Lance v. Wyeth, 624 Pa. 231

Wyeth manufactured Redux and Pondimin (fenfluramine/dexfenfluramine) and Redux was FDA-approved in 1996 with a prominent warning for pulmonary hypertension.
By 1997 Redux and related drugs were withdrawn from the U.S. market; thousands sued alleging injuries and death from use.
The Lance plaintiff filed in 2006, asserting Redux caused PPH and death, framed as Negligence—Unreasonable Marketing and Unreasonable Failure to Remove, not labeling deficiencies.
Wyeth moved for summary judgment, arguing that only impurities or deficient warnings support liability; relied on FDA regulation, learned intermediary doctrine, and traditional strict-liability limitations.
The Superior Court partially allowed negligent design claims, reconceiving them as strict liability and addressing Restatement principles (§395, §6(c)); decision raised questions about the scope of pharmaceutical liability in Pennsylvania.
The Pennsylvania Supreme Court agreed to review to determine whether drug manufacturers are immune from fault-based liability beyond impurities/warnings and whether negligent design can be pursued.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether pharmaceutical companies enjoy blanket immunity from fault-based claims	Lance argues RobWyeth should be liable for negligent design/marketing, not immune.	Wyeth contends only impurities or deficient warnings survive and regulatory regime immunizes broader claims.	Not immune; Pennsylvania may recognize fault-based claims beyond impurities/warnings.
Whether negligent design defect is a viable claim against FDA-approved drugs	Plaintiff contends design defect claims exist despite FDA approval and are not barred by comment k.	Wyeth argues comment k precludes negligent design defect for prescription drugs.	Court treats issue as one of first impression and allows further consideration; design-defect theory not categorically barred.
Whether Appellee preserved a negligent design defect claim to permit review	Appellee maintained a central design-defect theory since inception; waiver is unfounded.	Wyeth argues the claim was abandoned and not properly preserved.	Waiver rejected; court finds preserved theory merits consideration.
Role of federal regulation and learned intermediary doctrine in postmarket drug liability	FDA approval does not bar state-law negligence; postmarket information may create liability.	Deference to FDA decisions should shield manufacturers from broader fault-based claims.	Federal regulation does not exempt state-law fault liability; learned intermediary doctrine does not foreclose liability for lack of due care.

Incollingo v. Ewing, 444 Pa. 263 (Pa. 1971) (high duty of care for dangerous drugs; strict distinction between product focus and manufacturer conduct)
Baldino v. Castagna, 505 Pa. 239 (Pa. 1984) (recognizes warnings-based liability; discusses unavoidably unsafe products)
Hahn v. Richter, 543 Pa. 558 (Pa. 1996) (warns that negligence is the recognized basis for liability regarding prescription drugs)
Phillips v. Cricket Lighters, 576 Pa. 644 (Pa. 2003) (distinguishes strict liability from negligence; discusses product design duties)
Dissenting: Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068 (2011) (FDA vaccine preemption discussion shaping drug-device liability debates)