Federal law requires that drug manufacturers follow “current Good Manufacturing Practices” (cGMPs) in making their pharmaceuticals. Nevertheless, the complaint for this class action claims that a company in India sold an active pharmaceutical ingredient that was adulterated with a probably carcinogen, and that the ingredient found its way through two American companies to the pharmacy at Walmart.
The Nationwide Class for this action is all persons or entities who bought or took adulterated irbesartan. An Illinois Subclass has also been proposed, encompassing those who bought or took the adulterated drug in Illinois.
The Food and Drug Administration (FDA) sets the cGMP standards, which refer to organizations and personnel, buildings and facilities, equipment, control of components and containers, production processes, packaging and labels, and other matters. The FDA is entitled to enforce these regulations in any facility around the world that produces drugs for the US market.
Aurobindo Pharma Ltd. has a facility in Hyderabad, India that makes irbesartan active pharmaceutical ingredient (irbesartan API). Irbesartan API is used in making generic irbesartan, a drug used to treat high blood pressure and certain complications of type 2 diabetes.
The FDA investigated the Aurobindo facility in April 2017 and issued a Form 483, which cites conditions that violate its regulations. It inspected the facility again in February 2018, but found the same problems, including unsanitary equipment and mosquitoes in close proximity to the product. It issued Autobindo another Form 483.
The complaint contends that the poor conditions at the facility resulted in certain batches of irbestan API becoming adulterated with N-nitrosodiethylamine or NDEA. The complaint calls NDEA “a probable human carcinogen.”
According to the complaint, the adulterated irbesartan then went to the American company ScieGen Pharmaceuticals, LLC, which used it to make irebsartan tablets, which it then passed on to another Amercian company, Westminster Pharmaceuticals. Westminster then continued the processing of the product, including packaging it, labeling it, and distributing it to retailer around the US, including Walmart, Inc.
On or about October 26, 2018, the FDA announced that Aurobindo had recalled twenty-two batches of irbesartan, all of which were sent to ScieGen. Two days later, ScieGen issued its own recall notice. Later, Westminster joined in as well. Plaintiff Barbara Kruk bought the medication from Walmart. Walmart eventually contacted her to recall the medication.
The complaint claims that those who bought the adulterated irbesartan wasted their money and are now at greater risk for cancer. It claims violations of laws on failure to warn, breach of contract, negligence, and strict product liability, as well as violations of the Illinois Consumer Fraud and Deceptive Business Practices Act.