Lance v. Wyeth, Inc.

Summary

The Pennsylvania Supreme Court considered whether Pennsylvania products-liability law permits claims against a pharmaceutical manufacturer for negligent design, marketing, testing, or failure to withdraw an FDA-approved prescription drug, beyond claims based on impurities or inadequate warnings. The case involved Redux, an appetite suppressant alleged to have caused pulmonary hypertension and death, and addressed the relationship between negligence theories, strict liability, comment k to Restatement § 402A, and FDA regulation.

Holdings

1. Under Pennsylvania law, a pharmaceutical company violates its duty of care if it introduces a drug into the marketplace or continues to market it with actual or constructive knowledge that the drug is too harmful to be used by anyone. Pennsylvania law does not immunize pharmaceutical companies from fault-based liability for such conduct.
2. Comment k's protection against strict liability for unavoidably unsafe products does not categorically bar negligence claims involving prescription drugs.
3. A manufacturer or supplier has a duty to cease further distribution of a product when it knows or reasonably should know that the product is too dangerous to be used by anyone.
4. The learned-intermediary doctrine does not diminish a pharmaceutical manufacturer's duties or insulate it from liability where the alleged product is so dangerous that no warning would be sufficient and no physician, if appropriately informed, would prescribe it.
5. The plaintiff did not waive the theory because Wyeth itself sought a categorical rule barring all pharmaceutical-products-liability theories other than impurities and warnings, thereby providing a fair opportunity to address the scope of the proposed preclusion.

Questions Presented

1. Whether Pennsylvania law immunizes pharmaceutical manufacturers from negligence liability for introducing or continuing to market a prescription drug that the manufacturer knew or should have known was too dangerous for anyone to use.
2. Whether Pennsylvania's adoption of Restatement (Second) of Torts § 402A comment k, which limits strict liability for unavoidably unsafe products, also bars negligence-based design, marketing, or failure-to-withdraw claims.
3. Whether the plaintiff waived a negligent-design or related negligence theory by styling her claim as negligent marketing and failure to withdraw.
4. Whether the learned-intermediary doctrine insulates a pharmaceutical manufacturer from liability where the alleged danger is so severe that no warning would make the drug appropriate for any patient.

Disposition

other