Benicar Lawsuits Increase Dramatically

Trenton, NJThe number of Benicar lawsuits sitting in a multidistrict litigation for pretrial proceedings has increased dramatically between June and July. Benicar side effects lawsuits allege patients suffered adverse reactions to taking Benicar, including sprue-like enteropathy.

As of July 15, 2015, the number of lawsuits consolidated for pretrial proceedings in MDL 2606 was 915, according to court documents. That’s up from only 70 consolidated lawsuits as of June 15, 2015 - a dramatic increase.

Lawsuits are consolidated for pretrial proceedings when they have similar questions of fact. The consolidation is not a comment on the merits of the lawsuit, but it is simply an acknowledgement that the claims are similar. In the case of Benicar lawsuits, the allegations are that Daiichi Sankyo Inc. and Forest Laboratories Inc. failed to adequately warn about the risk of developing sprue-like enteropathy.

Benicar (known generically as olmesartan) is an angiotensin II receptor blocker used to treat high blood pressure. Lawsuits allege patients developed sprue-like enteropathy - marked by severe diarrhea and weight loss - after using Benicar. Lawsuits were filed after a July 3, 2013 warning from the US Food and Drug Administration (FDA) that olmesartan was potentially linked to sprue-like enteropathy, noting there was “clear evidence of an association between olmesartan and sprue-like enteropathy.”

The FDA issued its warning after identifying 23 serious cases of sprue-like enteropathy linked to Benicar in the FDA Adverse Event Reporting System. At the time, the FDA approved changes to Benicar’s label to warn about the potential for sprue-like enteropathy.

A 2012 study published in Mayo Clinic Proceedings found that of 22 patients who developed sprue-like enteropathy, the health of 18 improved after discontinuing olmesartan therapy.

In January 2015, a lawsuit filed against the makers of Benicar laid out the plaintiffs’ injuries. The lawsuit (case number 3:15-cv-159) alleges that Benicar is unreasonably dangerous and was negligently designed and developed. Furthermore, plaintiffs allege the FDA found enteropathy could take months to years after starting Benicar therapy to develop.

Plaintiffs also allege studies concerning Benicar’s side effects were “submitted on a delayed basis to the FDA” and that some Benicar marketing materials were misleading because they made unsubstantiated claims about the medication’s effectiveness.

Lawsuits are still in the early stages, as the addition of more than 800 lawsuits to the MDL suggests. The MDL is in District Court in New Jersey, before Judge Robert B. Kugler.