The Supreme Court case of Wyeth v. Levine presented the question of whether state-law claims against drug manufacturers for failing to properly warn consumers about dangerous risks associated with their products should be displaced by federal law and Food and Drug Administration (FDA) regulation. CAC has filed an amicus curiae brief in support of allowing state common law claims to work in conjunction with FDA oversight, because neither the Constitution nor the principles behind it support such a broad intrusion into the States’ ability to protect their citizens, particularly where Congress has not expressed its intent to preempt state law.
The respondent in this case, Diana Levine, sued the pharmaceutical company Wyeth in Vermont court based on injuries she suffered—including amputation of her right arm— after she was injected with a dose of Phenergan, an anti-nausea drug manufactured by Wyeth. Wyeth was aware that a method of injecting Phenergan—called “IV push”—could cause gangrene and ultimately amputation if the drug penetrated a patient’s artery. Ms. Levine, who initially went to a Vermont hospital seeking treatment for migraine pain, was given an IV-push injection of Phernergan. The Phenergan penetrated her artery and caused extremely painful gangrene. She had first her hand, and then her forearm up to her elbow, amputated. While this trauma and excruciating pain would be horrifying for anyone, it is particularly so for Ms. Levine: prior to these side-effects of Phenergan, she was a professional musician—performing concerts, recording her music for sale, and creating musical programs for children.
The Vermont courts agreed with Ms. Levine that Wyeth should have precluded the IV-push method of administering Phenergan, given the known and serious risks (and the rather insignificant need for IV-push administration when other, safer methods were commonly used to treat nausea). However, Wyeth—and its supporters, such as the Chamber of Commerce, Product Liability Advisory Council, and the federal government—have challenged this ruling in the U.S. Supreme Court, arguing that federal drug-labeling laws trump state-law actions intended to hold drug companies liable for inadequate drug warnings. Despite the fact that Congress has never expressly preempted state-law claims based on inadequate drug labeling, Wyeth asked the Court to preclude Ms. Levine’s claim because it would “frustrate the purposes” and underlying objectives of federal drug-labeling law.
CAC filed a brief
to support Ms. Levine, presenting the Court with an explanation of why the text and history of the Constitution do not support preempting State law in this case. The Supremacy Clause of the Constitution, which states that valid federal enactments shall be the “supreme” law of the land, does preempt State law when it directly conflicts with federal law or when Congress has specified in legislation that it intends to displace State law. But it does not authorize the courts to look behind the text of a federal law to find “purposes” or objectives that, in its view, would be frustrated by a long-standing state-law remedy. CAC argued in its brief that preempting State law based on implied congressional purposes runs counter to the healthy federal-state balance established by the Constitution, the text and history of the Supremacy Clause, and the constitutionally designed separation of powers between our legislative and judicial branches. With this brief, CAC encouraged the Court to move its preemption jurisprudence back in line with the Constitution, while protecting access to valuable state law remedies.
Read a statement
from CAC's President, Doug Kendall on the Supreme Court's March 4, 2009 ruling
in Wyeth v. Levine