A $7.75 Million Vioxx Verdict Is Overturned
31 CommentsBy Ed Silverman // May 14th, 2008 // 2:16 pm
A Texas appeals court has overturned a verdict that Merck lost in a Vioxx case, the Associated Press reports. Two years ago, the widow of 71-year-old Leonel Garza was awarded $7 million in compensatory damages and $25 million in punitive damages, although the punitive amount was later reduced to $750,000 under state law.
Garza, who had a history of heart disease, died of a heart attack after taking Vioxx briefly. After the trial, a juror admitted borrowing thousands of dollars from the widow, Felicia Garza. The appeals court found insufficient evidence to support the jury’s verdict, according to a statement from Ted Mayer, a lawyer for Merck.
Paul
Ahhh, there are two sides to every story, surprise surprise
HorusCat
Paul,
My sentiments exactly….an elderly, probably retired person with no financial potential, with heart disease dies of a heart attack. Let’s give him $7 million dollars in damages (for what? Like he was going to earn $7 million dollars in the next 5 years of his expected life span?). Americans are idiots and most should not be allowed to vote OR serve on juries.
laura
HorusCat,
I truly hope that you never experience the loss of an “elderly” loved one due to negligence on the part of a drug or medical device company. I don’t think you understand that this man’s widow would probably give $700,000,000 to have him back. Lawsuits are not initiated because the plaintiffs want to make money, and the compensation is not only based upon how much money the victim would have made. The survivors feel a very deep desire to make sure that justice is served as well as a desire to somehow justify the loved one’s loss by making sure that no one else ever has to go through what they have gone through. And, as someone who has lost an “elderly” loved one due to the negligence of a medical device company I am deeply offended by your remarks.
Jaynesday
HorusCat
“Americans are idiots and most should not be allowed to vote OR serve on juries.”
How proud you must be to be so superior to we Americans.
HorusCat
laura,
There’s no rule against being offended. Whether the widow would pay $1 or $1 billion to get her husband back is irrelevant. The point in assigning damages is to COMPENSATE
HorusCat
Crud. I hate when that happens.
The point is that damages are meant to be compensation for loss earning potential, not to put a value on a human life.
The bigger point is that this man had on-going, severe cardiovascular disease. You have NO proof, and evidently neither did the plaintiff, that VIOXX caused the heart attack. People can have heart attacks without a drug causing them. I am sure that man also ate carrots, and as Doug Bremner recently pointed out, vitamin A and beta-carotene are associated with increased cardiovascular events. Shall we sue the farmers? You haven’t proved causality, therefore your implication that my comments are insensitive are off-base. That is a tired tactic to try to shut someone up–calling them offensive, or racist, or whatever the flavor of the day is. Whether it is offensive or not, the plaintiff did not prove that Vioxx caused the man’s MI and his life wasn’t worth the huge judgment the jury came down with.
Jaynesday
HC
I have always been at a loss to really understand why some people feel that preemption makes any sense at all. Your comment clarifies that lack of understanding. Thanks for revealing yourself.
HorusCat
Jaynesday,
When the average American knows more about American Idol and Brittany Spears than the Constitution, the rule of law, the importance of individual liberty and private property rights to a representative republic such as the United States and the basics of economics, yes, I do feel superior. More importantly, I believe that a basic understanding of the principles underpinning our system of government and a grave reluctance to vote yourself largesse from the public treasury should be prerequisites to voting.
When a histrionic ambulance-chaser can “channel” an unborn baby and win millions of dollars in malpractice judgments from juries who act on emotions and not reason, I think there is a problem with the tort system. If the average person believes that an elderly man with heart disease only died of a heart attack because of a short spell on Vioxx, then yes, I believe that “Houston, we have a problem.”
The average American doesn’t understand how his heart works, let alone how scientific trials work. The difference between relative risk and absolute risk is HUGE–and no juror should be allowed to serve who cannot understand the basic fundamentals of scientific research.
HorusCat
Preemption doesn’t have anything to do with it. Common sense has EVERYTHING to do with it. The man had heart disease. People with heart disease die of heart attacks. Neither you nor any coroner out there can prove that Vioxx caused that man’s heart attack.
Preemption only comes into play when there is proof of causality for an event. No proof of causality here; ergo, no issue with preemption. Stay on the subject. Of course, per usual with folks on this site, when you can’t argue substance, name-call.
Jaynesday
HC
HorusCat says - Americans are idiots and most should not be allowed to vote OR serve on juries.
Also -
That is a tired tactic to try to shut someone up–calling them offensive, or racist, or whatever the flavor of the day is.
I don’t have to say much HC. You’ve said it all.
HorusCat
Jaynesday says:
I have always been at a loss to really understand why some people feel that preemption makes any sense at all. Your comment clarifies that lack of understanding. Thanks for revealing yourself.
Well, I’ve always been at a loss to understand how anyone can argue that an abortion should be performed on a viable infant, but I manage to get along with the cognitive deficit, so I trust that you will manage, too, Jaynesday.
Once again, you fail to respond to the substance of my remarks. Please explain to me why someone who does not understand the concept of relative risk vs absolute risk and/or the concept of statistical significance vs clinical significance should be allowed to sit on a jury that is considering these issues? Obviously, the appeals court agreed with my assessment–they threw the case out for lack of evidence.
Jaynesday
Sorry HC
I’m just more interested in the basis of your beliefs than listening to you retoric.
Let’s just leave it alone. This subject has gone through the ringer countless times without too many people changing their minds. However I seem to remember someone considering changing from pro to anti preemption. I know I will never change my mind. At its very basis the arguments for preemption are much, much to shallow.
Concerned
Horsecrap, did you go off your zoloft? You’re sounding awfully hostile and agitated.
Laurie
“Please explain to me why someone who does not understand the concept of relative risk vs absolute risk and/or the concept of statistical significance vs clinical significance should be allowed to sit on a jury that is considering these issues? ”
Your statements are the exact reason the Constitution mandates a “jury of your peers” and not a jury of scientists and pharma reps. Everyone is entitled to their day in court and that RIGHT needs to be protected with everything that we have. I never want to see someones legal dispute decided by those who may have created that dispute in the first place. Just because someone doesn’t have an advanced degree in statistics doesn’t mean they can’t understand what an attorney is telling them. The attorneys job is to make sure that expert witnesses present the information so that the jury understands it. It’s a system that has worked for years, until pharma ended up in court.
Justice in Michigan
The history of the Vioxx litigation is actually one of the best cases one could make in favor of the jury system.
Merck won most of the cases that went to jury - about 70%. Far from “runaway juries” bringing famine to the land, we see a complex and nuanced pattern.
That is not surprising. The causality aspect of these cases will inevitably be complex and various, and so one would expect a range of outcomes.
In their settlement, most of the best causality cases against Merck - those MIs and strokes that happened to young and healthy people with well documented medical histories and which took place post-VIGOR and before the 2002 label change - never came to trial.
The absolute risk for Vioxx was roughly the same as the absolute benefit for Lipitor. And, of course, arthritis is not a life-threatening condition in virtually all cases.
Justice in Michigan
Just caught this bit from above: “Americans are idiots and most should not be allowed to vote OR serve on juries.”
Relating this to other thread, _that_ truly is a fascist sentiment. All you’d have to add is “or have children.”
Paul
What a tragedy this has been.
A bunch of plaintiff lawyers, in the end, have resulting in the denial of thousands of real patients in need of a fairly decent pain medication. The AEs turned out to be relatively low incidence. For acute, non-chronic, pain this was an excellent drug.
Hope most plaintiffs (those who don’t have a case) learn a lesson
LNT
I wonder if the verdict would have been overturned if there hadn’t been the unfortunate situation with the juror borrowing $ from the widow? It seems to me that this alone is grounds for a mistrial.
Nathan
Justice,
This is way, way off of the “pharma” type topics, but I understand where HC is coming from on this one. I don’t completely agree with her, but she has a point. I believe that it was Stalin (?) who said that a democracy could never survive because it’s constituents would gradually vote themselves a larger and larger perportion of government money (entitlements) until the government was essentially bankrupt. We see this happening now! How high do tax rates have to get before a democracy is considered socialist? 50%? 60%? We already see many democracies approaching these tax rates. Ours will soon follow given the massive entitlement programs that we have combined with the retirement of the baby boom generation. We say we are a free-market democracy. But in reality we are moving more and more towards socialism. A democratic socialist country seems like an oxymoron - but it isn’t. We are moving that way quite rapidly I’m afraid! Voters are vitally important to the future of our country. We neet voters who are educated and understand the implication of thier votes. HC’s point is that a great number of people voting today don’t seem to have a grasp on any of the major issues our country is facing. Why SHOULD they be allowed to “willy nilly” determine our destiny?
HorusCat
Justice,
I was also being tongue-in-cheek, as anyone familiar with my posts on this blog would have known. But it was too much fun to play with Jaynesday to point out that I was being extreme in order to make a point.
But I might go along with “have children,” especially those who produce them without any intention of caring for them, thus essentially unloading them on the state (read: taxpayers) to take care of. On a non-tongue-in-cheek level, I don’t believe someone should be free to reproduce if they cannot take care of the products of their activities. No one has a right to produce children that their neighbors have to care for with food stamps, subsidized housing, higher medical costs, etc. If I am forced by the coercive state to provide for the multiple children of people ill-equipped to even care for themselves, then I should be able to say, “Enough.” I think if the state is going to play Mommy, then it should require reliable birth control for those who have shown they cannot or will not care for the children they produce before benefits are given. And don’t start with the whole spiel that it is society’s fault: I have friends in a position to know who acknowledge that they intentionally get pregnant in order to further other ends–this is not the case of just not knowing any better.
HorusCat
Jaynesday,
Again I will say that this case had nothing to do with preemption in its course of being overturned. The argument was not that the case should never have been brought, but that the plaintiff failed to prove its case.
As for preemption, prima facie getting rid of it sounds great. But do we end up with a circumstance similar to what we have with gasoline, where companies have to produce “boutique” products geared to the individual laws of every state where the product is marketed? That is one reason gas prices are high. Or do we end up with a few states with large populations (CA, NY) implementing such restrictive policies that pharma companies just go along with those policies, thus perhaps limiting R&D in order to limit liability in politically-powerful states?
I don’t really have a stance on preemption yet. I need to do more reading about it and probably hear more of what Justice has to say, since he seems to be an expert on the topic. I just know that sometimes well-meaning actions have consequences that become more onerous down the road than the precipitating events themselves.
Bingo
HC says “When the average American knows more about American Idol and Brittany Spears than the Constitution, the rule of law … I do feel superior.”
But she also seems to hold the Constitution in rather low regard. She rails against the “nanny state” yet one can infer from her comments about abortion that she would prefer it to be outlawed or restricted.
Does holding mutually contradictory positions undermine the arguments for one or the other?
If “idiots” shouldn’t be allowed to serve on juries (or vote?) what about, uh, jerks? Or whomever happens to hold different views from my own? Which, to some people, seems to be equivalent to an “idiot.”
Justice in Michigan
HC - Your comment I found “beyond the pale” was the second in the thread, expressing your agreement with Paul. Seems bizarre to be “tongue in cheek” in that context.
I have read a great many of your posts. These reminded me of the ones you wrote when you first arrived on Pharmalot. (You yourself spoken then of anticipating being “flamed”).
I responded to you then in more or less the same way. And, since then, while we may well disagree, I have found you to be a valuable and thoughtful participant here.
I look to getting back on that track!
laura
“As for preemption, prima facie getting rid of it sounds great. But do we end up with a circumstance similar to what we have with gasoline, where companies have to produce “boutique” products geared to the individual laws of every state where the product is marketed?”
HorusCat,
If medical device preemption is reversed, it will not eliminate the FDA’s oversight of medical device companies. States will not be able to place any restrictions upon medical device companies or require them to change their products or their labeling. That power will still remain with the FDA. What it will do is to once again allow state court tort claims. It is as simple as that. Is this giving the state the power to place requirements upon medical device companies? I would argue that a state court claim is not a state “requirement”. When a medical device company is sued, the state does not require them to do anything. It is up to the company to decide if they will change their product or its labeling, stop manufacturing their product, or continue status quo. That is simply a business decision on the part of the medical device company not, as pro-preemptionists argue, a “requirement” placed upon the company by the state.
Justice in Michigan
Perfectly said, Laura. The “chaos” theory beloved by preemptors has no substance in the context of the tort system. And, indeed, products that _do_ meet FDA requirements - assuming FDA determinations are based on full and accurate dislosure by manufacturer - are de facto protected from liability in any case. That has been, and remains, a powerful and generally successful defense.
Conversely, FDA has not uncommonly changed its labeling and warnings _as a result of_ civil liability - because of suppressed studies and other relevant safety data that emerges in the course of discovery.
That is why a number of the panelists noted yesterday that the tort system has, most of the time, _reinforced_ FDA’s mission. That was also FDA’s own position in most instances until the current administration.
As Kessler said yesterday, there are, indeed, occasional instances in which FDA requirements and state court determinations can be at odds. Such cases - clear and direct conflict - oughut to be preempted.
But they are rare and certainly not rational grounds for invoking preemption across the board.
HorusCat
Justice,
My agreement with Paul may have seemed outrageous, but damages are meant to make whole someone who has been financially harmed, not indeed to put a value on a human life. The bare fact is that the life of a 71 year old, retired, ill person is not “worth” $7 million in monetary damages. If I am killed by negligence or maliciousness by another person or corporation, the process of assigning damages involves determining the present value of what I would have produced over the course of my lifetime. Straying into the areas of “loss of conjugal privileges” and “companionship” mean getting into that whole argument about what is the value of a human life. The truth then is that no monetary value is high enough. So you get these outrageous judgments that do nothing more than raise the cost of goods and services and enrich the trial bar. Punitive damages are yet another issue. Only in America do we get these outrageous monetary judgments…they are practically unheard of elsewhere. But then, only in America is the trial lawyer’s bar one of the largest contributors to politicians.
I would suggest a Board of Scrutiny, much like some states have for malpractice–a group of scientifically and medically trained persons who can look at the evidence and put it into context before allowing or disallowing a suit to proceed. Such a Board might well say no to the 71-year old man with prior history of serious heart disease and yes to the healthy 38-year old woman who dropped dead after long-term use of Vioxx (which happened to one of my high school classmates).
As for preemption, I think I stated above that I am not knowledgeable enough about it to have much of an opinion. The way you frame it makes sense, but I would have to do more investigation before making up my mind.
Bingo,
Show me in the Constitution where it guarantees the right to an abortion, and I will concede ambiguity in my arguments. Only in America, where convenience trumps morality can you have an issue of whether a baby who accidentally survives an abortion should be allowed to live or not. But I guess even viable and outside the womb, a “fetus” isn’t a person until the nanny state and NARAL says it is.
Justice in Michigan
This just a caveat to the post immediately above HC’s. A colleague has pointed out that there are times when a company meets FDA requirements but _deliberately_ does not pursue studies that might document a problem of which they are aware or which they strongly suspect. Or they use a carrot or stick to try to persuade an outside resesarcher not to pursue such a study (I am personally aware of such instances).
This would be in the category of a “delinquency of omission” and is a good example of why FDA compliance, while not trivial, has been traditionally and appropriately viewed as a “basic requirement.” Viewed both ethically and legally, it may be sufficient to cover liability. Or it may not be.
Bingo
So is the state making reproductive choices for people (by, say, limiting access to abortion or various forms of birth control) somehow not the nanny state? How about a state in which some people are determined to be less worthy of serving on a jury or voting?
In your infinte appreciation of the Constitution do you find support for your assertion that stupid or ignorant people should have fewer rights and responsibilities (voting, serving on juries, for example)?
I take it that your political position is that the state is somehow ill suited to making judgements for individuals except when the decisions they would make offend your sensibilities. In those cases, where the “morality” of the individual choice doesn’t meet your standards, it sounds as if you’re happy to accept rule from above. It sure seems like you’d be perfectly happy with a totalitarian system as long as you are the one in charge.
“I don’t believe someone should be free to reproduce if they cannot take care of the products of their activities.”
And you condemn the nanny state? So should they be forcibly sterilized or should abortion be mandatory in such cases?
Stranger than Fiction
Perhaps the Appeals Court is stacked. Perhaps the situation is similar to that detailed in john grisham’s recent book, called “The Appeal.” let’s all let corporate America off the hook!
HorusCat
Bingo,
A. I was being tongue-in-cheek and expressing frustration with the general level of education in America. Take a Valium.
B. Abortion is only a “personal” choice if you don’t see the product of human sexual intercourse as human. If you see a “fetus” as a human, then it is not a matter of a woman’s reproductive rights, but of a separate human being’s RIGHT to life. Thus, limiting abortion privileges is the ultimate celebration of the individual–the newly created individual. Leaving the decision about the availability of the abortion privilege to the states would take power away from the nanny state and return it to the people–who should be perfectly capable of deciding for themselves what is moral and what is not.
C. I have no problem with humans reproducing like rabbits and providing even less parenting than the aforementioned rodents as long as I don’t have to pay for their lack of responsibility. Reproduction is only a RIGHT if it is accompanied by RESPONSIBILITY. You don’t have the right to foist your progeny off on me to care for them. And once again, the law of unintended consequences comes into play and we end up with more illegitimate children who are abandoned by their parents and ill-served by the mommy state. Perhaps if we quit incentivizing irresponsible behavior, the behavior would diminish? But that, too, would take power away from the nanny state, which needs as many people as possible dependent upon it in order to maintain its power.
D. Our founding fathers did not anticipate a “democracy.” In fact, there was strong argument about limiting the right to vote to property owners. Once again, I have no problem with morons voting. What I object to is the collaboration of dependent adults and the state in an effort to maintain state control, regulate behavior, enable many to live off the work of a few and deprive others of their private property. Socialism doesn’t work, yet that is what an uneducated and selfish citizenry will provide for itself.
E. I believe the state should make as few “judgments for the individual” as possible, from stupid seat belt laws to recreational drug use. Along with that, I think the state should refrain from financially accommodating those who make ill-informed choices.
Bingo
HC
The abortion issue only came up by way of example, so I’ll refrain from arguing those particulars.
“Leaving the decision about the availability of the abortion privilege to the states would take power away from the nanny state and return it to the people–who should be perfectly capable of deciding for themselves what is moral and what is not.”
This makes no sense. Shifting the authority from one governmental jurisdiction to another doesn’t substantially change the relationship of individual to state power. You’re just choosing to submit to a somewhat more local nanny (by your terms).
Mostly what I find absolutely astounding is your constant assertion that Socialism is the natural outgrowth of individual selfishness, yet you cling to a basic libertarian ethos that is completely based in selfishness. To paraphrase: “Don’t make me share, don’t tell me what to do with my resources” combined with an unabashedly elitist and ill-disguised authoritarian attitude of “lots of people are morons (but not me) and can’t be trusted to make decisions because they’ll choose something I don’t like.”
actual quotes:
“Socialism doesn’t work, yet that is what an uneducated and selfish citizenry will provide for itself.”
“What I object to is the collaboration of dependent adults and the state in an effort to maintain state control”
Yes, the government is in cahoots with welfare recipients to keep you down and steal your stuff.