Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases.
To contact Derek email him directly: derekb.lowe@gmail.com
Twitter: Dereklowe
From the editorial pages of the Washington Post we have this, and I could not have said it better myself:
. . .Unfortunately for Merck, scientific facts didn't play much of a role in the first Vioxx trial, which ended on Aug. 19. The Texas jury in that case awarded $253.4 million to the widow of a man who died of a heart attack triggered by arrhythmia, which is not a condition Vioxx has been proven to cause. The jury, declaring that it wished to "send a message" to Merck, decided to make an enormous symbolic award anyway. Besides, said one juror afterward, the medical evidence was confusing: "We didn't know what the heck they were talking about." Because Texas law limits the size of jury awards, the final cost to Merck is likely to be closer to $2 million. But the precedent set by the jury is ominous. Merck is facing about 5,000 similar lawsuits. If every one of those costs the company $2 million, the total price will come to $10 billion -- if, of course, a company called Merck is still around to pay it.
Politicians and regulators should be asking themselves whether a system of massive cash awards to people who may or may not have been adversely affected by Vioxx is a logical, fair or efficient way to run a drug regulatory system. They should also be asking whether juries that scorn medical evidence are the right judges of what information should or should not have been on a prescription label. After all, Vioxx was produced and sold legally. The drug was approved by the Food and Drug Administration, and its label did warn of coronary side effects. It is possible, even probable, that Merck was negligent in its decision to ignore early warnings of the cardiovascular risks of Vioxx. But the company has already paid a price for that negligence, in the losses it has suffered after abruptly taking Vioxx off the market. Fair compensation for the injured needn't entail disproportionate financial punishment as well. . .
That is exactly my opinion on the matter, and it is a weird experience, for me at least, to have my views line up so perfectly with those of a major newspaper's editorial page. If the New York Times had come out with this one, I'd have to sit down and fan myself for a while. Let us celebrate this gust of good sense and hope for more of the same, as the second Merck/Vioxx trial (in New Jersey, this time) goes hammering along. . .
1. echibby on September 20, 2005 9:50 PM writes...
I think the Merck verdict was horrendously wrong, but I have two observations:
1) If the jury couldn't understand the science, isn't part of the problem the defense team not properly presenting their case? If I were Merck, I'd fire the lawyers and get new ones ASAP.
2) My own hypothesis, not supported by any analysis, is that the lawsuit caps in palce in TX contributed to the large verdict... if the jury knew their award would stick, they might not have gone to $250 million, but instead awarded something more reasonable. As it is, the knowledge of whatever they awarded would be countermanded by the prevailing law in TX was an incentive to over-award... an example of price controls distorting the market. The conclusion- abolish caps on awards... counterintuitive, and I don't quite believe it myself.
3. tim mayer on September 21, 2005 7:59 AM writes...
Surely this is a problem that can over-come by the proper teaching of science in schools. My dream is to see chemists adveritising during the Jerry Springer Show the same way lawyers do now.
4. Derek Lowe on September 21, 2005 8:57 AM writes...
Daen, you're right on the face of it, but opportunity costs are nonetheless real money. Vioxx was selling merrily along, with every expectation of continuing.
If you loan me $1000, and I pay you back the same $1000 in five years, have I assessed a penalty on you, or not? (If your answer is "no", please drop me an e-mail so I can forward my bank routing number. . .)
5. Tom Bartlett on September 21, 2005 8:57 AM writes...
This is not the same as exploding Ford Explorers. Anything that makes it to market has been extensively reviewed by the FDA. The FDA knew about the edema associated with Vioxx and still approved the drug, based on percieved risk vs. benefit. These lawsuits against approved drugs are FRIVOLOUS and should be banned. Congress should RETROACTIVELY toss out jury-trials for drugs, since, clearly, jurys of people too stupid to get out of jury duty can not deal with the substance of these cases.
6. The Novice Chemist on September 21, 2005 10:45 AM writes...
Tim, I think you're right on that one. If only we had a television show that showed the joys and glamor of being a scientist. (Something other than CSI, which is silly, silly Hollywood science.)
But you'd think there's a lot of drama about being a scientist. Failure, interpersonal relationships, big ideas, etc. Where's a good screenwriter when you need one?
7. qetzal on September 21, 2005 10:46 AM writes...
echibby wrote:
1) If the jury couldn't understand the science, isn't part of the problem the defense team not properly presenting their case?
You're implying that there is a proper way to effectively present such a case to a lay jury. I think the Post editorial (and Derek) are challenging that assumption.
2) My own hypothesis, not supported by any analysis, is that the lawsuit caps in palce in TX contributed to the large verdict... if the jury knew their award would stick, they might not have gone to $250 million, but instead awarded something more reasonable.
I wouldn't be surprised if the jury was unaware of the $2 million cap, unless they were specifically told of it during the trial (which seems unlikely to me).
Also, the concept of a "more reasonable" award is quite troubling in a case where there appears to be no evidence supporting the plaintiff's claim.
Not that I think Merck deserves a complete pass on Vioxx. If, in fact, they withheld important safety information, they should be held accountable. Just not (apparently) in this specific case.
In reality, it seems this jury has increased the harm to any real victims. They attempted to give a huge chunk of money to someone who was apparently not harmed by Vioxx. (At least, not in a forseeable way.) That money becomes unavailable to compensate real victims. The verdict also makes it easier for future non-victims to wring cash from Merck, further reducing potential compensation for any true victims.
Whatever you think of the tort system in general, this is a terrible verdict.
8. Giagan on September 21, 2005 12:30 PM writes...
I don't understand how the verdict of the Ernst trial in Texas can stand. Merck's lawyers shouldn't have had to teach science to any jury since it is the plaintiff who has the burden of proof. In this case, they had to prove that Vioxx killed Ernst. Having failed to prove this (I'm almost certain they didn't even try to, as they employed other tactics), how can this be a fair trial? I have a serious problem with this.
With regard to the harm this jury has done, it doesn't stop at Merck's money going to false or true victims. It's been said before, but this verdict potentially hurts society by taking a step toward crippling Merck and the entire pharmaceutical industry.
9. Daniel Newby on September 21, 2005 4:14 PM writes...
Giagan said "Merck's lawyers shouldn't have had to teach science to any jury since it is the plaintiff who has the burden of proof. In this case, they had to prove that Vioxx killed Ernst."
Juries do not investigate truth, they compare presented evidence. The most convincing evidence wins.
What I have read on the Web (take one grain of salt by mouth as needed) is that Merck's presentation was poor. They snowed the jury with details, cross-examined poorly, and in general ran a poor dog and pony show. Consider the coroner who testified to arrhythmia as cause of death. Well the deceased didn't have a heart monitor recording his rhythm at the time of death. It's just a wastebasket diagnosis that means "damned if we know what killed this man but his ticker was already doing poorly". A good trial lawyer should have been able to tear that witness into little pieces.
10. echibby on September 21, 2005 8:52 PM writes...
qetzal, interesting comments. I must admit my complete ignorance of how juries are informed of how to award damages, etc. It would be interesting to know how much they knew (or were told) as to what the limits are. And by "more reasonable," I didn't mean to imply the verdict is justified. I speculated that if the jury was going to award damages, knowledge of a maximum amount awarded would (in their minds) be an incentive to move from "reasonable" to "excessive."
I have to agree with Daniel Newby- the Merck lawyers were fully aware of how the system works, right down to jury selection. It was their job to offer evidence to the jury against any Vioxx/death connection. It presents a problem when jury members state that they couldn't understand the witnesses for the defense. Those witnesses presumably knew they weren't lecturing to fellow researchers, but citizens with varying degrees of scientific backgrounds.
That said, I'm of the opinion that cases such as this should be decided by an independent panel of qualified physicians/clinicians/etc- extending to medical malpractice cases. Or at the very least, having malpractice cases vetted by such a panel before reaching trial.
I'd like to see Merck executives go to jail, if clinical evidence was withheld. But letting the jury system run roughshod over our drug development and delivery system is a form of mob (in)justice, nothing less.
NJ.com:
In a major victory for Merck, a New Jersey jury today found the drugmaker properly warned consumers about Vioxx risks. The finding means Merck won't be held liable for the 2001 heart attack suffered by an Idaho man taking the painkiller.
... [Read More]
1. echibby on September 20, 2005 9:50 PM writes...
I think the Merck verdict was horrendously wrong, but I have two observations:
1) If the jury couldn't understand the science, isn't part of the problem the defense team not properly presenting their case? If I were Merck, I'd fire the lawyers and get new ones ASAP.
2) My own hypothesis, not supported by any analysis, is that the lawsuit caps in palce in TX contributed to the large verdict... if the jury knew their award would stick, they might not have gone to $250 million, but instead awarded something more reasonable. As it is, the knowledge of whatever they awarded would be countermanded by the prevailing law in TX was an incentive to over-award... an example of price controls distorting the market. The conclusion- abolish caps on awards... counterintuitive, and I don't quite believe it myself.
Permalink to Comment2. daen on September 21, 2005 3:58 AM writes...
But the company has already paid a price for that negligence, in the losses it has suffered after abruptly taking Vioxx off the market.
Permalink to CommentHmm. Lost opportunity costs are not the same as having to pay a fine.
3. tim mayer on September 21, 2005 7:59 AM writes...
Surely this is a problem that can over-come by the proper teaching of science in schools. My dream is to see chemists adveritising during the Jerry Springer Show the same way lawyers do now.
Permalink to Comment4. Derek Lowe on September 21, 2005 8:57 AM writes...
Daen, you're right on the face of it, but opportunity costs are nonetheless real money. Vioxx was selling merrily along, with every expectation of continuing.
Permalink to CommentIf you loan me $1000, and I pay you back the same $1000 in five years, have I assessed a penalty on you, or not? (If your answer is "no", please drop me an e-mail so I can forward my bank routing number. . .)
5. Tom Bartlett on September 21, 2005 8:57 AM writes...
This is not the same as exploding Ford Explorers. Anything that makes it to market has been extensively reviewed by the FDA. The FDA knew about the edema associated with Vioxx and still approved the drug, based on percieved risk vs. benefit. These lawsuits against approved drugs are FRIVOLOUS and should be banned. Congress should RETROACTIVELY toss out jury-trials for drugs, since, clearly, jurys of people too stupid to get out of jury duty can not deal with the substance of these cases.
Permalink to Comment6. The Novice Chemist on September 21, 2005 10:45 AM writes...
Tim, I think you're right on that one. If only we had a television show that showed the joys and glamor of being a scientist. (Something other than CSI, which is silly, silly Hollywood science.)
But you'd think there's a lot of drama about being a scientist. Failure, interpersonal relationships, big ideas, etc. Where's a good screenwriter when you need one?
Permalink to Comment7. qetzal on September 21, 2005 10:46 AM writes...
echibby wrote:
1) If the jury couldn't understand the science, isn't part of the problem the defense team not properly presenting their case?
You're implying that there is a proper way to effectively present such a case to a lay jury. I think the Post editorial (and Derek) are challenging that assumption.
Permalink to Comment2) My own hypothesis, not supported by any analysis, is that the lawsuit caps in palce in TX contributed to the large verdict... if the jury knew their award would stick, they might not have gone to $250 million, but instead awarded something more reasonable.
I wouldn't be surprised if the jury was unaware of the $2 million cap, unless they were specifically told of it during the trial (which seems unlikely to me).
Also, the concept of a "more reasonable" award is quite troubling in a case where there appears to be no evidence supporting the plaintiff's claim.
Not that I think Merck deserves a complete pass on Vioxx. If, in fact, they withheld important safety information, they should be held accountable. Just not (apparently) in this specific case.
In reality, it seems this jury has increased the harm to any real victims. They attempted to give a huge chunk of money to someone who was apparently not harmed by Vioxx. (At least, not in a forseeable way.) That money becomes unavailable to compensate real victims. The verdict also makes it easier for future non-victims to wring cash from Merck, further reducing potential compensation for any true victims.
Whatever you think of the tort system in general, this is a terrible verdict.
8. Giagan on September 21, 2005 12:30 PM writes...
I don't understand how the verdict of the Ernst trial in Texas can stand. Merck's lawyers shouldn't have had to teach science to any jury since it is the plaintiff who has the burden of proof. In this case, they had to prove that Vioxx killed Ernst. Having failed to prove this (I'm almost certain they didn't even try to, as they employed other tactics), how can this be a fair trial? I have a serious problem with this.
With regard to the harm this jury has done, it doesn't stop at Merck's money going to false or true victims. It's been said before, but this verdict potentially hurts society by taking a step toward crippling Merck and the entire pharmaceutical industry.
Permalink to Comment9. Daniel Newby on September 21, 2005 4:14 PM writes...
Giagan said "Merck's lawyers shouldn't have had to teach science to any jury since it is the plaintiff who has the burden of proof. In this case, they had to prove that Vioxx killed Ernst."
Juries do not investigate truth, they compare presented evidence. The most convincing evidence wins.
What I have read on the Web (take one grain of salt by mouth as needed) is that Merck's presentation was poor. They snowed the jury with details, cross-examined poorly, and in general ran a poor dog and pony show. Consider the coroner who testified to arrhythmia as cause of death. Well the deceased didn't have a heart monitor recording his rhythm at the time of death. It's just a wastebasket diagnosis that means "damned if we know what killed this man but his ticker was already doing poorly". A good trial lawyer should have been able to tear that witness into little pieces.
Permalink to Comment10. echibby on September 21, 2005 8:52 PM writes...
qetzal, interesting comments. I must admit my complete ignorance of how juries are informed of how to award damages, etc. It would be interesting to know how much they knew (or were told) as to what the limits are. And by "more reasonable," I didn't mean to imply the verdict is justified. I speculated that if the jury was going to award damages, knowledge of a maximum amount awarded would (in their minds) be an incentive to move from "reasonable" to "excessive."
I have to agree with Daniel Newby- the Merck lawyers were fully aware of how the system works, right down to jury selection. It was their job to offer evidence to the jury against any Vioxx/death connection. It presents a problem when jury members state that they couldn't understand the witnesses for the defense. Those witnesses presumably knew they weren't lecturing to fellow researchers, but citizens with varying degrees of scientific backgrounds.
That said, I'm of the opinion that cases such as this should be decided by an independent panel of qualified physicians/clinicians/etc- extending to medical malpractice cases. Or at the very least, having malpractice cases vetted by such a panel before reaching trial.
Permalink to Comment11. Jeremy Abrams on September 23, 2005 11:26 PM writes...
I'd like to see Merck executives go to jail, if clinical evidence was withheld. But letting the jury system run roughshod over our drug development and delivery system is a form of mob (in)justice, nothing less.
Permalink to Comment