Anderson v. Merck & Co., Inc.

Background

Amy Anderson sued Merck & Co., Inc., Merck Sharp & Dohme Corp., Organon & Co., and Organon, LLC. She alleged that the defendants manufactured and sold Singulair, that montelukast—the drug’s active ingredient—could cause neuropsychiatric injuries, and that the defendants knew of those risks but failed to provide adequate warnings. She also alleged that the defendants promoted Singulair to California physicians while misrepresenting its safety.

The Food and Drug Administration required a boxed warning and a new medication guide for Singulair in March 2020. Anderson alleged that she could not reasonably have discovered the full extent of the risks or the defendants’ alleged concealment until that warning was issued. She asserted claims for strict liability based on failure to warn, negligence, negligent misrepresentation, breach of express warranty, and breach of implied warranty.

Personal jurisdiction and conceded claims

The defendants preserved an argument that the court lacked personal jurisdiction over them. Relying on its earlier ruling in a related proceeding, the court found no material difference in the relevant facts and denied the motion to dismiss for lack of personal jurisdiction.

Anderson conceded that her strict-liability design-defect claim should be dismissed. She also conceded that her negligence claim should be dismissed to the extent it was based on a manufacturing defect. The court dismissed those claims pursuant to her voluntary dismissal.

Statute of limitations

The defendants argued that Anderson’s claims were barred by the statute of limitations, meaning the deadline for filing them, and that she had not adequately alleged a basis for delaying that deadline under California’s discovery rule. The discovery rule can delay the start of the filing period until a plaintiff discovers, or has reason to discover, the facts supporting a claim.

The court found Anderson’s allegations insufficient. Although she alleged that she learned of the relevant risks when the FDA required the boxed warning, she did not provide facts explaining when or how she learned about that warning or what she did before then to investigate her symptoms. The court also noted that she described earlier warnings and studies about possible neuropsychiatric events but did not explain why that information would not have put her on notice to investigate her claims.

The court therefore granted the defendants’ motion to dismiss based on the statute of limitations. It did not dismiss the claims with prejudice. Instead, it found no evidence of bad faith and could not conclude that amendment would be futile, so it granted Anderson leave to amend.

Federal preemption

The defendants also argued that federal law preempted Anderson’s negligence claim. Federal preemption can prevent a state-law claim from proceeding when it conflicts with federal requirements. The court discussed Supreme Court decisions concerning whether state-law drug claims against brand-name or generic manufacturers are impossible to comply with alongside federal drug regulations.

The court found the reasoning of decisions declining to apply preemption to certain pre-approval design theories more persuasive than the contrary approach. Based on the record and allegations before it, the court concluded that the defendants had not shown that Anderson’s design-defect claims were preempted. The court stated that the defendants could renew the argument if Anderson amended her claims to show that they were not time-barred.

Disposition

The court granted in part and denied in part the defendants’ motion to dismiss. Anderson received permission to file an amended complaint by December 12, 2022, and the defendants were ordered to answer or otherwise respond by January 6, 2023.