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Federal Judge Rids Labeling Claims in Zantac MDL

Federal Judge Rids Labeling Claims in Zantac MDL

A Florida federal judge presiding over sprawling multidistrict litigation involving the carcinogens found in the heartburn medication Zantac cut more claims from the litigation, holding that design defect claims are barred by federal law.

The judge rejected arguments by consumers and third-party payers that their claims are not preempted because the heartburn drug was misbranded, as the presence of a cancer-causing substance in the drug was not disclosed.

“As with generic drugs, a claim based on an allegation that a brand-name drug’s FDA-approved formulation renders the drug misbranded is a pre-empted claim because the drug’s manufacturer cannot independently and lawfully change a drug formulation that the FDA has approved,” the judge said.

The FDA issued a warning in September 2019 that trace amounts of NDMA were found in Zantac and similar generic drugs. On April 1, they pulled all prescription and over-the-counter drugs featuring ranitidine – the active ingredient in heartburn medications – from the market over concerns that the drug, when stored above room temperature, could produce unacceptable levels of carcinogen.

Since a brand-name manufacturer can strengthen warnings on drug labels without waiting for the FDA’s sign-off – as part of the agency’s changes being effected process – a labeling claim against a branded drug manufacturer isn’t necessarily preempted, the judge said.

“Therefore, the plaintiffs are granted leave to replead design-defect claims against the defendants that are based on the labeling of ranitidine products,” the judge said.

The judge also dismissed state law claims seeking to recoup monetary losses from buying over-the-counter ranitidine, finding the Congress didn’t intend for any state to classify a claim as a product liability claim when the plaintiff was not personally injured.

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Litigation Updates

Zantac Lawsuit Update June 2022

May 26, 2022

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Zantac Lawsuit Update June 2022

Zantac Lawsuit Update May 2022

May 20, 2022

May 20, 2022

Zantac Lawsuit Update May 2022

Zantac Multidistrict Litigation Sets Out For 2023 Bellwether Trials

October 29, 2021

October 29, 2021

Zantac Multidistrict Litigation Sets Out For 2023 Bellwether Trials

Federal Judge Rids Labeling Claims in Zantac MDL

January 11, 2021

January 11, 2021

Federal Judge Rids Labeling Claims in Zantac MDL

Veterans Prescribed Zantac at the VA have Filed Zantac Lawsuits

November 9, 2020

November 9, 2020

Veterans Prescribed Zantac at the VA have Filed Zantac Lawsuits

New Class Action Zantac Lawsuit Includes Claims from More Than 200 Zantac Users

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September 16, 2020

New Class Action Zantac Lawsuit Includes Claims from More Than 200 Zantac Users

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