Montero v. Teva Pharmaceuticals USA Inc.

Background

Emely Montero alleged that she used Teva’s generic oral contraceptive, Tri-Lo Sprintec, from approximately February 2010 through August 2016. She alleged that the drug caused life-threatening blood clots, including a pulmonary embolism, and other injuries. She claimed that the defendants promoted the drug as safe and effective, failed to conduct sufficient testing, and failed to adequately warn the Food and Drug Administration, health-care providers, and consumers about the risks.

Montero asserted state-law claims for negligence, strict product liability, breach of express warranty, breach of implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, and fraud. Janssen had previously been dismissed because the court found that it did not manufacture, distribute, or sell Tri-Lo Sprintec. Teva was the remaining defendant and moved for judgment on the pleadings.

Legal standard

The court applied the same standard used for a motion to dismiss for failure to state a claim. It accepted the complaint’s factual allegations as true and considered whether they stated a plausible claim for relief.

Federal-law displacement of the claims

The court explained that federal law requires a generic drug’s labeling to match the labeling of the corresponding brand-name drug. Under Supreme Court decisions addressing generic drugs, a generic manufacturer cannot independently strengthen the drug’s warnings or change the drug’s composition. State-law claims that would require those actions conflict with federal law and are therefore preempted, meaning federal law displaces the conflicting state-law claims.

The court identified three categories of Montero’s allegations: defective design, inadequate testing, and failure to warn. It held that the design claims were preempted because Teva could not redesign the generic drug while complying with federal law. The inadequate-testing theory was also preempted to the extent it suggested that Teva should have determined the drug was too dangerous and stopped selling it. The court rejected that theory because federal preemption law does not require a manufacturer to stop selling a product to avoid state-law liability.

The failure-to-warn claims were preempted because Teva could not change the generic drug’s package labeling. The court also held that this reasoning applied to alleged failures to provide additional warnings through communications with health-care providers and advertisements.

Fraud-related claims

The court noted that federal law did not automatically resolve claims based on affirmative misrepresentations or concealment. However, Montero’s fraud-based claims primarily relied on allegations about the drug’s labeling, so they were preempted to that extent.

To the extent those claims went beyond labeling, the court held that they failed to meet Federal Rule of Civil Procedure 9(b), which requires fraud to be pleaded with particularity. For misrepresentation claims, the complaint had to identify the time, place, and content of the alleged false statement. For concealment or omission claims, it had to identify the omitted information, the person responsible, the context and manner of the alleged deception, and what the defendant obtained through the alleged fraud. The court found that Montero’s allegations were conclusory, did not identify a particular misleading statement or concealment, and did not distinguish between the defendants or identify a particular speaker or responsible person.

Disposition

The court granted Teva’s motion for judgment on the pleadings and dismissed the complaint with prejudice. It canceled the scheduled oral argument, directed the Clerk to terminate the open motion, and ordered the case closed.