What is Zantac?
Zantac is the trade name for Ranitidine and it was a popular medication that reduces the body’s production of stomach acid. The medication has been sold over the counter and by prescription for decades to treat and prevent ulcers of the stomach and intestines, gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, peptic ulcer disease, acid indigestion, and heartburn. Ranitidine was the 50th most prescribed medication in the United States.
On April 1, 2020, the U.S. Food and Drug Administration (FDA) requested that all ranitidine (Zantac) products be pulled from the market immediately. The FDA discovered that a probable human carcinogen, N-Nitrosodimethylamine (NDMA), increases within Zantac over time, especially if stored in higher than room temperature areas. In fact, the FDA found NDMA in Zantac at levels between 3,000 to 26,000 times higher than FDA approved standards. NDMA is a known carcinogen.
The Plaintiffs’ Complaints
Plaintiffs from all over the country have filed three separate master complaints against Defendants: (1) a personal injury complaint; (2) a proposed nationwide consumer class actions; and (3) a proposed class action on behalf of third-party payers.
Court’s Rulings in Zantac MDL
In December and January, Judge Rosenberg issued a number of Orders and rulings related to Defendants’ various Motions to Dismiss. Two of her Orders related to preemption and innovator liability are discussed here.
Pre-emption: Defendants (generic drugmakers, retailers, and distributors) argued that all state law claims should be dismissed. Defendants argued that Plaintiffs’ state law claims are pre-empted by federal law because they cannot remedy design defects or provide additional warnings while remaining in compliance with federal law. PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013). Plaintiffs argued that the claims are not pre-empted “because the claims are based on the fact that ranitidine products were misbranded when sold and on Defendant’s failure to take actions that they could have taken while remaining in compliance with federal law.” The Court agreed with Defendants, citing Mensing and Bartlett, in that the misbranding counts are pre-empted by federal law against the generic drug manufacturers. The Court explained that “[d]espite the availability…to make changes [to the drug’s label], generic drug manufacturers have an ongoing federal duty of ‘sameness’ that requires ‘the warning labels of a brand-name drug and its generic copy must always be the same.’” Thus, generic manufacturers can only change the label when the brand-name label is updated or the FDA instructs them to do so.
However, Plaintiffs argued that the expiration dates for the products could have and should have been changed without FDA pre-approval and Defendants should have tested and shortened the expiration dates to ensure drug stability. Accordingly, Plaintiffs argued that they can pursue state-law claims that are based on Defendants’ failure to warn consumers that the ranitidine had expired and Defendants’ failure to test the products to learn of its expiration. The Court agreed, citing Wyeth v. Levine, 555 U.S. 555 (2009), that a “failure-to-warn claim is not pre-empted if a drug manufacturer has the ability to change drug labeling through the CBE process without waiting for FDA approval…” However, because the master complaints did not state claims based on expiration dates and testing, the Court granted Plaintiffs leave to amend these allegations consistent with her ruling.
State Law Negligence Claims (Innovator Liability): the Defendants claimed, among other things, that innovator liability was only recognized in two states: California and Massachusetts. Plaintiffs disagreed and argued that under a substantive Erie analysis, the majority of other states would recognize negligence causes of action against the generic brand manufacturers for its deficient warning labels. The Court purportedly conducted an Erie analysis and concluded “that none of the 35 jurisdictions that the Court analyzed would recognize Plaintiffs’ theory of liability under which Defendants may be held liable for injuries sustained by Plaintiffs’ ingestion of a product that Defendants did not manufacture, sell, or distribute.” In addition, the Court concluded that Plaintiffs failed to allege a prima face case of specific personal jurisdiction as to any Defendant in California or Massachusetts and that California and Massachusetts do not have legislative jurisdiction within those states that have general personal jurisdiction over Defendants. The Court dismissed Plaintiffs’ claims without prejudice and with leave to amend to plead a prima facie case of personal jurisdiction in California and Massachusetts.
While the court’s recent Orders may appear to sound alarms for Plaintiffs and consumers, they should be taken in the context in which they have been issued. These actions involve hundreds of Defendants and dozens of causes of actions against different Defendants. First, Plaintiffs were granted leave to replead claims against Defendants based on expiration dates, testing, storage and transportation conditions, warning the FDA, manufacturing defects, and the Magnuson-Moss Warranty Act, as well as to replead their derivative counts, consistent with the Court’s Order. Second, the Plaintiffs’ causes of actions against all of the branded manufacturers remain. Third, subject to repleading, there are multiple viable causes of action against the generic manufacturers, retailers, and distributers, despite the pre-emption rulings. In short, the case is alive and well.
How May Lightfoot, PLLC can help?
Je Yon Jung, Senior Counsel at May Lightfoot, argued on behalf of the Plaintiffs’ regarding Defendant’s Innovator Liability Motion to Dismiss on December 14, 2020. Ms. Jung was selected to be on the Plaintiffs’ Steering Committee of the MDL in May 2020. She continues to be deeply involved in the massive discovery related to this MDL, as well as participating on the Science/Expert subcommittee in preparation for the upcoming Daubert battle. May Lightfoot filed the first Zantac case in the District of Columbia. For more information about Zantac, go https://www.maylightfootlaw.com/practice-areas/mass-torts/zantac-claims/. Contact us for a free consultation at (202) 506.3591 or firstname.lastname@example.org.