Merck’s Vioxx can cause Heart Attack with One Dose

posted on:
September 20, 2005

author:
Staff

Merck & Co.’s painkiller Vioxx may cause heart attacks with one dose, a heart expert said at the second product-liability trial over the drug, disputing the company’s claim that only long-term users are at risk.

Dr. Benedict Lucchesi testified on behalf of Frederick Humeston, who took Vioxx intermittently for two months before his heart attack in September 2001. Merck pulled the drug last September after saying it doubled the risk of heart attacks and strokes after 18 months of daily use.

"There’s every reason to believe” that a single dose "can lead to an adverse response,” Lucchesi, a University of Michigan pharmacology professor, told jurors in Atlantic City, New Jersey. “I definitely think that Vioxx can cause a heart attack in the right person.”

Humeston, a 60-year-old postal worker and former U.S. Marine from Boise, Idaho, claims in his lawsuit that Merck knew of Vioxx’s health risks for years before pulling it from the market. Merck faces about 5,000 Vioxx suits and billions of dollars in potential liability, analysts say.

Merck contends Humeston had a heart attack because of his weight, blood pressure and work-related stress. The company says it had no scientific proof of Vioxx’s dangers before last September.

Lucchesi also disputed Merck’s explanation of why Vioxx caused five times as many heart attacks as rival naproxen in the so-called Vigor study in March 2000. Merck claimed naproxen, used in the painkiller Aleve, protected the heart. Lucchesi said the results instead showed that Vioxx posed a greater risk.

`This is Nonsense’

"When I saw the explanation for the Vigor results, my immediate response was this is nonsense,” Lucchesi said. “There is no evidence that I know of to show that” naproxen protects the heart.

Merck, the No. 3 U.S. drugmaker, emphasized the Vigor finding that Vioxx caused less stomach distress than naproxen, a point that wasn’t in dispute, Lucchesi said. Merck introduced Vioxx, which inhibits the Cox-2 enzyme, in May 1999 as an alternative to pain relievers that cause stomach bleeding. Vioxx accounted for $2.5 billion in annual sales before it was pulled.

Lucchesi testified for a second day that Merck ignored indications dating to 1997 that drugs like Vioxx block one of the body’s natural defenses against blood clots. The company, based in Whitehouse Station, New Jersey, was "forewarned on multiple occasions” by researchers that Vioxx would increase clotting, he said.

`Potential for Harm’

"I don’t know how any learned scientist could not recognize the potential for harm,” said Lucchesi, who will undergo cross-examination this afternoon. Merck failed to conduct studies to determine the risks to patients such as smokers and people with heart problems, he said.

Merck shares fell 39 cents, or 1.4 percent, to $28.51 in New York Stock Exchange trading at 2:03 p.m. They have fallen 37 percent in the past year.

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