Initially hailed as a superior non-steroidal anti-inflammatory drug (NSAID), Vioxx spent only a few years on the market before it was the focus of thousands of consumer lawsuits. Within five years of being approved by the U.S. Food and Drug Administration (FDA) for the treatment of arthritis and menstrual pain, the painkiller was linked to thousands of heart attacks, strokes and deaths. At the same time, the drug’s manufacturer, Merck, vehemently denied any problems.
However, studies quickly found that Vioxx dramatically increased the chance for a fatal heart attack or stroke. One such study, called Vioxx Gastrointestinal Outcomes Research, or VIGOR, found a striking cardiovascular risk. Instead of pulling the drug from the shelves, Merck grudgingly agreed to allow a label change to reflect the heart risks but continued to publicly deny any problems.
On Sept. 30, 2004, after a second study confirmed the drug caused severe cardiovascular problems, Merck was forced to initiate a worldwide recall of Vioxx. However, by this time, up to 25 million Americans had taken Vioxx, with millions more having taken the drug worldwide.
Victims and Families Sue over Vioxx
Within weeks of the Vioxx recall, injured patients across the nation were seeking justice in court. Up to 38,000 people died from heart attacks or strokes after taking Vioxx, with a total of about 160,000 patients injured. While some of the victims had had ongoing heart problems, many more did not.
With an abundance of cases, a federal multidistrict litigation (MDL) was established in Louisiana with nearly 50,000 claimants. An MDL is often considered better than a class-action lawsuit in large-scale product liabilities cases such as this one because it can bring greater settlement awards based on individual injuries. Other claimants filed private lawsuits in state courts nationwide.
The first Vioxx state trial returned a $235 million verdict for a Texas family after the jury deliberated for two days. While some of the award was later overturned, it was a still a big victory for the plaintiffs. At the same time, the federal MDL trials also revealed stories of personal tragedy after taking the drug. The first federal case to go to trial was the family of a 53-year-old Florida man who died of a heart attack one month after taking the drug. He took Vioxx for back pain and was in good health otherwise. While the man’s family initially won the case, it was later wholly overturned. Even though Merck won 11 of the 16 MDL test trials, which are used as a litmus test for future trial outcomes, the company decided to settle with all the claimants without admitting fault.
The company’s shareholders were angling to sue as well, saying they lost billions because Merck deceitfully marketed Vioxx. While the eventual settlement agreement only allowed for $12 million in legal fees, Merck agreed to changes within the corporation. That included hiring a chief medical officer to monitor product marketing and safety.
Legal Claims against Merck
To resolve the consumer claims quickly and quietly, Merck set up a $4.85 billion settlement fund and paid nearly 35,000 complaints. The varied financial settlements to injured patients allowed for compensation in accord with injuries. Of the original 59,365 claims, about 25,000 resulted in no payment. The remaining claimants received a sliding-scale settlement based on individual injuries. Of the 20,591 heart-attack claims, which included 2,878 deaths, payments ranged from $18,000 to $1.79 million. For the 12,447 valid stroke claims, including 590 related deaths, settlements ranged from $5,000 to $820,000.
Civil Claims against Merck
At the same time, Merck was continually trying to deflect major criminal charges related to its shady marketing and sales tactics and allegations of mismanagement. A U.S. Senate Finance Committee hearing investigated the drug company’s cozy ties with the FDA, questioned the company’s $195 million direct-to-consumer marketing plan and looked into possible Medicaid and Medicare fraud. Today, Sen. Charles Grassley, R-Iowa, continues to question Merck’s relationship with the FDA, charging the FDA and Merck collaborated to hide the Vioxx side effects.
Although Merck agreed to pay $950 million and plead guilty to a federal misdemeanor related to its marketing practices, many were outraged by the settlement because the company still gleaned billions of dollars in Vioxx profits and was hardly reprimanded for the related deaths. The company did pay a $321 million criminal fine, $426 million to the federal government and $202 million to 48 states and the District of Columbia to settle civil claims that Merck’s illegal marketing influenced doctors to prescribe a drug they would not have otherwise prescribed.