Levine Files Preemption Brief With Supreme Court
27 CommentsBy Ed Silverman // August 8th, 2008 // 9:04 am
As the November review nears, Diana Levine and her attorneys have now filed their brief with US Supreme Court, laying out their argument as to why preemption should be, well, preempted. Why does this matter? Here is some background…
During an emergency room hospital visit, Levine was given a Wyeth nausea med called Phenergan, which was administered improperly and caused the Vermont musician to lose her right arm below the elbow. She successfully argued that, even though the 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 has appealed again and now the US Supreme Court will be reviewing the case.
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 that 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.
In her brief, Levine maintains Congress’ “long acceptance” of state failure-to-warn claims against drugmakers undermines Wyeth’s argument; the Food Drug & Cosmetic Act does not express an intent to preempt state-law failure-to-warn claims; statutory history does not support preemption; the FDCA didn’t compel the “specific warning that was found inadequate in her case but does permit drugmakers to strengthen warnings;” FDA regulations encourage and permit label changes to increase safety; Wyeth can comply with the Vermont ruling without changing its label; Vermont law jives with federal procedures; and the FDA has offered an inconsistent position.
“Diana Levine needlessly lost her arm and her livelihood from an unnecessarily dangerous method of administering a drug intended to relieve nausea,” her attorneys conclude. “Wyeth never made FDA aware that IV-push injection greatly increased the risks of gangrene, and its Phenergan labeling similarly omitted any warning of those risks. Vermont’s duty to warn of such risks is perfectly consistent with federal law and promotes Congress’s paramount interest in ensuring safe use of drugs.”
This is a lengthy brief and we are still rummaging, so feel free to dig in yourself - here are all 96 pages. For further background, you can read an interview with Levine, the Wyeth brief and the brief filed by the US Solicitor General.
Dan A.
I’m interested as to how much training was given to the staff of the ER, and by whom, if any was performed.
Justice in Michigan
Just this bit,
“And she contended Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change.”
The last part had been my own understanding, but it appears to be a good deal more complicated. I need to get “up to speed,” but apparently there had been a few label revisions related to this issue and, at the time of Diana L’s experience at the ER, there was still a “process” going on concerning the label/warnings. Exactly what role Wyeth played, and their relationship with FDA throughout as related, needs further explication.
In any event, _if_ it turns out that FDA did a genuinely thorough and thoughtful review of the facts known, _and_ Wyeth made every reasonable effort to inform FDA of what they knew, then I would support a narrow version of preemption in this case. This follows the logic of Catherine Sharkey’s work that I have mentioned. The burden is on the FDA to demonstrate that they, indeed, had done a thorough review of the relevant risk, as well as on the company’s role being transparent.
That means the discovery process would still go forward as in a normal failure-to-warn claim. And FDA would have to keep better records than it normally does. As Sharkey has argued, if the FDA wants such power, then they need to do the work - and be able to do the work - that rationally justifies it.
As far as I know, both the Bush FDA and the preemption lobby are strongly opposed to this position. They want full and unqualified preemption, without bringing in either FDA’s review or the company’s relationship with it.
It is conceivable the Supreme Court could rule narrowly, upholding some version of what I’ll call the Sharkey perspective, but not preemption acrosss the board.
Dan A.
Equally disturbing is that this medication, I presume in oral form, is available OTC in certain coutries in Europe, I understand.
atlex
JiM,
I think you are saying what I’ve been saying all along. This may not be a particularly good case to make a determination on no matter what side of the issue you are on. While it would be an interesting ruling if the court made a firm determination, I would not be surprised if Wyeth got a victory, but the pre-emption issue remains as murky as it is today.
Atlex
atlex
Dan A.,
The safety of the drug, when given orally is not in question in this case. It is a very safe that has been used for decades. This case involves the intravenous use of the drug and its toxicity to the veins when used in high concentrations.
Atlex
Dan A.
Agree with Justice and Atlex.
IV administration of this drug, I understand, is to be given in an existing venous catheter, so perhaps the hospital is at fault more or instead of Wyeth.
Marilyn Mann
Ed, To avoid confusion, I suggest you change the headline to “Levine files antipreemption brief . . .”
Justice in Michigan
Corollary to the above - it obviously remains uncertain whether the above approach could work in the context of current FDA-industry realities. And lots of definitional questions involved.
Justice in Michigan
Atlex - Didn’t see your post when I wrote last.
Yes, this is a terrible case for the actual preemption issue. But there is good reason to believe that the current Solicitor General brought it forward precisely for that reason. It gives the preemption lobby the best chance of attaining their goal.
I am less “optimistic” (from my perspective) than you that wide preemption won’t be upheld in this case, despite its inappropriateness in that regard, because of the current make-up of the Court. I hope I’m wrong.
Justice in Michigan
re: the medicine, many of you know much more than I do. But my understanding is that it was not IV in general, but “push IV” (more aggressive than a drip) that caused the injury to DL because of injection into an artery.
Those risks were known with that mode of delivery. The question is whether Wyeth made reasonable good faith efforts to warn about them and FDA made thorough and reasonable review to support its labeling as related.
Again, my understanding is that the relevant labeling questions were still “in process” at the time of DL’s injury.
atlex
JiM,
As I have written before, I am in favor of preemption, but within limits. FDA labeling decisions based on fraudulent or intentionally missing information should not have these protections. Good faith efforts (as my read of the case suggests happened here) by pharma companies to work with the FDA in updating labels should not be penalized. As you imply, your greater concern is that the court will rule for a broad definition of preemption that may protect the former. While our lawyers may not agree, I think most folks in the industry would be satisfied if those relatively rare cases of intentional abuse of the system continue to be penalized.
Atlex
Justice in Michigan
Atlex - I think we are mostly on the same page. The practical problem remains of how to document “good faith efforts” if there is a question about it. The current discovery process has been critical in that regard.
Preemption, certainly as understood by its supporters, would effectively end that process. I believe that would be a very bad thing (for all of us, including the industry, as I have often said).
Chris
What about the scenario where the FDA review itself was questionable? (i.e. FDA failed to make sure labeling adequately warned providers)? Isn’t this what the group of FDA whistleblowers are alleging?
Justicein Michigan
Chris - Yes, indeed. For the Sharkey perspective to be viable, FDA would have to be able to document and defend the adequacy of its review of the particular issue in question.
That will require some significant institutional changes at FDA, and the current FDA doesn’t want to go near them. As above, this perspective also means there is a way to know that FDA had the info it needed (from company) to make such a review.
Chris
Given that the FDA typically refuses to get involved with any litigation, I am not seeing this as a viable option, particularly if their bias tends to be towards the pharma companies.
Justice in Michigan
Agree, Chris. Aside from any question of bias, FDA does not want to be involved just as you say. Sharkey is arguing that, if the agency wants that power, it is _obliged_ to get involved. That is, you want the authority; then take appropriate responsibility.
Will they? I very much doubt it.
Ava
here’s an interesting thought: everyone sems hung up on the idea that the drug company is at fault for not properly labeling, and in some cases, I don’t doubt that. But there are cases where a certain warning–or even precaution–has been proposed by the pharma company, and rejected by the FDA. I’ve even heard of one such circumstance in which the FDA wrote the company a letter reprimanding them for conveying a rejected precaution to doctors. Without at least some form of preemption, pharmaceutical companies *again in some limited circumstances* would be subject to lawsuits when in fact they are not to blame.
thoughts?
Dianne
Ava – What happened in the circumstance you mentioned? If it was something that resulted in a trial, then the plaintiff and defendant each had an opportunity to seek justice.
FDA preemption takes away the right of the injured party to seek justice. If we are stripped of that right, the facts of a case will not come out, industry will be shielded, and our health and safety will be in peril.
I would rather stay with Freedom and Justice for All.
Justice in MI
Ava = What you heard is actually preemption lobby propaganda. The only consequence of adding a warning that the FDA decides is inappropriate or unnecessary is that the warning is removed. It virtually never happens, in any case. And it does not require preemption if it did - once again, the FDA just does what it always does.
If you know of a case in which a company has been sued for conveying a precaution not otherwise on the label, please do let us know. Otherwise, it is one of those “rumors” that have a way of coming from to Corp Lawyers, Inc.
Ava
JiM- I can’t give specifics of the circumstance in which it happened (I can only say it’s one of my company’s competitors), but suffice it to say I have knowledge of the event independent of the preemption lobby. They were not sued for conveying a precaution not on the label: to the contrary… they wanted to put a precaution on the label, the FDA rejected it, and they’re being sued for failing to warn consumers of that very precaution.
And Dianne - i understand that preemption may make it harder to seek recourse in a legitimate case in which a plaintiff has been injured, but i think it’s important to look at both sides: without preemption, there could be many frivilous or unfounded lawsuits alongside those legitimate ones, the one result of which would be to cause pharma to cover their legal losses by again raising the cost of medications that are already expensive enough. This is not to say i’m for unconditional preemption or for an unconditional lack of preemption. Perhaps there needs to be some other means by which situations such as this could be avoided.
laurie
“I can’t give specifics of the circumstance in which it happened (I can only say it’s one of my company’s competitors), ”
This was probably the Effexor warning. Wyeth wanted to put the suicide/violence warning on it’s labeling. The FDA was in the process of investigating this effect and told Wyeth to remove their warning until the Columbia study was completed. It was removed because the FDA wanted a consistent warning across the category of ssri/snri drugs after the study was completed.
Dianne
Ava – I’m not an attorney. Is there a lawyer in the house?
Actually, preemption will make it virtually impossible to seek legal recourse.
A policy that undermines our civil liberties is dangerous. Giving product immunity to any industry in unconscionable.
Tort reformers like to play the frivolous lawsuit hand. This has been a favorite tactic to “educate” Americans against trial lawyers. In reality, cases without merit usually do not go to trial.
“There are two legal mechanisms that quickly and inexpensively resolve frivolous lawsuits. The truly frivolous lawsuits are often ‘thrown out of court’ when the defendant files a motion to dismiss. If that fails, a defendant may still file a motion for summary judgment, which requires the plaintiff to present actual evidence that he or she ‘has a case’ and that there are no laws that prevent the plaintiff from winning.
Motions for summary judgment are decided by judges – not juries - so any lawsuit that makes it past a summary judgment has some merit. Motions to dismiss and motions for summary judgment quickly and inexpensively weed out lawsuits that don’t have any merit. And often, a plaintiff on the losing end of either motion is ordered by the court to pay the defendant’s legal fees, thus discouraging people from filing frivolous suits in the first place.” - http://www.corpreform.com/questions_answers/index.html
It is expensive to go forward with a claim after it has been dismissed. The average person would not be able to do so.
Most frivolous cases are filed by big corporations who can risk the cost.
See: Public Citizen | Press Room - U.S. Businesses File Four Times More Lawsuits Than Private Citizens And Are Sanctioned Much More Often for Frivolous Suits - http://www.citizen.org/pressroom/release.cfm?ID=1799
What we need is education about the erosion of our civil liberties under the Bush administration.
CMC guy
JIM you must have never dealt with FDA if you believe “The only consequence of adding a warning that the FDA decides is inappropriate or unnecessary is that the warning is removed”. In spite of claims of coziness the reality is that interactions with industry are largely adversarial, particularly when it comes to labeling issues. In most cases companies will submit proposed language and such but the FDA exercises final call on result. Negotiation can be lengthy because involves clinical/technical, legal and marketing aspects and each often want certain things a specific way. Not “obeying” the FDA can make future more problematic if a company is perceived as uncooperative (long institutional memory). I agree companies can be hesitant to push changes especially with data is unclear (wish do not believe is hiding data) but know frustrations of dealing with FDA without precise information.
Justice in Michigan
CMC - Your post doesn’t address the mine above. I was responding specifically to Ava’s post on a company wanting to _add_ a warning that FDA rejected - not about labeling negotiations in general, which I have followed pretty closely in some intances, but certainly not a “spcialty.” I agree that, if a company _removes_ or _ignores_ a warning that FDA wants on, they could be in hot water. That’s not what my post concerned.
It is possible that Laurie has cited the example I’ve asked for - where a company added a warning, withdrew it because of FDA disagreement, and then was sued for not having it.
Obviously, I would side with the company in such instances. And I can’t imagine they would have lost a suit if they had had to remove a warning that the FDA rejected. I am still awaiting some kind of evidence that happened - warning added, FDA rejected, company sued, suffered consequences.
I was also responding to the notion that FDA itself would hold the company for “misbranding,” which is one of the stock points of the preemption folks. Again in the context of an _added_ warning, which is what my post concerned, I do not believe FDA ever penalized a company in such a context. The warning was simply removed.
Justice in Michigan
Also for Ava - Unfortunately, there is not much between preemption and no preemption. Catherine Sharkey’s position, which I’ve mentioned a few times, may be the closest.
Keep in mind that FDA approval and compliance are _already_ a part of virtually ever failure-to-warn claim. That is, even without automatic preemption, companies have been claiming for many years that they were in compliance with FDA, and that defense - if supportable - has served them well. So it is not as though FDA approval/compliance has not been part of the picture all along. That is also why FDA itself, until the current administration, has not viewed the tort system as competing with its own regulation. Instead, it has explicitly described it as “complementary” in monst instances. Please do hold on to that point - it’s an important one.
The point of preemption is that FDA approval/complaince would be the _only_ thing in the picture. And, yes, this would include even situations of a company committing fraud or other serious misrepresentations - either to FDA, physicians, or the public
Like pregancy, I’m not sure there is such a thing as having a “little bit of preemption,” but Sharkey’s position may be a road to that end.
Justice in Michigan
The Sharkey article I’ve been referencing can be found at
http://colloquy.law.northwestern.edu/main/2008/07/what-riegel-por.html
If you download the PDF, you’ll get the whole article. (Otherwise, the site just has Part I.)
Certainly, if the Effexor history is as related, Wyeth would be shielded, which I would take as a good thing.
tm
preemption -what happens to justice for all.