Sua Sponte

The Supreme Court handed down an opinion today in Riegel v. Medtronic, Inc. that really helps shield makers of medical devices from state tort lawsuits when their devices malfunction and cause injury.  The decision (8-1, Justice Ginsburg dissenting) basically says that the FDA’s “premarket approval” mechanism preempts state action, even though – as the dissent points out – the federal regulatory scheme doesn’t create a federal cause of action.  Although the decision doesn’t stop lawsuits claiming that devices were made improperly (AKA, not up to FDA standards), it may nullify suits claiming design defects.  This is a big deal for medical devices, which include pacemakers, defibrillators, drug-coated stents, heart pumps, and prosthetic hips.  The same arguments can now be made for drug manufacturers (think Vioxx), though drugs are regulated under separate laws.  Some lawmakers who supported the initial laws are unhappy with the SCOTUS decision and vowed to pass legislation to fix “this nonsensical situation.”  (Via NYT.)  Professor Turley has blogged about the same decision here.  You can read the SCOTUS opinion here.