Friday, August 19, 2005
Vioxx and Merck: The blogosphere responds
As you have heard, Merck loses the first Vioxx case:A Texas jury on Friday found drug maker Merck & Co. Inc. negligent in the death of a man taking its popular painkiller Vioxx and awarded his widow $253 million in the first of thousands of Vioxx lawsuits to go to trial.PointofLaw.com:
The stunning verdict was certain to be greatly reduced under Texas law, but Merck's stock fell sharply as investors feared it could set a precedent for more than 4,200 lawsuits charging that the company hid the drug's' health risks.
"So, in essence, the jury expropriated Merck's Vioxx sales from Oct. 2001 through Feb. 2002. Though the verdict seems not to have been structured as a punitive award (Texas has a strict limitation on punitives at twice economic damages and $750,000 above noneconomic awards), it sure sounds like one.
And thousands of other Vioxx suits are pending--for which this expropriative penalty won't have any preclusive effect."
Evan Schaeffer's Legal Underground:
"One important thing to take away from today's verdict, even though it will presumably be reduced by virtue of the Texas law on punitive damages, is that this was a case perceived to have causation problems that made it virtually unwinnable for the plaintiffs. The verdict is very good news for victims of Vioxx and a terrible omen for Merck."
Galen's Log:
"This isn't about justice. This is about greed. While I doubt the excessive settlement will survive appeal, there will be thousands of such cases coming. Whatever profit Merck mananged from Vioxx, it won't be enough. Did Merck bring it on to themselves? One should consider that the Vioxx debacle could happen to any and every pharm company. Whatever their sins, none of us will be well served by destroying the pharm industry.
Even the other victims of Vioxx should be angry. The first hand in the cookie jar just took a big handful."
CancerDoc:
"Does anyone think that the recent verdict against Merck in the Vioxx debacle will actually change anything? Lawsuits are pending and this $253 million verdict will certainly have repercussions for the next few years. I suppose this is an example of the system responding to the overwhelming influence of Pharma on health care. I guess only time will tell if any longlasting effects will occur."
Corante - In the Pipeline:
"It shouldn't be any surprise to find out that I think that this is terrible news. While I think Merck really pushed Vioxx too hard, as have the other companies with COX-2 inhibitors, I don't see a way to justify that large an award. This might open the door to a number of such awards, and Merck could end up spending its money fighting for its life rather than trying to bring new drugs to market. Enough of these losses, followed by losses on appeal, could sink the company completely.
I know, I know. They should have thought about that before flogging Vioxx to everyone that could bend their finger joints, right, right. But if every new drug we take to market is going to have a reasonable chance of ruining the company, why bother? And I know the answer to that one, too: 'just make sure they're safe.' What tiny words "sure" and "safe" are. You wouldn't think that they could cause the trouble that they do."
***********
What do I think? I believe that the science was on Merck's side. After all, there are many other causes of sudden cardiac death that are unrelated to Vioxx. Only 65 to 70 percent is attributable to heart disease, 10 percent due to structural heart disease, and 15 to 30 percent noncardiac in origin. That leaves a definite possibility that Vioxx was not responsible for Mr. Ernst's death.
That being said, Merck got killed on trial. Their expert witnesses came off poorly, and the plaintiff's lawyer skillfully played the emotion card - which certainly trumped science in this case.
Posted by Kevin |
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Comments:
Facts that are irrefutable (look up the VIGOR and APPROVE clinical trials to see for yourself):
1) Vioxx was linked to doubling the risk of stroke/MI
2) Vioxx does NOT increase the risk of death. Let me say that again. Despite the fact that strokes/MI increase with vioxx, it does NOT increase the risk of death.
3) The VIGOR and APPROVE studies (which are the only ones that looked at the risk of CV events and rofecoxib) show that the stroke/MI risks increases ONLY after a minimum of 18 months of being on the drug.
4) Mr. Ernst was on the drug for only 8 months
5) The VIGOR and APPROVE trials studied only strokes and MI (heart attack). They never found any connection between arrythmias (Mr. Ernst's proximate cause of death) and Vioxx.
6) The absolute risk of Vioxx causing CV events is still low. According to the APPROVE study, it was only 3.5% in their study group (compared to a 1.5% risk in placebo group).
I report, you decide
1) Vioxx was linked to doubling the risk of stroke/MI
2) Vioxx does NOT increase the risk of death. Let me say that again. Despite the fact that strokes/MI increase with vioxx, it does NOT increase the risk of death.
3) The VIGOR and APPROVE studies (which are the only ones that looked at the risk of CV events and rofecoxib) show that the stroke/MI risks increases ONLY after a minimum of 18 months of being on the drug.
4) Mr. Ernst was on the drug for only 8 months
5) The VIGOR and APPROVE trials studied only strokes and MI (heart attack). They never found any connection between arrythmias (Mr. Ernst's proximate cause of death) and Vioxx.
6) The absolute risk of Vioxx causing CV events is still low. According to the APPROVE study, it was only 3.5% in their study group (compared to a 1.5% risk in placebo group).
I report, you decide
# posted by 
: 8:51 PM
: 8:51 PM
I think I would believe your report more if you offered cites and you weren't anonymous. One brief google search yielded the following article.
http://ccjm.org/PDFFILES/Karha12_04.pdf
On the second page is a graph of cumulative incidence and it looks compelling. I know nothing about the relative merits and I'm sure that this is one of hundreds of such articles, but it's hardly as cut and dry as you are suggesting. Please give the cites for each of the points above so I can make an informed decision. Are these points due to lack of data or lack of evidence. (For example, did they collect detailed long-term mortality information. My recollection is that these studies were way too short for those kind of endpoints.)
Thanks.
P.S. You need to read the article that Kevin is linking to since it explains #5. The plaintiffs put on a videotaped deposition of the coroner who did the autopsy where she specifically addressed that point and (in the opinion of the reporter) devastated the defense.
http://ccjm.org/PDFFILES/Karha12_04.pdf
On the second page is a graph of cumulative incidence and it looks compelling. I know nothing about the relative merits and I'm sure that this is one of hundreds of such articles, but it's hardly as cut and dry as you are suggesting. Please give the cites for each of the points above so I can make an informed decision. Are these points due to lack of data or lack of evidence. (For example, did they collect detailed long-term mortality information. My recollection is that these studies were way too short for those kind of endpoints.)
Thanks.
P.S. You need to read the article that Kevin is linking to since it explains #5. The plaintiffs put on a videotaped deposition of the coroner who did the autopsy where she specifically addressed that point and (in the opinion of the reporter) devastated the defense.
If the punitive award, which under Texas law will be reduced to $26 million, were to be awarded to say, the National Institutes of Health, would so many of you be so against it?
What if punitives went somewhere besides the plaintiff?
What if punitives went somewhere besides the plaintiff?
This case is an elegant example of the failings of civil jurisprudence in this country - it chooses to not only compensate but adminster punishment. Criminal jurisprudence requires a "beyond a reasonable doubt" standard in order to administer punishment. No such standard limits civil juries. In this case there is well beyond a reasonable doubt regarding refecoxib's role in Mr Ernst's death. Nonetheless, 12 Texas jurors saw fit to enact a severe punishment. But, Merck is rich, you say. Ok, but 224 million is a lot of money. How many uninsured Americans would have healthcare with that investment? Also, I'm not sure the any greater good is served by lawyers, as Evan Schaefer points out, shopping for new Gulfstreams.
The jury decided to compensate, their assumed job - but to the tune of 24 millions dollars. That is interesting in itself. If I died today my projected earnings until retirement would be approx 5 million over 30+ years. Did Mr. Ernst, 6 years from retirement age have a remaining lifetime projected income of 24 million dollar? If so I'm going to go work for Walmart.
If civil juries are given the freedom to punish, they need higher standards. Emotions masquerading as facts do nothing to strengthen our justice system. Rather, they make civil jurisprudence an unregulated arm of governance.
The jury decided to compensate, their assumed job - but to the tune of 24 millions dollars. That is interesting in itself. If I died today my projected earnings until retirement would be approx 5 million over 30+ years. Did Mr. Ernst, 6 years from retirement age have a remaining lifetime projected income of 24 million dollar? If so I'm going to go work for Walmart.
If civil juries are given the freedom to punish, they need higher standards. Emotions masquerading as facts do nothing to strengthen our justice system. Rather, they make civil jurisprudence an unregulated arm of governance.
# posted by : 9:54 AM
: 9:54 AM
Chuck, based on your review of the testimony and evidence presented at trial, what would have been appropriate?
The whole - $224 million would have insured a lot of Americans - is a canard. If physicians received a punitive damage verdict against health insurers, couldn't we argue the same thing?
The purpose of punitives is to deter conduct. We can't jail a company for negligence. Companies only exist to make money, so to change their actions society has decided that we will punish them using money. The amount reflects the jury's judgment on what it would take to deter similar conduct in the future based on Merck's earnings. Of course, Texas law will knock it down significantly.
What number did you have in mind?
The whole - $224 million would have insured a lot of Americans - is a canard. If physicians received a punitive damage verdict against health insurers, couldn't we argue the same thing?
The purpose of punitives is to deter conduct. We can't jail a company for negligence. Companies only exist to make money, so to change their actions society has decided that we will punish them using money. The amount reflects the jury's judgment on what it would take to deter similar conduct in the future based on Merck's earnings. Of course, Texas law will knock it down significantly.
What number did you have in mind?
For what it's worth, I think Merck earned this loss. I was aware there was a problem early on and advised my parents away from taking COX2 inhibitors because of a rising amount of data suggesting the negative effects. Merck had to have known this as well. The studies at that time were not controlled for cardiac risk though, so you couldn't draw any hard conclusions. HOWEVER, if Merck really was downplaying the risk in their marketing to doctors, then they were taking a big chance. I often hear academic physicians complain that drug reps are misleading physicians about the risks and effectiveness of the drugs they peddle, and that they have become more effective in recent years by displaying marketing pieces made to look like journal articles. From the reaction of jury members, it sounds like the plaintiff's attorney used this marketing to convince jurors that Merck was playing down a known risk. I think this verdict is the chickens coming home to roost.
The present concept of punitive awards as practiced in the USA is a shameful canard. What it amounts to is a delegation--or rather a shirking-- of criminal due process to the civil judiciary, with the attendant lower standard of proof and the potential great enrichment of the civil tort bar. Never mind having to show actual damages: all that matters is how you feel about those damages, and if you feel really bad, well, the sky is the limit.
I wonder how our gullible public would feel about delegating other forms of punishment reserved to the state? If I can fine my neighbor, why can't I also imprison him?
Punishment belongs to the state, it shouldn't be passed off to the tort bar, no matter how greasy the palm.
I wonder how our gullible public would feel about delegating other forms of punishment reserved to the state? If I can fine my neighbor, why can't I also imprison him?
Punishment belongs to the state, it shouldn't be passed off to the tort bar, no matter how greasy the palm.
# posted by : 1:49 PM
: 1:49 PM
I agree with the previous commenter. If wrongdoing was committed, the proper venue for punishing that wrongdoing is the criminal court system. The system of punitive damages being assessed by civil courts is seriously flawed, particularly in cases like this with thousands of local trials each with widely differing standards of jurisprudence. The public good, and justice itself, would be better served in the criminal court system.
# posted by : 3:29 PM
: 3:29 PM
"How do you punish a company in criminal court?"
You prosecute their officers. You prosecute the company as a corporate entity. Convicted officers can be fined or imprisoned. Convicted corporations can be fined.
You prosecute their officers. You prosecute the company as a corporate entity. Convicted officers can be fined or imprisoned. Convicted corporations can be fined.
# posted by : 3:11 PM
: 3:11 PM
Whew! Now that Martha Stewart is under House Arrest and you guys want to put Gilmartin in jail, i'm much less worried about Bin Laden running around out there, and not worried at all that there are Ten Level 3 Sex offenders living in my zip code.
# posted by : 3:22 PM
: 3:22 PM
"You prosecute their officers. You prosecute the company as a corporate entity. Convicted officers can be fined or imprisoned. Convicted corporations can be fined."
You have to prove a criminal offense beyond a reasonable doubt. That would be almost impossible for what is usually negligence.
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You have to prove a criminal offense beyond a reasonable doubt. That would be almost impossible for what is usually negligence.
# posted by : 12:09 AM
: 12:09 AM
