First Vioxx Lawsuit
A jury has decided the first Vioxx lawsuit, a wrongful death case heard in a Texas courtroom. By a 10-2 vote on August 19, 2005, the jury held Merck (the maker of Vioxx) liable and awarded $253.4 to the widow of Robert Ernst, a Wal-Mart employee who died of a heart attack while taking Vioxx.
The Damages
Before reaching a verdict, the jury which was comprised of 7 men and 5 women deliberated for 10 1/2 hours over two days. The jury divided the award as follows:
- $450,000 for economic damages
- $24 million for mental anquish and loss of companionship
- $229 million in punitive damages
The plaintiff reportedly had been seeking $40.4 million in damages. According to MSNBC, the punitive damage amount is expected to be reduced according to Texas state law limits - capping punitive damages at twice the amount awarded for economic damages (lost pay) and up to $750,000 above the award for non-economic damages (mental anguish and lost companionship). The maximum award the plaintiff can receive in this case after the reduction is made according to the law would be $1.65 million for punitive damages with the total award not exceeding $26.1 million.
The Trial
Ernst died in 2001 of a heart attack. The lawsuit debated the cause of the fatal heart attack. Was it Vioxx that caused the heart attack or was it arrhythmia secondary to clogged arteries as reported in his autopsy report?
The pathologist who performed Ernst's autopsy testified during the trial that a blood clot likely caused the arrhythmia and a subsequent fatal heart attack. The pathologist could not offer 100% certainty that there was a blood clot (not found during the autopsy) or heart attack. The jury demonstrated by its verdict that it believed the theory that a blood clot caused the arrhythmia and that Merck and Vioxx were liable.
The eyes of the nation focused on the first Vioxx lawsuit.
- What message was the verdict sending to all drugmakers and the U.S. Food and Drug Administration?
- What would be the feeling of the 20 million people who had used Vioxx before it was recalled on September 30, 2004?
- What impact would the verdict have, if any, on the 4,200 Vioxx lawsuits filed since its recall?
Vioxx Lawsuits
Not all Vioxx lawsuits are wrongful death suits. The plaintiff in the next Vioxx lawsuit which is slated to begin September 12th in New Jersey is a man who survived a heart attack in 2001 but blames Vioxx for causing the attack. The first federal Vioxx lawsuit is scheduled to begin November 28th.
Analysts are suggesting that if Merck continues to lose more of the Vioxx lawsuits, the number of Vioxx lawsuits may multiply exponentially. Analysts also suggest Merck may be forced to settle Vioxx lawsuits instead of battling them one by one, if the trend becomes that of Merck losing. For now, it is speculation but what is certain is that Merck will appeal the Ernst decision.
The Problem With Vioxx
Vioxx was launched in the United States in 1999 for the treatment of arthritis and was marketed in 80 countries and used by 84 million people worldwide.
The decision to recall Vioxx followed a three year trial, known as APPROVe (Adenomatous Polyp Prevention on Vioxx), which was a study to determine the effect of Vioxx on the recurrence of neoplastic polyps of the large bowel in patients with a history of colorectal adenoma. The study revealed that an increased risk of cardiovascular complications began 18 months after patients started taking Vioxx.
Merck has been accused of concealing data which sent up red flags about the heart risk.
COX-2 Inhibitors
Vioxx was the second of a promising new class of drugs known as COX-2 inhibitors. The first of the class was Celebrex, approved by the FDA in 1998, and still being marketed. The third COX-2 inhibitor, Bextra was FDA approved in 2001 and withdrawn from the market in April 2005 due to lack of adequate data on the cardiovascular safety of long-term use of Bextra, increased risk of adverse cardiovascular events in short-term coronary artery bypass surgery trials, and reports of serious and potentially life-threatening skin reactions.
The Fallout
The recall of Vioxx stirred up concern over the entire class of COX-2 inhibitors and caused the FDA to come under scrutiny as well as older arthritis drugs known as NSAIDs (nonsteroidal anti-inflammatory drugs). NSAIDs are drugs commonly prescribed to reduce inflammation and relieve pain.
When the COX-2 inhibitors were developed, they were marketed as having a gastrointestinal profile which was more safe. The popularity of the COX-2 inhibitors soared, that is, until the heart risk became a question.
The FDA has changed the label on Celebrex and all other NSAIDs to include additional warnings. As for Vioxx, the legal issues will continue to play out.
Related Resources
Sources: MSNBC, CNN Money, ABCNEWS.com, Merck Press Release <http://www.merck.com/newsroom/press_releases/corporate/2005_0819.html>
