The United States Supreme Court decided the highly anticipated Wyeth v. Levine case, yesterday. In its 6 to 3 decision, the court said said Congress could have required pre-emption in the case but did not. Instead, said Justice John Paul Stevens, writing for the majority, “it determined that widely available state rights of action provided appropriate relief for injured consumers.” Justice Stevens distinguished this case from the recently decided Riegel case where Congress had adopted an express pre-emption provision for medical devices. Justice Stevens wrote, that the drug agency had, in the past, welcomed state injury lawsuits to complement federal regulation. But in “a dramatic change in position” in 2006 [engineered by the Bush administration], the agency reversed that long held position despite its “limited resources to monitor the 11,000 drugs on the market.”
Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Stephen G. Breyer joined in Justice Stevens majority opinion. Conservative Justice Clarence Thomas voted with the majority but wrote a separate opinion, stating his objection to “far-reaching implied pre-emption doctrines” tending to “wander far from the statutory text.”
This is a wonderful pro-justice decision; a ruling for the drug industry would have meant almost total immunity to the drug industry for an FDA approved drug, whether it maims (as Phenergan did to Diana Levine) or kills, as Vioxx and Fen Phen have done to hundreds.
As reported previously, at this location, my state, Michigan, has such a legal standard: Michigan law, passed in 1996, during the very conservative, anti-justice Engler administration, provides total immunity to the drug industry for FDA approved drugs. This law has been a disaster for Michigan citizens, maimed and/or killed by dangerous FDA approved drugs, with no chance to hold the manufacturer liable for damages. The lack of compensation in these cases leaves Michigan taxpayers to pay the bill for victims’ treatment or death instead of the billion dollar companies that caused these injuries and/or death.
Dr. Henry Greenspan, who teaches about the FDA, ethics and policy at the University of Michigan, Ann Arbor, wrote a terrific op-ed piece in the March 4, 2009 edition of the Detroit Free Press, calling Michigan’s drug law “meritless”. He views the Opinion of the Court as asserting “that Congress never intended FDA regulation to trump state law, and neither did the FDA itself”. Dr. Greenspan believes that Michigan’s drug industry immunity law “cedes to FDA a power that the full spectrum of the justices – from liberals like Ruth Bader Ginsburg to conservatives like Clarence Thomas – rejected as “meritless,” “untenable” and “without reasoned explanation.””
The Wyeth decision will not remedy Michigan law. Only Michigan’s own courts or its legislature can do that. According to Greenspan’s article, the Michigan House of Representatives voted, in 2007, 70-39, to rescind the law, but the state Senate killed it in follow-up committee.
My advice? If you are a Michigan citizen, contact your state Senator and/or State Representative and tell them that it is time that Michigan joined the other 49 states in the union and protected its citizens from these dangerous drugs and from the people who make them. Tell them that the ability to hold drug makers accountable for bad drugs not only supports simple justice, but is a significant deterrent to the creation of unsafe products like Phenergan. There are current bills under consideration in the Michigan House to rescind these laws. Make your state Senator or Representative tell you where they stand on this important legislation. If they are against it, make them explain, as Dr. Greenspan puts it, “why it is reasonable to continue to strip Michiganders of rights that are held by citizens in every other state” and why “they know better than two-thirds of the Supreme Court”. Yes, March 4, 2009 was a good day for justice in 49 of our United States; justice continues to be denied in Michigan.Thousands of lives have been harmed; take action before this cruel legislation harms thousands more. Let them know that they will be held accountable in the next election.
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