Glaxo Loses Preemption Ruling In Paxil Suicide
28 CommentsBy Ed Silverman // August 29th, 2008 // 11:45 pm
On September 14, 2002, 16-year-old Jake Garrison shot himself to death, eight months after first being prescribed the Paxil antidepressant. And so a lawsuit was filed against Glaxo, claiming the drugmaker knew there were risks associated with off-label use pediatric use of Paxil and, therefore, had a duty to warn of those risks.
However, Glaxo cited preemption as a reason for the suit to be dismissed. Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness.
In this case, the drugmaker maintained that a direct conflict existed between failure-to-warn claims under New Jersey state law and the federal Food, Drug & Cosmetic Act. New Jersey law stipulates that a drugmaker must warn of all known adverse effects of a drug as soon as reasonably feasible after learning of any danger. Lawyers for the Garrison family rejected the argument in their motion.
However, Glaxo contended that, had it included warnings about an increased risk of pediatric suicide in the Paxil label, the pill would have been considered misbranded under federal law. And since Glaxo could have not remained in compliance with both state and federal law as it stood prior to September 2002, when Garrison committed suicide, Glaxo argued a conflict existed, triggering preemption of New Jersey law.
But Judge Ronald Buckwalter of the US District Court for the Eastern District of Pennsylvania rejected the argument by ruling FDA regs allow a drugmaker to “unilaterally add a warning on a drug, so long as the drug manufacturer has reasonable evidence of an association of a serious hazard with a drug.”
Here is his 53-page ruling, in which he also wrote:
“Arguably, Glaxo possessed such reasonable evidence of an association between Paxil and pediatric suicidality as early as 1998, at the conclusion of their own Studies 329 and 377, the data from which initially triggered the FDA’s concerns.
“The mere fact that Glaxo elected not to submit the results of those studies until April of 2002, when it filed a supplemental NDA seeking approval of an indication for pediatric use, does not detract from the fact that it may have had reasonable evidence of a hazard prior to that time…The mere fact that the FDA had not ordered Glaxo to include this warning prior to 2002, does not mean that it could not have legally done so.”
Preemption is a hot legal topic these days. The US Supreme Court will review a case on November 3, and if you have some time on your hands, open this link to you will find background material and numerous briefs backing and opposing preemption.
By the way, this is the second Paxil case this summer in which preemption was rejected as a defense. This is the other one.
UPDATE: Glaxo sends us this statement: “Any suicide is a tragedy and a reminder that depression and other mental illnesses can be fatal. These are serious medical illnesses, and untreated depression is the greatest risk factor for suicide.
“We remain firm in our belief that we acted properly and responsibly in the conduct of our clinical trials program for Paxil, documentation and submission of results from studies to regulators, and communication of important safety information to regulatory agencies, the scientific community, and the public. GSK strongly believes that FDA has the responsibility to determine whether the labels on medicines offered in the US are appropriate. The agency has the scientific expertise and the ability to evaluate the potential risks and balance them against the benefits of the medication, so that doctors have good information upon which to make prescribing decisions.
“We are disappointed with the outcome of this case and are considering our options.”
Justice in Michigan
Preemption is a “hot topic”? Holy cow, you wouldn’t know that from Pharmalot! ;) May its temperature only increase!
_This_ is the kind of case that the Supreme Court _should_ be considering as the test of preemption - not Levine. The fact that a preemption-favoring Solicitor General got the Court to take on Levine shows us (yet again) the politics involved in this process.
The relevance of the CBE rule-changes to preemption are also transparent in this case - whether Glaxo could have/should have changed the label before waiting for FDA approval.
Clearly, this judge views FDA regulation as “a floor, not a ceiling,” which was the traditional FDA view in the pre-Trojan (Troy) period.
This case also reveals how bogus is the “misbranding” defense as well as the claim of some “impossible” conflict between state and federal law. Indeed, it reveals how duplicitous that argument is.
Had Glaxo submitted the data it had in ‘98/’99 (which it did not), sent out an appropriate warning (which could have been a Dear HCP letter, not necessarily label change), and _then_ had that change overruled by the demonstrably considered judgement of FDA (that is the only consequence Glaxo would have faced), preemption might make sense.
As the facts stand, this case shows us how logically and ethically bantam-weight the “preemption argument” actually is.
Matthew Holford
Let’s see:
1. We’ve discovered that we’ve got a shite drug;
2. we’re not going to tell anybody about it, including our regulator;
3. People have found out that our drug is shite, and are suing our sorry, corrupt (but obviously, only in my opinion) arses;
4. We’re going to argue that the regulator’s decision, made without the full facts, that the drug was safe, entitles us to dismiss all claims against us.
Have I summed it up correctly? And doncha just love it, when people refuse to take responsibility for the fucking grotesque mess they’ve made?
Matt
truthman30
While the preemption argument usually dominates these cases, people seem to forget that these are children who committed violent suicides because of the effects of a dangerous and deadly drug. Effects of Paxil that GSK were aware of but failed to warn about because it would damage their profits and the marketing of Paxil to the profitable adult population.
http://abcnews.go.com/images/Primetime/paxil_bpg.pdf
http://consumerist.com/consumer/gsk/paxil-unafraid-to-demonstrate-bling-in-98-memo-188811.php
http://abcnews.go.com/images/Primetime/paxil_remarkable.pdf
http://groups.google.com/group/Parents-Against-TeenScreen/browse_thread/thread/d3546540f38c11c7
Certd
Don’t forget, GSK hired the king of preemption Daniel Troy. Disgusting.
Anne PME
I am starting to wonder what comes next. Will Glaxo and Troy will be arguing that all Glaxo product safety issues are due to the physicians and other health care professionals who prescribe Glaxo drugs, the pharmacists and techs who dispenses them, and the patients who take them?
Think about all of the money that Glaxo could be spending on research and development. Instead, these Glaxo execs and their associates are spending other peoples money on these types of legal fees and on spin doctors to fix their reputations.
Too bad Glaxo and other pharma stockholders cannot force these company execs and their associates to foot their own bills. On second thought, this might be good for Glaxo execs and attorneys because it might give them an excuse to whine some more and revisit their ‘blame your stockholders’ legal strategy.
laurie
This is the perfect example of why preemption is a HUGE problem. With Paxil, GSK had the information about the suicide risk AND the lack of efficacy in the Paxil 329 study, done in 1998. They chose to NOT give this information to the FDA, resulting in this childs death.
To attempt to use preemption in this case, attempting to blame the FDA for not requiring a warning is the height of arrogance for GSK. If the study was never shown to the FDA, then the FDA’s failure to mandate label changes is moot.
PERFECT example of what we can expect to see if preemption goes through. It opens the door to hiding data, and then claiming preemption when all hell breaks loose.
truthman30
Preemption in regards to cases like this could be legalized “manslaughter”?..
vince
In Ca. a similar case was dismissed on the basis of the next pharma shield preemption. If this doctrine is upheld by the courts what will be needed is ‘a good supply of body bags’.
Justice in Michigan
I don’t agree with all the comments that have been posted on the anti-preemption petition, which now has more than 300 signers, including David Graham, Howard Brody, Tom Lamb, Doug Bremner, and others known to people on this site.
But what is clear that these comments represent a very small drop in an ocean of public outrage. If and when the wave breaks, the “image problem” about which the industry is concerned now will look minimal by comparison.
There has been no “failure to warn” about what preemption will bring.
If those who genuinely support preemption continue to believe, after the most serious reflection, it is the right policy, they should stick to their principles. If not, there is too much at stake to “wing it.”
Nathan
Justice and other preemption interested parties:
Check out this web site. It’s an interesting discussion of automobile safety standards and preemption. Evidently, the law specifically says this about auto safety standards: “Compliance with a motor vehicle safety standard prescribed under this chapter does not exempt a person [or corporation] from liability at common law.”
Yet, auto manufacturers are still trying to make exactly the same preemption case the pharma companies currently are. Anyway, this link really supports your view (not mine). But as I’ve said, I have rather mixed feelings about preemption. My main concern is frivolous lawsuits… Preemption would shut down those lawsuits, but I think you are right it would cause other problems.
Anyway, here’s the link:
http://www.progressiveregulation.org/NHTSA_preemption.cfm
Jaynesday
Nathan, The following sentence sounds very familiar around here.
“That specific language notwithstanding, three times in the last several years NHTSA has baldly asserted that a proposed regulation would preempt state tort law, thus making it impossible – if upheld by the courts – for crash victims to sue for damages when manufacturer negligence caused them harm, provided that the equipment in question complied with NHTSA’s regulations.”
Next in line for preemption is the Federal Railroad Association. If you say yes to one what right to have to say no to any?
Jaynesday
Here is some news about the FRA and its apparent battle for preemption.
“But the railroad preemption battle is not over. The Federal Railroad Administration (FRA) included preemption language in its recent notice of proposed rulemaking regarding passenger equipment safety standards. The rule’s preamble states that the “FRA believes that it has preempted any state law, regulation, or order, including state common law, concerning the operation of a cab car or [multiple-unit] locomotive as the leading unit of a passenger train.”
If the rule becomes final, a railroad could use it to argue that it is immune from liability if the lack of appropriate strength of cab cars or multiple-unit locomotives causes injury to passengers. AAJ will file formal comments in this proceeding.”
I imagine that federally regulated industries are like circling airliners waiting for the runway to be cleared. As soon as the drug/device preemption battle is decided. They will be free to land.
Senator McCaskill puts it this way
“There’s preemption language popping up everywhere like Spring flowers,”
Justice in Michigan
Thanks, Nathan, for the reference. And also to Jaynesday. Yes, this is part of a general movement to protect several industries from liability.
As I suggested to Chris2, let’s call them “exploitative lawsuits” rather than “frivolous.” That’s really what we’re concerned about, and I think it pinpoints the problem on that side. “Frivolous” is, to me, a frivolous word, more a diss than a discussion, if you know what I mean.
(Like we wouldn’t talk about “frivolous” misrepresentations of risks or benefits, although, of course, some would be more serious than others.)
Melody
At some point, can states step in and pre-empt those seeking to do business within individual states? Enough public outrage about the lack of redress for harm done to citizens COULD encourage states to ban a product or a corporation from “doing business” within their borders. How would it impact GSK (or others), for example, if Florida decided that Paxil could not be sold within the borders of Florida; or that GSK–because of irresponsible, but not illegal acts (under preemption authority)–was banned? If Paxil were ‘illegal’ in Florida, could it be dispensed through VAs located inside of Florida?
With the politicization of regulatory agencies seen in recent years, does the pharma industry want to expose the FDA’s ‘dirty laundry’ in a states’ rights battle?
Justice in Michigan
Hi Melody - I think this really _would_ provoke preemption - if the ground was that a product was unsafe, it would constitute a state setting up its own regulatory agency (which civil liability does _not_ do, despite preemptors’ arguments). Not to mention patients who do benefit from a particular product and the power of the Chambers of Commerce (which is actually the most powerful and well-funded lobby).
What individual states can do is what some have - e.g., bring suits over Medicaid fraud (via suppressed studies), file amici (as 47 state Attorneys General did in Levine), and the like.
As for the last question, FDA’s ‘dirty laundry’ seems to get exposed every couple of weeks in the latest GAO study or similar. In the meantime, regulatory capture is no “secret,” it is just not quite “understood” yet by most folks. So,as above, I do think pharma is setting itself up for a backlash of the kind we’ve never seen.
Anne
The FDA (and other government agencies that were wrecked under the Bush Administration) are overdue for a major backlash. One way, which is starting to creep along, is individual states taking action limiting dangerous drugs, requiring that they be given as a court of last resort, and the like.
Those that have not been heard from in the pre-emption dialog are the families of the dead. Though they may have received a pittance in a lawsuit, what they really want is justice. Justice is not money. It is a criminal trial and prison for those who knowingly put lethal drugs on the market. Perhaps this action would soothe their ever-present grief and help clean up the poisonous behavior of the drug companies.
Lisa Van S
Anne,
I agree with you 100%!! But, and with all due respect, I disagree with your perception of the Bush Administration. It was the White House who initiated the investigation of the adverse effects of Paxil, in Aug/Sept of 2002. I have a White House Letter to prove it!
Justice in Michigan
Anne - Michigan, where we have had full preemption for twelve years, has heard from plenty of family members. Some are very active in preemption nationally. As we say here, “We are your future.”
Where do you see states taking actions as described? All I’m aware of is in Medicaid formularies. Thanks.
Justice in Michigan
Lisa - Can you tell us more? Who in the White House initiated the investigation or under what office?
Lisa Van S
Justice
“Can You tell us more”. Publicly,.. No. You can e-mail me privately, and I will be more than happy to fill you in.
truthman30
As far as I am aware (but I could be wrong) , it seems that GSK “bamboozled” the FDA and the UK MHRA (UK medicines regulator), apparently (according to Peter Breggin) , GSK distorted the original clinical trial data which indicated Paxil (Seroxat) had an effect of increasing suicidal thoughts more than a placebo.
If this is true, then I think the regulators surely cannot be held accountable? …
Either way..
The whole things stinks to high heaven, and the FDA and the MHRA should have acted sooner..
I wonder what’s going on with the current US probes of GSK and Paxil by the department of Justice in the US? .. anyone any clue?
I would be surprised if GSK are ever held accountable for the Paxil mess though, Those whom yield wealth and power also seem to be able to miraculously rise high above common law..
Are pharmaceutical companies untouchables? ..
It seems so..
Justice in Michigan
T’man - The court’s decision, linked in Ed’s post that begins this thread, summarizes the history pretty well. You and others here probably know all of it in mujch greater detail, but it is a pretty good overview of what Glaxo did and did not make known to FDA at various points.
As far as preemption in general, there is no question that this has been a project pushed by the current administration. They have made no secret about that; it is, indeed, a point of pride for them. While there were a scattering of preempiton stirrings earlier, Dan Troy’s era marked a turning point - what has become famously known as the “180 degree change” in policy. Comments by earlier FDA Chief Counsels also make clear how profound the change was.
John Greaves
Comment and question to Lisa - why can’t you disclose what you know about White House involvement in the investigation of GSK? You seem to think that the secrecy of the White House’s official actions is OK? In a free democratic society there is no place for such secrecy. Please respond.
Lisa Van S
“In a free democratic society there is no place for such secrecy”
LIKE PAXIL STUDY 329?
Secrecy?…. No, Just protecting a patient’s right to privacy.
David S
LVS, citing the protection of patients’ rights to privacy with regard to 329 is laughable at best; as anyone knows, specific people aren’t even cited in medical studies - only data. And that Bushco initiated an “investigation” into paxil in 2002 - well; it would be funny if it were funny, but it isn’t. The Federal gov knew about serious adverse paxil side effects as early as 1993 through 1995 - Bushes, Clintons, Gores, McCains, Obamas - they’re ALL pushing this stuff, and they’re all trying to lawyer themselves out of any accountability. It’s 2008, folks. You’re late.
Lisa Van S
David S,
patients’ rights to privacy/329????
I wasnt refering to an individual in the clinical trial.
David S
Oh - I’m sorry - it was you that said, “a patient’s right to privacy”. Is “a patient” not “an individual”-? Perhaps you were referring to the corporation as individual? And it’s “right to privacy”? (high whistle)
Lisa Van S
David S
Fishing?