 that olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy. Plaintiffs, who filed their first suits in 2014, accused the company of inadequately warning about the drug’s risks and misrepresenting its safety.