It is fitting that Monday, the day before the presidential election, the Supreme Court will hear argument in Wyeth v. Levine, a case that illustrates both the importance of Supreme Court rulings to ordinary Americans and the aggressive efforts of the outgoing Administration to use the Court and its own regulatory authority to protect corporations from being held accountable for the harms caused by their products.
Diane Levine is a Vermont musician who went to the hospital for treatment of a migraine headache and left with her arm amputated and career in ruins. Ms. Levine sued the pharmaceutical company, Wyeth, which manufactured the anti-nausea drug that caused gangrene to develop after being injected into her arm. A Vermont trial court awarded Levine $6.7 million for her injuries and Wyeth has asked the Supreme Court to overrule this verdict, asserting that a federal drug labeling law "preempts" Levine's state law personal injury action. Breaking with the position taken by past Democratic and Republican administrations, the Bush Administration filed a brief supporting Wyeth.
This is a critical case. For decades, drug manufacturers have known that they will be held accountable in state court when their products harm patients instead of healing them. This accountability protects Americans against unsafe products and Congress never intended to strip drug consumers of this important form of protection. In this brief filed before the Supreme Court, we have asked the Supreme Court to jettison a form of preemption known as "implied obstacle" preemption, which promotes a freewheeling analysis by judges into the "purposes," rather than the textual provisions, of federal statutes.
Hopefully the Court will use the Wyeth case to get its own preemption act together. But the case is just as important as an illustration of the power of the next President and the incoming Congress to undo the Bush Administration's aggressive use of preemption as a tool for corporate deregulation.
In the 70 years since the Federal Food, Drug & Cosmetic Act (FDCA) was enacted, state-law remedies for a drug company's failure to adequately warn consumers of the dangers of their products have existed in harmony with the statute, which governs drug-labeling and is the relevant federal law in Wyeth. Congress has amended the FDCA several times, but has never expressly preempted state law claims against drug manufacturers--even though it chose to include an express preemption clause regarding medical devices (as discussed in last term's case, Riegel v. Medtronic).
The Bush Administration, however, favored insulating drug manufacturers from liability under state law, and so, in an introductory statement or "preamble" to its most recent prescription drug labeling rule (effective June 2006), the FDA made clear its belief that "FDA approval of labeling under the act . . . preempts conflicting or contrary State law." This revision of long-standing FDA policy on preemption in the drug labeling context was made over the objection of career agency officials, including the highest official in the drug review process, who warned that "much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false." According to a report released today by the House Committee on Oversight and Government Reform, "the White House played a significant role in the preemption provisions and pressured the agency to reject the concerns of career experts."
This attempt to achieve "preemption by preamble" not only places Americans' health and safety at risk, but it also circumvents Congress and the Constitution--the Supremacy Clause, after all, states that the laws of the United States are supreme, not federal agency preambles. This is akin to the President Bush's use of signing statements as a way of trying to limit the meaning of the bills (such as the Congressional ban on torture) it is signing into law, and it is indicative of the abuse of executive power that has come to characterize this administration.
The good news is that the Bush Administration's use of "preemption by preamble" may be undone even without the help of the Supreme Court in Wyeth. A top priority of the new administration should be to review the preemption decisions by the Bush Administration and reverse them unless Congress has declared clearly in federal law its intent to displace state law. And Congress can overturn any holding by the Court in Wyeth, as well as a long-list of other bad preemption decisions by the courts in recent years, by amending the laws in question and clarifying that the states should not be inappropriately displaced by federal law.
The Court needs to do its job and rule for Diana Levine in Wyeth. But the results of the election held the day after the Wyeth argument should have an equally great impact on the ability of states to serve as laboratories of democracy and the availability of remedies for individuals who are harmed by corporate wrongdoing.
(This post was written by Doug Kendall and Elizabeth Wydra, Constiutional Accountability Center's Chief Counsel. For more analysis of how the Constitution favors progressives, visit Constitutional Accountability Center's blog, Text and History.)
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