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Wyeth v. Levine

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Brief Fact Summary.

Plaintiff was injected with a drug that caused gangrene, eventually costing the plaintiff her hand.

Synopsis of Rule of Law.

The FDA’s drug labeling requirements do not preempt state law product liability claims.

Points of Law - Legal Principles in this Case for Law Students.

After rejecting Wyeth's impossibility preemption argument, Justice Stevens suggested that the presentation of clear evidence that the FDA would not have approved a change to the drug's label might form the basis for impossibility preemption.

View Full Point of Law

Plaintiff was injected with a drug manufactured by the defendant to treat her headaches and nausea on several occasions.  As a consequence of the injections, she developed gangrene, which eventually required the amputation of her arm up to her elbow.  She incurred substantial medical expenses, and lost her source of income as a professional musician.  She brought suit for the injuries, but the defendant countered that her claims were preempted, and thus invalid.


Do the FDA’s drug labeling requirements preempt state law product liability claims?


No, the FDA’s drug labeling requirements do not preempt state law product liability claims.


Justice Alito, J. (joined by Roberts, C.J. and Scalia, J.)

The justices disagree with the opinion of the majority because they feel it improperly allows a jury to be an arbitrator of the federal law as it relates to preemption

When a higher authority of law takes priority over other law.

.  The justices feel this should; be the realm of the legislature.


Justice Breyer, J.

The justice concurs separately to further emphasize that the requirement to comply with both sets of laws would neither preempt the state law, nor frustrate the purpose of either.

Justice Thomas, J.

The justice agrees with the majorities position that there in no preemption in the case at hand, but disagrees with their analysis of the purpose of the law as it relates to preemption.


The court found for the plaintiff, and held that the FDA’s drug labeling requirements do not preempt state law product liability claims.  In coming to this conclusion, the court found that the defendant did not prove it was impossible to comply with both the federal and state requirements, nor would the purpose of either the state or federal law be frustrated by requiring compliance with both sets of laws.

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