Lawsuit Filed Against Unichem, CVS Claims Mislabeled HCTZ Caused Death of Mississippi Man

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Unichem Pharmaceuticals (USA), Inc. is among the defendants in a proposed class action that claims mislabeled medication is to blame for the death of the plaintiff’s father. Also filed against CVS Mississippi Pharmacy, LLC and CVS Pharmacy, Inc., the suit follows the voluntary recall of hydrochlorothiazide (HCTZ) 25 mg tablets in July 2015.

According to a warning letter published by the FDA on July 31, 2015, the recall was issued “as a precaution because a clopidogrel tablet was found in a bottle of the product.” The notice warned that a clopidogrel tablet, if taken instead of HCTZ, can result in “bleeding and/or bruising.” The notice also noted that missing a dose of HCTZ can cause “uncontrolled blood pressure or swelling caused by excess fluid.” The recall reportedly affected all lots of Unichem-manufactured 25 mg HCTZ tablets that had been distributed since May 21 of that year.

The complaint states that the plaintiff’s father, who had been prescribed HCTZ for hypertension, was found dead 15 days before the recall was issued. The lawsuit argues that the defendants’ quality control suffered from “numerous deficiencies” that allowed “adulterated and misbranded” medication to be sold to consumers. Further, the case claims the defendants “knew, and/or had reason to know” that the medication was unsafe but failed to issue a timely warning to consumers, including the plaintiff’s father. From the complaint:

“The named defendants had a continuing duty to warn the decedent and all patients of the dangers associated with the voluntarily recalled HCTZ 25 mg tablets. If the decedent had time been made aware of the voluntary recall and the information regarding the risks of ingesting clopidogrel, he would not have used it.”