At the behest of Wisconsin Governor Scott Walker, a state Senate committee has proposed a bill that would protect drug and device makers from liability in state lawsuits, so long as their products were approved by the FDA. The only exception that would be granted under the legislation is if a manufacturer committed fraud against the FDA.
The move comes four months after a similar effort in North Carolina was shelved, but not before generating some controversy over the extent to which consumers would be able to recover any damages from products that may have harmed them. Like the North Carolina proposal, the provisions in the Wisconsin bill would be among the most restrictive in the nation (here is the bill).
At issue is preemption, which is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA unsuccessfully argued two years ago before the US Supreme Court that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness (back story).
However, the US Supreme Court ruled three years ago in a case brought against the Medtronic device maker that patients injured by defective devices cannot sue for damages in state courts if the FDA approved the device under the pre-market approval process (read here). Recently, though, the PMA process has come under fire. Of 113 products recalled between 2005 and 2009 for posing potentially life-threatening risks, 71 percent were never tested on humans, suggesting reforms are needed (back story).
Opponents of the Wisconsin legislation - which mirrors a law in Michigan, the only state in the country to have preemption on its books - argue that citizens will lose the right to recover damages from harm that citizens in other states are allowed to pursue. Earlier this year, by the way, a Michigan appeals court ruled the state cannot sue Merck in an effort to recover millions of dollars spent on the Vioxx painkiller (read this).
"The bill eliminates the check on manufacturers the civil justice system provides," Ed Vopal, president-elect of the Wisconsin Association for Justice, tells The Center for Media and Democracy's PR Watch. "Manufacturers will have less of an incentive to make their products safe...All this bill will do is prohibit Wisconsin citizens from pursuing justice in the civil court system. It would be devastating for Wisconsin consumers."
The bill, by the way, was one of several submitted to Walker as part of a 'Special Jobs Session' and, essentially, mimics a version of the ALEC 'Drug Liability Act,' according to PR Watch. What is ALEC? As PR Watch notes, this is a corporate-funded national organization that works to craft 'model' bills that legislators can then take on a ready-made basis to propose in their states.
11 Comments
Yes, my friends, here we go again.
It appears that ALEC, Inc. view Wisconsin as ripe for picking. But, of course, the Walker regime has run into deeper (and more highly publicized) opposition on several issues in ways they almost certainjly did not "appreciate" in advance.
Will be interesting, in several ways, to see how this evolves.
On a related note, I learned this morning through an interested friend that FDA has formally and definitively rejected the scaffolding created to argue preemption during the Bush II/Dan Troy era at FDA.
In particular, they rejected the "preemption preable" tacked on to the 2006 labeling law that had been invoked by corporate's attorneys in a number of preemption cases and to which the U.S. Supreme Court, almost unanimously, gave no deference in the Levine case.
I believe Riegel v. Medtronic only applies where the device went through the pre-market approval (PMA) process.
Welcome to the Corptopian States of America.
How can we reasonably expect these poor pharmaceutical corporations to keep making monstrous profits from their newest production plants in China and India; if we allow average citizens of America to hold them accountable for their defective products in a court of law...
Marilyn-I believe you are correct
Yes, concur with this understanding of Riegel. So the WI bill would greatly widen device preemption within that state.
1. Insurance subrogation clauses- one part of Alec is 'backstabbing' another part of the same organization? 2. Does Wisconsin have a False Claims Act and if so, then Wisconsin would become ineligible for some of the FC money that is protected under preemption? I wonder if the Governor knows about this? Ref: http://www.statehealthfacts.org/profileind.jsp?rgn=51&ind=260&cat=4
My understanding is that the Governor and state legislators will be very well informed about the various issues surrounding the proposed statute.
That said, the exclusion of Michigan's AG from the recent Vioxx settlement because of our preemption law was specifically decided in the MI Supreme Court. The decision came as no surprise in the context of that court.
I don't know if the WI SC would end up in a similar role. From what I gather, if so, one would expect a similar result.
Is the proposed Wisconsin law based on tort-reform--a policy that is now being revealed as a business-friendly, corporate wealth enhancing, civil right stealing method that keeps average Americans out of the court room and unable to hold corporations accountable when their products harm or kill? If so, and if it passes, the people of Wisconsin won’t even know what happened until it is too late.
The only way to get rid of FDA preemption is to tell the people what it really is. That would take a main-stream maverick willing to tell the truth. The words “FDA preemption” and “tort-reform won’t do.” For real change, Americans need to hear something that will grab their hearts…something like “You’re losing your rights.”
See: Susan Saladoff's film 'Hot Coffee' documents attempts to limit people's access to courts – In the Arena - CNN.com Blogs
This is just one more reason why I will be setting plenty of time aside to collect signatures for Walker's recall here in WI.
On Wisconsin, Evelyn!
The latest is that the immunity forces there may be running scared. It would, indeed, be very bad press (near suicidal) for them to go forward with this right now. But, if Walker survives, expect it back. And useful to expect it either way.
BTW, in response to an oped of mine that ran there, some commenters expressed resentment (probably feigned) over someone from Michigan interfering with "our Wisconsin law."
Of course, the proposed law was mostly drafted by the usual suspects at ALEC, in one of those Viginia suburbs where groups like that hang out.