Investigations: Vioxx

Vioxx was taken off the market on September 30, 2004 because the risk of heart attack and stroke outweighed its therapeutic benefit.

View a summary of Vioxx litigation to date

Vioxx (generic name “rofecoxib”) is a nonsteroidal anti-inflammatory (“NSAID”) which belongs to a class of drugs known as Cox-2 inhibitors. NSAIDs, such as naproxen (Aleve) and ibuprofen (Advil), have long been used to treat arthritis pain. However, treatment with NSAIDs has been limited in many patients because of the gastrointestinal side effects that can occur with use. These side effects may include gastritis, esophageal reflux, and peptic ulcers.

Vioxx and other Cox-2 inhibitors, such as Celebrex and Bextra, have been marketed as safer than traditional NSAIDs because they have been designed to selectively inhibit Cox-2 enzymes thus allowing for therapeutic pain relief, while not inhibiting Cox-1 enzymes which allows for normal production of the stomach’s mucosal lining. As a result, many individuals who could not take traditional NSAIDs because of the associated gastrointestinal risks have been prescribed Vioxx or other Cox-2 inhibitors.

Unfortunately, Cox-1 and Cox-2 enzymes are also active in the clotting process within the body’s blood stream. Cox-1 enzymes assist in the formation of blood clots, while Cox-2 enzymes inhibit blood clot formation. The major problem with selective Cox-2 inhibitors, such as Vioxx, is that they place the body in a “pro-clot” state that can lead to serious cardiotoxic events such as heart attack and stroke.

Signs of Vioxx’s risks emerged soon after approval of the drug by the U.S. Food & Drug Administration (“FDA”) in 1999. The VIGOR (Vioxx GI Outcomes Research) study, completed in March 2000 and published by the New England Journal of Medicine in November 2000, evaluated 8,076 rheumatoid arthritis patients who were randomly assigned to receive either 50mg of Vioxx per day (twice the approved dosage for chronic use) or a standard dose of 1,000mg of naproxen per day. While patients receiving Vioxx experienced a lower incidence of gastrointestinal side effects, they were also found to experience a higher rate of serious cardiovascular thrombotic events such as heart attacks. In April 2002, the FDA instructed Merck, the manufacturer of Vioxx, to begin enclosing an insert in all Vioxx packaging warning of the high rate of serious cardiovascular side effects demonstrated in the VIGOR study. Prior to the addition of this warning, many prescribing physicians were unaware of the associated risk of heart attack.

In August 2004, Dr. David J. Graham, a clinical physician working in the FDA Drug Center’s Office of Drug Safety, published a report suggesting that the estimated 93 million prescriptions written for Vioxx may have contributed to 27,785 heart attacks and deaths between 1999 and 2003.

Finally, on September 30, 2004, Merck voluntarily withdrew Vioxx from the market.

Lewis Saul & Associates has been involved in the national Vioxx litigation since its inception. We were the first firm to file a Vioxx suit in New Hampshire and we have since filed several Vioxx cases here in Maine. All federal Vioxx litigation has now been consolidated in a Multi District Litigation court (or “MDL”) in New Orleans, Louisiana and Lewis Saul & Associates continues to be involved in all Vioxx MDL proceedings.

If you believe that you, or someone you know, has suffered a heart attack, stroke, or other clot-related injury as a result of taking Vioxx, please call Lewis Saul & Associates toll-free at (888) 747-5342 or fill out our convenient online contact form and a member of our firm will contact you by the next business day for a free consultation.

Summary of Vioxx Litigation to Date

• Ernst v. Merck – Robert Ernst, a 59-year-old marathon runner, died suddenly in 2001 of an apparent heart attack after taking Vioxx for approximately six months. Although Merck’s defense team argued that Ernst had died from cardiac arrhythmia (a condition which has not been shown to be caused by Vioxx), on August 19, 2005 a jury in Texas Superior Court found Merck liable in Ernst’s death. The jury awarded Ernst’s widow $253 million in punitive and compensatory damages. Merck has said they will appeal the verdict.


• Humeston v. Merck – Frederick “Mike” Humeston, a U.S. Postal worker and former Marine, suffered a mild heart attack after taking Vioxx for approximately two months to ease the pain caused by shrapnel injuries in his left knee. The plaintiff sustained the injury during his U.S. Marine Corps service in Vietnam. Humeston’s doctors blamed the heart attack on Vioxx, saying that Humeston, a hiker and former mountain guide, had clear arteries and no history of heart disease. Merck’s defense team argued that Humeston’s heart attack was most likely caused by his history of high blood pressure, excess weight, and job stress. A New Jersey state jury agreed with Merck and, on November 3, 2005, they found in favor of the pharmaceutical company.


• Plunkett v. Merck – Richard “Dicky” Irvin, a 53-year-old seafood distributor from Florida, died suddenly of a heart attack in 2001 after taking Vioxx to alleviate back pain for approximately one month. The lawsuit filed against Merck by Irvin’s widow, Evelyn Irvin Plunkett, was the first Vioxx case to be tried in Federal Court. But on December 12, 2005, with a Houston jury unable to reach a unanimous verdict, the judge declared a mistrial. Ultimately the case was retried in New Orleans and, on February 17, 2006, the jury found in favor of Merck. Merck’s defense cited Irvin’s short-term use of Vioxx and pre-existing coronary artery disease as the main factors contributing to their victory in the case.


• McDarby & Cona v. Merck
• John McDarby – 77-year-old retired insurance agent, John McDarby, fell and broke his hip after suffering a heart attack in his living room in 2004. McDarby, a diabetic who took Vioxx for four years, was left wheel-chair bound and unable to care for himself. In a split verdict, a New Jersey state jury found Merck liable for McDarby’s injuries and awarded him $4.5 million in damages.


• Thomas Cona – 60-year-old businessman (and John McDarby’s co-plaintiff), Thomas Cona, was stricken with a heart attack while playing golf in 2004. He had been taking Vioxx for nearly two years. While the jury found that Merck failed to adequately warn both men about the possible cardiac risks associated with Vioxx use, they believed the drug was a factor only in McDarby’s heart attack. Cona was ultimately awarded a mere $45 as compensation for the cost of his medication.


• Garza v. Merck – Leonel Garza, a 71-year-old retiree, died of a heart attack after taking Vioxx for less than one week. Although Merck has steadfastly denied that short-term use of Vioxx can produce cardiotoxic effects, a Texas state jury disagreed and found Merck liable for Garza’s death. Garza’s family was awarded $32 million in compensatory and punitive damages. However, because of a Texas state law capping punitive damages, that amount will likely be reduced. Merck has vowed to appeal the verdict.