ATLANTIC CITY, N.J. (1010 WINS) -- Merck & Co. won a crucial legal victory on Thursday, when jurors decided that the drugmaker's Vioxx painkiller, now the subject of more than 13,000 product liability lawsuits, was not responsible for the heart attack of a 68-year-old woman.
The case was the first in which jurors considered whether Merck failed to warn patients about the drug's cardiac risks, rather than just doctors as in prior trials.
The jury found that Merck properly warned doctors but did not warn the woman of the cardiac risks of the drug. However, the jury of five men and two women found that Vioxx was not a substantial contributing factor in Elaine Doherty's 2004 heart attack.
Merck will not have to pay compensatory or punitive damages in the case. The jury also found that Merck did not violate New Jersey's consumer fraud law, meaning it met standards of honesty and good faith in its marketing of Vioxx and did not conceal information about the drug's cardiovascular risks.
Doherty's husband, Daniel, clutched his wife's hand as they rose before the verdict was read. Afterward, the couple spoke quietly with their attorneys but did not comment as they left the courtroom.
The jurors, sitting in Atlantic County Superior Court, reached their decision in the second day of deliberations. The victory was the fourth in seven Vioxx trials for Whitehouse Station, N.J.-based Merck, which plans to appeal the multimillion-dollar verdicts against it in the other three cases.
Lawyers for Doherty, a grandmother of six from Lawrenceville, N.J., alleged during the 5 1/2-week trial that Vioxx was a major cause of her heart attack and that Merck downplayed the risks of Vioxx both to doctors and to patients. Doherty, the first female Vioxx user whose case came to trial, had taken Vioxx for 2 1/2 years before suffering a mild heart attack in January 2004.
Merck lawyers countered that company officials disclosed the drug's risks appropriately and that Doherty's own cardiac risk factors, including obesity, diabetes, high blood pressure and high cholesterol, were responsible for her heart attack.
Doherty's lawyers, though, stressed that she had lost nearly 100 pounds and improved her health significantly in the years before having her heart attack.
At its peak, Vioxx was a $2.5 billion-a-year blockbuster for Merck. It withdrew Vioxx from the market on Sept. 30, 2004, saying research showed it doubled risk of heart attack and stroke after 18 months' use. Data released since then indicate the heart risks started much sooner and persisted at least a year after people stopped taking Vioxx, although Merck has disputed that.
Merck has vowed to fight each Vioxx lawsuit individually and has set aside $970 million in reserve for its legal costs, of which $285 million had been spent as of the end of 2005.
______________________________________________
Key Events Involving The Safety of Vioxx and Other Painkillers:
- May 1999: Food and Drug Administration approves Merck & Co.'s Vioxx, a 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 heart-protecting qualities rather than a defect in Vioxx, but was rebuked by 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.''
- April 2002: FDA changes Vioxx package insert 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 manager and marathon runner.
- Sept. 30, 2004: Merck voluntarily withdraws Vioxx from the market after halting a long-term study that it said showed Vioxx could double risk of heart attack or stroke if taken for 18 months or longer. The study, called APPROVe, had focused on whether Vioxx could prevent reoccurrence of colon polyps.
- February 2005: FDA panel concludes Vioxx and other similar drugs all pose heart risks, but the others should be available to consumers.
- Aug. 19, 2005: Texas jury finds Merck liable for 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.
- Nov. 3, 2005: A jury in Atlantic City, N.J., rules Merck was not responsible for a heart attack suffered by Boise, Idaho, postal worker Federick ``Mike'' Humeston, who had taken Vioxx for about two months.
- Nov. 28, 2005: Squeezed by Vioxx lawsuits, tumbling revenues and other troubles, Merck announces it will eliminate 7,000 jobs and five production plants and revamp manufacturing in the first phase of a global reorganization.
- Feb. 17, 2006: In the first federal Vioxx case to go to trial, jurors in New Orleans cleared Merck in the death of Richard ``Dicky'' Irvin, who died after taking Vioxx for about a month. The verdict came on retrial after a federal judge in Houston three months earlier declared a mistrial when a jury failed to reach a verdict in the case.
- April 11, 2006: A jury in Atlantic City, N.J., split in a two-plaintiff trial, awarding damages to 77-year-old John McDarby, who suffered a heart attack after taking Vioxx, but absolved Merck in the case of 60-year-old Thomas Cona.
- April 21, 2006: A jury in Rio Grande City, Texas finds Merck liable in the death of Leonel Garza, a 71-year-old who had suffered from heart disease for 23 years and died after taking Vioxx for less than a month. The jury orders Merck to pay $32 million.
- May 11, 2006: Merck announces that follow up data from the APPROVe study show Vioxx users weren't at increased risk of heart attack or stroke in the year after stopping the drug, but prominent doctors says the data show risk was elevated for at least a year.
- June 26, 2006: The prestigious New England Journal of Medicine publishes a correction to the APPROVe Vioxx study indicating the risk of heart problems was elevated soon after people began taking the drug _ not only after 18 months of use as Merck still contends.
- June 27, 2006: A Los Angeles Superior Court jury begins hearing the case of Stewart Grossberg, a 71-year-old Vioxx patient who had a heart attack in 2001 after taking Vioxx for 26 months.
- July 13, 2006: A jury in Atlantic City, N.J., rules Merck was not responsible for a heart attack suffered by Elaine Doherty, a 68-year-old diabetic homemaker who had been obese but lost nearly 100 pounds and improved her health years before the heart attack. The case was the seventh of at least 16,000 lawsuits to reach a verdict. It brings Merck's scorecard in the trials to four wins, three losses.
E-Mail Story
Print Story
