Henry Greenspan

Big Noise From The Mitten State: PART I —The Natives Get Restless

As Cyrus Dugger has reported for Tort Deform, Michigan has the distinction of being the only state in the nation in which drug companies enjoy absolute immunity from civil liability. Before former Governor John Engler went Texan and started talking about "jackpot justice" and the like, he created his own hellhole right here at home. In 1995, he got the state legislature to pass a law that banned civil action against pharmaceutical manufacturers if their drugs had received FDA approval--a particularly draconian version of what we now call "FDA preemption." Thus, for the past ten years, Michigan residents (or their survivors) who have been injured by fen-phen, Rezulin, Baycol, Vioxx, and the dozen other drugs that have been withdrawn because of safety problems have been shut out of court. Because of our statute, Michiganders who have tried to file in federal court or in other states have also been denied.

It should be noted that the 1995 law had two exceptions. If approval was based on either bribery of the FDA or deliberate withholding of risk data from the agency (both criminal felonies) such that the drug would not have been approved had the truth been told, immunity would not apply. In practice, however, these "exceptions" have proven to be meaningless. First, only the FDA can bring action for fraud against itself. Over the past twenty years, there has not been a single case of the FDA doing so which meets Michigan's criteria--felony fraud prosecution coupled with a drug's withdrawal. Second, as our 1995 law has been interpreted by higher courts, Michigan's immunity remains absolute even if there were a felony fraud conviction and consequent drug withdrawal. (Note these criteria are separable. A company could deliberately withhold safety data that, once disclosed, would change a drug's warnings ["the label"] but not result in full withdrawal. That situation was apparently never even considered by the legislators who passed the Michigan law.)

Since the immunity law's passage, it has been fully acknowledged by the Michigan Manufacturers' Association that it "was intended to safeguard the Upjohn Co.," which has since been acquired by Pfizer. Indeed, Pfizer has taken over all the large drug companies that once dotted Michigan: Upjohn, Pharmacia, Parke-Davis, and Warner-Lambert. Balanced against Motown's always uncertain auto industry, the hope in '95 was that big pharma and biotech would back-up the state's economy. A little baksheesh seemed appropriate.

The significance of Michigan's absolute immunity, and its survival for a full decade, has not been lost on national anti-tort activists. Engler, now head of the National Manufacturers' Association, has politicized that organization, making the appointment or election of ant-tort judges a primary mission. He celebrates his " Michigan model" as a standard for the nation. Similarly, law firms that defend drug companies hype Michigan's "absolute 'fda compliance' defense." A Gibbons newsletter, for example, insists that, "unlike the Michigan statute," even the strongest anti-tort laws in other states "do not act as a complete bar to product liability claims."

Partly because of publicity generated by the Vioxx disaster, efforts to rescind Michigan's absolute immunity law have gained new life in the past couple of years. A group of drug-injury victims and their survivors ("Drug Industry Immunity Must End" or "DIIME") has managed to generate awareness of the immunity law across the state (one of the biggest obstacles to rescinding is that Michigan citizens initially find it hard to believe that we actually have a law this regressive). A second group of which I am a founder, "Justice in Michigan"--primarily composed of policy analysts, physicians, bioethicists, and economists--has also lent support. Four bipartisan bills to rescind drug industry immunity were introduced in the Michigan House during the current session. The bill that has progressed the farthest was brought by Representative Edward Gaffney, a Republican legislator one of whose constituents, a physician in the prime of his career, suffered a devastating stroke which he believes was caused by Vioxx.

Gaffney recalls thinking that his bill, a compromise relative to other rescinding bills, would "sail through" the Michigan House. And, indeed, it is clear that there are enough votes in the House to pass it, just as statewide polls consistently show that rescinding immunity is favored by nearly 70% of Michigan citizens.

What Gaffney had not foreseen was the determination of the other side. Michigan suddenly hosted a parade of anti-tort luminaries. Engler teleconferenced his way into an abruptly created "Tort Reform Committee" in the State legislature. Sherman "Tiger" Joyce, President of ATRA, visited Michigan incarnate. So did Daniel Troy, former FDA Chief Counsel and "godfather" of the contemporary FDA preemption doctrine. Troy reworked an earlier paper to include a section specifically defending Michigan's 1995 law, and his talk--presented at a meeting of the Federalist Society in Ann Arbor--was webcast to relevant Michigan legislators and beyond. In the meantime, the 2006 annual meeting of ATRA, opened by special guest Karl Rove, was reportedly much preoccupied by the smoke rising in Michigan. The natives were restless. Clearly, for the pro-immunity boys (they mostly are), it was time to restore order.

[To be continued in Part 2—"And Then it Really Got Ugly"]

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Posted at 9:35 AM, Sep 26, 2006 in
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