TorteDeForm

Justinian Lane

This Bextra lawsuit shows the injustice in preempting lawsuits against pharmaceuticals

As regular Tortdeform readers know, the U.S. Supreme Court is set to decide the case of Wyeth v. Levine, a case involving a woman whose arm had to be amputated because of an anti-nausea drug.  Diana Levine’s lawsuit is called a failure-to-warn lawsuit; she argues that Wyeth should have included a stronger warning that administering the drug a certain way can cause gangrene.  Wyeth’s position is that since the FDA approved the warning label, Wyeth shouldn’t be liable for not putting more information on the label.  (When I say label, I mean the pamphlet that accompanies prescription drugs and is read mostly by doctors.)  If Wyeth gets its way, the Supreme Court will rule that the failure-to-warn lawsuits over drugs approved by the FDA are preempted by federal law.  In other words, no one will be able to file failure-to-warn lawsuits – even if the pharmaceutical knowingly conceals information from the public or the FDA.  If preemption becomes the law of the land, the victims of the next Vioxx won’t have their day in court.

This Bextra lawsuit again reminded me of the injustice of preempting failure-to-warn lawsuits:

Dec. 23 (Bloomberg) -- Pfizer Inc., the world’s biggest drugmaker, must pay a research center $38.7 million for stealing data compiled by the foundation on its Bextra pain-killer drug, a California jury determined.

State court jurors in San Jose yesterday found that Pfizer stole the information from the Ischemia Research and Education Foundation, which for more than 20 years has collected data on post-surgery medications, reactions, and placebo effects, said Pat Harris, an IREF lawyer. Pfizer said its conduct was “proper” and it will appeal the verdict. 

Source: Bloomberg.com: News

Does it seem right that if a pharmaceutical knowingly, purposely, and intentionally hides deadly side effects of a drug from the public, that pharmaceutical wouldn’t even have to pay the medical bills of those injured by the drug… but if that same pharmaceutical steals safety data about their own drug they can be liable for tens of millions of dollars?  Can we really call it a justice system if it won’t punish a pharmaceutical for killing people but will punish it for stealing information?

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Posted at 2:44 PM, Dec 24, 2008 in FDA | Federal Preemption
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"In other words, no one will be able to file failure-to-warn lawsuits – even if the pharmaceutical knowingly conceals information from the public or the FDA."

This is just false. Here's what Wyeth said at oral argument:

". . . we are not seeking here a rule of field preemption. We are not seeking to preclude tort remedies for conduct that violates Federal law." Transcript at 11.

Conduct that "knowingly conceals information from the public or the FDA" would violate federal law, and as a consequence would not be preempted under Wyeth's theory of preemption. Aren't you misrepresenting Wyeth's narrow claim of preemption as a broader claim than it really is? Wyeth says pretty much the same thing in its brief:

"Wyeth does not argue that Congress intended to occupy the field of pharmaceutical safety; nor does it contend that Congress intended to preempt all common-law liability for unsafe drugs." Wyeth reply brief, at 21.

It also points out that concealment of relevant drug risk information is not at issue in this case:

"Obscuring that patent conflict, respondent and a chorus of amici treat this case as though it were about something else -- a case in which a drug manufacturer concealed risk information from FDA, or in which material information about a drug’s risks emerged after FDA approved the drug and its labeling. Whatever might be said about preemption in those situations, they are most definitely not this case. Respondent never argued that Wyeth concealed information from FDA." Id. at 3.

Under Wyeth's preemption theory, a conflict arises only when the FDA labeling regime requires the approved label (and state tort law requires another, different label) in the absence of new drug risk information. Since the FDA labeling regime does NOT require that its previously-approved label be retained in light of new drug risk information, it follows that a conflict cannot arise between what the FDA requires and what state law requires when new drug risk information (previously concealed) is in play. There would be no conflict preemption in such a case.

A state tort law failure-to-warn suit based on newly disclosed drug risk information that was previously concealed would not, therefore, be preempted.

Posted by: implied preemption | December 25, 2008 12:11 AM

"In other words, no one will be able to file failure-to-warn lawsuits – even if the pharmaceutical knowingly conceals information from the public or the FDA."

This is just false. Here's what Wyeth said at oral argument:

". . . we are not seeking here a rule of field preemption. We are not seeking to preclude tort remedies for conduct that violates Federal law." Transcript at 11.

Conduct that "knowingly conceals information from the public or the FDA" would violate federal law, and as a consequence would not be preempted under Wyeth's theory of preemption. Aren't you misrepresenting Wyeth's narrow claim of preemption as a broader claim than it really is? Wyeth says pretty much the same thing in its brief:

"Wyeth does not argue that Congress intended to occupy the field of pharmaceutical safety; nor does it contend that Congress intended to preempt all common-law liability for unsafe drugs." Wyeth reply brief, at 21.

It also points out that concealment of relevant drug risk information is not at issue in this case:

"Obscuring that patent conflict, respondent and a chorus of amici treat this case as though it were about something else -- a case in which a drug manufacturer concealed risk information from FDA, or in which material information about a drug’s risks emerged after FDA approved the drug and its labeling. Whatever might be said about preemption in those situations, they are most definitely not this case. Respondent never argued that Wyeth concealed information from FDA." Id. at 3.

Under Wyeth's preemption theory, a conflict arises only when the FDA labeling regime requires the approved label (and state tort law requires another, different label) in the absence of new drug risk information. Since the FDA labeling regime does NOT require that its previously-approved label be retained in light of new drug risk information, it follows that a conflict cannot arise between what the FDA requires and what state law requires when new drug risk information (previously concealed) is in play. There would be no conflict preemption in such a case.

A state tort law failure-to-warn suit based on newly disclosed drug risk information that was previously concealed would not, therefore, be preempted.

Posted by: implied preemption | December 25, 2008 12:14 AM

Implied - Something that no one ever talks about but which I have personal experience with is that with preemption the ability to even find representation for a product liability case will be zero to none. In my case, 2 years ago my family and I were able to find a law firm to represent us in our fight for accountability against a medical device manufacturer. Then came preemption. Our lawyer now is obviously much less enthusiastic about pursuing our case. "This is no longer the case we signed up for".

"Knowingly concealed information" will certainly be much more "concealable" with preemption. It kind of makes the 'catch me if you can' game a little more unfair for the harmed or as you might call us the frivolous.

Posted by: Axiomatic | December 25, 2008 10:08 AM

Implied Premtion, Axiomatic, et al,

Almost years after finding a Biggie law firm to represent me in litigation for both heart attack and stroke (with nothing happening), I recently read John Grisham's "The King of Torts." Astonishing! Just slip in your favorite pharmaceutical company for the drug maker, the name of the killer drug for the one that got you, your tort law firm for the several in the novel, your lawyer for any one of the crooked lawyers in the novel, and your Congressman/Senator for the corrupt politician in the story and you will see in lifesize characters the Vioxx, Bextra, and other similar Product Liability litigations in progress.

Merck set aside $4.5 Billion for settlement of 50,000+ Vioxx lawsuits, promised to start making "partial" payments August 20th, and made their first "partial" payments a week ago. Big Deal (Merck made more than $10 Billion on the sale of Vioxx) Figure the roll-over on $4.5 Billion and you will quickly understand why Merck is tickled pink to leave the $$$ in their bank account from August to January and let the litigants see their homes, cars, retirement and living (and life) go down the tubes. If Merck stalls long enough, the interest alone will pay off the litigants and they can "develop" (aided and abetted by the FDA) another killer.

A New Jersey judge set the legal fees cap at 32%, which immediately generated a huge complaint from the Trial Lawyers Association that 32% of $4.5 Billion isn't enough for their (minimal) efforts.

Gives us another example of the the sterling character of tort firms in general and tort lawyers in particular .... beginning with SH..

Posted by: Lois M. Smith | December 25, 2008 3:18 PM

Implied: I'm not claiming that Wyeth concealed info from the FDA with this drug. While you're right that if a pharmaceutical did conceal information it would be a violation of federal law, you're wrong when you say those lawsuits wouldn't be preempted. Buckman Co. v. Plaintiff's Legal Comm., 531 U.S. 341 (2000) held that claims of fraud on the FDA are preempted by the Food Drug and Cosmetic Act.

"Under Wyeth's preemption theory, a conflict arises only when the FDA labeling regime requires the approved label (and state tort law requires another, different label) in the absence of new drug risk information."

And that means that almost all failure-to-warn claims will be preempted; plaintiffs couldn't proceed on a theory that an FDA-approved label was inadequate.

Posted by: Justinian Lane | December 25, 2008 4:40 PM

"And that means that almost all failure-to-warn claims will be preempted; plaintiffs couldn't proceed on a theory that an FDA-approved label was inadequate."

Simply not true. You're right that Buckman would preempt allegations of fraud that would require state courts to act as fact-finders in place of the FDA, but Buckman would not preempt failure-to-warn claims in which the FDA itself has made a finding of fraud. Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961, 966 (6th Cir. 2004):"Buckman prohibits a plaintiff from invoking the exceptions on the basis of state court findings of fraud on the FDA. Such a state court proceeding would raise the same inter-branch-meddling concerns that animated Buckman. But the same concerns do not arise when the FDA itself determines that a fraud has been committed on the agency during the regulatory-approval process. Cf. Buckman, 531 U.S. at 351 ('[F]raud-on-the-FDA claims would also cause applicants to fear that their disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.'). Thus, in this setting, it makes abundant sense to allow a State that chooses to incorporate a federal standard into its law of torts to allow that standard to apply when the federal agency itself determines that fraud marred the regulatory-approval process. In the final analysis, the exemptions are invalid as applied in some settings (e.g., when a plaintiff asks a state court to find bribery or fraud on the FDA) but not in others (e.g. claims based on federal findings of bribery or fraud on the FDA)."See also Buckman, at 354 (Stevens, J., concurring) ("If the FDA determines both that fraud has occurred and that such fraud requires the removal of a product from the market, state damages remedies would not encroach upon, but rather would supplement and facilitate, the federal enforcement scheme.").

An agency finding of fraud would thus evade Buckman preemption, force the disclosure of previously concealed "new" drug risk information, and obviate the FDA's approved-labeling requirement that was previously in conflict with labeling required by state law. Since the FDA labeling regime does not require that its previously-approved label be retained in light of new drug risk information, it follows that a conflict cannot arise between what the FDA requires and what state law requires. No conflict, no preemption.

Posted by: implied preemption | December 25, 2008 11:43 PM

And I should add: if you disagree with even this narrower reading of Buckman, too bad -- the parties aren't relitigating Buckman in Wyeth v. Levine.

Posted by: implied preemption | December 25, 2008 11:48 PM

As a participant in the Vioxx settlement I can assure you it stinks, they need to very careful a decision.

My rights were tossed to the side. Talk about duress. Part of the agreement was that if I did not participate, my lawyers had to drop me (after 6 years)and I would need to start all over again.

Under the agreement, my lawyers HAD to recommend that I join the agreement. Under my contract with them, I had to do it.

Then, the negotiating committee tossed in everything, including the sink, to Mercks lawyers.

I am being penalized for taking heart medication AFTER my MI. My medical records prove I did not have a heart condition prior to taking Vioxx.

Once the TPA looks over the claim, Merck still gets to approve or deny the claim at their own whim, at there is not a thing one I can do about it. If I challenge the decision and lose, I'm tossed out with nothing and cannot come back on Merck, ever.

I'm pretty sure just a few of my civil rights are in question here, but Judge Fallon put his Ok to it.

Think about it.

Posted by: EDP | December 26, 2008 3:34 PM

Implied, do you know when the last time the FDA determined a pharmaceutical committed fraud? I'm not asking to be sarcastic - I'm genuinely curious.

Posted by: Justinian Lane | December 26, 2008 6:25 PM

I happen to know the answer to Justinian's question because I've done a fair amount of work tracking it down relevant to our Michigan preemption law, which also has an alleged "fraud exception." I have used FOIA's which FDA has responded to.

There is not a single case - NOT ONE - since 1992 in which FDA/DOJ found a company guilty of deliberate (felony) fraud in the context of failure to warn (There are a few well known such cases in the context of off-label promotion, mainly because the FDC virtually forces DOJ to take action in some circumstances.)

FDA folks themselves told me this was not because companies have become more 'angelic.' It is because once they get a remediation agreement, label change, or drug pull, they have no particular interest or resources to pursue the arduous and costly process of prosecuting fraud.

So the so-called "fraud exception" to preemption - in Michigan and nationally - is itself fraudulent.

Posted by: Justice in Michigan | December 30, 2008 4:40 PM