Daiichi Sankyo has reached an agreement to pay up to $300 million to settle approximately 2,300 lawsuits alleging the Japanese drug makers of failed to warn consumers that its blood pressure medication Benicar® could cause gastrointestinal illnesses. Benicar is used to treat high blood pressure (hypertension) in adults and children 6-years-old and older.
Now pending is the finalization of the Tokyo-based company’s settlement, which requires a minimum of 95 percent of all Benicar claimants to agree on and opt-in to the proposed settlement capped at $300 million.
Despite the settlement, Daiichi Sankyo, currently valued at $12.4 Billion, refuses to admit any culpability.
In a statement, Daiichi Sankyo made it clear that its settlement fund cannot and should not be equated with admitting liability. In fact, the company still believes that any lawsuits against its Benicar products are baseless and without merit. According to the company’s Executive Chairman, Glenn Gormley:
“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.”
Benicar Lawsuits Date Back to 2014
The U.S. Food and Drug Administration (FDA) approved Benicar’s active ingredient olmesartan medoxomil in 2002, but it wasn’t until January 2014 when the first lawsuits were filed against the drug maker, alleging that Benicar use was linked to gastrointestinal illness, and that Daiichi Sankyo had failed to adequately warn of such illness. Benicar lawsuits alleged that the drug makers also mispresented the drug’s safety.
Eventually, given the sheer number of lawsuits, these cases were consolidated into multidistrict litigation in a New Jersey federal court.
Side Effects of Benicar
Plaintiffs claim that the company’s blood pressure drugs did not carry labels warning of gastrointestinal side effects, such as sprue-like enteropathy until 10 years after its introduction.
Side effects of Benicar, and other olmesartan-based “sister” medications – Benicar HCT®, Azor®, and Tribenzor® – can include:
- Sprue-like enteropathy or colitis
- Chronic diarrhea
- Weight loss
Sprue-like enteropathy is widely considered to be very serious. In fact, the FDA warned of the illness in a 2013 safety announcement, and subsequently required Daiichi Sankyo to change its Benicar labels in 2013 to include this warning. The illness comes with symptoms of chronic diarrhea and substantial weight loss. Ultimately, sprue-like enteropathy can lead to hospitalization.
In 2012, around 10.6 million olmesartan prescriptions were dispensed in the U.S. alone. Given this figure, it’s possible that even more Americans were injured by Benicar and its sister medications than the settlement numbers indicate.
If one considers holding large corporations accountable for their behavior as vital to public health, safety, and wellbeing – especially when that corporate behavior results in needless injuries – then this Benicar settlement marks a significant victory for all Americans.