Thursday, March 5, 2009


Hallelujah! Yesterday was a bright day in the history of American law as a majority of Supreme Court justices cut through the malarkey tossed out for years by the pharmaceutical industry and ruled without question that the law permits lawsuits against the industry for failing to adequately warn about dangers to its products. In Wyeth v. Levine, a 6-3 majority ruled that state court cases can proceed against drug manufacturers despite the contention that the FDA must approve the labeling on drug products. For years the drug industry has claimed that lawsuits are preempted by the approval requirement. The FDA, the agency that has brought us the recent Salmonella fiasco based on its ineptness in supervising manufacturers and suppliers of foodstuffs, is notoriously ill-equipped to satisfactorily supervise the 11,000 prescription drugs in the American market place. Episode after episode of corporate charlatanism within the industry itself has demonstrated unequivocally that drug companies are only too willing to sacrifice peoples' lives to make a buck or two (or several billions). When called to task in a civil lawsuit, the standard industry defense is that "the FDA made me do it" in the sense that even though the warning may not have been adequate in a given situation, the FDA would not permit additional language that would have made the product safer. FDA approval of any given drug for years has been the practical equivalent of one obtaining a driver's license. Issuance of the permit by the state does not carry a guarantee that the driver will be a good one. It is important to keep in mind what is at stake here. In Michigan, as an example, it is estimated that there are 28,000 prescription drug-related deaths each year. As an aside, Michigan is the only state also currently to prohibit lawsuits against the industry if the FDA has approved a drug. The rejection of the precise contention as the basis for the Michigan law in Wyeth (which involved the use of a drug in Vermont) will undoubtedly impact the situation in Michigan. Stay tuned on that one.

Also worthy of comment is the impact of Obama's election on the potential selection of Supreme Court justices and the thought processes of those men who have been selected by the likes of Bush and his minions. Justice Alito, writing for himself, Chief Justice John G. Roberts and Justice Antonin Scalia, added that juries see only the “tragic accident” before them and “are ill-equipped to perform the F.D.A.’s cost-benefit-balancing function.” The agency, by contrast, he wrote, “has the benefit of the long view” and “conveys its warnings with one voice.” I can't tell you how many times I have sat in a courtroom and heard drug company lawyers spout the same garbage. Justice Alito doesn't mention that the drug industry spends more on advertising each year than it does on research. Nor does he mention that the FDA employee who decides what warnings should be placed on a given drug is likely to an employee of that drug's company the next year. The reality of the situation is (keep in mind that I worked for the predecessor corporation of Wyeth for seven years) that the FDA is a straw man in the scenario between drug company, the doctor and the patient. Alito is an elitist who is either hopelessly naive or, more likely, so business-oriented that he cannot see the irony in terming a benefit-safety evaluation (the heart of all drug use) as cost-benefit-balancing (as above). Fruedian? Perhaps not, but revealing it is. Thanks be to Obama and the future of the Supreme Court.

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