Wednesday, February 18, 2009


FDA Preemption Ground Zero

Once again, the great State of Michigan will attempt to repeal it's full FDA preemption law which goes back t0 1995. Except for a few flukey instances, no Michigan citizens have been able to file suit against drug companies if their drug has been FDA approved and is in compliance. There are, de facto, no exceptions because of related higher court decisions. That includes a company having committed fraud in the approval or post-approval process.

Two years ago, three bills to repeal our preemption law were passed in the state House by a vote of 70-39, with most but not all Democrats joined by one-third of the Republicans voting against preemption. That parallels state polls, which suggest about 70% of Michiganders are in favor of repealing our preemption law.

The state Senate, which is controlled by a small pro-preemption majority (about 2 votes) killed the bill in committee.

So now we begin again. Below a trio of bills introduced to rescind Michigan's preemption law. A difference between now and 2007 is that many of the pro-preemption Senators will be running for office. You can be certain, whatever the Levine decision, that there will be a great deal of noise coming from the Mitten State on this issue. Keep your ears open.

HB 4316 of 2009 (Lisa Brown) Torts; product liability; limitation on liability for drugs that have been approved by federal food and drug administration; rescind.Last Action: 2/17/2009 referred to Committee on Judiciary

HB 4317 of 2009 (Deb Kennedy) Civil procedure; statute of limitations; drug product liability cases previously prohibited because of FDA approval defense; allow to be commenced within 3 years after repeal of the defense. TIE BAR WITH: HB 4316'09Last Action: 2/17/2009 referred to Committee on Judiciary

HB 4318 of 2009 (Dian Slavens) Consumer protection; unfair trade practices; liability for inaccurate representations concerning risks of certain drugs, medications, and supplements; clarify.Last Action: 2/17/2009 referred to Committee on Judiciary


  1. I just returned from Pharmalot, where I found oodles of information about tort reform in Michigan.

    Click on my name above to access some additional information on the 2007 proposed legislation, which was defeated.

  2. Thanks, Nancy. BTW, there may be some connection between that piece you linked--and other stuff on Pharmalot about Michigan--and the dude who goes by "Justice in Michigan."

    Only the shadow knows.

    As reported above, the 2007 legislation was not "defeated" when humans actually had a chance to voite on it. The House repealed Michigan's preemption law 70-39. The state Senate prvented it from going further.

  3. For preemption-aholics....and academic types...

    A conference upcoming at NYU which includes the whole spectrum of opinions on preemption (not only FDA preemption):

    "Tort Law in the Shadow of Preemption"

    Friday, February 27, 2009 | 8:30 AM - 4:00 PM
    Greenberg Lounge

    Annual Survey of American Law Symposium: "Tort Law in the Shadow of Preemption."

  4. Justice, are we lifting the curtain here?

    I concede my notion that SB No. 43 (2007) was defeated; rather, as reported by Ed Silverman, certain Senators stalled the bill[]. I note as well that the Discharge Committee postponed the bill on 12/12/2007.

    Justice, I am posting for further discussion an excerpt from your insightful 2007 historical perspective on SB No. 43, which I found in the Pharmalot blog archives (And, no, I am not apple polishing.):

    < The issue was key in some of the 2006 state elections, and - as their first order of business in January 2007 - the Michigan House voted to repeal our immunity law by a vote of 60-41, with solid bipartisan representation. But the State Senate has proved to be the stumbling block to full repeal - a matter of 3 votes or so that would need to change. Statewide polls show that Michigan citizens favor repealing our shield law by about 70%.

    As Ed notes, the “rationale” of the argument in favor of preemption is that courts ought not to “second-guess” the FDA. The reality, however, is that no court has ever “second-guessed” FDA, nor made any judgment whatever about what FDA should or shouldn’t have done. Rather, civil liability_complements_FDA regulation, which was the FDA’s own position until the current Administration. Viewing FDA compliance as a basic requirement, courts have asked: (1) Even if technically in compliance, has this company done more to play_with_regulation than _by_ it (what Jerry Avorn of Harvard calls “passive-aggressive” compliance) such as through delaying or disguising important risk information. (2) Is there a pattern of deliberately misleading physicians and the public in areas that are not covered by FDA regulation at all - such as through inappropriately spinning journal articles, intimidating researchers, and so on []. >

    < The “second-guessing” arguments serve to divert us from the essential patterns of conduct in cases like this. Once again:

    1. What did a company know?
    2. When did they know it?
    3. What did they do about it?[] >

    The new bill, HB 4316 (2009), requires that the plaintiff in a product liability case demonstrate that the product was “not reasonably safe.” Language in the current law which says that the company is not liable for damages if a drug was approved by the FDA is stricken, and attention is refocused on (in Justice’s words) the essential patterns of company conduct.

    William Nelson reiterated in a VA National Ethics Teleconference the importance of applying moral reasoning to situations such as this:

    < I believe that there will continue to be a blurring between the role of law, compliance, government ethics and health care ethics. In fact, the blurring will increase. I am concerned that the distinctions are getting harder to recognize. Theoretically, there are distinctions between law, government ethics, and health care ethics, but to the average administrator and clinician the distinctions are pretty fuzzy. Unfortunately this blurring can be fostered when the ethics community tends to look to an organization’s policy or regulation as a primary source of ethics guidance as opposed to what moral reasoning might guide one to say, this is right thing to do. > Source: A Personal Reflection on the Evolution of Ethics in VHA, October 2003, National Ethics Teleconference, National Center for Ethics in Health Care, United States Department of Veterans Affairs [].

  5. This is good news, I guess. But then, again, it may just be the beginning of another big let-down.

    I learned about our odious law in 2006 when a family member was harmed by FDA-approved drugs. I couldn’t believe it. “How could a law like that happen in America?” “Why didn’t I know about it?” I sent out a gazillion emails to everyone I knew with a letter to send to their representative and senator and left fliers all over town. A friend and I wrote a letter to senate majority leader Mike Bishop, who actually responded. We thought for sure the law would be rescinded. It wasn’t. It passed the House, but Bishop blocked all attempts for a senate vote.

    My friend is a motivational speaker for sales reps. We are on opposite sides of the political aisle, however, we have a lot in common, and we both dearly love America. He flies all over the county and spends a lot of time catching planes at Detroit Metro. He is a people magnet and folks are drawn to him. He tells them about our law, and they are always in disbelief. There has not been one individual he has met that knew about Michigan’s law.

    My husband and I are new members of a Democratic group in our area. At a recent meeting we told them about Michigan's law and FDA preemption. There were over two hundred people in the room. Only one person knew about our law; no one had heard of FDA preemption. They were all in shock. They could not believe their ears.

    I want to be fair here. In the past 14 years, there has been one good TV segment, 11:00 p.m. news, about our law. The reporter has since been relocated to CNN Pakistan. I’ve seen him once. And one good Detroit Free Press article. The paper has since changed hands and, during the last election, endorsed the Supreme Court Justice who wrote the decision supporting our law.

    I will continue to do every thing I can to let folks know about our law. However, I just want to say,

    “Dear Newspapers, TV, Radio, and Political Leaders, you sold out your fellow man and your country. Whatever you received in trade will never be worth the principles on which this country was founded. Shame on you.”

  6. I don't think it was ever much of a curtain...

    The core point, in my view, has always been making FDA approval/compliance the _sole_ criterion upon which liability depends. That does not mean I think it's irrelevant. And, indeed, in most actual cases it _is_ relevant, an important part of a company's defense, as it should be if there are good grounds.

    That is also why I've always felt the Levine case was a weak one. (Which is also why the then Solicitor General brought it to the SC in my view.) Because it is a relatively weak tort case, it can be used to establish a "preemption beachhead," which I believe has been the goal. The alterative would have been a different decision in the first place. But I'm in Michigan, not Vermont.

    In any event, the SC has the option of remanding the case back to Vermont and not ruling on preemption at all--narrow or broad. That, in my view, would be a fine outcome.

    S. Dogwood--You know I share your views. I also think the times they are a changin'. So here I will risk two predictions:

    The Michigan Senate will change after the 2010 election, and Michigan's law will be (bad) history a few months later. And, whatever the SC does, Waxman and Co. will modulate it. There may well be provisions limiting punitive damages, etc., which I am also not against. So there will be, in my view, appropriate and just compromises in which the claims of the people, industry, and FDA will be in rightful balance.


  7. Congress may revisit Medical Device preemption:

  8. Thanks, James. I just found the NYT article myself, and I'm going to try a little experiment. For some reason, the link you included didn't work for me. So I want to see if this one does.

  9. I got your html back, Justice, here's the link to the preemption article.

    And I can't remember if I saw it here or somewhere else, but AZ is taking the bold step of protecting their patients by fighting to keep company documents about Seroquel sealed in a lawsuit. Supposedly the docs show that AZ knew Seroquel could cause weight gain, diabetes, and other health problems, but for our sake they chose not to tell us. Isn't that sweet of them? I'm all warm and tingly.

    And, just for fun, we can throw in here that the DoJ is joining the whistleblower case against J&J's subsidiary Scios for off-label selling of Natrecor.

    Fun stuff, huh?


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