Monday, August 22, 2005

Merck/Vioxx Redux

I suspect that many (of the few) who read this blog are very familiar with Kevin, M.D.'s site, which is a good compendium of medical news. A frequent commenter at that site is Curious JD, who offers his legal perspective when there is a discussion of a medicolegal topic at Kevin's site. He also had a few questions for me in regards to my recent post about the Merck/Vioxx verdict. Rather than addressing those questions in the comments, I would like to flesh out my concerns and answers in this post.

CJD: How much of the trial testimony or admitted exhibits have you reviewed in coming to the conclusion the verdict was faulty?

Actually, none, as those are not readily available to me. However, as a matter of principle, I believe that the premise of holding a corporation liable for a person's death is untenable when:

  1. The examining pathologist at the patient's post mortem stated that he had coronary artery disease, a much more likely source for his death
  2. The pathologist blamed that death on an arrhythmia caused a blood clot in a coronary artery....which she did not find at autopsy (you sort of need proof of a "smoking gun" if you claim there is one). None of the trials looking at Vioxx demonstrated an increased risk of arrhythmia, and the increased heart attack risks showed up only after the patient was on the drug for a minimum of 18 months (this gentleman had been on it 8 months).
  3. There is no evidence that Merck put out Vioxx to intentionally harm patients
  4. There are other, similar medications on the market which have the same profile and side effects as Vioxx, which were developed in response to a perceived need, and which work well to address that need ---- and which were approved by the FDA
  5. Medicine is a fluid science; we find things out every year which seem to contradict what we believed to be true last year. I'd recommend that you read about the evolution of the ACLS protocol --- which has changed so much that it is hardly recognizable to those who first learned it 10 years ago. And, by the way, things that were once in vogue, and then were banished from the protocol, are back in vogue again. This is true in all aspects of medicine.
CJD: By the way, that "outrageous sum" (which will never be paid), represents about 1% of Merck's 2004 revenues. Just to add a little perspective.

What difference does that make? What if it was .001% of Merck's 2004 revenues? This is not "perspective," it is rationalization for taking money away from a corporation to suit the jury's perception that Merck "needs to be punished."

CJD: By the way, do you ever think the tort system is "insane" when the defendant wins? Or is it only when the plaintiff wins?

I think the tort system is insane when:
  1. The "tort" involved is a fabrication --- particularly when it is based on junk science. I'd recommend you review the studies about breast implants.
  2. The amount of money "awarded" is totally out of proportion to reality --- as in this case. What, exactly, makes this poor gentleman's death worth $450,000 in economic damages for lost pay and $24 million for mental anguish and loss of companionship, excluding the $229 million in punitive damages.
  3. The only defendant in the suit is the one with "biggest pockets." Why, for example, was this man's physician not sued? Or his insurance company (which I am sure had a pharmacy schedule mandating which COX-2 inhibitor he was allowed to receive)?
  4. The suit is a class action, designed to ensure that a large amount of money
  5. The attorney makes anything other than a flat fee. Yep, that's right, I think it's high time we established a legal counterpart to Medicare. After all, we are told by trial attorneys that anything that acts to inhibit unfettered access to suing is just flat out unconstitutional. So, let's set up "LegalCare," and ensure that everyone has the same access to attorneys, to sue whomever they please, all for a government-determined fee.
In all honesty, I fear that there is a disconnect between reality and fantasy these days in our courts. We need to grow up, and realize that sometimes, shit happens, and it's nobody's fault. I'm not a lawyer, but these guys are -- read what they have to say, as I suspect they say it in a less emotional, better to understand way.