Benicar, a high blood pressure medication – along with related drugs, Benicar HCT, Azor and Tribenzor – has been linked to severe gastrointestinal injury. Consequentially, thousands of lawsuits were filed against drugmaker Daiichi Sankyo, with a settlement reaching $300 million. Here is what you should know about the multidistrict litigation.
Benicar was first approved by the U.S. Food and Drug Administration (FDA) in 2002 to treat high blood pressure. Benicar’s active ingredient is olmesartan medoxomil. The drug is an angiotensin II receptor blocker; it works by blocking a hormone called angiotensin II, which causes blood vessel constriction and high blood pressure. Essentially, the medication keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.
Benicar and its generic varieties are taken by millions of Americans each year.
Mayo Clinic Study
The Mayo Clinic was the first to observe gastrointestinal problems associated with Benicar in 2012. A study of 22 individuals was conducted; each patient was taking olmesartan and suffering from chronic diarrhea. Among the patients, there was a median weight loss of 40 pounds and 14 required hospitalization. After patients stopped taking Benicar, they recovered and gained back an average of 27 pounds.
The original diagnosis was Celiac disease, but blood tests confirmed that the issue was sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss, closely mimicking that of Celiac disease.
After conducting its own review of Benicar, the FDA released a safety announcement in July 2013 warning that olmesartan can cause sprue-like enteropathy. According to the FDA announcement, enteropathy may develop months to years after starting olmesartan, and the condition sometimes requires hospitalization. Changes were approved and made to the labels of drugs containing olmesartan to include this concern.
In June 2014, the FDA reviewed cardiovascular risks for diabetics taking olmesartan. The results were non-conclusive, as there was no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication in diabetic patients. However, further label updates were required to include information from some of the studies.
The Lawsuits and Allegations
People who took Benicar filed lawsuits claiming they were unaware it could cause serious gastrointestinal problems. Allegations included that the drugmaker:
- Brought products to market that cause serious gastrointestinal injuries
- Inadequately warned about the risks
- Misrepresented the safety of their products, despite knowing or having enough information to know that Benicar is unsafe
- Designed defective, unsafe and dangerous products
- Did not adequately test the drugs
- Created products that cause harm, far outweighing the benefits
- Valued profits over the safety and wellbeing of patients
- Caused patient harm and financial losses
In 2015, there were thousands of claims against Benicar. A group of federal judges ordered that the claims be consolidated. The following is a timeline of the litigation.
Benicar Litigation Timeline
- April 2015: The U.S. Judicial Panel on Multidistrict Litigation centralized all Benicar lawsuits from other states to New Jersey federal court.
- September 2015: The New Jersey Supreme Court formally centralized dozens of state lawsuits to Atlantic County Superior Court.
- August 2017: Drugmaker Daiichi Sankyo Inc. and co-promoter Forest Laboratories Inc. agreed to pay $300 million to settle claims in both state and federal courts that Benicar caused gastrointestinal injuries. The settlement addressed nearly 2,300 cases filed as a group in state and federal court, concluding over two years of litigation played out before Judge Kugler and U.S. Magistrate Judge Joel Schneider in federal court, and Judge Nelson C. Johnson in state court.
- September 2019: Judge Robert B. Kugler entered an order to establish a qualified settlement fund.
- October 2019: 111 Benicar lawsuits remained in a multidistrict litigation in New Jersey.
- July 2020: MDL No. 2606 was officially dismissed by Judge Robert B. Kugler.
For more mass tort and class action updates like this, subscribe to our blog.