Biogen Loses Preemption Argument In Tysabri Case
23 CommentsBy Ed Silverman // August 7th, 2008 // 1:23 pm
A federal judge dealt Biogen and Elan a blow by refusing to move a lawsuit over the death of a patient, who had been treated with their Tysabri multiple sclerosis med, from a state court in Boston, where Biogen is based, to a federal court in Iowa. And in doing so, US District Court Judge Douglas Woodcock supported the arguments against preemption as a reason for his ruling, The Wall Street Journal writes.
Preemption is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness, and the concept shields them from liability claims under state law. The US Supreme Court this November will review a case involving a Vermont woman and Wyeth.
The lawyers for the drugmakers hoped to convince Woodcock to move the state lawsuit involving the late Joseph Tofanelli to federal court because, they argued, it ultimately hinges on the FDA’s role as regulator of prescription drugs. But Woodcock rejected their argument by refusing to wade into this contentious debate. “The defendants are essentially proposing that I exercise federal jurisdiction given the unsettled nature of the law in this area. I decline their offer,” he wrote.
Woodcock said that the federal preemption doctrine that is being contended in the upcoming Supreme Court case “is not consistent with the current state of Massachusetts products liability law, under which compliance with FDA labeling regulations does not necessarily protect the manufacturer from
state law failure to warn claims.” Here is the ruling.
Tysabri has been linked to rare cases of a potentially deadly brain disease, progressive multifocal leukoencephalopathy, or PML, and new cases were reported last week, although Tofanelli died of herpes encephalitis, another unusual brain disorder.
In 2006, a new warning was added to Tysabri’s label, noting that “in post-marketing experience, one patient who received Tysabri developed herpes encephalitis and died.” That patient was Tofanelli, his widow’s lawyer, Alex MacDonald, tells the Journal. Tofanelli received a Tysabri injection in February 2005, twelve days before the drug was withdrawn. It returned in 2006 with strengthened warnings approved by the FDA, the Journal notes.
Justice in Michigan
You don’t suppose Judge Woodcock is related to … ?
I don’t know much about the overall Tysabri history. But this ruling against moving the case is based, in essence, on a judge saying defense lawyers should not “second guess” the Supreme Court.
Ed - it must become tiring to reiterate the preemption definition every time it comes up. Your work is always appreciated. My own bias would write:
“Drugmakers and the FDA argue preemption exists by maintaining agency actions provide the _exclusive_ word on safety and effectiveness, and the concept shields companies from liability claims under state law, even if FDA’s approval was obtained by fraud or other misrepesentations that could be unearthed by whistleblower cases or through the civil discovery process.”
But I’m just a country non-lawyer.
Pat
’supercedes’ is spelled ’supersedes’.
thom1
thom is a tard
Jaynesday
JiM, I think the reason that preemption has to be redefined is that when you describe what it is you see the total blatant pharma bias of it. Restating it is like watching a horror show or an act of violence on TV. Restating it strikes your senses as something that can’t be true but is.
As I’ve watched the issues in Pharmalot for the past months it becomes more obvious that a lot of the Pharma environment is one of hide and seek, political and monetary bribery, people that are on the take, lying, cheating etc. It almost seems that some pharma can’t seem to exist without underhanded supports that are funded by huge amounts of money.
I contend it is due in part to the disconnection of the consumer with the producer. What fills the space between is what breeds corruption.
I know we can’t live without pharma and I know this isn’t all that pharma is but it appears that too much of it is.
Steve Knows
Pat,
Check the dictionary. Both word spellings are correct. Anyway, I hope you have more to offer than spelling corrections, like the content of the blog.
It seems to me that the federal government (FDA) should have preemption in order to keep the flow of commerce aligned rather than every state making their own rules.
Jaynesday
Steve,
I would be all for an aligned flow of commerce if the flow was safe and honest. I really would.
laurie
“It seems to me that the federal government (FDA) should have preemption in order to keep the flow of commerce aligned rather than every state making their own rules.”
While commerce is pharma’s goal, the public’s goal is drug safety and full disclosure. Until that happens preemption leaves the public with no recourse for suppression of data that could result in life threatening adverse effects. Any industry that has no accountability for their actions is ripe for abuse.
The FDA has proven that the do not have the resources to ensure that decisions about approval are made with ALL of the information available to the manufacturer.
The public should not be asked to accept the decision of the FDA when the FDA decisions are made on half truths and incomplete data, as evidenced by recent revelations.
Justice in Michigan
Steve writes: “It seems to me that the federal government (FDA) should have preemption in order to keep the flow of commerce aligned rather than every state making their own rules.”
Well, we’ve raised our leg near this fire hydrant many times, so I will (try to) be brief.
1. Tort law has nothing to do with “states making their own rules.”
2. It has to do with whether FDA is the only institution able and willing to insure that FDA’s own regulations are fulfilled. Until the current (Bush) administration, FDA viewed civil liability and its regulations as “complementary systems of consumer protection” in most instances.
3. Thus, FDA approval and compliance remain a very strong defense for any company against which action is brought. Litigants would have to show that, in essence, the company did not meet even the minimum requirements of FDA approval/compliance.
4. FDA’s own regulatory record re: a particular risk, the discovery process in civil cases, as well as whistleblower revelations, allows that to be decided fairly. No bit alone does.
5. You might ask: Why can’t FDA do the policing itself. Simple. It’s not a police organization. Its Office of Regulatory Affairs and Criminal Investigation does a bit, but a very small bit.
6. Why not fund those offices to do more? If we did, we would have a Stalinist sized FDA, which I don’t think anyone wants. And it is outside their core mission, which is public health, not law enforcement.
End of hydrant.
Steve Knows
Laurie, I can’t argue your stand. It’s correct but not acceptable.
Justice, sad but true. What bothers me is, if each state has their own rules, then it will be almost impossible for any kind of union consistency. The drug companies would be spending a whole lot more time trying to pay attention to the rules in the various states when, at least for now, the FDA is the only source, not the best in my opinion. They are in bad need of a past due reconstruction. They don’t need a retrofit, they need a complete tear down with a well thought out method of operation, aka, MO.
Justice in Michigan
Steve - I agree with your assessment of FDA. The key issue is that civil liability is _not_ equivalent to a state setting up an independent FDA. So the whole issue of “paying attention to the rules in various states” is simply a red herring. It does not exist. It will not exist.
Only the FDA has jurisdiction over labeling, etc., and that will remain true, just as it has been true during the past hundred years in which we have had both FDA and product liability laws. _That_ is the system we have now. How much “chaos” do you feel? Preemption would destroy it.
Once again, most product liability suits that ocncern drugs also include the record of whether the manufacturer has been in compliance with FDA. So there is no issue of contradictory standards here, or competing ones. Rather, it is a question - in most instances - of parallel, complementary claims.
Unfortunately, if we left it to FDA alone, there would be no accountability whatsoever, and essentially no way to know whether a company has been in compliance or not. There is irony there, but it is true.
Let me recommend Catherin Sharkey’s recent writing on this. She takes a middle position between absolute preemption and retaining the system we have now. It is, in my view, the most rational and balanced perspective we have heard. You can find it by googling via her name.
laurie
“It’s correct but not acceptable”
???????
“The drug companies would be spending a whole lot more time trying to pay attention to the rules in the various states when, at least for now, the FDA is the only source, not the best in my opinion.”
There are many industries that have to conform to state law. Yes, it’s alot of work on the part of the company trying to work within the varied “rules”. That’s part of being in business. But to allow an agency, that has proven that they cannot do the job adequately, be the ultimate decision making for the public is ludicrious.
The FDA needs to be completely overhauled before preemption should even be considered a viable option.
Justice in Michigan
Once again, I would emphasize that the argument about some “chaos” of conflicting standards is entirely spurious.
For one hundred years we have had both FDA and civil liability. They have worked well together. FDA agreed with that until the Bush administration appointed Dan Troy and his allies. Those are the same folks who worked, in the 90s, not to defend FDA but to dissolve it. Read Phil Hilts, _Protecting America’s Health_.
So there is no problem. No contradiction. No chaos. No varied rules. Truly.
What preemption means is taking at least half of the current system of consumer protection and basic legal rights - again, the ones that have been in place for many decades - and throwing them away.
So the only actual problem to be solved except defeating preemption itself.
Steve Knows
Laurie and Justice, maybe I can clarify the matter of preemption in state vs Feds by moving to a comfortable analogy.
Murder case verdicts before the states don’t always come out the way the victims family and prosecutors would like. The accused is then recharged by the federal government as a violation of the victim’s civil rights. Usually, when it gets that far, the outcome is different, the accused is convicted. I understand that we are talking civil, not criminal in the case at hand but, it does make a salient statement. Just another form of preemption.
Justice in Michigan
Steve - I don’t follow the analogy, but perhaps you intend this: if there is no civil liability (state tort law), “perpetrators” will later be found out, and punished, by the FDA and Justice Department.
That would make sense except that it essentially never happens. As often discussed here, and documented by various sources, the FDA/DOJ bring almost no enforcement actions, particularly in the drug arena, that create meaningful accountability. There are several reasons for this that I won’t reiterate. Ironically, again as documented in a recent post by Ed, the few more serious actions it does take (very rarely) are triggered by outside sources - whistleblowers or the very civil liability system that preemption would make irrelevant.
So the loop is closed, the door is locked, and the lights turned off.
laurie
” The accused is then recharged by the federal government as a violation of the victim’s civil rights. Usually, when it gets that far, the outcome is different, the accused is convicted.”
If this was the case with the past action by the FDA, I don’t think anyone would have a problem with it. But the above scenario, as the FDA stands today, would be:
The accused is then presented to the FDA, who send him a warning letter 8 months later telling him not to kill anyone else and he goes home.
Steve Knows
All I pointed out is, this is just another form of preemption. I am aware of the civil actions and the criminal actions. Either way is a preemption.
I’ll go out on a limb, the feds will have the preemption over states. There are just too many technical/scientific considerations for states to enter this forum as the last word in pharmas/bios.
Of course, there are larger penalties in a federal court than state. Many lawyers would love to see this as a potential open door to riches.
laurie
“Of course, there are larger penalties in a federal court than state. Many lawyers would love to see this as a potential open door to riches.”
Do you understand what preemption in the case of drugs truly means? There would be no lawsuits at the federal level. If a drug is FDA approved case closed.
Maybe I’m missing something in your view of preemption.
Steve Knows
Laurie,
I have had a lot of experience in these matters and there are many latent areas ANY lawyer could attack. To say that the final word would be the FDA is not accurate. In the court system there are three tiers, Superior, Appellate and then the Supreme court. “Appellate” means just that, “appeals”.
Many people do not understand that anyone can sue, but will they prevail? So to say the FDA is the end of the line is naive.
Usually, attorneys sue who they think are culpable, not the FDA. The FDA rules may then be used as evidence if it is to the benefit of plaintiff counsel. The same would hold for the defendant. Sometimes they do prevail.
Justicein Michigan
Steve - Respectfully, I can only tell you you don’t get it as far as what FDA preemption means.
I would suggest looking through this site for other discussions of it or just google FDA preemption.
It has nothing to do with levels of courts, etc. If and when preemption is upheld (as it already has been in the device arena), it has the force that any Supreme Court decision - Roe v. Wade, etc.. It is “the law of the land.” Once that happens, no Appelate court is going to take a case based on a doctrine that, in essence, the Supreme Court has already ruled on. Periodisimo.
Steve
Justice,
If you wish to believe you are correct, that’s fine. I don’t enjoy fencing games.
laurie
Thanks Justice, thought I was missing something but your explanation is my exact understanding of what the effects of preemption are.
Dianne
Justice – Your definition of preemption is exactly right. Our Constitution guaranteed that Americans would have due process of law. Now that right is being challenged.
Tort reformers feel like they are about to win. Unfortunately, if FDA preemption becomes “The Law of the Land,” they will be amongst the victims.
Justice in MI
OK, Steve. Do some research and see what you think. It’s not about fencing, btw, just discussing. That’s a great thing about this site.