A Fort Myers man who said his heart problems started after he took Vioxx last month is now suing the drug’s manufacturer, launching the state’s first related class-action lawsuit against Merck & Co.
The pharmaceutical manufacturer voluntarily withdrew its popular pain medication Sept. 30 after a new study showed Vioxx increased the risk for cardiovascular problems such as heart attack and stroke in patients taking Vioxx more than 18 months.
The Lee County case is based on the ambiguous heart problems of Fort Myers resident Robert Lane, 38, a seasoned furniture mover who hurt his calf muscle on Sept. 16 while working in Naples.
Thirteen days after a Lee County doctor prescribed him Vioxx for the pain, Lane said he began experiencing tightness in his chest, shortness of breath and then chest pains.
After hearing about Merck’s global recall of Vioxx, Lane said he really became frightened. On Oct. 4, he went to the hospital and was admitted for testing.
“That really scared me,” Lane said. “It was getting real bad, and I had never had no heart problems. I knew something was just weird.”
Unfortunately, Lane said, neither the hospital nor his family doctor could conclusively diagnose Lane’s heart problems, but Lane said he’s now taking some sort of preventive heart medication. He felt something had to be done about this.
“I’m saying to myself, ‘What did I do to deserve all this stuff?’ ” Lane said. “When I heard there was a recall, I said, ‘You’ve got to be kidding me.’ I have never had heart problems and now I don’t know what’s wrong with me. I decided to go to an attorney.”
The complaint alleges Merck knowingly concealed serious cardiovascular risks associated with Vioxx and made the “conscious, tactical and economically motivated decision to expose its consumers to significant health risks posed by known dangers and side effects.”
Besides seeking awards for damages and medical treatment, the suit requests that Merck create a court-supervised medical monitoring program, notify people who took Vioxx of potential cardiovascular and pulmonary harm and fund more studies into the risks as well as research into possible cures.
Merck, whose stock plunged almost 27 percent when it pulled Vioxx, announced to stockholders last week the recall cost the company $552.6 million from its third quarter 2004 earnings.
The company estimates at least 105 million U.S. prescriptions were written for Vioxx since its launch in 1999 through August. As of Oct. 15, Merck reported it is fielding some 300 lawsuits related to Vioxx, which include about 900 plaintiff groups claiming personal injuries.
The company also is facing related federal securities lawsuits from stockholders and former employees.
The company won’t comment on specific suits, but said it is prepared to wage a fight in court.
“The company believes it has a meritorious defense to the Vioxx lawsuits and will vigorously defend against them,” Merck spokeswoman Anita Larsen said.
The class-action suit is the second Vioxx-related lawsuit from Southwest Florida.
Last month, Naples resident Frances Dunleavey filed an individual suit against Merck in Collier County on behalf of her husband, Edward, 48, who died last year from a heart attack after taking Vioxx for three years.
“He had no symptoms, then he died in the middle of the night,” said Dunleavey’s attorney, who’s suing Merck for negligence, misrepresentation, breach of warranty and other alleged wrongdoing.
This is not the first time Merck has contended with accusations of misrepresentation.
In 2001, the Food & Drug Administration sent a warning letter to the company asserting that Merck continues to minimize potentially serious cardiovascular risks, omit crucial risk information to patients and physicians, minimize certain harmful drug interactions and promote unapproved uses.
“Your minimizing these potential risks and misrepresenting the safety profile for Vioxx raise significant public health and safety concerns,” wrote Thomas Abrams, FDA’s director of drug marketing, advertising and communications.
Merck was warned to cease all misleading promotional activities and issue clarification letters to health care providers or face regulatory action.