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Drug manufacturer Merck institutes a recall

On September 30th, 2004, drug manufacturer Merck suddenly withdrew its drug Vioxx (rofecoxib) from the market after continuing reports showed that patients taking it faced a substantially increased risk of several dangerous cardiovascular problems, including heart attack, stroke and congestive heart failure. The company made the decision following a three-year clinical trial to determine the drug’s effectiveness in treating colon cancer.

More than two million Americans are currently taking Vioxx for arthritis, migraines and acute menstrual pain. Another 84 million people around the world have taken Vioxx since its introduction into the market in 1999.

Early concerns
The first concerns about Vioxx’s safety emerged as early as 2000, when researchers noted a higher incidence of heart attack and high blood pressure than in patients taking other pain relievers. However, apparently ignoring these results, Merck insisted that Vioxx had a “favorable cardiovascular safety profile.” In 2001, the FDA warned the company about its failure to disclose these risks:

“Your minimizing these potential risks and misrepresenting the safety profile for Vioxx raise significant public health and safety concerns... [Your] claim in the press release that Vioxx has a ‘favorable cardiovascular safety profile,’ is simply incomprehensible… in fact, serious cardiovascular events were twice as frequent in the VIOXX treatment group…” – Thomas W. Abrams, FDA Director, Division of Drug Marketing, Advertising, and Communications, Sept. 2001
Risks associated with taking Vioxx
In 2004, studies conducted by the FDA and other independent researchers revealed that patients taking Vioxx had an 80% greater risk of being diagnosed with congestive heart failure and a 50% greater risk of heart attacks than patients taking similar anti-inflammatory medications. Studies also revealed that those taking the maximum dosage of Vioxx experienced a three-fold increase in their risk of a heart attack.

FDA officials estimate that Vioxx has been linked to as many as 27 thousand heart attacks since 1999. Many more may have suffered from other cardiovascular diseases associated with it. In spite of the mounting evidence following its debut on the market, Merck continued to spend hundreds of millions marketing Vioxx to the public — yet patients taking the drug were not adequately informed of the dangers associated with it.

“I believe that there should be a full Congressional review of this case. … Sadly, it is clear to me that Merck’s commercial interest in [Vioxx] sales exceeded its concern about the drug’s potential cardiovascular toxicity.” – Eric J. Topol, M.D., The New England Journal of Medicine, October 21, 2004
Are you at risk?
If you or a family member have taken Vioxx and:

have been diagnosed with heart disease, stroke or congestive heart failure that developed taking Vioxx, or
have suffered a heart attack, and
have no prior history of cardiovascular problems
then contact us to discuss your potential claim.

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