“If you are distressed by anything external, the pain is not due to the thing itself, but to your estimate of it; and this you have the power to revoke at any moment.”
Two of the earliest Vioxx suits which went for the plaintiffs have been overturned or reduced. In Texas an appeals court overturned a twenty-six million dollar verdict. In New Jersey the court reduced the award for a plantiff who blamed his MI for a heart attack from fourteen million to nine million. Both were clients of Mark Lanier.
Mark Lanier, a plaintiffs’ lawyer who was involved in both cases decided Thursday, criticized the decisions and promised appeals. But plaintiffs face an uphill battle.
In the Texas case, three appeals court judges simply reversed the verdict of a jury that had spent six weeks hearing testimony from more than a dozen witnesses. Essentially, the appeals court threw out the views of the plaintiffs’ experts.
“The judges wrote a simple decision that defies medicine and the trial itself,” Mr. Lanier said. He said he would appeal the verdict “to the Supreme Court, if necessary.”
At this point, beyond the individuals seeking damages, these rulings have little impact. Merck has already reached a settlement. The appellate courts’ rulings do however continue the demonstration of the weakness of the plaintiff’s claims against Vioxx. As the NYT says,
The rulings on Thursday leave lawyers for plaintiffs with just three victories, all with relatively small verdicts, in the nearly 20 Vioxx cases that have reached juries.
So news that ghostwriters contributed to VIGOR and other Merck studies of Vioxx are making the rounds. Here’s the WSJ Health Blog on the report. The ‘revelation’ appears in what is essentially a glorified editorial in JAMA. While I don’t know about the Vioxx studies in particular ghostwriting is not something new within medical publishing and not something I find reprehensible in general. As for what Merck did in particular the JAMA editor-in-chief is flailing out,
AMA itself published one of the Vioxx studies that was cited in Dr. Ross’s article.
In that case, in 2002, a Merck scientist was listed at the lead author. But Dr. Catherine D. DeAngelis, the journal’s editor, said in a telephone interview Tuesday that, even so, it was dishonest because the authors did not fully disclose the role of a ghostwriter.
“I consider that being scammed,” Dr. DeAngelis said. “But is that as serious as allowing someone to have a review article written by a for-profit company and solicited and paid for by a for-profit company and asking you to put your name on it after it was all done?”
Despite that much of the evidence in the published JAMA ’study’ is essentially circumstantial and at least some of the accused have come forward to say that the authors of this new study are simply downright wrong.
[A]t least one of the doctors whose published research was questioned in Wednesday’s article, Dr. Steven H. Ferris, a New York University psychiatry professor, said the notion that the article bearing his name was ghostwritten was “simply false.” He said it was “egregious” that Dr. Ross and his colleagues had done no research besides mining the Merck documents and reading the published medical journal articles.
Look, Vioxx is dead and I’m just not sure there is much to be learned for future practice. The nature of what went wrong has been sensationalized ot no end and any study of the practices which led for big bad Vioxx to harm so many people will be likewise sensationalized and of little real value in reforming pharmaceutical related research and the drug approval process.
I’ll hide my insecurity and not even try to argue concerning my typos,
Please be more precise in your practice of medicine than you are in your blogging! First off, I (Mark Lanier) was not the “defense attorney.” I was the “Plaintiffs’ attorney.”
Or apparent lack of empathy,
The guy who wrote this original article is an idiot. He is young, doesn’t care about other people…
You can certainly get a chuckle out of the flamboyant messages and the commenters’ complete lack of understanding of statistics by reading the comments as linked to above.
I will try to shed some light on whether Mark Lanier is wasting his time lurking on obscure medical blogs (From Medskool gets ~100 unique visitors a day and hosts a far from thriving debate on Vioxx litigation). The poster does use Mr. Lanier’s readily available public email address but the IP address logged takes us out to Avon, Colorado. Not New York or Los Angeles or Houston.
That doesn’t preclude it from actually being Mark Lanier, maybe he owns a ski cabin up there or something of the sort.
If it actually is him and Mr. Lanier visits the site again I welcome him to continue to comment.
In anycase, if you’re interested in reading some actual refutation of the claims made by Mark then (as always) head on over to Overlawyered’s post.
Merck recently anounced one of the biggest settlements in American civil history for those plantiffs suing it over the infamous COX-2 inhibitor Vioxx. When Merck first got sued their liability was estimated as high as $25 or 30 billion dollars, but Merck did surprisingly well with its promise to fight each suit individually.
Take that back - stunningly well.
But the legal fees and the uncertainty factor weighing on its stock and earnings made settling (finally) in Merck’s best interest. A few days ago I was sympathetic to their decision from a financial standpoint but bemoaned it based on the job they had done showing looney-bin plantiffs out to make a buck what life is all about.
But now, the Los Angeles Times has a story saying Merck may have gotten an even bigger last laugh than I initially suspected. On the surface, $5 billion dollars is a lot of money, but probably chump change when you consider the decades of legal fees they’re facing (and the occasional award charged to them). And of course its pocket change compared to what some suspected would be Merck’s original liability for Vioxx.
The highly unusual agreement not only requires 85% of plaintiffs to agree before it can be finalized but also might unduly force some claimants to settle or risk losing their lawyer.
That’s because the deal includes highly unusual restrictions on plaintiffs’ lawyers. The settlement requires them to recommend the deal to all of their clients or none. In addition, lawyers must stop representing any clients who turn it down as long as they don’t violate ethics rules.
Settle or lose your lawyer.
“It’s always the clients’ decision to accept a settlement or not, and lawyers aren’t going to do anything that’s unethical,” he said. But “those considering this should know these are not easy cases to try in court.”
The emphasis is my own for the funniest line in the entire story. That’s not the point though. The point is, there is no major plantiff lawfirm who is going to let their clients walk away from this deal.
“Look The Settlement Is Just Like Cotton Candy. You Like Cotton Candy, Right?”
The biggest plantiff attorneys are going to be selling this settlement to their clients, like pie to a fat kid. You’re either going to take the deal or you’re going to end up some shaftball attorney representing you when you go to trial. Good luck getting a dime out of Merck represented by some guy working out the warehouse district.
Oh the woe. The pharmaceutical industry couldn’t give two-cents about the status of physician’s medical liability, so let us not confuse the issue. Even so, I thought that the Vioxx trials were a clear example of the kind’ve litiganous society we’re living in.
So many cases, with so many risk factors for CAD and yet somehow these plantiffs who had taken Vioxx for all of a week in some cases felt that they knew Vioxx had caused their heart attack and they expected a jury of their peers to come to the same conclusion.
Merck’s initial refusal to settle these cases and to take them all on was not decided based on anything but the finances I’m sure, but still held some nobility in a world where so many are forced to duck and cover when pelted with medical lawsuits. But after three years of putting up such a fight, Merck has finally settled for nearly $5 billion dollars.
As proof of the soundness of their decision from a financial standpoint, their stock immediately went up. Still it is sad to see considering Merck’s ’success’ in defending itself to this point.
The settlement, one of the largest ever in civil litigation, comes after nearly 20 Vioxx civil trials over the last two years from New Jersey to California. After losing a $253 million verdict in the first case, Merck has won most of the rest of the cases that reached juries, giving plaintiffs little choice but to settle.
Pressure on Merck to not continue to tie up the court system, is ridiculous if true.
Judges in Louisiana, New Jersey and California, who oversee nearly all the lawsuits, had pressed for a deal before a new wave of trials was scheduled to begin in January.
[Plantiff attorney Danny] Becnel credited Judge Eldon Fallon of Federal District Court, who is overseeing the federal lawsuits from his court in New Orleans, with pressing the two sides to the table.
“He had everything to do with it,” Becnel said. “He was critical.”
A much more reasonable pressure to apply would’ve been to the steering committee for the plantiff attorneys, for them to drop most of their markedly frivolous cases.
But, even with that pressure Merck still obviously made this decision as a financial one.
Merck, which has already spent more than $1.2 billion on Vioxx-related legal fees, the settlement will put to rest any fears that Vioxx lawsuits might bankrupt the company, or even have a significant financial impact. While eye-popping, the settlement payment represents less than one year’s profits for the company, the third-largest American drug maker.
[T]he agreement is far smaller than Wall Street analysts and lawyers predicted when Merck withdrew Vioxx, and especially after the verdict in the first case. In 2005, most analysts estimated that Merck’s ultimate liability in Vioxx would be between $10 billion and $25 billion.
Another chapter comes to a close in the Vioxx ordeal.
[N]one of the 45,000 people who have sued Merck, contending that they or their loved ones suffered heart attacks or strokes after taking Vioxx, have received payments from the company. The lawsuits continue, for now in a state of legal limbo, with little prospect of resolution.
In combating the litigation, Merck has made an aggressive, and so far successful, bet that forcing plaintiffs to trial will reduce the number of Vioxx lawsuits and, ultimately, its liability.
Promising to contest every case, Merck has spent more than $1 billion over the last three years in legal fees. It has refused, at least publicly, to consider even the possibility of an overall settlement to resolve all the lawsuits at once.
The strategy’s successes, from the view of Merck and its shareholders, are clear. In the last year, the company has won most of Vioxx cases that have reached juries. Though its stock plunged immediately after the Robert Ernst verdict, it has since risen 80 percent, easily outpacing those of other big drug makers. And estimates of Merck’s ultimate liability, once as high as $25 billion, are now closer to $5 billion, said C. Anthony Butler of Lehman Brothers.
I’ve sounded like a schill for pharma on this blog when it comes to Vioxx but you cannot read these case reports and news articles of individual suits and not be stunned. People with incredible risk factors for MI and CVD or with diagnosed CAD, who take Vioxx for two weeks and then want to put some responsibility for their MI on the drug? Not even a physician could sit up there with a straight face and give a completely accurate percentage for Vioxx’s contribution to the plantiff’s heart attack (versus all their other risk factors) in most of these cases. And we want twelve lay men and women, who have nothing better to do than serve on a jury, to sort it out?
Get real. I continue to applaud Merck for fighting every single Vioxx case.
The New Jersey Star Ledger (via WSJ Health Blog) comments on the mail and email and calls Merck recieves asking them to put Vioxx back on the market. How does the ridiculous Consumer Union respond?
A skeptic from Consumers Union says: “A person’s conviction that something is helping them or that only one thing will help them is often erroneous. The impact may be exaggerated.”
Are you kidding me? Big Brother knows what is best?
Vioxx Helped A Lot Of People
The fact all the information wasn’t out there about Vioxx’s risk was a terrible shame. I don’t know what to believe in terms of whether there was some element of deliberate deception in that. But…when it comes to drugs, as long as:
1) There is some benefit from taking it
2) All the risks are out in the open
…then people and their physicians should be able to weigh the risk versus benefits for themselves. They shouldn’t have the FDA do it for them (yeah, yeah Vioxx was ‘withdrawn’ by Merck).
The panel fielding the question on whether to approve the pain killer in the U.S. voted 20 to 1 against it! Okay, it isn’t that shocking, as we’ll see this was expected. But still, 20 to 1!
Food and Drug Administration officials were unusually harsh in their criticism of the medicine. “What you’re talking about is a potential public health disaster” if Arcoxia is approved for sale, Dr. David Graham, an F.D.A. safety officer, told the panel.
This is a little bit of an offbeat comparison. Mind you it is a comparison which Merck itself undertook,
The studies showed that Arcoxia causes nearly three times as many heart attacks, strokes and deaths as naproxen, a popular pain pill sold as Aleve, but was no more effective in curing pain. Patients taking Arcoxia suffered worrisome increases in blood pressure.
Consider that naproxen is by prescription only in most of the world, but in the U.S. a twelve year old can walk out of the grocery store with bottles of Aleve. Meanwhile, ectoricoxib (Acroxia) is available by prescription in plenty of countries but not in the U.S (ed: according to Consumer Affairs it is available in 62 countries).
Clearly the FDA knows something a good chunk of the world doesn’t?
That isn’t to say I disagree with the decision on Acroxia. Without reading anything but what is published by the NY Times, it is hard to disagree with the conclusions of the panel,
Dr. James Fries, a panel member and rheumatologist from Palo Alto, Calif., dismissed Merck’s argument that arthritis sufferers need a pain pill that is no different from the 20 others that they can already take. “A new drug has to have some reason” to use, Dr. Fries said.
Agreed Martha Solonche, a panel member from New York, said: “The idea should not be that we need new drugs. The idea should be that we need better drugs.”
This conclusion on Acroxia has been coming for months and months. From Consumer Affairs back in September 2006,
David Graham, a Food and Drug Administration insider, claims the new drug, Arcoxia, may be as risky for the heart as Vioxx.
Graham aired his concerns in an editorial posted on the Journal of the American Medical Association’s website. In characteristically blunt language, Graham accused the pharmaceutical giant of engaging in “misdirection and disinformation presented in the guise of science.”
There is no real surprise with the panel’s findings. But I suppose it brings up an oppurtunity for what I think is a real question. What do we want government’s role to be in the whole drug business. Do we really want them running the risk vs. benefit analysis for us? “Well, we can see absolutely no circumstances anytime, why any doctor or his patient would want to use this drug…so phoey with it!”
There’s the optimistic hope that many of these cases were filed in the hope that Vioxx would go class action, and the defendants would get paid off without huge legal proceedings or expenses. But as the time drags on and Merck continues to win cases it is becoming clear to a number of these baloney trail lawyers that it isn’t worth it sticking around.
I really wonder whether the Plaintiffs’ Steering Committee (or individual trial lawyers with large inventories of Vioxx cases) are buying off plaintiffs with weak cases so that Merck doesn’t have a pile of victories in the early going, something that has effectively shut down other pharmaceutical mass tort litigation that settled for nuisance sums.
[The commercial] is unusual for its length — two-and-a-half minutes rather than the usual 30- to 60-second spots — and for the fact that it was the sole sponsor of the ABC newscast, meaning that there were fewer commercial interruptions and fewer minutes over all devoted to advertising. It was the only ad during last Monday’s program.
The ad uses animated line drawings rather than actors, with a voice-over narrator who spends much of the time comparing Celebrex with the safety of other painkillers and discusses the risks associated with it use.
At least one consumer advocacy group is getting its name in the media by raising a little tussle over the ad.
Public Citizen, a consumer group, asked the Food and Drug Administration this morning to ban the Celebrex television commercial, alleging that it gives consumers a false impression that the prescription drug has no more safety risk than some other painkillers.
Dr. Wolfe, [director of Public Citizen’s Health Research Group,] in his letter to the F.D.A. commissioner…said that the ad violated the law because it contained “false or misleading statements” that might lead consumers to underestimate the risks of Celebrex and use it instead of safer painkillers that are just as effective.
“The overall purpose of the ad is to make it appear, contrary to scientific evidence, that the cardiovascular dangers of Celebrex are not greater than those of any of the other Nsaid painkillers,” the letter said, referring to nonsteroidal anti-inflammatory drugs. “Further, it asserts that certain gastrointestinal problems are, if anything, less frequent with Celebrex than with two popular over-the-counter (OTC) painkillers.”
You need to go read Point of Law’s new post on the most recent Vioxx dismal. The case was dismissed with prejudice by the Plantiff. If you haven’t been paying attention this is one of many suits to come to such a conclusion.
I can honestly say I thought the large number of plantiffs dropping cases was odd.
I figured however the ranks of those plantiff dismissed suits were rife with attorneys who were in the game waiting for Merck to lose some and go the way of a class action settlement. As the process dragged on, and with a ‘weak’ case on their hands they bailed instead of facing the cost of a trial.
That reasoning might display my complete ignorance of the legal process. In any case, Point of Law has some very different and interesting reasoning:
I really wonder whether the Plaintiffs’ Steering Committee (or individual trial lawyers with large inventories of Vioxx cases) are buying off plaintiffs with weak cases so that Merck doesn’t have a pile of victories in the early going, something that has effectively shut down other pharmaceutical mass tort litigation that settled for nuisance sums.
Point of Law finds faults in a Vioxx trial which went to the jury on December 20th in California. Including the fact the case involves two defendants with wildly different facts of case.
Jurors Returned Home To Prepare For The Holiday Season
Lawyers for Albright, who works in the paint department of a Lowe’s store, told jurors he should receive as much as $5.75 million in his lawsuit. But jurors rejected Albright’s claims that Vioxx caused his heart attack and that the company failed to reveal potential dangers of the drug before pulling it from the market in 2004.
The best quote come from the the plantiff lawyers, the same ones who know just enough science to think cyclooxygenase is when you put air in you bike’s tires.
That wasn’t funny. Okay, in anycase,
‘’We’re disappointed, but it’s tough when you go against a Goliath,'’ he said.
Oh if only you had remembered to bring your slingshot to court!
Yes, that is the reason you lost. You didn’t lose because your client was obese with a history of diabetes and hypertension.
The jury needed well under two hours to decide that Vioxx was not the primary cause of 51-year-old Anthony Dedrick’s 2003 heart attack and that Dedrick’s physician had adequate warning from Merck of the Vioxx heart risks.
During the trial there was testimony that Dedrick, who took Vioxx for his arthritis for six months before his heart attack, had abused cocaine and alcohol and was a heavy smoker.
“The alcohol and cocaine abuse certainly make it a most challenging case; we recognized that going in,” Birchfield said.
“But we also recognize Mr. Dedrick was taking Vioxx for six months and he was exactly the kind of patient who should not have been taking it.
And oh yeah, he was a diabetic, with hypertension, and a terrible lipid profile. Still, even with the drug use I think this case is less outrageous than say…Garza v. Merck.
With the new HPV vaccine and success in the litigation arena, Merck is holding itself up quite well after what some thought would be a company crushing disaster when Vioxx was first pulled. Maybe this’ll encourage other large manufacturers (laden with resources to fight) to forgo the class action path when there are questions about the validity of plantiff claims (everyone jumps on that bandwagon when commercial products go bad).
I did my undergrad work in USC's School of Cinema-Television Cinematic Arts. I have a Bachelors of Fine Arts in Writing for Screen & Television. I loved it, but a future of waiting tables and taking meetings with B-List producers was not for me.
This blog is ostensibly to discuss healthcare policy and maybe educate a few of my fellow medical students. But it will stray into current events, politics, and other science topics when they draw my interest
Other odd notes about me:
I've skied half the resorts on this list (Squaw Valley/Lake Tahoe, Snowbird/Park City, Whistler, Taos, Vail)
I "played" lacrosse in high school and through a club level team in college
Nothing on this website is to be taken as medical advice. I am not a physician. Please consult a physician concerning any health related questions.
This blog is entirely self funded. It accepts no advertising or other supporting revenue. The author has no relevant financial relationships to disclose.
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Endorsements
"Please be more precise in your practice of medicine than you are in your blogging!"
- Mark Lanier
