In 1999, the FDA approved Vioxx for use as a pain reliever. At that time, Merck Pharmaceutical, the manufacturer of Vioxx, sponsored a study that showed that Vioxx tended to cause fewer ulcers or other gastrointestinal problems than other pain relievers, specifically naproxen. This study found that while instances of ulcers were reduced, the chances of heart attack or stroke were increased at least three times. Merck actually stated that Vioxx helped protect against heart problems and cited the study.
Over the next few years, five additional studies were conducted which continued to show that Vioxx caused significantly greater risk of heart attack or stroke. These studies were, essentially, ignored by Merck.
Additionally, the FDA warned Merck on several occasions about its marketing. The first letter, sent in 1999 within months of Vioxx’s approval, warned Merck that its marketing of Vioxx was false and misleading. The second letter, sent in 2001, again stated that its marketing was false and misleading and required Merck to stop making false claims and send letters to healthcare providers about the problems with Vioxx. The third action by the FDA, in 2002, was to make Merck to relabel Vioxx, listing the findings from the studies and recommending that doctors not prescribe Vioxx to patients with heart disease or in higher doses.
In August of 2004, the FDA finally launched its own study, showing that the use of Vioxx was linked to more than 27,000 heart attacks or sudden cardiac deaths. The FDA stated, once and for all, that the use of Vioxx did not protect against heart problems. Merck responded by withdrawing the drug from the marketplace.
These studies show that Merck was well aware of the dangers of Vioxx but still marketed Vioxx as not only being safe, but actually being a way to protect against heart disease. This can increase your chances of recovering against Merck and, in some states, may allow a claim for punitive damages.
If Vioxx was prescribed for you after the letter to healthcare professionals was sent by Merck or after the label changed and you had a preexisting heart disease condition, it may help you prove a malpractice suit against your doctor. And finally, the fact that Merck finally had to take Vioxx off the market can help you prove that your heart attack or stroke was caused by taking the drug.