We have already written at length about the nationwide litigation alleging contamination of Valsartan, Losartan, and Irbesartan, with carcinogenic substances. Basically, the claims are that generic versions of those drugs were being made overseas using poor manufacturing processes that caused the drugs to be tainted with impurities.
That contamination included the probable human carcinogen N-nitrosodimethylamine (NDMA), prompting mass recalls by the Federal Drug Administration (FDA). Those pending lawsuits point out that NDMA is the substance actually used in research facilities to induce cancer in lab rats. Accordingly, individual claims in those cases allege serious injuries such as liver damage and various cancers (including liver, kidney, colorectal, and gastric cancers).
Not surprisingly, similar contamination has now been found in other foreign-made drugs. Just within the past few days, the FDA has announced that NDMA has also been found in Zantac (ranitidine) that was manufactured overseas. Zantac is both a widely used over-the-counter drug (for treatment of heartburn associated with acid ingestion), as well as a prescription drug (for treatment of ulcers and gastroesophageal reflux disease).
The FDA continues to investigate these findings to determine whether additional mass recalls of Zantac are now required. If nothing else, this latest issue should, hopefully, prompt the FDA to take a much closer look at foreign-made generic drugs that are reaching, and allegedly injuring, patients in the United States.
COPYRIGHT © 2020, STARK & STARKNational Law Review, Volume IX, Number 263