On December 1, 2018, a proposed class action lawsuit was filed in the U.S. District Court for the Middle District of Florida Tampa Division (“federal court”) regarding Walmart and the other defendants’ (Aurobindo Pharma Ltd., ScieGen Pharmaceuticals, Inc., and Westminster Pharmaceuticals, LLC) “manufacturing, distribution, and sale of generic irbesartan prescription medications containing an active pharmaceutical ingredient (“API”) adulterated with N-nitrosodiethylamine (“NDEA”), a probable human carcinogen.” Irbesartan is a prescription medication mainly used to treat high blood pressure and diabetic nephropathy.
The federal class-action lawsuit alleges: “Due to manufacturing defects originating in Defendant Aurobindo Pharma Ltd.’s (“Aurobindo”) facility in India, certain batches of irbesartan active pharmaceutical ingredient were supplied to Defendant ScieGen Pharmaceuticals, LLC (“ScieGen”), and thus introduced to the United States market, that were adulterated with the probable human carcinogen, NDEA (the “Adulterated Irbesartan”). After ScieGen used the Adulterated Irbesartan to manufacture and produce finished generic prescription irbesartan tablets, ScieGen shipped the tablets containing Adulterated Irbesartan to Defendant Westminster Pharmaceuticals (“Westminster”) in or about Tampa, Hillsborough County, Florida. Westminster, in turn, further manufactured, labeled, packaged, and
distributed the tablets containing Adulterated Irbesartan to pharmaceutical retailers nationwide, including Defendant Walmart Inc. (“Walmart”).”
The federal class action lawsuit further alleges: “Plaintiff and the putative class members were injured by paying the full purchase price of their medications containing Adulterated Irbesartan and by paying for incidental medical expenses. These medications are worthless because they are contaminated with carcinogenic and harmful NDEA and are thus not fit for human consumption.”
What Is Irbesartan?
Irbesartan is a generic drug generally used to treat high blood pressure and diabetic nephropathy, a complication of type 2 diabetes which affects the kidneys. Irbesartan is the generic form of the brand-name drug Avapro. Avapro was initially approved by the FDA and marketed in the United States in 1997.
The federal class action lawsuit alleges: “As a result of Aurobindo’s poor quality-control measures and failure to comply with cGMPs [current Good Manufacturing Practices], its irbesartan API became adulterated and contaminated by NDEA. NDEA is not an FDA-approved ingredient for branded Avapro or generic irbesartan. None of Defendants’ irbesartan products (or any irbesartan product, for that
matter) identify NDEA as an ingredient on their products’ labels or elsewhere … By introducing their irbesartan products into the United States market under the name “irbesartan” as a therapeutic equivalent to Avapro and with the FDA-approved label that is the same as that of Avapro, Defendants represented and warranted to end users that their products are in fact the same as and are therapeutically
interchangeable with Avapro … The presence of NDEA in the Adulterated Irbesartan: (1) renders Defendants’ irbesartan products non-bioequivalent (i.e., not the same) to Avapro and thus non-therapeutically interchangeable with Avapro, thus breaching Defendants’ express
warranties of sameness; (2) was the result of gross deviations from cGMPs thus rendering Defendants’ irbesartan products non-therapeutically equivalent to Avapro, and thus breaching Defendants’ warranties of sameness; and (3) results in Defendants’ irbesartan
containing an ingredient that is not also contained in Avapro, also breaching Defendants’ warranty of sameness (and warranty that the products contained the ingredients listed on each Defendants’ FDA-approved label) … Due to its status as a probable human carcinogen as listed by both the International Agency for Research on Cancer (“IARC”) and as determined by pharmaceutical regulators such as the European Medicines Agency and the FDA, NDEA is not an FDA-approved ingredient in irbesartan. The presence of NDEA in the
Adulterated Irbesartan results in Defendants’ irbesartan products being non-merchantable and not fit for its ordinary purposes (i.e., as a therapeutically interchangeable generic version of Avapro), breaching Defendants’ implied warranties of merchantability and/or
fitness for ordinary purposes.”
The FDA announced on October 26, 2018 that Aurobindo had recalled several batches of irbesartan API that it had dispatched to ScieGen. Aurobindo recalled 22 Batches of its irbesartan API, all supplied to ScieGen, and all contaminated with NDEA. The FDA announced that on October 30, 2018, ScieGen had issued its own recall of irbesartan that it supplied to Westminster as well as Golden State Medical Supply, Inc.
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