Merck Loses Bid to Nix Punitive Damages; Deliberations Today

A judge last Friday rejected Merck & Co.’s request to abort a hearing aimed at establishing whether the company must pay punitive damages to a former Vioxx user already awarded $4.5 million for a heart attack he blamed on the drug.

Merck, which was found liable in a verdict last Wednesday for failing to warn of the arthritis drug’s risk, asked Superior Court Judge Carol Higbee to end the punitive damages phase of the trial, saying plaintiffs’ attorneys hadn’t proven the company knowingly misrepresented Vioxx’s risks to federal regulators.

But Higbee denied the motion, setting the stage for closing arguments and deliberations Monday on the issue of whether to give 77-year-old John McDarby more money. Under New Jersey law, the jury could award up to five times the amount of compensatory damages — in this case, $22.5 million.

On Wednesday, the same jury awarded $3 million to McDarby and $1.5 million to his wife, saying that Merck failed to warn of the drug’s risks and that the company had misrepresented them to prescribing physicians.

It also found Merck intentionally suppressed information about the risks of Vioxx, which was ultimately pulled off the market in 2004 after being linked to heart attacks and strokes.

On Friday, the second day of the punitive-damages hearing began with the playing of videotaped depositions by Merck statistician Deborah Shapiro and former Merck Research Laboratories chief Edward Scolnick.

After that, the six-woman, two-man jury’s attention was turned to whether Merck showed “wanton and willful” disregard in omitting unfavorable Vioxx safety data in submissions to the U.S. Food and Drug Administration.

Plaintiffs attorney Mark Lanier engaged in a spirited cross-examination of Dr. Lisa Rarick, a former FDA executive called to testify by Merck in a bid to prove the company gave all of its relevant Vioxx safety data to regulators.

Citing a Merck analysis of Vioxx safety data that pooled information from clinical studies, Lanier told jurors the company submitted an amended version of the document to the FDA, leaving out statistics showing increased risk of heart attacks.

Rarick, a former obstetrician who has earned $175,000 as a litigation consultant for Merck since 2004, acknowledged the statistics were omitted from the 2000 document but said the FDA already had that data from the underlying individual studies used to compile statistician Shapiro’s “meta analysis.”

Questioned by Merck lawyer Mike Brock, Rarick told jurors the company submitted all the information about Vioxx that it was required to.

But Lanier insisted Merck dragged its feet in doing so, and at a time when Merck was in negotiations with the FDA to amend Vioxx’s label.

“Every month that Merck delayed getting the label changed, Merck made substantial profits over what they would’ve made if the label was changed, didn’t they?” Lanier asked.

Rarick said she didn’t know about the financial data and couldn’t answer that.

Merck, based in Whitehouse Station, faces about 9,650 suits in state and federal courts over Vioxx.