Rosewolf v. Merck & Co., Inc.

Background

Joshua Rosewolf sued Merck & Co., Inc., Merck Sharp & Dohme Corp., Organon & Co., and Organon, LLC. The defendants manufactured and sold Singulair, a brand-name drug containing montelukast. Rosewolf alleged that montelukast could cause neuropsychiatric injuries, that the defendants knew about those risks, and that they failed to provide adequate warnings and misrepresented Singulair’s safety while educating California physicians.

Rosewolf alleged that he used Singulair from 2005 through 2008 and experienced depression, hostility, suicidal thoughts or behavior, and tics. The Food and Drug Administration required a prominent warning and a new medication guide for Singulair on March 4, 2020. Rosewolf alleged that he and his physician would not have used or prescribed the drug if they had known about the risks.

Defendants’ Motion

The defendants moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), which allows dismissal when a complaint does not allege enough facts to state a legally sufficient claim. They argued that Rosewolf’s claims were barred by California’s two-year deadline for personal-injury claims and that he had not adequately alleged facts supporting the discovery rule.

The discovery rule can delay when a claim begins to run until the plaintiff discovers, or has reason to discover, the facts supporting the claim. To plead that the rule applies, Rosewolf had to allege how and when he discovered those facts and why reasonable diligence could not have led to that discovery earlier.

Court’s Analysis

The court found Rosewolf’s allegations insufficient. Although he identified the FDA’s March 4, 2020 warning as the point when he was put on notice, he did not allege that he actually saw the warning on that date. The court also noted the twelve-year gap between his stopping Singulair in 2008 and the warning, as well as his allegation that symptoms developed while he was taking the drug.

The complaint did not explain when Rosewolf actually learned about the warning or what he did before then to investigate his symptoms. The court also rejected his reliance on decisions involving patients who alleged that they depended on their doctors to explain the causes of their injuries, because Rosewolf did not allege that he discussed his symptoms with his physician or depended on the physician for that information.

The court further held that Rosewolf did not explain why earlier warning labels and studies described in his complaint would not have put him on notice to investigate his claim.

Ruling

The court granted the defendants’ motion to dismiss. It also granted Rosewolf leave to amend because it could not conclude that amendment would be futile. Rosewolf could file an amended complaint within 21 days after the court issued a separate order addressing motions in related cases; the defendants would then have the time allowed by the Federal Rules of Civil Procedure to respond.