Vioxx Federal Judge Sees 2008 Focus on Stroke Cases

Next year’s federal Vioxx trials may focus on people who had strokes after taking the once popular painkiller, the judge assigned to handle pretrial matters in all 8,575 federal lawsuits said last Friday.

“We may carve out five or six stroke cases and try them,” U.S. District Judge Eldon E. Fallon told attorneys for plaintiffs and manufacturer Merck & Co., which pulled the blockbuster drug from the market in 2004 after studies indicated it doubled cardiovascular risks.

The five cases heard so far in federal court all involved people who had heart attacks after taking Vioxx. Merck, based in Whitehouse Station, N.J., won four of them.

“I don’t have an end game in sight, but I’m moving in that direction,” Fallon said.

The judge said arguments on two disputes may wait on testimony from the governors of Mississippi and Indiana about their consultations with the U.S. Food and Drug Administration as new drug label rules took effect.

Plaintiffs’ lawyers have subpoenaed Gov. Haley Barbour, R-Miss., a former lobbyist whose clients included major drug companies, and Gov. Mitch Daniels, R-Indiana, a former executive for Eli Lilly and Co.

Fallon said he would schedule hearings later on Merck’s requests for a new trial in a case it lost and for permission to immediately appeal Fallon’s ruling on the FDA label question.

Merck faces about 26,950 lawsuits from people who claim the drug caused heart attacks or strokes and Merck failed to provide enough warning about cardiovascular dangers. A 16,400 are in state court in New Jersey, with additional cases in other states.

The suits include about 45,225 plaintiffs, and Merck has agreed to let another 14,450 potential claimants sue after their statute of limitation expires.

Lawyers for individuals and companies suing Merck subpoenaed the governors for videotaped testimony about their responses when asked by the FDA whether the new label rules would violate states’ rights.

That will have a direct bearing on Merck’s request for permission to immediately appeal a ruling that FDA’s approval of a label does not protect drug makers from lawsuits claiming a label’s warnings were inadequate, plaintiffs’ lawyer Russ Herman of New Orleans said Friday.

FDA made that claim in the preamble to rules that took effect in January 2006. Fallon ruled early this month that the arguments are “entirely unpersuasive” and two trials may proceed.

After the hearing Friday, plaintiffs lawyer Arnold Levin of Philadelphia said FDA was supposed to get states’ opinions about whether a proposed rule would violate states’ rights.

“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.

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 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.”