Merck & Co. won a major victory in the battle over its Vioxx painkiller Thursday when a New Jersey state jury found that the drug maker properly warned consumers about the risks of the medication. The finding means Merck won’t be held liable for the 2001 heart attack suffered by a man taking Vioxx.
After deliberating for less than eight hours over three days, the jury cleared Merck of allegations it failed to warn consumers about the drug’s risks and engaged in “unconscionable commercial practices” in marketing it to doctors and their patients.
The verdict was Merck’s first win out of two Vioxx-related trials. In August, a Texas jury found the company liable in a Vioxx user’s death. Damages there will be cut to about one-tenth of the jury’s $253 million award due to that state’s caps on punitive damages.
Much of the seven-week trial, eagerly watched by lawyers and plaintiffs from around the country, relied on the testimony of medical experts. Witnesses for Merck testified the company believed Vioxx was safe for the heart before the drug was pulled from the market a year ago after a study showed it doubled risk of heart attacks and strokes when taken for at least 18 months.
The company faces more than 6,500 similar lawsuits, which Merck, based in Whitehouse Station, N.J., said it plans to fight one by one. Thursday’s verdict means it might take several more cases before lawyers can find any sort of precedent that might determine Merck’s ultimate Vioxx liability. In the meantime, each case — including a federal trial scheduled to begin in Houston Nov. 28 — will continue to draw the attention of pharmaceutical companies, lawyers, consumers and stock analysts.
Stock analysts said the company clearly will face huge legal costs given its plan to fight each lawsuit individually. The company has set aside just $675 million for legal defense costs, but nothing for jury awards or settlements.
“It’s still going to be a marathon” in the courts, said Barbara Ryan, pharmaceuticals analyst at Deutsche Bank North America.
Members of Merck’s legal team, some with tears in their eyes, hugged each other after the New Jersey verdict.
“I feel pretty good,” said lead counsel Diane Sullivan. “I’m proud of the folks at Merck.”
The verdict capped a trial centering on Frederick “Mike” Humeston, 60, of Boise, Idaho, who was stricken two months after he began taking the drug to ease pain from a Vietnam war knee injury.
Kenneth C. Frazier, senior vice president and general counsel of Merck, said in a statement, “there will be other Vioxx trials and we will vigorously defend them one by one over the coming years. Merck acted responsibly, from performing extensive clinical trials comparing Vioxx to NSAIDs (nonsteroidal anti-inflammatory drugs) or placebo in almost 10,000 patients prior to approval, to monitoring the medicine while it was on the market to voluntarily withdrawing the medicine when we did.”
Humeston’s lawyer, Chris Seeger, said he was “absolutely surprised” by the verdict.
“I have to kind of sit and reassess what went wrong here. My desire to try more cases is way up right now,” Seeger said. “Merck is based in New Jersey. Maybe that factored into this jury pool.”
Only one juror, casino worker Juan Garcia, voted that Merck failed to give adequate warnings to doctors about the link between Vioxx and increased risk of heart attacks and strokes.
“I think they should have known and explained more to the doctors and everyone,” Garcia said. He said he also believed Vioxx was a factor in causing Humeston’s heart attack.
But Vickie Heintz, who works in a manufacturer’s credit department, said she believed stress and Humeston’s other health problems were responsible for his heart attack.
“I thought he had way too many health other issues,” Heintz said. “His medical records were riddled with many medicines.”
Merck’s lawyers had appeared to be fighting a losing battle, repeatedly clashing with Superior Court Judge Carol E. Higbee, who denied key motion requests by them and threw out the testimony of Merck’s first witness on procedural grounds.
On five different occasions, Merck asked her to declare a mistrial. Each time, she refused.
In the end, that turned out to be a blessing — and a much-needed one — for Merck, which pulled Vioxx off the market last year after a study showed it increased the risk of heart attacks and strokes after 18 months’ use.
The six-woman, three-man jury concluded that Merck adequately disclosed information about the drug’s risks and could not be held accountable for Humeston’s heart attack. The jurors voted 8-1 that Merck properly warned doctors about risks with Vioxx and voted unanimously on three counts that Merck did not mislead doctors about the drug’s safety.
Humeston’s lawyers painted a picture of the two-time Purple Heart winner as a victim of a greedy drug company that put profits before patients, rushing Vioxx to market in an unsuccessful bid to beat rival Celebrex onto drugstore shelves.
About 20 million Americans took Vioxx after it hit the market in 1999, embracing it for its effectiveness in relieving pain while sparing them the upset stomachs, ulcers and other gastric problems associated with some other analgesics.
At its peak, Vioxx was a $2.5 billion-a-year blockbuster.
No risk from short-term use?
It worked for Humeston, alleviating pain in his left knee, which sustained shrapnel injuries during his U.S. Marine Corps service in Vietnam. But on Sept. 18, 2001, Humeston took two Vioxx pills after work and within hours suffered a mild heart attack.
His doctors blamed it on Vioxx, saying Humeston — a hiker and former mountain guide — had clear arteries and no history of heart disease. He wouldn’t have taken it had he known about the heart attack risk, lawyer Chris Seeger told jurors.
Merck repeatedly reminded jurors that the U.S. Food and Drug Administration had approved it as safe and effective on four occasions for use against different types of pain, the last a month before Merck recalled it.
The company’s lawyers cited Humeston’s elevated blood pressure, weight and stress from an ongoing dispute he was having with his U.S. Postal Service bosses, saying they were to blame for his heart attack, not Vioxx.
Merck’s expert cardiologist testified that that call was the “absolute trigger” for the heart attack.
While Humeston made for a sympathetic plaintiff, he also was a relatively healthy one, appearing in court for nearly every day of testimony and taking the stand for one day.
In the Texas case, the victim was a Wal-Mart produce manager who died after taking Vioxx; his widow was the plaintiff.
Merck’s lawyers also told jurors there was no scientific link between short-term Vioxx use and heart attacks.