Sunday, April 19, 2009


Two Groups Join Forces Against Device Preemption and Michigan's Shield Law

(yes, an issue dear to some of our hearts....)

Two Anti-preemption Groups Unite
For release, April 20. 2009

Americans for Drug and Device Accountability (ADDA) and Justice in Michigan (JIM) have announced their consolidation into a single organization dedicated to fighting FDA preemption in the drug and device arenas, and on both the state and national levels. Their updated website is

ADDA was formed one year ago and consists of business people, patient advocates, healthcare professionals, and concerned citizens. Members represent the full political spectrum—from conservative Republicans to liberal Democrats. They also include current and former employees of the pharmaceutical industry who agree that FDA preemption is bad policy—a disaster for patient rights, public health, and industry accountability. A petition initiated last year quickly gathered nearly 1,000 signatures and comments, including those of Dr. David Graham of FDA, Dr. Joel Lexchin, Dr. Doug Bremner, Dr. Howard Brody, Vera Sharav, Tom Lamb, and many more.

JIM was formed four years ago, primarily by social scientists, policy analysts, and bioethicists in Michigan. Along with issues of healthcare and social justice generally, the organization’s focus has been on Michigan’s unique drug industry shield law, passed in 1996, that fully bars Michigan citizens from bringing suit over drugs approved by the FDA. Michigan’s law is the most draconian in the nation. Courts have ruled that even the most egregious negligence or fraud would not open the courthouse to Michigan citizens. That is thirteen years of justice denied.

Both ADDA and JIM believe that it will take legislative action to restore justice. On the national level, this means the Medical Device Safety Act which would restore the right of citizens to bring suit in the medical device arena. In Michigan, it means rescinding drug industry immunity. The Michigan House has already voted twice to do so. But the bills have been killed by a small number of immunity supporters in the Michigan Senate.

The national and state levels of these issues reinforce each other. Across both parties, and across this land, citizens are recognizing that the days of special interest legislation—along with the era of government arrogance and irresponsibility—are drawing to a close. Before long, we will look back at this time as a nightmare from which we will be thankful to have awakened. In the meantime, Americans for Drug and Device Accountability and Justice in Michigan fight toward that dawn.

Join us.


  1. I certainly hope something can be done. Here is another item on this issue from the Lansing State Journal

  2. Thanks, gonefishin!

    Actually, the Supreme Court rejected Michigan's kind of preemption law 9-0. Even the dissenters--Alito, Scalia, and Roberts--affirmed that there was no inherent conflict between product liability suits and the FDA. It depended on the particular regulatory history of the drug or device.

    So, as said before here, Michigan is on its own legal planet. And some of our Senators seem to think they are more expert on all this than _all_ the Supreme Court Justices.

  3. Thank you, Justice, for your direction and focus.

    There is no amount of money that will ever replace one’s good health. And, there is no good reason, ever, to deny an other human being justice.

    Besides all that, as my brother says, “This is America, dammit.”

  4. Heads up! Gardiner Harris reports: "Rare F.D.A. Meeting to Discuss Complaints on Device Approval..."

  5. Hi All,
    I haven't been over here in a while. I hope conversations are going well. Here's an article I saw on "In Vivo" taht I thought would interest the crowd over here.
    All the best - I still miss our Pharmalot days, but life has gotten busy enough that I'm sometimes glad to not widdle my hours away debating!

  6. Hi Nathan,

    Yeah, I saw that. The days of golf and scotch are over?

    Hope you're well! As you no doubt saw, there is at least a chance Ed may return with some version of the Lot via In Vivo. That would certainly be great.

  7. For those who interested in a bit of an update, and red meat, re: Michigan's full immunity law...

    Senator Mike Bishop Declares War on Democratic
    Process and Rational Public Policy

    From: Americans for Drug and Device Accountability / Justice in Michigan

    April 20, 2009
    For Immediate release

    In a story that appeared in today’s Grand Rapids News (4/20/09), Senate Majority
    Leader Mike Bishop has declared war on the majority of Michigan citizens. In
    every poll, and in the State House, they have voted overwhelmingly to repeal
    Michigan’s drug industry immunity statute. Bishop has announced he will not
    allow a vote in the Senate or even in a Senate committee: “I don’t have any
    intention of taking this up.”

    Attempting to justify his view, Bishop points to a University of Michigan study that
    estimates the contribution of bioscience (pharmaceutical and biotech companies) to
    Michigan’s economy between 2002-2006. In fact, that study shows a precipitous
    decline in industry-related jobs, and this was before the economic collapse we have
    experienced over the past three years. There is neither data nor logic that backs
    Senator Bishop’s claims.

    Bishop also asserts that the struggle to end drug industry immunity is “politics of
    the worst kind” and that trial lawyers have “commandeered the Democratic
    party.” This is hate-mongering of the worst kind, and it is, sadly, what we have
    come to expect from defenders of drug industry immunity.

    Here are points of relevance:

    (1) In statewide polls, 70-85% of Michigan citizens are in favor of repealing drug
    industry immunity. Can they all be trial lawyers?

    (2) The most respected voices in American medicine, The New England Journal of
    Medicine and the Journal of the American Medical Association, have come out
    four—square against “FDA preemption,” which is the doctrine that underlies
    Michigan’s law (that FDA approval should fully shield a company from liability). It
    takes a critically important public health issue for mainstream American medicine
    to defend lawsuits. Have all the doctors also been “commandeered” by “trial

    (3) In the Wyeth v. Levine case, every member of the United States Supreme Court,
    including the three dissenters, wrote against the doctrine that underlies our
    Michigan law: that FDA approval should automatically bar product liability.
    Writing the dissent, Justice Samuel Alito notes: “To be sure, state tort suits can
    peacefully coexist with FDA’s labeling regime, and they have done so for decades.”

    Does Senator Bishop imagine that Justice Alito, Justice Scalia, and Chief Justice
    Roberts have also been “commandeered” by trial lawyers? And does he view the six justice
    majority in the case—including Justice Thomas—also playing “politics of the
    worst kind”? Does he view himself as better informed on these matters than all nine
    Justices of the United States Supreme Court?

    The reality is this. The suppression of democratic process and the politicizing of
    drug industry immunity are coming from Senator Bishop himself, and his allies. It
    would be as comforting as it would be misinforming to view the issue of drug
    industry immunity as one more example of Democrats versus Republicans, Trial
    Lawyers versus Commerce. But it is anything but.

    The doctrine that underlies our Michigan immunity statute was described by the
    New England Journal of Medicine as a disaster for patient rights, industry
    accountability, and public health. This is not about politics. It is about the public
    good and rational public policy.

    Let’s end the war. Let’s return facts and logic to the Michigan Senate. Let’s bring
    justice home.

  8. A subrogation clause allows an insurer to recollect previously paid claim amounts from the responsible party. Embedded below is the 'welcome' and 'acceptance' clause (i.e. acceptance of subrogation) from a major health insurer's individual certificate of coverage (i.e. the contract).

    In this case, the health insurer has published that they were aware of potential safety issues with Vioxx within four months of their Pharmacy and Therapeutics Committee writing it on to their drug formulary. For some reason, they apparently chose not to tell their contracted 'partners'...doctors, pharmacists etc., or their policyholders (i.e. the people who pay their salary) about these potential safety issues.

    I am not sure if the FDA was contacted; however, I am aware that published reports indicate that certain insurers and/or their PBM subsidiaries have contacted the trial attorneys who sued on behalf of Vioxx patients to demand that they identify policyholders that they authorized and billed for Vioxx, and to demand settlement information about their customers' (note that I use the word ‘customer ‘ very broadly) Vioxx settlements. In other words, these companies appear to be enforcing their right to subrogate and recollect previously paid (and likely booked and reported) claim amounts.
    Curiously, it would appear that neither these health insurers nor their PBM subsidiaries have the capacity to identify and/or notify their contracted 'partners' or their 'customers' about the potential safety issues and the amounts that they apparently authorized and charged the policyholder in co-payments, deductible amounts, and the amounts that they charged the policyholders' plan. It is interesting to note that despite this, reports indicate that certain insurers and PBMs paid bonuses based on their reporting and their CEO's apparently certified under Sarbox that they had adequate (booking and reporting) systems in place. I would also assume that billed amounts for Vioxx were likely reported as an expense against income, and submitted as part of actuarial data to prove the need for premium increases, perhaps even in cases where the policyholder died or was disabled and forced onto Medicare and/or Medicaid.

    As they invoke their subrogation clauses, it will be interesting to see how the insurers and PBMs book and report (or re-book and re-report) these amounts. It is a rather interesting profit model…
    "By accepting plan coverage you agree:
    • Your signed application for coverage is your authorization of our right of subrogation.
    • To notify us of any event which could result in legal action, a claim against a third party, or a claim against your own insurance.
    • To notify us of any payments you receive as a result of legal action, a claim against a third party, or a claim against your own insurance.
    • To cooperate with us in exercising our right of subrogation by providing all information requested.
    • To sign documents we deem necessary to protect our rights; and

    • To do nothing to interfere with our subrogation rights.
    If you do not comply with the above, you may be responsible for expenses we incur in enforcing our subrogation rights."

    So, at least in this case, the people who stand to lose the most because of the recent supreme court preemption decision are the patients, doctors, and pharmacists. The people who may gain the most are the health insurers & PBMs, and their associates who may include certain trial, insurance defense and white collar defense attorneys; and others.


Note - Due to a time out issue with Blogger, you may receive a message that requires you to resend your comment. This will not affect its contents.