Supreme Court Protects Generic Drug Companies In Pliva v. Mensing Decision

In Pliva, Inc. v. Mensing, 564 U.S. ___ (2011), a decision issued on June 23, 2011 by the United States Supreme Court ruled that generic drug makers cannot be sued under state law on the basis that they failed to provide adequate warning labels about potential side effects, effectively overturning U.S. appeals court rulings that allowed such lawsuits.

The generic drug companies in Pliva argued that federal law requires generic drugs to have the same labels as their brand-name equivalents.

Therefore, if the labels have been approved by the U.S. Food and Drug Administration, then such lawsuits are barred by federal law.

By a 5-4 vote, the majority opinion, delivered by Chief Justice Clarence Thomas, agreed with the generic companies and held that under the Supremacy Clause of the Constitution, federal drug regulations applicable to generic drugs preempt any conflicting state laws.

Justices Sonia Sotomayor, Ruth Bader Ginsberg, Stephen Breyer and Elena Kagan dissented.

Pliva v. Mensing Judgment:

www.mainepersonalinjurylaw.com/uploads/file/Pliva v Mensing.pdf

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