A Wichita woman has joined the legions of lawsuits that have sprung up across the country in recent weeks over the pain relief drug Vioxx.
Betty Smith has filed suit in Wichita federal district court against Merck & Co., the New Jersey-based manufacturer that pulled Vioxx from the market at the end of September.
Smith, 70, is claiming that taking Vioxx caused her to have a heart attack that required bypass surgery.
rom 1999 to this fall, doctors wrote millions of prescriptions for Vioxx to help relieve pain, mainly to arthritis patients. Many showed outstanding results.
But studies began emerging that suggested such dangerous side effects as heart attacks, strokes, kidney damage and blood clots. Some studies showed Vioxx doubled the risk of serious heart attacks. One study showed a five-fold increase in heart problems among patients taking the drug.
The latest study, released by the U.S. Food and Drug Administration, came out Sept. 30, the day Merck announced the withdrawal of Vioxx from the market.
Smith’s is one of hundreds of lawsuits being filed across the country. Merck is trying to have the cases consolidated in one federal court jurisdiction.
The Wichita lawsuit contends that Merck knew about the dangers of Vioxx as early as 2000, a year after it went on the market.
The company says it acted responsibly.
“Merck was vigilant in monitoring and disclosing the cardiovascular safety of Vioxx, and we absolutely disagree with any implication to the contrary,” the company said in a statement.
“The company worked diligently with the FDA and the regulatory authorities in other countries to ensure that the safety profile of Vioxx was reflected appropriately in the prescribing information,” the statement added.
The FDA study showed 27,785 more patients suffered heart attacks or died on Vioxx than those who took Pfizer Inc.’ s Celebrex. The study looked at 1.4 million patients enrolled in the nation’s largest health maintenance organization, Kaiser-Permanente.
Merck contends that its early studies showed Vioxx was no more dangerous than placebos.
But two weeks ago, the Wall Street Journal published a report based on sealed records it obtained in another court case. The Journal said the documents contain internal company communications questioning Vioxx’s safety as early as 1997.
Smith’s suit is using those and other contentions to charge the company with negligence, fraud and violations of the Kansas consumer protection act. She seeks both actual and punitive damages.
Doctors are watching with interest.
“If what the company says is a fact, then it’s going to be hard to prove they did anything wrong,” said Douglas Vine, a Wichita cardiologist. “But if it’s true they hid information, then they’re in trouble.”