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Comments

Ted

Rangel's complaint is that the eventual cost to Merck is going to be substantially higher than any reasonable measure of the damage actually caused by Vioxx, and that this seems unfair given that Merck erred, if at all, on the side of caution.

We're talking about an issue that, even using the FDA numbers (released for the first time 9/30/04), affects 1.3 people out of every 1000 who use the drug for eighteen months. (It's also unclear whether the actual number is considerably lower than that, because people who don't use Vioxx often use aspirin, which reduces the risk of cardiac events--as Rangel points out, we haven't seen whether the new study accounts for aspirin usage.) What exactly was Merck and the FDA supposed to do differently than they did to discover this? And what methodology would you use to prevent such a drug from reaching the market in the first place?

Evan

Ted: Remember "personal responsibility"? Among tort reformers, that's the doctrine that people who get hurt should often bear the burden of their loss--or something like that.

I believe that corporations have responsibility too. In this case, it appears that thousands of people died because Vioxx was defective. If it turns out that Merck is responsible under the law of product liability, I don't think it's "unfair" if Merck ends up paying more than exactly the "reasonable measure of the damage actually caused."

As for the FDA, I was pointing out what seems to be a problem. I don't have an answer to the problem at this moment, except to say that I don't like the idea of granting immunity to drug companies. Do you like that idea? I think you sidestepped the issue in your comment.

Dylan

How about instead of "personal responsibility" we go with "informed consent"? You pay your money and you take your chances. It would, in fact, be a good thing if consumers were allowed to take the more dangerous drugs that the FDA doesn't approve, provided they decide the risk is worth it to them.

If fully disclosed, chances of bad, even fatal reactions to medicine are in no way the "fault" of the drug company, and the tort system is an awful way to offer insurance. The only test of whether a drug is "defective" should be whether something equally effective with lower risks exists to everyone who takes both medicines. Everything else should be freely available, buyer beware.

Evan

Dylan: If by "drugs that the FDA doesn't approve," you mean things like pot and heroin, and you're arguing that they should be legal--well, that's another issue. Any plaintiff suing the "manufacturer" in that situation better have a good lawyer. The same would be true even if such drugs were legalized.

You go on to say, "If fully disclosed, chances of bad, even fatal reactions to medicine are in no way the 'fault' of the drug company." The concept of "fault" doesn't matter much in a claim for strict products liability, but I know what you mean. Even so, your clause "if fully disclosed" is telling. To prove a defense of assumption of risk, a defendant has to show that the plaintiff knew of the specific defect in the product and understood the risk of injury. I don't know how the factual evidence will play out in the Vioxx cases, but the allegation is that Merck knew of the dangers posed by Vioxx as early as 2000 and failed to notify consumers. And in the fen-phen case, to take another example, neither Pondimin nor Redux warned of the possibility of heart valve damage.

Finally, there's gobs of evidence showing that drug companies, in deciding about warning labels, consider how those labels will affect sales. Less warnings means more sales. What do you say about that? And how about the idea of immunity for drug companies once the FDA approves a drug?

Dylan

I just think the tort system should be abolished in favor of duels.

Mojo

I agree with what I see as part of dylan's point, that companies that have fully disclosed the risks of their drugs shouldn't be held as accountable as those (such as Bayer in the Baycol case) that hide negative information. If we had universal health care, a better safety net, and an FDA that actively looked out for the interests of consumers rather than those of drug companies that might even work. We'd have effective group risk by the whole country. The FDA would determine which drugs were reasonably safe and what the risks were. The patients would take only the risks they chose to. The patient/hospital wouldn't be stuck with the tab when drugs turned out not to be as safe as expected. A patient who was financially harmed by a drug (e.g. unable to work) could still enjoy some reasonable minimum level of quality of life. The government would take action in those cases where a company hid negative information. And we wouldn't have the problem with lawsuits where two equally injured plaintiffs get wildly different compensation (if any). Of course, that's in a world that I'll never see.
Of course, dylan's last point would work as an even more effective deterent.

Evan

Mojo: You mention "Dylan's last point"--you mean his point that "the tort system should be abolished in favor of duels"? Interesting he (and you) should say that, since I once challenged Dr. Rangel to a duel. When he wasn't able to attend, I wrote the post Trial Lawyer Draws Gun, Then Tell a Story. It was lots of fun and no one was hurt!

Turning to your Utopian vision for the world you admit you'll "never see"--I like it, but as you mention, I don't think it's ever going to come about. You're right that drug companies which do fully disclose the risks of their drugs would be in a much better position in court. But then you hold up Bayer as an example of a company that did it right with its drug Baycol. Bad example! There's plenty of evidence that Bayer hid the risks of Baycol. For starters, take a look at this link, which includes an article from the New York Times (second) and some commentary about it (first).

Ted

I'd like to see the basis for the claim that Merck was aware of this risk (as opposed to aware of the possibility of a risk) in 2000. In 2000, there were several studies, one that showed an increased risk, and the rest didn't. In response, Merck engaged in more study, and it was that additional study that resulted in the withdrawal. According to Rangel, as late as 2002, the evidence was hardly clearcut; still, Merck added warnings then. I'm happy to be educated, but I still don't see a single tortious act that Merck committed.

Developing drugs is not like owning a tiger or keeping explosives in the backyard; it's a socially beneficial activity, and should not be a strict liability offense.

Funny you should link to an article about the Bayer Corpus Christi Baycol case, since Bayer won that case -- perhaps because it was precisely the type of case that Rangel complained about, where a plaintiff who happened to take Baycol tried to blame the drug company for poor health problems that had nothing to do with Baycol. Bayer settled with plaintiffs actually seriously injured by Baycol.

Evan

Ted:

(1) You note that "Bayer settled with plaintiffs actually seriously injured by Baycol." In the Corpus Christi case that Bayer won, Bayer offered to settle with the plaintiff for $250,000, according to the Wall Street Journal (10/5/04, pg. B4). Doesn't that mean the plaintiff was seriously injured, according to your own analysis? Sometimes even juries are wrong.

(2) I certainly agree that developing drugs is "a socially beneficial activity." But if the drug companies are going to develop drugs by testing them on unsuspecting humans, meanwhile making billions of dollars, they ought to at least be up front about it. Or to put it another way, many of the drugs that have been removed from the market seemed to suffer from a lack of development before they were marketed.

(3) As for Merck's conduct in 2000, I'll respond by quoting the Wall Street Journal again (10/5/05 pgs. B1 and B4)--

[S]ome plaintiffs say they have evidence that Merck has known for some time that Vioxx presented a problem. In particular, they point to a Sept. 17, 2001, warning letter the FDA sent to Merck Chief Executive Raymond Gilmartin. In the eight-page letter, the FDA says Merck engaged "in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed" in a clinical trial . . .

Drug companies that overstate the benefits of a drug or that minimize its risks are taking a gamble that people won't be hurt. In the case of Vioxx, many were. Merck knew the odds and chose to take the gamble--now it seems they're going to have to pay up.

Ted

A $250,000 offer in Corpus Christi on the eve of trial is pretty much a nuisance settlement offer, isn't it? I can't promise that it cost Bayer more than $250,000 to try the case because Bartlitt Beck has unusual billing arrangements, but a one-month trial like that is usually a considerably more expensive affair. Meanwhile, Watts was asking for hundreds of millions of dollars for a two-week hospitalization of an 82-year-old, so my statement that the Corpus Christi case was precisely the type of case that Rangel was complaining about remains accurate.

The FDA letter you mention (and thank you--I wasn't previously aware of it), seems to complain more that Merck's rejection of the 2000 study overstates the benefits of the different drug naproxen in exonerating Vioxx--except the first google result for "naproxen platelet" comes up with an NIH study that to my eye appears consistent with the Merck statements and alternative hypothesis for the single study's differing result. I'd link to it, but I'm getting a note that this is "comment spam", keeping me from doing so. The 2001 letter refers to the 2000 study I had already mentioned. I don't know enough about the procedure for issuing FDA warning letters to know whether this is meaningful evidence. A September 25, 2001 USA Today story about the FDA warning letter notes that the FDA had not requested Merck to change its warning. Merck did change its warning label in April 2002; again, I don't know enough to know whether eight months is a reasonable delay, but it hardly strikes me as slam-dunk evidence of negligent failure to warn, much less for the punitive damages that will inevitably be requested.

Again, you're essentially proposing strict liability (plus penalties) for lack of perfect foresight. Any set of a couple of dozen studies are going to generate numerous false alarms, and saying that any adverse reaction revealed in any study creates strict liability if it turns out not to be a false alarm is to say that there will be no new drugs at all.

Mojo

Evan; I was trying to cite Baycol as a case where a drug company failed to reveal negative information about a drug. I'm sorry if I didn't make that clear.

Evan

Mojo: No, you were clear; I misread it. My fault.

Chris Rangel MD

See my response on 10-9-04.

www.rangelmd.com

Jester

--
Why speculate about doc Rangel's proposal?

Just mosey on up to the Great White North: Michigan. We have an 'FDA immunity' law just like that proposed at the federal level.

Once a drug has struggled to overcome the almost impossible odds of achieving FDA approve (like Vioxx did despite the same evidence then, that is now being trucked out, now, to support is removal from the market) the manufacturer has a 'get out of jail free' card and is above the law, immune from civil justice just like the good doc prescribed.

And --just like they said-- no one gets hurt or killed by bad drugs anymore in Michigan! Vioxx has caused no problems at all in Michigan as can be proven by the fact that no lawsuits have been filed by those injured (or the estates of those killed) by Vioxx. See? It worked!

In Michigan, we are all living (well...most of us...) happily ever after in our post-tort reform world and Merck's $2.3 billion in Vioxx profits from last year are safe and sound! Minus those profits that might end up in the pockets of anti-justice folks like doc Rangel.

x174

Good ol' Dr. Rangle sure has got the industry's party line down verbatim. Apparently, the good doctor can't see that that the medical industry and the pharmaceutical industries are also an integral part of the "greedy opportunism." I.e., they knew in 2000 about the contraindications yet Merck continued to sell their "medicine"-- waiting until the last day of the third quarter of 2004 to recall Vioxx. Mmm. . . sounds like "reckless indifference" to ensure continued profits to me. Who cares about the patients when their is a "decent" buck to be earned, eh Doc? The fact that Rangel would like to protect such blatant malfeasance from legitimate lawsuits reveals his dark hand.

Kudos to the author of "Is the FDA a toothless watchdog?" Your simple pensive statements effectively expose Rangel's baloney:

But let's think about that for a minute. Dr. Rangel wants a rule that once the FDA approves a medication, the drug manufacturer gets a free pass--no lawsuits.

charlie

I hope Doc Rangle does not have a stroke which leaves him disabled like that freaking vioxx did to me.I tell you, I don't trust any drug anymore

Andrew Spark


In the cause of life saving drugs, it is controversial issue but otherwise more rational thinking agrees with beneficial the disease effect as the patient is the centre of attention in the health care system.

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