The next federal Vioxx trial opens in federal court today in The Big Easy.
It focuses on a man who began taking the painkiller after its label said that it could increase the risk of heart attacks. But Robert Garry Smith, 56, said he didn't realize the drug, once a blockbuster for Merck, might have brought on his February 2003 heart attack until he saw a lawyer's television advertisement in 2005.
"I was a perfectly healthy man until I took Vioxx and I had a heart attack," Smith, a maintenance supervisor at a chemical plant in the Cincinnati suburb of Covington, Ky., said in a pretrial deposition.
More.
For those of you who are interested here is a "timeline" of events in the Vioxx Saga:
-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 a study known as VIGOR, in which patients taking Vioxx had five times the rate of heart attacks than those taking an older pain reliever, naproxen. Merck contended naproxen had cardioprotective effects that prevented users from suffering heart problems.
-September 2001: FDA sends Merck a warning letter saying a promotional campaign "minimizes the potentially serious cardiovascular findings" and "misrepresents the safety profile of Vioxx."
-April 2002: FDA changes Vioxx package insert to reflect VIGOR heart attack findings.-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 at least 18 months. 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 should be available to consumers.-Aug. 19, 2005: Texas jury awards $253.4 million to the widow of Robert Ernst, who died in May 2001. Texas punitive damage caps will cut that to about $26 million.
-Nov. 3, 2005: A jury in Atlantic City, N.J., clears Merck in September 2001 heart attack of Boise, Idaho, postal worker Federick "Mike" Humeston, who had taken Vioxx for about two months.
-Feb. 17, 2006: Federal jurors in New Orleans clear Merck in the May 2001 death of Richard "Dicky" Irvin, who took Vioxx for about a month. This was a retrial; a December trial ended with a hung jury.
-April 11, 2006: A split verdict in Atlantic City, N.J. A state jury awards $13.9 million to 77-year-old John McDarby, who had a heart attack in April 2004, after four years on Vioxx. But it absolves Merck in the case of 60-year-old Thomas Cona, stricken June 9, 2003, after almost two years on the drug.
-April 21, 2006: A jury in Rio Grande City, Texas, awards $32 million to the family of Leonel Garza, 71, who had heart disease for 23 years and died in 2001 after less than a month on Vioxx.
-June 26, 2006: The prestigious New England Journal of Medicine publishes a correction to APPROVe: the risk of heart problems rose soon after people began taking the drug, not only after 18 months of use as Merck still contends.
-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. She had a heart attack in January 2004, after 2 1/2 years on the drug.
-Aug. 8, 2006: A jury in Los Angeles clears Merck in the 2001 heart attack suffered by Stewart Grossberg, 71.
-Aug. 17, 2006: A state judge in New Jersey overturns Merck's victory in the Humeston case, saying evidence uncovered since the November verdict warranted a new trial. She found of particular note the revelation that Merck left some heart attack data out of its VIGOR report.
-Aug. 17, 2006: A federal jury in New Orleans orders Merck to pay $51 million to Gerald Barnett, who began taking Vioxx in 2000, had a heart attack Sept. 6, 2002, and continued taking Vioxx until the week before it was withdrawn from the market.
-Aug. 30, 2006: Federal judge orders a new trial on Barnett's damages, saying $50 million compensatory is "grossly excessive."
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