End Pre-Emption, Support The Medical Device Safety Act

End Pre-Emption, Support The Medical Device Safety Act

Two recent Supreme Court cases on federal pre-emption have made a mess of tort law, confusing and endangering consumers by holding that a patient who is injured by a dangerous drug can sue the manufacturer, but a patient injured by a dangerous medical device cannot. How this happened, and what to do about it, inside.

Supreme Court Rules For Injured Consumer In Big Pharma Case

Supreme Court Rules For Injured Consumer In Big Pharma Case

The Supreme Court ruled 6-3 in favor of Diana Levine in Wyeth v. Levine. Levine, a musician, had her arm amputated when an anti-nausea drug was improperly administered in her artery, and sued the manufacturer for failing to warn of the risks on the drug’s label. Wyeth claimed that her case was pre-empted by federal law.

Big Pharma Goes Before Supreme Court To Get State Lawsuits Banned

Big Pharma Goes Before Supreme Court To Get State Lawsuits Banned

“Pre-emption” is a legal doctrine that says the federal government can claim all regulatory power over an area or subject, barring states from acting on their own. The drug maker Wyeth has brought a case before the Supreme Court arguing that a woman in Vermont, who lost her arm due to a drug complication that Wyeth knew about but did not publicize, cannot sue them in state court because of pre-emption. Wyeth says that only the FDA has the power to regulate it—and since the FDA approved Wyeth’s drug label, it’s the FDA’s responsibility. We think Wyeth is pretending to care about federal-versus-state power in an attempt to weasel out of any responsibility.