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Vioxx® Increases Heart Attack Risk

Vioxx® User's Widow Should Receive $253.5 Million, Texas Jury Rules

ANGLETON, TX -- August 23, 2005-- A Texas jury has ruled that Merck must pay $253.5 million to the wife of Robert Ernst, an active 59-year old man who died after taking the company's painkiller, Vioxx®. This is the first personal injury verdict involving Vioxx® and other closely related drugs (Ernst, et. al. v. Merck & Co Inc., No. 19961-BHO2, District Court of Brazoria County). Although Merck is expected to appeal the decision, the case should pave the way for thousands of Vioxx® lawsuits.

Robert Ernst had run marathons and taught aerobics. He took Vioxx® for eight months to treat the pain of tendinitis, an inflammation of the tissue connecting muscle to bone. Mr. Ernst died of an irregular heart beat or arrhythmia, according to the autopsy.

Vioxx® caused the arrhythmia, which led to a blood clot and a heart attack, according to Mrs. Ernst's attorney. The jury agreed with his analysis. It also considered Merck's deceptive marketing practices and failure to disclose knowledge about Vioxx® health risks. It concluded that Merck was negligent and did not provide adequate warnings about the drug.

"I felt Merck knew something was going on as early as 1997," noted juror Lorraine Blas, who said that she took a close look at Merck's internal e-mail on heart problems (Los Angeles Times, August 20, 2005). Other jurors also expressed concern about Merck's version of events.

The verdict consisted of $24.4 million in actual damages and $229 million in punitive damages. Jurors agreed upon the large punitive award in order to send a message to Merck about the importance of disclosing drug safety issues, the New York Times reported. "Respect us, that's the message," said Derrick Chizer, one of the jurors. "We expect accountability, we expect them [Merck] to be open with us, we expect them to be honest with us, " commented Marsha Robbins, the jury forewoman (NY Times, August 20, 2005).

Vioxx®'s Checkered Past

The Food and Drug Administration approved Vioxx® (rofecoxib) in May1999 to treat the symptoms of osteoarthritis and rheumatoid arthritis. The drug was also used to treat acute pain and to lessen the discomfort of menstrual cramps.

A few months before Vioxx® was approved, Merck had begun a study known as the Vioxx® Gastrointestinal Outcomes Research (VIGOR) clinical trial. Over 8,000 patients with rheumatoid arthritis were checked for stomach problems (N Engl J Med. 2000 Nov 23; 343(21): 1520-8). Some took Vioxx® while others took naproxen, a more traditional painkiller. Patients taking Vioxx® increased their chances of heart attacks, strokes, and blood clots compared with those in the naproxen group.

In February, 2000, Merck began the APPROVe clinical trial, designed to use Vioxx® to treat patients with colon polyps. The study was finally stopped in 2004 because Vioxx® users had an increased risk of heart attacks and strokes compared with patients who took placebos (fake pills). The risk was greatest in patients who had been taking Vioxx® for more than 18 months.

Merck revised the Vioxx® label in 2002 to include warnings about heart attacks and strokes. Upon the advice of the Food and Drug Administration (FDA), Merck withdrew Vioxx® from the market in September, 2004.

A Dangerous Trio: Vioxx®, Bextra® and Celebrex®

Vioxx® is a nonsteroidal anti-inflammatory drug (NSAID) that blocks cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins may cause inflammation and pain. Vioxx® interferes with the form of cyclooxygenase known as COX-2, and is therefore referred to as a COX-2 inhibitor.

Other COX-2 inhibitors include Bextra® (valdecoxib) and Celebrex® (celecoxib). The drug maker, Pfizer, took Bextra® off the market in April of this year because it increases the risk of heart attacks and strokes. In addition, Bextra® may cause a severe skin allergy known as Stevens-Johnson syndrome.

Celebrex® is the only COX-2 inhibitor that may still be sold in the United States. Sadly, Celebrex® has also been linked to increased heart attacks and strokes, particularly in patients who have already had coronary bypass surgery.

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