Preemption Prelude: More On Wyeth vs. Levine
37 CommentsBy Ed Silverman // September 19th, 2008 // 8:31 am
Regular visitors to this site are likely familiar, at least in passing, with the debate over preemption, which the US Supreme Court will take up on November 3. And now The New York Times takes a look at the case, which involves a Vermont musician named Diana Levine who was given a Wyeth’s Phenergan nausea med during a hospital visit. Unfortunately, the drug was administered improperly and she lost part of her right arm. She sued Wyeth for inadequate labeling and won. Now, Wyeth is appealing.
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.
At issue, as the paper notes, are a couple of questions that many Pharmalot readers have been kicking around for months: Does the FDA 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?
“Federal pre-emption is the fiercest battle in products liability law today,” Catherine Sharkey, a law professor at New York University, tells the Times. “The court clearly recognizes this, as it has agreed to hear so many cases and seems eager to give clarity to what has been, to date, an undisputably muddled area of law.”
You can read the story here, our interview with Levine, Levine’s brief, Wyeth’s initial and reply briefs, the brief filed by the US Solicitor General and various friend of the court briefs (please scroll down to the bottom for the links).
Justice in MI
The beat goes on. As discussed in the other very recent thread - and many times here - the problem is that the Levine case does not represent the majority of product liability cases. The usual key negligence questions - what did a company know, when did they know it, what did they do - simply do not enter in here as clearly as they do in, say, Vioxx, Baycol, fen phen, Paxil, etc..
Thus, if you only had the NYT article to go by, you would not be well informed about what preemption - most of the time - is really about.
That said, I’m glad they’re talking with Sharkey.
Nathan
I just posted this on the other Levine thread, but I’ll repost it here because I think it represents the crux of the argument FOR preemption: (this was the dissenting opinion in the Vermont supreme court case)
“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.”
SIMON
As long as drug companies line the pockets of politicians your day in court will be limited. Nuf said.
voice from the wilderness
Vermont doctors are still not suggesting cannabis as a safer alternative to their patients, even though we have a medical marijuana law.
This woman would still have her arm.
I wonder why the doctor gave her a drug that he knows causes gangrene when he could have told her to try marijuana for her migraine and nausea. She should sue him, too.
Godspeed, Diana!
Nathan
voice from the wilderness,
While I think that you might be a little spaced out, you bring up a good point that I’d love to hear people’s opinions on: Why is she suing the drug manufacturer? Why not just sue the doctor? It seems that she would have a much more clear-cut case by going after the doctor that administered the drug using a non-standard method of administration that was clearly warned against….
Justice in MI
Hi Nathan - You’ll see I responded on the other thread. I am disappointed by this NYT article so, of course, they will hear from me. Every now and then I “get lucky” on the op ed page.
I agree that, like the Quaid case, this is one in which the caregivers share significant responsibility. But the wider point is that it’s a lousy case on which to hang preemption, which is why it was brought forward as it has been. Clear negligence - including fraud - would obviously have made it harder for the Court to ignore the more profound flaws in the preemption argument. They would have to say, well, the FDA/DOJ handles that. And then - to the degree that reality enters in - they would have to face the fact that, in actuality, FDA/DOJ virtually never do.
Justice in MI
BTW, just reread NYT article and see that Levine did take action against clinic as well.
Jaynesday
Nathan’s quotes from NYT: (agreed good explanation of preemption side)
“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 assumes that the FDA really knows what the risks are. Their knowledge is solely based on pre-market trials in which the manufacturer is biased toward a favorable outcome. The current FDA management is also apparently biased in the same direction.
“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.”
(A jury hears even _more_ information than the FDA had at its disposal at the time of product approval. Often this information is even more incriminating and reveals the deception that the manufacturer employed to attain approval of their product. If you have to revert to deception to attain product approval any “greater good” that you claim is suspect. Therefore punishment is required and the only punishment that litigation can dole out is monetary.)
I wish there was another way to cause manufacturers to be responsible at pre and post approval times. Currently there is no other way.
I agree with Dr. David Graham that we should put the responsibility for post approval monitoring in a different organization than the one that also approves the product.
Product liability litigation is kind of a blunt force that can provide correction but is sometimes misguided or overdone. But again it’s all we have. Litigation could be thought of as a vote. One person votes against a manufacturer when they take them to court. The force of the vote has to be strengthened through sometimes excessive monetary means.
We need a force that has more pin point accuracy and efficiency. One way to accomplish this would be to force the consumer of a product to “vote” on the effectiveness and cost of the product they take (with the counseling of their doctors). They either vote that they like or don’t like the product as they consume it. The benefit of their vote would be that they can use this to communicate with those in their common community about the product. The results of all the votes would bear on a new consumer’s decision to take the product.
By doing this I would concede preemption because we now have a fair means to force accountability on to the manufacturer.
Who loses –
The manufacturers who are proven poor performers,
The trial lawyers,
The folks looking for a quick buck through litigation,
Those who rely on statistical analysis of trial information to argue the benefit of their product
Who gains –
The consumer – (safer products at lower cost),
The manufacturers who are proven good performers,
The FDA who is no longer torn by competing priorities and influences
Chris
> the crux of the argument FOR preemption: …“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.”
Nathan,
You seem to feel that preemption is related to whether the drug should or should not be on the market. In this case, nobody is claiming the drug should not be on the market. They are claiming that the labeling provided inadequate warning for safe use.
Justice in MI
Re: Jayneday’s concept - I don’t see how such a vote could help in practice. If, for example, I’m taking a statin, I would have no idea whether it did nor did not make any difference in my personal health outcomes over time (positive or negative). I might ‘feel good’ about some surrogate endpoints, or ‘feel bad’ about not reaching those endpoints or because of expense or AEs, but the bigger picture (including my own bigger picture) would escape me.
The most we have are relative risks and benefits on the level of populations, whatever individuals think about their meds, including their individual medical fates.
Maybe I’m missing the point?
SIMON
Nathan/Justice,
How would either one of you reflect on this issue if it were the Bextra/Vioxx litigation?
Jaynesday
JiM, If I follow your question,
The patient would not make the determination about good or bad (”vote”)by themselves, this would be in consultation with their doctor/s. The patient may only be giving a small amount of information while the doctor would have other health data to contribute.
Concerning the populational data - the individual data could be gathered and analyzed in a central (non governmental) institution, then published nation wide for all doctors to use in patient care.
I think you have mentioned a source that already does something like this so formalizing their activity might be all that is needed. Along with a better data collection system and numberous issues like confidentiality, independence, reporting format, funding etc. you know, minor things like that. :-)
Does that make any sense?
Jaynesday
To me the FDA is made up of two branches. The pre-market approval and labeling branch – “Legislative” and the post approval monitoring branch – “Judicial”
How crazy would it be to have both of these branches of our government combined? (that could never happen right?)
Furthermore preemption sets this kind of combined system in concrete by absolutely handing over the judicial branch to the legislative branch.
Ha! So preemption is unconstitutional due to the separation of powers! Case closed
Chris
Jaynesday-
I think it is great that we have people thinking about ways to improve the current system, and I know you have proposed this feedback mechanism before. Unfortunately, I believe your proposal is unworkable for the following reasons:
1) Logistics. Who is going to pay for setting up this system, creating awareness among consumers, designing and maintaining the enormous database, creating the feedback mechanisms, etc. The system would be incredibly expensive. How would such a system be funded and who would do it?
2) Furthermore, you suggest that the consumer ‘vote’ in conjunction with their physician. Physicians currently have insufficient time and now you are seeking to add an additional discussion so a joint vote could be made.
3) Drugs are not equally effective or appropriate for everybody — One size does not fit all. Patients take multiple medications and have different comorbidities. For some drugs, age and sex can also play a role in resulting efficacy and safety. How would such a system take these multiple factors into account?
4) It is not clear that the resulting information would be useful in making a decision on which drug to choose. Physicians already have strong perceptions for most drugs on patient satisfaction, effectiveness and safety which they take into account when making their decisions. Perceptions of safety and efficacy (by both consumers and physicians) are what drive the prescribing decision, and influencing these perceptions is the basic goal of marketing. Also, it is the subgroups which may be more relevant. For example, most on Vioxx would probably have given it high grades. In this system you would never pick up that people were dying from heart attacks. Or Paxil when given to children increases the risk of suicide, etc. Bottom line: such as system would not address the current issues.
Jaynesday
Thank-you Chris for your comments! I don’t profess to be an expert in this field. My thoughts are all based on my background in business and what I’ve come to know as my common sense which could certainly be foolishness to someone else. I’ve always agreed with the notion that someone outside of a system can sometimes see improvements that those within the system can not. This may or may not be the case here so I appreciate your comments. I will comment back.
1) Logistics. Who is going to pay for setting up this system, creating awareness among consumers, designing and maintaining the enormous database, creating the feedback mechanisms, etc. The system would be incredibly expensive. How would such a system be funded and who would do it?
Me - I would have to rely on the expertise of the constantly improving computer software experts. I do know that the current Adverse Event system is obsolete and unworkable. It needs to be replaced and a ground up revamp would be an opportune time to implement a completely new system. I think that the current science would suprise you.
2) Furthermore, you suggest that the consumer ‘vote’ in conjunction with their physician. Physicians currently have insufficient time and now you are seeking to add an additional discussion so a joint vote could be made.
Me- 2) Physicians time constraints – Definitely not an expert here but couldn’t a standard codified form be established for each type of drug that would allow for a streamlined set of questions and answers? This would minimize time and might even help to give focus to a doctor/patient consultation. The form could be designed to go in different directions depending on the answers supplied and output alerts when certain answers are given.
3) Drugs are not equally effective or appropriate for everybody — One size does not fit all. Patients take multiple medications and have different comorbidities. For some drugs, age and sex can also play a role in resulting efficacy and safety. How would such a system take these multiple factors into account?
Me- 3) Variations in patients including comorbidities - This could actually be helped by the database system. The patients personal data, history other drugs taken etc. could be analyzed and compared to the similar others in the database. It might alert the doctor sooner about an issue.
4) It is not clear that the resulting information would be useful in making a decision on which drug to choose. Physicians already have strong perceptions for most drugs on patient satisfaction, effectiveness and safety which they take into account when making their decisions. Perceptions of safety and efficacy (by both consumers and physicians) are what drive the prescribing decision, and influencing these perceptions is the basic goal of marketing. Also, it is the subgroups which may be more relevant. For example, most on Vioxx would probably have given it high grades. In this system you would never pick up that people were dying from heart attacks. Or Paxil when given to children increases the risk of suicide, etc. Bottom line: such as system would not address the current issues.
Me - Would this system lend itself to decision making on what drugs to take or not take? I think it would facilitate such a decision. The experience of all patients taking the drug would be at the disposal of the doctor not just the experience he/she has had with his own patients. Of course the doctors own experience would be a part of the equation. Concerning decisions based on marketing – Marketing would have much less importance with this type of system. The data would be real world data free of influence, glitz and persuasion by other doctors. Concerning the drugs that many people have good experiences with but others are killed by – This system would alert to deaths of people on the drug very quickly. It could not determine if the death is related to the drug but it could alert the doctor that they have a patient that has similar characteristics (not sure of the medical term) as the one that has died. This might be benefitial to the doctor and patient.
Sorry for the long answer
Justice in MI
SIMON - I’m not sure which issue you’re referring to - preemption in general?
Perhaps it is relevant to say this. In Warner-Lambert v. Kent, the current FDA/DOJ argued that preemption should apply _even if FDA/DOJ sucessfully prosecuted a company for felony fraud in in the drug approval/FDA compliance process_.
That would cover any worst case scenario, whatever drug one was talking about.
I won’t reiterate all their reasoning for this - it has to do with FDA/DOJ also claiming that only they know what “optimal” punishment should be, and that civil liability would upset that “delicate balance” of carrots/sticks.
Personally, I find that line of thinking near obscene. So do a number of legal scholars, btw, who favor versions of preemption.
Chris
Jaynesday -
Since you are proposing having this replace the Medwatch system, I assume you are then proposing that this system be developed and funded by the FDA?
Just A Thought
I’m a little tired of the argument that suggests that taking pharmaceuticals is a risk when one kept me well for 13 years before the risk was changed, along with the drug, with full knowledge of that additional/new risk by the manufacturer- and the FDA who seemingly encouraged them. Unneccesary risk foisted on people, and for what?
That’s the agency that we want to have the final word on safety?
“However, the criteria Pfizer used was not requested by the FDA to show bioequivalence and was different from the FDA criteria, according to an FDA spokeswoman. She adds that the FDA was unable to review the study protocols before Pfizer proceeded and the agency doesn’t know why Pfizer chose different acceptance criteria. Nonetheless, the agency did approve the new Dilantin.”
This is your protective body at work. Be very afraid.
Jaynesday
Chris,
I would hope that something other than the FDA could be used to develop, fund and control this system. I would stay away from any organization that has politically appointed management.
SIMON
As hard as it is for me to say it…let’s not blame the FDA 100%. They can only make their determination on what they are told by the pharmaceuticals. Pfizer has a history on not letting the FDA in on everything. Adverse reactions go unpublished and are never entered into the equasion.
I believe it would be very had to find anyone who does not have ties to the pharmaceutical industry to be on any form of organization to replace the FDA
Jaynesday
Simon, good point - and to your point - a new system needs to be completely separate from manufacturer reporting of product performance(AE). No more of the fox guarding the hen house!
Or at least this system should run parallel to the FDA’s system. In doing this we might induce a measure of proper functioning in the AE system also.
I wouldn’t suggest we replace the FDA, just provide a separate product monitoring and customer reporting system. But you’re right the fox would make it a point to establish very close ties with such a system.
It’s taken years for pharmaceutical influence to develop in the FDA. Hopefully we’ve been cautioned.
laurie
” They can only make their determination on what they are told by the pharmaceuticals. ”
And THAT’S the argument in a nutshell! So why would preemption be a good thing?
To give the FDA the final word on a drug risk is ludicrous. It is well known that the FDA has no ability to get ALL of the information that is available on a specific drug.
So to make their decisions the final say is flawed logic.
Chris
Jaynesday -
> I’ve always agreed with the notion that someone outside of a system can sometimes see improvements that those within the system can not.
I agree as well. I also know how frustrating it is when you see what appears to be a great solution to a problem and no one will listen or provide feedback which is why I am responding to your posts. The primary issue here is that the potential benefit of such a system does not outweigh all the logistical and practical concerns. To get at some of the benefits you are looking for would take close to an electronic medical record, and then you have accuracy and input issues (i.e. who is going to input all this information of medical history and concomitant medications?) What is the incentive for a consumer to do this for multiple medications, and every time they get a different medication? Personally, I would not want to bother. This would also mean you potentially end up with a biased sample.
Jaynesday
Chris,
Thanks for your feedback. You’re right electronic medical records would be needed. It would be a huge job to initiate something like this. Moving away from paper is always difficult but I would think that electronic records will be the norm someday. Maybe not soon enough though.
Anne
I have often wondered what it would have taken to save my child from death due to Zyprexa. A political FDA did nothing, and Eli Lilly hid the lethal side effects, and so he is dead. No individual case like Ms. Levine, but part of a mass tort. (I know it is not part of the Supreme Court case, but the uneven way death by Pharma, or maiming,is treated in courts and states is also a blot on the nation). I wouldn’t trust the FDA’s having the last word for anything. And we tried to get Dr. Graham’s separation of powers through last year when PDUFA came up for reauthorization. Well, of course Pharma won and pre and post marketing studies are lumped together: Fox guarding the henhouse indeed. That is what we will have if the Court votes for pre-emption. We will just be missing the right for a citizen to sue for damages and death; one of the few “rights” available to the average citizen.
Jaynesday
Anne, I certainly feel your pain. My mother was lost to a poorly designed medical device. I just won’t accept that nothing can be done when the injustice and deficiencies of the situation are so obvious.
Justice in MI
Realizing I’m skipping over some really interesting stuff (which I hope to come back to), I want to respond to Nathan’s citation from the article:
““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.”
No. A jury views the safety of a drug through the lens of a single patient whose catastrophic injury _might have been avoided_ had the company acted differently. If they find the company accountable, they have concluded it reasonably _ought_ to have acted differently. “All drugs have risks” is both true and beside the point.
Reasonable people can disagree on the answer to this question in specific cases. In the Levine case, for example, I am not certain where I stand myself. But we should at least be clear on what the question is.
Had Wyeth unilaterally warned about the known dangers of IV push, would that have somehow changed the “optimal” risk/benefit analysis as supposedly performed by FDA? Is it realistically imaginable that such a warning could have had any negative public health consequence re: the use of phenergan in general?
To conclude the latter - which is the core of the argument that Nathan quotes - we would have to see FDA’s analysis that the risk (to other patients) of warning further about IV push outweighed the potential benefits of such a warning - not just for Diana Levine, but for the whole population of potential pts receiving phenergan.
In this case, I doubt such an analysis exists. This “measured and mutlifacted policy analysis,” I suspect, is fully a fairy tale as far as phenergan IV push is concerned.
Nathan
JIM says:
“we would have to see FDA’s analysis that the risk (to other patients) of warning further about IV push outweighed the potential benefits of such a warning”
Why would you have to see the analysis? It’s a judgment call. It’s a judgment call that we have given the FDA the authority to make. We haven’t given the courts the authority to make that judgment call. The FDA may or may not have made the right decision — but it is their decision to make. Not a jury’s and not a judge’s.
This whole thing kind of reminds me of about two years ago when a baby seats we used for my daughter was recalled because the manufacturer didn’t include a warning against setting the seats unsecured on a tabletop. A couple of kids died when parents set the kid in a seat on a tabletop and went into the other room and the baby fell on the floor. Our society has become absurd. We’ll never be able to create enough warnings to substitute for common sense.
Wyeth warned against inadvertent intra-arterial injection. Isn’t that enough of a warning for a trained physician? Do they also have to warn against oral, rectal, and vaginal administration? Obviously I’m being sarcastic, but there comes a point when we have to assume that the provider and/or patient will use common sense and proper judgment.
AA
Hi Nathan,
You said:
“Wyeth warned against inadvertent intra-arterial injection. Isn’t that enough of a warning for a trained physician? Do they also have to warn against oral, rectal, and vaginal administration? Obviously I’m being sarcastic, but there comes a point when we have to assume that the provider and/or patient will use common sense and proper judgment.”
You may have a point about it being enough of a warning for a trained physician. I haven’t read enough of the case to say yes or no.
But to expect the patient to know about the different methods of injection is a bit over the top. Hopefully, you just wrote that without thinking and were specifically referring to the provider.
Anyway, as well informed as I consider myself to be, if I need to know about the different methods of injection for a drug, then medicine is in even worse shape than I thought it was.
AA
Justice in MI
Won’t comment on the particulars of Levine.
As far as “judgment call,” if it’s not based on any kind of analysis, there is no judgment that has been exercised.
If FDA wants to claim preemption, they are obliged to have done the work that would justify it. This, btw, is Sharkey’s argument as well.
Otherwise, talk about “optimal weighing of risks and benefits is, once again, horse hockey.
Nathan
Justice,
I’m saying that some warnings have to be based on mere “judgment calls” and not on a strict interpretation of evidence. Again, are they supposed to warn against oral, rectal, and vaginal administration as well? Why not? Surely harm would be expected, right? But I’m sure no specific studies have been done on those routes of administration because they were never INTENDED as routes of administration. Why would the FDA have weighed evidence for IV-push? They clearly warned against inadvertent intra-arterial injection. Isn’t that enough of a warning for a trained physician or nurse?
Nathan
One more thing Justice:
You don’t want to comment on the particulars of the Levine case? Isn’t that what the court will rule on? I’m sure they are going to consider the ramifications of preemption — but I suspect that the majority of their ruling will be based on the particulars of the specific case in question.
Justice in MI
Hi Nathan - All this stemmed from your own quating: “A jury does not engage in a measured and multifaceted policy analysis.”
So where is the “measured and multifacted policy analysis” re: phenergan. It has become a “judgment call.” If that is what it is, FDA and juries are more or less on the same level.
Re: Levine, I’ve commented on the particulars many times, including in this thread. But none of us would be talking about if it hadn’t been put forward as a test of preemption. And what is interesting to me in the story that began this thread is that the premptors’ strategy appears to be going for a first-down rather than a touchdown. The Court may award them six points anyway, but it’s an interesting strategy.
BTW, what do you think about my response to Simon above. Do you agree with the current FDA/DOJ that, even if a company is found to have committed felony fraud in the approval or compliance process, they should be immune from civil liability?
Bio Ethics Person
A little bit late coming to this discussion thread.
The concept of not wanting to “overwhelm” patients with information as an excuse to “edit” the information we choose to put forward is a very weak one.
This is about informed consent. If the nurse and doctor knew all of the facts and risks they would have been able to explain those risks to the patient. The patient then would be able to carefully consider if the pain of the migraine was worth the potential risk caused by the IV push.
When clinical trial data is manipulated, with held, embellished or omitted it impedes decision making, either by the health care team but most certainly by the patient. The information on the potential harm of an IV push for this drug was known, but not clearly labeled. I am quite curious to know why that information was not clearly indicated.
True, patients will never know as much as their doctors. Apparently, not even doctors know, or least have access to, all that they are supposed to know.
I hope Levine wins. But the sad reality is, at the end of the day, she will still be an amputee. Everyone else in this case will go on with their lives - with all of their limbs and health.
chester
I am interested in finding out where McCain/Palin and Obama/Biden stand on the upcoming legal battle of Preemption in the pharmaceutical industry, whereby US citizens will not have a legal right to sue for damages caused by
Drug companies because the drug was approved by the FDA. (LOL)
This is an entire area that has been ignored by both parties and someone needs to address the issue.
Until the FDA is cuts all ties from the pharmaceutical companies, (MONEY AND INFLUENCE)
the courts cannot allow such action.
chester
REACTIONS TO FDA APPROVED DRUGS.
TAKE A LOOK !
http://www.druglib.com/adverse-reactions_side-effects/bextra/seriousness_death/reaction_pulmonary_embolism/
Chrimik
I am weighing in really late on this issue; but here goes. Two things disturb me. The first is that the FDA currently receives so much of it’s funding from the companies it is supposed to watch. Secondly, health care professionals rely way too much on the companies to be a source of information about the drugs. Information the company distributes by it’s very nature will always be biased. The companies are in business to sell drugs. I do not like litigation; but we are stuck with it until we develop a different system to alter behavior.