A Pennsylvania man is the latest of 1,800 plaintiffs to file a mass tort claim against the makers of the blood pressure medication Benicar (olmesartan), charging that it causes gastrointestinal side effects including diarrhea, colitis and sprue-like enteropathy.
Dale W. Hank, Jr., of New Kensington, PA, filed suit on Dec. 30 in Benicar Product Liability Litigation in MDL 2606, Case No. 1:16-cv-09590-RBK-JS, in federal court in Camden, New Jersey before US District Judge Robert B. Kugler.
The number of federal actions is up from 1,430 since June 2016. (In separate litigation, another 76 cases in a multicounty litigation in Atlantic County, New Jersey.) The federal defendants include:
- Daiichi Sankyo, Inc.
- Daiichi Sankyo U.S. Holdings, Inc.
- Daiichi Sankyo Co., Ltd.
- Forest Laboratories, LLC, f/k/a Forest Laboratories, Inc.
- Forest Pharmaceuticals, Inc.
- Forest Research Institute, Inc.
In 2007 Hank began taking Benicar and Benicar HCT. As a result he suffered nausea, diarrhea, vomiting, abdominal pain/discomfort, malabsorption, fatigue, malnutrition, dehydration, inflammation, villous damage/atrophy/blunting, sprue-like enteropathy, olmesartan associated enteropathy, colitis, intestinal injury and damage.
Widely prescribed despite FDA warning
In 2012, Doctors wrote a total of approximately 10.6 million prescriptions for Benicar, and approximately 1.9 million patients received a dispensed prescription for olmesartan-containing products from U.S. outpatient retail pharmacies.
The drug will become more widely available because of the expiration of the olmesartan patent. Mylan Pharmaceuticals Inc. and Lupin Limited began making generic versions of Benicar and Benicar HCT in 2016.
The U.S. Food and Drug Administration issued a warning in July 2013 that olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.
The FDA concluded in 2013 that Benicar was responsible for 23 serious reports of health related problems, which in some cases required hospitalization. The FDA found, “clear evidence of an association between olmesartan and sprue-like enteropathy.” It ordered changes to the labels of these drugs to include this concern.
Meanwhile, litigation has been stalled until April, when the first bellwether trials may be held. Plaintiffs’ expert reports were due on November 30. Upcoming deadlines in the federal litigation include:
- January 31, 2017 – Defendants’ expert reports due;
- February 28, 2017 – Expert depositions completed, and
- March 31, 2017 – Motions for summary judgment and Daubert motions due.