Merck’s defense witness Jerome Cohen, M.D., a St. Louis cardiologist, said his ties to pharmaceutical companies did not influence his opinion that Vioxx did not cause Patricia Schwaller’s death.
Cohen, who returned to the witness stand for cross examination by plaintiff’s attorney Andy Birchfield in Madison County’s first Vioxx trial, repeatedly rejected suggestions that he was “going out on a limb” with his opinion.
“Not at all,” Cohen said. He said that in spite of a study which led to the drug’s recall, he took a step back and “looked at the totality of the data package.”
On Monday Cohen testified Schwaller’s heart attack was due to years and decades of morbid obesity.
Frank Schwaller of Granite City sued Merck in 2005, alleging that Vioxx caused or significantly contributed to the death of his wife after she used the arthritis pain-reliever.
Schwaller claims Vioxx was defectively designed, inadequately tested, dangerous to human health, and lacked proper warnings, which subjected users to risks of heart attacks, strokes and other illnesses.
Cohen said he looked at “causality” when arriving at his opinion in Schwaller’s case.
“What was the causality of Mrs. Schwaller’s death?,” Cohen posed. “There is no evidence between sudden cardiac death and the use of Vioxx.”
Birchfield took issue with Cohen’s previous testimony regarding a study that compared cardiovascular events at various intervals between patients in a trial taking Vioxx and a placebo, referred to as the “18 month issue.”
“You’re a good listener,” Cohen told Birchfield.
“I’ve had a few days,” Birchfield said.
“To sharpen your knives,” Cohen said. Jurors and the audience laughed.
Birchfield projected for jurors a graphic listing the names of 32 doctors who advised the Food and Drug Administration that they agreed in 2005 that “Vioxx significantly increases the risk of cardiovascular events,” as well as a committee of the American Heart Association. In an adjacent column with a header, “Consensus of Scientific Community,” it listed only the name of Jerome Cohen.
Cohen said he stood by his report.
In an August 2005 memo to the FDA, two scientists wrote that Cox-2 drugs,a category Vioxx belongs in, were associated with increased risks of serious adverse cardiovascular events.
Cohen said that the term “associated” was an important distinction.
“Association is not the same as causing and that is important for the jury to know,” Cohen said.
Merck is expected to wrap its case by as early as Thursday. Closing arguments are expected to begin Monday.ou
Early in the examination, Cohen told Birchfield he owns stock in several major pharmaceutical companies including Merck, Pfizer and Bristol-Myers Squibb. He said he lectures for an industry speakers bureau which nets him between $1,500 and $2,500 per engagement, but that the total amount he has earned either as a speaker or an expert is not a large percentage of his income.
“Based on the opinion you’ve given on Vioxx, Merck would know in advance your opinion on this case,” Birchfield asked.
“Not true,” Cohen answered. “Every case including Mrs. Schwaller’s is unique.”