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Testimony Comes to End in Vioxx Case 2006-04-08
By Reuters

Testimony Comes to End in Vioxx Case

ATLANTIC CITY, April 7 (Reuters) — A former official from the Food and Drug Administration testified Friday that Merck & Company properly submitted all information on its Vioxx drug to regulators, ending testimony in the punitive phase of the product liability trial.

Jurors now need to determine whether Merck withheld material information from the F.D.A. as they consider punitive damages.

On Wednesday, the jury said Vioxx was a significant contributing factor in the heart attack of John McDarby, 77, and awarded him and his wife a total of $4.5 million in compensatory damages.

The jury also determined that the drug was not a significant cause of a heart attack suffered by a second plaintiff, Thomas Cona.

Under questioning from a Merck lawyer, Mike Brock, Dr. Lisa Rarick, who worked at the F.D.A. for 15 years and is now a consultant, said a review of documents on Vioxx submitted to the F.D.A. showed Merck acted properly.

"They always had submitted the appropriate information," Ms. Rarick told New Jersey Superior Court.

She added that she never saw any evidence that suggested anything was missing.

A plaintiff's lawyer, W. Mark Lanier, sought to paint Ms. Rarick as a hired gun for Merck who could not have possibly reviewed all the information the company sent to regulators.

After hearing closing arguments Monday, jurors will receive instructions from the judge and then begin their deliberations.

Under New Jersey law, any punitive damages awarded as punishment to rectify a wrong committed by a defendant would be capped at $22.5 million — five times compensatory damages.

Earlier Friday, Merck asked the judge to dismiss the punitive damages phase of the case, arguing that the plaintiff's lawyers had not presented evidence showing the drug maker hid data about its painkiller from regulators.

Judge Carol E. Higbee, who has presided over the case, denied Merck's motion.

Mr. Lanier has argued that Merck intentionally omitted part of the analysis that showed a "statistically significant" increase in heart attacks for Vioxx users when Merck submitted it to the F.D.A. in 2001.

Merck maintains it submitted the heart attack data, but not the analysis because it would have been inappropriate to break out heart attack data as a separate analysis.


 
 
 
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