Wyeth Vs. Levine: Preemption Posturing Continues
13 CommentsBy Ed Silverman // September 17th, 2008 // 2:06 pm
As the November 3 hearing before the US Supreme Court nears, Wyeth has now filed a brief replying to the filing by Diana Levine, a Vermont musician who was given a Wyeth nausea med called Phenergan during a visit a hospital emergency room (you can read the brief here).
However, the drug was administered improperly, causing her to lose her right arm below the elbow. She successfully argued that, even though labeling complied with FDA requirements, the adequacy of the warning still wasn’t established for a particular method of administering the drug.
And she contended Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change. Levine was awarded more than $6 million and, despite appeals, the Vermont Supreme Court sided with her. But Wyeth appealed again. (Read our interview with Levine here).
Wyeth’s defense hinges on preemption - the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
However, Wyeth’s attorneys, in the new brief, argue that Levine’s case is not really about failure to warn and, therefore, preemption is really not in play…
“Whatever might be said about preemption in those situations, they are most definitely not this case. Respondent never argued that Wyeth concealed information from FDA, and never contended that Wyeth should have changed its labeling to reflect information that came to light after its labeling was approved. Respondent tried this case on the theory that FDA had the pertinent information but reached the wrong conclusion, and that the jury should set FDA right. In this situation, state tort law is undoubtedly preempted.”
This past summer, Levine’s attorneys made this argument: The issue is whether a drugmaker “may be held liable under stats law for inadequately warning that one method of administering an anti-nausea drug causes unacceptable risks of amputation. When neither Wyeth nor FDA performed any risk-benefit analysis of different ways of administering Phenergan, preemption simply provides a windfall for the drug maker. It decreases manufacturers’ incentives to improve safety and to inform FDA of risks, impedes FDA’s ability to protect consumers, and denies compensation to victims of dangerous drugs for catastrophic but avoidable injuries.”
Hat tip to Drug and Device Law
Dan A.
preemption is a pointless factor in such cases. The FDA is flawed, as shown by drugs they have approved that have been dangerously unsafe. So an FDA approval is a flawed argument for preemption. And will be until the FDA achieves perfection with its approvals of such things as medications.
Justice in MI
I’m still trying to sort this out. I suppose it might be said that Levine is arguing that Wyeth “failed to warn” (to a reasonable degree) about the dangers of IV push delivery. Somewhere, I recall the argument that Wyeth should have at least sent a Dear HCP letter about it or taken the initiatve via CBE. [Of course, Wyeth's lawyers argue CBE reqires "new information" and CBE is not relevant in this case (especially given latest CBE redefintion) and that FDA had already rejected - or at least not affirmed - the need for further warning].
But, as Ed writes, “failure to warn” generally suggests that manufacturer was in some way negligent (or worse) re: informing FDA of safety info in its posession - by delay, camoflage, actual concealment, distraction, etc.. Of course, this is the kind of failure to warn asserted in cases re: Paxil, Vioxx, fen-phen, Baycol, etc..
Personally, I was struck by the sentence, “Whatever might be said about preemption in _those_ [my emphasis] situations, they are most certainly not this case.” Perhaps reply briefs usually go for the “win” and let the amici argue for the wider principle. But, at least here, there is an open door to the Court for a narrow ruling of preemption in the particular circumstances of the Levine case, but not “in those [other kind of] situations.”
If there is sense to this, the Levine decision may be a smaller step toward or away from broad preemption than has often been assumed.
Salmon
“Respondent tried this case on the theory that FDA had the pertinent information but reached the wrong conclusion, and that the jury should set FDA right. In this situation, state tort law is undoubtedly preempted.”
Why shouldn’t a jury set FDA right? Isn’t that part of the reason for having citizen’s petitions, advisory committees, and public hearings in order to get the input and perspective of patients as to what is right when there is a judgement call. Plus we have a number of cases where FDA management has retaliated against reviewers simply at the insistence of drug companies.
Salmon
David Y
This is one of those situations where you wish there was some sort of “no fault” insurance fund. Diana Levine is a perfectly innocent individual who gets nasty migraine headaches and expected, and pretty much receive standard medical care, and then suffered a very rare complication of treatment. It’s no one’s fault. Yet her disability is devastating and serious. She should be entitled to some sort of compensation, but not on the basis of it being someone else’s fault. There should be a pool of money generated via a number of resources and a portion given to individuals like this.
Nathan
David Y,
Are you suggesting a “bad luck” pot of money? That’s absurd! Who would fund it? Who determines who gets the money?
I agree that this was really no one’s fault. But sometimes sh*t happens in life and we learn to deal with the hand that life gives us — even if we don’t like it. Bad things happen all the time that aren’t really anyone’s fault. Do they get compensated?
Chris
Why do you say it was no one’s fault given that the drug was inadvertently (and thus inappropriately) administered into an artery rather than a vein?
Justice in MI
I am not for holding a company accountable if there was no reasonable way they could have acted that might have made a difference. Levine is arguing that there _were_ such ways - communications to HCPs and a CBE. Whether that argument makes sense, and Wyeth should be liable for not so acting, is the crux of the case.
Re: the FDA, if the situation is as bad as some posters have recently described, they are grim indeed. But compensating Diana Levine is not the answer to cleaning house there either. That said, Salmon makes interesting points re: citizens’ petitions, etc.. If one followed Catherine Sharkey’s viewpoint, FDA would have to show (to a judge) - and not simply assert - that it reviewed whatever relevant risk in an appropriate way in order for preemption to kick in.
Sidelight - the one place the reply brief veers off point is a footnote in which NEJM’s analysis of the fen-phen (Wyeth’s Pondimin/Redux) case is rejected.
jooe
You all are missing the point. You are arguing the facts of the trial, which Wyeth was already found to be at fault and ordered to pay Miss Leving $6 million dollars. The issue at hand is pre emption. Does the FDA stamp of approval protect all pharmaceutical drugs from lawsuits. Thus making humans guinea pigs for the pharmaceutical industry. There will be no reason to spend money on lab rats when they can just run their tests on us humans, and make us pay them to take their medicine. Then when we are injured, have the US taxpayers pay our medical/disability expenses for the rest of our lives under Medicaid or Disability. Look at all of the Vioxx users that have cost the taxpayers billions of dollars in Medicare/Disability, all because Merck lied and hid facts about their dangerous drug. As a US taxpayer, I don’t believe I should have to pay for Merck’s liability.
Nathan
There was a nice article in the NYTimes this morning about the Levine case.
http://www.nytimes.com/2008/09/19/us/19scotus.html?pagewanted=1&_r=1&hp&adxnnlx=1221819274-t95zI9T5%20PzloMXpxbRB/A
I thought they did a great job of distilling the debate down to two sentences: “Do the F.D.A. and other federal regulators set minimum safety standards that states are free to augment? Or do they make judgments about the optimal balance between risks and benefits that states must follow?”
Obviously I lean towards the latter. They also quoted the dissenting opinion from the Vermont supream court. Again, an interesting statement that I agree with: “No drug is without risks. The F.D.A. balances the risks of a drug against its benefits to maximize the availability of beneficial treatments. A jury does not engage in a measured and multifaceted policy analysis. Rather, a jury views the safety of the drug through the lens of a single patient who has already been catastrophically injured.”
laurie
““No drug is without risks. The F.D.A. balances the risks of a drug against its benefits to maximize the availability of beneficial treatments”
This statement should be true, but the recent lack of disclosure to the FDA of known risks of certain drugs makes this a moot point.
Until the FDA sets in place a system of obtaining and evaluating ALL the information that a drug company has about a drug, then they cannot be considered the final word on a drugs safety.
We are far from that situation.
Jaynesday
Nathan,
I agree with laurie - in different words -
Drug and device companies have too many incentives (pre and post)along with too much ability to hide critical information from the FDA. The only incentive against hiding critical information is litigation.
Honesty is the best policy but too often greed is the trump card.
Jaynesday
And unfortunately the FDA is handing out trump cards.
Justice in MI
As posted in the Levine thread, I believe the NYT article missed the boat re: the issues most often at issue in preemption cases.
Preemption, at core, is not about whether the FDA sets “optimal” guidelines. It is about whether they had the information that would have enabled them to do so. And, if not, what can be done, and by whom?