Personal injury attorneys representing clients who have allegedly been harmed by the prescription drug Vioxx are congratulating themselves over a historic judgment rendered recently. On August 19, 2005, a judge awarded the family of Bob Ernst $253.4 million due to his death from the drug. Vioxx, which had been prescribed most often for arthritis pain, was withdrawn globally by its maker, Merck, after research trials showed it increased patients' chances of a heart attack. Although Merck pulled the drug off the market in September 2004, legal action against this leading pharmaceutical giant will continue and expand. Let’s take a look at why Vioxx has become a litigation lightning rod.
In 1998 as Merck was running clinical trials for Vioxx, company reports to the FDA stated that there were no cardiovascular signals apparent. This meant that there were no telltale signs that the drug could cause heart problems for users. Later, however, it was revealed that an internal study conducted by Merck around the same time – Study 090 – revealed serious cardiovascular problems as compared to patients not taking Vioxx. The study was never published by Merck as the company insisted that it was not large enough to provide definitive data.
The following year the FDA gave Vioxx its approval and the drug became the second nonsteroidal anti-inflammatory medication [or COX-2 inhibitor] to hit the market. Celebrex, another problem drug, was the first.
Merck widely and thoroughly launched a marketing campaign upon the introduction of Vioxx to the marketplace. Indeed, by 2003 the drug had entered 80 nations with sales exceeding $2.5 billion. Still, there were problems looming as ongoing tests conducted by Merck hinted of potential deadly side effects.
As early as 2001, the FDA recommended label warnings be put on prescriptions warning users of potential side effects. In addition, Merck was warned by the FDA to quit misleading physicians about potential side effects.
As potential problems began to surface, they served as red flags to industry watchdogs, to the FDA, as well as to personal injury attorneys who began to gather evidence to show that Merck was negligent. Indeed, web sites and advertising campaigns – meant to inform and attract patients harmed by the drug – were launched and fairly soon the internet, radio, television, and print media were flooded with advertisements asking those suspecting harm from Vioxx to come forward.
With the September 2004 announcement that Merck was withdrawing Vioxx, personal injury litigation was well on its way to being established. By early 2005, the first cases were filed and the Ernst case became the first Vioxx lawsuit to be settled.
Wrongful death lawsuits against Vioxx’s maker, Merck, are expected to increase as the result of the Ernst decision. Personal injury attorneys insist that thousands of former Vioxx users and/or their families are due compensation for Merck’s neglect. It remains to be seen if juries will render judgments as large as the Ernst judgment and whether courts will uphold these amounts. Nevertheless, it is certain that Merck is in for a long battle that will reach well beyond its US base.