Maryland Court Dismisses All Claims Against Manufacturers and Retailers of Generic Ranitidine

By: GDLD | 2.8.22 | Case Results

A Maryland court has dismissed all claims asserted by the Mayor and City Council of Baltimore against the manufacturers and retailers of ranitidine, the generic version of the heartburn medication Zantac.

In a 23-page memorandum opinion, Judge John Nugent of the Circuit Court for Baltimore City analyzed and applied the doctrine of federal preemption, which arises out of the Supremacy Clause of the United States Constitution and declares federal law to be supreme. Citing two United States Supreme Court authorities, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013), Judge Nugent held that federal law required the labeling and design of generic medicines to match those of brand-name drugs. Because generic manufacturers were not free to change their products’ labeling and design, state law could not hold them liable for failing to do so.

Judge Nugent also rejected an attempt by the City to bypass the preemption doctrine and impose liability on the generic drug manufacturers for failing to change the products' container design, expiration dates or storage and transport practices – which the City had argued were not prohibited by federal law. Instead, Judge Nugent agreed with the generic manufacturers that these causes of action were not recognized under state law, and that the Circuit Court was not an appropriate forum to recognize such novel claims.

On the same grounds, Judge Nugent also held that claims against retailers of generic ranitidine were preempted. The City's allegations would have imposed liability merely for selling ranitidine, which federal law permitted; that would conflict with the Supreme Court’s holding in Bartlett. However, Judge Nugent allowed the City’s claims to proceed against the manufacturers of brand-name Zantac.

The City's complaint had named ten manufacturers of generic ranitidine, seven retailers, and four brand-name manufacturers. The motion to dismiss on behalf of the generic manufacturers was filed by the law firm of Goodell, DeVries, Leech & Dann, LLP, with attorneys Richard M. Barnes, Linda S. Woolf, Kamil Ismail, and Sean Gugerty, who represent Perrigo Research and Development Company. Mr. Barnes and Thomas Yoo of Holland & Knight also serve as co-liaison counsel for generic manufacturer defendants in a federal multidistrict litigation in the United States District Court for the Southern District of Florida.