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.
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
"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.
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."
For more information, or to speak with Alliance for Justice President Nan Aron, contact Kelly Landis or Kyle Murphy