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Drug Maker Off Hook In Vioxx Case

A federal jury handed Merck & Co. a major victory on Friday, clearing the drug maker of any responsibility in the death of a 53-year-old Florida man who had a heart attack after taking its once popular painkiller Vioxx for less than a month.

This was the second court victory for Merck, and the first in a federal court. The company had argued in this case that plaintiff lawyers never proved any link between Vioxx and the heart attack Richard "Dickey" Irvin suffered in 2001. Merck's lawyers contended Irvin's age, gender and diet all put him at risk for heart attacks

It was also the second time jurors heard the case brought by Irvin's family. In Houston, where the case was heard in November and December because of damage from Hurricane Katrina, jurors were unable to reach a verdict. Merck won a state case in New Jersey last year while it lost one in Texas.

Irvin's widow, Evelyn Irvin Plunkett; the youngest of their three daughters, Ashley Irvin; and their only son, Richard Irvin III, all testified that Irvin's health had been excellent up to his heart attack.

Plunkett left the courtroom in tears without talking to reporters.

"Obviously the family is very upset," said her attorney, Andy Birchfield.

He said the biggest problem was Judge Eldon Fallon's ruling, shortly before the trial, that two of their experts — a cardiologist and a pathologist — could not testify that Vioxx was to blame for Irvin's heart attack. They were experts in their fields, but not about Vioxx, the judge ruled.

"With all due respect, we think that (ruling) was error," said Birchfield. He said he would be talking with Plunkett about whether to appeal.

Phil Beck, a lawyer for Merck said he believes the verdict indicates the jury found "that the Merck scientists lived up to their legal and ethical responsibilities when manufacturing and marketing Vioxx and making the decision to take Vioxx off the market."

Shares of Merck rose 90 cents, or 2.5 percent, in after hours trading. They closed up 7 cents at $36.05 Thursday in regular trading on the New York Stock Exchange.

The jury deliberated for 3 hours and 40 minutes, the shortest period of any of the four juries yet in Vioxx-related cases.

Observers said the verdict was a clear victory for Merck but that the company will face more formidable cases later on this year when it faces plaintiffs who took Vioxx for 18 months or longer. Merck removed Vioxx from the market after a study showed it doubled patients risk of heart attacks and strokes after 18 months.

Still, Howard Erichson, a professor at Seton Hall Law School said this verdict may keep plaintiff lawyers from filing short-term use cases. It may also help Merck because the judge overseeing all the federal cases has said he wants to discuss a settlement after trying the first four.

"To the extent that ultimately there is a wide settlement, this win plays in Merck's favor," said Erichson.


But on the conference call, Merck senior vice president and general counsel Kenneth Frazier, reiterated that the company intends to try each case individually. So far, about 9,600 have been filed.

Frazier also said that the study which caused Merck to withdraw Vioxx may give plaintiff lawyers a data point to use in their cases, but they still face the burden of proof in proving that the drug was a cause of the heart attack or stroke. He noted heart attacks are common and have many causes including high blood pressure.

Irvin took Vioxx for back pain, but never saw a doctor about it. Instead, the resident of St. Augustine, Fla., called his son-in-law, an emergency room physician who lived in another city. He hadn't been able to keep down the first two painkillers prescribed by Dr. Richard Schirmer. After he tried a sample given to him by an acquaintance, he asked Schirmer for Vioxx.

Schirmer testified that if the label had included a warning about heart attack risk, he wouldn't have prescribed Vioxx for his father-in-law.

Much of the evidence put on by Plunkett's attorneys focused on whether Merck should have added a warning to the label after it learned in early 2000 that patients taking Vioxx in a drug test called VIGOR had five times as many heart attacks as those on naproxen, another painkiller.

In his closing argument, Birchfield noted epidemiologist Wayne Ray's testimony that the drug probably was to blame for 54 percent of all heart attacks among people who suffered them while taking Vioxx. In Irvin's case, he said, that meant a 54 percent chance that the drug was among reasons for the heart attack.

Merck learned of the VIGOR study results in 2000. Had it stopped selling Vioxx or put a warning label on the drug then, he said, Irvin's son-in-law, an emergency room physician, would not have prescribed Vioxx for Irvin in April 2001.

"Did they rein in their massive marketing campaign? ... No. They pushed on wide open," he said. And he quoted the comment of Dr. Eric Topol, a cardiologist subpoenaed for videotaped testimony while at the Cleveland Clinic.

"He said that was human experimentation," Birchfield continued. "Merck was playing Russian roulette for money with Dickie Irvin."

Beck countered that no physician testified that Vioxx caused Irvin's death. "In fact, no doctor testified that Vioxx was even a small factor in Mr. Irvin's heart attack and death."

In 2000, when VIGOR was published in the New England Journal of Medicine, Merck said the difference in outcomes among patients taking Vioxx and those on naproxen was probably because naproxen protected the heart. It said it immediately reported the data to the U.S. Food and Drug Administration.

The fact that it reported lower numbers to the New England Journal of Medicine than it did to the FDA was the subject of testimony by the journal's executive editor, Dr. Gregory Curfman. "The company wanted to keep the journal article pristine for the purposes of marketing. And it worked — for a while," Curfman said in a videotaped deposition.

Merck said the data reported to the journal occurred before a cutoff date set when a safety monitoring board for the study asked for analysis of cardiovascular side effects. Curfman said the journal should have been updated.

The case could be the first indication of outcomes in federal court, generally seen as more disciplined and friendly to businesses than state courts.

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