Merck Accused of Putting Vioxx Profits Before Safety

posted on:
December 8, 2005

author:
Staff

Dec. 8 (Bloomberg) — Merck & Co. put profits ahead of consumers’ safety by hiding heart risks of its Vioxx painkiller, a lawyer told a jury in closing arguments of the third trial of a lawsuit filed over the drug.

Merck, the world’s third-largest drugmaker, failed to warn doctors and consumers about studies showing Vioxx posed a greater risk of heart attacks and strokes for users such as Richard ‘ ‘ Dicky" Irvin, said Andy Birchfield, a lawyer representing Irvin’s family. Irvin died after taking the drug for 23 days. His family argues Vioxx caused a blood clot that led to his fatal 2001 heart attack. Merck disputed the claim in its arguments.

"They were losing patents on other drugs," Birchfield told jurors in federal court in Houston today. ‘ ‘”They were in a race to beat" a competing painkiller to market. "They weren’t going to let safety get in the way."

Merck is looking for its second win in litigation over Vioxx after a New Jersey jury found last month that the drug didn’t cause a mail carrier’s heart attack after short usage. Another victory would bolster Merck’s arguments that the drug didn’t harm short-term users and reduce pressure on the company to settle almost 7,000 Vioxx lawsuits filed so far.

Merck pulled Vioxx off the market in September 2004 after its own studies linked it to an increased risk of heart attacks and strokes for some users. Whitehouse Station, New Jersey-based Merck has set aside $675 million to fight Vioxx claims. The company’s shares fell 34 percent since Vioxx was withdrawn.

Journal Accusations

As the jury began deliberating the case today, the New England Journal of Medicine asked authors of a Merck-sponsored 2000 Vioxx safety review to correct a paper on the study’s results. The journal claimed the authors failed to include in their calculations three heart attack cases linked to the drug.

Jurors in the Irvin case heard testimony on the study, including about the three heart attacks. Irvin’s lawyers contend the study showed Vioxx users faced five times the risk of a heart attack or stroke compared with those who take another painkiller, naproxen. Merck contends the study showed the heart-protective properties of naproxen, sold as naproxen, rather than any high heart-injury rate linked to Vioxx.

‘ ‘ It’s consistent with what we said — they took every opportunity to downplay the risk and mislead doctors," said attorney Christopher Seeger, who represented the Vioxx user in the New Jersey case Merck won.

‘’Here is a leading journal accusing them of scientific misconduct," Seeger said. ‘ ‘It’s going to change the landscape of the litigation. It’s one thing for a lawyer to accuse them of wrongdoing, but when the New England Journal of Medicine, which has no axe to grind, accuses them of wrongdoing, it’s pretty amazing."

Withdrew From Market

Merck voluntarily withdrew Vioxx from the market after a 2004 safety study found increased risks of heart attacks and stroke in those who used it for at least 18 months, company lawyer Phil Beck said in his closing arguments. Outside experts said all Merck had to do was beef up label warnings, he said.

‘ ‘We did the responsible thing, the thing we hope all companies would do," Beck said. ‘ ‘We believe our good name is at stake in this case."

The five-woman, four-man jury heard eight days of testimony about Vioxx and lrvin’s death.

In the first case to go to trial, a Texas state court jury in August ordered Merck to pay $253 million to the family of a man who died after taking the drug for about eight months. The verdict likely will be reduced to $26 million under state law.

100,000 Claims?

A judge overseeing all federal litigation over Vioxx has said the company ultimately may have to defend 100,000 such claims.

Irvin, who managed an Augustine, Florida-based seafood distributor, died in May 2001 after taking Vioxx for lower-back pain. Lawyers for his family contend the former college football player was in good health and that Vioxx caused his sudden heart attack.

Merck’s lawyers counter that Irvin’s age, weight, clogged arteries and family history were to blame for his death. They also dispute that Vioxx caused heart attacks in anyone who took it for less than 18 months.

Throughout the case, the Irvin family’s lawyers sought to persuade jurors that Merck faced the loss of billions in sales in the early 1990s because some of its best-selling drugs, including heartburn treatment Pepsid, were losing patent protection.

Vioxx Design

Merck scientists designed Vioxx to be easier on the stomach than other anti-inflammatory drugs, hoping it would become a ‘ ‘ blockbuster drug," Birchfield argued. The company rushed the drug to market in hopes of beating Celebrex, a competing painkiller, he said.

In haste to reap profits from the drug, Merck never did a study specifically focusing on whether Vioxx caused an increased heart attack risk in uses, Birchfield said. It also ignored warning signs in Vioxx safety reviews, such as the 2000 study, downplayed the drug’s risks and attacked its critics, he said.

Merck sent ‘ ‘false signals to the medical community to explain away" the increased heart attack risks found in Merck’s 2000 study of Vioxx, Birchfield said. He said it was part of the company’s effort to ‘ ‘drown out the warning flags" about Vioxx.

On the question of whether Vioxx caused Irvin’s death, Birchfield pointed to testimony by his family that the former college football player was in good health and had no symptoms of heart disease.

Other Factors

The family’s medical experts said the fact one of Irvin’s arteries was 60 percent clogged wouldn’t have put him at high risk of suffering a heart attack unrelated to his Vioxx use, Birchfield told jurors.

"Dicky Irvin had heart disease, but that would not have killed him," Birchfield said. "It had to be something else and that something else was Vioxx."

The family’s lawyer urged jurors to focus on the ‘ ‘ important public health" issues raised by Merck’s handling of Vioxx.

"You’ll either put your stamp of approval on what Merck did in developing and marketing this drug or you’ll say we’re not going to tolerate that type of conduct," he said.

Beck said the case boiled down to a question of what caused Irvin’s death. Merck’s medical experts said existing plaque from Irvin’s clogged arteries broke off and formed the clot that killed him.

‘ ‘ I f there’s plaque rupture, then Vioxx did not play any role" in Irvin’s death, Beck argued. He said that neither of the cardiologists called by the family’s attorneys testified that ‘ ‘Vioxx contributed a smidgen to Mr. Irvin’s death."

No Rush to Market

Beck disputed the family’s accusations that the company’s executives rushed Vioxx to market without adequate safety testing because they ‘ ‘ didn’t care whether they killed patients so long as they made a buck for Merck."

Shares of lvlerck fell 61 cents to $29.68 in New York Stock Exchange composite trading today.

The case is Plunkett vs. Merck & Co., 05-MD-1657, in the Eastern District of Louisiana.

To contact the reporter on this story:

Jef Feeley in Houston at jfeeley@Bloomberg.net.

Last Updated: December 8, 2005 17:58 EST

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