JAMA Editors Opposes Preemption
35 CommentsBy Ed Silverman // October 21st, 2008 // 2:03 pm
Preemption may not be discussed at playgrounds or bars, but the topic is heating up as a November 3 US Supreme Court review draws ever closer. The case pits Wyeth against a Vermont musician who lost part of an arm after a drug was administered improperly due, in part, to an insufficient effort to label the med correctly (back story here and here).
At issue is 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.
The other day, Wyeth began a publicity campaign to defend its position. Now, the Journal of the American Medical Association has run an editorial lambasting preemption. This is an excerpt…
“Given the current imperfect process for approval and the flawed postmarketing surveillance system, the drug and device regulation process is at best an inexact and incomplete science. Until these deficiencies in the system are remedied, some patients inevitably will continue to experience harm from the use of newly marketed products as well as from use of other approved medications. Just as with other consumer products that cause harms, consumers (ie, patients) who are injured by defective medical devices or by pharmaceutical products with inadequate warnings of potential harms may have to resort to legal action as recourse for their injuries…Litigation and state tort law ‘provides a system of civil justice designed to compensate patients, deter unreasonably hazardous conduct, and encourage innovation in product design, packaging, labeling, and advertising.’
“Thus, tort law serves in effect as a way to close regulatory gaps in the FDA premarketing approval process and to provide a mechanism for postmarketing surveillance. Moreover, litigation has been a rich source of information about how drug and device manufacturing companies behave, such as with off-label promotion, guest and ghost authorship, and reporting of safety findings. Without the information revealed by the public release of documents in tort liability actions, many of these behaviors would remain unknown, some drug manufacturers’ judgments about safety issues would be hidden from view, review, or oversight, and the FDA would not be able to uncover them either…
“The Wyeth v Levine ruling will have far-reaching and profound implications for patients and drug safety. If the court rules in favor of Wyeth, endorsing preemption, patients will lose an irreplaceable method for seeking remedies for injuries resulting from pharmaceutical agents that were approved by FDA. As with the medical device preemption ruling, such a decision would likely result in thousands of lawyers defending drug manufacturers to file motions in state courts to dismiss plaintiffs’ claims under preemption. In a recent products liability lawsuit, a Philadelphia judge ruled that the federal National Childhood Vaccine Injury Act preempts tort claims of design defects and failure to warn, effectively immunizing vaccine manufacturers against liability claims…
“One of the most important ways to ensure the health of the nation is to be certain that medical devices and pharmaceutical agents are safe. The FDA is not infallible and the recently increased resources do not include a crystal ball. Therefore, unless and until the FDA drug approval process and the postmarketing surveillance system improve significantly, patients must have a means to seek recourse through tort litigation against product manufacturers. Anything less may well preempt the well-being and safety of the public.”
Justice in MI
I guess that makes it unamimous.
James R
Wow, the JAMA editorial says it all. However, it would help if physicians would not take a drug company’s “word” for it. Physicians do not have to prescribe any medication when they have not seen all data regarding it, favorable or unfavorable. Preemption will likely keep more unfavorable data unavailable to physicians. That’s sad.
Drug manufacturer’s can always chose to do the right thing, there’s no law against that.
Just A Thought
I wonder how long it will take to get a ruling. It is absolutely nuts that this one case is left to decide such an important issue for the country. Is it at all possible for the court to rule for Wyeth without making the broader statement? Because, damn, I wouldn’t want to be the person who has stripped away the rights of the people. You know there will be a battle to overturn it and history is not going to look at these justices favorably for making the ruling based on one case.
The suspense is killing me.
Predictions?
Just A Thought
James, I think the physicians have little choice but to trust the drug companies, sadly. Drugs are the tools of their trade and if they can’t trust them it makes it very difficult to practice.
Marilyn Mann
If the Court rules for Wyeth, Congress can amend the statute to provide that state tort law is not preempted. In fact, it could do that now.
Justice in MI
To JAT and Marilyn -
The Supreme Court has three major options in Levine. (1) They could remand the case (send it back to Vermont). This is unlikely since they agreed to hear it. (2) They could rule narrowly, saying that preemption applies in cases in which FDA has appropriately reviewed relevant risk/benefit and no one is claiming that company was delinquent in reporting so that FDA could make such a review (the last part does apply to Levine), or (3) they could rule broadly, saying preemption applies across the board, even in circumstances in which there is a claim of fraud, deceit, or negligence in compliance on the part of company.
Those latter, the Court would say, are potentially criminal matters that should be handled by DOJ (even though we know that essentially never happens). Preemption of state tort remedy would remain in place - even if DOJ successfully prosecuted felony fraud.
Preemptors in general favor option 3, as does the current administration, and Wyeth as was clear in their release posted today. Others have pushed for 1 or 2. I won’t make a call because I would rather be pleasantly surprised than disappointed. It would probably at least be a few weeks after the hearing to know the decision, but the questioning at the hearing will give some idea where things appear headed.
To Marilyn - It is unclear that Congress can amend the relevant statute re: drugs. Unlike devices, where there is an explicit provision regarding preemption, there is no such statute in the arena of drugs. If you believe DDL, we would virtually have to rewrite the Constitution to undo preemption in the drug arena. I don’t believe that, but I do believe it is likely to be complicated, with lots of room for delay, slick lawyering, and bad compromises.
That said, Congress had an opportunity to add an anti-preemption provision in the FDAAA. They failed to do so, and the bill passed overwhelmingly (just as FDAAA failed to achieve many other things).
JaT
Thanks for the explanation, JiM.
Justice in MI
Here’s another way of saying why it would be hard for Congress to reverse preemption in the arena of drugs (as opposed to devices).
Unlike the Medical Devices Act (MDA) which includes an explicit statement on preemption, the FDCA, under which pharma is regulated, has no such statement one way or other. So we have had to rely on FDA’s own interpretations. In general, until the current administration, those interpretations have been against preemption.
What the Supreme Court has to do, in essence, is surmise the intent of Congress at the time the FDCA was passed. And what, all things considered, makes sense to presume as the intent of Congress in this arena. Whatever the current Congress does would not, in itself, answer that question.
Doug Bremner MD
Catherine DeAngelis is probably still pissed off about the CLASS study of Celebrex that was published in JAMA when she was the editor, in which the authors withheld data from the second six months of the study during which time Celebrex patients were shown to have an increase in heart attacks.
Doug Bremner MD
The editorial mentioned that legislative action would be needed if the justices ruled in favor of preemption, maybe that process should be started now.
Justice in MI
Hi Doug - As I (tried to) post on your own blog, the half-CLASSED study is a perfect example of why preemption is a bankrupt doctrine. FDA has no jurisdiction over med journal editorial policy. So even though the study was fraudulent, and misled many (including JAMA editorial writers), it stands outside regulatory control. It _would_, however, be relevant in civil litigation…as long as that still exists. As I’ve quoted before, even FDA’s Bob Temple said the fraudulent article, what he called “hype,” “probably has more impact than our labeling does.”
As far as starting now, many of us have been trying to get it started for several years. That is why we have tried to get every candidate - from Prez on down - to take a position. That is why we supported the anti-preemption plank in FDAAA until it was pulled out.
The ’start now’ train has been whistlin’ a long time. (There is, as you probably know, legislation to reverse Riegel. But it hasn’t gone anywhere yet.)
Nathan
So here’s a question for you: The Riegel case was supposed to clear out liability cases against medical device manufacturers, right?
So here’s my question: Has it? Have all those lawsuits really disappeared?
Phrma ResearcherIII
This JAMA Editorial is a must read. It’s correct and compelling. Preemption is the current FDA administration’s last great gift to PhRMA and it would be tragic. With money, investigative powers and time, the inappropriateness of preemption could easily be demonstated. Just take almost any major drug label change for a safety issue, for example, a tigher warning or a new black box. If you go behind it and look at the reports and the communications you will in at least 75% of the cases find months and months of back and forth dialogue between the company and the agency debating the data and negotiating the new label change. And in many cases, the prescribing physician is in the dark while that it happening. It is unacceptable. The only thing compelling the companies to move faster is product liability. If we want to encourage early release of new safety data, we have to be prepared to hold companies accountable when they don’t do it.
Justice in MI
Nathan - Good question, to which I don’t have an answer. There are at least some cases which have gone to the manufacturing defect issue, which would seem to be more likely in the device than drug arena.
If the core question is whether preemption “really works,” come to Michigan. I can point you toward many people whose potential cases re: fen-phen, rezulin, baycol, vioxx, and about ten more well knowners never got to court.
So, yes, those potential lawsuits fully disappeared (because they never were); along with those people’s trust in the industry, the FDA, government, and more.
The preemptors invariabily cite Michgan as their model. So, indeed, we are your future.
Justice in MI
A question back, for Nathan or whomever if you support preemption:
How do you explain to yourself the fact that the editors of both NEJM and JAMA have come out hard and unequivocably against preemption?
Do they not “get it” re: law and health policy?
atlex
JiM,
Increasingly, the (current and previous) editors of both of these journals have become stridently anti-pharma. Take a look at the roster of editors and examine their outside writings. I think you’ll find that my statement is relatively accurate. That being said, it doesn’t make them right or wrong, it just suggests that they have a pre-existing bias that many of us in the industry accept as part of life. Additionally, these are medical journals, not legal journals. While anyone can offer a legal opinion, I’m not sure why theirs has any special relevance.
Atlex
Chris
Holding companies accountable is not anti-pharma.
jooe
Here is a copy of an email that was under protected order until the plaintiffs got it released. It shows the exact mentality of the drug companies:
Email from Paul Soons (Dr Paul Soons, Vice President Clinical Development)
“Just got a strange(great??) idea on solving the issue of which product to take as reference product in a possible future (BE) study if we were to reformulate EVRA…why not take an IV comparison in such trial and really confirm what is in the label: “…releases 20 micrograms of EE to the blood stream per 24 hours…and…Css of EE during one week of patch wear is approx. 40-50pg/ml…”
So this is how they pharmaceutical companies trick us. They did not tell the women that the estrogen level on the package was for IV administation and not the patch that was worn on the body. And this email is directly from the VP/Dr. of Clincial Development. And you want to trust these folks?
Michael L
Forget the facts of this particular case for a moment. The real issue here is one of policy. Who should “pay” when the inevitable happens. Should the injured party bear the burden of the injury when they “willingly and knowingly” accepted the risk of the treatment? Should the drug companies subsidize these injured patients because they are profiting from selling their drugs?
This is not an easy question and it is certainly not as black and white as the JAMA editors make it out to be. Patients likely are not at risk of losing the ability to bring a tort claim based on negligence or fraud. If a company sits on adverse safety data, an injured plaintiff will still (most likely) have the ability to bring a state claim. However, what is in jeopardy is the ability to bring a state claim based on warning standards exceeding those of the FDA. Another way to phrase the question is, “Should states have the ability to set higher warning standards than the FDA.” If they, should, what, really, is the FDA’s role? Ultimately, a decision to allow states this right would also mean that the FDA is not the final authority on product safety.
Looking at the problem from an economic perspective, Pharma has a better ability to pay for injuries (and injuries are inevitable). The users of the products, together, can subsidize the injured. On the flip side, however, this increases the price of medicines (to what extent can be argued because we’re talking primarily about maximized-monopoly pricing), limiting the number of patients who have access. Also, increasing the severity of the warnings on medicines could cause inappropriate under-utilization. That’s why the FDA is supposed to balance risk/benefit — to maximize appropriate use. Undermining the FDA’s authority in that regard could distort the public health equities at stake.
Obviously, this just scratches the surface. From a policy perspective, this may be one of the most difficult cases the Supreme Court has faced in recent years. For this very reason, the Court will likely find a way to punt this to congress. It really isn’t the court’s role to make this kind of a policy determination.
jooe
Michael L, you bring up a lot of good points and questions we need to ask. Preemption would be a noble idea, if we could trust the drug companies. With the ghost writing, deceit, and manipulation of the actual drug testing that big pharma is doing, how can you trust that the FDA is approving a drug that they don’t actually test themselves? Do you feel confident that the drug companies are being truthful when they submit a new drug for approval? Until the FDA is actually involved with drug testing, the deceit will continue. The drug companies need to start being held responsible (criminal) for their lies and fraud.
BP Watch
JAMA is correct! Take them all to the woodshed, especially the top management, who only thinks about profits and not patients! Levy personal fines and jail time for fraud and maybe this type of activity will stop. Don’t and they’ll laugh all the way to the bank.
Former pharma Marketing Exec
Quite frankly, in my opinion, the reason why JAMA and the NEJM have come out clearly against preemption is because the doctors themselves realize that in the end the consumers (patients) must have the final word.
The doctors do a delicate dance with Pharma on a daily basis. They rely on the drugs to treat the patients, they are trying to stay in the loop and influence as best as they can.
More Physician associations are mandating that their members no longer lend their names to “ghost written articles” and they require them to review all, ALL of the raw data before co-authoring any papers. This is as it should be.
Doctors should be held accountable for their work especially if it leads to endorsing any product.
In my opinion, Doctors should welcome any legislation that would hold them accountable for any trial study results that is found to be misleading if not fraudulent. This gives the doctor the ammunition to go back and stand up to Pharma.
There has got to be complete transparency.
Something else that the FDA should be mindful of is the amount of times one particular doctor is used as a P.I. in any one disease category. Sometimes there is a very fine line between expert opinion and “empire building”.
The time has come to put an end to preemption!
“Four score and seven years ago our fathers brought forth, upon this continent, a new nation, conceived in Liberty, and dedicated to the proposition that all men are created equal.
….
that this nation shall have a new birth of freedom; and that this government of the people, by the people, for the people, shall not perish from the earth.”
James R
Michael. Your statement that “increasing the severety of the warnings of medicines could cause inappropiate under-utilization” IS inappropiate. If a product is not safe and effective as advertised, then it should not be on the market. If that means that the drug is under-utilized, so be it.
Justice in MI
Atlex - I think this probably goes around in circles. If the journals have that bias, where did it come from? Certainly we know that a number of the editors, including Marcia Angell, were no more friendly to trial lawyers than to pharma. So something certainly has changed.
Re: medical/law, the issue here is really one of policy that is at the crossroads of all of these interests - industry, regulation, medicine, law, government, etc.. Thus, the views of JAMA and NEJM must certainly be given significant weight within the wider discussion (I didn’t hear you disagreeing with that).
Re: Michael’s post, I would differ on most of the key points, but that’s what makes policy discussions policy discussions.
Justice in MI
re: michael’s post -
“If a company sits on adverse safety data, an injured plaintiff will still (most likely) have the ability to bring a state claim.”
Not according to the FDA/DOJ in their Kent brief. And not according to Wyeth’s own release unless there is a “manufacturing defect. It is true the 2006 preamble adds some ambiguity on this.”
“Another way to phrase the question is, “Should states have the ability to set higher warning standards than the FDA.” If they, should, what, really, is the FDA’s role?”
Pre-Troy, most judges viewed FDA as setting minimal standards - floor not ceiling. But only in rare cases are ‘higher standards’ at issue anyway. The issue is compliance with existing standards.
“Also, increasing the severity of the warnings on medicines could cause inappropriate under-utilization. ”
This is one of those hypothetical assertions without data. The case has tried to be made re; SSRIs but the evidence has not supported it.
last bit - I would greatly hope that the Court would punt this back to Congress. Given the current Court, and its political context, I am far less confident that it will.
Jaynesday
Michael L - Very Good points - Some question that I have though.
You say - Who should “pay” when the inevitable happens. Should the injured party bear the burden of the injury when they “willingly and knowingly” accepted the risk of the treatment? Should the drug companies subsidize these injured patients because they are profiting from selling their drugs?
Given that in most cases the consumer can’t afford to pay, especially without insurance, wouldn’t the cost be transfered to you and I?
Is it true that the consumer really is willing and knowlegeable with regard to the products they consume? Especially products that show adverse events that were not studied or revealed.
Also a small point but your term “subsidize injured patients” is peculiar to me. Maybe you don’t see product litigation as a means to force safer product design onto the manufacturer. After all the source of the problem is the initial design and that is where the best countermeasure to loss is established.
You say - Patients likely are not at risk of losing the ability to bring a tort claim based on negligence or fraud. If a company sits on adverse safety data, an injured plaintiff will still (most likely) have the ability to bring a state claim.
A manufacturer is protected even for negligence or fraud under this preemption but even if they weren’t how would the patient know without the turning over of evidence in a law suit? If the FDA can’t get the truth I doubt that John Q. could.
You say - Also, increasing the severity of the warnings on medicines could cause inappropriate under-utilization. That’s why the FDA is supposed to balance risk/benefit — to maximize appropriate use.
Couldn’t it be argued that preemption will cause some manufacturers to inappropriatly over-utilize their product? And concerning the FDA’s responsibility to do risk/benefit analysis, I understand that this is rarely done.
Overall wouln’t you say that we have an inappropriately high level of injury and death caused by today’s drugs and devices? How would preemption cause that number to decrease rather than continue it’s yearly increase?
Justice in MI
Following Jaynesday’s post - Do we have a single example anywhere of a patient forgoing a medication that might have benefitted them because of litigation-induced “overwarning”?
What we know is that pts, and docs too, almost never read the label anyway. It’s also striking that, even though we hear about defensive “overwarning” by companies, it never seems to happen. Rather, companies generally seem to fight for minimal, not CTA, labels. Obviously, this is clearest in blockbuster arena.
laura
Michael L,
You question was…
“Forget the facts of this particular case for a moment. The real issue here is one of policy. Who should “pay” when the inevitable happens. Should the injured party bear the burden of the injury when they “willingly and knowingly” accepted the risk of the treatment? Should the drug companies subsidize these injured patients because they are profiting from selling their drugs?”
In my family’s case, after my mother had a fatal reaction to a medical device, I can tell you Medicare payed, hundreds of thousands of dollars. Thank God that my father wasn’t presented with the bill, but are you willing to pick up the tab for fraudulently researched and reported drugs and medical devices? That is what drug and medical device companies are asking you to do. They aren’t really concerned with having “fifty different entities regulating what they do” and they’re not really concerned with “not having enough money to continue with research and development”. They’re worried about having to be held accountable for what they place on the market for public consumption. The real question is, are we, the public, willing to remove their accountability?
Justice in MI
This is a comment that goes back up to the top of the thread re: what Congress could do if the SC upholds broad preemption. I am quoting directly from Drug and Device Law Blog, from whom I always learn a lot even though we are on different sides of the preemption issue. They write:
“(The argument raised in Levine is constitutional in nature, grounded in the Supremacy Clause of the Constitution. Clever legislators could, however, surely draft mere statutes that would effectively undo any protection that a favorable decision provided to drug companies. A filibuster-proof Senate would allow the dominant party, if it were so inclined, to introduce and pass that type of bill.)”
So hat tip to them, and a revision of my initial response to Marilyn in light of this comment.
Jim
JiM
According to the brief filed on behalf of the respondant, when the FDCA was originally passed Congress contemplated a legislative inclusion of an individuals Right to Action that would include preserve an individual’s right to bring a lawsuit. This provision was not included in the final draft of that became law as according to the brief Congress at the time felt it was not necessary.
I am sure the Supreme Court will address this concern and grant it very little weight. The Supreme Court will conclude that the failure to include this provision in the law protecting an individuals right to private action makes this issue moot; they will ignore the reason Congress felt that the law was unnecessary and rule that since the actual law is silent on the issue of preemption the Agency’s current interpretation of preemption is covered under the Chevron Deference Doctrine and the Agency’s interpretation will be upheld. Therefore in the 3 scenarios you cited above my bet is with number three.
Just a guess.
Although it may have been posted here before, I have included an attachment to the briefs filed in this case for anyone interested in reading the various positions.
http://www.abanet.org/publiced/preview/briefs/nov08.shtml#wyeth
Michael L
I’m not sure if anyone is still reading this thread, but, just in case, a few quick responses:
1. Has there been under-utilization of specific drugs because of irrational fears? Absolutely. Has there been over-utilization of specific drugs because of irrational exuberance? Absolutely. For an example of an underused class of drugs, see pain relievers in the ’90s. Doctors were so afraid of abuse and addiction that they were failing to adequately respond to complaints of pain. In the past 8 years, many strides have been taken to make pain the “5th vital sign” and to treat it, and appropriate treatments, more seriously. For an example of overuse, see Nexium. Is there anything about an isolated enantomer that makes Nexium so much better than Prilosec that upwards of 60% of former Prilosec users currently use Nexium (at substantially higher cost)? Doubtful.
2. And we really are talking about who is going to pay for inevitable injury. Preemption will have little effect on the ability to bring a fraud claim. Unless the court abandons precedent, preemption will only address what the FDA is authorized to regulate - safety/efficacy balancing. A good question raised is whether the FDA’s regulation should be considered a minimum standard (potentially increased by the judgment of the states based on relevant facts), but I doubt that would be a good policy call. The FDA should establish THE standard — they are the agency dealing directly with the companies — they have the best ability to police marketing practices. The question to ask, I imagine, is how they can best accomplish that goal. Labeling changes take time, and time is of the essence when new safety risks emerge. Perhaps the FDA can undergo a form of informal adjudication and direct companies to act prior to official label changes. The FDA is admittedly arcane in its procedures. Perhaps preemption would be the kick in the pants the FDA and congress need to update the system.
3. Yes, patients and doctors are not really informed about the risks of drugs. Since the mid 90’s, pharma has moved away from fair balance, much to the detriment of the companies’ credibility. Currently doctors rely on competitors to hear about the side effects of competing products. This situation is far from ideal, and is probably not going to be fixed soon. The best agency to police this would be the DOJ, but I still think there is room for private claims for promotional practices short of outright fraud to the FDA (or to customers). Perhaps the best middle ground in the preemption debate would be to preempt strict liability claims for improper warning based on FDA labeling, but allow claims for improper warning based on the actions of individual representatives interactions with physicians — and hold the companies liable for their employees. That could be the kick in the pants the companies need to shape up promotional practices.
Doug Bremner MD
No the purple pill is not better. I can tell you why the editors of JAMA are becoming more negative and are against preemption, it is because they have become annoyed over the years but debacles like the CLASS study where they were hood winked by misrepresentation of data, lack of disclosure, etc etc. How do I know this? Because they told me. And yes I do think that the opinion of doctors matters. Because this is not just a legal issue, it is a political issue. I.e. it is not any more clear why the Supreme Court should be poised to be making a decision to strip Americans of their rights any more than they picked our president eight years ago.
Former pharma Marketing Exec
Dr. Bremner,
Great points!
Government of the people, by the people, for the people - doctors are people too! So are the people who work in pharma, but sometimes they forget that they are people and they behave like, well, like corporations….
Michael L
Was the CLASS study, as presented, that bad? The Washington Post, granted, did a fairly good hatchet job, but look at the statistics. In the diclofenac arm, so many patients dropped out the study lost power. (And the real problem was that, looking at the full set of data, celecoxib offered no better GI AE rates than did comparator NSAIDS).
In all fairness, these things should have been disclosed to JAMA at the time, but really — if they were, and if they were acknowledged in the article, they would’ve been largely ignored. The problem with the CLASS presentation was in the lack of complete transparency . . . but all that aside, there wasn’t much to hide.
Leon McEntire
Big pharma cannot hide beind the FDA to avoid taking responsibilty for defective and harmful products it produces and brings to market. They are mistakenly assuming that the FDA’s approval or temporary approval exempts them from a State’s authority to protect its citizens. Recall that a State has jurisdiction over all matters except those specifically given to the Federal Government. I don’t think any State has relinquished any authority in this matter.
Anoher reason Big Pharma is off base here is its assertion that once FDA puts its stamp on the product it is all OK. However, all the data submitted to FDA by the drug companies is used by the FDA to justify granting approval for marketing. If this data is inacurate, flawed, biased, or fraudulent and the FDA doesn’t catch it, then who should be held liable? The FDA?? I think not.