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Citing Merck misconduct, jurors find for plaintiff in Vioxx retrial.

An Idaho man who alleged that Vioxx caused his 2001 heart attack has prevailed against its manufacturer, Merck & Co., Inc., after he lost his first trial and was granted a new one based on evidence that Merck had withheld safety data. (Humeston v. Merck, No. ATL-L-2272-03 (NJ. Super. Mar. 12, 2007).)

Frederick Humeston's first trial ended in a defense verdict in November 2005. But after new evidence came to light that Merck had misrepresented the heart attack risk linked to Vioxx, New Jersey Superior Court Judge Carol Higbee vacated that verdict in August 2006. Higbee is overseeing all the Vioxx cases filed in her state against Merck, based in Whitehouse Station, New Jersey.

In March, jurors awarded Humeston and his wife $20 million in compensatory damages and $27.5 million in punitive damages, voting 8-0 that Merck's actions "were an extreme deviation from reasonable standards of conduct," according to the jury verdict form. They determined that Merck failed to warn physicians about the increased risk of heart attacks; that the company intentionally suppressed, concealed, or omitted risk information from physicians and consumers; that Humeston's doctor would have altered his prescribing decision if he had been adequately warned; and that Vioxx was a substantial contributing factor in Humeston's heart attack.

Christopher Seeger, a New York City lawyer representing Humeston, said the fact that jurors awarded higher punitive than compensatory damages shows that they believed Merck needed to be punished. "This jury found by clear and convincing evidence that Merck's conduct was malicious, oppressive, and outrageous," Seeger said.

Humeston was tried together with another case, Hermans v. Merck The jurors found that Merck did not fail to warn in Brian Hermans's case; he died after suffering a heart attack in 2002, five months after Merck changed Vioxx's label.

The company changed the label after a study called VIGOR (Vioxx Gastrointestinal Outcomes Research), which it sponsored, revealed a statistically significant higher incidence of serious cardiovascular thrombotic events with Vioxx than with naproxen, another nonsteroidal anti-inflammatory drug (NSAID). Merck withdrew Vioxx in 2004.

The Humeston and Hermans trial was conducted in two phases. In the first, which consolidated both cases, jurors considered what Merck knew about the risk of Vioxx, what warnings it gave physicians, and whether those warnings were adequate. In the second, the same jurors determined whether Vioxx caused each plaintiff's heart attack and damages. The two-phase trial was designed to speed up the cases, because several of them can be tried together on liability and then each can proceed separately on damages, Seeger explained.

Mark Lanier, a Houston lawyer who represents Hermans, called the two-phase trial "a great way to move a large block of cases, but the cases will need to be all in the same time category to avoid the problems inherent in a case like Hermans, where the plaintiff starts taking Vioxx before a label change but has a heart attack after a label change." He added, "Those cases need individual attention to determine if the label change made a difference."

Although the jury found against Hermans on failure to warn, Lanier noted that it found in both cases that Merck violated New Jersey's consumer fraud statute, so the company must pay economic damages and attorney fees and expenses.

So far, Merck has won more Vioxx cases than it has lost, and it has vowed to fight each case in court. Two weeks after the Humeston verdict, a jury in Madison County, Illinois, found in the company's favor in Schwaller v. Merck. (No. 05L687 (Ill. Cir. Mar. 27, 2007).) Merck has announced it will appeal the result in Humeston.

Among the information that surfaced after Humeston's first trial was the New England Journal of Medicine's "expression of concern," published in December 2005, that the authors of the VIGOR study withheld data, misrepresenting the risk of heart attack from Vioxx.

Other studies have shed light on the risk of intermittent Vioxx use. Merck initially maintained that risk increased only after 18 months of use. (See Allison Torres Burtka, Vioxx Studies Question Timing of Heart Attack Risk, TRIAL 98 (July 2006).)

Seeger said that because Humeston was a short-term user of Vioxx, his case should be encouraging to other short-term-use plaintiffs. The idea that only long-term use is dangerous "has been corrected in the medical literature, and juries see through it, too," he said.

"For plaintiff lawyers, this is an example of why not to give up," Seeger said. He added that although Idaho has a $250,000 cap on noneconomic damages, it doesn't apply to Humeston's award because the jury found Merck's conduct to be willful and reckless. Idaho law also limits punitive damages to three times compensatory damages, a cap the award did not exceed.

"These cases add to the momentum that works to the plaintiffs' advantage over time," Lanier noted. "I've said repeatedly that these cases are very difficult." He compared them to asbestos litigation, in which defendants won most cases for the first 5 to 10 years.

"Then the momentum shifted" in favor of plaintiffs, he said. In the Vioxx litigation, "these wins will add to that momentum and bring Merck's reckoning closer."
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Title Annotation:news & trends
Author:Burtka, Allison Torres
Date:May 1, 2007
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