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

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.

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About this Author

Martin P. Schrama, Stark Law, Intellectual Property and Litigation Law Attorney
Shareholder

Martin P. Schrama is a Shareholder in Stark & Stark's Commercial Litigation, Mass Tort, Intellectual Property and Green Litigation Groups. Mr. Schrama has extensive experience litigating on both the trial and appellate levels of the federal and state courts of New Jersey and New York, as well as numerous other jurisdictions throughout the nation in a pro hac vice capacity. This experience also extends to regular practice before AAA, JAMS and various other alternate dispute resolution fora.

The primary focus of Mr. Schrama’s practice is...

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Stefanie Colella Walsh, Pharmaceutical Litigation Attorney, Stark Law Firm
Shareholder

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 also handles litigation related to nursing home negligence and abuse claims, elder abuse, and assisted living facility litigation.

Recently, Ms. Colella-Walsh was a member of the national trial team involved the first trial in the country of a TVT-Secur transvaginal mesh device case against Ethicon/Johnson and Johnson. 

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