The $300 million settlement will resolve about 2,300 lawsuits from people who developed a chronic intestinal illness known as sprue-like enteropathy after taking the blood pressure medication olmesartan in Benicar, Azor, or Tribenzor.
The payouts for each plaintiff will depend on how many days they were hospitalized and the extent of their intestinal damage.
The agreement applies to about 2,000 lawsuits consolidated in federal court in New Jersey, plus hundreds of other Benicar lawsuits in the Superior Court in Atlantic County and other state courts.
Daiichi Sankyo created Benicar and Forest Laboratories marketed olmesartan. Plaintiffs say the drug-makers should have known about the risk of sprue-like enteropathy before the FDA warning, but failed to warn patients.
Daiichi Sankyo did not admit liability and believes the lawsuits are without merit, but said 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.”
For more information, please visit the Olmesartan Product Liability Litigation Settlement website.
The link between Benicar and sprue-like enteropathy was identified in August 2012 by Dr. Joseph Murray, a gastroenterologist at the Mayo Clinic who treated 22 patients from 2008 to 2011.
The FDA warned in July 2013 that olmesartan blood pressure drugs such as Benicar, Azor, or Tribenzor could cause chronic diarrhea with severe weight-loss.
The FDA reported 23 cases of sprue-like enteropathy and warned that intestinal problems might not develop for several months or years after the patient starts taking Benicar.
The problem is that many patients were misdiagnosed with Celiac disease, so they continued taking Benicar. By the time doctors realized their blood pressure drug was to blame, some of the patients had permanent intestinal damage (villous atrophy) and malnutrition.
The federal lawsuits are centralized under U.S. District Judge Robert B. Kugler in New Jersey — Multi-District Litigation (MDL No. 2606) — In Re: Benicar (Olmesartan) Products Liability Litigation.