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First Valsartan, Now Zantac: Cancer Causing Impurities in Foreign-Made Drugs

By Martin P. Schrama & Stefanie Colella-Walsh on September 19, 2019
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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.

As always, please feel free to contact Stark & Stark to speak with one of or attorneys, free of charge, who can help assess any defective drug or medical device claims that you may have.

Photo of Martin P. Schrama Martin P. Schrama

Martin P. Schrama is an expert Civil Trial Attorney as certified by the Supreme Court of New Jersey. He is also the Chair and Co-Founder of the Stark & Stark Mass Tort Litigation practice, as well as a member of the firm’s Commercial…

Martin P. Schrama is an expert Civil Trial Attorney as certified by the Supreme Court of New Jersey. He is also the Chair and Co-Founder of the Stark & Stark Mass Tort Litigation practice, as well as a member of the firm’s Commercial Litigation and Intellectual Property practices.

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Photo of Stefanie Colella-Walsh Stefanie Colella-Walsh

Stefanie Colella-Walsh is a Shareholder and member of Stark & Stark’s Litigation, Insurance Coverage & Liability, Intellectual Property and Mass Torts Groups where she concentrates her practice in complex litigation with a focus in mass tort and pharmaceutical litigation. She is currently involved…

Stefanie Colella-Walsh is a Shareholder and member of Stark & Stark’s Litigation, Insurance Coverage & Liability, Intellectual Property and Mass Torts Groups where she concentrates her practice in complex litigation with a focus in mass tort and pharmaceutical litigation. She is currently involved in representing numerous plaintiffs in federal and state environmental and pharmaceutical mass tort cases, as well as state and federal class action litigations based upon commercial, employment, civil rights, investments/securities and consumer fraud claims. Ms. Colella-Walsh frequently writes about timely legal and legislative developments impacting plaintiffs in mass tort and product liability actions for Stark & Stark’s Mass Tort Law Blog.

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  • Posted in:
    Food, Drug & Agriculture
  • Blog:
    Mass Torts Law Blog
  • Organization:
    Stark & Stark

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