Jury Says Merck Misled FDA, Awards Another $9M to Heart Attack Victim

This article is from the archive of The New York Sun before the launch of its new website in 2022. The Sun has neither altered nor updated such articles but will seek to correct any errors, mis-categorizations or other problems introduced during transfer.

The New York Sun

ATLANTIC CITY, N.J. – A jury ordered Merck yesterday to pay $9 million in punitive damages to a 77-year-old man who had a heart attack after taking Vioxx, concluding the drug maker misled the U.S. Food and Drug Administration about the painkiller’s heart risks.


The verdict is a further defeat for Merck six days after the New Jersey Superior Court jury awarded $4.5 million in combined compensatory damages to the same man, John McDarby, of Park Ridge, N.J., and his wife. Yesterday’s verdict brings their total awards to $13.5 million.


Last week, the jury of six women and two men found Mr. McDarby’s use of Vioxx for about four years played a substantial role in his 2004 heart attack, and that Merck had failed to properly warn of Vioxx’s cardiovascular risks. The jury also found last week that Merck violated the state’s consumer-fraud law in Mr. McDarby’s case.


“It’s a door to hope for us,” Mr. McDarby’s wife, Irma McDarby, said yesterday outside the courthouse here. She said her husband, who gets around in a wheelchair, wasn’t at the courthouse because he wasn’t feeling well, though he has attended previous court sessions. “We’ve had very little to work with. Now he can get care for everything he needs.”


It was the first punitive-damages verdict in New Jersey against a pharmaceutical company since the state legislature placed limits on such damages in the mid-1990s, lawyers on both sides said. That law made it tougher for people to win punitive damages from drug companies, which have major operations in the state, including Merck’s Whitehouse Station, N.J., headquarters.


“This jury has sent a message out from the backyard of pharmaceutical land that they take their policing powers seriously,” plaintiff attorney Mark Lanier said.


Merck lawyers said the company would appeal both the punitive-damages verdict and last week’s verdicts in the compensatory-damages phase of the trial. “We think the jury was not allowed to see and hear all the evidence,” a spokesman for Merck’s legal-defense team, Chuck Harrell, said.


Mr. Harrell added that Merck would continue its strategy of evaluating and defending itself against cases on an individual basis, rather than seek any broad settlement. “We’re in this for the long haul,” he said. “Each case is different.”


An attorney for Mr. McDarby, Ellen Relkin, said Merck’s plan to appeal meant the McDarbys probably won’t see any money from Merck for at least a year.


The verdict was a blow to Merck particularly because New Jersey law makes it hard for plaintiffs to win punitive damages. “New Jersey is a very drug company-protective state in its punitive damages law,” a law professor at Fordham Law school, Ben Zipursky, said.


There was, however, some consolation for Merck in the fact that the punitive award was below the $22.5 million cap set by state law in Mr. McDarby’s case, or five times compensatory damages.


And Mr. Zipursky doesn’t believe the verdict significantly increases pressure on the company to start settling cases. He noted that the same jury didn’t award substantial damages in another man’s case last week, which seemed to vindicate Merck’s strategy of handling cases one-by-one.


The punitive-damages phase of the trial, which began Thursday, centered on whether Merck withheld information about Vioxx’s safety risks from the Food and Drug Administration, or misrepresented it. The jury also had to determine whether that information was material and relevant to the “harm” in question, and whether Merck showed a wanton and willful disregard of someone’s rights.


The jury, which began deliberating Monday afternoon, voted 7 to 1 in favor of Mr. McDarby on these questions.


Among the evidence presented by Mr. McDarby’s attorneys during the punitive phase was an October 2000 internal Merck analysis that found a higher cardiovascular risk with Vioxx. Plaintiff lawyers said Merck never submitted this to the FDA. Merck argued that the analysis was preliminary and not required by the FDA, and said it did submit the underlying clinical data.


The New York Sun

© 2024 The New York Sun Company, LLC. All rights reserved.

Use of this site constitutes acceptance of our Terms of Use and Privacy Policy. The material on this site is protected by copyright law and may not be reproduced, distributed, transmitted, cached or otherwise used.

The New York Sun

Sign in or  create a free account

By continuing you agree to our Privacy Policy and Terms of Use