NEW ORLEANS – Govs. Haley Barbour of Mississippi and Mitch Daniels of Indiana have been subpoenaed by lawyers for people who blame their heart attacks or those of family members on the once-popular painkiller Vioxx. 

Both governors have past ties to the drug industry, and plaintiffs’ lawyer Russ Herman said they were subpoenaed to testify about consultations with the U.S. Food and Drug Administration before the agency set new drug label rules in 2006.

The FDA contends that, because the rules define what must be stated on prescription drug labels, they pre-empt state law. Therefore, claims that a company’s warnings were inadequate under state law would be invalid, FDA says.

“‘The FDA said it ran a survey about, basically, how consumer rights would be affected” by such a statement, said Herman, spokesman for a committee set up to represent plaintiffs’ lawyers in federal lawsuits against Vioxx manufacturer Merck & Co. (NYSE:MRK)

“We want to find out exactly what these conversations were with the FDA and what these governors actually did. And we want their documentation on their position that consumer rights and states’ rights wouldn’t be affected,” Herman said.

Thousands of federal Vioxx cases are before U.S. District Judge Eldon Fallon, who was assigned to handle pretrial litigation for them.

Some suits ask Merck to pay an insurance company or health care provider’s expenses for purchasing the drug. But most are rooted in claims that label warnings about possible cardiovascular effects were inadequate.

Failure to warn’ is a state claim, but where there is no parallel federal law, federal courts apply state laws in the jurisdiction where a lawsuit is filed.

The plaintiffs’ steering committee also has subpoenaed the Council of State Governors, the American Legislative Exchange Council, the National Conference of State Legislators and the National Governors Association for records of similar contacts with FDA.

Documents in the federal court’s online filing system show Barbour is to give a videotaped deposition on Sept. 4 in Jackson, Miss., and Daniels on Sept. 11 in Indianapolis. The documents state that subpoenas were mailed Tuesday, the day they were filed in federal court.

Barbour, whose clients as a lobbyist before he was elected governor included some of the nation’s largest pharmaceutical companies, cannot comment because he has not received a subpoena, spokesman Pete Smith said.

Daniels was an official for Eli Lilly and Co. (NYSE:LLY) from 1993-2001. Daniels spokesman Brad Rateike said he had not heard about the subpoena.

FDA spokeswoman Susan Cruzan could not be reached for comment.

“This is a request for information from sources outside of Merck. At this point it is too soon to say whether Merck will weigh in on the request,” said Ted Mayer, a company lawyer.

Fallon ruled July 3 that FDA’s stand “is entirely unpersuasive,” and the lawsuits may proceed. He will hear arguments Friday on Merck’s request to let it appeal that decision immediately, rather than after final rulings in two cases on which Fallon ruled.

Also on Friday’s docket is Merck’s call to retry the case of Gerald Barnett, a former FBI agent who blames Vioxx for a heart attack he suffered in 2002.

The jurors who heard his case awarded Barnett $51 million. Fallon overturned that as excessive. Rather than hold a new trial on damages, Barnett accepted a $1.6 million judgment suggested by Fallon.

Merck contends that by doing so, Fallon usurped a job that should have been done by a jury. And, the company said, “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.”

 



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