Wednesday, March 4, 2009


Supreme Court Sides With Plaintiff and Vermont, 6-3

The above is a headline I never thought I would be writing, at least not this decade. I have not had time to read beyond the overall summary. But it does appear that every major pro-preemption argument was rejected by the 6-3 majority, including the capacity of Wyeth to have independently warned and the intent of Congress that FDA regulations _not_ preempt state tort law. The opinion below:

No doubt, there will be more to say later--just got this ten minutes ago.


  1. It's a great day!


  2. OMG! Wonderful news!

    Bye, Bye FDA preemption!

    Hello Michigan!

  3. Thank you for posting the opinion, Justice. I am looking forward to reading and discussing it here.

  4. Hello, Michigan, indeed!

    But, as Yogi said.....

    There is still Riegel in which the SC upheld preemption 8-1 in the device arena. This has primarily to do with its interpretations, in that case and earlier, of the language of the MDA. Undlike the FDCA, the MDA has an explicit preemption provision. That said, its backers insist that that had to do with states setting up independent regulation of devices and was not intended to preempt tort law (which is not regulatory per se).

    Re: today's decision, I have still to read the details, especially the dissents. At core, it is a 4-1-1-3 decision. The four (Stevens, Kennedy, Ginsburg, Kennedy) issue a stinging rejection of the core _legal_ pro-preemption arguments. In essence, they reject the claims associated with the whole superstructure erected via FDA's Office of Chief Counsel over the past three years, singling out the "preemption preamble," the revised CBE regulations especially as interpreted in this case, the clear evidence that Congress did not intend such preemption (most important point), and the suggestion that Wyeth could not (easily) have satisfied both state and federal law.

    In several places, the language is almost contemptuous of Wyeth's arguments, suggesting overreach beyond credulity.

    Breyer concurred but wanted to leave the door open for circumstances in which some more limited version of preemption, properly grounded in legitimate statutory law, remains conceivable.

    Thomas concurred most essentially on his characteristic textualist grounds. The notion of "implied preemption" is just too speculative given what is and isn't in the Constitution or otherwise codified.

    I will read the dissents later. But what this means, I think, is that there is a solid 5-4 majority against FDA preemption more or less regardless. Breyer's caveat is narrow.

    Whatever else, this result shows how hard it is to predict these things. Thomas's position makes sense in retrospect--given his philosophy--but one rarely knows how he will go. Breyer's comments in Riegel seemed to many to seal the deal the other way in Levine. And Kennedy was something of a question mark.

    Meanwhile, many broader policy questions concerning the relationship between industry and FDA remain, of which preemption is just one part.

  5. Jayne's day is DawningMarch 4, 2009 at 10:12 AM

    It is wonderful that what makes sense to some of us apparently is sensible in the eyes of the Supreme Court.

    For almost two years I have been honestly trying to understand how a viewpoint on preemption can be justified. I can understand the concerns about abusive litigation, but I've never seen the evidence of its real affect against drug/device companies.

    Let me be as civil as possible here - Back in your face Daniel Troy, this is not a Hollywood movie! (I refer to his comments made during his "invention" of device preemption)

  6. Justice,
    Does this mean that Michigan preemption is now unconstitutional? If so, will you change your screenname? :->

    Let the lawsuits roll! Just kidding.
    Interesting that pharma stocks seem unaffected by the ruling. I think most industry analysts are not suprised by the ruling.

  7. This sobering thought from one of the folks who has worked very hard against our Michigan full shield law. Today's decision makes it even more pathetic, but it does not automatically remove it. So the fight goes on, and I hope folks out there will join us as you can.

    "Huge victory.

    But the Michigan law has still destroyed hundreds of lives.

    And it will continue to be enforced by local courts and will serve to keep counsel from filing claims for months, or years."

    Sobering, indeed. Even if she had lost today, Diana Levine was lucky compared with the citizens of Michigan. She had a day in court. Folks here do not.

    Today certainly helps our fight. But it does not end it.

  8. Hi Nathan,

    I didn't see your post until mine above. But, indeed, I still need my name--in some ways, more than ever!

    I don't know enough law to give a full explanation, but the issue is not Constitutional in the sense of a state, say, setting up slavery. States are still free to create their own liability law system (which is really what Thomas's concurrence was about).

    That said, as above, Michigan has become even more an outlier than it was.

  9. If Justice Kennedy was indeed the swing vote, then I agree with Nathan's assertion, that is pharmaceutical insiders expected a ruling against Wyeth.
    Justice Kennedy's opinion on preemption is expressly cited in Cipollone v Liggett, a case which did involve a preemption Statute. In Cipollone Justice Kennedy imposed a highly technical reading of the preemption clause in question and ruled for the Plaintiff. His opinion in Lohr v Medtronics followed this same reasoning.
    Justice Thomas was one of the Justice's that I expected to vote in favor of preemption and he surprised me. His concurrence was based upon the simple fact that there is no Statutory Language that expressly prohibits State Court Tort Claims. Unlike his Conservative brethren on the Court, Justice Thomas' concurrence reads like that of an individual who truly believes in limiting the role of Federal Government unless the law states otherwise.
    Meanwhile, Roberts, Scalia, and Alito continue to demonstrate their pro-business agenda. In Reigel and other cases, Scalia repeatedly points out the plain language of the relevant Statute, yet here, where there is no express Statute, he and his fellow dissenters rely on previous caselaw to support their view, thus attempting to engage in the same type of judicial activism they have criticized in the past.

  10. This is great news, and to a certain extent has refreshened my faith in due process of the law.

    From a personal account, I have had that injection 4 times in the last decade. The last time I had that injection was in 2001 and the nursing staff consulted heavily with the doctors in ER before administering it, and were very vigilant. I didn't understand what the fuss was about until I heard about the Levine case. However, let me clearly state, that this drug was administered to me in a foreign country where healthcare is government controlled and sponsored. I have to believe that in some cases, although it shouldn't, this made a difference in my case.

    In any event, I think that it would have been hard for the supreme court to vote any other way. Particularly in light of the recent actions by the group of FDA reviewers and their complaints about the over influence of industry.

    As you point out Justice, this is but one piece of the puzzle and I suspect it will take quite a bit of analyzing to understand how and why this all came to be. I too, will read back over the history of it, as I am particularly interested in what was communicated and how? I am interested in knowing this in the sense of understanding why it was that the seriousness of this drug and it ability to do such harm was misunderstood in the first place. This is a critical area.

  11. I think I just lost what I was writing, but apologies if it shows up!

    Anyway, I'm not much of a court watcher. But, in retrospect, the increasingly demogogic, even bizarre, tone of some of the pro-preemption op eds suggested that they were already anticipating a battle in Congress (over Riegel) and that the action would be in the legislative rather than judicial realm.

    But, at core, no idea.

  12. I'm guessing that a loss on this decision was already priced into pharma stocks. In spite of the "bad" result, pharma stocks were up 2.6% today (Dow was up 2.2%).

    Here's a quote from a CNN article today: "Weisburd said the Wyeth decision leaves companies with uncertainty and exposes them to different state-based standards that may second-guess the warnings on a label. For example, he said, drug makers could face lawsuits for providing too little information on a label or for giving too much because it will obscure the most important warnings.

    "What is a company supposed to do?" he said.

  13. Here's a quote from "CMC guy" over at "In the Pipeline" (he used to write occasionally back at Pharmalot)
    "Although I am not really an advocate of preemption I think this was poor decision. If you read about the facts of the case as AliG suggests this was not about what Wyeth did/didn't do but shifting blame to the "deep pockets" (although Wyeth may be guilty of attempting to use a Sledge-hammer to drive a screw by claiming preemption). The trial lawyers are probably partying as they can continue to file questionable suits that would have been prevented by the opposite ruling. Makes one question the nature of the legal system (if did not already).

    As I understand it the specific info warning against bolus injection was not an approved text by the FDA which is the 2nd issue that troubles me here. Preemption is only viable if the FDA does its job correctly. Having been party to several "Label Negotiations" it is a complex process that entails Clinical, Regulatory, Legal, Marketing, Executive and Technical people from the company side so reaching consensus is a chore before dealing with Agencies. The FDA is typically very hard-fisted in this stage and in the end they do control (final say) what labeling is provided for the drug. The process means even 'simple' changes aren't easy to make and although would expect FDA to be acutely responsive to potential problems they are so bureaucratic delays can be lengthy so a companies hands are tied. Unfortunately FDA seems to be broken lacking the personnel and proper expertise "

  14. Here's a AP News article discussing the impact of this decision on pharma research. Here's some quotes followed by the link:
    "Analyst Steve Brozak of WBB Securities said due to the ruling, drugmakers are “going to make a dollars-and-cents decision on what (research) programs will go ahead and what drugs will be pulled” from the market.

    “They’ll defend the blockbusters, but the smaller drugs with meaningful downside” will be sold to small companies, possibly overseas, or shelved quickly, Brozak said.

    Brozak and Gordon, the Michigan professor, said the industry could reduce innovation, or shift to slight improvements in existing drugs rather than breakthroughs, to avoid lawsuits."

    "Drug industry analysts said the ruling, upholding a $6.7 million jury award against Wyeth, will make drugmakers scrutinize safety issues of all experimental drugs in development, as well as existing products.

    “They will weigh how prevalent the side effect is, how serious the side effect is, versus the number of people benefiting from the drug and the amount of money being made by the drug,” said Erik Gordon, an analyst and professor at University of Michigan’s Ross School of Business."

    We already see it -- why do you think big pharma only goes after blockbusters? Anything with a market of less than ~$1 billion per year isn't worth the risk of marketing it. We risk major lawsuits, and only gain "pennies". That's why there are so few innovative drugs to treat orphan diseases. It's not that the innovation isn't there: It's that the risk (lawsuits and clinical cost) isn't worth the reward.

    Good luck America -- I hope you like your generic meds. That's about all you'll be getting now!!

  15. Nathan,

    Couple of points:

    - No comapany has _ever_ suffered anything for providing "too much" information. This is one of those red herring arguments that have been part of preemption's house of cards. It's about time to put it away. The SC, in effect, said essentially the same thing about this kind of reasoning.

    - As far as innovation and blockbusters, that is what has been going on for the past sixty years, during which we have had both regulation and lawsuits. Why have we had innovation at all under such horrific circumstances?

    The reality is that the really large lawsuits are, in general, over blockbusters, for the obvious reason that so many people take them. So if that's what industry does, it will, indeed, make it more vulnerable, not less.

    But having read this kind of threat talk as long as there has been an FDA at all (the same predictions--verbatim--were used to try to prevent the creation of FDA and then dissolve it in the nineties--I think we're reasonably safe in assuming that it's more of the same.

    The bitterness of your last line saddens me. Blame the lawyers for the industry's problems. Curse the rest of us. I hope you'll also look up rather than out--up the hierarchy, that is--to those plush offices where pharma's fate is actually being determined.

  16. Here is what Gordon said after the part Nathan quoted:

    “This is like blood in the water for plaintiff lawyer sharks,” and will encourage more lawsuits, Gordon added.

    Useful analysis.

    Surpringly, perhaps, Bert Rein, Wyeth's lawyer in the case, is quoted as saying he _doesn't_ expect more lawsuits as a result. Perhaps he only meant over phenergan? That does't really make sense.

    Nor does the whole notion when you think about it. Wyeth suffered the largest combined verdict in history over fen-phen--several billion dollars. In that context, the Levine verdict is infinitesimal.

    And yet it is going to change the course of pharma history? Did Wyeth stop innovating after fen-phen? They actually seem to have done better in recent years than many among their competitors.

    All that said, I will also say, yet again, that no one has a monopoly on virtue. There are, indeed, exploitative lawsuits. There is plenty of room to reform punitive damages, which is where the really large verdicts come from.

  17. Nathan,
    One of the quotes you sited I find to be very hopeful. Just the thing that a product liability lawsuit should do; cause corporations to give proper focus to consumer safety.

    "Drug industry analysts said the ruling, upholding a $6.7 million jury award against Wyeth, will make drugmakers scrutinize safety issues of all experimental drugs in development, as well as existing products."

    I say well done Levine.

    In your last sentence, you seem to have very little faith in the pharmaceutical industry.

    Concerning future products, I say we have the intelligence to do better, we just need the desire. The easy route has been closed. We have to do the hard work of making a better product than we made yesterday. It can and will be done.

  18. Well said. I do not think the victory of today will increase the amount of lawsuits. I think claims of that nature are extreme.

    Some of the quotes here from industry seem to be slanting more toward threats and fear mongering then anything I can say would be based on solid hypothesis of any sort.

    As for this particular quote:"Drug industry analysts said the ruling, upholding a $6.7 million jury award against Wyeth, will make drugmakers scrutinize safety issues of all experimental drugs in development, as well as existing products.

    “They will weigh how prevalent the side effect is, how serious the side effect is, versus the number of people benefiting from the drug and the amount of money being made by the drug,” said Erik Gordon, an analyst and professor at University of Michigan’s Ross School of Business."

    I see tighter scrutiny and complete transparency of communication of the issues of risk and benefits as a plus in all of this.

    The fact of the matter is pharma has to bring the drugs to market. They cannot simply decide to not serve a market, they will put themselves out of business. Furthermore, this particular comment deserves a more critical look into how today's decision affects informed consent overall.

    In a system where the patient must to some extent pick up the tab for the error, i.e. disability, health care rehab, whatever, they need to be fully cognizant of any and all of the inherent risks. The argument that patients can never know fully and therefore can never be fully informed is a red herring and it is time we moved on from it.

  19. The proverbial acorn has fallen on the heads of drug company leaders and they are crying, “The sky is falling.” Leaders who have Jaynesday’s can-and-will-do-better attitude will succeed in producing safe and effective drugs, and earn public trust.

    Michigan should consider strengthening state product liability laws for two reasons: 1) to protect consumers from unreasonably dangerous products and 2) to compensate for the current lack of oversight and regulation of drug and device companies.

    Former Marketing gets down to the nitty gritty of informed choice, which is defined by Dr. James Weinstein as “a comprehensive understanding of all the options and their possible risks and benefits (Groopman 233).” [1]

    Dr. Groopman (233) writes, “[Dr.] Karen Delgado is a model in this regard. She infuses common sense into the scientific results from clinical trials; she is unafraid to question custom and tradition; she sees medicine as a calling and not a business; and she avoids financial temptations that could subtly guide her practice. Patients often come to her after reading newspaper articles or watching TV reports that feature physicians’ testimonials about results from a research study or an alleged breakthrough. ‘That may be what they believe,’ Delgado tells her patients, ‘but now let’s talk about what we know and what we don’t know.”

    [1] Groopman, Jerome. How Doctors Think. Boston: Houghton Mifflin, 2007.

  20. FPME writes: "The fact of the matter is pharma has to bring the drugs to market. They cannot simply decide to not serve a market, they will put themselves out of business."

    That's a load of crap. Buisnesses and entire industries HAVE gone out of buisness due to changing market conditions. If it isn't profitable to bring a drug to market, companies will simply fail as shareholders shift thier money to more profitable industries. Don't kid your yourself: Drug discovery is not "inevitable". The legal and regulatory framework created by our government can have a devistating impact upon pharmaceutical innovation.

    I hope I'm wrong and that this industry thrives in the face of this ruling. But I just don't see it happening. The industry is already undergoing a massive contraction. (Have you tried to find a job in pharma recently?) This is just one more "nail in our coffin"....

  21. Hi Nathan,

    I do not see it as a nail in anyone's coffin, and clearly neither do investors, judging by what happened on the markets after this ruling.

    Drug discovery is inevitable, to use your words.

    Informed consent, transparency, ethical trials and standards must prevail for all of our sakes. Shareholders are also patients. Each and every one of us will have to seek treatment at one time or another in our life. In the game of life, no one gets out alive.

    The companies that might go out of business will have only themselves to blame for not being the visionaries they need to be to see the change in the market, harness it and flourish.

    Nancy, I read the book "How Doctors Think" it is quite good.

  22. Up in Michigan…

    “This law has been disastrous for thousands of people like us-people who took drugs like Vioxx, Rezulin, fen-phen and Bextra, all of which were approved by the U.S. Food and Drug Administration. These drugs, and others, were later pulled from the market due to their links with health problems like hypertension, stroke, liver failure and cardiac failure.

    Yet those of use who have been harmed by these dangerous drugs have no voice. We are excluded from taking action against the big pharmaceutical companies that marketed drugs they knew to be harmful and then made billions while we got sick.

    What we ask of lawmakers is simple: the repeal of Michigan's law granting the drug industry immunity, and the chance for those of us who have been harmed by prescription drugs since 1996 to hold the big prescription drug companies accountable.” From D.I.I.M.E. (Drug Industry Immunity Must End)


    The United States was very blessed yesterday, well, except my poor orphaned state of Michigan. I was so happy when I learned about the Levine decision. This was the America I love. But then I remembered, that decision didn’t apply to me or my family and friends or any of the good people of this great state.

    Why, in America, was this allowed to happen? Where were our Patrick Leahy and Henry Waxman to fight for us? Government leaders who could tell the world how outrageous our law is and how our civil rights have been trampled beyond belief.

    We hear about all the other civil injustices in the world. Why is our tragedy kept quiet? What did Michigan do to deserve this? Are we ever going to be re-admitted to the United States of America?

  23. And Another thing, as a Pharma marketing expert the Levine case and yesterdays' ruling provides great marketing information resources. To all my former colleagues in pharma marketing, read the health blogs, read the comments from this case, here is free information from the public. This is information you would usually have to pay consultants hundreds of thousands of dollars to deliver to you in your ivory towers....

    Transparency, integrity and credibility must be restored to our healthcare system including all industry that provides goods and services to it.

  24. 1) Drug discovery is based upon drug approval and upon drug utilization (ability to pay for drugs). Neither approval nor utilization is "inevitable" -- and therefore, neither is drug discovery. (at least not in a corporate setting -- maybe academics/government is a different story)
    2) Investors didn't see this decision as a new nail in the coffin -- the countless lawsuits of recent years are the nail that has already been driven in. The supreme court decision just was an opportunity to remove one of the many nails that are killing us. Investors correctly recognized that the price of these lawsuits had already been factored into pharmaceutical stock prices long ago.

    This decision yesterday may well be the best decision. I'm upset because I believe that the public, lawmakers, and payers have too high of expectations for new drugs. We cannot possibly simultaneously achieve the expectations of all these groups given the current legal, regulatory, and patent environment. THAT is why this industry is collapsing. This decision was just one more indication to me that I'm part of a sinking ship.

  25. Here's the root of my frustration:
    There are 3 key factors in the quality of a medication: Safety, Efficacy, and Cost.
    Governments, payers, and the public are demanding improvements in all three areas simultaneously. That is just an impossibility. We can improve two out of three, but we CANNOT improve all three at the same time.

    FPME, I anticipate your responce: That's the job of science - to drive technical improvements that aren't possible today. That's true: However, science is INCREMENTAL -- we take baby steps forward that only become apparent on a timescale of 5-10 years. The demands of the public and government are for immediate improvements in all three areas. It can't happen. Instead, the industry is just throwing in the towel by having mass layoffs and consolidation.

  26. Nathan, I wrote this before I saw your last comment so I think you might have answered it. But I'll ask anyway.

    Here's a thought, maybe you can give us your opinion.

    Has the industry outrun itself? Or has the desire for high profit products along with the ability to design and market them, outrun the science to produce safe ones? Is it that the consumer wants these "almost like miracle" drugs and will pay dearly for them, pushed the industry past it's capability? Are we all the problem.

    And if so what does this mean to the industry and to the consumer? Where do we go from here?

    It would be like the consumer asking a manufacturer - "I want to be able to fly without a plane and I'll pay you a gazillion dollars if you can do it."
    If I'm the manufacturer I'll do whatever it takes to make it happen, even if I have to make the consumer just think that he's flying. After all if I don't someone else will.

    In this scenario it would be prudent to stipulate if the consumer really does try to fly and kills himself that there will not be any liability (a la preemption).

    Is this where we are?

  27. I like the way this discussion is going, and I thank Nathan for hanging in and adding to what he has said.

    I agree that these are enormously complex policy questions, not solved _either_ by imposing preemption or by rejecting it. I also agree with what Nathan writes about risks, and what pharma is up against. As I've said elsewhere (apologies to Catholics and Dutch people), being a top decision-maker in pharma is like being a priest in Amsterdam. Temptation brims from every window. When you factor in patent expiration, drying up pipeline, blockbuster model, "evidence-free zone" before AEs are known in wider population, all the incentives are toward "pushing the envelope" while you have time to do so. And, indeed, it's not just about greed. It's about maintaining a company that is doing a zillion great things--creating jobs, contributing to the community via tax base and otherwise, along with the sgood products.

    Under these circumstances, I think the whole range of potential external sanctions and their consequences--civil suits, criminal actions, regulation--need to be throught through very hard. I have rejected preemption because I have believed (I think CMC guy said this as quoted) it was a very large hammer on a more complicated nail. A kind of nuclear option that would, in short order, do more harm than good, including for the industry.

    So we're back to the situation as it was (except in Michigan). Class actions have already been reformed. Punitive damages can be reformed. If it makes sense to extend NDA review in some instances, consideration can be given to extending patent life. Companies which really do play by the rules should be rewarded in substantive ways, at the very least in public acknowledgment by FDA and relevant, objective others. Studies have shown at a few percentage points increase in public trust does translate into a higher percentage increase in profits.

    Anyway, there are many ways to address the issues Nathan raises. Preemption's defeat as one of those ways does not chage that. Maybe it will even help us think harder about the relevant dimensions.

  28. Nathan, I do understand how this is frustrating. It does seem like such an impossible task. We all have to see how informed consent is a critical key to the problem.

    Each and everyone of us in society has an obligation to inform and educate ourselves to protect ourselves from illness and disease. We have to do more to ensure that children do not start smoking. We need to teach children good eating habits/diets at an earlier age. We need to avoid over processed foods and food with too much sugar and salt. We need to get out and exercise more, not just become members in the gym, we need to go for a jog, play a game of street baseball. If we would get out into the neighborhood more, there might be a reduction in crime. We need to prevent disease and yes, we need to decrease the amount of drugs we use. Our water filtration systems cannot remove certain drugs from our drinking water.

    We need to implement plans that promote the true partnership of doctors with patients. I have said this before, they do this in England, Dr's get bonuses on how well their patients stay healthy.

    We are all to blame for inflated drug costs, we all want to earn top dollar. We all are guilty of "magical thinking".

    Preemption wouldn't have fixed any of this, and I think it would have hindered the much needed dialogue.

    Science does move in baby steps to a point Nathan. In 2004 a famous scientist announced a potential breakthrough in a drug that could potentially cure Acute Myeloid Leukemia. That year the federal government gave his team a grant of a million dollars to fast track it. Late in 2007 it was ready for human trials, the Leukemia and Lymphoma Society took over the drug and it has been shipped to Europe and no one can find it. The LLS nor the researcher are talking....

    Apparently the trial is hung up in "red tape" in Europe.....

    People are dying from all sorts of leukemia's, and we are letting this get hung up in red tape....

    This is one case, there are several others....

  29. Wednesdays ruling made me think there is indeed justice left in this country. I was high on the news for several hours. But let's not forget that there is another problem looming. Something much bigger. Something that many of you may have not yet considered.

    I am sure you have heard about the potential and the attempt for medical records to be made accessable from practitioner to practitioner. From what I hear, this is also to be used so that a government body can assist doctors in the newest information and to interject opinions of appropriate treatments. It sounds convenient. But consider including another government agency in your health decisions. Government is NOT capable of making medical decisions.

    Worst case scenarios:
    Your cholesterol is 260 overall. You refuse statins. The government decides that you are either no longer qualified for certain treatments... or they tax you because you are a potential drain on the new universal health care system. Even if you have private insurance because eventually you will be on medicaid.
    You no longer have the right to refuse medications. Considering the ability of drug companies to influence people without a science background, or to omit full disclosure on any particular medication, the government could very well give pharma biased advice.

    Sorry to kill your buzz. Please folks, why would you fight for your right to due process and not fight for the right to maintain your very personal information to be kept private? No one should come between the doctor/patient relationship. No government panel is going to be capable. Say you start talking like you are sad and they insist you take antidepressents. Or say you have cancer and they insist that you undergo chemo even though your chances are slim and you don't want to suffer through it.
    Think that isn't possible? Think again. Preemption would look like a picnic.

  30. Anonymous,

    Give a source, where is this coming from?

  31. I couldn't find the exact article I was looking for, but search 'Health Care Czar' under different search engines & look around. It's everywhere.

    Malpractice suits will be moot under centralization?
    Sounds like preemption to me.

    This requires some research and study. Seriously, spend a couple hours and read these things thoroughly.

  32. Read the comments following the article from the last link for 'Emergency Physicians Monthly'. The article itself comments on centralization making malpractice suits moot.

    Sounds like preemption to me.

  33. I don't know about how the government might intrude on our health care (sounds bad)but I've often thought that electronic records could be used to reform the Adverse Event system. The current system seems to be archaic and ignored.
    A properly designed and used AE system is crucial.

    Taking it to the next step would be utilizing nation-wide alerts and advisement help for doctors and patients.

    My two cents.

  34. The articles above are terrifying! Read them all! Who knew?

  35. With the exception of DDL, the pro-preemption blogs are inflamed today--so far over the top, they are coming back up from the bottom.

    The hatefulness of the rhetoric--the usual vampiric images of blood-sucking trial lawyers--competes outdoes anything even the most fervent (and misguided) pharma-haters spew.

    This is the kind of crap (pardon my Australian) that poisons everyone's wells.

  36. Justice, give me an example -- post a few links. I haven't seen anything of the sort in the blogs I follow. The my pharma/biotech blogs that I follow are really indifferent to the issue.

  37. I'll get back later with particular links later, Nathan. The last bit from Gordon pretty much sums it up--the whole issue comes down to greedy trial lawyers who will now devour everything good in the universe.

  38. Hmmm....Had read bits from Peter Pitts on Drugwonks, but the piece seems no longer accessibile on his site. No idea what that means.

    Overlawyered has a somewhat more acid/ironic take, equipped with requisite visual of shark about to eat a poor little goldfish.

  39. After months of reading the opinions for preemption the basic talking points become clear and continue today.
    1. Evil Trial Lawyers - a real hatred for anyone that might attempt to put hands on precious profit. All that do are just greedy.
    2. Conflicting requirements – You know the tune.

    Here's my point. The majority of opinions written using these two arguments use words like, could or may.
    Product liability law suits may increase to unbearable limits.
    Conflicting requirements could destroy our industry and our health.

    Using these qualifiers they boldly ask us to trust them. I really wish I could but actual fact, history and the current FDA/pharma quagmire say I can’t. I'm glad that the SC saw through their tactics.

  40. Preemption would not have made trial lawyers extinct, but it sure would have helped Pharma keep their hands in the cookie jar....

    I am now at the point where I find the comments and pro preemption rhetoric amusing. Quite frankly I haven't quite decided if we should applaud them for their courage be so public about their own ignorance or just continue to rub their noses in it by constantly pointing it out to them in rebuttals to their silly commentaries...

    I am leaning toward the former, hopefully it will let their readers know what neanderthals they are...

  41. There are versions of preemption I would support. While it isn't perfect, I think the vaccine law makes sense, and it does not prevent people from filing if they choose.

    If it could be shown that company released all info in a non-spun way about a relevant risk--both to FDA and in all promo materials, including CME, clinical trial registry, and journal publication--and FDA made considered, non-politicized review--I would cede to the claims of both company and agency in such a case.

    In other words, I am not a "strict liability" person.

  42. Jaynesday writes: Preemptors argue that "Product liability law suits may increase to unbearable limits."

    I would disagree. I would phrase it this way: "Product liability lawsuits HAVE ALREADY increased to unbearable limits."

    You can see this evidenced in many ways:
    1) The pharma industry faces more lawsuits (by far) than any other industry. ~17,000 pending cases in 2006. I can't find more recent #'s.
    2) Pharma's run towards lower liability therapeutic areas like vaccines and cancer. Lawsuits for vaccines are largely banned and few people sue when a cancer drug fails. If they live, they are happy to be alive - they generally don't sue. Massive amounts are R&D dollars are being shifted to these two areas.
    3) The unwillingness of pharma to go into niche (orphan) markets. The risk is too big, the reward is too small. I'm sure you will disagree with this, but here it goes: I genuinely believe that the reason we don't have more treatments for niche (orphan) diseases is that the risk of lawsuits far outweighs the potential benefits for the company.

  43. a few==

    --I'm definitely willing to believe that orphan drug development is impacted by lawsuit risk. I just want to see any kind of data that supports it. If it does, it does.

    --Just a point of info. Only some vaccines are protected and only to a limited extent. Patients are _not_ restricted from filing suit in the normal way if they don't like the verdict of the "vaccine court."

    --If R&D going into vaccines and cancer that seems to me a good thing. At least as compared to many recent "blockbusters": Baycol, Vioxx, Nexium, Zyprexa, the ED drugs, et. al.. I'm not saying there isn't a place for these (with probably the exception of Baycol). But, all in all, I'd rather see R&D where Nathan suggests it's going.

    --As always, I want to focus on what are the demonstrably exploitative lawsuits. There certainly are those. They are usually based in fraudulent claims--pt. never took drug, injury couldn't possibly relate to drug, etc. Obviously, more likely in class actions, which are also more limited.

    --I don't know how to assess relative lawsuit numbers without having some comparative data re: how many people used relevant products, etc.. I am ready to agree that there is an exploitative "piling on" pharma if there is more data to show it.

    And if that _is_ true, I would also support the kind of limited preemption that Sharkey has proposed and which some part of the Levine decision could also be interpreted to suggest.

  44. Maybe the reason for so many product liability lawsuits against the pharmaceutical industry is directly related to the safety of the products they sell.

  45. One key ingredient is that patients and consumers of drugs have to be informed. I would argue that the reason for so many lawsuits is not just because of the safety issues, but clearly there is misinformation and misguided communication on these drugs. Consumers/patients become frustrated - they sue.

    The marketing arm of Pharma has done a great job in marketing and selling what I call "magical thinking". We have a magical pill that fixes this or that. Well, there are no magical pills, if they "fix" anything they fix at a cost of something else. The patient has to decide if they are willing to pay the price.

    Getting back to the Levine case, if she knew their was a remote chance she would literally pay with her right arm in order to alleviate immediate suffering from the migraine induced nausea, would she have taken the risk? Maybe, just maybe, if they would have sat down and read through the product with her, maybe, just maybe, she would have insisted for the slow drip IV administration of the drug. We don't know, but it is a scenario that is worthy of some thought.

    As Nathan pointed out, Vaccines and Cancers are a good area, and I encourage research in this area as well. However, I think we will see an increase in cancer drug lawsuits. The reason being the same as all the other reasons. If the risks and benefits are not clearly laid out and patients now find they are dealing with a heart/lung issues brought on by the cancer drug, that they were not advised about, they should seriously consider retribution.

    The bottom line is the more we know, the more we are proactive, the less likely people are to sue.

    Preemption would not fix the information/knowledge gap that exists....

  46. I believe I have posted this in the past however it goes directly to the core of informed consent. Prior to Thanksgiving, a very close friend of mine from died lung cancer. His doctor a, a renowned oncologist was treating him with combination therapy; my friend researched the drug agents that were being used and the recommendations on one the drugs was that it was a single action agent. My friend may have opted for the combination therapy, and in fact after having been apprised of the information on the drugs, he decided to continue the combination therapy. However, the key is, the doctor never informed him that this therapy was not the recommended course of action and after his quality of life declined, primarily through the additional drug agent (he was continually hospitalized after treatment), he decided to forego the additional drugs.
    At the present time and probably for the foreseeable future, the only answer for patients is to become their own advocates.
    Far too many individuals suffering from chronic or devastating illnesses put too much faith in the medical practitioners and unfortunately, through my own experience I have found a level of arrogance and a dismissive attitude among medical professionals towards those individuals who take the time to educate themselves on the symptoms affecting their own bodies.
    Suffice it to say that my own negative attitude towards "magic pills," the pharmaceutical industry, and the FDA is predicated upon my own experience.

  47. One of the better post Wyeth/Levine editorials:

  48. FPME writes: "Maybe, just maybe, if they would have sat down and read through the product with her, maybe, just maybe, she would have insisted for the slow drip IV administration of the drug. We don't know, but it is a scenario that is worthy of some thought."

    That's EXACTLY what I have been saying all along!!!!!!! This case was NOT about Wyeth!!! It was about her doctors not reviewing the labeling! Aside from preemption, it is just sickening to me that she won this lawsuit. The DOCTORS were at fault here -- not the pharma company. She just went after the ones with the bigger pockets. SHE is the greedy money-grubbing party here -- not Wyeth!

  49. I might have agreed with this view had I not just read through the whole Wyeth v. Levine case.

    What surprised me was how ambiguous and uncertain the Phenergan label actually is. The most it would have suggested, had the PA discussed it with Diana Levine, would have been something like:

    "This could be messy if I really screw it up."

    I don't think such a statement would lead the average person to a considered weighing of risks and benefits.

    To my own surprise, regarding the _inherent_ dangers of IV push, there is very little.

  50. p.s. I would never have agreed with calling Diana Levine a "greedy, money-grubbing" whatever for the same reason that Nathan objected to such degrading language in another thread.

  51. Justice,
    Can you please post exactly what the labeling was? I read a version of the label (but I don't know whether it was pre-Levine or post-Levine). The version I read was VERY clear.

    As I've said before, I think cases like this are leading us down the road to where drug labels will likely be like a auto-owners manual: a 10-50 page book that never gets opened.

  52. Just one more point, Levine did sue the doctors and healthcare team as well.

    So, she was pretty thorough and rightfully so.

    Nathan, there is nothing wrong with a black box warning label for this type of situation. That would have forced her health care team to have the discussion with her. She may have either insisted for the IV drip, or refused that treatment all together.

  53. Nathan

    I agree that the Levine Case was really about Medical Malpractice and not about labeling requirements. The prevailing knowledge recognized for quite some time that the IV Push method of administration should be avoided. However, this was not the issue in front of the Supreme Court, the Court was not ruling on the merits of the Levine case.
    The issue was whether the Courts should ignore years of established legal precedence, which recognized the rights of individuals to pursue State legal actions against federally regulated industries or adopt the premise endorsed by Wyeth, who argued that compliance with FDA labeling regulations is a shield against individual State Law Tort actions.
    The FDA joined the suit on behalf of Wyeth and during 2006 the FDA issued their own regulations which preempted State Tort Claims. In most instances where an agency interprets Federal Statutory law, the Federal Agency’s interpretation is given deferential treatment; the 2006 regulation was considered by the Court but it was not given any weight. The reasoning of the Court was the agency did not pursue the correct channels for the adoption of regulatory changes. Had the FDA followed the proper procedures and the regulations were adopted, I believe this would have shifted the burden to Levine and her attorneys would then have had to argue that the regulation was outside the scope of Congressional Intent (1).
    The preemption argument is not limited in scope to the pharmaceutical industry; there have been numerous cases in other areas where State and Federal jurisdiction overlap.
    Examples of where this conflict exists can be found in EPA guidelines; California has greater restrictions on emissions then other States; however to achieve these stricter standards California had to request a waiver from the EPA (2).
    Another example is in Air Travel; in response to lengthy delays which kept passengers in airplanes for periods of up to 8 hours awaiting takeoff, NY passed a consumer law which required that passengers could not be held in an airplane for more then 3 hours. The law was struck down on the basis of the language found in the Airline Deregulation Act of 1978 (link Attached).
    In the end the case came down to maintaining a balance between Federal and State Authority.


    1) I believe the attorneys for Levine, in their Brief, made this argument.

    2) At the present time there is a debate as to whether the State standards can be strengthened; California has tightened their emission standards but the EPA, under the Bush Administration refused to grant the necessary waiver.

  54. I'll be posting later about some of the particulars in the Levine decision. But, yes, Jim is right that the primary foci of the majority were (a) whether Wyeth could have changed the label unilaterally without any jeopardy; and (b) whether there is any evidence that Congress intended the FDCA to preempt state common law. The answer was a resounding "yes" to the first question and a resounding "no" to the second.

    The entire superstructure of the past few years -- premable, CBE changes, etc. - were essentially put aside as deserving of no deference. The procedural point re: the preamble that Jim raises was certainly relevant, but I am less of the view it would have made a difference because of the strength of the other arguments.

    As I will post later, the version of preemption defended by the dissenters was itself very narrow. So, in summary, one could include that the broad preemption that we have so often heard advocated was rejected 9-0 by the Court. I'll try to demonstrate that later.

    Re: the label, both sides in the Court did take up the question of how complete and explicit it was re: IV Push, even though this was not the preempiton issue per se. It was relevant to the dissenters, because they needed to show that FDA did a complete and full job in getting to the label. That is the key reason, from their perspective, it should preempt--not how much was on it, but how deliberate, careful, and thorough was the regulatory process that led to it.

    For their part, the majority emphasize that there was lots of "stuff" related to some of what could happen if a practitioner wasn't careful in using IV push. But nowhere, from their perspective, was there some version of: "Don't even think about this unless there is really no other option."

    Again, that was the trial court issue. It was relevant in the SC in order to establish, on the majority side, that this was not as clear, thorough, and deliberate as the dissenters suggested. Indeed, at one point the majority suggest that the dissent did a better (more carefully considered) labeling job than Wyeth and FDA.

    I don't have the label itself at hand (so to speak), but, even if I did, there would remain interpretive questions about what went _into_ its creation, which--for the SC--remain more important than what it said.

  55. p.s. BTW, this last point suggests that the prediction we often hear--that companies will defensively label to smithereens--would do nothing to help them.

    That is, again, because the key issue re: preemption will be the thoroughness of FDA and comapany's process for determining the label.

    Thus, throwing on more warnings, in itself, will be beside the point.

  56. Here's some quotes from the Phenargen label, as it appeared in 2000 when Levine was injured. Judge for yourself if you think that IV-push was an acceptable mode of administration based on the labeling read by the doctors. The answer is quite clear to me...

    “[t]he preferred parenteral route of administration is by deep intramuscular injection.” If an intramuscular injection is ineffective, then “it is usually preferable to inject [Phenergan] through the tubing of an intravenous infusion set that is known to be functioning satisfactorily.” Finally, if for whatever reason a medical professional chooses to use IV push, he or she is on notice that “INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY.”
    “Under no circumstances should Phenergan Injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene”
    “Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection of Phenergan Injection, usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances.”

  57. FPME suggests a black box would have been appropriate. Fine. Is a company capable of issuing it's OWN black box warning without FDA approval of the warning? I dare say: NO, THEY AREN'T! Thus, your solution, though maybe appropriate, is irrelevant to this case.

  58. Hi Nathan -- I don't have the label in front of me, but I think you are adding wording that may be implied, but is not exactly what is on the label. Is this precise text there?: "Finally, if for whatever reason a medical professional chooses to use IV push, he or she is on notice that"...

    Since you don't have it in quotes, I'm assuminng it was _not_ so stated on the label, but, yes, could be interpreted as implied.

    What I can tell you is that the majority in the Supreme Court focused on this part:

    “it is usually preferable to inject [Phenergan] through the tubing of an intravenous infusion set that is known to be functioning satisfactorily.”

    "Usually preferable" is not, in itself, much of a warning to do what may not be "preferable." And, if the warning about gangrene did not directly follow some version of the text as you wrote it, then it is just kinda out there. It is not specifically suggesting that IV push should be a last resort because of the risks. It is saying that, if you screw up IV push (indavertently), gangrene can happen.

    Those are different things.

    As you know, I have always been "agnostic" about the original Levine verdict for the reasons you suggest. But, again, what the Supreme Court ruled was not on that verdict, but on the preemption defense. And even the minority who sided with Wyeth made it their business to base their argument on more than what the label said and whether it was "FDA approved."

    Rather, they went "behind" the label, trying to reconstruct its creation in order to prove that this was a risk about which FDA and Wyeth deliberately thought through, with an equally thought-through warning.

    The majority on the Court did not believe that process happened. The minority did.

    But, even agreeing with the minority, that sets a rather high bar for preemption--that there has to be some "document trail" that shows the care with which FDA "optimized" the warning in light of risks and benefits while viewing the big picture.

    Preemptors have simply asserted that, if it's on an FDA label, that process _must_ have happened. The minority in Levine--those who ruled for Wyeth--did _not_ accept that.

    Instead, they asserted that, if you are going to make such a claim about "optimal" weighing," then you had better be able to back it up with the paperwork. Otherwise, it is so much wind, not worthy of deference.

  59. Justice,
    1) I agree with you about the basis for the SC decision. The decision was really about preemption, not about this case. However, this case is a great example of "lawsuits gone wild" in my mind.
    2) Here's the verbatim text from the label. (capitalization towards the end is mine) Link at the bottom of the post.

    INADVERTENT INTRA-ARTERIAL INJECTION: Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection of [Phenergan], usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Intravenous injection was intended in all the cases reported but perivascular extravasation or arterial placement of the needle is now suspect. There is no proven successful management of this condition after it occurs . . . .
    WHEN USED INTRAVENOUSLY [PHENERGAN] SHOULD BE GIVEN IN A CONCENTRATION NO GREATER THAN 25 MG PER ML AND AT A RATE NOT TO EXCEED 25 MG PER MINUTE. When administering any irritant drug intravenously it is usually preferable to inject it through the tubing of an intravenous infusion set that is known to be functioning satisfactory.
    Please note the sentence in caps. Following a graphic description of gangene, the label states "WHEN USED INTRAVENOUSLY [PHENERGAN] SHOULD BE GIVEN IN A CONCENTRATION NO GREATER THAN 25 MG PER ML AND AT A RATE NOT TO EXCEED 25 MG PER MINUTE." MMmmm. Any qualified or unqualified physician should recognize that this desribes an IV drip. The doctor screwed up. Maybe the warning should have been in all-caps. Maybe there should have been an excalmation point, or maybe it should have been written in red. Whatever. The label said it. The physician didn't follow it. Case closed -- this should have been dismissed long ago.

  60. It was actually a PA, who apparently was so distraught at what happened that she exclaimed at the time that she would gladly give up her her own arm if that could undo what happened.

    This has no legal relevance, but it's nice to remember that there are real people involved in these things.

  61. Nathan,

    You are right, companies cannot issue their own black box warning. Black Box Warnings are usually issued based on the information supplied to the FDA from the drug company.

    In July 2007 Ed on Pharmalot posted a story about a Whistle blower from Novartis for a new cancer drug. He accused them of compromising their results and in effect "hiding" the cardiac incidences that had occurred during the clinical trial. The information came to light, just before the FDA was set to approve the drug. The new information delayed approval for three months and when approval was finally granted, they received a black box warning. Had the approval gone through with the approval, the black box warning would not have been there, because the FDA was not given the information. I thought that was an interesting story in general.

    However, in light of what the nine FDA reviewers have told President Obama's team lately, we can now see how it is when you compromise systems that are put in place to protect patients, you do so at the risk of suffering through law suits when inevitably, the truth comes out, because there are way too many people involved in having to keep the "secret" so the truth will always come out.

    In reading through the wording on this label, I do believe stronger terminology should have been used, and additionally, if there was a black box warning, there would have been a stronger consultation at the time of drug administration.

    That being said, I suffer from Migraines, and I have had that drug administered on 4 separate occasions since 1996, each time was through IV drip and was administered by a doctor standing right in the room. The last time I received this drug was in 2007. When this drug is administered properly, it is fantastic, it works great, but it isn't worth my right arm.

    The wording I would have went for is "THIS DRUG MUST BE ADMINISTERED THROUGH IV DRIP ONLY". Spell it out, this is usually being delivered in an ER, there is too many chances for things to go wrong. We need to give ourselves a break. If we can do something that minimizes the risk of something really going wrong, we should do so. You are right Nathan, the stakes are high and this is precisely all the more reason for communication. Hind sight is 20/20.

    Everything you say is right Nathan, science works in small increments, risk benefits have to weighed. What I am saying is that has to be communicated. Pharma has done a great job in getting people to believe they are super heroes, then when the truth comes out because expectations were not managed, people get mad.

    As we all agree this case wasn't the best case to make a move for preemption..


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