Vioxx

When Did Merck Know Vioxx Was Deadly? – WebMD

Merck should have known Vioxx was deadly years before they pulled the drug from the market, a study of Merck’s own data suggests.

The study, published in the current issue of the Archives of Internal Medicine, is by Joseph S. Ross, MD, of Mount Sinai School of Medicine, and colleagues. The study authors were paid consultants to plaintiffs’ lawyers in Vioxx lawsuits — in which much of the Merck data first was revealed.

“By our analyses, the association is clear that by June 2001 — more than three years before the drug was eventually taken off the market — the risk could have been known,” Ross tells WebMD.

Merck took Vioxx off the market in November 2004, after the “APPROVe” study conclusively demonstrated that Vioxx users had more heart attacks and strokes than patients receiving a placebo.

In their study of data from Merck-sponsored clinical trials, Ross and colleagues found that:

By December 2000, data from 21 trials showed that the risk of a heart- or stroke-related adverse event (a cardiovascular thromboembolic event or CBT) or death (from all causes) was twice as high in Vioxx patients — but the finding was just shy of statistical significance, meaning it could have been a chance finding.
By June 2001, pooled data showed Vioxx increased the risk of a CBT adverse event or death by 35% — a statistically significant finding, meaning it is unlikely to be a chance finding.
By April 2002, adding new studies to the pooled data showed Vioxx increased the risk of CBT or death by 39%, a statistically significant finding.
By September 2004, adding new studies to the pooled data showed Vioxx increased the risk of CBT or death by 43%, a statistically significant finding.

In a written statement and in an interview with WebMD, Merck says the study is flawed. It maintains that the company acted responsibly both in conducting safety studies and in pulling the $2 billion per year drug from the market as soon as it was aware that the drug increased the risk of heart attack and stroke.

“We fundamentally disagree with their conclusions that there was an actionable signal before September 2004,” Doug Watson, PhD, senior director of medical science for Merck Research Laboratories, tells WebMD.

Watson says that when Merck looked at the data, its researchers

Vioxx settlement checks going out August 28, 2008

Partial payments for people claiming withdrawn painkiller Vioxx caused heart attacks will go out starting Aug. 28 under the $4.85 billion settlement between drugmaker Merck & Co. and plaintiffs’ lawyers, the claims administrator said today.

Those payments will amount to about 40 percent of each plaintiffs’ estimated total payout, but it’s unclear how many people will be getting checks in the first batch going out.

The settlement, meant to end the bulk of personal injury lawsuits against Whitehouse Station-based Merck, was reached in November. Merck pulled Vioxx from the market on Sept. 30, 2004, after its own research showed the once-blockbuster arthritis pill doubled the risk of heart attack and stroke.

During the monthly status conference with the federal judge in New Orleans coordinating most of the massive Vioxx litigation, Orran Greer of claims administrator BrownGreer PLC said 49,954 eligible claimants have now registered for a settlement.

That amounts to more than 97 percent of claimants eligible for the settlement — well above threshold levels the company required for the deal to proceed — and most of the others cannot be located by their attorneys, Greer told U.S. District Judge Eldon Fallon.

Greer said Merck waived its right to walk away from the settlement on Aug. 4 and, over the next two days, deposited $500 million in one escrow account and gave the claims administrators a letter of credit worth up to $4.1 billion to cover payments to claimants.

Courts Reject Two Major Vioxx Verdicts

Two major court victories for Merck on Thursday pushed the litigation over the painkiller Vioxx closer to conclusion and highlighted the increasing difficulty that plaintiffs’ lawyers were having in winning lawsuits against big drug companies.

A state appeals court in Texas overturned a $26 million jury verdict against the company in a lawsuit brought by Carol Ernst, whose husband, Robert, died in 2001 after taking Vioxx. In reversing the verdict, the appeals court found that plaintiffs had not proved that Vioxx caused Mr. Ernst’s death.

Separately, an appeals court in New Jersey sharply reduced a verdict in another Vioxx case. The court ruled that the jury should not have been allowed to award punitive damages against Merck or to find that Merck had committed consumer fraud. Only compensatory damages of $4.5 million were permitted, the court said.

The rulings on Thursday leave lawyers for plaintiffs with just three victories, all with relatively small awards, in the nearly 20 Vioxx cases that have reached juries. Mark Lanier, a plaintiffs’ lawyer who was involved in both cases decided Thursday, criticized the decisions and promised appeals. But plaintiffs face an uphill battle.

Ghostwriters Used in Vioxx Studies

Vioxx was a best-selling drug before Merck pulled it from the market in 2004 over evidence linking it to heart attacks. Last fall the company agreed to a $4.85 billion settlement to resolve tens of thousands of lawsuits filed by former Vioxx patients or their families.

The lead author of Wednesday’s article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said a close look at the Merck documents raised broad questions about the validity of much of the drug industry’s published research, because the ghostwriting practice appears to be widespread.

“It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician,” Dr. Ross said, whose article, written with colleagues, was published Wednesday in JAMA, the journal of the American Medical Assocation.

Testing a Legal Ideal In Vioxx Settlement

If you listen to brainy law professors who have been studying big injury cases, you will learn that lawyers no longer owe their clients a duty of loyalty. They say this approvingly, even enthusiastically.

The idea that lawyers must represent one client at a time, give independent advice, follow instructions and, in general, act with fierce and single-minded loyalty is, these professors say, a lovely idea but an outmoded one. It is something out of the Age of Chivalry, or at least the 20th century.

“Speaking of individualized notions of lawyer loyalty is sort of like the mindset of the French military in 1940,” said Richard A. Nagareda, a law professor at Vanderbilt and the author of a recent book called “Mass Torts in a World of Settlement.”

Professor Nagareda was speaking at a forum at the American Enterprise Institute this month, and he was explaining why a proposed $4.85 billion settlement of lawsuits concerning the painkiller Vioxx represents progress, even though the deal puts extraordinary pressure on the lawyer-client relationship.

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