pageok
pageok
pageok
The Vioxx Litigation and the Judicial System:

Ted Frank at Point of Law reviews evidence that the judicial system is not exactly working well in the Vioxx litigation, at least in certain jurisdictions. Joinder of in-state plaintiffs (who are later dropped from the case)to avoid diversity jurisdiction, trial court judges ignoring Daubert trilogy standards for the admissibility of expert testimony, juries ignoring overwhelming evidence against plaintiffs to favor hometown plaintiffs against "evil" (and wealthy) out-of-state corporate defendants--unfortunately, this has a very familiar ring to it. It's hard to see how the Texas Supreme Court will let the evidentiary rulings stand, as Texas has recently taken among the hardest lines against "junk science." The big danger for Merck, I think, is the temptation to enter a global settlement before it's able to win the inevitable appellate rulings that plaintiffs who took Vioxx for short periods of time simply have no sound evidence of causation.

Houston Lawyer:
Vast numbers of people would continue to take Vioxx if it were left on the market with a warning of possible side effects. But the government must treat us all as children, unable to make rational choices on our own. The judiciary could stop this if they wanted to.
4.25.2006 5:06pm
Roger (mail):
Of course, Ted Frank will always say this about any lawsuit brought on behalf of injured poor people by first-generation non-BIGLAW lawyers. Also, since he rarely cited the precedent that actually binds the courts, or points out the errors, we will have to leave it to lawyers to analyze these cases.

Whatever the case, I don't see what the problem is. Ted Frank doesn't believe in the concept of inadequate representation, and while I am sure that Merck can't afford lawyers of its own, and must rely on legal aid, any failure to raise the Daubert issue in these trials is obviously harmless.
4.25.2006 5:10pm
Cornellian (mail):
Although I think judges (particularly state court judges) share some responsibility for the problem, I certainly don't think that diminishes the responsibility of Congress and state legislatures for dealing with this problem.

So long as you have elected state court judges depending on money from the plaintiff's bar to get re-elected you're going to have judges who will send junk cases to juries. For all that Republicans complain about activist federal judges, they know as well do that you'll get a far fairer proceeding in federal court than in state court in these types of cases, which is why Congress passed the Class Action Fairness Act.

For a start, I'd have states abolish an elected judicial branch and have a system parallel to the federal system in which judges from the superior court level upwards are nominated by the executive, confirmed by the legislature and have some security of tenure. That would be good for a start. I'd also institute "loser pays" attorney's fees rules and tougher pleading requirements. With these three measures you could solve about 90% of the problem.
4.25.2006 5:12pm
Dick King:
I understand that the Ernst case hasn't been registered by the Plaintiff's attorneys yet, a step needed before it can be paid and also needed before an appeal can be filed. Certainly I haven't heard of any appeal being filed, and Merck is certainly going to do that as soon as they can.

Does anyone have any info on this? Are they holding off because the Ernst case may have more value as a client magnet than it has as a source of revenue, because the lawyers know well that the case won't do well under appeal?

-dk
4.25.2006 5:16pm
Rational Actor (mail):
I hardly think that Merck/Vioxx is the most serious evidence of a breakdown in the efficacy of the judicial system. They have gotten a tough break in that they have lost cases where there is little evidence to suggest that Vioxx could have contributed to the plaintiff's cardiac event. However, I don't have a lot of sympathy for them. They were extremely aggressive in their interpretation of clinical trial data, and their marketing practices bordered on unethical -- perhaps in the legal world, it is a virtue to create reasonable doubt in a jury, but they were training their salesforce to evade doctors' questions on the safety profile of the drug. They don't make themselves a particularly sympathetic defendant in this case.
And as for the Houston lawyer's complaint about the government treating us like children -- Merck voluntarily pulled the drug from the market because of the bad publicity they managed to garner themselves.

Had they from the get-go acknowledged that there were cardiac side effects, and promoted the drug ONLY to those patients who suffered adverse GI effects from standard NSAIDs, they would be in a much better position today. But, they went for the bigger market share, convinced lots of people who didn't need the drug to take it anyway, and they are paying the price now.
4.25.2006 5:37pm
DavidBernstein (mail):
R.A., tort law requires that Merck be held liable for injuries it actually caused, not for its aggressive interpretation of clinical data. How'd you like to be sued for negligence for hitting a pedestrian, when you were driving 80 in a 55 zone but didn't actually hit anyone?
4.25.2006 5:40pm
Armen (mail) (www):
Great analogy, but causation is not absolute, it's based on a preponderance of the evidence. What if someone was hit and all other cars were driving at 55? What if two guys shoot...anyway you get the idea.
4.25.2006 5:48pm
Mike BUSL07 (mail) (www):
Hopefully the fall-out from this mess will be that tort-reform will be brought closer to the front burner.
4.25.2006 5:58pm
Arthur (mail):
"The big danger for Merck, I think, is the temptation to enter a global settlement before it's able to win the inevitable appellate rulings that plaintiffs who took Vioxx for short periods of time simply have no sound evidence of causation."

Well, that's one danger that Johns Manville successfully avoided. Sometimes the evdience looks different to appellate courts than it does to bloggers, in part because bloggers haven't actually seen all of the evidence.
4.25.2006 6:03pm
Houston Lawyer:
Appointing judges instead of electing them only makes them unresponsive to the will of the people. You should hear the caterwauling here in Texas from the plaintiff's bar about our elected judiciary. The electorate can be convinced that runaway lawsuits hurt everyone.
4.25.2006 6:29pm
Ted Frank (www):
NB that the post David links to is only one of a series of posts on the Vioxx litigation by the Point of Law writers. Check also my AEI working paper (and Part II) from December, which has more factual and legal background, especially on the question of Texas expert evidentiary standards.

Roger, what is the basis for your claim that Merck waived the Daubert arguments?

R.A., it's not true that Merck was "training their salesforce to evade doctors' questions." That's purely the plaintiffs' spin on documents that say no such thing. Unfortunately, the media has bought the spin wholesale, but you can read the documents yourself and see otherwise.
4.25.2006 6:44pm
Cornellian (mail):
Appointing judges instead of electing them only makes them unresponsive to the will of the people. You should hear the caterwauling here in Texas from the plaintiff's bar about our elected judiciary. The electorate can be convinced that runaway lawsuits hurt everyone.

The job of the judiciary is to apply the law not to be responsive to the will of the people. Being responsive to the will of the people is the legislature's job.
4.25.2006 6:52pm
Rational Actor (mail):
David -
it is fair to assume that very few people like to be sued for negligence or any other tort, regardless of the merits of the case against them. However, if I spent three years driving through a neighborhood going 25 miles per hour above the speed limit, putting countless people at risk in the process, and the only effective mechanism to stop my behavior was to sue me for negligence, then I would not be surprised if I was sued, I would not expect too much sympathy from the residents of that neighborhood, and I would not be surprised if they awarded damages against me in a jury trial.
I don't believe I made the assertion that the Merck verdicts were all in accordance with tort law. I only said that the fact pattern casts them in a very bad light, that I have no sympathy for them and that I don't believe their situation comprises the most serious problem in the judicial system today.
4.25.2006 7:12pm
Rational Actor (mail):
Ted - thanks for the link; it's been years since I played Dodgeball. I've spent enough time working with pharmcos to know how they spin their drugs.
4.25.2006 7:19pm
Peter Wimsey:
R.A., it's not true that Merck was "training their salesforce to evade doctors' questions." That's purely the plaintiffs' spin on documents that say no such thing. Unfortunately, the media has bought the spin wholesale, but you can read the documents yourself and see otherwise.


I haven't followed the Merck verdicts very carefully, but I did just read the linked documents - and it does look like they were training their sales force to evade doctor's questions. Calling the game "dodgeball" doesn't help Merck's case, nor does describing doctors' medical questions as "Obstacles" suggest that Merck's goal was to provide disinterested clinical advice. (Obstacle 4. "I'm concerned about the possible cardiovascular effects of Vioxx.")

Of course this is not the whole story - you would need to see how Merck's canned answers relate to actual clinical information - but the document looks like more than just spin, and perhaps the reason that news media, plaintiffs attorneys, juries, and other people find the dodgeball document designed to evade doctors' questions is because that's what it looks like it was designed to do.
4.25.2006 7:21pm
Stan (mail):
The autopsy showed two incidents of thrombotic occlussions and there was testimony about what was taken and when. Clearly Vioxx has been shown to cause the inhibition of prostocyclin, so it's an even more likely for someone with already occluded arteries to suffer a an MI. (Someone with prior heart disease should never have been put on Vioxx.) I don't understand your point about there being no causation in light of the facts put to the jury. Clearly this was a thrombotic MI and the patient had no history of blood clotting I don't believe. I also don't know how you know that the dismissed claims were not settled and dismissed by stipulation. Perhaps you know something I don't. But clearly the deceased died of a thrombotic MI, which were known by Merck in at least 2000 and withheld. I guess I just don't see why you're so adamant that there wasn't causation.
4.25.2006 7:22pm
Stan (mail):
Mike BUSL07, how will tort reform help anyone? I don't understand your logic.
4.25.2006 7:29pm
Ted Frank (www):
I don't understand your point about there being no causation in light of the facts put to the jury.

How about the fact that the plaintiff wasn't even taking Vioxx?

Merck in at least 2000 and withheld

Merck didn't withhold any data, in 2000 or otherwise. The full VIGOR results were released to the FDA, and the FDA-approved warning labels (which the agency states are a ceiling as well as a floor) had the full VIGOR results on them. And the NEJM article's conclusions differ not a jot from the full VIGOR results.

Peter, how would you suggest pharmaceutical representatives without medical degrees be trained to answer doctors' questions if not with canned responses? Doctors aren't stupid, and if reps are evading questions, they're not going to sell drugs. You can criticize the pedagogical means of using a game to teach reps canned responses as "Office Space"-style "flair," but it's hardly sinister.

As for how tort reform can help the situation, it could correct some of these injustices. There are many safe, effective drugs—inter alia Bendectin, Lyme disease vaccine, GBS vaccine—that aren't being sold in this country solely because of the disastrous liability system we have. And there's no telling what life-saving drugs aren't being developed because of the disincentives created.
4.25.2006 8:02pm
Stan (mail):
Not taking Vioxx? Where do you get that from? Dr placed on a 7 day trial of an "anti inflammatory," followed by notation on billing sheet to Vioxx. Then his wife testified that the a substitute cardiologist gave a month of samples (until his regular cardiologist returned). That the jury believed this shouldn't be a question of law.

Re: NEJM, didn't the author write that they learned data about cv risk was deleted from the disk two days before submission? I'm pretty sure it did.

re: FDA, I'm not sure what defense this offers. Dr. Graham's testimony about being the FDA was pretty worthy of offensive summary judgment (even as it related to Voixx).

re: Sales force. Have you seen the materials? I have. It's not a mystery why punitives have been found.

re: so can we cap lawsuits between corporations also or just people? Are there lawsuits disasterous also?
4.25.2006 8:32pm
Mike BUSL07 (mail) (www):

Mike BUSL07, how will tort reform help anyone? I don't understand your logic.

Stan, the problems tort reforms seek to redress are, (to be very incomplete about this) the costs imposed on society by spurious lawsuits and jackpot verdicts. By introducing, say, stiffer fee-shifting rules and capping damages, we discourage these trends. Then, Stan, Merck can pour the money it's currently spending litigating into research, attracting talented employees, etc. Then we have better, and possibly cheaper drugs on the market. That's how tort reform helps. I hope you now understand my logic.
4.25.2006 8:40pm
Stan (mail):
I'll add since I just noticed you operate a tort reform agency that I'm a trial lawyer in Boston. It's really difficult to get a jury verdict and takes a lot of work. I generally get along with the other side very well, who also works very hard, and we maintain a mutual respect for one another throughout the process. Trial lawyers in general are ethical, respectful and intelligent people in my view and are often on both ends of bad rulings, particularly on late Friday afternoons. But we learn to overcome them and move on. If they rulings are prejudicial, we may choose to appeal. But actual trial lawyers working in the system are the only ones who can really credibly speak about what the liablity system is like in my view. I'm sorry if you have stock in Merck, but I think there's plenty of evidence to let these cases go to a jury and there are plenty of places where the worst conduct will not get a plaintiff's verdict. Either way, it takes a lot to get a verdict.
4.25.2006 8:46pm
Stan (mail):
Well without getting into a tort reform debate, a long-standing FDA official has testified that the FDA is not equipped to protect us from bad drugs. FDA salaries are paid for by drug companies, at least partially, since the 1993 PUFA. So, let's just assume that there is an unscrupulous company that desires to sell drugs in the U.S. What will prevent this hypothetical company from selling a drug it knows to be harmful if not deadly?

Now, with respect to fee shifting, I'm not sure how much stiffer you can get. I just won a jury trial in December and got all my costs taxed. I believe there's a U.S. that presumes this. There's also Rule 68 offers of judgments.

With respect to capping, what are you going to cap? Non-economic damages? There is no credible evidence that capping lawsuits will reduce insurance rates. What would be the purpose otherwise? A mother who loses her child from gross negligence, but does not work, would get zero. Is that the result you're looking for? If so, I think that's un-American.

Do you know how much money insurance company CEO's make a year? I know one company that the CEO makes 8 Million. That's almost the amount of compensatory damages in the Garza case...annually.
4.25.2006 8:58pm
Mike BUSL07 (mail) (www):
Well, Stan, that explains why you take it so personally. But the last thing I'm doing is trying to malign the trial bar. And I certainly don't have the first-hand anecdotal evidence to contradict yours - I'm not a trial lawyer, or a lawyer at all for that matter, for another year anyway.

But, the fact that your colleagues are apparently congenial, and that verdicts go "either way," does not address what I said. I was talking about systemic problems that are widely believed to exist, as many candid trial lawyers themselves admit.

And Stan, the fact that you are a trial lawyer doesn't really make you more credible on the issue. It just raises the suspicion that you are talking with your wallet.
4.25.2006 9:01pm
HLSbertarian (mail):
R.A said: However, if I spent three years driving through a neighborhood going 25 miles per hour above the speed limit, putting countless people at risk in the process, and the only effective mechanism to stop my behavior was to sue me for negligence, then I would not be surprised if I was sued...

If you spend 3 years driving 25 over the limit without consequence, that probably says more about the speed limit than about your conduct. Not to mention the fact that a negligence suit is hardly the only recourse to stop lawbreaking.

Causation, in addition to being fundamental to our system's notions of fairness and justice, is a check making sure that we punish the imposition of actual risk, not just what some claim is actual risk.
4.25.2006 9:12pm
Steve:
Fee-shifting proposals tend to be massive overkill. Most lawsuits are not frivolous, and both sides have meritorious positions; yet someone is certain to lose. What we need is stricter enforcement of the rules on the books relating to frivolous claims (and defenses!). As Stan says, offers of judgment exist as well.
4.25.2006 9:28pm
Mike BUSL07 (mail) (www):
Steve, I don't intend to say that we should Abandon the American rule. But I don't think you can enforce frivolous claims and defenses according to the same standard, except affirmative defenses.
4.25.2006 9:37pm
Steve:
There are plenty of claims that simply should be paid. Consider why we require a party seeking to set aside a default judgment to demonstrate the existence of a meritorious defense; the reason is that there is not a meritorious defense to every action!
4.25.2006 10:00pm
Rational Actor (mail):
MikeBUSl07 -
Merck is not hurting for money, even with the legal costs they currently bear. If they wanted to spend more money on research &development, they could. However, I fail to see how that would lead to cheaper drugs on the market. Rx companies tend to have 95%+ gross margins, and if you believe the schpiel that they need to charge the prices because it costs them $800mm to develop a new drug, then I have a bridge to sell you. They spend far more on sales and marketing than they do on R&D or the actual raw ingredients that go into the drug.
As far as tort reform is concerned, there is no question that there are many better ways to handle the medical malpractice issue, but imposing arbitrary caps is not going to do the trick. The system should ideally be one that encourages physicians and other providers to fess up to their mistakes, have an independent board determine fair patient compensation based on damages suffered and a system to punish incidences of gross negligence.

HLSbertarian -
I am not a lawyer, but I am a little confused by your statement. Do you really mean to say that our legal system should "punish the imposition of actual risk" as opposed to punish for actual adverse outcomes that result from our actions? For instance, if I take an action that has a 20% likelihood of causing your death (or to soften it, substantial financial loss), but it does not, do I have some liability because I subjected you to a 20% risk of harm? I don't think that is what you mean, but it is what you wrote.
4.25.2006 10:10pm
anonymous coward:
Rational Actor is correct. Merck pays shareholders a very substantial dividend. If they knew of worthwhile R&D projects, they should be investing in them already, not returning cash to shareholders.

Tort reform, if it means much of anything, would more likely result in millions for the execs and pennies (per share) to the shareholders.
4.25.2006 10:47pm
HLSbertarian (mail):
R.A:

When I said "punish the imposition of actual risk," the emphasis was on the "actual" (as I was hoping was made clear by the rest of that sentence). I read your original comment as saying that since Merck had engaged in risk-imposing behavior, you didn't care too much whether the plaintiffs could show actual causation, and I was writing to disagree. My point was that in addition to all of the other good reasons for the causation requirement, it helps somewhat to clear up the murky calculus of potentialities in the evaluation of undue risks.
4.25.2006 11:07pm
Mike BUSL07 (mail) (www):
Steve, a claim should only be paid if it's supported by sufficient evidence to overcome the burden of proof. The default judgment situation is completely different, because the defendant there was given an opportunity to at least deny the claim, but didn't.

RA, the fact that some big rich company is "not hurting for money" is hardly a reason to take money from it. Before you take money from Merck, you should make sure that it's going to people with valid claims and not in obscene amounts. Besides that, you can't seriously dismiss the problems in our justice system, because "Merck is not hurting for money." The system isn't one of income redistribution, and whatever Merck does with the money, will likely be for the benefit of Merck, as it should be
4.25.2006 11:26pm
Mike BUSL07 (mail) (www):
anonymous coward,

is the fact that you don't like how Merck, (according to you) disposes of its money a good reason to allow even bad claims against them to go forward?
4.25.2006 11:28pm
Steve:
Steve, a claim should only be paid if it's supported by sufficient evidence to overcome the burden of proof. The default judgment situation is completely different, because the defendant there was given an opportunity to at least deny the claim, but didn't.

Can you show me where I said otherwise? All I said was that just as there are lawsuits that should not be brought by the plaintiff, there are lawsuits that should not be contested by the defendant.

Yes, of course you have the legal right to force the plaintiff to meet his burden of proof. But where the issue is not reasonably in dispute, you do not have the right to force him to go through years of litigation at his own expense, to collect on a debt that should have simply been paid in the first instance.
4.25.2006 11:41pm
Steve:
RA, the fact that some big rich company is "not hurting for money" is hardly a reason to take money from it.

You completely, 100% missed the point.

The point was that it is fallacious to argue, "if Merck didn't have all these litigation costs, it could be developing new lifesaving drugs." Because Merck has substantial resources with which to conduct R&D, even after they pay their litigation costs, we can infer that the reason they choose not to do so is because that additional R&D would not be profitable - not because all their money is going to tort costs.
4.25.2006 11:44pm
Mike BUSL07 (mail) (www):
Steve, someone who deserves to lose on summary judgement should lose on summary judgement - clear enough. I'm really not sure why we arguing about that part. We seem to agree.

As to what I said to RA, first I have to confess that it's not so much that I missed the point, but that I tried to pull one over. (It's faster than doing research about Merck's R&D, especially when I'm outlining all night). But there remains the argument that regardless of whether Merck chooses to do R&D or not, they are entitled to their profits w/o having to share them with plaintiffs who apparently can't prove causation or abide by the rules of evidence.
4.26.2006 12:05am
Steve:
Steve, someone who deserves to lose on summary judgement should lose on summary judgement - clear enough. I'm really not sure why we arguing about that part. We seem to agree.

No, we don't agree. I am saying that if the defendant has no legitimate defense, he should pay the plaintiff's costs and fees, just as you expect the plaintiff in a frivolous lawsuit to pay the defendant's costs. You seem to be arguing for a strange double standard, where the plaintiff must bear his own costs for however many years it takes to obtain summary judgment even if there is no meritorious defense to the action.
4.26.2006 12:16am
Mike BUSL07 (mail) (www):
Steve, you can go ahead and pick that bone, but I'm not saying that defendants should be free to act vexatiously. Defendants should however be able to put plaintiffs to their burden. If you don't like it, I hear the civil law system is working out real well in Europe.
4.26.2006 12:20am
anonymous coward:
"is the fact that you don't like how Merck, (according to you) disposes of its money a good reason to allow even bad claims against them to go forward?"

Who says I don't like how Merck spends their money or whatnot? I hate lies, e.g. tort reform will cure cancer and bring the planets into alignment, not capitalism.

If you don't believe the highly credible source of yours truly, you can find out Merck's dividend for yourself in approximately 10 seconds.
4.26.2006 12:27am
212 (mail):
OK, so how much should it cost to compensate what you believe is the accurate number of deaths and heart attacks caused by the drug (some of them had to have actual causation, even if there's no telltale signs to detect afterward), and the going rate (according to insurance estimates, anyway) of about $7M for each life. Now add on the punitive sanctions for deceptive marketing practices...

In fact, to the extent that anyone would have chosen a safer drug instead of vioxx, but for the deception, there's good cause to justify a disgorgement of those ill-gotten gains. (Winning a case on it, however is harder, so it's likely playing out through the punitive damages.)

To me, it sounds like the company is making out pretty well. The problem I think you have is deciding who among all those who took the drug and died or nearly died did so as a result. Sorting the wheat from the chaff. Below is my response. (Please let me know if I've mischaracterized the argument.)

---------------

The argument that the burden of proof has not been met is the "2.0 correlation" argument. (If the standard background risk is 1.0, the 2.0 measure would require that there be proof that Drug X made Result Y twice as likely as normal to occur, or else this instance of Result Y is not automatically more likely than not to have been caused by Drug X, and therefore cannot not pass a "preponderence of the evidence.")

The problem with this argument is mainly that actually harmful activity is underdeterred. Under this theory, if a Drug X made Result Y only 1.99997 times more likely than normal to occer (it's a hypo, don't knitpick about standard deviations), then none of the victims would be compensated at all, even though there would be actual (though not retroactively detectable) causation for nearly half of those who suffer Result Y after taking the Drug X.

The flip side of this is that there is overcompensation whenever the risk ration passes 2.0, because all of those who take Drug X and subsequently suffer Result Y will be compensated, even if they would have suffered Result Y anyway.

The undetectability of actual past causation why there's a very strong danger of marketing a drug to a population with a high background rates of the complication also caused by the drug. However, this does not mean that subsequent suits are somehow overcompensation, and thus overdeterring otherwise useful behavior (selling Drug X). Marketing to a population with a high background rate is MORE dangerous (and should be more deterred) because of the significantly higher difficulty of detecting the actual risks created by the drug in the first place. It's an informational market defect that inhibits the functioning of any ideal market for the drug, and justifies a more stringent corrective measure as a deterrent.

As for FDA approval actually counting for something, stage II and III drug trials require so few participants that a drug can outright kill 1 in every 200 patients the first time they take it (in a way that leaves no question of causation), and it would never come up in the testing. That is why there is so much lip service to post-approval market data in the rush to get drugs approved (except that there's very little actual followthrough).

It's getting really off topic to get into the problem with letting the market sort out huge casualty counts on a population scale in the treatment of trivial conditions, and how much less markets can be trusted when the harm is harder to pin on the actual cause because the population can suffer similar effects naturally. However, the "efficiency analysis" for why it is not actually overdeterring societally useful behavior is pretty much as stated above.
4.26.2006 12:57am
Steve:
Steve, you can go ahead and pick that bone, but I'm not saying that defendants should be free to act vexatiously. Defendants should however be able to put plaintiffs to their burden.

You speak in the vaguest of terms. If the defendant has no good-faith basis to contest plaintiff's allegations, but forces the plaintiff to pay for years of litigation in order to obtain summary judgment, do you consider that "acting vexatiously," or do you consider it "putting plaintiffs to their burden"?
4.26.2006 1:03am
Mike BUSL07 (mail) (www):
what do you think? assume for a hot second that im not retarded.
4.26.2006 1:19am
212 (mail):
Also, the problems of 2.0 correlation (and juries deciding that a this particular instance there was actual causation, regardless of population-level risks) are a perfect example of why a global settlement is preferrable to hashing it out case-by-case.

Justice is not served by letting the company get off scott free for all of them. The Jury verdicts reflect this. However, efficiency is also not served by letting them get off scott free. An activity that causes that much harm should he deterrent. Due to information disparities, Merck is the one who could have deterred that harm at the lowest cost. As such, the burden imposed, the value of the harm caused, should be on them.

That's true in this specific case, with this specific marketing plan. If they allowed warning labels, and hadn't marketted to the elderly, the least cost avoider for each incident of harm would have been the patient/victim. But that's not what Merck did.

Given that you can't tell which heart attacks of patients were caused, they should all get a baseline share of the statistical whole, and those with risk factors for vulnerability given more than the average, but usually less than if they had their case alone. <b>In short, it's a perfect setting for a class acton post-judgement award allocation process. . .</b>

. . . as opposed to a reason Merck should get off scott free in every case.

Look, maybe I'm being an idealist, but the law's not supposed to be about winning and losing cases. I still think it's about just (Just) results. Merck's not supposed to get off completely, neither are they supposed to be robbed. The just have to pay just compensation, but they hurt alot of people, and just compensation is big number. And the money they defrauded their customers out of by claiming they were safe... that's what's coming out in the Punitive damages...

Anyway, just my opinion...
4.26.2006 1:41am
Gene Vilensky (mail) (www):
I don't think that MIke's argument is that these lawsuits would deter Merck. Rather, it's that it would deter new entrants to the pharmaceutical market since they might not have the vast resources Merck has to defend against a massive lawsuit.

I have several doctors (and med students and medical residents/interns) as friends and they are all shocked by what is happening with Merck right now. Most are otherwise left of center, but this issue really troubles them. They do think that there is significant evidence that the tort system is driving innovation away.
4.26.2006 2:06am
t e (mail):
Why isn't it that all the people who know how to run a jury trial are stuck writing log blogs? And, while I guess every tort-reformer suck-up likes to bash Texas juries, one might want to keep in mind that there was a recent plaintiff's verdict and punis in New Jersey - Merck's back yard.

And, no, the big danger for Merck is not that it is going to enter a global settlement prematurely before the get all of their reversals, the big danger for Merck is that they are going to stick to their pig-headed strategy of trying every case.

There will be several cases tried in CA this summer and then the judge who is coordinating the cases has indicated that she is going to send the hundreds and hundreds of cases back to their original venues. Merck will have several hundred simultaneous jury trials to look forward to in the summer and fall of 2007. And if Merck loses and gets hit with punitive damages in pharma-friendly New Jersey - just wait.
4.26.2006 2:35am
Steve:
what do you think? assume for a hot second that im not retarded.

What are you talking about? You're the one who started off by arguing that defendants should be bound by a different standard than plaintiffs when it comes to taking frivolous positions, and you now seem to have morphed your position into God knows what. Why can't we all just agree that those who waste the courts' time with frivolous arguments should be sanctioned, period, no matter which side they may be on.
4.26.2006 3:45am
Roger (mail):
I think it is cute the way non-lawyers repeat everything that they are told to repeat -- especially by companies that hold them in such low regard.

What is even cuter is the way you people despite state court judges, but then constantly talk about how the federal courts are unelected and bad.

Also, what is cute is the original poster (and others) inability to distinguish between "without merit" and "frivolous." Though I don't think that most of you can define either term.

Keep up the good work!
4.26.2006 8:36am
Stan (mail):
Gene Vilensky:

Is it more important to put drugs on the market or is it more important to provide safe treatment to patients? While I understand that some drugs (such as cancer cures) have a more expedient market need, wasn't this an anti-inflammatory drug and aren't there a number of anti-inflammatory treatments out there? I deal with the medical profession every day and my sister is a clinician. I don't believe that the opinion of your friends in the medical profession represent the community as a whole. My experience is that prescribing doctors are pretty pissed off at Merck as more information comes out, because it possibly exposes them and risks the health f their patients, many of whom they have lifelong relationships with. So if your friends are suprised at the verdicts, I suspect they're not well enough informed about the issue. Hasn't every jury found liability--some not finding causation? The majority have I believe.
4.26.2006 9:43am
Rational Actor (mail):
Gene -
I don't think there is a lack of participants in the pharmaceutical or biotech space today. And, I don't think there is a way to estimate how many companies have chosen not to go into business or introduce a drug for fear of being sued. However, given the price differential between new patent protected drugs that often have minimal benefit over older, generic drugs, I doubt that adding more entrants to the pharma r&d world will lower costs.

What specifically shock these doctor friends of yours? The fact that patients with tenuous causation claims against Merck are being awarded damages? That Merck trains its sales force with a game called "dodgeball," and specifically tells them how to assuage physician concerns about the safety profile of the drug? That Merck intimidated third party researchers who raised questions about the drug's safety. If they are scared of the former, point them to www.sorryworks.net. People are a lot less inclined to sue their provider, and are more willing to accept the fact that accidents happen, if they feel they have been treated fairly.
Also, ask those friends why they would prescribe a Cox-2 inhibitor to a patient who suffered no GI effect from a standard NSAID, but had an elevated risk of cardiac disease.
4.26.2006 11:08am
Stan (mail):
And let me say something else, to all you tort reformers (who haven't really offered a reason why the present system doesn't work)... Do think that law firms build businesses on going out and filing frivolous lawsuits because the insurance companies are just stupid and will pay claims no matter what (which doesn't EVER happen)? Does that even make sense? They would be bankrupt in a day, at least most of them. Plaintiff's lawyers have to carefully choose cases and, with med mal cases, wouldn't take a case usually without gross negligence. That's a fact.

What you're not seeing, because you're on the outside of the system you're critical of, is that the judicial system helps an enormous amount of parties with their conflicts and many, many times, but sides are satisfied with the results. You pick out a few examples of high verdicts apparently in an attempt to find things to talk about and offer them as examples of a flawed system. In statistical analysis, aren't the top and bottom ten percent or so automatically sloughed off anyway? I think what you're not seeing, because you're not practicing lawyers in the system, is that the "study group," works and works well.
4.26.2006 11:23am
Stan (mail):
...and I don't mean that negatively about not being in the system, I'm just suggesting that you don't have the proper prospective.
4.26.2006 11:29am
Rational Actor (mail):
Stan - prospective or perspective? Was that a Freudian slip, because tort reform would seem to be a prospective problem for you ;-0 (That was intended as humor, so please do not take offense)
I would, however, beg to differ with your use of the word "proper." I come at this problem from more of a health policy perspective, which may be different from that of an active trial lawyer, but not necessarily "improper." I do not consider myself to be a "tort reform alarmist," in that I do not support arbitrary caps on damages. However, I do think that there are better systems to (i) compensate patients from damages they suffer as a result of faulty care, (ii) punish doctors who exhibit a pattern of negligence and (iii) reduce the overall level of medical errors by encouraging industry participants to share information on common problems and strategies to ameliorate them.
4.26.2006 12:20pm
Stan (mail):
I think my spelling is better than I've exhibited. Boy I hope so. Perhaps autocorrect is creating a virus in my spelling, which sounds like an area for a New Drug Application. :)

I guess my point is that the system works for the vast majority of people, including medical negligence cases. Unless you handle these cases regularly, there's not really any other way of knowing this in my view.

How else would you propose a system that adequately compensates a victim and effectively maintains good medical care?

I think that high insurance rates are solely the result of profiteering by insurers. Insurance rates have not been substantially affected in states with caps.
4.26.2006 1:22pm
Rational Actor (mail):
Stan - insurance rates tend to be cyclical in nature, and depend on lots of factors. I think that the actuaries went a bit berserk with their projections of losses, which flowed through the system at the same time that investment profits were declining. The whole story makes for good headlines and scares the bejeezus out of docs and others, and does provide an opportunity for carriers to enhance their margins.
I believe that Denmark and Sweden have pretty good systems that offer reasonable compensation to injured patients and bereaved parents, make it incumbent on all healthcare professionals to inform patients if they have been injured and are entitled to compensation, and provide for reasonable appeals processes in front of objective administrative boards.

I can't claim to have done exhaustive research on the subject, but my understanding is that most people in those countries are satisfied with their systems.
4.26.2006 1:43pm
tgibbs (mail):
Stan--There are a number of anti-inflammatory drugs out there, but they all share a set of problems. The nonselective NSAIDs in general increase the risk of GI bleeding, which can be life-threatening. Indeed, it remains unclear whether patients taking Vioxx were more at risk--even including the increased risk of CV complications--than patients taking older NSAIDS. The steroids also carry some serious risks, especially for long-term use.

It is beginning to look like NSAIDS in general exert two kinds of cardiovascular effects--a protective effect and a damaging effect. For the older nonselective agents, the protective effect appears to be greater. The selective agents such as Vioxx seem to lack the protective effect, but carry a greater risk of GI bleeding.

There is also the fact that not everybody responds equally well to "equivalent" drugs. Why this should be so is unclear, but there are clearly quite a few people who would continue to take Vioxx if it were available, even given what is now known about CV risk. For that matter, I happen to know that some people at Merck were taking Vioxx themselves, and some of them held onto their personal stocks when Merck took the drug off the market. It is all very well to say there is no "expedient need" because these are not "cancer cures," and to dismiss those who merely suffer from pain. But for many people quality of life is at least as important as life extension, and a well-tolerated anti-inflammatory drug can literally be the one thing that makes life worth living for some people with severe arthritic pain.

So having Vioxx off the market altogether is almost certainly not a good thing. This is an outcome that has been enforced by our legal system, not best medical judgement. And Merck's fate will almost certainly discourage other companies from pursuing other such treatments for arthritic pain. A drug that is given chronically to a large, aging population who are not suffering from a life-threatening illness runs a serious and unavoidable liability risk. In the current environment, a drug with the risk of aspirin would almost certainly be abandoned early in development.
4.26.2006 2:53pm
Stan (mail):
Were the cv effects not idiosyncratic, I may agree. But I do not philisophically agree in keeping a drug on the market that can cause death in 25 year olds (without any indication whatsover) for the effective treatment of osteoarthritis pain. The drug unknowingly kills people.

If the warnings were adequate, there would be no cause of action anyway, would there? If a doctor looked you in the eye and said, this drug could kill you, you proceed to take it and it kills you, where's your lawsuit? Look at Lotronex, by GW. It was taken off the market (same reason, causing deaths) and put back on with a scripting system. No lawsuits anymore.

I also disagree that the lawsuits disuade drug makers from doing R&D on anti-inflammatory drugs. If there's money to be made and a safe mechanism of action, they'll find a way to make it. I agree that it may reduce R&D into Cox-2...it was intially a good hypothethis, but good and honest testing would have shown that it didn't meet the standard to sell it (safe and efficacious). But by the time it hit phase 4, Merck obviusly had too much money invested. There's the problem.

It's not enough to say that a drug or product helps people. It has to help people while not hurting others. Isn't that the way we want to live in this country? It's the way I want to.

By the way, weren't there reports that the preventing of GI bleed claim was way overstated by Merck? I'm really sure there were and that Vioxx didn't really make that much of a difference in that vien (no pun intended). In fact, didn't the DDMAC warn Merck on this issue? Here's a 2001 warning about not including GI adverse events (inter alia)...

4.26.2006 3:34pm
Stan (mail):
Were the cv effects not idiosyncratic, I may agree. But I do not philisophically agree in keeping a drug on the market that can cause death in 25 year olds (without any indication whatsover) for the effective treatment of osteoarthritis pain. The drug unknowingly kills people.

If the warnings were adequate, there would be no cause of action anyway, would there? If a doctor looked you in the eye and said, this drug could kill you, you proceed to take it and it kills you, where's your lawsuit? Look at Lotronex, by GW. It was taken off the market (same reason, causing deaths) and put back on with a scripting system. No lawsuits anymore.

I also disagree that the lawsuits disuade drug makers from doing R&D on anti-inflammatory drugs. If there's money to be made and a safe mechanism of action, they'll find a way to make it. I agree that it may reduce R&D into Cox-2...it was intially a good hypothethis, but good and honest testing would have shown that it didn't meet the standard to sell it (safe and efficacious). But by the time it hit phase 4, Merck obviusly had too much money invested. There's the problem.

It's not enough to say that a drug or product helps people. It has to help people while not hurting others. Isn't that the way we want to live in this country? It's the way I want to.

By the way, weren't there reports that the preventing of GI bleed claim was way overstated by Merck? I'm really sure there were and that Vioxx didn't really make that much of a difference in that vien (no pun intended). In fact, didn't the DDMAC warn Merck on this issue? Here's a 2001 warning about not including GI adverse events (inter alia)...

4.26.2006 3:34pm
Rational Actor (mail):
Tgibbs -
I agree with you that it is not good to have Vioxx off the market entirely. Cox-2s should be (and are -- Celebrex) on the market, with labeling to indicate that they should be prescribed to patients who suffer adverse GI effects from non-discriminating NSAIDs, but not to patients at risk of adverse cardiac events.
HOWEVER, the legal system did not enforce this outcome. Merck voluntarily withdrew the drug. Why? I can't say for sure, but it probably has a lot to do with the fact that they spent several years denying that there was any cardio impact from the drug, and training their sales force to "dodge" questions about cardiac safety as third party researchers had voiced those concerns.
I am not an expert in tort law, but it is hard to see how Merck would incur incremental liability from patients who took the drug today, with the cardiac profile of the drug having been fully disclosed to them.
4.26.2006 3:42pm
Ted Frank (www):
The fact that the New Jersey court is "in Merck's backyard" is hardly dispositive to the question whether Merck got a fair trial in the Cona/McDarby case. One plaintiffs' law firm is sending around a letter arguing to the world that they think Judge Higbee's courtroom is the best possible place to try a Vioxx case; her evidentiary rulings and refusal to grant summary judgment on the punitive damages question certainly provide some indication why several thousand out-of-state cases have voluntarily been filed there.
4.26.2006 7:57pm
Stan (mail):
Actually I think they're filed there to destroy diversity and stay out of the MDL (and get your case moving).

So you're saying that Merck did not receive a fair trial in New Jersey?
4.26.2006 9:59pm
Mandamus (mail):
"I am saying that if the defendant has no legitimate defense, he should pay the plaintiff's costs and fees, just as you expect the plaintiff in a frivolous lawsuit to pay the defendant's costs. You seem to be arguing for a strange double standard, where the plaintiff must bear his own costs for however many years it takes to obtain summary judgment even if there is no meritorious defense to the action."

From the Ontario side of the line, that seems to be the exact problem which requires tort reform in the US. There is absolutely no reason for an unmeritorious defendant to settle before trial. And if the action is delayed through a paper blizzard of motions, the plaintiff may run out of funds or settle at a lower level. The system demands that tactic.

In Ontario (and most of Canada and Brtain etc.), loser pays, is the rule. Also in Ontario, costs are assessed by the court, fixed and made payable forthwith on a motion, generally. The costs are generally a time by rate calculation, at a partial indemnity rate, except in exceptional circumstances when a substantial indemnity rate is ordered. At present the max rate for partial indemnity purposes for a 20 year lawyer is $350.00 and I have been granted at $450 for substantial indemnity purposes. (And that was for successfully defending a motion for summary judgment, where everyone agreed (including the motions judge) that the defendants would ultimately be found liable, but summary judgment was not available because of factual contentions and the question of contribution between defendants and contributory negligence by the plaintiff. That cost the plaintiff $50,000 each for 2 sets of defendants! Plus paying their own lawyer!).

Failing to pay costs as fixed can result in the action being dismissed, or a defence struck out. A plaintiff can only avoid this result by showing that it would not be just to have a meritorious claim dismissed because of impecuniosity. (ie, the impecunious plaintiff would have to be able to successfully resist a motion for security for costs, which necessarily means having a good claim. An impecunious defendant is basically s.o.l.

Also Ontario has an Offer to Settle regime, where *either* side may make an offer. If the offer is open until trial starts, and the offeror does "better" than the offer, the offeree has to pay substantial indemnity costs from the date of the offer through the trial. So an early offer, which is 'generous' can carry substantial benefits at the end, to either side.
I have one of those stupid actions at present for $17,500, involving 3 parties, and aside from the 'pay them $5,000 together with the other defendant's $5,000 to make it go away or pay me $5,000 to go ahead' bargaining, I will be making an offer to settle of $20.00, in expectation of a judgment dismissing the action and the prospect of recovering a nice sum. That is not available to a defendant in the US, as I understand it.


Plus the Rules provide that a lawyer may be assessed costs personally where the lawyer has caused costs to be incurred, without reasonable cause or wasted by undue delay, negligence or default. The comduct must be "inexcusable and merit reproof".

I know of one action where the factual contentions in the Claim are manifestly false, which an on-line real property title search (~$30.00 cost) would have proven. A lot of time will be spent dealing with that crap. In other contexts, NOT conducting a title search would be professional negligence. Is it such a default as to merit an order for costs against the lawyer personally? Time will tell, but I think the answer is and should be 'yes'. Again, that sort of sanction does not seem to exist in the US. Anyone can force a defendant to spend large amounts of time and effort to defend against a frivolous claim. And even though frivolous claims do get struck, it takes far too long to reach that point.

Neither of these mechanisms seem to exist in anything other than vestigial form in US courtrooms (yes I know about the Federal Court Rule, but it seems to be honoured in its desuetude and ineffectiveness).

As to electing versus appointing judges, this is a 'flip a coin' proposition. On the one hand, appointing judges 'forever' can lead to problems of 'attitude' or 'viewpoint'. The Democratic party would not be so shrill about judicial appointments if these were not such powerful positions. On the gripping hand, having to get elected can result in some other problems of 'viewpoint'...Myself, I would prefer that either appointments OR elections be for one fairly long fixed term: 7 to 10 years and out.
4.27.2006 2:56pm
tgibbs (mail):
Stan
"If the warnings were adequate, there would be no cause of action anyway, would there?"

In a fair world, that would be true. All of the information that Merck had was made available to doctors and patients, including the elevated incidence of cardiovascular events.

"It's not enough to say that a drug or product helps people. It has to help people while not hurting others. Isn't that the way we want to live in this country? It's the way I want to"

Absolutely not! As a pharmacologist and a patient, I most certainly do not want to be limited to drugs that can't hurt me. Currently, I am taking Lipitor for cholesterol control and ibuprofen for a separated shoulder. BOTH of those drugs have the potential to hurt me; indeed, either one of them could kill me. For that matter, I am hard put to think of any useful drug that does not carry some level of risk of serious adverse effects, in many cases including fatality. If you are willing to sacrifice efficacy in the name of absolute safety, then your best option is homeopathy, not pharmacology.
4.27.2006 7:24pm
Happy-lee (mail):


http://www.lewrockwell.com/sardi/sardi53.html

Link above is to a short piece that may answer the general causation question. As for specific causation, can you really set things up so as to show how that last grain of sand on the boat caused it to sink? Vioxx caused the patient's blood to thicken -- a lot. For some, this means headaches; for others it means death. How to prove? In the end, that is what Merck claims the plaintiffs need to show -- and it reeks of self-serving over-reliance on causation as a defense. Merck lied. It lied to make lots of money. It lied knowing thousands or hundreds of thousands of consumers would die. It deserves to suffer the same fate by means of a thousand multi-million dollar verdicts. All the bla bla about utilitarian notions (oh, boo hoo, will big pharma survive to deliver more great drugs like Vioxx?) and legal concepts (oh, how do we ever prove something specifically caused the injury at issue?) gloss over the core problem: people were lied to and some of these people died as a result of believing the lies. In short, they were robbed. The entire justice system ought to be focused on how to compensate victims of robbery.
4.27.2006 11:11pm
Stan (mail):
tgibbs,

I think the claim is that Merck failed to disclose what it knew. Nevertheles, warnings are also a function of communication. I have worked with an expert , Dr. Glinert, before about linquistics of warnings. Without going into it too much, if you start a sentence in a warning saying "Although there were signs of GI adverse events, the events were generally..." it serves to underplay the warnings. Doctors are just people and a company can have a significant effect on the weight a presiber places on warnings. I've deposed doctors who say detailers come in and say things like, "oh dont worry about that, it's just in there as a precaution." Dr. Glinert did a study where 80% of participants believed there to be less fat in products labeled "No Fat" than in products labeled "Fat free." He learned that pharm comnpanies study this and use it in commercials, such as "Ask you doctor is it is right for you." When the FDA asks, the pharm response is they mean as if it is indicated. When you ask tv viewers, they think it means to ask their doctor to prescribe it to them. This is the intended effect. I'm sure you've read about some of the sales materials, including the Merck detailer "Dodgeball" game about fielding questions from doctors relating to Vioxx. So if you start with an inadequate warning and water it down in the doctor's office, the result again is underplaying the seriousness of side effects. Do you think sales people should be able to detail doctors? Studies have shown a three week very significant spike in sales of a drug after a detailer makes a visit.

I also believe that our culture is way way way way way overmedicated. No offense. The focus on treating symptoms rather than than exploring the underlying cause is akin to cutting the wire that illuminates the check engine light in your car.

But my point is that if there are drugs that cause an idiosyncratic (no way of telling who it effects) and seroius adverse effect and there are other, safer treatments for the malody, the drug should not be on the market. Incidentally, this is the formula the FDA uses for market approval. And I don't mean misused, I mean when the drug is used and prescribed as indicated (of course all drugs can harm people, so can OTCs). A drug should do good without doing bad in my view. Not do good sometimes, it should do good for everyone who uses according to the directions, and it should be proven to be safe for people it's prescribed to before putting it on the market. I do not believe that was done with Vioxx and a number of other drugs...Baycol, Lotronex, Rezulin, Fen Phen, on and on.
4.28.2006 12:29am
Stan (mail):
mandamus, I don't think there should be fee shifting in legitamate disputes as it may discourage people from hiring lawyers and, while that seems self-serving, the judicial system is far more efficient and fair when both sides have trained officer of the court assisting them. It is also unfair to people who do not have the funds accessible that corporations do. A person and a corporation should be treated identically with appreciation of circumstances. This is a policy issue.
4.28.2006 12:35am
Rational Actor (mail):
tgibbs -
If you believe that Merck made all of its data readily available to the general physician community, I suggest you read this:

http://www.ahrp.org/infomail/05/06/vioxxNPR060905.php

A brief excerpt:
"Dr. Louis Sherwood's campaign to "fix" Vioxx critic Gurkirpal Singh began with a series of phone calls to Singh's bosses at Stanford University.

"I don't usually receive phone calls on a Saturday at home from representatives of drug companies," says James Fries, a professor of medicine at Stanford. "So it was definitely unusual."

The call came on Oct. 28, 2000. " I received a call from a medical director at Merck, stating that someone on my staff had been making wild and irresponsible public statements about the cardiovascular side effects of Vioxx," Fries says. He says Sherwood hinted there would be repercussions for Fries and Stanford if Singh's statements didn't stop. He was left with the sense that Merck's financial support to Stanford was at risk.
4.28.2006 11:23am
tgibbs (mail):
Stan--

Still, there is no evidence that Merck failed to disclose what it "knew." Indeed, the fact that people high up in Merck were taking Vioxx--and allowing family members to take it--right up until Merck took it off the market argues against the notion that Merck "knew" anything about a disproportionate risk. As a matter of fact, I happen to know that at least one person at Merck kept their personal stash of Vioxx after it was taken off the market. And as far as the data is concerned, nobody has yet been able to identify any significant results that were not disclosed in a timely manner to the FDA and the medical community.

I do think that a reasonable case could be made that Merck was overoptimistic in attributing the lower incidence of cardiovascular effects in the naproxen group (in the VIGOR) trial to a protective effect of naproxen. I've looked over the naproxen literature, and while such an interpretation is plausible, it would require a protective effect of naproxen that is on the high end of what has been observed in clinical studies. The question can be raised of whether it was improper of Merck to so vigorously defend a point of view that they honestly believed to be correct. But if that is really sufficient basis for liability, why are people trying so hard to paint Merck as dishonest? As for the "dodgeball" game, I've now seen the actual materials, which are now available online, and it turns out not to be training in how to "dodge" questions about cardiovascular effects of Vioxx--rather, it is a flash card game structured in the form of a dodgeball game, with an actual, physical ball, in which the person catching the ball has to answer one or more questions about Vioxx, which range over all of the properties of the drug, not merely cardiovascular issues. The dodge bit arises because occasionally you draw a card that says "Dodge" and you survive a round without having to answer a question at all. Looks like a fun way to structure flash card training, although I'm sure that by now Merck has come up with something that is not so susceptible to distortion.

"But my point is that if there are drugs that cause an idiosyncratic (no way of telling who it effects) and seroius adverse effect and there are other, safer treatments for the malody, the drug should not be on the market. "

Pretty much all drugs occasionally cause idiosyncratic effects--completely unpredictable effects that are unrelated to the known mechanism of action of the drug, and that presumably arise from rare genetic variants within the human population. The concern about the COX-2 inhibitors such as Vioxx is that the cardiovascular effects are mechanism related rather than idiosyncratic. That doesn't mean that there will not be a statistical distribution of effects. With all drugs, some people will be more or less sensitive to either the therapeutic or side effects of the drug. For this reason, whether there are safer alternatives to a drug is very much an individual matter. Some people just happen to respond better to one drug than another, just as some people are more susceptible to the potential toxicities than another. Risk factors can sometimes be identified, although most often this is more a matter of guesswork than science--for example, excluding people with cardiovascular problems if a drug has a cardiovascular risk, even though there may be no actual evidence that the risk of the drug is related to those "risk factors." But for most drugs, there is simply no reliable way of completely avoiding harmful or dangerous reactions. So the notion that drugs can reasonably be made completely safe when used according to directions is nonsensical.

By the way, I think a lot of people would agree that it would be better to get at the underlying cause of an ailment rather than treat its symptoms. These days, the underlying causes are beginning to be understood. Unfortunately, fixing those causes within the body has turned out to be very difficult, and at this stage to carry risks that are at least as great as conventional pharmacology. You may recall a recent effort to fix a gene defect that ended up inducing cancer and killing the people that it was designed to help.
4.28.2006 3:04pm