Supreme Court Nixes Preemption In Michigan

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lawsuit2.jpgIn a closely watched decision, a divided Supreme Court is leaving intact a ruling favoring people who sued a drugmaker, saying they had been harmed by a medicine to fight diabetes, the Associated Press reports.

The dispute stems from several suits over the Rezulin diabetes drug that was sold by Warner-Lambert, which is now owned by Pfizer. The pill was yanked in 2000 after links to nearly 400 deaths and hundreds of cases of liver. The Supreme Court split 4-4 in the case, with Chief Justice John Roberts not participating, the AP writes. UPDATE: Roberts sat this one out because his financial disclosure form filed last May indicated he held Pfizer stock between $10,000 and $50,000, according to the AP.

A group of 27 Michigan plaintiffs, including relatives of six Rezulin patients who died from liver damage, sued the drugmaker in 2000 for negligence and defects in the design and manufacture of the drug. Michigan law, however, prohibits product-liability suits against meds approved by the FDA. But it allows the suits to proceed if plaintiffs can show that a drugmaker misrepresented or withheld info from the FDA that would have prevented the agency from approving the drug. The plaintiffs contended Warner-Lambert misled the FDA about the extent of liver damage among patients in its clinical trials.

“The appellate decision stands, but it’s only the appellate court - not the Supreme Court - speaking,” says Mark Hermman, a partner at Jones Day, whose clients include drugmakers, and who is one of two attorneys who write The Drug and Device Law blog. “We’re thus left in exactly the situation today that we were in two weeks ago: The appellate courts are divided, and we don’t know what the law is nationally.”

The Supreme Court action “will allow Michigan residents harmed by drugs that are unsafe or provide inadequate warnings to have a fair chance in our courts, and hold companies accountable for their actions,” says Jon Haber of the Association for American Justice, which represents trial lawyers. “While those plaintiffs will get justice in the courtroom, we hope the Supreme Court’s decision in Levine v. Wyeth this fall will continue to allow Americans in any state to hold drug companies accountable.”

The 2nd U.S. Circuit Court of Appeals in New York ruled that the exception to the Michigan law was not preempted by federal regulations, enabling the plaintiffs to pursue the case, which Pfizer appealed. However, the Rezulin dispute doesn’t apply to all pharmaceutical suits, because it focuses only on whether state courts can consider allegations that a drugmaker misled the FDA to win approval for its med. The larger preemption issue involving product-liability claims, in general, will be heard later this year. That case involves Wyeth and you can read about it here.

“Most serious adverse effects are not fully discovered until a drug has been on the market for several years. The reality is that patients will be injured in the interim. At a time when the FDA is, by its own admission, underfunded, lacking in the resources of the industry, and lacking the expertise to adequately protect the public health, the ability of injured patients to hold drug companies liable for injuries caused by their products is particularly important,” says Allison Zieve, an attorney at Public Citizen, which handled the Supreme Court briefing and argument for the plaintiffs.

Today’s outcome is in contrast to another preemption ruling last month concerning medical device makers. In that case, the US Supreme Court voted to 8-1 that patients can’t file lawsuits against device makers when their products were approved by the FDA. The court reviewed a lawsuit that pitted Medtronic against a woman whose now-deceased husband suffered a disabling injury when a balloon catheter burst during angioplasty. Medtronic argued that the Food, Drug, and Cosmetic Act expressly preempts state law claims brought by patients who were hurt by devices that received premarket FDA approval.

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  1. I must say I’m surprised. Reading the transcript of the arguments in this case, it looked like it was all going the other way, with the possible exception of two Justices.

    I will read the decision. But this result slightly more hopeful for those of us who think preemption is a disastrous policy - 68% of Michigan citizens (there are not that many trial lawyers!) of both parties; NEJM and JAMA; and - increasingly - I suspect most of the rest of the country.

    That said, it is likely Roberts would have joined the other side had he not had to recluse himself. So the Levine case remains a different ballgame.

    As far as I’m concerned, this issue should be part of every campaign, from the Presidential down to Congressional, fed and state, both parties. It is an issue worth thinking through hard, and then having representatives who are, indeed, committed to whichever view one has.

  2. Update. There has been a lot of confusion about what this decision really means. Folks on all sides are jumping on their bandwagon.

    Until we have the pariculars, and look at them very carefully, we should hold on parades.

  3. Nathan, please refrain from promoting my website as a scam. If it were a scam, I would be forced to take it down. It remains on the internet because it is all fact.

    I’m not on Pharmalot often, I’m trying to figure out if you represent Pharma, or are just plain ignorant.

  4. Rita, what website are you refering to? I didn’t even write a comment in this thread. BTW, I am employed in the pharma industry, but I don’t claim to represent anyone’s opinions other than my own.

  5. Nathan, I was having trouble getting my post to go through, I guess going back and forth between articles it landed here. For that I apologize. However, in another area Lisa had posted my website address, you refer to my website as a ’scam’. Even Glaxo acknowledged my daughter’s suffering… Your not simply stating an opinion by stating this, you are promoting my site as a scam and should back up your statement.

  6. If anyone still sees this thread, I have learned that there is no written decision under these circumstances, nor are we likely to know (definitively) which Justices voted how. That is because a tie means no new law, precedents, etc..

    If Ed would like to organize a fund to send me to law school so I’d know stuff like this, I would be grateful. Otherwise, plastics.

  7. Hi Justice,

    Law school? Well, I am considering a Pharmalot scholarship program, but for the moment, the concept is restricted to retraining frazzled journalists to support themselves after blogging. But you can be next in line.

    Cheers
    ed

  8. Ed, Much thanks! My wife has already nixed my running for Congress (she says I should get a “real job”), so it’s this or paper route. Perhaps the Star-Ledger……

    Never mind.

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