It is universally recognized that the medical community in the United States has an obligation to look out for the best interests of the public on health and safety issues. That obligation includes being concerned about anything that would jeopardize the health and safety of the American people. A recent editorial by the Editor in Chief and Executive Deputy Editor of the Journal of the American Medical Association entitled “Prescription Drugs, Products Liability, and Preemption of Tort Litigation” indicates a real concern in the medical community about the effects of federal preemption. This is what the editorial writers of this most prestigious publication had to say about preemption in light of the case currently before the U.S. Supreme Court:
The Wyeth v. Levine ruling will have far-reaching and profound implications for patients and drug safety. If the Court rules in favor of Wyeth, endorsing preemption, patients will lose an irreplaceable method for seeking remedies for injuries resulting from pharmaceutical agents that were approved by FDA. As with the medical device preemption ruling, such a decision would likely result in thousands of lawyers defending drug manufacturers to file motions in state courts to dismiss plaintiffs’ claims under preemption. In a recent products liability lawsuit, a Philadelphia judge ruled that the federal National Childhood Vaccine Injury Act preempts tort claims of design defects and failure to warn, effectively immunizing vaccine manufacturers against liability claims. As shown in the study by Giezen et al., many safety problems are identified only after drug approval. The human body is in a constant state of change and the effects of some drugs will manifest only after exposure over time. Furthermore, some serious adverse drug effects are quite uncommon and require use of the drug in large numbers of patients to become evident. The safety of drugs in a clinical trial, the study type used for FDA approval, is based on specific participant types, numbers, and design that cannot ensure the true safety of a drug. In addition, manipulation of study results by the drug manufacturers (who almost always sponsor studies used for decisions about drug approval) can obscure the true safety profile of a drug.
If the Court rules for preemption in Wyeth v Levine, Congressional action will be necessary to remove preemption of state tort litigation involving claims of products liability for prescription drugs. Otherwise, the current system of FDA approval of drugs would have to be changed to preserve the health of the public. Under this alternative approach, no drug could be fully approved until long-term studies with large numbers of participants had been completed and marketing would have to be greatly limited until full FDA approval is achieved. Surely, the drug manufacturers would not be pleased with such a system; however, without such safeguards, patient safety would be jeopardized. Either way, Congress, not the Supreme Court, seems better suited to decide public policy on patient safety, and it is telling that many members of Congress have joined amici briefs to remind the Court that Congress already has decided not to grant preemption to drug manufacturers.
One of the most important ways to ensure the health of the nation is to be certain that medical devices and pharmaceutical agents are safe. The FDA is not infallible and the recently increased resources do not include a crystal ball. Therefore, unless and until the FDA drug approval process and the postmarketing surveillance system improve significantly, patients must have a means to seek recourse through tort litigation against product manufacturers. Anything less may well preempt the well-being and safety of the public.
I have to wonder if those in the Bush Administration who are pushing preemption so hard have read this editorial. Sadly, I seriously doubt it. Even if they did, with Dick Cheney and Karl Rove calling the shots on preemption, it would do no good.
Source: Journal of the American Medical Association
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