Edwardsville- Pharmaceutical giant Merck ignored warnings and tried to cover up risks associated with its blockbuster painkiller Vioxx, a lawyer Wednesday told the jurors in the case of a Granite City woman who died suddenly of a heart attack after spending 20 months on the drug.
Those claims came during opening statements by Andy Birchfield, an attorney for the husband of Patricia Schwaller, who died in August 2003. The courtroom was packed Wednesday with legal teams for both sides, reporters and spectators watching the first salvos in the Midwest’s first trial over Vioxx.
The case is drawing extra attention in part because it’s being heard in what tort reform activists have deemed one of the worst venues nationwide for corporate defendants.
Birchfield, an Alabama attorney, spent the better part of two hours outlining Merck’s development of Vioxx, which was released in 1999 and earned billions of dollars for the company. Merck pulled the drug voluntarily from the market in 2004 after a study seemed to show Vioxx, a member of class of drugs called Cox-2 inhibitors, significantly increased the risk of heart attack.
Merck has repeatedly denied liability and has vowed to fight each of the more than 27,000 suits claiming the company skirted early warnings about the drug in favor of mammoth sales. Birchfield’s opening statements hint that the trial here will attempt to show Schwaller’s death was the product of a larger pattern of Merck’s negligence in warning doctors and patients of the risks of Vioxx.
The family is expected to ask for tens of millions of dollars in damages.
“She should not have been taking Vioxx,” Birchfield told the jurors. “She wouldn’t have been (taking it) if Merck had done the right thing.”
In a brief opening Wednesday, Dan Ball, a St. Louis lawyer representing Merck, said Birchfield was skewing the facts of the case and using the trial as an opportunity to bash Merck and the pharmaceutical industry. He was scheduled to continue opening statements today.
“This case is about whether it’s fair and it’s right to blame Merck for this tragedy,” Ball said, adding that the debate over Merck’s actions in developing Vioxx “had nothing to do with Mrs. Schwaller.”
Merck’s defense focuses heavily on Schwaller’s medical history, including her struggles with obesity, diabetes, high blood pressure and high cholesterol. At age 52, Schwaller’s weight had fluctuated between 250 and 300 pounds; she stood 5 feet 2 inches tall. Merck maintains that Schwaller died of her own complications.
Birchfield acknowledged that Schwaller had multiple risks for heart disease, but said that the woman was “pushed over the edge” by Merck’s negligence. He told jurors that during the trial they would hear hours of testimony about Merck’s promotion of the drug and claims by Schwaller’s own doctor that he didn’t know the risks of Vioxx.
Merck has faced repeated claims around the country that its studies were hurried and flawed sometimes excluding demographics already at risk. Birchfield is expected to present evidence gleaned from more than 20 million documents provided by the company that warning signs were present even before the drug was released.
Ball defended Merck, saying that the company conducted more than 100 studies of Vioxx during the drug’s development and only some showed the increased risk associated with the drug. The Food and Drug Administration approved the drug four different times, but Merck pulled it midway through a study in September 2004 more than a year after Schwaller’s heart attack. Subsequent reviews in medical journals have suggested the drug’s purported benefits that it was easier on the stomach than other painkillers were vastly outweighed by the risks.
Birchfield also presented and is likely to revisit internal e-mails between Merck scientists, including one that condemned a warning label proposed by the FDA. In that message, a lead Merck researcher called the label “ugly cubed” and called government regulators “bastards.”
Merck’s own marketing practices including training for its employees will also face scrutiny at trial. Drug representatives were given instructions on how to handle doctors’ concerns about Vioxx risks, and some scientists and universities allegedly were threatened for publicly questioning the drug.
Ball said Birchfield was portraying isolated notes and memos out of context to distract the jury from Schwaller’s personal issues.
That argument “is designed to do one thing and that’s to put Merck in a bad light,” Ball said. “It’s out of context and weaves a story that has very little to do with Mrs. Schwaller.”