Vioxx is NOT GUILTY . . .

[Deb in IA]

Merck, manufacturer of the popular arthritis drug Vioxx, was found not responsible for a patient's heart attack:



Major victory for Merck in N.J. Vioxx trial
Jury finds drug maker not responsible for patient's heart attack

Updated: 12:21 p.m. ET Nov. 3, 2005
ATLANTIC CITY, N.J. - Merck & Co. won a major victory in the battle over its Vioxx painkiller Thursday when a New Jersey state jury found that the drug maker properly warned consumers about the risks of the medication. The finding means Merck won’t be held liable for the 2001 heart attack suffered by a man taking Vioxx.

After deliberating for less than eight hours over three days, the jury cleared Merck of allegations it failed to warn consumers about the drug’s risks and engaged in “unconscionable commercial practices” in marketing it to doctors and their patients.

The verdict was Merck’s first win out of two Vioxx-related trials. In August, a Texas jury found the company liable in a Vioxx user’s death. Damages there will be cut to about one-tenth of the jury’s $253 million award due to that state’s caps on punitive damages.

Much of the seven-week trial, eagerly watched by lawyers and plaintiffs from around the country, relied on the testimony of medical experts. Witnesses for Merck testified the company believed Vioxx was safe for the heart before the drug was pulled from the market a year ago after a study showed it doubled risk of heart attacks and strokes when taken for at least 18 months.

The company faces more than 6,500 similar lawsuits, which Merck, based in Whitehouse Station, N.J., said it plans to fight one by one. Thursday’s verdict means it might take several more cases before lawyers can find any sort of precedent that might determine Merck’s ultimate Vioxx liability. In the meantime, each case — including a federal trial scheduled to begin in Houston Nov. 28 — will continue to draw the attention of pharmaceutical companies, lawyers, consumers and stock analysts.

Members of Merck’s legal team, some with tears in their eyes, hugged each other after the New Jersey verdict.

“I feel pretty good,” said lead counsel Diane Sullivan. “I’m proud of the folks at Merck.”

The verdict capped a trial centering on Frederick “Mike” Humeston, 60, of Boise, Idaho, who was stricken two months after he began taking the drug to ease pain from a Vietnam war knee injury.

Humeston’s lawyer, Chris Seeger, said he was “absolutely surprised” by the verdict.

“I have to kind of sit and reassess what went wrong here. My desire to try more cases is way up right now,” Seeger said. “Merck is based in New Jersey. Maybe that factored into this jury pool.”

Mistrial refused
Merck’s lawyers had appeared to be fighting a losing battle, repeatedly clashing with Superior Court Judge Carol E. Higbee, who denied key motion requests by them and threw out the testimony of Merck’s first witness on procedural grounds.

On five different occasions, Merck asked her to declare a mistrial. Each time, she refused.

In the end, that turned out to be a blessing — and a much-needed one — for Merck, which pulled Vioxx off the market last year after a study showed it increased the risk of heart attacks and strokes after 18 months’ use.

The six-woman, three-man jury concluded that Merck adequately disclosed information about the drug’s risks and could not be held accountable for Humeston’s heart attack. The jurors voted 8-1 that Merck properly warned doctors about risks with Vioxx and voted unanimously on three counts that Merck did not mislead doctors about the drug’s safety.

Humeston’s lawyers painted a picture of the two-time Purple Heart winner as a victim of a greedy drug company that put profits before patients, rushing Vioxx to market in an unsuccessful bid to beat rival Celebrex onto drugstore shelves.

About 20 million Americans took Vioxx after it hit the market in 1999, embracing it for its effectiveness in relieving pain while sparing them the upset stomachs, ulcers and other gastric problems associated with some other analgesics.

At its peak, Vioxx was a $2.5 billion-a-year blockbuster.

No risk from short-term use?
It worked for Humeston, alleviating pain in his left knee, which sustained shrapnel injuries during his U.S. Marine Corps service in Vietnam. But on Sept. 18, 2001, Humeston took two Vioxx pills after work and within hours suffered a mild heart attack.

His doctors blamed it on Vioxx, saying Humeston — a hiker and former mountain guide — had clear arteries and no history of heart disease. He wouldn’t have taken it had he known about the heart attack risk, lawyer Chris Seeger told jurors.

Merck repeatedly reminded jurors that the U.S. Food and Drug Administration had approved it as safe and effective on four occasions for use against different types of pain, the last a month before Merck recalled it.

The company’s lawyers cited Humeston’s elevated blood pressure, weight and stress from an ongoing dispute he was having with his U.S. Postal Service bosses, saying they were to blame for his heart attack, not Vioxx.

The night before the heart attack, Humeston was called by his personal physician in response to an office visit by Postal Service fraud investigators in which they showed him a secretly-recorded videotape of Humeston working on a car at his home.

Merck’s expert cardiologist testified that that call was the “absolute trigger” for the heart attack.

While Humeston made for a sympathetic plaintiff, he also was a relatively healthy one, appearing in court for nearly every day of testimony and taking the stand for one day.

In the Texas case, the victim was a Wal-Mart produce manager who died after taking Vioxx; his widow was the plaintiff.

Merck’s lawyers also told jurors there was no scientific link between short-term Vioxx use and heart attacks.

 

[sodaseller]

Merck, manufacturer of the popular arthritis drug Vioxx, was found not responsible for a patient's heart attack:



Major victory for Merck in N.J. Vioxx trial
Jury finds drug maker not responsible for patient's heart attack

Updated: 12:21 p.m. ET Nov. 3, 2005
ATLANTIC CITY, N.J. - Merck & Co. won a major victory in the battle over its Vioxx painkiller Thursday when a New Jersey state jury found that the drug maker properly warned consumers about the risks of the medication. The finding means Merck won’t be held liable for the 2001 heart attack suffered by a man taking Vioxx.

After deliberating for less than eight hours over three days, the jury cleared Merck of allegations it failed to warn consumers about the drug’s risks and engaged in “unconscionable commercial practices” in marketing it to doctors and their patients.

The verdict was Merck’s first win out of two Vioxx-related trials. In August, a Texas jury found the company liable in a Vioxx user’s death. Damages there will be cut to about one-tenth of the jury’s $253 million award due to that state’s caps on punitive damages.

Much of the seven-week trial, eagerly watched by lawyers and plaintiffs from around the country, relied on the testimony of medical experts. Witnesses for Merck testified the company believed Vioxx was safe for the heart before the drug was pulled from the market a year ago after a study showed it doubled risk of heart attacks and strokes when taken for at least 18 months.

The company faces more than 6,500 similar lawsuits, which Merck, based in Whitehouse Station, N.J., said it plans to fight one by one. Thursday’s verdict means it might take several more cases before lawyers can find any sort of precedent that might determine Merck’s ultimate Vioxx liability. In the meantime, each case — including a federal trial scheduled to begin in Houston Nov. 28 — will continue to draw the attention of pharmaceutical companies, lawyers, consumers and stock analysts.

Members of Merck’s legal team, some with tears in their eyes, hugged each other after the New Jersey verdict.

“I feel pretty good,” said lead counsel Diane Sullivan. “I’m proud of the folks at Merck.”

The verdict capped a trial centering on Frederick “Mike” Humeston, 60, of Boise, Idaho, who was stricken two months after he began taking the drug to ease pain from a Vietnam war knee injury.

Humeston’s lawyer, Chris Seeger, said he was “absolutely surprised” by the verdict.

“I have to kind of sit and reassess what went wrong here. My desire to try more cases is way up right now,” Seeger said. “Merck is based in New Jersey. Maybe that factored into this jury pool.”

Mistrial refused
Merck’s lawyers had appeared to be fighting a losing battle, repeatedly clashing with Superior Court Judge Carol E. Higbee, who denied key motion requests by them and threw out the testimony of Merck’s first witness on procedural grounds.

On five different occasions, Merck asked her to declare a mistrial. Each time, she refused.

In the end, that turned out to be a blessing — and a much-needed one — for Merck, which pulled Vioxx off the market last year after a study showed it increased the risk of heart attacks and strokes after 18 months’ use.

The six-woman, three-man jury concluded that Merck adequately disclosed information about the drug’s risks and could not be held accountable for Humeston’s heart attack. The jurors voted 8-1 that Merck properly warned doctors about risks with Vioxx and voted unanimously on three counts that Merck did not mislead doctors about the drug’s safety.

Humeston’s lawyers painted a picture of the two-time Purple Heart winner as a victim of a greedy drug company that put profits before patients, rushing Vioxx to market in an unsuccessful bid to beat rival Celebrex onto drugstore shelves.

About 20 million Americans took Vioxx after it hit the market in 1999, embracing it for its effectiveness in relieving pain while sparing them the upset stomachs, ulcers and other gastric problems associated with some other analgesics.

At its peak, Vioxx was a $2.5 billion-a-year blockbuster.

No risk from short-term use?
It worked for Humeston, alleviating pain in his left knee, which sustained shrapnel injuries during his U.S. Marine Corps service in Vietnam. But on Sept. 18, 2001, Humeston took two Vioxx pills after work and within hours suffered a mild heart attack.

His doctors blamed it on Vioxx, saying Humeston — a hiker and former mountain guide — had clear arteries and no history of heart disease. He wouldn’t have taken it had he known about the heart attack risk, lawyer Chris Seeger told jurors.

Merck repeatedly reminded jurors that the U.S. Food and Drug Administration had approved it as safe and effective on four occasions for use against different types of pain, the last a month before Merck recalled it.

The company’s lawyers cited Humeston’s elevated blood pressure, weight and stress from an ongoing dispute he was having with his U.S. Postal Service bosses, saying they were to blame for his heart attack, not Vioxx.

The night before the heart attack, Humeston was called by his personal physician in response to an office visit by Postal Service fraud investigators in which they showed him a secretly-recorded videotape of Humeston working on a car at his home.

Merck’s expert cardiologist testified that that call was the “absolute trigger” for the heart attack.

While Humeston made for a sympathetic plaintiff, he also was a relatively healthy one, appearing in court for nearly every day of testimony and taking the stand for one day.

In the Texas case, the victim was a Wal-Mart produce manager who died after taking Vioxx; his widow was the plaintiff.

Merck’s lawyers also told jurors there was no scientific link between short-term Vioxx use and heart attacks.

Guilty implies it was crimal charge. They were found not to be liable.

I won't pretend to have any idea of the science involved or any knowledge of whether there is really a causal link. I wil tell you that a plaintiff already under suspicion of mail fraud may result in a defense verdict regardless of whether jurors were persuaded that Vioxx could have been a causitive factor

 

[Lessa of Pern]

No surprise here.

and no surprise at the Texas verdict either.

the Texas verdict, finding Merck liable, was in a county that is notoriously pro plaintiff. both the judges and the jurors tend to lean towards huge verdicts. a lot of those verdicts get overturned iat the appellate level.

the New Jersey jury pool tends to be different. you may get a jury with a strong pro plaintiff bias, you may get one with a pro defense bias, or you may get one with no preconceived notions.

 

[luvwinnie]

The only article I read on this said he had his heart attack while eating milk and cookies...and all I could think was "Well, if that was usual for him, MAYBE his diet contributed to it." I think it's very hard to prove WHAT caused the heart attack.

 

[sodaseller]

It is nearly impossible in any single instance to prove that any one factor caused a heart attack, Even on conditions that medical science accepts as proven, they do so by making statistical correlations over 1000s of cases. Heck, the Man in Black built up an immunity to iocane poisoning ;>

In each correlation, there is plenty of contrary evidence, just not enough to alter the statistical analysis. And even that is subject to reporting bias, as we do not engage in controlled experimentation on humans


So proving (or disproving) causation in any one case is always difficult

 

[Deb in IA]

I won't pretend to have any idea of the science involved or any knowledge of whether there is really a causal link. I wil tell you that a plaintiff already under suspicion of mail fraud may result in a defense verdict regardless of whether jurors were persuaded that Vioxx could have been a causitive factor

Direct cause and effect relationships are extremely difficult to establish, both in the courtroom and in biomedical research. In something as complex as human health, there are so many confounding variables that cannot be controlled, that many times only an "association" can be scientifically established.

Humeston may have been under investigation for mail fraud, but he was also portrayed as a sympathetic plaintiff, who was relatively healthy and appeared every day in court.

 

[sodaseller]

Direct cause and effect relationships are extremely difficult to establish, both in the courtroom and in biomedical research. In something as complex as human health, there are so many confounding variables that cannot be controlled, that many times only an "association" can be scientifically established.

Humeston may have been under investigation for mail fraud, but he was also portrayed as a sympathetic plaintiff, who was relatively healthy and appeared every day in court.

I agree 100% on the former - see my post above. I realy don't know how he came across - I'm just relying on the story. But I know that if you have baggage like that, juries will often rule against you for that reason alone. I admit I am speculating

 

[Disney Doll]

Well, I don't know if I would rule against someone if I knew they were being investiagted for fraud, but it would certainly make me question their integrity and wonder if their claim was accurate. It would make me think that this guy had "slippery" morals at best, and if he would defraud his job, then he would probably also sue a drug comapny (read deep pockets) without true probale cause.

 

[Geoff_M]

In the Texas case that Merck lost the defense made one critical error: they assumed the jury would understand the science they presented. Namely that the type of cardiac event the medical examiner said the person likely died of hasn't been linked to Vioxx. Jurors interviewed said that Merck science sounded like "Blah, blah, blah" to them and they didn't know what to make of it. This time it looked like Merck showed up loaded for bear.

 

[becker1123]

I'm glad Merck was found not liable for this death. What people sometimes forget is that Vioxx helped a lot of people. For those with rhuematoid arthritis and other related conditions, Vioxx allowed many of them to have a much better quality of life. I know I'd choose to live with better controlled pain even if it meant some other small risks. Lawsuits like this serve to make a few people rich and limit the future choices and opportunities for the rest of us. In my opinion, Merck acted ethically with regard to Vioxx and should not be put out of business with lawsuits like this.

 

[Geoff_M]

What people sometimes forget is that Vioxx helped a lot of people. For those with rhuematoid arthritis and other related conditions, Vioxx allowed many of them to have a much better quality of life.

Which is percisely why the FDA officially has no objection to Merck marketing the drug again, even with the possible cardiac issues. They have said the benefits outway the risks, based on the data seen so far, and have only added additional labeling with the NSAIDs instead of ordering them off the market.

 

[Lessa of Pern]

In the Texas case that Merck lost the defense made one critical error: they assumed the jury would understand the science they presented. Namely that the type of cardiac event the medical examiner said person likely died of hasn't been linked to Vioxx. Jurors interviewed said that Merck science sounded like "Blah, blah, blah" to them and they didn't know what to make of it. This time it looked like Merck showed up loaded for bear.

I don't know the details on the Texas case, but you're probably right. I've taken a few CLE courses on what captivates a jury...and detailed scientific explanations usually don't do it.

the good news for Merck in the Texas case...the intermediate appellate court has the right to review the expert testimony to see if it meets Daubert standards ...by that I mean the appellate judges don't have to take the jury's word for it, they can review the reliabilty of the scientific evidence as if they are the factfinder.

 

[Deb in IA]

the good news for Merck in the Texas case...the intermediate appellate court has the right to review the expert testimony to see if it meets Daubert standards ...by that I mean the appellate judges don't have to take the jury's word for it, they can review the reliabilty of the scientific evidence as if they are the factfinder.

So the Texas decision is under review? I knew the award had been capped, but if it is under review, I'm assuming even the capped amount has not yet been paid out?

 

[sodaseller]

In the Texas case that Merck lost the defense made one critical error: they assumed the jury would understand the science they presented. Namely that the type of cardiac event the medical examiner said the person likely died of hasn't been linked to Vioxx. Jurors interviewed said that Merck science sounded like "Blah, blah, blah" to them and they didn't know what to make of it. This time it looked like Merck showed up loaded for bear.

I wasn't at that trial, but in my experience jurors can get complex concepts if they are s presented correctly. Nothing can seem more dense than antitrust litigation, but if you have expert that speaks plainly and you conduct the examinations by requiring simple explanations of terms, jurors do fine.

While jurors will not learn in a short period of time what experts in the field take years to learn, I frequently find that it is a cop out when a litigant says jurors were too dumb to understand. That said, I recently had a judge after a 4 hour evidentiary hearing announce his ruling in a way that made it clear that he confused certain companies, thinking that an e-mail referring to an agreement between Company A and Company C was about one between Company A and Company B. I debated whether to correct the record or leave it screwed up for appellate purposes. My most worthy opponent corrected it to protect his order from appellate vulnerability, to which the judge immediately clarified that he "misspoke" and "realized that".

My point is that it's up to the lawyer to communicate the ideas. If the facts truly are on "your" side undisputedly, you should be able to get that across. Those who say they were "robbed" often are misrepresenting or misunderstanding how one-sided the evidence supposedly was. By definition those disputes that reach trial are usually close cases

 

[Lessa of Pern]

I'm sure one of my colleagues in Texas will correct me if I'm wrong, but generally speaking, if you disagree with a trial verdict, and choose to file an appeal, you don't have to pay the judgment until the appeal is heard. rather, you may have to file a bond which would guarantee payment if you lose the appeal, or you may have to deposit money into the court's bank account to ensure that the judgment is paid if you lose on appeal.

from what I understand, Merck filed an appeal from the Texas verdict, asserting (amoung other things) that there was no scientific evidence to support a link between Vioxx and the patient's death. Merck press release on the appeal under these circumstances, Merck very likely filed an appeal bond as part of the process to bring the case to the appellate court. the appeal probably won't be heard for many months.

 

[sodaseller]

I'm not in Texas but they do have a bond procedure - the Texaco case involved that

 

[Lessa of Pern]

I wasn't at that trial, but in my experience jurors can get complex concepts if they are s presented correctly. Nothing can seem more dense than antitrust litigation, but if you have expert that speaks plainly and you conduct the examinations by requiring simple explanations of terms, jurors do fine.

While jurors will not learn in a short period of time what experts in the field take years to learn, I frequently find that it is a cop out when a litigant says jurors were too dumb to understand. That said, I recently had a judge after a 4 hour evidentiary hearing announce his ruling in a way that made it clear that he confused certain companies, thinking that an e-mail referring to an agreement between Company A and Company C was about one between Company A and Company B. I debated whether to correct the record or leave it screwed up for appellate purposes. My most worthy opponent corrected it to protect his order from appellate vulnerability, to which the judge immediately clarified that he "misspoke" and "realized that".

My point is that it's up to the lawyer to communicate the ideas. If the facts truly are on "your" side undisputedly, you should be able to get that across. Those who say they were "robbed" often are misrepresenting or misunderstanding how one-sided the evidence supposedly was. By definition those disputes that reach trial are usually close cases

true, but...a jury is going to fall asleep in all they hear is expert testimony from one side, and a heartbreaking tale of misery from the other. defense counsel has to find issues -- other than the complicated science -- to captivate the jury.

and in certain counties in Texas, a defense counsel could tapdance in his underwear for the jury and never get their attention.

 

[Geoff_M]

While jurors will not learn in a short period of time what experts in the field take years to learn, I frequently find that it is a cop out when a litigant says jurors were too dumb to understand

I would agree with that. But I don't think anyone has made the charge that the Texas jury was "dumb". The error was on the part of the Merck defense team on the manner in which they presented their defense. It looks like they may have learned this time around.

 

[sodaseller]

true, but...a jury is going to fall asleep in all they hear is expert testimony from one side, and a heartbreaking tale of misery from the other. defense counsel has to find issues -- other than the complicated science -- to captivate the jury.

and in certain counties in Texas, a defense counsel could tapdance in his underwear for the jury and never get their attention.

No disagreement. I don't do anything close to PI. I will say that I usually represent the "big guy", and if I have to go to trial, I insist on having a top executive in to testify as to company as a whole and everything you can to show a positive culture. IMO, too many are scared to have anyone be the "face" of the company or to testify about what it is about. They fear impeachment, but I think jurors understand no person or company is perfect but want to hear that they try.

I also find that a good story showing that those at the top weren't just born that way helps. One of my recent CEOs started out himself in the scrap business; another started in his garage after taking out a second mortgage. When jurors hear that, they appreciate them more, IMO

 

[DawnCt1]

I sure wish they would put it back on the market. It was a good choice for me. One daily dose. Naproxyn causes gastritis, Ibuprofen requires more frequent dosing, I had problems with Bextra as well. (which is now off the market) but Vioxx was perfect. I still have some I am hoarding for those days when I can't turn my head to drive and when its gone, I will not be happy. Maybe by then it will be available again.