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Kathleen Messerschmidt, of Green Bay, Wis., are suing Vioxx maker Merck & Co. for heart attacks they blame on the since withdrawn painkiller.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)

NEW ORLEANS -- 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 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 won four of them.

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 the 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.

The 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.