Kennedy Replacement On Supreme Court Could Impact FDA Preemption Law, Sales Of Contraceptive Devices
A Changing Supreme Court's Impact on Medtech: Part 1
President Trump’s promise to replace retiring Justice Anthony Kennedy with a new, more conservative justice could have big implications on the court’s future rulings on a range of device-related issues, from US FDA pre-emption to IUD sales, to Affordable Care Act coverage of devices.
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In upcoming health-care cases likely to come before the high court in the next couple of years, a more conservative Supreme Court – thanks to the confirmation of Brett Kavanaugh – could issue rulings that would overturn portions of the Affordable Care Act concerning preexisting conditions. The new court could also have an impact of issues of federal preemption and court deference, or lack thereof, to federal agency interpretation of statute.
Supreme Court To Clarify Whether Manufacturers Are Shielded From Failure-To-Warn Suits When FDA Rejects Label Warnings
Merck v. Albrecht will resolve interpretation of high court's landmark Wyeth v. Levine ruling and could shield companies from certain litigation; case involves adequacy of Fosamax labeling of bone fracture risk.
The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.