UPDATE: Our story on today's decision appears here at legaltimes.com.
As we reported here earlier, the Supreme Court ruled this morning in a widely-anticipated business case, Wyeth v. Levine. By a 6-3 vote, the Court rejected Wyeth's arguments that the federal drug labeling law pre-empts "failure to warn" claims filed in state courts. It was a major loss for the pharmaceutical industry which, like other businesses, prefers one federal regulatory regime over the different rules of 50 states.
The ruling was a victory for Diana Levine, a Vermont musician who lost her forearm to gangrene after improper administration of a Wyeth drug. She claimed the drug's label failed to warn medical workers of the dangers of the way in which she was given the medicine.
Businesses and the Bush administration made a strong push for implied pre-emption in this and other cases, a campaign that may now be foreclosed by the Court's decision.
The decision today was a landmark in the making, and has triggered reaction from a wide range of groups. A sampling of some of the comments we've received:
American Association for Justice: "The Supreme Court reaffirmed the principle that state lawsuits perform a valuable and important function in ensuring accountability in uncovering drug hazards... Today's decision in favor of Diana Levine proved that even if you are just one person, you can fight for justice and hold your wrongdoer accountable."
Pharmaceutical Research and Manufacturers Association of America: “We continue to believe that the expert scientists and medical professionals at the Food and Drug Administration (FDA) are in the best position to evaluate voluminous information about a medicine’s benefits and risks and to determine which safety information to include in the drug label… Unfortunately, patients could ultimately suffer if the Supreme Court’s decision forces healthcare providers and patients to second-guess FDA-approved labeling.”
Alliance for Justice: “Today’s victory for Diana Levine is really a victory for all American consumers. 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.”
Wyeth: "The U.S. Supreme Court’s ruling in Wyeth v. Levine is disappointing, not only for Wyeth, but for patients and public health in general. Patients are best served by a national standard for the labeling of prescription medications – set by the medical and scientific experts at the U.S. Food and Drug Administration (FDA). When lay juries are permitted to second-guess the experts at FDA on the benefits and risks of particular medicines, the result is uncertainty for patients and doctors alike about how and when to use prescription drugs."
People For the American Way: “Today’s ruling was a welcome, and rare, victory for the rights of American patients and consumers. The pre-emption policy advocated by Wyeth would have irresponsibly shut off the ability of states to safeguard the health – and very lives – of Americans. Such a policy would inevitably result in more tragic cases like that of Diana Levine.”
Constitutional Accountability Center: “Today is a great day for Diana Levine and for our Constitution. The Constitution requires that the federal government and the Supreme Court respect the role of the States in protecting their citizens, and Justice Stevens’ opinion does just that… More broadly, Constitutional Accountability Center has urged the Obama administration to review and reverse a number of Bush administration positions that inappropriately limit state authority and policy experimentation. The Supreme Court’s pointed rejection of the Bush administration’s “preemption by preamble” approach here should convince President Obama of the need to return to a policy of respect for the constitutionally-protected role of states.”
Public Citizen Litigation Group: “Drug companies are not perfect, and they sometimes fail to identify and inform doctors and the Food and Drug Administration (FDA) of problems with their products or their products’ labels. Nor is the FDA perfect. It is overworked and underfunded, and it depends almost entirely on drug companies for information about the safety and effectiveness of drugs. Perhaps most important, once a drug is marketed to thousands of people, we learn of things that we never knew in the clinical trials for that drug - problems that arise over the years as doctors prescribe and patients take the drug day in and day out. For all these reasons, legal immunity for drug manufacturers - as called for by the drug companies and the Bush administration - would have been a huge mistake.”
Sen. Patrick Leahy, D-Vt.: "This decision to uphold the Vermont Supreme Court's ruling in Wyeth v. Levine has far-reaching effects on the ability of countless Americans to seek justice in their courts. Diana Levine's life and career have suffered irreparable - yet preventable - damage. The Court's decision soundly rejects the anti-consumer position of the Bush administration, and reaffirms Congress' primacy concerning the extraordinary power to preempt state law. Most of all, the decision reclaims for all American citizens the ability to seek justice in their courts of law… While recent Supreme Court decisions have shielded big business from accountability and have undermined stronger state consumer protections, this ruling alters that earlier course and affirms that Congress never intended to preempt state laws in the way claimed by Wyeth and the Bush-Cheney administration, claimed.”
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