This week, Tokyo-based pharmaceutical firm Daiichi-Sankyo Ltd. announced that it will pay out $300 million to settle approximately 2,300 cases filed by plaintiffs who allege that its olmesartan blood pressure medications were responsible for their intestinal injuries. This comes two years after the company paid $39 million to the U.S. federal government over allegations that it had made illegal payments to physicians who agreed to prescribe its products.
The settlement covers patients who suffered as a result of taking Benicar, Benicar HCT, Azor and Tribenzor. The agreement was reached soon before the cases were scheduled to go to trial.
Plaintiffs allege that Benicar and other olmesartan drugs caused a serious intestinal disorder known as sprue-like enteropathy. This condition, symptoms of which include abdominal pain, diarrhea, diverticulitis, colitis and nausea, mimics celiac disease. It was initially mistaken for celiac until 2013 when a physician at the Mayo Clinic found that patients’ symptoms improved once they stopped taking Benicar.
Plaintiffs allege that Daiichi-Sankyo was aware of these health risks and withheld that information from health care professionals and consumers. Last year, there were serious questions raised about the clinical trial that led to the drug’s approval by the FDA in 2002 – primarily, why the product, after years of development, underwent testing for only three months.
Injured parties began filing lawsuits in 2013, after the FDA added a warning to the packaging.
Under the terms of the settlement, Daiichi-Sankyo admits to no wrongdoing. Although the company continues to maintain that the claims against it over Benicar and similar olmesartan drugs are without merit, executive chairman Glenn Gormley expressed his approval of the outcome. “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,” he said in a statement to the media. The settlement will also resolve claims against Daiichi-Sankyo’s U.S. marketing and sales affiliate, Forest Laboratories.
The settlement is not a done deal; 95% of the plaintiffs will need to agree to the terms before it goes into effect. The individual awards will vary according to the severity of the plaintiff’s injuries.
Settlement negotiator Troy Rafferty, partner in the Levin Papantonio law firm, which filed the first Benicar lawsuit in 2013, said “I am very pleased we could reach a settlement that will result in a just, fair and speedy resolution for these deserving clients.”