- Daiichi Sankyo Company and Forest Laboratories are going to spend up to $300 million to settle product liability litigation for olmesartan combination products (Benicar, Benicar HCT, Azor and Tribenzor).
- The suits, filed from January 2014, alleged that these antihypertensives caused sprue-like enteropathy and other severe gastro-intestinal symptoms, claiming that the drug had been designed in a defective manner.
- The settlement fund will be used to settle the 2,300 cases already filed as well as specific unfiled claims, and the legal fees of claimants. Daiichi Sankyo believes that the claims are without merit, and does not admit liability.
In 2013, the Food and Drug Administration warned that olmesartan medoxomil could cause sprue-like enteropathy, a gastrointestinal disorder where severe, chronic diarrhea can lead to substantial weight loss. This may begin months or years after beginning treatment, but improve after discontinuing the drug. The warning is now reflected in the label.
"Daiichi Sankyo is committed to the health and safety of all patients taking our medications," said Glenn Gormley, executive chair and president of Daiichi Sankyo. "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."
Olmesartan is one of Daiichi Sankyo's "mainstay" products, with income of ¥42.8 billion ($386 million) in the three months ending June 30, 2017. This was down 34.8% on the three months ending June 30, 2016, when the revenue was ¥65.7 billion ($593 million). This was a result of loss of exclusivity and generic competition in the U.S. and Europe, with revenue declining by 71.5% in the U.S. alone. The company believes that the impact to the financial position will not be material because the money will primarily be sourced from Daiichi Sankyo Group's insurance companies, and only supplemented from company funds.