Vioxx trial begins as more evidence of Merck’s misconduct disclosed
As the jury of five women and seven men is seated in Angleton, Texas, and opening arguments begin today in the Vioxx lawsuit brought by widow Carol Ernst, she may have some help from a non-profit health organization that conducts clinical research studies, opposes unethical human experimentation, and promotes alternatives to animal research. Physicians Committee for Responsible Medicine (PCRM) has filed a lawsuit alleging that Merck wrongfully relied on tests showing Vioxx was safe in animals while ignoring mounting evidence that the drug is dangerous to humans. This is believed to be the first time a U.S. pharmaceutical company has been sued specifically for relying on animal tests to show incorrectly that the drug was safe for humans. (Related article: Merck knew of Vioxx risks but decided to hide them)
The lawsuit charges that Merck was well aware of the limitations of animal testing — that animal studies are often inconsistent, species-dependent, and not useful in predicting drug safety or efficacy in humans. At least nine of 11 mice and rat studies, for example, showed Vioxx to be beneficial for animal hearts. The suit accuses Merck of using these and other inapplicable animal data to justify keeping Vioxx on the market. It also states that Merck knew of more effective safety assessment methods, such as postmarket surveillance of patient reactions, in vitro tests using human cells and tissues, and computer modeling, but failed to employ these methods. (Related article: Merck did not disclose dangers of Vioxx)
Such practices are commonly used in the United States by drug companies that often rely on doubtful statistics to get faster approval from the FDA. The agency, many experts charge, is in bed with the drug industry, and simply ignores what the pharmaceutical firms do. Senator Chuck Grassley has been working hard to make the FDA focus more on saving the lives of American people rather than help the drug companies market dangerous drug. Dr. David Graham, an expert at the FDA, has repeatedly accused the agency of favoring drug companies over American people. (Related article: FDA incapable of ensuring drug safety in America)
Vioxx was recalled last year after enormous amount of evidence was available that showed that the drug should be on the market. Up to 60,000 Americans may be dead after taking Vioxx, according to FDA estimates. Merck is facing over 100,000 Vioxx related lawsuits, and the latest suit from PCRM carries more weight because of the amount of scientific evidence that is being presented. At a news conference, Dallas-based cardiologist John Pippin, shared the results of his research, including a new “smoking gun.” Dr. Pippin presented data from an unpublished study on African green monkeys that Merck used as additional evidence of Vioxx’s supposed safety. (Related article: Merck hid risk of death from Vioxx)
“Merck endangered public health by relying on inapplicable animal tests rather than relevant and available human data,†says Dan Kinburn, PCRM associate general counsel. The injured plaintiff, Nancy Tufford, a PCRM member from Minnesota, is seeking $1 million in damages because she developed congestive heart failure while taking Vioxx.
The trial in Texas, expected to last five weeks, is likely to be closely watched by Vioxx victims. While the outcome may have only minimal impact on how other lawsuits are decided, the knowledge that Vioxx lawyers gain from the trial will be helpful in building more solid evidence in future trials. Merck has vowed not to settle any Vioxx litigation out of court and has announced that it intends to fight each lawsuit individually.
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