Rosewolf v. Merck & Co., Inc.

Background

The court considered motions to dismiss filed by Merck & Co., Inc., Merck Sharp & Dohme Corp., Organon & Co., and Organon, LLC. Joshua Rosewolf, Mark Starr, Tyler Skinner, and Shauna Gibson alleged that Singulair’s active ingredient, montelukast, caused neuropsychiatric injuries and that the defendants knew about those risks but failed to provide adequate warnings on Singulair’s label. The plaintiffs asserted claims for strict liability based on defective design, strict liability based on failure to warn, negligence, negligent misrepresentation, breach of express warranty, and breach of implied warranty.

The court explained that federal drug regulations make the brand-name manufacturer responsible for the accuracy and adequacy of its label, while generic manufacturers generally must use the same labeling as the brand-name drug. The plaintiffs alleged that they were prescribed and ingested branded or generic Singulair after 2012, except that Rosewolf alleged he was prescribed Singulair before the defendants’ patent expired. They also alleged that the Food and Drug Administration required a prominent warning and a new medication guide in 2020.

Personal Jurisdiction

The defendants sought dismissal for lack of personal jurisdiction, meaning they argued that the court could not properly exercise authority over them. The court applied the test for specific jurisdiction, which asks whether the defendants deliberately engaged with California, whether the claims arose from or related to those activities, and whether exercising jurisdiction would be reasonable.

The court denied dismissal on this ground. It concluded that the plaintiffs’ allegations about the defendants’ research, sales, marketing, and promotion of Singulair in California were sufficient to connect the claims to California. The court held that those activities could count even if some plaintiffs ingested generic montelukast, because California law assigns responsibility to brand-name manufacturers for the Singulair warning label.

Failure to State a Claim

The defendants also moved under Rule 12(b)(6), which tests whether a complaint alleges enough facts to support a legally recognized claim. The plaintiffs conceded that Count I, the defective-design claim, and the portion of Count III not based on failure to warn should be dismissed. The court therefore granted the motions in part on that basis.

The court denied dismissal of the failure-to-warn allegations in Counts II and III. It concluded that the plaintiffs alleged facts describing what the defendants knew about the risks, why the Singulair label was allegedly inadequate, and why the plaintiffs’ physicians would not have prescribed the drug if those risks had been disclosed. The court found those allegations sufficient at the pleading stage even though the plaintiffs did not identify their physicians by name.

The court also denied dismissal of the negligent-misrepresentation claims in Count IV. It found that the plaintiffs had alleged who created the label, when and where the drug was prescribed and ingested, what information the label allegedly omitted, and how the alleged omissions caused harm. The court further denied dismissal of the express- and implied-warranty claims in Counts V and VI, relying on its conclusions that the failure-to-warn and negligent-misrepresentation allegations were sufficient.

Disposition and Next Steps