Merck & Co. put profits ahead of consumer safety by hustling a blockbuster arthritis medicine to market, then routinely denied the drug’s potentially lethal health risk, an attorney for a former Vioxx user told jurors Wednesday in a trial over her death.
An attorney for Merck countered that Patricia "Pete" Schwaller’s 2003 sudden demise from a heart attack, while tragic, perhaps had more to do with the 52-year-old woman’s obesity, diabetes, high blood pressure and other risk factors than Vioxx.
"There are two sides to every story," Dan Ball argued on Merck’s behalf during opening statements in the Midwest’s first trial over Vioxx, which Merck pulled off the market in 2004 after research showed it increased the risk of heart attacks and strokes.
Patricia Schwaller’s family says the Granite City woman had been taking Vioxx for man than 20 months and had no previous heart attacks, strokes or symptoms of congestive heart disease before she collapsed and died Aug. 8, 2003.
A Schwaller attorney, Andy Birchfield, told jurors that Merck’s own documents show the company "worked hard to keep the truth about Vioxx and its (potential cardiac) dangers quiet," even before the drug won Food and Drug Administration approval in 1999.
Despite documented red flags about Vioxx rasied by outside medical experts and the company’s own advisers, Birchfield said, Merck found Vioxx to be a cash cow worth keeping on the market at all costs, alone accounting for 7 percent of the company’s revenue.
"Merck engaged in an aggressive, well-orchestrated marketing campaign to give doctors the false assurance that Vioxx was safe," he said. When doctors questioned the drug, he argued, Merck brought their silence with grant money or discredited them.
Just weeks after Merck’s science chief, Dr. Edward Scolnick, warned in an internal e-mail that "cardiovascular events are clearly there" as possible Vioxx side-effects, the company issued a news release affirming Vioxx’s "favorable cardiovascular safety."
But on Wednesday, Ball waved off such claims, accusing Birchfield of cherry-picking form the 21 million Merck documents, including internal e-mails, supplied to the plaintiffs "to weave his story" mischaracterizing the 116-year-old company’s conduct.
As it has done in previous Vioxx trials, Merck argued that heart problems by certain plaintiffs, including Patricia Schwaller, were caused by pre-existing health issues, not Vioxx.
Merck acted responsibly by voluntary withdrawing drug, Ball said.
"Never once did the FDA say you should remove this medicine from the market," he said.
Whitehouse station, N.J. -based Merck has been deluged with more than 27,000 personal injury lawsuits and another 265 potential class-action lawsuits alleging harm from Vioxx. Merck, which has reserved $1.64 billion in its Vioxx legal defense fund, has won most of the roughly dozen trials involving Vioxx so far.
The Schwaller case is expected to be watched closely to see how the legal wrangling over Vioxx plays out in America’s heartland-notably in Madison County, which in recent years has tried to shed its reputation as a plaintiffs’ paradise in big-money lawsuits.
The trial is expected to last four to six weeks.