Preemption Is Alive And Well In Michigan
9 CommentsBy Ed Silverman // November 25th, 2009 // 12:25 pm
Three Michigan women blame a pair of Novartis drugs - Aredia and Zometa - for causing their osteonecrosis, which is the death of jaw-bone tissue. But a federal appeals court has ruled they can’t proceed with their lawsuits because Michigan law bars most product liability claims, Mealey’s Emerging Drugs & Devices. The word for this is preemption.
Preemption, you may recall, is the notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA unsuccessfully argued earlier this year before the US Supreme Court that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness (background here). But Michigan has its own preemption law and the only exception is when fraud is committed on the FDA.
Patricia Fragomeli, Frank Biocca and Jack Cuthbert claim Novartis did commit fraud by allegedly withholding or misrepresenting info about ONJ after the FDA approved the drugs. Their lawsuits were later transferred to Aredia/Zometa multidistrict litigation in federal court in Tennessee, where they appealed a denial for additional discovery. But the Sixth Circuit US Court of Appeals panel ruled there was no fraud committed on the FDA in the Aredia/Zometa cases (here is the opinion). And so they are out of luck. The upshot: Michigan residents are unlikely to successfully fiele a product-liability lawsuit over a drug.
Evelyn Pringle
I don’t know why, but I thought Michigan had finally did away with that law.
It all drags on for so many years that I lose track of things I guess.
Justice in Michigan
No Evelyn, Michigan is a very long way from having repealed the law. It was voted away twice in the State House, but a slim (Republican) majority in the State Senate has kept it in place.
There are a few amendments to be made to Ed’s story.
1. It is not simply that fraud has to be proven. It is that the FDA, or FDA/DOJ acting in concert, have to prove, in a felony fraud conviction, that fraud against the FDA has taken place. Whatever a private plaintiff is able to prove is immaterial. That is the core of the Garcia precedent and was the core of the decision in this case.
“In this circuit, the federal Food, Drug and Cosmetic…preempts such claims, unless some federal…agency has already found the requisite fraud on the FDA. See Garcia v. Wyeth-Ayerst Laboratories,
385 F.3d 961, 966 (6th Cir. 2004). There is no such finding here.”
That is the ballgame. Not whether felony fraud occurred–it might very well have–but that a federal agency has to have proven it in court. This happens essentially never. (Because of plea-bargaining, etc., such cases do not go forward.) The need for such a federal finding was challenged in Warner-Lambert v. Kent, heard by the Supreme Court, but ended in a 4-4 non-decision because Roberts recused. Thus, the Garcia precedent stood. (Almost certainly, Roberts would have supported it anyway.)
In the meantime, there is an additional clause in our law–that “the drug would not have been approved, or would be withdrawn, had the fraud not occurred.” That condition must also be met. (The hypothetical version, “would not have been,” has been rejected by almost all courts, so the reality is that a drug actually has to be withdrawn in the context of federally-proven felony fraud for liability to kick in.)
So, for example, you could still have federally- proven felony fraud such that a warning would have to be altered (say, an added black box). But, as long as the drug remains on the market, there is no liability in Michigan. Zilch.
As far as I know, both of these drugs are still on the market–with whatever warnings. That fact alone would have precluded the company’s liability in Michigan.
Indeed, there has been NO case in the past twenty-five years that meets the so-called “exceptions” of Michigan’s preemption statute. So, in actual practice, Michigan’s law in an absolute bar to a company being held liable, including instances in which it committed fraud.
Justice in Michigan
This addendum:
As I’ve noted elsewere, preemption in Michigan is actually more absolute than what even the minority (Roberts, Alito, Scalia) considered appropriate in the Levine case.
So Michigan is in a legal Bantustan of its own.
Want to learn more? Go to:
http://www.pharmaccountability.org
patrons99
Thank you, Justice in Michigan, for your legal insights and the link to learning more on this topic. Here’s a question from a layperson (non-attorney) trained in the school of legal hard knocks: If federal preemption is the rule rather than the exception, why not fight bad pro-pharma federal laws (of which there are several, e.g., the PDUFA) in federal court from the get-go, under the federal declaratory judgment act and federal civil RICO act. By avoiding state court proceedings completely, there would be less risk (e.g., Younger abstention) and possibly less legal cost, where federal judges are generally more familiar with federal laws and variations in state law from state to state are no longer an issue.
Justice in Michigan
patrons99–As another non-lawyer, I’m not sure I follow the particulars of your argument, so just a few points that I hope respond to some of what you’ve written:
–FDA reform (including any change with PDUFA) is no substitute for civil liability in appropriate circumstances. With the exception of the FDA under Bush2, FDA itself has agreed that state tort law has_supported_, rather than competed with, its own regulatory mission.
–Preemption is certainly not “the rule” in the area of drug product liability. Michigan citizens are the exception in being denied rights held by citizens in every other state.
–The fact that someone like Evelyn Pringle, otherwise well informed, thought are law was no more is a great example of how alone Michigan is. We need your help, folks.
Justice in Michigan
In case anyone wants some talking points with their leftovers, here are some of the faves that the Chamber of Commerce, PhRMA, their lobbyists and pols, repeat about the Michigan law.
All are demonstrably untrue. Nevertheless, truth has never gotten in their reiteration.
1. If a company doesn’t “play by the rules,” they do not have immunity.
(As up the thread, playing by the rules has nothing to do with it. There has to be felony fraud conviction and concommitant drug withdrawal, both together. Those are the conditions that haven’t been met in any case in 25 years.)
2. Michigan citizens can “petition the FDA” in some sort of relevant way.
(This would mean petitioning the FDA to open up a criminal investigation. FDA has explictly rejected the idea that citizen petitions could be used to this end. In any event, it is an absurd notion on the face of it.)
3. Immunity from liability protects drug company innovation, needed medications, and life on earth.
(No one has ever explained how taking legal rights from 3% of the U.S. population could impact the well-being of drug companies that can be sued in the other 49 states.)
4. Immunity from liability protects Michigan’s jobs and its already devastated economy. Companies would leave Michigan if the law would change.
(Of course, the reality is that virtually all the major pharma companies _did_ leave Michigan, precisely during the time we’ve had the immunity law. We are left with a skeleton crew of the industry relative to what was once here. And where did they go? To bastions of “tort reform” like Connecticutt, Massachusetts, etc..
In the meantime, public funds pay for injuries that would otherwise be company responsibilities. Estimates are that the immunity statute has cost Michigan millions of public dollars.)
Jaynesday
Justice,
In the past I remember some very long and interesting debates on various sites regarding preemption. What became of the pro-preemptors?
Justice in Michigan
I think they’re eating left-overs….
But seriously, DDL is still doing their thing, but the whole effort was clearly slowed by the Levine decision and the end of the Bush administration.
In Levine, even the pro-Wyeth minority (Alito, Scalia, Wyeth) essentially rejected the whole Dan Troy “project.”
Meanwhile, as you well know, preemption remains in the arena of devices. It is not clear that Congress has the will to do anything about that, especially as so many pols from both parties have been revealed as being on the take.
And, of course, no one cares much about Michigan or knows what’s going on, as we’ve seen evinced here.
Joe
Evelyn, Michigan remains a drug dealer’s paradise. Most Michigan residents do not even know our drug immunity law exists, and the drug companies know that only too well.
America beware – preemption is coming to a state near you, unless you stand up and fight like hell.
Related:
http://www.huffingtonpost.com/joanne-doroshow/medical-malpractice-tort_b_350573.html
http://pharmalittle.blogspot.com/2009/02/midnight-train-for-preemption.html