Over 1,400 lawsuits have been filed against makers of over-the-counter versions of what was once the leading brand of heartburn medicine, Zantac. Plaintiffs allege that taking Zantac caused them to develop cancer. In April 2020, the FDA requested the removal of Zantac and all products containing the active ingredient ranitidine after testing revealed that long-term storage and temperatures higher than room temp transformed ranitidine into a cancer-causing byproduct, NDMA.
But recently, a U.S. District Court Judge in Florida, dismissed claims against manufacturers of over-the-counter, generic versions of Zantac.
The reason why the claims were tossed has nothing to do with the very high presence of NDMA in Zantac (nearly 30,000 times more FDA’s allowable limit), or whether NDMA is in fact carcinogenic. Rather, U.S. District Court Judge Robin Rosenberg, who is overseeing more than 1,400 Zantac suits, consolidated in multidistrict litigation in the Southern District of Florida, dismissed claims because of something called the preemption argument.
What is the preemption argument?
From a legal textbook perspective, according to Cornell Law, the preemption doctrine refers to the idea that a higher authority of law will displace the law of a lower authority of law when the two authorities come into conflict.
Here’s how that applies in Zantac litigation…
Zantac claims have been filed in state courts. But because of FDA labelling decisions, Judge Rosenberg ruled that “State law would require [generic Zantac manufacturers] to redesign or re-label ranitidine products, which they could not do under their federal duty of sameness,” Rosenberg wrote, according to reporting by FiercePharma.com. Judge Rosenberg added, “[Manufacturers] were not required to stop selling the products in order to comply with both federal and state law. Thus, the failure-to-warn and negligence claims are preempted.”
FiercePharma explains the preemption argument is a long-standing legal position the pharma industry has used with increasing effectiveness. But the argument doesn’t always work. In May, the Ninth U.S. Circuit Court of Appeals shot down Bayer’s preemption argument that the EPA’s backing of glyphosate preempts Roundup weedkiller cancer claims. In doing so, the Ninth upheld a California District Court’s judgement in favor of plaintiff Edwin Hardemann, who was awarded approximately $25 million.