Someone asked what was one of the most challenging cases I have worked on as a drug and medical device litigator for the past 23 years.
It was the Vioxx litigation.
When the drug was first introduced to the market by Merck in 1999, I had concerns it could easily become a future mass tort projects. It had all the hallmarks that are often present in a dangerous drug lawsuit:
- It was being used to treat a non-life threatening chronic condition
- The manufacturer was using aggressive direct-to-consumer advertising
- It was a billion-dollar market opportunity
- Limited pre-clinical studies had been conducted
My first client was an exceptionally fit retired professional athlete who suffered a heart attack in his late 40s after taking Vioxx for a short period in 2001. His only risk factor for the massive heart attack was taking Vioxx, an arthritis drug with a unique mechanism of action safer for the stomach than traditional NSAIDs but created an elevated risk of cardiac events due to Cox-2 inhibition. In the ensuing months, I was contacted by hundreds of additional patients who had sadly also suffered heart attacks while taking Vioxx.
From 2001 through early 2004, the litigation was exceptionally challenging, because the drug was still on the market and loved by many prescribing physicians. Undeterred, I worked with lawyers from around the country pushing for the discovery of Merck’s confidential documents, which ultimately showed that the makers of Vioxx knew of the risks of the drug, long before it was even approved for sale, but marketed it to millions of patients without an adequate warning regarding unique cardiac risks or safety testing. Early, the defendant vowed to settle no Vioxx cases and claimed that it would force every patient to go to trial, even if it took many decades. Merck contended that it had done nothing wrong regarding its development and sale of Vioxx. Many trials occurred with mixed results for plaintiffs and defendants, and at a tremendous cost to the parties and the court system. The ultimate cost, of course, was to those patients who were severely injured or killed by taking Vioxx.
In September of 2004, years into the litigation effort, Vioxx was recalled due to an increased risk of cardiac adverse events. Even after the recall, the litigation continued and Merck still contended that the drug was perfectly safe and that it had no legal responsibility for the patients injured or killed because of Vioxx-induced injuries. From 2004 through 2007, Merck continued to aggressively litigate in both state and federal courts before finally relenting and entering a $4.85 billion settlement program.
The protracted litigation fought on multiple fronts was time-consuming and challenging, but also provided an opportunity for patients and their lawyers to effectuate positive change by forcing a bad drug off the market and compelling a battle-hardened defendant to compensate those who had been harmed by its defective drug.