Judge Expects Vioxx Stroke Cases

Diane Sullivan, attorney for Merck & Co., holds up a package of Vioxx during opening arguments in Atlantic City, N.J., in this Jan. 22, 2007 file photo. Plaintiffs Mike Humeston, of Boise, Idaho, and the estate of Brian Hermans, represented by his sister, Kathleen Messerschmidt, of Green Bay, Wis., are suing Vioxx maker Merck & Co. for heart attacks they blame on the since withdrawn painkiller. Drug developer Merck & Co. said Monday, July 23, 2007 its second-quarter profit jumped nearly 12 percent on an across-the-board rise in drug sales, and the company boosted earnings guidance for the year. However, it took another charge to cover costs of its massive Vioxx litigation. (AP Photo/Mary Godleski, file) (Mary Godleski - AP)

"The FDA forgot to do that. After the rule took effect, they said, `Whoops! How about talking to the governor of Indiana? He's OK, he used to be CEO for a drug company. How about talking to the governor of Mississippi? He's OK; he used to be a drug lobbyist.'"

But, Levin said, the FDA never made their responses public.

The FDA contends that since its rules control what is on the labels, they pre-empt state law _ the controlling issue even in federal court claims that a warning is inadequate. Merck wants to appeal now, rather than after final rulings in the two specific cases on which Fallon ruled.

Herman said the question also affects Merck's request for a retrial of its only loss in federal court _ a suit filed by retired FBI agent Gerald Barnett of Myrtle Beach, S.C., who had a heart attack in 2002.

Fallon said he may hold that hearing after getting Barbour and Daniels to testify or hold the hearing sooner and wait to rule until the depositions are in. The governors' testimony could come by September.

Merck lawyer Phil Wittmann said he didn't think the governors' testimony was relevant to Barnett's case. But Fallon said he had mentioned the issue in a footnote to his ruling. "This issue has come up in every case," he said.

Merck contends Fallon usurped a jury's job when he proposed a $1.6 million award to Barnett to replace the $51 million jury judgment he had found excessive.

Jurors in Barnett's case decided he should get $50 million to compensate him for injuries from a 2000 heart attack and $1 million in punitive damages against Merck. Fallon ruled the compensatory damages were unreasonable, since Barnett was retired and had made a good recovery.

As an alternative to a retrial on damages, Barnett asked the judge to suggest a more reasonable award, and accepted Fallon's recommendation: $1 million in punitive damages, $600,000 in compensatory damages.

Merck contends that by doing so, Fallon usurped a job that should have been done by a jury. And, the company said in court documents, "Because there is no way to determine what damages the jury concluded Mr. Barnett suffered, let alone what compensation it awarded for each component of his damages, there is no way to lop off _ or even calculate _ the `excessive' part of the jury's award."