Wyeth Files Brief For Levine Preemption Case
10 CommentsBy Ed Silverman // May 28th, 2008 // 9:01 am
This is going to be one closely watched case. The background: Eight years ago, Diana Levine entered the emergency room of a Vermont hospital because of a severe migraine. She was given a painkiller and another med, Wyeth’s Phenergan, to treat the nausea brought on by the first drug. But it was administered differently using an IV push method and the incident eventually caused Levine, a professional musician, to lose her right arm below the elbow.
Levine successfully argued that, even though Phenergan labeling complied with FDA requirements, the adequacy of the warning still wasn’t established. And Levine’s attorneys 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.
At issue is preemption - the that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The Supreme Court ruling could, therefore, determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
In its brief, Wyeth argues the Vermont Supreme Court got it wrong because it is “impossible” to comply with both state law and FDA labeling requirements, and that the requirement to comply with state law to preclude the IV push method would “obstruct the purposes and objectives” of the Food, Drug and Cosmetic Act and its implementation by the FDA. In short, Wyeth’s attorneys maintain “the Vermont judgment conflicts With Congress’s public health objectives.” There is much to read in this brief - please enjoy.
Hat tip to Drug and Device Law
Justice in Michigan
Will read brief (I thought I had already, but must have been the lower court version).
Whatever the merits of this case, I will say again that tort suits have nothing to do with “state law requirements.” That’s the preemptors’ language. It may be that this _particular_ case is not a good one for plaintiff because company acted appropriately re: warnings.
However, that has nothing to do with an inherent conflict between state civil liability and FDA regulation, which have co-existed well, and with the FDA’s blessing, for 75 years.
Justice in Michigan
Hi Ed, I don’t know if the Levine and other supporting briefs have been filed yet, but I hope you will also post the links here if/when they do.
What makes the Levine case atypical, of course, is that Wyeth is said to have requested the label change and that FDA rejected it. The vast majority of such cases do not involve that kind of back story, which will certainly count in Wyeth’s favor, as I believe it should.
Beyond that, this really comes down to a traditional case in which the relevant questions remain:
1. What did the company know?
2. When did the company know it?
3. What did the company do, or attempt to do, in response to that knowledge?
Companies are usually judged liable when there was a reasonably clear pattern of misleading physicians, the public, and/or the FDA; engaging in a series of pratices that Jerry Avorn calls “passive aggressive compliance” (delaying, disguising, distracting submissions to FDA) which are delinquent but short of outright criminal fraud; willfully ignoring “red flags” and certainly not doing studies to assess the magnitude of the problem (or suppressing/spinning such studies if they are conducted; or trying to camoflage known signals in FDA reporting); misleading promotional materials (which may or may not have provoked FDA warning letters); intimidating or bribing relevant academic researchers whose work may be relevant; deliberate burying or misrepresenting data (full felony fraud), and so on.
It is the pattern of such actions - some of which are entirely outside FDA purview - that constitutes potential liability. And, of course, meeting FDA requirements - even despite such activity - will also count in the manufacturer’s favor, even if some or many of such delinquencies have also occur.
So, once again, the question in any case comes down to whether reasonable people would conclude that activities such as the above occurred and that, as a result, harm was done. FDA compliance remains a key part of what any jury considers. But it does not provide a full and absolute shield, which is what preemptors argue for.
Conversely, no lay jury has the power to amend a label, withdraw a drug, mandate remedial action, or take any other such action which remain solely and unchallenged within FDA’s jurisdiction.
Meanwhile, if serious delinquencies have occurred, victims of such actions remain entirely without recourse under preemption, even if full felony fraud was part of a company’s actions.
The preemptors and their lawyers will say it’s all about the _other_ lawyers. But the editors of NEJM, JAMA, and the New York Times (which called preemption “a perverse legal doctrine”) would suggest that those who can only accuse _others_ of greed would do well to look in the mirror.
laura
Justice,
You said:
“What makes the Levine case atypical, of course, is that Wyeth is said to have requested the label change and that FDA rejected it. The vast majority of such cases do not involve that kind of back story, which will certainly count in Wyeth’s favor, as I believe it should.”
As a victim of the Supreme Court’s medical device preemption ruling, I have to wonder, why are these “imperfect” cases allowed to become the defining cases regarding preemption?
The Riegel v Medtronic case was similar to Levine v Wyeth in that there were “muddying” circumstances. In Riegel v Medtronic, the surgeon had inflated the catheter beyond label specifications, and yet the Supreme Court’s ruling in this case was the “end all”, quite literally, as far as whether state tort liability lawsuits can occur. Now, in Levine v Wyeth, the company has seemingly complied with FDA orders and requested a label change. Is this the case that should be mandating whether or not drug preemption is advisable? I am certain that there are many cases that can clearly illustrate why preemption is a catastrophic policy. Why aren’t these cases brought before the Supreme Court?
The Supreme Court’s decision is an across the board, no questions asked ruling. It seems to me that they should be choosing cases that clearly define the policy that they are ruling on.
Justice in Michigan
Laura,
First, I am sorry to hear about your own situation. Second, you ask the perfect question.
I’m still learning a lot about this myself. But here is some of what I extrapolate.
There is an expression about bad cases making good law - or the other way around - but I think that depends on who owns the ox.
In this case, the Solicitor General (Prez appointee) plays a significant role in arguing whether a case should or shound not be “granted cert.” (heard by Court). Thus, while Court makes ultimate decision, it does not do so in a vaccum.
Hopefully, someone better informed will add or substract from this!
Justice in Michigan
As Ed would say, hat tip to Wiki…
Here is a better answer - I had at least a little of it right. The gist: cert. is granted if 4 of 9 justices want it to be, after they toss around the issues. The Solicitor General’s view may or may not be called upon. The Chief Justice’s views clearly play an important role, not surprisingly.
Does the choice of case impact its outcome? It would certainly seem so to me. But wudda I know….?
*************************************
Selection of cases
Since the Judiciary Act of 1925 (”The Certiorari Act” in some texts), the majority of the Supreme Court’s jurisdiction has been discretionary.[3] Each year, the court receives approximately 7500 petitions for certiorari, of which approximately 150 are granted.[4] In theory, each Justice’s clerks write a brief for the Justice outlining the questions presented, and offering a recommendation as to whether certiorari should be granted; in practice, most Justices (all of the current court, except Justice Stevens) have their clerks participate in the cert pool.[5]
During the Justices’ regular conference, the Justices discuss the petititions, and grant certiorari in less than five percent of the cases filed. (During the 1980’s and 1990’s, the number of cases accepted and decided each term approached 150 per year; more recently, the number of cases granted has averaged well under 100 annually). Before each conference, the Chief Justice prepares a list of those petitions he believes have sufficient merit to warrant discussion. Any other Justice may also add a case to the “discuss list”; cases not designated for discussion by any Justice are automatically denied review. The Court or a Justice may also decide that a case be “re-listed” for discussion at a later conference; this occurs, for example, where the Court decides to request input from the Solicitor General of the United States on whether a petition should be granted.
The votes of four Justices at Conference (see Rule of four) will suffice to grant certiorari and place the case on the court’s calendar. If the Supreme Court grants certiorari (or the certified question or other extraordinary writ), then a briefing schedule is arranged for the parties to submit their briefs in favor of or against a particular form of relief. During this time, an individual or group having an interest in a case but is not a party to the case may submit a motion to appear before the court as amicus curiae (”friend of the court”). Except for certain specific categories (such as lawyers for state and local governments) or where all parties to the case consent, it is in the Court’s discretion whether such motions are granted.
The grant or denial of certiorari petitions by the Court are usually issued as one-sentence orders without explanation.
Justice in Michigan
For Laura and Interested Others -
The summary below from a “highly placed” source re: the role of the Solicitor General (SG). Wyeth v. Levine is, of course, a private case.
Since the current SG certainly endorsed cert. in Wyeth, one can see the interaction between the Exec and Judic. re: cases chosen and potential impact on outcomes.
**********************************************
The SG, sometimes known, as “the tenth Justice,” has a lot of
credibility with the Court. In a government case, the SG typically
opposes cert. if the government won in the court of appeals. If the
government lost, the SG makes the decision on whether to seek cert.
Just because the government asks for cert. doesn’t mean the Court will
grant it, but it is more likely than not and much more likely than when
a private party seeks cert. In a non-party case, SG policy is not to
weigh in at the cert. stage unless “invited” by the Court to do so; this
is true even where the government filed an amicus brief in the court of
appeals. Invitations are fairly common in significant statutory cases,
but not a given by any means. An invitation means that at least some
Justices would like guidance on whether to take the case — basically,
they want to know whether (in the SG’s view) the case was wrongly
decided, whether there is a conflict in the circuits only they can
resolve, whether it raises an important legal issue, whether there is
some quirk in the case that makes it a poor vehicle for review, whether
other cert. petitions are pending that better present the important
issue, and/or whether there is some regulatory or statutory fix in the
works that would make review inadvisable or unnecessary. I’m sure the
SG has a very good track record in getting the Court to grant or deny
cert., but, again, the Court doesn’t always follow the SG’s
recommendation.
Justice in MI
If anyone wants to revisit this - it is often suggested in commentary on Levine that Wyeth “proposed” a label change that FDA rejected. I find know such evidence in the brief linked here. Rather, what one reads is an ongoing procoess of label consideration and reconsideration by FDA. It is not clear, at least here, what the company’s “preferences” were.
Dianne
JIM – Thank you for re-introducing Levine. This topic is timely, as Levine is right around the corner, and will impact every single American.
This Fall, Levine will challenge the civil right of all of us to hold a drug company accountable for harm or death caused by a FDA approved drug.
The New England Journal of Medicine (NEJM) called FDA preemption, “A disaster for patients’ rights, public safety, and industry accountability.”
FDA preemption is not being reported by media, or discussed by the candidates running for president.
It is urgent that the American public is made aware of FDA preemption. Further, they (we) deserve to know where our elected officials stand on this issue.
I sincerely hope this topic is revisited. Thank you.
Justice in MI
Hi Dianne - I don’t think there’s any doubt it will be revisted here on Pharamlot. But, as far as the public, I’m less hopeful.
As you know, part of the problem is how extremist a doctrine preemption is (e.g., no civil liability even if felony fraud, etc.).
People have a hard time believing that could possibly be true. We’ve seen that initial disbelief here, and elsewhere, many times.
BTW, my interpretation of Levine above has been confirmed by people much more expert about all premutations of the case than I am.
Dianne
Hi Justice – It is unbelievable. Folks do not believe their civil rights can be taken away, until it happens to them. At that point, they are left defenseless. As Americans, we believe we always have the right to a fair hearing…but with FDA preemption, fairness will not exist.
FDA preemption is a blatant assault on our civil liberties.
I am concerned for my children, family, friends and country. The NEJM has it right.
As some readers here may have read, for 13 years, the good people of Michigan have lived under “The Drug Immunity Law,” the predecessor to FDA Preemption. John Engler, whose administration passed the policy, said Michigan’s law would be the “model” for the country.
Knowledge of our law has been limited. It is usually when a drug victim is in need of legal help do they find their civil right of legal redress has been taken away.
Most Americans have no idea what FDA preemption is, or how it will affect their lives.
We need to write the media and demand they report on this devastating policy. Further, it is vital that Senators Obama and McCain, and our representatives and senators are asked where they stand on FDA preemption.
Thanks, again, for opening up this issue.