Montero v. Teva Pharmaceuticals USA Inc.

Background

Emely Montero brought claims for negligence, strict products liability, breach of express warranty, breach of implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, and fraud against Teva Pharmaceuticals USA Inc. and Ortho McNeil Janssen Pharmaceuticals, Inc. She alleged that her injuries resulted from using Tri-Lo Sprintec.

Janssen moved to dismiss the claims against it for failure to state a claim. The opinion states that Janssen did not manufacture, distribute, or sell Tri-Lo Sprintec. Instead, Janssen made Ortho Tri-Cyclen Lo, and Tri-Lo Sprintec was the generic version of that product. The complaint and Montero’s opposition memorandum contained conflicting statements about whether Janssen manufactured Tri-Lo Sprintec. The court also took judicial notice of Food and Drug Administration records indicating that neither Janssen nor a Janssen-affiliated company had been approved to sell Tri-Lo Sprintec.

Court’s Analysis

Montero sought to proceed under an “innovator liability” theory, arguing that the manufacturer of a brand-name drug may be liable for injuries caused by the generic version, particularly when the generic manufacturer uses the brand-name product’s warning label. The court stated that courts applying New York law had consistently rejected that theory.

The court concluded that Montero had not sufficiently alleged that Janssen owed her a duty or caused her injuries. It also stated that Montero had not shown that she could allege facts plausibly connecting Janssen to the alleged injuries. Because amendment would therefore be futile, the court denied leave to amend.

Ruling

Judge Alvin K. Hellerstein granted Janssen’s motion to dismiss with prejudice. The Clerk of Court was directed to terminate Janssen as a party. The opinion does not state a disposition of Montero’s claims against Teva Pharmaceuticals USA Inc.