Preemption: Coming To A Drug Near You?
37 CommentsBy Ed Silverman // April 7th, 2008 // 7:48 am
As the controversial debate over preemption heads toward the US Supreme Court this fall, another example of a drugmaker’s conduct is used to illustrate the stakes involved. In this case, The New York Times cites internal company documents showing Johnson & Johnson obscured evidence that its Ortho Evra birth control patch delivered more estrogen than standard birth control pills and potentially increased the risk of blood clots and strokes.
But because the FDA approved the patch, J&J is arguing it can’t be sued by women who claim they were injured by the product - even though its old label inaccurately described the amount of estrogen it released. More than 3,000 women and their families have sued J&J, asserting that patch users suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the Times notes, the FDA received reports of at least 50 deaths associated with the drug.
However, the paper writes that J&J documents and e-mails show that even before the FDA approved the patch in 2001, J&J researchers found it delivered more estrogen each day than low-dose pills. When results were reported publicly, J&J reduced the numbers by 40 percent. The FDA didn’t warn of potential risks until 2005 - six years after J&J’s own study showed the high estrogen releases. At that point, the product labeling was changed, and prescriptions fell 80 percent.
For years, the Times points out, FDA officials acknowledged that lawsuits could aid oversight of safety issues. More recently, the agency has argued lawsuits could lead to an overlapping patchwork of rules that would burden drugmakers and might discourage patients from taking useful meds. The agency and industry now maintain FDA approval of a drug supercedes state lawsuits challenging safety, efficacy, or labeling.
The Ortho case, however, suggests that Johnson & Johnson, like other drugmakers, is not always quick to tell the FDA about potential problems with its meds, the paper writes. But lawyers for Johnson & Johnson say that patients should not be allowed to sue the health care giant because the FDA. approved the patch and its label. “FDA is responsible for making those decisions,” John Winter, a lawyer for J&J, tells the paper.
The full story contains details about the study changes made by J&J researchers…
pharma pr hack
This case shouldn’t fall under preemption because the actions of J&J in taking six years to fess up with a correlation between their incorrect “corrective factor” and the deaths is negligence pure and simple. It would be different if they weren’t hanging their marketing hat on an untruth, if they hadn’t already had the answer and if they didn’t readily acknowledge it was factually inaccurate but then hide behind the FDA’s skirt when their actions come to light. If they had been above board without applying a corrective factor and being upfront about the estrogen which was applied through the patch then preemption would definitely be a valid argument. But if they had done all that, they probably wouldn’t be facing lawsuits.
Atlex
I agree with pharma pr hack. When fraud is involved, pre-emption doesn’t apply. That is something that isn’t apparant in the NY Times article.
Ed Silverman
Hi Folks,
You both raise a good point concerning fraud. Nonetheless, the J&J attorneys are apparently citing preemption as a defense anyway. Perhaps such a maneuver could be called testing the limits or an attempt at nibbling away at the edges. It may not work, but this will be interesting to watch.
Regards
ed
Janet
Is it a known fact that the FDA did not know anything about a correction factor or is it an assumption?
Ed Silverman
Hi Janet,
Good question. Unfortunately, that’s not clear from reading the article. One can try to read tea leaves - as I often do in attempting to discern the precise wording of an FDA response - but it is not an exact science. This becomes harder still as a second-hand exercise.
ed
DefLaw
There seems to be some misunderstanding about preemption. Negligence, fraud, even willful misconduct do not overcome the preemption defense. The defense is absolute. If the drug is approved by the FDA, even if bona fide safety risks come to light subsequent to marketing, even if the manufacturer illegally promotes an unproven off-label use in a patient population in whom the drug has never been studied, preemption means the injured patient has no right to go to court. Preemption assumes that any and all misconduct will be policed and punished solely by the FDA. If the Supreme Court adopts preemption, it would not matter if J&J intentionally lied to the agency - the victims would have no cause of action under state law and no right to compensation, period.
Lisa Van S
DefLaw,
The U.S. Supreme declined to take up Miller vs Pfizer. so why should they take up preemption?
DefLaw
They took up Wyeth v. Levine
Lisa Van S
DefLaw,
That’s an adult case,… are children of lesser value, in the eyes of the Supreme Court?
DefLaw
I don’t know the history of Miller v. Pfizer - I believe it’s a Prozac case involving suicidality, yes? I can’t comment on what issues where appealed and which were not.
Lisa Van S
It was a Zoloft case, and involved the suicide of a 13 year old. Dan Troy became infamous due to being FDA’s Chief Counsel, and his ties to Pfizer. Preemption was born.
Lisa Van S
DefLaw,
You do know that Suicidality isnt a word?
DefLaw
My understanding, based on discussions with a friend who is a psychiatrist, is that suicidality is a term which loosely encompasses a number of recognized self-destructive behaviors, including, e.g., cutting. It may not be a word to you, but it is a word used by real clinicians. Sorry.
I know there has been a lot of blame placed on Dan Troy, and he deserves it, but his successors have been just as rabid about preemption as he has been. Dan Troy didn’t write the FDA regulatory preamble of January 2006 that asserts that state cases are preempted. Also, I believe that Troy - as a member of the Federalist Society - probably got the idea from someone else, as the conflict preemption concept has been going around for a while. By the way, at least 4 members of the Supreme Court are also members of the Federalist Society (Scalia, Thomas, Alito, Roberts) as well as Cheney’s counsel, David Addington, and John Yoo. Quite a nasty bunch.
I still don’t know what issues were appealed in the Miller case, but I do know that the preemption is directly before the Court in Wyeth v. Levine.
Justice in Michigan
Back to what DefLaw stated, that is absolutely correct. Fraud on the FDA does not open a company to civil liability. It only opens a company to the possibility of criminal or civil action taken by the FDA/Justice Department. And, as has been reiterated here, this almost never happens.
The FDA/DOJ brief in the Kent case made the above points particularly clear. FDA/DOJ have no interest in their actions being “gatekeepers” to lawsuits. Thus, their finding of fraud, or not finding of fraud, has no bearing on preemption.
For those of you who still lean toward preemption - and I know there are many - I hope you will think seriously about the implications of this.
As for Lisa’s question, the reason the Supremes took up Wyeth is because a) Wyeth asked them too and b) it is not the strongest case for plaintiff in other respects. Thus, from the perspective of the Solicitor General, in the current administration which has pushed preemption as you know, this is the case that was put forward.
As for reading the minds/politics of the Supreme Court, I will leave that to others.
Justice in Michigan
But add this. Besides the implications for accountability, preemption provides no means of compensation for those who were injured by a fraudulently approved drug.
Worth thinking hard about.
HorusCat
Justice,
I don’t know where I stand on preemption; haven’t given it much thought. But as for means of compensation for those who are injured by what you call a “fraudulently” approved drug…surely this is an aspect of the problem that could be remedied legislatively? There could be a pool, such as exists with vaccines.
Janet
Who exactly is going to fund this pool? Why shouldn’t the cost be borne directly by the company who committed the fraud?
Justice in Michigan
HC - Yes, as mentioned in earlier thread, that is true. What I do not recall is whether this applies to all vaccines or only those that are mandated.
BTW, I borrowed the word “fraud” from the opening posts in this thread. The point was about circumstances that preemption does and does not cover. So it was not about “what I call.”
Re: another point for DefLaw - while Dan Troy had left FDA when the preemption preamble came out, he was closely involved in its authorship, as he has noted himself. But you are absolutely correct that he is no one-man band.
Lisa Van S
Janet,… its the taxpayer. Industry reaps billions in profits, while children are maimed and killed due to ineffective drugs. The U.S. Supreme Court may become another entity, that, could be dangerous to one’s health!
Lisa Van S
DefLaw,
Exactly,.. a Psychiatrist. When the word is placed in the webster dictionary, along with a definition, only then will I consider it a word.
Jane
Lisa (Off topic) Do you have a link that list the age of the child, the state, and the medication being prescribed?
HorusCat
Justice,
I don’t know much about the vaccine fund, despite the fact that I have an autistic child…haven’t done any research into it. Such a fund could theoretically be developed for all pharmaceuticals, funded by the companies, much as workers’ compensation pools exist, funded by business, that insure occupations that attract no commercial insurors.
The beauty of such a pool is that it could short-circuit the legal process, where much of the money goes into the coffers of the lawyers. It would also eliminate the punitive damages portion of claims, which America is almost alone in fostering.
Bob Freeman
The discussion inticed me to look up the link. I don’t know if it’s accessible from the body of this reply:
http://www.hrsa.gov/vaccinecompensation/VIC_Trust_Fund.htm
Lisa Van S
Jane,
Not sure what you are asking for.
Justice in Michigan
Bob - Much thanks for supplying that link. Lots of interseting stuff. Among other things, I hadn’t realized it is still possible (now) to sue a vaccination manufacturer is their vaccine is not one of the covered ones (there are about a dozen) or if one rejects the compensation offered by the “pool.” Thus preemption is limited, even in vaccine arena.
HC - The civil justice system has many flaws, just like the FDA and industry. My argument has always been that we are better with both civil liability than FDA than either one alone. That was also FDA’s own view until the current administration.
I also wish there were a way to get more money to deserving patients and less to their lawyers, but I am not sure what the right balance is, practically. Trial lawyers are so often monolithically demonized (just like pharma) that this discussion is rarely rational.
Similarly, the role of punitive damages, and their frequency, is more often part of name-calling than deliberation. From my perspective, such awards are rare and virtually always reduced significantly on appeal. New Jersey’s law limits PD to a jury’s decision that there was deliberate fraud involved. That was decided in one of the Vioxx cases there. Moot given Vioxx settlement, but I think criteria certainly need to be clear. Had Warner-Lambert won Kent, of course, there would be no possibility for juries to make such determinations at all.
HorusCat
Justice,
Your points are well taken. The problem with jury trials is that juries often decide to award damages not because of perception of wrong-doing, but because of the emotional feeling that “someone should pay” or “the company can afford it.” Perhaps an independent arbitration court or something like that would be possible.
Jane
Lisa, thanks I found what I was looking for.
Jaynesday
HorusCat
I can see your side of the coin however the other side is the one where the Drug/Device companies hide critical data from the FDA and or the public to keep their product on the market. I agree with your idea of an independent arbitrator. Becoming emotional about the facts or hiding the facts both end up damaging one party or the other.
Justice in Michigan
The research on juries is equivocal. Of course, there are those cases that have become famous (OJ, etc.) re: jury nullification. But it is also clear that many jurors bend over backward precisely _not_ to be swayed by that kind of emotion - that is, not to fit that stereotype about jurors.
Clearly, the issue is not emotion but justice. Moral outrage or sympathy are not negative emotions and need not cloud fairness and clarity. The wide range of outcomes in the Vioxx cases tell us how unpredictable all of this is, and how it is not reducible to any easy generalizations about juries and jurors.
Likewise, the checks and balances provided by the appeal process.
The question becomes - why is a jury of twelve citizens less an independent arbitrator than some other scheme?
Justice in Michigan
An interesting sidelight. In his own blog, Drug Wonks, Peter Pitts (who has also visited here) anticipated the NYT article. He concludes:
And if the Gray Lady follows precedent, there will be a same-day editorial supporting the general view of the article — that FDA preemption should be struck down as a general principle because of, among other things, the evil pharmaceutical industry and an agency that is “in the pocket” of same. Who does this help? Consumers? No. Trial lawyers? Yes. (And we all know that Alex Berenson has many of these folks on speed dial – and visa-versa.) So on Sunday, brew your coffee, toast your bagel – and count how many times trials lawyers are quoted in the article.
In reality, thre was no such editorial. And plantiff’s lawyers were quoted twice, the same number of times that industry lawyers were quoted. Also quoted were a range of company spokespeople, FDA officials, etc.
Why do these guys call themselves “wonks”?
HorusCat
Justice,
What IS a wonk? Is it like Charlie Brown’s teacher, who you only ever heard go “Wonk, Wonk, Wonk”?
Jaynesday and Justice,
I have to stop and ask myself what is the objective? It is to create an environment where there is as little incentive as possible for a company to obscure and obfuscate so that problems can be solved as they arise, with warning to everyone and appropriate risk-benefit analysis, and to provide recourse and recompense to those who are hurt when this doesn’t happen. And to provide for criminal punishment of those who knowingly allow harm to be done.
So, how do we do this? On one side, we must create a business environment where companies can make a profit in return for taking risks. They aren’t going to make a profit on everything, there will be a lot of failure, and they have to do sales and marketing, so the public may have to let up on the price, price, price blathering. In return, we can demand complete transparency except where “trade secrets” are concerned. (No one is asking for the secret formula for Coke.) We set up some sort of system where data are published, side effects can be collected, collated and assessed for meaning; and dialogue and conversation occurs. We talk about how we do trials and their inherent limitations. If we can do this, then if a disaster occurs where no fraud has occurred, we have a neutral body that provides recompense. If fraud occurs, it’s Katie-Bar-The-Door, Mr. CEO, your ass is on the line.
The issues are terribly complex–from how to sort the wheat from the chaff with adverse events, to how to design meaningful, ethical trials, to how to talk about off-label uses of drugs. (You can get the schizoid effect from this site–people angry about off-label use of psychotropics, and angry because an insurance company wouldn’t pay for an off-label use of a cancer drug. Can’t have it both ways, people!) We need to talk about profit and private enterprise and admit that we want our pharma stock to do well in our 401ks, but not at the expense of the patient. We need to talk about patient responsibility and how risk-averse Americans have become. We need to talk about giving physicians more time with their patients in order to really talk to them–and paying them for that time. We need to talk about how we are going to pay for all this. And we probably need to keep it out of the sound-bite happy politicians who don’t really want to solve anything, they just want to get re-elected.
harpy
“Wonk” is a synonym for “wanker.” ;)
Or this:
a person who studies a subject or issue in an excessively assiduous and thorough manner: a policy wonk
HorusCat
harpy,
I like wanker. What a great word.
Justice in Michigan
HC - A brief response since thread is off the front page anyway.
It is clear that the current incentive structure and relevant institutions (FDA, etc.) encourage the following:
- Pushing the law until the law pushes back. Essentially playing _with_ regulation rather than playing by it.
- Only enough compliance to cover-butt if/when one is caught.
- A series of ways resonsibility for consequences is diffused, camouflaged, and denied.
I could go on. As an industry (as opposed to the individuals who work in it) pharma ceos are our contemporary robber barons. Things will change. It’s a quesiton of how long and how many people are hurt along the way.
Justice in Michigan
I was too glib in my last response. Gut was wonked out.
HC writes: ” have to stop and ask myself what is the objective? It is to create an environment where there is as little incentive as possible for a company to obscure and obfuscate so that problems can be solved as they arise, with warning to everyone and appropriate risk-benefit analysis, and to provide recourse and recompense to those who are hurt when this doesn’t happen. And to provide for criminal punishment of those who knowingly allow harm to be done.”
I fully agree. But how can that happen with a blockbuster model (make hay while sun shines); the relative ease of getting around regulators; the the ticking patent clock; etc. As I’ve sometime said, being in the pharm. industry is like being a priest in Amsterdam (apologies to Catholics and Dutch people). The temptations are enormous.
When other companies yield, there is a virtually inevitable race to the ethical bottom. All that you mention re: transparency, reasonable ROI, makes sense to me. But I cannot get beyond the notion that pharma needs some kind of inner renewal that may, in part, depend on a different business model, but I don’t think we (all of us) can afford to wait for that.
Re: my particular bugaboo, preemption, it will be a disaster for industry as I’ve said many times. Not only do you get Amersterdam; you get it for free. Human frailty is such that there is no mystery what the final chapter will be. And the short-run party will become a genuine disaster - for companies and for all of us who depend on them.
If anything will kill the “golden goose,” it will be the tsunami of outrage that follows from there.
So companies should fight for lawsuit reform, yes. Scuzzy lawyers should be treated the same way as scuzzy everyone else. But a total shield is a DTC ad from pharma to the rest of us that says: “We can’t be trusted to do the right thing. That’s why we need to work in the dark.”
It’s the worst possible message for an industry that needs to regain public trust. And, scuzzy lawyers notwithstanding, it is an unnecessary message given the integrity that has been, and can be, key in this industry. Work for that. Work against scuzziness everywhere.
Nuclear options like preemption get what nuclear options always get. Scorched earth.
Jaynesday
We seem to be riding a litigation pendulum driven by politicians, as is so often the case. But when this much money is involved who can keep the politicians from mucking things up? (even when lives are at stake)
Justice in Michigan
One can admire the success of the preemptors, even while one profoundly disagrees with them. In some respects, it goes back to the modern American conservative movement, Goldwater days. It manifested itself mainly as deregulation in the Reagan and then Gingich era, although “tort reform” was central in Bush Sr. And Jr’s gubernatorial races in Texas. It wasn’t invented by Karl Rove, but it was given enormous new life as an issue.
Particularly in Texas, there were many benefactors willing to help. Tom DeLay’s strategy of gerrymandering Texas and thereby creating a permanent Republican majority was also tied centrally to “tort reform” as an issue. DeLay was personally obsessed by it, as were some of the major (talking super-”rangers”) contributors to the movement.
Once Dan Troy moved from defending Big Tobacco and Pharma into the FDA Chief Counselor role, the effort took on an ideological super-structure that was, if nothing else, creative. No one said that trial lawyers were hiding weapons of mass destruction, but the suggestion, at least, was that - as a profession - they _were_ weapons of mass destruction. It has obviously caught on, the mirror image of the satanizing of pharma.