March 4, 2009, Washington, DC —"Today's victory for Diana Levine is really a victory for all American consumers," said Alliance for Justice President Nan Aron.  The Supreme Court, in a 6-3 decision, rejected the premise that drug manufacturers who fail to warn consumers of the dangers associated with their products can evade responsibility for the harm they do to Americans.   "The six justices who stood up for accountability sent a clear message that FDA approval does not necessarily grant a corporation a license to hit and run," Aron noted.

Justice Stevens' opinion for the Court also completely discounted the Bush administration's assertion that FDA-approved drug labels set a ceiling for regulation. The language claimed that state suits demanding different warnings were prohibited.  Justice Stevens observed that the FDA's "views on state law are inherently suspect in light of" the agency unilaterally making the rule without permitting any comment from states or other parties affected by the policy.  The FDA also made the clearly misleading claim that the 2006 regulation would "not contain policies... that preempt State law."

Unsurprisingly, President Bush's two appointees to the Supreme Court, Chief Justice Roberts and Justice Alito, together with archconservative Justice Scalia, defend the 2006 regulation; they also go much further, arguing that jury verdicts that contradict the FDA's judgment are invalid because "juries are ill-equipped to perform the FDA's cost-benefit-balancing function."  "Today, we can be thankful that the views of these three defenders of corporate immunity did not prevail," observed Aron.

The dangers posed to consumers do not end with the happy outcome in Wyeth v. Levine, however. Millions of other Americans who use medical devices are still left without recourse if they are injured.  This is why Congress must act swiftly to pass the Medical Device Safety Act.  The proposed bill would make clear that FDA approval to market does not preempt victims from having unsafe product lawsuits heard by juries in state courts.

"Congress must make clear that big corporations do not have a right to 'hit and run' by causing serious health damage and then walking away from legal responsibility," concluded Aron. "Passage of the Medical Device Safety Act will protect the victims of unsafe products and ensure that manufacturers have a strong incentive to make safe products in the first place."