IT'S HERE!

  • A NEW BOOK BY EVAN SCHAEFFER



    How to Feed a Lawyer (and Other Irreverent Observations from the Legal Underground)

    Click on the book cover for details!

« | Main | »

Comments

Aaron

If you don't mind clarifying something about the trial (and happen to know), did the defense move for summary disposition on the basis that "Vioxx can't cause arrythmias"? (And if not, why not?)

E2

I can't help but to wonder if Victor's positions are rooted in his own failures as a plaintiff's lawyer. Evan- Can you find out if Victor is nothing more than a jealous lawyer who seeks to destroy that which he could not do well?

Ted

From the war stories he was telling me and Evan, he sounded like a fairly successful-for-his-time plaintiff's attorney to me, winning one of the first cases assessing punitive damages for a product with a design defect, though I imagine it was secondary to his successful career as an academic. I'm not aware of failed plaintiff's attorneys who go on to become successful corporate defense attorneys. (Of course, I'm not aware of that many successful plaintiff's attorneys who go on to become successful full-time corporate defense attorneys. Dan Petrocelli comes to mind; Evan may have a better sense of this issue.)

Ted

I should clarify that the above observation is not meant to be evidence of differing skill between plaintiff's and defense attorneys. Rather, it reflects the modern economic reality that the plaintiff's attorneys BigLaw would reach beyond its snobbery to hire can do better for themselves away from BigLaw, even if they didn't already have the personal preference to do plaintiff's-side work.

Tom

I watched the entire meeting on AEI. Very well dont on all sides. I noticed that many of those on the panel discussed how potentially damaging this $253M verdict could be for Merck, but no one mentions how much profit Merck received from this drug. I don't remember what they've made on Vioxx, but I do remember seeing that Merck posted a $2.5 Billion PROFIT for the first half of this year.

Ted

Tom: Thanks for the praise.

To be precise, the Merck profit was $2.09 billion, reflecting entirely the other life-saving and life-improving drugs Merck sells (Zocor, Fosamax, Cozaar, Singulair, etc.), since Merck made no profit from Vioxx in the first half of 2005. If Ernst was the end of the Vioxx matter, that would be one thing, but the Ernst case represents less than 0.02% of the cases Merck faces, and that doesn't even count the class actions.

As at least three of the panelists noted, the verdict isn't just damaging to Merck and the widows who have Merck stock in their pension funds. It's damaging to anyone who hopes to live longer because of future pharmaceutical advances.

Matt

"It's damaging to anyone who hopes to live longer because of future pharmaceutical advances."

Well, considering lawyers and personal injury plaintiffs are already responsible for 9/11, what's crushing a few drug companies, eh Ted?

Your continued hyperbole is always appreciated.

Ted

Hey, Matt, glad to see you're still choosing to attack a strawman, since it implies that you can't refute the real me.

The point of my article was that trial lawyers could only be blamed for 9/11 if trial-lawyer logic was used, and, while I was happy to blame 9/11 on those directly responsible instead of those more remotely at fault, it would be nice if our liability system worked the same way. But it would be no fun addressing the arguments I actually make, now, would it?

There's no hyperbole here. The only thing being deterred by pharmaceutical tort liability for FDA-approved drugs is the production of life-saving drugs. The possibility of cases like Ernst does far more to damage health research than a thousand politicians demagoguing against fetal stem cells, but it will be a long time before we see Chris Mooney write that book.

Matt

Ted, to seriously address your 9/11 argument would be to dignify it. It is unworthy of that.

Spare us your Chicken Little predictions about the pharmaceutical industry. Everytime there is a verdict of any size against any industry, you predict their impending demise and the wholesale collapse of the American economy, along with horrific consequences to the consumer.

Ted

Matt, in response to my complaint that he attacks a straw-man instead of arguments I actually make, creates new straw men arguments that he falsely attributes to me. This is really boosting my confidence that my actual critique is correct, if disappointing that I can't find anyone here who's willing to take it on.

Tom

Ted, could you expand on your theory that pharmaceutical torts are deterring the production of life saving drugs? When I see that companies like Wyeth, Bayer, Merck, Pfizer and others are making billions of dollars it would appear to me that these companies would want to get as many drugs as possible to the market as fast as possible. Simple risk management should tell us that Merck made xxx profit from Vioxx and will end up paying out yyy in claims. If they end up paying out more than what they earned in profits the message should be... don't lie, conceal or cover up the adverse side effects of your billion dollar drug. Merck will not stop researching new drugs because of this, but maybe they'll be more forthright in presenting the findings of their clinical studies. Personally I believe that every adverse reaction report for every drug should be published on the FDA website for consumers and doctors to see.

Ted

Except Merck didn't "lie, conceal or cover up the adverse side effects of your billion dollar drug." It made a scientific judgment that with 20-20 hindsight turned out to be wrong, and meant that the drug was slightly riskier than previously indicated. Every drug will, simply by random chance, have statistically insignificant differences of adverse reactions. That's why the test is for statistical significance. And if companies are punished for failing to have perfect foresight, the result will be fewer drugs.

As it was, the jury punished Merck because it published the adverse side effects, but published it in the midst of all the other alleged adverse side effects: the jury thought the FDA-approved warning was too hard to find. (ATLA, for some twisted reason, is trumpeting the juror's quote showing this to defend the verdict.) Merck is supposed to guess in advance which adverse side effects turn out with further study to be the important ones? If the statistically insignificant adverse reactions are published side-by-side with the statistically significant adverse reactions, the result will be a cacophony that results in doctors undervaluing the statistically significant adverse reactions. The drug companies can't win: if they don't publish the statistically insignificant warning, they get accused of a cover-up; if they do publish the statistically insignificant warning, they get accused of making the warning hard to read.

Note also the costs of underuse of drugs. It was known for years that aspirin significantly reduced the risk of heart attacks and strokes, but the FDA refused to allow companies to advertise this fact. Thousands of people died who wouldn't have if drug companies were allowed to advertise this feature of aspirin.

When the transcript of the AEI event where Evan spoke gets published, I recommend it highly. Jack Calfee and Dan Troy had some interesting perspectives that seemed right to me.

Tom


I can tell you that in 2003 a full year before Merck recalled Vioxx, I had over 300 vioxx consumers write to my website complaining of adverse reactions, two thirds of those people suffered a stroke, heart attack or some type of heart ailment. If that little bit of data was significant enough for me and a group of plaintiffs lawyers to see a potential problem, why would it be so much more difficult for Merck to see it?

Evan

Ted: In painting a rosy picture of Merck's conduct, I believe you stand alone with Merck and Merck's lawyers. There is overwhelming evidence that Merck knew of the cardiovascular risks of Vioxx in the '90s even before the VIGOR results in 2000, yet chose to look the other way by failing to design a test that would assess this risk, and by making up scientifically invalid explanations for the VIGOR results (that whole "naproxen's heart-protective benefits could explain why there were more CV incidents with Vioxx" argument), and by dragging its feet on changing the official warnings (despite what you say, detailed information about the 2000 VIGOR results didn't show up in the PDR until 2003), and by training its sales reps to avoid directly answering doctor's questions. These failures, as well as others, are well documented in articles in the New York Times, the Wall Street Journal, and in a Congressional Report released on 5/5/05 that I've posted about before.

Merck's response is to say that it is a responsible company (maybe so, but not with respect to Vioxx) and that it needs to do a better job of explaining the bad documents to juries. I really don't see how Merck is going to do that, but its lawyers need to hit each bad document head on, rather than painting with a broad brush as you did in your comment.

You mention "hindsight," but there was no hindsight about it. Merck scientists had foresight. You also mention that all all drugs have risks that are unanticipated, and this is true; the trouble for Merck is that the CV risks of Vioxx were anticipated before it went on the market. Even though Merck did change the label as you indicated, Merck continued to market the drug to people who should never have had it, Merck continued to downplay the risk, Merck continued to mislead doctors, and Merck continued to repeat the laughable claim about naproxen's "heart protective" benefits--which, by the way, three live Merck employee-witnesses repeated again in the Texas case.

There is no doubt that Merck will win some cases on the issue of case-specific causation. If Merck wants to make any headway on the liability part of the case, however, I think it needs to rethink the "rosy picture" strategy and really deal with the bad documents and bad facts head-on.

Ted

There are many false statements in your last comment. For example, there's a great deal of literature on the cardioprotective effects of naproxen. I found "Solomon DH, Glynn RJ, Levin R, Avorn J. Nonsteroidal anti-inflammatory drug use and acute myocardial infarction. Arch Intern Med 2002;162:1099-104; Watson DJ, Rhodes T, Cai B, Guess HA. Lower risk of thromboembolic cardiovascular events with naproxen among patients with rheumatoid arthritis. 1105-10; Rahme E, Pilote L, LeLorier J. Association between naproxen use and protection against acute myocardial infarction. 1111­5" on the first link of a google search in thirty seconds. Even a recent FDA investigation into whether naproxen had adverse effects showed cardioprotective effects for naproxen, this found in the second thirty seconds of a google search.

Your claim that VIGOR was not in the PDR until 2003 is absolutely irrelevant. The study ended March 17, 2000, was discussed in a public teleconference and given to the FDA in June 2000, and was published in the NEJM in November 2000. The FDA asked for labeling changes in September 2001 to reflect VIGOR, and those changes were made in April 2002. And VIGOR did not show a statistically significant difference in sudden cardiac death, fatal heart attacks, unstable angina, or cerebrovascular thrombotic events.

Meanwhile, 16,500 die and 100,000 are hospitalized each year as a result of gastrointestinal bleeding from the use of NSAID medications for chronic pain, and those patients no longer have the option of Vioxx.

Evan

Ted: My first reference to naproxen includes the point I was trying to make--if naproxen has any heart-protective benefit, it's slight, and not enough to explain the differences between naproxen and Vioxx in the VIGOR study. I don't think you'll be able to find any scientists who dispute that, except for, perhaps, scientists employed by Merck. Other scientists employed by Merck would admit it. Some of them also say that when the naproxen argument was first made in 2000, it was conjecture and speculation; since then, they've been proven wrong. That's a defense, I suppose, but it's a weak one based on the fact that Merck employees did not act, in 2000, like their argument was merely conjecture and speculation.

As for the labeling questions--the problem with trying to vindicate Merck on the labeling alone is that Merck made no attempt to market Vioxx consistent with its labeling. I don't agree the labeling was sufficient, but let's say you're right. Merck's TV ads for Vioxx made no mention of cardiac risk. Merck downplayed the risk in public whenever possible. I don't always agree with the FDA, but I agree with the FDA's 2001 warning letter to Merck, when it said as follows about labeling and marketing:

(a) “You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular finidng that were observed in the VIGOR study, and thus, misrepresents that safety profile for Vioxx.”
(b) Merck’s claim that differences between Vioxx and naproxen in VIGOR were due to heart-protective benefits of naproxen “has not been demonstrated by substantial evidence.”
(c) “Your claim in the press release that Vioxx has a ‘favorable cardiovascular safety profile,’ is simply incomprehensible, given the rate of MI and serious cardiovascular events compared to naproxen.”

As for your position about Vioxx being beneficial to some who can't get it, I agree that that's too bad. If Merck would have marketed Vioxx to the group who could have used it--the group for whom its benefits exceeded its risks--it wouldn't be in the mess it's in, and Vioxx would still be available to some.

In the meantime, Celebrex is still on the market. Is that not an effective alternative?

Ted

Trial lawyers are doing their damnedest to sue Celebrex off the market, so I'm not sure you really want to make that argument.

In 2000, there were studies that showed no statistically significant difference in cardiovascular events; there was one study, VIGOR that showed statistically significant differences in some cardiovascular events and no statistically significant differences in other cardiovascular events. When you have data like that, there are multiple possible hypotheses: one is that Vioxx causes a slightly increased cardiovascular risk; the other is that Naproxen causes a slightly decreased cardiovascular risk that nudged statistically insignificant differences into statistically significant differences. The former hypothesis was, at the time, unsupported by and contradicted by other evidence; the latter hypothesis was supported by some, if not overwhelming, evidence that naproxen was cardioprotective. It's not at all scientifically unreasonable to adopt the second hypothesis as more consistent with the evidence; if anything, it's more reasonable, simply as a question of science and Occam's Razor.

The FDA, on the other hand, for better or worse, takes a very risk-averse approach that treats the standard of proof differently for positive claims than negative claims. Merck was going with the science; the FDA was going with its risk-averse policy, one that resulted in early (and apparently, if you are to believe trial lawyers, irrelevant) warnings for Vioxx, but also results in several beneficial drugs and drug treatments not being available in the US when they've been used safely in Europe for years. All studies that I'm aware of the look at the question indicate that the damage to American health from the "Type II" errors committed by the FDA far outweigh the damage to European health from the "Type I" errors committed by European regulators in their willingness to approve drugs faster. Drugs are released with incomplete information, because it's better to act on incomplete information. The FDA letter, Merck's response, and the insults hurled at regulators in internal Merck documents, is just further evidence of my point that the agency errs on the side of risk-aversion; that pharmaceutical companies (with good reason) resent, but cooperate with, the agency's requests; and that there's no need for a backup tort system to second-guess the agency's decisions.

You say this is foresight, rather than hindsight, but this is not so. One cannot look at the warning question in a vacuum with 20-20 hindsight and say "Aha! The new information turns out to show that you should have warned about this earlier!" because one has to look at the question in the ex ante context: what else would have required additional warnings if that standard is used? I still haven't seen anyone address the simple fact that warning for every statistically insignificant study result turns the warnings into meaningless slosh that makes accurate assessment more, rather than less, difficult--a problem, if you believe Mark Lanier and ATLA and the Ernst jury, that already exists for the current standards of implementing warnings, and meriting hundreds of millions of dollars of damages because Merck issued so many warnings that it was hard to find the warning that the jury decided after-the-fact was the important one. Instead, it's expected that a manufacturer is expected to know in advance which statistically insignificant results will turn into statistically significant results, know in advance which specific warnings will apply to which specific users, and warn about those, and only those, adverse effects.

Evan

Ted: You can have the last word with respect to Vioxx in this thread. As for Celebrex, you're right that trial lawyers aren't big Celebrex fans, but I'm wondering about you: do you consider Celebrex an effective alternative to Vioxx? It seems like a pretty big weakness in your argument that the removal of Vioxx from the market is contributing to 16,500 needless deaths each year from gastrointenstinal bleeding.

Verify your Comment

Previewing your Comment

This is only a preview. Your comment has not yet been posted.

Working...
Your comment could not be posted. Error type:
Your comment has been posted. Post another comment

The letters and numbers you entered did not match the image. Please try again.

As a final step before posting your comment, enter the letters and numbers you see in the image below. This prevents automated programs from posting comments.

Having trouble reading this image? View an alternate.

Working...

Post a comment

Your Information

(Name is required. Email address will not be displayed with the comment.)

My Photo

About Evan Schaeffer

Search Beyond the Underground


Sitemeter


Archives

cc