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Indiana governor subpoenaed in Vioxx litigation

Michael W. Hoskins
January 1, 2007
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Indiana Gov. Mitch Daniels will testify this fall in the ongoing federal court litigation involving recalled painkiller Vioxx, which is being blamed for thousands of heart attacks nationwide.

Documents in the U.S. District Court, Eastern District of Louisiana's online filing system show that subpoenas went out Tuesday, and Daniels will give a taped deposition in Indianapolis Sept. 11. Mississippi Gov. Haley Barbour is scheduled to do the same Sept. 4 in his home state.

Both governors have ties to the drug industry - Daniels worked as president of Eli Lilly's North American Pharmaceutical Operations for eight years until 2001 - and are being subpoenaed to testify about consultations with the U.S. Food and Drug Administration before the agency set new drug-label rules last year defining what must be printed on the prescription labels.

The FDA contends those rules pre-empt state law and therefore claims that a company's warnings were inadequate under state law would be invalid. "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 suit is filed, according to federal court documents.

Thousands of Vioxx cases are on the Multi-District Litigation docket before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana.

A July 3 order from Judge Fallon describes the FDA's stand as "entirely unpersuasive" and allows the litigation to proceed. A monthly pretrial conference is set for 9:30 a.m. Friday in the federal court, and the judge will consider Merck's request to appeal that decision immediately rather than waiting on final rulings in two cases involving that issue.

Vioxx - which had peak sales of $ 2.5 billion annually - was on the market from May 1999 through September 2004, when Merck voluntarily withdrew it in the wake of a clinical study showing increased risk of heart attack and stroke after 18 months of use. This revelation followed other evidence that had undermined Merck's justification for charging premium prices for Vioxx compared to similar prescription painkiller drugs. More than 14,000 cases exist, involving an estimated 20,000 plaintiff groups, and hundreds of attorneys and judges across the country. Court records show about 15 Hoosier attorneys have had their hands in this litigation.

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.
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