Plaintiff Attacks Merck on Safety at Second Vioxx Product Liability Trial

A product liability trial focused on whether the painkiller Vioxx caused a man’s heart attack started Wednesday, with his lawyer telling jurors the drug’s maker put profits over safety. Merck & Co., the drug’s manufacturer, asserted other causes were to blame.

Chris Seeger, lead attorney for 60-year-old Frederick “Mike” Humeston, a Boise, Idaho postal worker, said Humeston was a healthy, active Vietnam veteran who enjoyed hiking until he was stricken two months after his doctor prescribed Vioxx to relieve pain from a war injury.

Merck knew the drug had links to increased incidence of heart attacks long before Humeston’s Sept. 2001 heart attack but didn’t disclose it, Seeger said in his 90-minute opening statement.

“Did they issue a ‘Dear Doctor’ letter? No. Did they warn patients? No, they didn’t do that either. Did they change the label? No, they didn’t,” he said.

Under pressure to introduce new drugs because its patents on others were about to expire, Merck rushed Vioxx to market, cutting the customary development time in half, throwing a $1 million party for 3,500 sales associates to launch it and spending $100 million on consumer advertising, Seeger told the jury.

“The survival of the company” was on the line at the time of the drug’s 1999 debut, he said.

But Merck attorney Diane Sullivan countered that Humeston’s physical condition and other risk factors were to blame, not Vioxx. She said the Whitehouse Station-based company had published studies about safety risks and notified the Food and Drug Administration of their findings.

Merck’s scientists were keenly interested in potential safety concerns about the drug, she said, showing jurors a copy of a 2001 e-mail message from the company’s research chief, Edward Scolnick, written after a study showed an increased risk of cardiovascular complications for those taking the drug for more than 18 months.

“I was sick at the thought we were doing harm to patients,” Scolnick wrote.

“For you to believe the plaintiff’s case, you’d have to believe that all these people got together and did something sinister,” Sullivan told the jury.

Humeston, who survived his heart attack, limped into the courthouse Wednesday morning, holding hands with his wife Mary and favoring the damaged knee that earned him a Purple Heart and later prompted his doctor to recommend Vioxx.

Later, his family doctor testified the 6-foot-1 Humeston had almost none of the risk factors normally associated with heart attack victims in their mid-50s.

His blood pressure and cholesterol were normal, his arteries were clear and he didn’t smoke, said Dr. Gregory Lewer, a close friend who went whitewater rafting and hiking with Humeston. The man’s only real ailment was the knee injury, said Lewer. Humeston was overweight but never obese, he added.

Lewer as scheduled to return to the stand Thursday, after which Seeger plans to air videotaped testimony by Dr. Alan Nies, an expert witness.

The trial, one of about 2,475 Vioxx lawsuits pending in New Jersey, is the first since a Texas jury found Merck responsible forthe death of a Vioxx user and ordered a $253 million award. That amount is expected to be dramatically reduced because of a Texas law capping punitive damages in civil cases.

Attempting to seize a home-courtroom advantage, Sullivan emphasized Merck’s status as a major New Jersey employer and her own roots growing up in the state.

She noted that the company voluntarily withdrew Vioxx from the market last September, knowing it would cut into profits, trigger bad publicity and lead to more lawsuits.

“Now this man, surrounded by lawyers and public controversy, has come to believe that Vioxx caused his attack,” she said.

The trial will pit dueling medical experts, with Humeston’s lawyers relying on doctors and biostatisticians to buttress his contention that Vioxx caused the heart attack and Merck calling doctors, researchers and FDA officials to talk about what the company knew about the drug’s risks– and when.

The opening statements were thick with technical medical terms, the jurors hearing talk of “thromboembolic events,” “Cox-2 inhibitors” and something called “the FitzGerald hypothesis.”

“I don’t envy you having to hear about science, medicine and statistics for weeks,” Sullivan told jurors.

Vioxx, which had peak sales of $2.5 billion annually, was on the market from May 1999 through September 2004, when Merck voluntarily withdrew it.

Analysts say the company could end up spending up to $50 billion on settlements and jury awards in Vioxx cases.

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