Philly Judge Rules ‘No Preemption’ In Paxil Case
9 CommentsBy Ed Silverman // March 14th, 2008 // 7:05 am
A Philadelphia judge ruled this week that federal law can’t preempt a state product-liability claim concerning Glaxo’s alleged failure to warn about increased suicide risk of its Paxil antidepressant, The Legal Intelligencer reports.
Judge Allan Tereshko, the coordinating judge of Philadelphia Common Pleas Court’s Complex Litigation Program, denied a defense motion for summary judgment, ruling that federal preemption doesn’t preclude the plaintiffs from arguing Glaxo failed to fulfill its duty to warn users of Paxil of an alleged association between the use of the drug and suicidality. The drugmaker argued that the plaintiffs should be precluded from making that argument in state court under implied preemption.
“Defendant asserts that such inquiry is precluded by federal law since the content of the drug’s label is governed by federal law and the duty to supplement the label is somehow subsumed into the (FDA) regulatory scheme,” wrote Tereshko. “Defendant’s position is clearly not sustainable. Federal law in question unquestionably places the duty upon the manufacturer and does not preempt a state’s ability to allow one of its citizens to inquire whether the manufacturer breached that duty.”
This is the ruling. Last month, by the way, Glaxo won a Paxil case when a federal judge in California ruled that preemption trumped state courts.
According to attorney Bijan Esfandiari, who reps the family of Bobby Collins, a detective who committed suicide in 2002 while on Paxil: “Naturally, this is a significant ruling in the preemption battle and will benefit all of the plaintiffs in Pennsylvania’s Mass Tort Paxil Program. We further hope that Judge Tereshko’s scholarly decision will be relied upon as persuasive authority by courts in other jurisdictions.”
The lawsuit is the first Paxil case scheduled to go to trial in the common pleas court’s mass tort program. There are 60 cases pending in the Philadelphia Paxil program, according to Stanley Thompson, the director of the Complex Litigation Center. On a larger plane, the US Supreme Court will take up the preemption issue this coming fall involving a woman who sued Wyeth. You can read her story here.
Sol Weiss, a plaintiff’s attorney, told the paper he believes Tereshko’s decision shows that people who are injured by defective drugs or relatives of people injured can maintain their lawsuits in state court. “This is a very hot area of litigation because the pharmaceutical companies want a free pass,” Weiss said. “If these claims are pre-empted, then all these people who are injured won’t have a right to recovery…The people here, all the people who took all these SSRIs, these antidepressant drugs, and committed suicide, and families can’t seek redress.”
Tereshko said that it was not Congress’ intent for federal law to preempt state causes of action and that the Federal Food, Drug and Cosmetic Act is silent on that issue. He noted that congressional hearings leading up to the passage of the Federal Food, Drug and Cosmetic Act included the decision to not include a provision for a federal cause of action because common law rights of action existed.
Andrew Bayman, a lawyer with King & Spalding, which reps Glaxo, told the paper that the drugmaker’s position has reflected the FDA position, at the time, that there was no scientific basis for a link between Paxil and suicide. Putting such a warning on the drug would thus violate federal law, he said, and a state court lawsuit determining that the warning should have been different would conflict with federal law, the paper wrote.
Bayman told the paper that the FDA has the exclusive power and authority to approve drugs as safe, to label those drugs with warnings, and has warned of the dangers of “overwarning.” “To put warnings on - which some people say would only be on there to insulate manufacturers from liability - if that warning is not based on good scientific evidence, that really runs the risk of deterring people from seeking treatment. That’s why the FDA’s job is to strike a balance.”
Source: The Legal Intelligencer
Matt
This is great news!
Justice in Michigan
Overall, the preemption defense has lost more often than it’s won. But what happens in the Supreme Ct. will make the big difference (and how Congress reacts or - ideally, in my view - pro-reacts).
The “over-warning” argument has essentially no empirical basis, btw, but it’s been a favorite of the preemptors for a long time.
The perhaps sad fact is that labels, with the possible exception of black boxes with a lot of publicity, rarely make any difference whatsoever re: rx’ing. Classic example is how Vioxx sales changed not a whit after famous label change finally happened after all those months. One can probably assume same result if that warning had really been a warning, rather than a “precaution.”
Publicity and controversy, however, do make a difference. Avandia and Vytorni/Zetia rx’ing best recent examples.
Jack2
I think even the vaunted BBW will make less of an impact in time.
I don’t have the exact numbers, but the FDA required something like 25 BBWs between 1975-2000. They required about 50 between 2004-2007. Have the actual drugs really decreased in safety that much? Each additional BBW dilutes the impact of the other. I would closely consider any legislation that makes the label less useful to inform health care decisions.
The reason adding a warning to a drug label doesn’t make any impact in sales is that the labels are already so unwieldly they become useless and warnings get lost in the shuffle. Hopefully the new labels with their more stringent adverse reaction requirements and highlights page will result in prescribers at least looking at the highlight portion more often.
Justice in Michigan
Jack 2 - If the new labelling wasn’t hitched up with preemption, I’d be more hopeful about it.
Given the reality, why do you think Merck fought so hard against the changed label on Vioxx? Do you think it would have really hurt it against Celebrex?
JM
Justice,
Isn’t it that the labeling is hitched up to marketing? That new labeling on a competitor drug may trigger a new catch phrase in marketing.
To anyone, what marketing impacts do BBWs have besides precluding reminder ads and ensuring that the boxed warning appear in other ads?
ol cranky
this is such great news. ..I can’t wait to see the additional info detailing who knew and approved of intentional miscoding of suicidality in these trials
Bob Freeman
JM, my experience is entirely anecdotal so please take it with that caveat. Health professionals I know, clinical pharmacists and physicians, tend to view assignment of a BBW as somewhat arbitrary depending on the specific drug. I suppose the seriousness or perceived lack thereof is a function of their professional experience with the drug and the therapeutic class to which it belongs. Specific examples of drugs and BBWs don’t readily come to mind this AM.
Many years ago, as a young academic, I studied ad content and found that the provision of “negative” information about a drug actually increased the believability of the ad. This research was done over 25 years ago and I’m not current with what has transpired in the literature.
Former pharma Marketing Exec
This is a good move..
What about this statement from Bayman the lawyer for Glaxo
“Bayman told the paper that the FDA has the exclusive power and authority to approve drugs as safe, to label those drugs with warnings, and has warned of the dangers of “overwarning.” “To put warnings on - which some people say would only be on there to insulate manufacturers from liability - if that warning is not based on good scientific evidence, that really runs the risk of deterring people from seeking treatment. That’s why the FDA’s job is to strike a balance.”
When is a warning not a warning? Which warnings should we be warned about? Nausea, vomiting and water retention are o.k. to know about but we mustn’t tell them about suicidal tendencies? Do we have good scientific evidence that nausea, vomiting and water retention are/can be scientifically proven as being linked to the drug? No we don’t but we report it anyway.
Patients on these drugs must be closely monitored by healthcare professionals. Their close family members need to be educated on the risks of this drug. You cannot write a script for these things then send a person off into the world. However, these drugs are sold on the basis of how they are supposed to save money to the healthcare system because these patients do not require close monitoring as what would normally happen in seriously depressed cases. Mild cases shouldn’t be medicated, lifestyle changes need to be managed.
One question I have is, how much did the treating physician do to make sure the patient was followed. What did the doctor know. Call the treating doctors to the witness stand, let them say what information they had or did not have from Glaxo. Let them tell us about the CME they received on this product.
There is a great opportunity here to bring this information to the general public.
Justice in Michigan
This goes back to JM’s comment about the relationship between label and marketing.
I’m not enough “in the know” - others will be - but it does seem logical that, had Vioxx taken on the CV warning the FDA advisory committee suggested (fourteen months before the whittled down version appeared), we might well have heard DTCAs from Pharmacia/Pfizer:
“CELEBREX: The only new arthritis medication with no increased risk of heart attack or stroke!!! And…gentler on the stomach!!”
Of course, neither claim (especially the latter), would be borne out by the facts as we know them. FDA may have tried to reign them in on the latter, but we know that - in those years when Dan Troy oversaw marketing warnings - there hardly were any.