Once a leading prescription pain-relief medication worldwide, Vioxx (rofecoxib) and its manufacturer, Merck, fell from grace when scientists discovered the drug caused heart attacks, strokes and death.
Released in 1999, Vioxx is a non-steroidal anti-inflammatory drug, or NSAID, much like ibuprofen and naproxen. It was used mainly for acute pain such as arthritis and menstrual-related symptoms. Unlike the other NSAIDs, however, Vioxx is in a class of drugs called COX-2 inhibitors. That means Vioxx and other drugs in the same class directly target the enzyme COX-2, which is responsible for inflammation and pain.
Vioxx Side Effects
Early on, Vioxx, which was also sold under the names Ceoxx and Ceeoxx, was linked to severe health problems. Within months of the U.S. Food and Drug Administration (FDA) approval of Vioxx, Merck’s own study pointed to a four-fold increased risk of heart attacks when compared to naproxen. Merck later refuted the findings, saying they were unreliable.
It wasn’t until 2002 that Merck and the FDA agreed to include the cardiovascular risk information on the drug’s label. For years, Merck hounded the FDA to remove the adverse labeling claiming it wasn’t true. However, independent studies now show that Vioxx can cause heart attacks within the first two weeks of taking the drug.
Some scientists think Vioxx causes heart problems because it increases the likelihood of deadly blood clots. Others say the risk is linked to the drug’s propensity to elevate body fat. The exact cause may never be known.
By 2003, the $195 million Vioxx marketing machine was in full force, and sales for the drug reached $2.5 billion worldwide. It wasn’t until after Merck launched a second study, this time to review the drug’s effect on colon polyps, that the company was forced to reveal the truth. The company’s APPROVe study found that Vioxx raised the risk of a heart attack for those taking it for less than two years.
Merck Recalls Vioxx
On Sept. 30, 2004, Merck voluntarily withdrew Vioxx from the market worldwide. In the months that followed, a U.S. Senate Finance Committee convened to question the seemingly cozy relationship between Merck and the FDA.
Dr. David Graham, an FDA scientist, testified that FDA officials repeatedly tried to block his Vioxx findings that pointed to the drug’s propensity to cause heart attacks. Additional testimony from several other physicians pointed to Merck knowing about the risks early on but hiding them. Merck officials repeatedly denied the findings.
The subsequent lawsuits against Merck in America and overseas started within a year of the drug being pulled off the shelves. A multidistrict litigation (MDL), which is similar to a class action but typically has a better outcome for the plaintiffs, was established in New Orleans in 2005, and many more individual lawsuits were filed nationwide. Overall, more than 60,000 U.S. claims were filed in the MDL.
Even though Merck won 11 of the 16 Vioxx MDL test trials in New Orleans, the company agreed in 2007 to settle all the claims without admitting fault. It set up a $4.85 billion settlement fund and paid out nearly 35,000 claims.
In 2011, Merck agreed to pay $950 million and pleaded guilty to a federal misdemeanor charge related to its shady marketing and sales tactics. The company incurred a $321 million criminal fine and was ordered to pay the remainder to the federal government and state Medicaid agencies.