Painkiller Vioxx
Jury Rules Merck Is Not Liable for Heart Attack of Vioxx User
A jury ruled today that Merck was not liable for the heart attack of an Idaho postal worker that occurred after he took the painkiller Vioxx.
That result was in contrast to a verdict in August in which a Texas jury awarded $253 million to the widow of a man who died of an irregular heartbeat after taking the drug.
VERDICT BREAKDOWN
Counts regarding failure to warn of Vioxx risks:
1. Did Merck fail to adequately warn physicians of the link between Vioxx and higher risks of heart attack and stroke, which it knew or should have known about before Frederick "Mike" Humeston's heart attack?
Jury: NO by an 8-1 vote.
Counts regarding failure to warn of Vioxx risks:
1. Did Merck commit consumer fraud "by using unconscionable commercial practices" when marketing Vioxx to physicians?
Jury: NO by a 9-0 vote.
2. Did Merck "make misrepresentations that had the capacity to mislead concerning the cardiovascular risk of Vioxx" while marketing Vioxx to physicians?
Jury: NO by a 9-0 vote.
3. Did Merck "intentionally suppress, conceal or omit material information about an association between Vioxx" and increased risk of heart attack and stroke?
Jury: NO by a 9-0 vote.
The different outcomes mean that many more trials are likely to take place as plaintiffs and Merck, the nation's third-largest drug maker, try to figure out where they stand. The New Jersey jury of six women and three men had been deliberating since Tuesday in the case brought by Frederick Humeston, 60.
A jury ruled today that Merck was not liable for the heart attack of an Idaho postal worker that occurred after he took the painkiller Vioxx.
That result was in contrast to a verdict in August in which a Texas jury awarded $253 million to the widow of a man who died of an irregular heartbeat after taking the drug.
VERDICT BREAKDOWN
Counts regarding failure to warn of Vioxx risks:
1. Did Merck fail to adequately warn physicians of the link between Vioxx and higher risks of heart attack and stroke, which it knew or should have known about before Frederick "Mike" Humeston's heart attack?
Jury: NO by an 8-1 vote.
Counts regarding failure to warn of Vioxx risks:
1. Did Merck commit consumer fraud "by using unconscionable commercial practices" when marketing Vioxx to physicians?
Jury: NO by a 9-0 vote.
2. Did Merck "make misrepresentations that had the capacity to mislead concerning the cardiovascular risk of Vioxx" while marketing Vioxx to physicians?
Jury: NO by a 9-0 vote.
3. Did Merck "intentionally suppress, conceal or omit material information about an association between Vioxx" and increased risk of heart attack and stroke?
Jury: NO by a 9-0 vote.
The different outcomes mean that many more trials are likely to take place as plaintiffs and Merck, the nation's third-largest drug maker, try to figure out where they stand. The New Jersey jury of six women and three men had been deliberating since Tuesday in the case brought by Frederick Humeston, 60.
The jury, which heard seven weeks of testimony, also ruled that Merck appropriately advertised and marketed Vioxx, the popular arthritis and pain drug, providing a significant victory for the company, which plaintiffs' lawyers and other critics contend had hid its internal concerns about the drug's risks from doctors.
In the courtroom following the verdict the sense of relief among the defense team was palpable as lawyers hugged, kissed and cried.
Shares of Merck rose $1.58, or 5.6 percent, to $29.99, on the New York Stock exchange after the verdict was announced. The stock has fallen about 40 percent since the company removed Vioxx from the market in September 2004, after a clinical trial showed that the drug raised the risk of heart attack and stroke.
Merck immediately issued a statement saying that it was pleased with the outcome. "We represented a case that was solidly based on scientific evidence," said James C. Fitzpatrick, of Hughes Hubbard & Reed, a member of Merck's defense team. "Frederick Humeston would have suffered an attack when he did whether he was taking Vioxx or not."
While much of the evidence presented in the New Jersey and Texas trials was similar, the plaintiff in this case appeared to have a weaker case because he had suffered only a mild heart attack after taking Vioxx for two months while the plaintiff in the first case was the widow of a man who had died after taking Vioxx for eight months
In addition, the plaintiff's lawyer in the first case was W. Mark Lanier, considered a top trial lawyer, while the lead lawyer for plaintiffs in this case, Christopher Seeger, has tried only a handful of cases and at times appeared to bore the jury with long-winded explanations of difficult science.
Mr. Humeston also appeared to be a less sympathetic plaintiff than the widow in the Texas case, Carol Ernst. Evidence at the trial showed that he complained repeatedly in writing about his workload to his supervisors at the post office, which investigated his ability to work in the summer of 2001.
In August, a jury in Angleton, Tex., found Merck liable in the first Vioxx case to go to trial, and awarded $253 million to Ms. Ernst, whose husband died of an irregular heartbeat in 2001. Texas law would limit the award to $26.2 million, and Merck has said it will appeal.
Merck faces lawsuits from almost 12,000 people who contend that they or their family members were hurt or killed by Vioxx. Some epidemiologists have estimated that as many as 100,000 people may have suffered heart attacks as a result of taking Vioxx, a figure the company disputes.
Judge Carol E. Higbee, who presided over the Humeston case, is overseeing all 2,400 Vioxx-related suits that have been filed in New Jersey state court. Merck is based in Whitehouse Station, N.J.
The company's victory today in Judge Higbee's courtroom portends well for Merck in those subsequent cases, said Peter A. Bicks, a defense lawyer with Orrick, Herrington & Sutcliffe and who is not involved in the litigation.
"It shows that juries can comprehend Merck's medical defense that these people's health problems were not a result of Vioxx," he said. "While this is a long heavyweight fight, this is an important early-round victory for Merck."
Mr. Bicks said the ruling in Merck's favor might force plaintiffs who used only used Vioxx for a short time to reconsider their cases against the drug maker.
NYTimes 03.11.05
Key events involving the safety of Vioxx and other painkillers:
--December 1998: Food and Drug Administration approves Pfizer Inc.'s Celebrex, the first Cox-2 inhibitor, to treat arthritis. Cox-2 drugs, part of the nonsteroidal anti-inflammatory (NSAID) drug class, inhibit the Cox-2 enzyme, which promotes inflammation, but protect users against stomach bleeds and ulcers, unlike other NSAIDS.
--May 1999: FDA approves Merck & Co.'s Vioxx, another Cox-2 inhibitor, for treatment of arthritis and acute pain in adults.
--June 2000: Merck gives FDA results of VIGOR study, which shows Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve. Merck attributes the disparity to naproxen's cardioprotective qualities rather than a defect in Vioxx, garnering a rebuke from the FDA for making that assertion without scientific proof.
--September 2001: Merck receives a warning letter from the FDA about the company's post-VIGOR Vioxx promotional campaign "that minimizes the potentially serious cardiovascular findings" and "misrepresents the safety profile of Vioxx."
--November 2001: Pfizer's Bextra, also a Cox-2 inhibitor, approved by FDA.
--April 2002: FDA changes warning label on Vioxx to reflect VIGOR study results showing increased risk of heart attacks and strokes.
--May 2002: Carol Ernst sues Merck, alleging Vioxx triggered the May 2001 death of her husband, Robert Ernst, a 59-year-old Wal-Mart produce manager who ran marathons.
--September 2004:Merck stops long-term APPROVe study, saying it showed Vioxx could double risk of heart attack or stroke if taken for 18 months or longer. APPROVe had focused on whether Vioxx could prevent reoccurrence of colon polyps, and on cardiovascular effects. Merck then voluntarily withdraws Vioxx from the market.
--February 2005: FDA panel concludes Vioxx, Celebrex and Bextra all pose heart risks, but should be available to consumers.
--April 7: Pfizer withdraws Bextra from the market at request of the FDA, which said it carries additional risks of serious, sometimes fatal skin reactions. The FDA also says not just Cox-2 inihibitors, but all prescription NSAID drugs, should carry a black-box warning label about cardiovascular risks.
--July 13: A jury of seven men and five women is seated to hear the Ernst Vioxx lawsuit in semi-rural Brazoria County, south of Houston.
--July 19: U.S. District Judge Eldon Fallon schedules the first federal Vioxx trial for Nov. 28.
--Aug. 19: Texas jury finds Merck liable or the death of Robert Ernst, awarding his widow $253.4 million in damages. That will be reduced to about $26 million under Texas caps on punitive damages; Merck plans to appeal.
--Sept. 14: The second Vioxx trial begins with opening arguments in New Jersey Superior Court in Atlantic City, as lawyers for Boise, Idaho postal worker Frederick "Mike" Humeston argue his Sept. 18, 2001, heart attack was caused by Vioxx, which he had been taking for about two months.
--Oct. 24: In its quarterly earnings report, Merck says that as of Sept. 30, it has been named as a defendant in about 6,400 lawsuits over Vioxx -- about 160 of them potential class-action suits -- and has signed agreements with about 3,000 other claimants temporarily suspending the clock on their state's time limit to file suit. At least several hundred at additional lawsuits are filed in October.
--Nov. 3: Atlantic County Superior Court jury rules Merck & Co. not responsible for Humeston's heart attack.
In the courtroom following the verdict the sense of relief among the defense team was palpable as lawyers hugged, kissed and cried.
Shares of Merck rose $1.58, or 5.6 percent, to $29.99, on the New York Stock exchange after the verdict was announced. The stock has fallen about 40 percent since the company removed Vioxx from the market in September 2004, after a clinical trial showed that the drug raised the risk of heart attack and stroke.
Merck immediately issued a statement saying that it was pleased with the outcome. "We represented a case that was solidly based on scientific evidence," said James C. Fitzpatrick, of Hughes Hubbard & Reed, a member of Merck's defense team. "Frederick Humeston would have suffered an attack when he did whether he was taking Vioxx or not."
While much of the evidence presented in the New Jersey and Texas trials was similar, the plaintiff in this case appeared to have a weaker case because he had suffered only a mild heart attack after taking Vioxx for two months while the plaintiff in the first case was the widow of a man who had died after taking Vioxx for eight months
In addition, the plaintiff's lawyer in the first case was W. Mark Lanier, considered a top trial lawyer, while the lead lawyer for plaintiffs in this case, Christopher Seeger, has tried only a handful of cases and at times appeared to bore the jury with long-winded explanations of difficult science.
Mr. Humeston also appeared to be a less sympathetic plaintiff than the widow in the Texas case, Carol Ernst. Evidence at the trial showed that he complained repeatedly in writing about his workload to his supervisors at the post office, which investigated his ability to work in the summer of 2001.
In August, a jury in Angleton, Tex., found Merck liable in the first Vioxx case to go to trial, and awarded $253 million to Ms. Ernst, whose husband died of an irregular heartbeat in 2001. Texas law would limit the award to $26.2 million, and Merck has said it will appeal.
Merck faces lawsuits from almost 12,000 people who contend that they or their family members were hurt or killed by Vioxx. Some epidemiologists have estimated that as many as 100,000 people may have suffered heart attacks as a result of taking Vioxx, a figure the company disputes.
Judge Carol E. Higbee, who presided over the Humeston case, is overseeing all 2,400 Vioxx-related suits that have been filed in New Jersey state court. Merck is based in Whitehouse Station, N.J.
The company's victory today in Judge Higbee's courtroom portends well for Merck in those subsequent cases, said Peter A. Bicks, a defense lawyer with Orrick, Herrington & Sutcliffe and who is not involved in the litigation.
"It shows that juries can comprehend Merck's medical defense that these people's health problems were not a result of Vioxx," he said. "While this is a long heavyweight fight, this is an important early-round victory for Merck."
Mr. Bicks said the ruling in Merck's favor might force plaintiffs who used only used Vioxx for a short time to reconsider their cases against the drug maker.
NYTimes 03.11.05
Key events involving the safety of Vioxx and other painkillers:
--December 1998: Food and Drug Administration approves Pfizer Inc.'s Celebrex, the first Cox-2 inhibitor, to treat arthritis. Cox-2 drugs, part of the nonsteroidal anti-inflammatory (NSAID) drug class, inhibit the Cox-2 enzyme, which promotes inflammation, but protect users against stomach bleeds and ulcers, unlike other NSAIDS.
--May 1999: FDA approves Merck & Co.'s Vioxx, another Cox-2 inhibitor, for treatment of arthritis and acute pain in adults.
--June 2000: Merck gives FDA results of VIGOR study, which shows Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve. Merck attributes the disparity to naproxen's cardioprotective qualities rather than a defect in Vioxx, garnering a rebuke from the FDA for making that assertion without scientific proof.
--September 2001: Merck receives a warning letter from the FDA about the company's post-VIGOR Vioxx promotional campaign "that minimizes the potentially serious cardiovascular findings" and "misrepresents the safety profile of Vioxx."
--November 2001: Pfizer's Bextra, also a Cox-2 inhibitor, approved by FDA.
--April 2002: FDA changes warning label on Vioxx to reflect VIGOR study results showing increased risk of heart attacks and strokes.
--May 2002: Carol Ernst sues Merck, alleging Vioxx triggered the May 2001 death of her husband, Robert Ernst, a 59-year-old Wal-Mart produce manager who ran marathons.
--September 2004:Merck stops long-term APPROVe study, saying it showed Vioxx could double risk of heart attack or stroke if taken for 18 months or longer. APPROVe had focused on whether Vioxx could prevent reoccurrence of colon polyps, and on cardiovascular effects. Merck then voluntarily withdraws Vioxx from the market.
--February 2005: FDA panel concludes Vioxx, Celebrex and Bextra all pose heart risks, but should be available to consumers.
--April 7: Pfizer withdraws Bextra from the market at request of the FDA, which said it carries additional risks of serious, sometimes fatal skin reactions. The FDA also says not just Cox-2 inihibitors, but all prescription NSAID drugs, should carry a black-box warning label about cardiovascular risks.
--July 13: A jury of seven men and five women is seated to hear the Ernst Vioxx lawsuit in semi-rural Brazoria County, south of Houston.
--July 19: U.S. District Judge Eldon Fallon schedules the first federal Vioxx trial for Nov. 28.
--Aug. 19: Texas jury finds Merck liable or the death of Robert Ernst, awarding his widow $253.4 million in damages. That will be reduced to about $26 million under Texas caps on punitive damages; Merck plans to appeal.
--Sept. 14: The second Vioxx trial begins with opening arguments in New Jersey Superior Court in Atlantic City, as lawyers for Boise, Idaho postal worker Frederick "Mike" Humeston argue his Sept. 18, 2001, heart attack was caused by Vioxx, which he had been taking for about two months.
--Oct. 24: In its quarterly earnings report, Merck says that as of Sept. 30, it has been named as a defendant in about 6,400 lawsuits over Vioxx -- about 160 of them potential class-action suits -- and has signed agreements with about 3,000 other claimants temporarily suspending the clock on their state's time limit to file suit. At least several hundred at additional lawsuits are filed in October.
--Nov. 3: Atlantic County Superior Court jury rules Merck & Co. not responsible for Humeston's heart attack.
NYTIMES
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