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Zantac Defendants claim FDA Relationship Protects them from Liability

Zantac makers pleaded in court this week that their relationship with the FDA protects them from liability. More specifically, the embattled drug makers and distributors of Zantac argued that any liability claims against them for Zantac are “preempted” by federal law. Drug makers, retailers and distributors made their argument for preemption in a Florida federal court on Dec. 15, 2020.

Lawyers for Zantac makers, retailers, and distributors argued in Florida this week that any plaintiffs’ claims of injury from a cancer-causing chemical found in Zantac (NDMA) and its generic equivalent ranitidine are preempted by federal law. Lawyers defending Zantac argued that the defendants would have had to ask for permission or assistance from the federal government to make changes to the drug to comply with state law requirements.

“The heart of this complaint,” argued attorney Rachel Horton, who represented Zantac-maker Sanofi SA, “is that the branded defendants should have designed Zantac differently. But the regulations prohibit a manufacturer from unilaterally doing so.”

Recent Preemption Arguments Resurface

During the second day of a two-day video conference hearing on various motions to dismiss, the defendants claimed that two recent (comparatively, considering the age of tort law) Supreme Court decisions pave a path for them to escape liability for Zantac: 1.) PLIVA Inc. v. Mensing and 2.) Mutual Pharmaceutical Co. v. Bartlett.

Those two cases, both split in the last ten years by tightly partisan 5-4 votes from the nine SCOTUS justices, have sometimes served as precedents to allow drug makers to escape liability claims brought against them.

On the other side, an attorney for the plaintiffs said that state law claims can create several different duties to consumers, not all of which would conflict with federal law.

An attorney for the plaintiffs said, “There cannot be preemption when there are parallel claims like this.”

Pharmacy & Distributor Responsibility
A lawyer working for pharmacy and distributor defendants, meanwhile, urged the court to dismiss the claims against her clients. She said they are further removed from the manufacturing process and are not allowed to change the design, labeling, storage requirements or expiration date beyond what has been approved by the FDA. “Plaintiffs are asking to do something that’s never been done before: extend liability beyond manufacturers to all entities in the supply chain,” she claimed.

A plaintiff’s attorney retorted that retailers have often been held liable for selling defective products, even though they are not responsible for the design or manufacture of the products. He said it has been a public policy choice to hold downstream parties responsible.

“It’s liability without fault,” said Mr. Keller for the plaintiffs. “We recognize that the retailers didn’t necessarily do anything wrong, but they nonetheless have to pay to serve an important public policy.”

Zantac Lawsuits over Cancer-causing NDMA

The lawsuits accuse Pfizer Inc., Sanofi SA, Boehringer Ingelheim Pharmaceuticals Inc. and GlaxoSmithKline LLC, as well as generics makers, distributors, pharmacies and others in the supply chain, of false advertising, failure to warn and other claims associated with the discovery of cancer-causing chemical nitrosodimethylamine, or NDMA, in the medication.

In Sept. 2019, the FDA warned that trace amounts of NDMA were found in Zantac and similar generic drugs. On April 1, 2020, FDA pulled all prescription and over-the-counter ranitidine drugs from the market over concerns that if the drug were stored above room temperature, it could produce dangerous levels of the carcinogen.

The FDA has set an allowable daily limit of 96 nanograms of NDMA. Researchers have found more than 3 million nanograms in a single dose of Zantac. NDMA is also found in red meat, tobacco, and beer.

The case is In re: Zantac (Ranitidine) Products Liability Litigation, case number 9:20-md-02924, in the U.S. District Court for the Southern District of Florida.

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