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Henry Greenspan

Warner-Lambert v. Kent: A Fortunate Fluke

"It ain't over until it's over," said Yogi. In the wake of the Supreme Court's Warner-Lambert v. Kent decision, the first take-away is precisely that: As far as Michigan's 1995 drug industry immunity law, which shields pharmaceutical companies from lawsuits, it ain't over. Indeed, the Kent decision was a non-decision. It was a 4-4 tie with Chief Justice Roberts not participating because he owns stock in Pfizer/Warner-Lambert. And so drug industry immunity in Michigan changes not at all.

Of course, as their own attorney noted, the Kent plaintiffs got very lucky. Their luck depended on three main factors:

First, if Chief Justice Roberts had been able to participate, the decision almost certainly would have supported the company. His opinions in similar cases all suggest that.

Second, if the case had not ended up in the Second Circuit, which does not include Michigan, the decision would also almost certainly have gone against the plaintiffs. While attorneys can try to file in districts more likely to rule in their favor, the process is always complex and uncertain.

Third, we have learned more about the regulatory history of Rezulin, the drug at issue in the Kent case, than virtually any other medication. This is largely thanks to Pulitzer-prize winning reporter, David Willman, and a number of informants – both inside the company and at F.D.A.. Were it not for Willman and his informants, much of the Rezulin story would remain unknown. It is not a pretty tale.

All of this, then, constituted the Kent plaintiffs' "perfect storm." What are the odds of another case in which a conservative Justice cannot participate, in which a favorable Circuit Court turns out to be the venue, and in which a group of anonymous whistleblowers contribute in critical ways?

The odds of all of those things happening again are miniscule.

So we are left where we began. Michigan's law shielding drug companies from liability remains solidly in place. The Kent result was a fortunate fluke for a relative handful of people. For the rest of us in Michigan, the shield remains absolute.

In terms of what we can do, however, we are not where we began. One year ago, the Michigan House voted 60-39 to rescind our immunity law. The Michigan Senate has repeatedly refused to hold hearings on the issue. Nothing has happened. If Senate majority leadership has their way, nothing will continue to happen.

In the meantime, there are other cases the Supreme Court will hear – most notably, Wyeth v. Levine – in which F.D.A. preemption, the doctrine underlying Michigan's immunity law, will be decided more definitively. Most observers agree that, in this instance, the conservative majority will have their way. Drug industry immunity will become the law of the land.

One remedy remains. Every decision of the Supreme Court on such matters depends on an interpretation of the will of Congress. Congress has had numerous opportunities to state its will. It has consistently failed to do so.

This is an election year. And this need not be a partisan issue. Citizens should demand that every Congressional candidate – new or incumbent, Republican or Democrat – make a commitment. Either they will support legislation that denies F.D.A. preemption or they will not. We should not allow any hedging (there has been plenty from both major parties). As the editors of the New England Journal of Medicine recently wrote, F.D.A. preemption would have cataclysmic consequences for patient rights, for industry accountability, and for public health. The hour is late; the time is short.

In the meantime, our fight to rescind Michigan's own drug industry immunity will continue. For twelve years, we have endured the most draconian shield law in the nation. We have been the canary in the coal mine. What happens in Michigan has had, and will continue to have, national repercussions.

So it is, indeed, not over. The work to reject a law and a policy that is logically and ethically bankrupt will go on. And so will the work to hold accountable all those who seek to represent us, in Washington as in Lansing.

Henry Greenspan: Author Bio | Other Posts
Posted at 10:00 AM, Mar 13, 2008 in FDA | Federal Preemption | Pharmaceuticals | Supreme Court Rulings
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Comments

Bravo! Michigan’s drug immunity law has been the model for preemption -- Engler’s dream, our nightmare. Before we ever became a Democrat or Republican, we were, and are, Americans. We must demand, and should be able to expect, candidates and lawmakers, local and national, to make clear their stance on FDA Preemption.

Posted by: Dianne Hargrove | March 13, 2008 4:50 PM

Correction:

The Michigan House 2007 vote to rescind the immunity law was 70-39, not 60-39.

This included most House Dems and about 1/3 of House Reps.

In general, polls suggest Michigan citizen oppose immunity by about the same margin - between 60 and 70%.

Posted by: Henry Greenspan | March 16, 2008 4:43 PM