23 Comments

The plaintiffs/claimants are not stupid. We are outraged at our attorneys conduct and will not be victimized again. What does the PSC know of me, or my case? Why is my case forced to fit into the cookie cutter mold that the PSC has set up with Merck? Merck has dangled the carrot and created a big payday for the attorneys, NOT FOR THE PLAINTIFFS. It is a slap in the face to those of us who have suffered tremendous loss. 4.85 billion, minus the 2.7 billion going to attorneys, another 1/3 going towards repayment of the medical expenses already incurred; this is not justice and is not enough to pay the future medical expenses for those that have had continued medical problems. The amount left for the plaintiffs won’t even pay for their prescriptions. One plaintiff who suffered a heart attack after taking Vioxx is denied compensation because they had prior health problems. Do you take a drug if you are in perfect health? The Settlement is discriminating. The drug causes heart attacks whether you are 25 or 45. You still have the same result and that is damage to your heart requiring one stent after the other until the next thing you know they are ripping your chest apart. And, where is the compensation for punitive damages? How is Merck being punished for withholding data from the FDA in order to get this drug on the streets? Wasn’t it Merck that took pride in getting the drug approved in RECORD TIME? Merck is boasting another 7 drugs that are going to be pushed through the FDA in another marathon. That is going to make their stockholders day……The PSC represent many plaintiffs, and, I am certain, based on everything they have published, they feel fairly confident they have bullied all of their clients into “settling”, however, they have not reckoned with those members. We will be the unfortunate hold outs, and that may get us nothing but our day in court. To you Mr. Lanier, when you cash the check that you earned for the Ernst case, think about the rest that you sold down the river because you have no fight left in you. You have been bought.

Ms. Pickett’s comments mistakenly assume that the Vioxx plaintiffs are legally entitled to more than zero: as the post notes, the settlement (and the plaintiffs’ bar’s tactics to date) reflect the fact that the cases are worthless if fully litigated. (It’s also false that Merck withheld anything material from the FDA; there’s a reason the FDA has not prosecuted Merck for this, when they go after marketing violations at the drop of a hat, even when such technical violations benefit patients.)

The settlement is a huge windfall for plaintiffs’ attorneys who have brought tens of thousands of meritless cases, but not even I think they’re going to get $2.7 billion out of $4.8 billion.

No one’s called anyone stupid. The point is that Mark Lanier isn’t stupid, and would have no reason to settle unless he knew he couldn’t get a better deal by continuing to litigate. It’s not like he’s going to retire on his profits; he’s already indicated that he’s looking for the next meritless drug case. Why go on to something else unless the Vioxx well has been exhausted?

Of course, Ms. Pickett’s reaction is understandable given that plaintiffs’ lawyers have been publicly exaggerating the case against Merck for years now. Ironically, by giving their clients someone to blame and focus anger on, they have probably interfered more with the health of their clients than anything Merck did.

In response to Ted’s comment, I live in America. In America the common people have rights. When you are harmed intentionally, you have the right to seek compensation. I don’t see anywhere in the Constitution that says you have to lie down, keep your mouth shut and not expect to be compensated for what you have lost.

In response to your statement that the attorneys have thousands of meritless cases, why would an attorney take on a frivolous case? Can we call them ambulance chasers? Can we say they are playing a numbers game? Should I have to pay for their time spent on these cases with an award in which they are not entitled?

To say Merck was negligent in representing data to the FDA has been proven through internal e-mails and other correspondence. You must have missed all of that….It was Mark Lanier’s remarks during the arguments presented at the Ernst trial citing their withholding of information to the FDA. And I quote from the article dated August 19, 2005 by CNN writer Aaron Smith, “Lanier argued that Merck had concealed information about the health risks associated with the drug in order to protect sales. Lanier has used colorful analogies in his portrayal of Merck, which he has compared to Saddam Hussein and the three monkeys who see no evil, hear no evil, speak no evil.” I don’t believe Mr. Lanier would have argued the point had he not had facts to substantiate the claim. The jury was presented with some compelling evidence, don’t you think???

I would give 10 billion dollars to be able to go back to the day before my first dose of Vioxx.

Lawyers are the benefactors of this settlement. Maybe you should take the time to become better informed and do the math!

In America, an attorney can bring a meritless suit and make quite a bit of money when it’s cheaper for the defendant to settle than to defend itself, as any regular reader of this website knows. And that’s precisely what happened in the Vioxx litigation. It’s not fair, it’s not just, and it’s bad for the economy, and that’s why the laws need to be changed so that the Mark Laniers of the world don’t have the incentive to falsely raise the hopes of tens of thousands of people and then cash out a settlement achieved through legalized extortion.

Lanier argued lots of things that aren’t true. Fact of the matter is that Merck executives and their spouses were taking Vioxx. No one was harmed intentionally, or even negligently. The evidence of cardiovascular risk was ambiguous, and when it became less ambiguous, Merck pulled the plug immediately.

As a matter of law, courts are required to find that Merck did not defraud the FDA because the FDA has not found that it was defrauded. See the unanimous decision in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). Any court that failed to do this—such as the Ernst, Garza, and McDarby courts—are going to be reversed on appeal. Again, there’s a reason that the trial lawyers are settling now rather than waiting to be reversed on those cases, and there was a reason that Mark Lanier delayed the appeal of the Ernst case by failing to move for an entry of judgment.

The FDA had every bit of data that Mark Lanier has presented at trial, and chose to approve the drug, and the warning label, because, based on the scientific knowledge available at the time, the benefits outweighed the risks. Even now, with all of the new information available from the APPROVe study and other meta-studies, Canada has approved the reintroduction of Vioxx because the benefits outweigh the risks. Eighty percent of orthopedists say they wish Vioxx was still available on the market because it provides pain relief not available from other drugs that have their own side effects.

You’re obviously very upset, and it’s the nature of confirmation bias to want to find someone to blame and believe that tale, especially when someone slick like Mark Lanier tells a fictional story about a deep pocket’s wrongdoing, implicitly promises you will get rich, and gets a lot of publicity for it. I’m sorry for your health problems, but that doesn’t entitle you to a multi-billion dollar jackpot any more than my grandfather’s health problems entitled me to such a windfall.

Merck’s innocent investors are the benefactors of the settlement. Plaintiffs’ attorneys are the beneficiaries. And tens of thousands of plaintiffs who are legally entitled to zero will get about a $3 billion windfall. And the rest of us better hope that we don’t need a life-saving drug that isn’t going to be invented because of such litigation.

Ted,

Some clients will get over a million dollars for their heart attacks… Do you call that meaningless money? That is a fair settlement for not having to go to trial where the expenses alone exceed a million dollars meaning the victim must win over 3 million dollars every time to equal the settlement. And I can try maybe two to three of these cases a year… How long will it take the 1,000 clients I have to get justice in the court system? That is one reason this is a good settlement!

Final point, the U. S. Supreme Court is currently considering taking away plaintiffs lawsuits against drug companies for failing to warn about risks (“Preemption” is the legal term). Most pundits believe they will do so, although for everyone’s sake, I pray they don’t! If they do, the cases disappear… GONE… Don’t you figure the clients would rather have the money?

In short, there are more reasons than the two you gave for why we recommend this to our clients. We’re not foolish, and we know smoking guns when we see them!

Mark Lanier

Mr. Lanier:

I completely agree that the settlement is economically sensible for plaintiffs and their attorneys, even though the PSC has publicly stated that the marginal cost of a new case will be about $50,000, rather than a million dollars. It’s also economically sensible for Merck.

It’s just bad for the rest of us, who have to pay higher prices for our drugs so that you can hold a larger Christmas party. And it’s bad for America when attorneys can bring tens of thousands of meritless cases and make a billion-dollar profit off of it: it means that some other innocent investors are going to be victimized by the trial bar in the near future.

(I’ve confirmed via e-mail that the Overlawyered comment above is from Mr. Lanier.)

Ted,
If the cardiac risk was initially ambiguous, why did Merck eliminate individuals early in some studies when they begin to manifest cardiac symptoms? Mr. Lanier I don’t believe you think this is a good settlement for the plaintiffs. I’ve read too much from you, you are far from stupid–you know these aren’t meritless cases as Ted tried to suggest. This poison cost me a hell of a lot more than I will receive. Ted you mentioned your grandfather’d health difficulty. I’m sorry for him, and I don’t sure don’t know his condition. But, if his arthritic you might try a COX-2 INHIBITOR.

Mr. Lanier:
You said, “And I can try maybe two to three of these cases a year… How long will it take the 1,000 clients I have to get justice in the court system? That is one reason this is a good settlement!”

It seems to me a poor argument to use your high Vioxx caseload, which you solicited and accepted, as a reason why the settlement makes sense. Wouldn’t an attorney who had the best interests of the clients in mind limit his caseload to something that was doable in a reasonable timeframe if these cases would need to go to trial? Of course, that would require you to carefully chose those clients you accept by reviewing their cases for highest merit, so that your time wouldn’t be wasted on weak cases. It seems to me that what you did instead was to welcome, essentially, all comers, all the while knowing (based upon your last posted statements) that you would NEVER realistically be able to properly service those clients, if necessary, in a trial in court of law. To me this is UNCONSCIONABLE and should be reason enough for YOU to be held liable for legal malpractice. Honestly, how could you possibly recommend the settlement to ALL your clients, knowing full well that, if any/many/or even few of them have meritorious cases, they could stand to make sizable awards if they win in trial, versus what will be, in most cases, meager awards in the settlement, after attorney fees/costs and insurance subrogations are paid.

The Supreme Court is very unlikely to even hear, let alone find for pre-emption in the case you refer to. This is just a scare tactic to coerce that enormous pool of clients of yours (and the other law firms) to accept a deal that, in the aggregate, is fantastic for the lawyers, but unconscionable for the seriously injured vioxx victims/plaintiffs with meritorious cases, who will suffer and pay (both financially and in terms of health/quality and length of life) the rest of their lives. To say nothing of those who died!

I don’t know how you can live with yourself.

I am a Vioxx victim/plaintiff, and I will not be led like a sheep to slaughter solely for the financial interest of my attorney.

Ted
In the latest post you mention something like, “It’s just bad for the rest of us—” Implying the supreme tradgedy of the Merck contention is a monetary loss or loss of capital for innocent captalist out there. Most of us, maybe all or us (more likely) WOULD PREFER TO HAVE OUR LIVES BACK THAN ALL THE GOLD IN merck’s PURSE. I suspect you are not as rigid and glacial as you sound and that your not really in touch with the significance of the Merck’s Vioxx induced vascular epidemic

merck can rott in hell

This settlement does not fairly compensate those with risk factors. It’s hard to say Vioxx killed someone when they had risk factors, but we _can_ say with certainty that their risks were dramatically increased!

To me, it would be fair to first calculate _how much_ their vioxx use increased their risks, and then pro-rate the settlement amount.

These are some numbers I’ve posted elsewhere:

Let’s consider 6 people, with the following probabilities of a heart attack (determined using the Framingham model, for example):
.005
.03
.05
.10
.20
.50
What does a five-fold increase in risk do for each of them?
The person with a 0.5% risk now has a 2.5% risk
The person with a 3% risk now has a 14% risk
The person with a 5% risk now has a 22.6% risk
The person with a 10% risk now has a 41% risk
The person with a 20% risk now has a 67% risk
The person with a 50% risk now has a 97% risk!!!
.
As you can see, the poor overweight diabetic with a history of heart disease etc and who went to his doctor complaining about a back ache lost so very much due to the vioxx coverup.

Ted, I just don’t think you get it, and you won’t get it till it happens to you. You talk about the higher cost of drugs “for the rest of us”. Before I had a heart attack (after taking Vioxx for over a year) I took no drugs. Now, I take 9 pills a day and I will continue to take those drugs for the rest of my life. Before the heart attack I went to a doctor once a year for an annual checkup. Now I go four times a year for stress test and angiograms and prescriptions. I had to retire from a job paying $68,000.00 annually six years earlier than I planned because I just couldn’t keep up with the work. Now Merck comes along and offers me $109,000.00. After lawyer’s fees and insurance payback, I end up with $27,000.00 and you say that’s a good deal? I’ll be paying over $1,000.00 per year (I’m one of the luckly ones that has health insurance)for drugs and doctor visits. I’ve lost potential income of over $400,000.00, and on top of that, I will have the distinct privilege of being the first person in my family to die of heart problems, and you say that’s a good deal. I pray it never happens to you.

It seems we are having two debates here. One regarding Ted’s assertions that the Vioxx cases, in toto, have no value because the evidence that Vioxx increases cardiovascular risk is “ambiguous” and Merck did nothing to withhold information. Ted’s claims are quite at odds with Dr. David Graham and others’ analysis of the studies to date, and I trust Dr. Graham’s analysis more than I trust Ted’s. Dr. Graham also has first-hand knowledge of the FDA’s complicity in ignoring evidence or not pursuing or questioning red-flags aggressively. Ted can choose to believe that Merck and FDA are innocent and benign, even charitable organizations where “patients come first” but the facts show otherwise. The FDA is populated by people with strong ties to big Pharma. The fact that Merck spends more on advertising than research should tell him something, but Ted is clearly intent on believing that Big Pharma is really interested in finding new cures. In fact, most of the research on which truly breakthrough drugs is based (drugs that are very few and far between) comes from research conducted in university and government labs. Laws passed by Republicans allow the drug companies to purchase this research for patent – another form of taxpayer subsidy for corporations. The arguments of Mr. Lanier in the other debate, about whether the Vioxx settlement is a good deal for somebody who will $1 million dollars, are also flawed on their face. Ted has pointed out that future cases will not cost a million dollars each to pursue, citing the PSC itself. I haven’t checked the PSC statements, but it sounds right because at this point the MDL has essentially completed the discovery process and the trial package “product” which all us plaintiffs were waiting for had just been scheduled for Judge Fallon’s review in camera at about the time the settlement was announced. I find it difficult to believe that with all this PSC legwork, amply described at the time of the settlement, on which the PSC is basing its own claim take 8 percent of the legal fees, would leave future plaintiffs lawyers who have access to the trial package with costs anywhere near one million dollars per trial. And presumably, with each passing trial they would be developing a body of expertise that would further facilitate their work and putting pressure on Merck for a truly reasonable settlement. And for the $1 million dollar claimants who “benefit” from the settlment, let’s disclose fully the picture. Those claimant’s who get anywhere near one million or more (or for that matter, half a million) are those very claimants with the best cases – younger age, NO risk factors, long duration of Vioxx use, severe injuries resulting in great and probably permanent disability, and they must have documentation to prove they took the drug just before their medical event. Claimants who are either dead or close to death, or require full time nursing care may get 1.5 to 2 million. But all these award amounts are GROSS amounts. After significant reductions for fees and expenses (which could easily take 30-50 percent of the gross award) a claimant may still be faced with insurance subrogation. Depending on the risk of subrogation in any particular case, a person with a larger award may have huge medical bills associated with their heart attack or stroke. The settlement contains no clause protecting clients who face significant subrogation liens from having most or all of their award eaten up by these liens. And for someone who is now requiring full time nursing care, and facing a lifetime of medical bills, such an award is trivial. I am amazed that Mr. Lanier seems oblivious to these considerations. I was hoping that indeed this was not Mr. Lanier speaking, but apparently Ted has confirmed it is the real Mr. Lanier. Finally, the small number of cases that were tried cannot be assumed to represent the best cases. Members of the MerckSettlement discussion group already have described plaintiff profiles which sound far more favorable that those that were tried so far – for example, a woman her in her mid 20s who took Vioxx for two years and died leaving her two children. There are others as well – men in their late 30s with no risk factors. It is hard to believe that anyone, particularly Ted, who I believe is the same Ted who has engaged in statistical debates on other forums, would suggest that this small number of cases could possibly be representative of the tens of thousands of cases which were denied class status precisely because they were too varied to be grouped together. In my opinion, the Vioxx settlement is simply a very bad example of how the dynamics of mass tort litigation serve attorneys rather than injured plaintiffs. Hopefully, there are some attorneys out there who are at least equally concerned that their clients receive justice as they are with their own compensation.

“The evidence of cardiovascular risk was ambiguous, and when it became less ambiguous, Merck pulled the plug immediately”

It’s not clear it ever became less ambiguous. Looking at the Martin report Appendix Q, “APPROVe Trial Cardiovascular Data …,” p.49 there’s a graphic entitled “Kaplan-Meier Curves of Confirmed ATPC Cardiovascular..”

If that was the less ambiguous data let me assure you that anyone familiar with this type of curve should immediately notice the anomalous happenstance. The operative word is cumulative. Before month 540, both Vioxx and the placebo groups have the same steady rate. After month 540, the placebo group occurrences mysteriously dwindle to almost zero for another 540 months. This is indicated by the cumulative following month 540 barely changing. IOW: the placebo group occurrences effectively STOPPED while the Vioxx group continued the same as during the first 540 months. Outside of statistical fluke, the only other explanation is that placebo’s are PREVENTATIVE, which is absurd.

I hope this wasn’t the compelling evidence provided to the jury.

I can understand why Merck would believe the evidence would be perceived as damning so threw in the towel. Many people go glassy-eyed over 2+2. Trying to understand that curve would really be a problem.

A shame, really.

Correction to my previous post: that should have been day 540 instead of month 540 and the duration was 1080 days

1) Anonymous 4:53’s numbers are fictional. The best estimates for the relative risk of low-dose Vioxx are 1.25 to 1.5, not “5 times.” The vast majority–65 to 80%–of people who suffered cardiac events while taking Vioxx would have suffered those cardiac events even if they hadn’t taken Vioxx.

2) David Graham’s only study of the data (published in Lancet) failed to find statistical significance for risk for low-dose Vioxx. His more sensational figures are cherry-picked from other studies, and contradict the figures Graham himself used when writing memos for the FDA. This is documented in my working paper and forthcoming volume on the Vioxx litigation.

3) Whether Merck defrauded the FDA is a legal question under Buckman, rather than a subject of opinion to be debated between me and Mr. Graham or any of the commenters. As a matter of law, they did not, because the FDA says that Merck did not.

4) DAV demonstrates my point: the APPROVe data wasn’t available until 2004. It makes no sense to ascribe knowledge to Merck in 2000 that did not exist until 2004. And Merck withdrew Vioxx before APPROVe was completed.

5) Interesting that DAV mentions the ability of the jury to understand evidence: in trial after trial, the plaintiffs tried to get the jurors with the least amount of education. In trial after trial, the more educated a juror was, the more likely they were to find for Merck.

6) Again, the revealed preferences of the plaintiffs demonstrates why these cases are settling. If there were legal and factual merit to the cases they would be worth tens of billions. It’s because the cases don’t have legal and factual merit that the plaintiffs were (a) willing to settle for only $4.8 billion and (b) agree to almost-unheard of conditions of third-party screening to ensure that mass tort fraud did not occur in the settlement instead of a much less complicated inventory settlement where the trial lawyer divvies up the money himself. Do you think Lanier is so stupid to give up billions of dollars if punitive damages were a realistic possibility?

7) Henry Smith writes: “The Supreme Court is very unlikely to even hear, let alone find for pre-emption in the case you refer to.” I’d be fascinated why he thinks that: the Supreme Court is hearing two preemption cases just this term, and is likely to decide to hear a third, Levine v. Wyeth. Again, the Buckman preemption decision was unanimous. This isn’t controversial stuff when judges follow the law.

8) “It’s just bad for the rest of us” means everyone, not just investors in Merck and other legitimate businesses. For example, American pregnant women suffering from morning sickness cannot buy the safest, most effective drug to prevent such problems, because trial lawyers litigated Bendectin out of the country, even as it’s being used safely across the rest of the world. As a result, hospitalizations for dehydrated pregnant women have doubled. Many of us will be using the miracle drugs of tomorrow–and there will be fewer such drugs, because of the billions wasted on illegitimate product liability lawsuits and settlements. If a loved one dies because the drug that would have saved their life was never invented, however, you won’t be able to sue the trial bar.

9) Al Pennington, Vioxx is a drug, so I don’t know how you can say you’re both a Vioxx plaintiff and never took drugs. The deal is a good deal, because under the law, you are entitled to zero: Merck isn’t liable for your heart attack. The fact that the calculator suggests you’re entitled to only $109,000 suggests that you had several other risk factors for heart disease that are far more likely to be the reason for your cardiac problems.

10) I hold my opinion even though it has happened to me: I took Vioxx because a doctor misdiagnosed a torn rotator cuff as a strain. I’ve suffered injuries and side effects from antibiotics and other prescription medications. Drugs have side effects. We can either all become Christian Scientists or accept that fact. I’m sorry for your health problems, but you’d be much better off if you stopped blaming Merck for them when it wasn’t Merck’s fault, and you could recognize the $27,000 as a windfall you weren’t supposed to get in the first place.

Ted, If a drug increases the incident of heart attack from .001 to .002, I suppose you’d say that isn’t significant! I use the numbers I use because it’s easier for someone to understand how the drug effects someones chances of heart attack. Anyone can estimate their (low for most people) chances of a heart attack and then see how Vioxx would effect them. Vioxx actually does the most harm to those with other risk factors.

To your last point: All drugs may have side effects but we trust that we’ve been given the information necessary to know whether the risk of side effects are worth whatever benefit we might gain. Folks who had risks shouldn’t have been anywhere near Vioxx because they could just as easily taken Advil.

Anonymous, the term “Statistical significance” is a scientific term that has a specific meaning. If you’re incorrectly using it as a synonym for “significance,” as you did in your comment, you don’t understand what you’re talking about, and have no business discussing the issue.

The Vioxx label provided FDA-approved warnings reflecting the scientifically available information, which is all the law requires, and all the law can reasonably require. One can’t expect a manufacturer to have perfect foresight.

Advil (ibuprofen), incidentally, also has side-effects, including cardiovascular risk.

1. Plaintiffs do not have the resources to try 47,000 cases. That is why these were settled for perhaps less than what they are worth. Of course, as a defense attorney who made a living brow-beating plaintiffs into settlements, you already know this.

2. You answer your own question in the next breath: bulk settlement is appropriate because of the risk $10M settlements will be overturned on appeal. Again, a former defense attorney would know very well that meritorious cases are often overturned on procedural grounds.

3. It is absured to compare the side-effets of Advil to Vioxx.

4. So you would have no problem with Merck being able to cut corners to rush a product to the market, selling a drug they know hurts people, and throw larger Christmas parties with profits they made by evading responsibility?

5. How can you, on the one hand, concede the settlement was fair for plaintiffs, their attorneys, and Merck, yet insist that, on the other hand, this is an example of a “meritless” lawsuit?

Ted,

Great work as always! This whole thing was another multi-billion dollar shakedown by the trial lawyers, no two ways about it. You’ve done a fantastic job documenting the evolution of both the legal and medical issues in this distasteful saga.

Cheers,

Dr. Rob Oliver
http://plasticsurgery101.blogspot.com/

Ted:

Your assertion that juries don’t get it right is dead wrong. In study after study jury verdicts have been shown to fit the facts of the case as well as bench trials with experienced judges. You weren’t in the court room in New Orleans, the jury was. Frankly I trust them more than a man with an ax to grind.

I said the settlement was “economically sensible” for plaintiffs and Merck. I didn’t say it was “fair” for Merck: it’s not, because the lawsuits are meritless. Fair would be the PSC compensating Merck for the billion dollars they’ve spent defending themselves. Merck did nothing to merit liability. I would have a problem if Merck had defrauded the FDA. They didn’t, and the sales and label decisions reflected the appropriate weighing of costs and benefits at the time they were made.

Scott, I don’t say “juries don’t get it right.” Juries do get it right a majority of the time—and they even got it right a majority of the time in the Vioxx cases, especially when the plaintiffs weren’t able to manipulate the voir dire. But most of the plaintiff wins are going to be reversed because of legal errors committed by the judges. And I note that Judge Fallon noted that the jury didn’t get it right in the Barnett case—and I fail to understand why a jury that came to an irrational result on damages should be presumed to come to a rational result on liability.

ted:
I am mind-blowed by your comments. What a wise man you are. The country will be better off if there are more people like you.

By the way, do parties like merck have rights to file lawsuits against the trouble makers who made false claims in this vioxx scandal? If so, then they shall do it instead of this settlement since they may fully recover all of the loss they suffered in this ordeal through proper legal procedures.

God bless America.