On the heels of a labeling change inspired by the U.S. Food and Drug Administration, the makers, marketers and distributors of the drug Benicar (olmesartan medoxomil) face mounting lawsuits alleging the drug's relationship to gastrointestinal injuries.
Initially approved by the FDA in 2002, Benicar is "indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure," according to its prescribing information.
The pharmaceutical corporation Daiichi Sankyo is the main defendant in these actions, 15 of which as soon as April may be centralized before a single judge for pretrial management. A federal panel of judges in March will consider a motion to centralize.
The FDA raised the health risk; this is not something patients concocted. The FDA in July 2013 approved the addition of a condition known as sprue-like enteropathy to the list of Benicar risks. The prescribing information reads, in part, "Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy," an intestinal abnormality.
In a separate 2013 safety advisory, the FDA explained, "The enteropathy may develop months to years after starting olmesartan, and sometimes [it] requires hospitalization. If patients taking olmesartan develop these symptoms and no other cause is found, the drug should be discontinued, and therapy with another antihypertensive started. Discontinuation of olmesartan has resulted in clinical improvement of sprue-like enteropathy symptoms in all patients."
At the time the FDA issued its safety communication, the agency reported, "In 2012, a total of approximately 10.6 million prescriptions were dispensed, and approximately 1.9 million patients received a dispensed prescription for olmesartan-containing products from U.S. outpatient retail pharmacies. According to sales data, the majority of olmesartan-containing products were distributed to outpatient retail pharmacies."
Patients who knew something was wrong learned that they were not alone. The court brief that one plaintiff filed in support of grouping all of the cases together reads, "Early published literature indicated that severe gastrointestinal injuries may be a rare side effect of ingesting Benicar. Recent studies, however, suggest that this does not appear to be nearly as rare a side effect as was previously thought. A gastroenterology researcher at the Mayo Foundation for Medical Education and Research has been quoted as stating that the patients cited in medical literature as having suffered severe gastrointestinal injuries as a result of ingesting Benicar and other olmesartan drugs are just the 'tip of the iceberg.'"
One plaintiff explained to the panel that will rule on the motion to centralize that the outcome of the litigation will be based on numerous issues that all of the 15 original lawsuits share:
(1) Whether and to what extent Benicar and other olmesartan drugs have caused, or will cause, harmful effects in patients that ingested Benicar including but not limited to severe dehydration, severe malabsorption, rapid and substantial weight loss, chronic diarrhea, vomiting, significant abdominal pains, acute renal failure, and/or accelerated aging as a result of the body's inability to adequately absorb food and water over a period of months or years;
(2) When Defendants first learned of the connection between Benicar and other olmesartan drug usage and the foregoing harmful effects caused by ingesting Benicar and other olmesartan drugs;
(3) Whether, and for how long, Defendants concealed any such knowledge from prescribing physicians and physicians treating patients' gastrointestinal injuries;
(4) Whether Defendants defectively designed and/or manufactured Benicar and the other olmesartan drugs;
(5) Whether Defendants failed to provide adequate warnings and instruction concerning the usage and side effects of Benicar and other olmesartan drugs;
(6) Whether Defendants were negligent in their design and/or manufacture of Benicar and the other olmesartan drugs;
(7) Whether Defendants engaged in fraudulent and illegal marketing practices, including, but not limited to, making unsubstantiated claims regarding the effectiveness and superiority of Benicar and the other olmesartan drugs; and
(8) The nature and extent of past and future damages suffered by Plaintiffs as a result of ingesting Benicar and the other olmesartan drugs.
In the meantime, the FDA announced that it "will continue to evaluate the safety of olmesartan-containing products and will communicate again if additional information becomes available."
If you believe that an injury may be related to the use of a drug or medical device, contact one of the product liability attorneys at Reich & Binstock for a free consultation. No matter your state of residency, you may contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through its website.