Supremes bolster preemption defense

Share this article:

In a major test of the preemption principle, the US Supreme Court ruled 8-1 that patients can't file common-law claims challenging the safety and effectiveness of an FDA-approved medical device.

The case, Riegel v. Medtronic, involved a suit by the family of a man injured when a balloon catheter made by Medtronic burst while he was undergoing angioplasty after suffering a heart attack.

Writing for the majority, Justice Antonin Scalia said “Premarket approval is a ‘rigorous' process” that should preempt state laws.

The lone dissenter was Justice Ruth Bader Ginsburg.

Share this article:

Email Newsletters

More in News

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi and partner Regeneron attached a $67.5-million priority review voucher to their experimental cholesterol drug alirocumab, making for a tighter race with Amgen.

HHS shows how diabetes adds up

HHS shows how diabetes adds up

A 2005-to-2010 survey shows diabetics 65-and-up juggle at least four co-morbid conditions and five medications for them.

AstraZenca beefs up respiratory portfolio

AstraZenca beefs up respiratory portfolio

AstraZeneca has made an $875-million move to beef up its respiratory pipeline by making Almirall's lineup its own.