Daiichi Sankyo, Inc., a Tokyo-based drug maker worth an estimated $12.4 billion, agreed to settle nearly 2,300 patient lawsuits against its blood pressure medication Benicar® (olmesartan medoxomil) and its sister medications Benicar HTC®, Azor® and Tribenzor®.
Plaintiffs alleged the drug, used to treat high blood pressure (hypertension) in adults and children ages 6-years-old or older, caused intestinal damage and other gastrointestinal illnesses, such as sprue-like enteropathy or colitis.
The recent settlement means Daiichi will have paid out a total of $339 million in Benicar-related claims, including a $39 million settlement in a 2014 whistleblower case. The previous $39 million settlement resolved U.S. government allegations that Daiichi paid illegal “kickbacks” to doctors who prescribed their blood pressure medications over alternatives.
The first Benicar lawsuits were filed in January 2014 and were eventually consolidated into a multidistrict litigation (MDL) hearing before federal judge Robert Kugler in Camden, New Jersey. These suits claimed that Daiichi executives knew the medication could cause severe abdominal pain, diarrhea, diverticulitis, colitis and nausea and kept that information secret.
Benicar Drug Maker Offers Pay Out, But No Apology
In a press release following the settlement agreement, Daiichi’s Executive Chairman Glenn Gormley stated, “We believe a settlement is in the best interest of all, and will allow us to continue our focus on bringing to the market innovative medicines that help people live healthy and meaningful lives.”
In effect, Daiichi seems to be drawing a clear distinction between the settlement payouts and culpability, saying that settling the 2,300 lawsuits should not be considered an admission of liability. According to its press release, the Tokyo drug maker still believes that any lawsuits against Benicar and Benicar’s sister medications are without merit.
The United States Food and Drug Administration (FDA) approved olmesartan medoxomil, the active ingredient in Benicar, in 2002, but later studies showed in 2013 that the drug carried a link with intestinal damage. Upon the release of these data, FDA officials ordered Daiichi to include an updated label warning about the gastrointestinal risks.
Side effects of Benicar and other olmesartan-medoxomil-based blood pressure drugs include: chronic diarrhea, severe weight loss, severe dehydration, nausea and vomiting. Some of these ailments can be so severe they can lead to hospitalization.
Benicar’s settlement is capped at $300 million, meaning no funds will be available after that allotment is reached. Larger payouts will be given to Benicar patients who suffered for a longer period of time and from more serious injuries.
In order for the settlement to be finalized, 95 percent of all plaintiffs must agree to and opt-in to the terms set in the accord.
The $300 million settlement includes a sub-settlement that resolves claims against Forest Laboratories, Inc., a New York City-based company that sold Benicar and its sister medications in the U.S.