Vioxx Appeal Turns On Preemption Controversy
17 CommentsBy Ed Silverman // January 22nd, 2008 // 9:34 am
With all that attention focused on the Vioxx settlement and how many people have registered to participate in the $4.85 billion deal, the first appeal of a Merck loss is largely going unnoticed. Last week, a New Jersey state court heard arguments concerning a $13.5 million product liability verdict that was awarded to John McDarby and a small consumer fraud verdict for Thomas Cona, reports The New Jersey Law Journal (subscription required). Both men suffered heart attacks.
Merck’s lawyer, Doug Eakeley, argued that an “overwhelming accumulation of error and unfairness” warranted reversal, and contended Superior Court Judge Carol Higbee shouldn’t have let jurors in the McDarby case second-guess the FDA’s approval of a label that didn’t warn of heart attack risks, which is otherwise known as preemption. He maintained Higbee withheld from evidence a 2005 FDA memo detailing the history of Vioxx approval and excluded a former federal regulator’s testimony, the paper writes.
But Eakeley also argued that since the state’s Product Liability Act “cedes jurisdiction to the FDA,” there was no need to reach the preemption argument. He said the trial court improperly left it to the jury to substitute its own judgment. “The trial court directed the jury to conclude the FDA got it wrong based on no other data,” he said, according to the Journal. Pressed on why Merck didn’t change the label as soon as it learned from its own study that there was a fivefold increase in heart attacks among Vioxx users, Eakeley said Merck initially did not view those results as “statistically significant,” and it was not until later that the FDA determined the heart risks were sufficient to require a warning.
Arguing for the plaintiffs, Ellen Relkin contended her clients more than met their burden of proving that Merck concealed its knowledge about heart risks and refused to change its label even after the risks were reaffirmed by its own study. She argued the product liability claim isn’t preempted by the 2006 labeling amendments preamble, the paper wrote. “The preamble does not carry the force of law, it is internally inconsistent and it represents nothing more than a blatant and impermissible arrogation of power by a federal agency which has been excoriated by scholars and consumer groups,” Relkin said.
Source: The New Jersey Law Journal
Justice in Michigan
As I recall (but could be wrong), the FDA’s 2005 memo was part of its own attempt to explain why the agency acted as it did, took fourteen months to make the label change after the Advisory Committee recommended it in 2001, etc. Does anyone know who the “former federal regulator” was?
Ed Silverman
Dear Justice,
The former FDA person was Lisa Rarick.
ed at Pharmalot
Lisa Van S
Ed,
Why have Reporters become Cowards?…
Lisa Van S
Some times I question the ‘INTEGRITY’ of the Starledger!!!
Lisa Van S
Ed,
“Pharmalot” is a part of the Starledger.
Ed Silverman
Lisa,
Pharmalot is owned by The Star-Ledger of NJ, but is run separately, in so far as the site is independent of the newspaper and its own newsgathering process. Also, if there is an issue to discuss, what does have to do with Vioxx and preemption?
ed
Lisa Van S
You are right,.. This has nothing to do with preemption. As far as being Independent of the newspaper, thats crap!!! You criticise DTC, Pharmalot has been heavily promoted in the Starledger, As Industry would say,.. your claims have no merit.
Ed Silverman
Lisa,
Since Pharmalot is owned by The Star-Ledger, it will get promoted in its pages. But the editorial content is run independently of the effort to hunt and gather info to place in the newspaper, and vice versa.
ed at Pharmalot
Lisa Van S
Ed,
That was a very Diplomatic response!!
Justice in Michigan
Meanwhile, back to the topic…Thanks re: info on Larck, Ed.
This is precisely the kind of case that, ideally, should be the one upon which the Supreme Court rules on preemption. Here we have FDA’s own Advisory Committee recommending a label change with CV warning. Then the famous fourteen months. During which what happened? Was this careful scientific review of available data? A conscientious attempt by the experts, in FDA and company, asessing the issues, pooling the studies, weighing the risks and benefits, to come up with the most appropriate label?
Or was it something entirely different.
Most of us have read the descriptions (especially in the WSJ) of what actually transpired during those fourteen months. It provides a pretty good picture of how the time was actually used, what the motives and tactics were on Merck’s side, how they fared (very well, thank you), and so on.
So you have to imagine the same process, but entirely without the possibility of civil liability. None whatsoever.
Does anyone imagine the Vioxx label would _ever_ have changed? Before APPROVe? I would genuinely love to hear the scenario in which it would have.
Justice in Michigan
p.s. Someone may raise the question: But doesn’t the FDAAA now allow FDA to make label changes unilterally?
Response:
1. Yes, but the preemptors were arguing their case when the situation was as above. So, from their perspective, the change was irrelevant.
2. FDA may technically have that authority, but will they use it? What degree of delay will be provided through a process of company appeals, hearings, reviews, etc. etc. etc.
My guess is that may be about as easy to squeeze out fourteen months delay in the situation now as during the situation then.
Bob
Wow…
Someone with the initials LVS seems to be in a manic state right now…
Lisa Van S
Bob
Takes one to know one!.. If I were you, I wouldnt read anything into my conversation with Ed…. Its a NJ thing,… An Issue unfamiliar to you. Gee,.. thought you got hit by a bus!…
Lisa Van S
Justice in Michigan,
Sometimes, NJ Issues trump,.. Sorry to say ,.Michigan Issues. Hope you undersatand.
ol cranky
Lisa:
With all due respect, ads for pharmalot in the star-ledger (and vice versa) are very different from DTC issues. A reader is capable and permitted to decide for him/herself whether to read or subscribe to either publication. patents, in general, neither have the experience or training to know enough about prescription pharmacologic interventions to decide when it is safe and appropriate for them to do so (heck, most people take way too much latitude with their use of OTCs and so-called supplements). As such, these drugs are dispensed only with a prescription from a licensed HCP. DTC is used to sway people to self diagnose, pressure their HCP to prescribe and/or find someone else who will get them access if their HCP will not. In a health care setting, people are patients, not just consumers.
IMNSHO, DTC advertising of any and all systemically available treatments (including OTC drugs, “nutritional supplements” and vitamins) should be limited to those that meet GMP standards and should be required to be factually accurate. No manufacturer should be able to advertise and make claims for their product that have not been substantiated (i.e. “in clinical studies, people lost significant weight. . .” with a small disclaimer that the claims have not been approved by the FDA).
shade
ol’ cranky:
I agree that OTC and other supplements ought to be factually accurate. As I understand it though - DTC advertising of OTC drugs are monitored by the FTC, not the FDA. And some have been getting dinged lately for unsupported claims - like the “male enhancement” drug whose name has slipped my mind - Enzyte? They had to change their ad.
ol cranky
Shade:
you’re correct, the supplement industry is regulated by the FTC and they do a pretty pitiful job (possibly because they’re outside their realm of experience in evaluating the claims and are unable to understand that, on the rare occasion the cited clinical studies have actually been conducted, they haven’t been conducted using the actual product being advertised). Not that I have a great deal of faith in the FDA, I do think FDA regulation of OTC supplements/vitamins, etc. would be a marked improvement from the lax governance by the FTC.