Articles

Wyeth Vs. Levine: Joe Six Pack Trumps The FDA

The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay juries may evaluate the accuracy of FDA-approved drug labels written for healthcare professionals.

In other words, after a team of FDA regulators decide on the very best language to describe potential risks of a drug -  Joe Six Pack can overrule their expertise and hold the drug company liable for any deficit (as he interprets it) in label language, awarding millions to anyone who experiences harm, no matter how well disclosed that risk is.

I reached out to Wyeth’s attorney, Bert Rein, for comment. Here are the highlights from the interview (a podcast is available here)…

Dr. Val: The New York Times is calling Wyeth vs. Levine the most important business case in years. Can you summarize what just happened?

Rein: The court determined that Wyeth’s liability for Ms. Levine’s injury was not preempted by the FDA-approved drug label warnings. They were not convinced that the FDA had declined to strengthen the warning language on the label prior to Ms. Levine’s injury, though Wyeth had in fact requested a label change. In addition, the court held that the FDA’s regulatory regime was insufficient to preempt Ms. Levine from suing Wyeth, because the FDA doesn’t have a regulational requirement for all label updates to undergo federal approval. The court therefore ruled that the suit was well founded and that the state of Vermont should decide whether or not Wyeth’s conduct was appropriate.

Dr. Val: So basically this means that juries can decide whether or not a drug label is sufficiently caveated?

Rein: It goes farther than that. Juries don’t have to determine what the label should say, they merely have to decide that the label isn’t “good enough.”

Dr. Val: So jurors without any medical background are supposed to determine whether or not a drug label offers physicians sufficient warning about medication risks?

Rein: Correct. You’re asking lay people not only to make the decision, but to step into the shoes of physicians and say, “Do I think that label is good enough from a physician’s point of view?” By definition, drug labels are not written for lay people, but healthcare professionals. This is asking a lot of lay people, and I think this case is a good illustration of why juries get it wrong. They see an injured person and say “How could the labeling be adequate because somebody’s been hurt?”

Dr. Val: What impact will this court ruling have on the pharmaceutical industry?

Rein: It means that pharmaceutical companies will have to get “clear records” from the FDA on every drug label controversy going forward. This puts a tremendous burden on their already taxed resources. Also if juries can simply say “this drug label is inadequate” then how will the drug company know how to make it better? What drug companies will have to do is forbid the administration of drugs in circumstance that might incur increased risk. That shifts liability to the physician if they administer the drug outside of the prescribed method – and essentially makes the risk benefit decisions on their behalf.

Dr. Val: So won’t drug companies have to create really long drug inserts to prevent juries from misunderstanding the language?

Rein: Yes, that’s the direction that labels were going before the FDA tried to reform the system. When drug labels are that long, no one reads them. Then professionals really don’t get educated on the true risks and benefits of the drug. Long labels are not designed for provider education but for law suits. Jury dominance always results in risk aversion.

Dr. Val: And isn’t this risk aversion going to slow down the drug approval process in general?

Rein: The industry shies away from developing drugs that have massive liability. That’s why we don’t develop drugs for pregnant women, for example. Any time you unleash a potent liability system, it’s going to factor in to where research dollars are spent. The more the FDA is criticized, the more it tries to protect itself with long drug labels and lengthier reviews – which ends up slowing down the drug approval process and shifting liability to doctors.

Dr. Val: And phenergan has been safely administered over 200 million times… and so the risk aversion is pretty high, even now with this rather safe drug.

Rein: Right, it’s not as if the drug is rampantly causing injury. Twenty incidents out of 200 million applications is not a very high risk profile. And the few cases where it caused injury, the drug was administered incorrectly. But if you have an injured person sitting in front of a jury of lay people, it seems as if the logical conclusion is that if the warnings were adequate, this wouldn’t have happened.

If we take the American Foundation for Justice at its word, their next move is to try to change the law on medical devices so we can go after those as well. The Wyeth vs. Levine case is good for one industry – the lawsuit industry – and not really anyone else.

###

The Supreme Court decision text may be found here.

Posted in: Pharmaceuticals, Politics and Regulation

Leave a Comment (18) ↓

18 thoughts on “Wyeth Vs. Levine: Joe Six Pack Trumps The FDA

  1. knowdoubt says:

    You have aligned yourself with some very impressive company on this one, i.e., Clarence Thomas, Anotonin Scalia, Samuel Alito, and John Roberts, ideologues one and all. Of course, no one in the medical profession wants accountability, they would prefer to bury their mistakes and that be the end of it. No sympathy here.

  2. DoctorLaw says:

    This isn’t a case about whether a jury has the ability to evaluate a warning- it does, always has, always will- it’s a case about whether a state commonlaw claim thwarts the purpose of a federal regulation.

    In most negligence cases, a jury is the proxy for the “reasonable person” againt whose conduct that of the defendant is evaluated.

    In malpractice, product liability, and other cases where there is scientific testimony, a jury of citizens is still the proxy for the “reasonable physician”, “reasonable manufacturer”, etc. But in these cases, the juty is assisted by “expert testimony” proferred by the parties.

    Each side in this case no doubt presented days or weeks of expert testimony from physicians, researchers and industrial psychologists, each claiming that the other side was wrong. The jury simply detrmines which cavalcade of consultants is more credible. And that’s what juries do so well. They can spot who’s blowing smoke. They’re the only animal in the world with an IQ of 1200, and they’re the bedrock of our system of civil justice.

    This is clearly not a case about whether “Joe Six Pack can overrule [the FDA's] expertise and hold the drug company liable.” It’s just an arcane exposition on federal pre-emption.

  3. David Gorski says:

    It’s also not an entirely unexpected ruling. As NPR was discussing this morning, traditionally the federal government has sided with the plaintiffs in these sorts of cases. When this case was set to go to the Supreme Court, the Bush Administration took the very unusual step of siding with the drug company.

    I’m not saying that there aren’t aspects of this ruling that bother me (I agree that juries being able to overrule the FDA is one), but I don’t entirely buy the pharma line on it as laid down by Wyeth’s attorney, either. For one thing, Congress has had many opportunities to codify federal preeminence for the FDA and has declined to do so, indicating a clear intent that the FDA is not intended to overrule state law.

  4. oderb says:

    Putting aside the merits of the decision (though I do agree with DoctorLaw) I expected better from Dr. Jones and this blog than a series of leading questions posed to the Wyeth attorney.

    Why not interview the plaintiff’s attorney now and ask the same questions so your readership can independently evaluate the arguments and likely consequences of the decision?

  5. durvit says:

    I am loth to be involved in a framing discussion but that’s a fairly inflammatory post-title in such a context.

    This is more than a little reminiscent of Dr Val’s support for the Medscape people over the Gardasil nonsense.

    I expect better of the writers at SBM. We’re all familiar with the slavish devotion to balance being at the detriment of the consensus but this is one of those occasions when it would have been good to have included some of the opposing view and more of an insight (as per Dr Law) as to why this is about far more than the surface issues.

  6. Val Jones says:

    oderb: First of all, this is a blog, not a news outlet, so personal opinions are welcome and don’t require “both sides of the story” for publication. It was challenging to get key stakeholders in the case on the phone within hours of the verdict, and I think it’s pretty neat that a blogger was able to compete with mainstream media for time with spokespeople. I got Wyeth’s lead attorney on the phone and provided this blog post to give readers insight into his perspective. While it’s true that my opinion of the case is made clear in my line of questioning (and in my previous blog post here at SBM – where many agreed with me), some physician groups are equally concerned about the facts in this case and see things as I do. (e.g. ACEP)

    You may read similar reasoning in opinion pieces at the WSJ, Psychology Today, and the NYT:

    http://online.wsj.com/article/SB123621345651335085.html

    http://blogs.psychologytoday.com/blog/in-practice/200811/rational-health-care-siding-with-the-bad-guys

    Comments in the NYT: http://community.nytimes.com/article/comments/2008/11/07/opinion/07fri1.html

    It is easy to hate the pharmaceutical industry – it is more challenging to admit when they’re right, which many feel they were in this case.

  7. maus says:

    “You have aligned yourself with some very impressive company on this one, i.e., Clarence Thomas, Anotonin Scalia, Samuel Alito, and John Roberts, ideologues one and all. Of course, no one in the medical profession wants accountability, they would prefer to bury their mistakes and that be the end of it. No sympathy here.”

    Truly it is impossible to want accountability and disagree with the method and means of accountability. I don’t want Joe Six-Pack writing the rules. I don’t want the Pharm industry writing the rules. I want medial professionals writing the rules.

  8. Jurjen S. says:

    Speaking as a layman, I do think Bert Rein has a valid point when he notes that drug labels that are written to cover every contingency, rather than just the likely contingencies, are liable to become too long for anyone–prescribing physicians included–to bother with.

    There’s an old (in internet terms), and possibly apocryphal, story that did the rounds on Usenet, back in the day, when a Swedish company (probably Husqvarna) released its first chainsaw on the American market, and the American user manual was three times as thick as the Swedish version, the difference being made up of disclaimers, such as “do not attempt to stop the chainsaw with your bare hand.” According to the legend, within two years, the manufacturer was sued by a guy who had cut off his fingers while attempting to do just that, and while they managed to win the case by pointing out that the manual specifically said not to do that, it does illustrate that the user obviously hadn’t bothered to read the entire manual because it was simply too long to bother with.

    And yes, when we’re dealing with literature aimed at MDs, or at least NPs, one would expect a jury “of one’s peers” to at least be composed of NPs and MDs before it would be considered qualified to rule on whether a particular drug label provided sufficient information to the prescribing physician.

  9. marilynmann says:

    I wrote a short article on public policy arguments against FDA preemption of state failure-to-warn litigation for the ABA Health Law Section eSource. Here’s the link:

    http://www.abanet.org/health/esource/Volume5/04/Mann.html

  10. Kyle_Carm says:

    Some of what this boils down to is informed consent for treatment I think. I can’t honestly remember any doctor or nurse telling me what the hoped for benefits of a medication were vs. possible detrimental side effects. I’ve received IV phenergan twice over the years and was never informed of potential limb loss, nor any other side effect.

    As a former paramedic I told patients why I was giving them a drug and what I hoped it would do, and tried to let them know if any expected side effects might be. Fully granted it was just a couple of things but it was important in my training to let the patient know so as to make a basically “informed” decision.

    Agreed 20 in 200 mil is pretty low but I might have opted for oral or yes even rectal, both approved methods of administration of phenergan.

    And frankly I don’t want to be treated by a doctor who is unwilling to read and know what the possible reactions of a medication are. Medical error can occur from ignorance of the patient, doctor, or pharmaceutical companies. Some cases all 3 and no one is to blame. In others the patient is to blame, or the doctor or the company. The patient must inform the doctor of the info he needs so he can apply what he has been informed by the company to properly treat the patient.

  11. yeahsurewhatever says:

    Consider what the consequences would have been if the Supreme Court had ruled in the opposite direction.

    No, even simpler, follow the financial burden in both cases.

    Bert Rein correctly states that this ruling places a financial burden on big pharma. If there are more than three people in the world sympathetic to their plight that don’t work in that industry, I’ll eat my hat. It’s hard to sympathize with a money-grubbing corporation whose definition of “pharmacology” is often along the lines of “will this drug make us money at a greater rate than we will get sued over it”.

    On the other hand, the opposite ruling would have placed a financial burden on the judicial process, since who would evaluate the sufficiency of these labels if a jury is incompetent to do it? Not someone who works for free.

    I don’t intend to derail this into a philosophical debate about government, but suffice it to say that you will never catch an arm of the government acting to increase its own potential financial burden without any benefit. So that the ruling was self-interested is a given.

    Additionally, the Supreme Court could not feasibly have ruled any other way, as trial by jury is the cornerstone of the American legal process, and the jury must be the ultimate trier of fact in any case for which a jury is called. From the perspective of law qua law, this case could not have been resolved any other way, period.

    This is a fundamental failure of law which runs much, MUCH deeper than pharmaceutical labeling standards. A failure which is ultimately irresolvable without a great deal of dismantling.

  12. BenAlbert says:

    To KyleCarm,

    Hi Kyle, I’m a paediatric doctor in New Zealand, so this type of court case is thankfully remote from my practice. Our system’s design makes suing drug companies, doctors and hospitals thankfully rare.

    However, like most doctors I know well, I try hard to strike the right balance when informing my patients (and/or their parents) about the risks and benefits of any treatment and discussing their other options. However there is quite an art to this, the explanation must be tailored to the degree of information the patient would like to know, and should also include things that are very common, or things that are very severe. These of course are vague descriptors, how common is common? How severe is severe?

    It is just too simplistic to expect informed consent to involve explanation of every possible benefit and risk including severe ones which are extremely rare. In fact, in order to completely inform the patient you would have to impart a great degree of the medical school knowledge it took 6 years to learn in the first place. Realistically informed consent to me involves teaching them enough about their condition to understand why a medicine we recommend is the best option, what we hope it to do, and give them some idea of what sort of mild and common side effects are likely and warn them of relevant severe and rare ones. After this it is also to gain their consent to the treatment. The hope is that the patient will feel that they have retained some autonomy as the decision is made, and so that if they do suffer a severe side effect, they feel that they were forewarned.

    The aim is certainly not to educate them enough to make a completely informed decision themselves, it is next to impossible, and actually, a silly aim, I feel. They came to see a doctor for an expert opinion, not to learn the field and make the decision themselves.

    Now it is certainly debatable how much information should be imparted in this interaction and there is wide variation in how much my colleagues will say.

    But the risk we are talking about is 20 in 200 million, or 1 in 10 million. That is astonishingly rare. In fact it is so rare that it is likely that most 1 in 10 million risks for most drugs will be unknown. (The size of the study required to identify them specifically is prohibitive Only extremely widely used drugs could have these identified on post marketing surveillance and even then the lack of a control group and randomisation makes it hard to know if the drug even caused them to happen.)

    I don’t think I have ever warned a patient about a risk so rare. The rarest risk I warn about is probably HIV infection from a blood product which is ~ 1:2million in New Zealand. I warn about this one because of its seriousness and its stigma. If I had to warn about every risk as uncommon as 1:10million I would have no time to do anything else, patients would be overwhelmed with information, I would create more fear in the patients than is warranted (people have a terrible grasp of statistics), and honestly I would struggle to find information this precise.

    My point, and I don’t wish to seem to be attacking you Kyle (I’m sure I have exaggerated what you were suggesting), is that it is easy to argue that doctors should be providing full disclosure or warning of all risks. It is much harder to do that in practice with real patients with real sensitivities, and with real constraints on time and information. If the outcome of a court case such as this was to ‘increase informed consent’ by making the doctor dump a lengthy list of adverse effects in the patients lap to fully inform them in quick efficient time, I cannot see this improving the quality of decisions made, or the quality of the patient-doctor relationship or indeed the patients feeling of autonomy. Many patients would simply feel swamped, confused or scared.

    Next time I prescribe Promethazine (the generic name of phenergan, and in my opinion the appropriate name to use) to a patient I will not be warning them about a 1 in 10 million risk.

    -Dr Ben

  13. weing says:

    Maybe we should give patients a test showing that they understand the risks of the medication. They would have to retake it until they scored 100% before we could prescribe it. I’m sure it could be incorporated into the EMR somehow. The fax to the pharmacy wouldn’t go through until the score was 100%. Just think of all the money that would save.

Comments are closed.