biggest fda failures

How the New England Journal Missed Warning Signs on Vioxx

In August 2001, a Seattle pharmacist called a radio show on which Jeffrey Drazen, the top editor of the New England Journal of Medicine, was appearing. On the air, the pharmacist, Jennifer Hrachovec, begged Dr. Drazen to update an article in the journal that touted the benefits of the painkiller Vioxx while playing down its heart risks.

Dr. Hrachovec had been reviewing data on a Food and Drug Administration Web site indicating that patients in a Vioxx clinical trial had suffered more heart attacks than the journal article about the trial reported. “It bothers me there is more data from the trial than has ever been published and the New England Journal still hasn’t published an editorial or any kind of update,” she said. “My concern is that doctors are still using this and exposing their patients to higher risks of heart problems and they just don’t even know that that’s the case.”

Jury Finds Merck Liable in Vioxx Death and Awards $253 Million

In the first verdict of a Vioxx-related personal-injury lawsuit, a Texas jury found the drug’s maker, Merck, liable and awarded $253.5 million to the widow of Robert Ernst, who died in 2001 after taking the painkiller and arthritis medicine.

After deliberating for a day and a half, the jury of seven men and five women awarded Mr. Ernst’s widow Carol $24.5 million for mental anguish and economic losses. The jury also awarded an additional $229 million in punitive damages after finding that Merck had acted recklessly in selling Vioxx with knowledge of the risks associated with taking the drug. Two jurors dissented from the verdict, which did not have to be unanimous.

Merck plans to appeal the verdict, and such large judgments are typically reduced by higher courts.

Judge Ben Hardin of the Texas District Court announced the verdict on the fourth floor of the Brazoria County Courthouse in Angleton, about 40 miles south of downtown Houston, shortly after 1:45 p.m. Central Time.

Mrs. Ernst, her family and lawyers erupted in cheers and began to hug each other.

“The justice system in America works and it works very well,” W. Mark Lanier, the lead lawyer for Mrs. Ernst, said.

Jonathan Skidmore, a lawyer for Merck, the nation’s third-largest drug maker, said that the company continued to believe it had properly researched and marketed Vioxx.

“We believe the plaintiff did not meet the standard set by Texas law to prove Vioxx caused Mr. Ernst’s death,” Mr. Skidmore said.

With a flood of Vioxx lawsuits soon to reach juries, the size of the verdict may have important implications for both Merck and the entire drug industry, lawyers and analysts said. More than 4,000 Vioxx-related cases have been filed.

Merck has said it will fight every Vioxx lawsuit in court rather than settle cases and it reiterated that stance in a statement issued after the verdict was announced.

But today’s judgment illustrates the dangers of that strategy, especially because Mr. Ernst’s case had been viewed as relatively weak, lawyers said.

The jury award represents about 1.1 percent of Merck’s 2004 revenue, $22.9 billion, but it accounts for more than a third of the $675 million the drug maker has set aside for its Vioxx liabilities thus far.

The jury’s decision illustrates the legal dangers that drug makers face when they aggressively advertise their medicines to consumers, a practice that spread widely in the late 1990’s.

Evidence in Vioxx Suits Shows Intervention by Merck Officials

In 2000, amid rising concerns that its painkiller Vioxx posed heart risks, Merck overruled one of its own scientists after he suggested that a patient in a clinical trial had probably died of a heart attack.

In an e-mail exchange about Vioxx, the company’s most important new drug at the time, a senior Merck scientist repeatedly urged the researcher to change his views about the death “so that we don’t raise concerns.” In later reports to the Food and Drug Administration and in a paper published in 2003, Merck listed the cause of death as “unknown” for the patient, a 73-year-old woman.

The discussion of the death is contained in several previously undisclosed Merck records, including e-mail messages from Dr. Edward M. Scolnick, Merck’s top scientist from 1985 until 2002, and from Dr. Alise S. Reicin, a vice president for clinical research, that indicate Merck’s concerns about data contradicting its view that Vioxx was safe.

In one e-mail message, Dr. Scolnick said the drug trial that included the woman’s death had “put us in a terrible situation.” In others, he fiercely criticized the F.D.A. and said he would personally pressure senior officials at the agency if it took action unfavorable to Vioxx.

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