Zantac Recall Lawsuits Centralized in Southern District of Florida

Published on February 7, 2020 by Sandy Liebhard

A federal judicial panel has agreed to centralize all Zantac lawsuits stemming from recent recalls of contaminated heartburn drugs before a single judge in the U.S. District Court, Southern District of Florida.

Zantac Lawsuits Assert Similar Allegations

According to an Order issued on February 6th by the U.S. Judicial Panel on Multidistrict Litigation, more than a dozen Zantac lawsuits will be transferred to the new proceeding. The docket includes nine individual personal injury claims alleging medications tainted with N-Nitrosodimethylamine (NDMA) caused various cancers, as well as six consumer class actions seeking economic damages for Zantac purchases.

“These actions share factual questions arising from allegations that ranitidine, the active molecule in Zantac and similar heartburn medications, can form the carcinogen NDMA, either during storage or when metabolized in the human body,” the Panel wrote. “Plaintiffs uniformly allege that the manufacturers, sellers, and distributors of Zantac and other ranitidine medications knew or should have known that these medications exposed consumers to NDMA, and that defendants concealed the NDMA-associated dangers posed to consumers by these products.”

Any similar Zantac lawsuits filed in federal courts in the future will also be eligible for transfer to the new multidistrict litigation.

Why Was there a Zantac Recall?

Plaintiffs across the United States began filing Zantac lawsuits last September, shortly after  the U.S. Food & Drug Administration (FDA) warned that ranitidine-containing heartburn drugs could be contaminated with NDMA, a probable human carcinogen.

Valisure, an online pharmacy that tests every medication lot it sells, initially detected NDMA in ranitidine and has petitioned the FDA for a Zantac recall. While Valisure believes the impurity resulted from the instability of the ranitidine molecule, which purportedly degrades when subjected to the conditions created by digestion, the FDA is still working to determine if Zantac produces the carcinogen in the human stomach.

Last month, Emery Pharma also petitioned the FDA for a Zantac recall, after its tests suggested ranitidine produces unacceptably high levels of NDMA when exposed to heat for as little as five days, even after the drug has been packaged.

“Our preliminary data indicate that NDMA accumulates in ranitidine-containing drug products on exposure to elevated temperatures, which would be routinely reached during shipment and during storage,” the Emery Pharma’s petition states. “More importantly, these conditions occur post-lot release by the manufacturer. Hence, while NDMA levels in ranitidine may be acceptable at the source, they may not be so when the drug is purchased and subsequently at the time of consumption by the consumer.”

While the FDA has yet to order a Zantac recall, numerous generic drug makers have voluntarily pulled ranitidine products from the global market. Several retailers – including CVS, Walgreens, Walmart, and Rite-Aid — also removed the drugs from store shelves.

How the Zantac Litigation Will Work

The centralization of all federally filed Zantac lawsuits will allow these cases to undergo coordinated pretrial proceedings, including discovery and motions practice. This process reduces the potential for duplicative discovery and inconsistent rulings on motions, while preserving the resources of the courts, parties, and witnesses involved in the litigation.

At some point, the judge overseeing the multidistrict litigation will select a number of representative Zantac lawsuits for early bellwether trials. Although they’re not binding on other lawsuits pending in the proceeding, bellwether trial verdicts could provide insight into how future juries might decide similar cases.

While there is no guarantee of a global Zantac settlement, bellwether trial verdicts can also provide the parties with a pathway to such an accord.