We have written a great deal over the past several months about the evils of federal preemption. I predicted that when folks finally find out what this movement is all about, they would oppose it universally. It appears that is now coming to fruition. Top doctors at the helm of the nation’s most influential medical journal have given the Supreme Court some very good legal advice on this issue. The editors of the New England Journal of Medicine said in a friend-of-the-court brief which was filed with the High Court:
The Food and Drug Administration is in no position to guarantee drug safety. Lawsuits can serve as a vital deterrent and protect consumers if drug companies don’t disclose risks.
The preemption issue is in Wyeth v. Levine, a case to be heard this fall, that could have far-reaching implications for litigation over dangerous drugs, such as the painkiller Vioxx. Wyeth brought the case to the High Court, claiming it was protected from lawsuits. The drug company argued that the FDA’s judgment could not, in effect, be rejected by a state court. The executive branch and specifically the FDA itself have consistently rejected this position in past years. Now during the last days of the Bush Administration the ugly head of federal preemption is being raised.
It is most significant that the Journal editors urged the Justices to be skeptical about the FDA. In the brief the doctors said:
The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety. Without the discoveries dredged up by plaintiffs’ lawyers through liability litigation, the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.
The medical editors joined 47 state attorneys general and two former FDA commissioners — David Kessler and Donald Kennedy — in supporting the Plaintiff’s position on appeal. The case is being closely watched because earlier this year the Supreme Court ruled that manufacturers of FDA-approved medical devices were shielded from litigation in state courts. However, that case is quite different because Congress had spoken to the pre-emption issue with respect to medical devices. That’s not the case in Wyeth v. Levine.
The statute that applies to medical devices is different from the law that governs medications. The law in the medical devices case had a pre-emption provision. Congress has never put a pre-emption provision in the Food and Drug Act. Dr. Jeffrey M. Drazen, the Journal editor, said in an interview with the Associated Press that he hoped arguments over legal distinctions would not obscure the reality that the FDA is overwhelmed trying to keep up with drug safety problems, which can range from rare but serious side effects, to shortcomings in manufacturing plants as far away as China. In this regard, Dr. Drazen aptly stated:
Even if the FDA is doing the best it can, it simply can’t see the future clearly enough to pre-empt manufacturers from litigation. The (court) system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the public.
In my opinion, these doctors represent the views of most Americans who are knowledgeable about federal preemption and how it will affect people. If the Court rules for the drug company on this anti-consumer issue, it will be the worst possible thing for the health and welfare of the public. Without an open court system, the drug companies will have no fear of putting a product known to be dangerous and unsafe on the market.
Source: Associated Press
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