In August, Merck was held liable by a Texas jury in the first lawsuit involving its blockbuster drug Vioxx.

In a case that will have a profound effect on thousands of other cases filed against the drug manufacturer, Texas plaintiff Carol Ernst won her lawsuit, which blamed Vioxx for the death of her husband, Robert Ernst.

Mrs. Ernst was represented by Houston attorney Mark Lanier.

A 59-year-old marathon runner and Wal-Mart worker who was taking the arthritis painkiller at the time of his death, Ernst died of a heart attack in 2001.

The jury awarded more than $250 million in total damages, including $24 million for mental anguish and loss of companionship and $229 million in punitive damages.

“By the size of this award, the jury is saying that they disapprove of Merck’s conduct in the aggressive marketing and sale of Vioxx after Merck had internal knowledge of the risks associated with taking this drug,” said Mike Davis who serves on the Texas state court plaintiffs steering committee for Vioxx litigation.

New Jersey-based Merck says it will appeal the ruling, which is likely to be reduced under Texas’ limits on punitive-damage awards.

Vioxx Nation

Slack & Davis is one of the Southwest’s major players in Vioxx litigation, reviewing hundreds of cases from all over the nation.

Donna Bowen, partner, said, “There is evidence indicating that Merck suspected an increased cardiovascular risk early on and knew of an increased cardiovascular risk from mid-2000 through September 2004 when Vioxx was removed from the market.”

“Financial need overwhelmed good scientific judgment. Merck needed a big-selling drug because the patents of many bestsellers were expiring in the early 2000s. By 2002, Vioxx sales were approximately 10 percent of Merck’s $2.5 billion in total sales,” said Davis.

“Merck created a huge market for Vioxx even though some scientists questioned whether it was any more effective than standard over-the-counter pain relievers,” said Bowen.

According to evidence presented at trial, Merck conducted no studies to explore the cardiovascular effects of Vioxx before or after putting it on the market. The dangers only came to light as unexpected consequences of studies looking for other possible uses for the drug.

“Instead of warning doctors of the risks, Merck’s sales force was told to play dodge ball and avoid answering questions about potential cardiovascular risks,” said Davis.

Slack & Davis continues to review Vioxx claims nationwide.

Vioxx Timeline

November 1998: Merck submits an application to the Food and Drug Administration (FDA) seeking approval for the Cox-2 inhibitor drug Vioxx as a treatment for osteoarthritis, on the basis of clinical trials involving 5,400 patients. Merck represents that rates of cardiovascular risk were “similar” among patients taking Vioxx, placebo or other pain relievers.

January 1999: Merck begins the Vigor trial designed to test gastrointestinal impact of Vioxx. A month later, Merck begins the first of two tests to determine if Vioxx has a beneficial effect on Alzheimer’s disease patients.

May 1999: The FDA approves Vioxx.

February 2000: Merck starts the Approve trial designed to ascertain if Vioxx reduces certain colon polyps.

March 2000: Merck receives preliminary results of Vigor trial, suggesting higher risk of cardiovascular problems among patients taking Vioxx vs. patients taking the pain reliever naproxen. Merck later speculates that the difference is caused by the heart-protective effect of naproxen rather than the heart-risk effect of Vioxx.

March 2000: Merck announces preliminary results of the Vigor trial and submits data to the FDA. Later in the year, Vigor trial results are published in the New England Journal of Medicine.

February 2001: FDA advisory committee holds a hearing on Vigor trials.

April 2002: After lengthy discussions with the FDA, Merck revises the Vioxx label to include precautions about cardiovascular risk cited in the Vigor trial.

Aug. 25, 2004: Preliminary data from an FDA-financed study show patients who took Vioxx had a higher cardiovascular risk than patients who took Pfizer’s Celebrex. Merck disputes the study’s methodology.

Sept. 23, 2004: The independent safety monitoring board for the Approve trial recommends that Merck end the trial because of results showing that long-term use of Vioxx increases risk of heart attacks and strokes compared with patients who took a placebo.

Sept. 30, 2004: Merck says it is withdrawing Vioxx from the U.S. and worldwide markets.

Nov. 8, 2004: Merck reveals that its handling of Vioxx is being investigated by the Justice Department and by the Securities and Exchange Commission.

Nov. 18, 2004: The Senate Finance Committee holds a hearing on Merck and the FDA. Dr. David J. Graham, a veteran FDA researcher, accuses the agency of “a profound regulatory failure” in evaluating Vioxx that could easily be repeated with other drugs. Graham is the lead author of the FDA study that criticized Vioxx.

Dec. 23, 2004: The FDA issues a public health advisory urging doctors to weigh carefully the risks in prescribing medications for arthritis and pain, suggesting that they limit the use of medications known as Cox-2 inhibitors, which includes Vioxx and Pfizer’s Celebrex and Bextra.

Feb. 18, 2005: An FDA advisory panel votes 17-15 that Vioxx could be returned to the U.S. market under certain circumstances and restrictions. The panel also recommends, via a 17-13 vote with two abstentions, that Bextra remain on the market. The panel supports Celebrex by a 31-1 vote. An advisory panel to Canada’s health department recommended 12-1 that Vioxx be reinstated.

Aug. 19, 2005: A Texas state court jury decides against Merck in the first Vioxx product liability trial, assessing $253.4 million in economic and punitive damages. Merck says it will appeal.

Source: The Street.com