Benicar remains on the market despite an FDA investigation, scientific studies proving its risks, and millions paid in settlements.
Benicar, a hypertension medication, has been sold in the U.S. by Daiichi Sankyo since 2002. Its active ingredient, olmesartan, has been linked to celiac symptoms since 1965. Physicians who saw hypertension patients experiencing gastrointestinal symptoms similar to celiac disease found that the standard remedy – a gluten-free diet – was ineffective in treating symptoms. Patients remained critically ill and many died.
Research establishes Benicar risks
The Journal of Pharmacy Practice published a 2014 study on mounting evidence linking Benicar ingestion to celiac-like symptoms. The study included data used in prior research of olmesartan (1965-2013), as well as information obtained from the FDA. Researchers additionally evaluated data from 22 cases where patients with celiac-like symptoms improved after being taken off Benicar.
Shortly after the 2014 study was published and drug warning labels were updated, plaintiffs filed the first federal Benicar lawsuits alleging Daiichi Sankyo knew or should have known that drugs containing olmesartan caused celiac-like side effects known as olmesartan-associated enteropathy (OAE).
· July 2013: Benicar’s warning labels are updated in response to emerging evidence on its linkage to olmesartan-associated enteropathy.
· January 2015: Daiichi Sankyo settles U.S. and state Medicaid program claims that it violated the False Claims Act by paying kickbacks to physicians for prescribing Benicar (and other drugs) for $39 million.
· April 2015: The JPML transfers 15 civil Benicar lawsuits to MDL 2606, In Re: Benicar (Olmesartan) Products Liability Litigation in the U.S. District Court for the District of New Jersey.
· November 2017: Public Citizen and Public Citizen’s Research Group petition the FDA to recall all olmesartan drugs, including Benicar, from the market.
· October 2019: The FDA denies Public Citizen’s recall request, claiming Benicar’s warning label is sufficient. In the MDL, a qualified settlement fund is established, settling all but 111 cases.
Plaintiffs’ lawyers seek social justice
Irrespective of all the data proving Benicar seriously injures consumers, it remains on the market to this day. When left to its own devices, the pharmaceutical industry will never put people over profits. Whether by actively concealing evidence of product defects, misleading the FDA, or paying legions of attorneys and experts to defend them, they’ll continue to amass profits as long as we allow them to — hurting or killing people in the process.
Corporations take calculated risks knowing they will injure consumers every day. As long as their profit margins remain intact, they have no incentive to change their behavior. When companies lose a lawsuit here and there, they can easily weather the storm. They’ve built those costs into their business plans. But when many individual lawsuits that share important commonalities are brought together as a class-action suit, a formidable effort to change corporate behavior can be launched. Plaintiffs’ voices are heard, and suddenly we start to tip the scales.
Here at The Mass Tort Institute, we’re dedicated to providing the education, training, and networking opportunities that those advocating on behalf of mass tort victims need to succeed in changing the game.
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About the Author
Wendy Porter Lynn’s desire to make the world a better place sent her running years ago from the oil and gas industry into a career in nonprofits. She relishes any chance to help slay a corporate dragon that is harming and exploiting people. Originally from New England, she has studied fine arts and sociology, written poetry, traveled abroad, and consumed way too much coffee. She lives in Houston with her wonderful daughter and a moody cat.