This Fall the United States Supreme Court will hear arguments concerning a Vermont Supreme Court opinion that allowed Diana Levine to keep her $6.7 million verdict against Wyeth, the manufacturer Phenergan. The drug manufacturer did not warn against injecting the drug which lead to the amputation of her arm. It found that "the drug's label offered insufficient warning about the danger of that injection method compared with two other, safer ways to administer the drug." The issue is whether drug manufacturers are immuned from being sued if they have obtained FDA approval. This ridiculous defense was cooked up by the Bush administration to protect the contributors to its campaign. The FDA is an underfunded agency that is relegated to approving drugs based on the reports provided to it by the drug company under pressure to get its product out on the market in advance of competitors. This case is Levine is supported by "47 states, public-health groups such as the Texas Medical Association and patient-advocacy organizations," while "the Bush administration, the US Chamber of Commerce and groups representing drug makers are siding with Wyeth." The following are some excerpts from news reports regarding this offense to American consumers and our sense of right and wrong.
The Wall Street Journal (10/30, A3, Mundy) reports "Internal memos contradict the FDA's position in Wyeth v. Levine that "federal drug-approval and warning-label standards should trump stricter state laws." In the memos, two officials said "it is wrong to assume that FDA-approved drug labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers." John Jenkins, the top official in the drug approval section, in 2003 wrote, "Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date." Additionally, "the associate director of the FDA's division for drug evaluation and research, Jane Axelrad, objected to the idea that companies would put too much safety information on the label if they weren't controlled by the FDA." Rep. Henry Waxman (D-CA) released the documents, which "are likely to encourage him and other Democrats in Congress who want to pass bills reversing the Bush administration's pre-emption policy."
The Los Angeles Times (10/30, Savage) notes that the FDA officials said that "new information often comes to light that calls for new warnings to doctors and patients." The Times adds, "Contrary to the view of the White House and the FDA general counsel, the drug regulators said pharmaceutical manufacturers could not be trusted to warn patients of new risks." While "consumer-rights advocates said the internal documents showed that the staff experts at the FDA were overruled by the White House and its political appointees," the FDA Office of Public Affairs "defended its process."
CQ HealthBeat (10/29, Armstrong) reported that the congressional "report also suggested White House officials had a hand in the FDA rules. According to the report, a senior career FDA official 'stated unequivocally that without the language the rule will not go forward (this is per the White House).'" Gerie Voss, regulatory counsel with the American Association for Justice, "says the report provides evidence that the administration put the interests of consumers behind those of drug companies," adding, "It's clear that this should have some role in the debate over preemption and prescription drugs." While Voss said it is too late "for additional briefs to be filed in the Wyeth v. Levine case," he is "hopeful that the lawyer for Levine would incorporate the report into his arguments."
Bloomberg News (10/29, Blum, Stohr) pointed out that the House report said that "internal documents indicate that the Bush Administration weakened important drug safety regulations to shield manufacturers from liability. This is a serious abuse of the agency's public health authorities." It also found that "political appointees in the agency's Office of the Chief Counsel pressed for" the preemption rule.
The AP (10/29, Freking) reported that "the FDA has yet to provide a complete set of documents that would show communications between the White House and the agency, but some documents suggested the agency and the White House would not go forward with a rule on labeling until the pre-emption changes were included." Dow Jones Newswires (10/29, Favole) noted, "Jenkins' comments, as well as those of other FDA officials, were sent to then- FDA chief counsel Dan Troy, who is now general counsel for pharmaceutical giant GlaxoSmithKline Plc (GSK)."
What arguments do you think are most powerful to fight against Federal Preemption? Shouldn't the conservative voice of Federalism be with us on this issue?
