The U.S. Congress

In May 2008, the House Committee on Oversight and Government Reform held a hearing to explore whether FDA drug and medical device regulation should bar state liability claims.   Consensus exists among consumer and patient advocates in the field that FDA approval of a drug or medical device does not guarantee its safety.  Because of this, individuals who have been injured from an approved drug or medical device have been able to seek compensation for their injury under state law.  The compensation can cover, for example, lost income and medical expenses.  

The Supreme Court recently ruled in Medtronic v. Riegel that states could not “preempt” FDA’s federal authority and impose different, higher standards on device performance.  This significantly limits manufacturer liability for faulty or defective products.  This proposed change in policy, known as preemption, significantly reduces consumer rights, curtails consumer protections, and reduces manufacturer incentives to develop and manufacture safe products.

The Medical Device Safety Act of 2009, HR 1346 introduced by Reps. Henry Waxman (D-CA) and Frank Pallone (D-NJ), would overrule the U.S. Supreme Court's February 2008 decision in Riegel v. Medtronic which gave the FDA the right to severely limit the right of injured patients to sue medical device manufacturers.