Saturday, August 8, 2009

The Argument of Preemption In Practice

Wisconsin Court Finds Preemption Argument to be Invalid in Paxil Case

As reported in ExpertClick on August 7 2009 - "A Wisconsin federal judge has denied GlaxoSmithKline's claim of immunity from liability for a Paxil-induced injury case, allowing the plaintiffs product liability case to move forward. "

For months arguments for and against FDA Preemption have been bandied about both here and elsewhere on the internet. Countless hours of sometimes heated discussion have passed as we speculate on preemption’s use and its affect in the real world.

In the attached article we can see the real world attempted application of FDA Preemption in a court of law. Its use as a blunt force instrument to drive plaintiffs out of the court room has failed in this case.

The case is also significant because it involves the Paxil – Suicide allegation. It will be interesting given what we already know about GlaxoSmithKline's management failures with Paxil. The court will now be able to take a deep dive into the situation.

Note that the court held, among other things -

  • "Federal law does not prohibit drug manufacturers from updating their labels to warn of known risks when the FDA-approved labeling did not include the updated language. Instead, a drug manufacturer has a duty to advise consumers of risks because it 'bears responsibility for the content of its label at all times.”

  • "State tort claims are harmonious with Congress' regulatory goals and do not compel application of preemption"
  • ". . . the fact that the FDA approved prior Paxil labeling without an enhanced warning does not mean that the agency would oppose a request by GSK to include such a warning"
  • "GSK's 'overwarning' argument also assumes that the subject drug label warns of a non-existent risk," however, the Court stated that it "refuse[s] to find that Paxil does not increase suicidality as a matter of law"
  • "State law litigation provides an additional oversight on drug labeling and helps flesh out which warnings are 'substantiated' and necessary for the protection of consumers"


  1. Thanks, David--

    The arguments rejecting FDA preemption in the Wisconsin case are pretty much identical to those used in Wyeth v. Levine. What may be especially interesting (I haven't read the opinion) is they extent to which they cite Levine. I assume a lot.

    Levine, in turn, reiterated arguments made against preeption in a great many lower court decisions as well as in a range of commentary on the issue (by Vladeck, Kessler, et. al.).

    For me, the interesting thing will be how much lower court decisions, like this one, will see themselves bound by Levine. Prior to that SC decision, cases like this one were about 60-40 against preemption, and there were (and still are) many. So what has the impact been since? (Some cases premised on preemption as a defense have been withdrawn, seeing the "writing on wall.")

    Still, the issue is anything but finished. Beyond the device question and the draconian law in Michigan (the arguments for which the _entire_ Supreme Court rejected in Levine), there are cases with a range of permutations that may well make their way to the Supreme Court again at some point. The question will not be preemption in general, though, but its application in particular situations. In Levine, for example, even the dissent supported Wyeth based on the particular history of FDA's label review. The fact that the drug and its label were "FDA approved" was _not_, in the opinion of those Justices (Scalia, Alito, Roberts), sufficient in itself to justify preemption.

    Thus, short of a major reversal by the Court, the "big issue" of preemption has been resolved. And so preemptors have focused more on a state by state strategy, trying to replicate some versionof Michigan's law in other states.

  2. Addendum....

    Having now read the link (!), I see that this decision was almost entirely based on Levine. Indeed, that's where most of the quotations come from.

    It appears that this was a decision about dismissal or summary judgment--not a ruling about the merits of the case itself (but about the merits of preemption as grounds for not hearing it).

    Of course, it is also a release from plaintiffs' attornys, who have been central in the Paxil litigation for a long time.

    Direct "conflict preemption" appears to be the core argument used by GSK. That the company would have been violating the law even if it knew facts relevant to warning because it could not have made a label change without FDA approval.

    It is pure Troyism. And, of course, Troy himself is now Chief Counsel and second in command at GSK.

    And the beat goes on.

  3. Justice to your point about hearing the merits of the case - it is true that arguments made in this case appear to be mainly based on the merits of preemption and not on the actual merits of the case. I am surprised that this is still the case post-Levine.

    Could it be that Mr. Troy simply “re-worded” preemption in GSK’s defense? This comment from the article –

    “In its motion, GSK argued that it deserved complete immunity from liability, claiming that it was prohibited from disclosing to the public truthful information about the suicidality risks associated with Paxil. In essence, GSK argued that, because the FDA did not "make" GSK warn about the suicidality risk, it could not have warned or disclosed these risks any sooner.”

    Either way, with preemption or with a presumed preemption work around, the merits of the facts of the case are intended to be avoided at all costs.

    And that is what is criminal about Mr. Troy.

  4. Btw, for information on Mr. Troy's sorted past see THIS from Senator Maurice Hinchey's - Issues and Legislation page on the US gov. site.

  5. After reading the ruling it does appear that the GSK defense argument was made before Levine so their legs were cut out from under them.

    And these arguments against drug Preemption are sound yet it is not right that they are not considered sound for medical devices or the people of Michigan.

  6. For legal eagles, the decision can be found at:

    What I get from it is that GSK reworked its preemption defense after, and in light of, Levine. Based on a series of interactions between GSK and FDA since 2007, GSK argues that it would have been "impossible" to add warnings and still meet FDA's labeling requirements.

    The judge argues that this "impossibility" defense is not held up by the history in question.

    That said, the case is an interesting one in terms of the subtlety (or casuistry, for the more cynical) with with such arguments are woven.

  7. Below a pertinent snippet from the decision:

    "As discussed, the Supreme Court directly rejected each of GSK’s original
    preemption arguments. However, GSK offers modified arguments following the
    issuance of Levine, as it must. GSK now argues that the FDA would not have
    approved an enhanced warning regarding suicidality for Paxil’s label even if GSK
    had proposed one. GSK further argues that the Forsts’ state law claims pose a risk
    of “overwarning” because there is no association between Paxil and increased
    suicidality in adults. Despite GSK’s refined arguments, it still fails to establish that
    preemption of the Forsts’ state law claims is appropriate.
    GSK correctly asserts that Levine does not render state law failure-to-warn
    claims immune to preemption in every case. Indeed, the Supreme Court left open
    the possibility that “some” state law claims may frustrate the achievement of
    Case 2:07-cv-00612-JPS Filed 07/29/2009 Page 7 of 17 Document 143
    congressional objectives in the federal regulation of drug labeling. See Levine, 129
    S. Ct. at 1204. However, a defendant drug manufacturer faces an exacting burden
    to establish preemption of state law claims because compliance with both state and
    federal requirements for drug labeling is not impossible “absent clear evidence that
    the FDA would not have approved a change” in the drug’s labeling. Id. at 1198.
    This “impossibility preemption” is a “demanding defense” and cannot be established
    simply by showing that the FDA approved the label which was in place at the time
    of the plaintiff’s injury. Id. at 1199.
    GSK tries to provide “clear evidence” that the FDA would have rejected
    enhanced warnings for Paxil by pointing to the amount of interaction it had with the
    agency and the FDA’s repeated review of Paxil’s safety data. GSK implies that
    because the FDA never required an enhanced warning in the past, despite
    exhaustive and repeated review of SSRI safety issues, that the agency concluded
    such warnings were unwarranted and inappropriate. However, the court does not
    deem GSK’s evidence sufficient to establish “impossibility preemption.”

  8. So many reasons and/or ploys for ignoring the damage Paxil has done to so many people. And with FDA preemption they would have in essence been accepted.

    Immunity from prosecution is a powerful tool that must be used only for those that can be trusted.

    I wonder how many GSK/Paxil's there are in the Medical Device world?

  9. No shortage, we can be sure.

    Just confirmed today that Michigan's absolute immunity (full shield from liability, even when fraud) also covers devices. There was some question about that.

    Here is small glimmer for Michigan. If Hamburg FDA actually does what she said--and pursues criminal prosecution rather than the usual plea bargaining--that could open up the possibility of at least a few liability cases in Michigan.

    Bottom line is that FDA/DOJ have to follow-through. Without completed prosecution, there is no fraud legally-speaking, regardless of what actually happened. Plea-bargaining erases all that.

  10. For those who may be nostalgic for Pharmalot, here is a thread that went up when Dan Troy took his current job with GSK.

  11. States beware. The preemptors can’t win at the Supreme Court, so they’re coming in the back door. Georgia shooed them away, but they’ll be back. Their Sonny gov. likes them, just like Engler likes them. Like red ants, Michigan can’t get rid of them or their draconian law. Michigan needs help. In fact the country needs help because we have an infestation problem that is spreading. A strong insecticide is needed. Hopefully, “Hamburg FDA actually does what she said--and pursues criminal prosecution rather than the usual plea bargaining--that could open up the possibility of at least a few liability cases in Michigan.” And elsewhere.

  12. The other states that are immediately targets for the preemptors are Texas (which already has a new law that is close, but not as total, as Michigan's shield), Oklahoma, Georgia, and a few others.

    The preemption campaigns in these states have all the usual rhetoric: greedy trial lawyers sucking your blood, the end of innovation and life on earth, and other thoughtful perspectives. The U.S. Chamber of Commerce, which spends for lobbying money (by far) than any other organization, is solidly involved.


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