VIOXX® Trial Week Two: “Risk of Heart Attacks Can Occur at Any Time,” Cardiologist Testifies; Jurors Learn About “Scientific Misconduct” and “Intimidation.”
For Immediate Release – Feb. 2, 2007
ATLANTIC CITY, N.J. – A top cardiologist has testified, during the second week of trial, that virtually all relevant medical studies about the drug VIOXX®, including Merck’s own VIGOR study, reveal increased rates of heart attacks and other forms of coronary distress. Dr. Eric Topol, the former head of the Cleveland Clinic, testified that Merck, the maker of VIOXX®, misled the federal Food and Drug Administration, the medical community and consumers about the harmful effects of VIOXX®. Jurors viewed Topol via videotape of a November 2005 deposition.
Jurors also saw and heard videotaped testimony from Stanford medical professor Dr. James Fries, who had complained to Merck’s CEO about a pattern of intimidation against members of the medical community who raised public concerns about VIOXX®. Fries described a weekend phone call in October 2000 from Merck’s Vice-President of Medical Affairs. According to Fries, Dr. Louis Sherwood told him that “…someone would flame out and there would be consequences for Stanford,” if criticism of VIOXX® by one of Fries’ employees continued. According to Fries, numerous critics who raised concerns about the safety of VIOXX® were pressured by Merck.
Inside the courtroom, the main in-person witness has been Dr. Alise Reicin. The Merck Vice-President has previously been described in internal employment reviews as “a tireless defender of the VIOXX® franchise.” During three days of testimony, Dr. Reicin has sparred with attorneys for plaintiffs. Going through a series of company documents and E-mails, plaintiffs are seeking to establish that Dr. Reicin presided over a massive VIOXX® marketing campaign more concerned with profits than safety.
Dr. Reicin has rejected suggestions that she ignored early medical evidence showing that VIOXX® increased the risk of heart attacks by as much as 500%. Jurors were shown early VIOXX® television advertisements and news releases produced by the company that fail to disclose what company already knew – that VIOXX® was responsible for an unusually high number of adverse coronary events among early users of VIOXX®.
The drug was approved by the FDA in May 1999 for the relief of osteoarthritis and menstrual pain, and later for treatment of the signs and symptoms of rheumatoid arthritis. Merck pulled the drug from pharmacy shelves in September 2004.
This week, in response to the public outcry over how VIOXX® was handled by government regulators, the FDA announced that it would begin issuing drug “report cards” designed to detail unexpected side effects that emerge after a drug has been approved. The reports would include follow-up studies and details about how specific drugs are being used.
Jurors in the Atlantic City, New Jersey trial are hearing testimony involving VIOXX® patients Brian Hermans, who died of a heart attack in 2002 after taking VIOXX® for nearly nineteen months, and Frederick Humeston, who suffered a heart attack in 2001. Mark Lanier is representing Kathleen Hermans Messerschmidt, Brian Hermans’ sister. Mr. Humeston is represented by Chris Seeger of New York’s Seeger Weiss LLP.