The Work

October 31, 2008 3:04 PM

Gearing Up for Wyeth v. Levine

Posted by Zach Lowe

In our interview yesterday with Hunton & Williams partner Sheldon Bradshaw, the lawyer, a former FDA chief counsel, criticized a Congressional committee report over the agency's stance on drug warning labels preempting lawsuits against drug makers.

Bradshaw suggested the House Government and Oversight Committee issued the report to hurt the upcoming case Wyeth v. Levine, scheduled for arguments before the Supreme Court on Monday, over whether FDA approval of a drug makes drug companies immune from lawsuits brought by injured patients. The plaintiff, Diana Levine, had most of her right arm amputated after a physician's assistant mistakenly injected an anti-nausea drug into her artery. Levine's team argues the label on the drug should have warned doctors never to administer the drug intravenously. The drug company, Wyeth, says they should be immune from the suit because the FDA approved their warning label--which did warn about the damage that could result from an accidental injection into an artery.

Not surprisingly, Wyeth's team at Wilmer Cutler Pickering Hale and Dorr, led by Seth Waxman, echoed Bradshaw's criticisms of the House report, suggesting preemption was controversial within the FDA. Today, the firm delivered a letter to the clerk for the high court suggesting the report is biased, politically timed, and "not entitled to any persuasive weight." (Hat tip to Drug and Device Law, the top notch blog that reported on the letter today.)

The Wilmer letter echoes many of Bradshaw's arguments. It notes that the report found only two major sources of dissent within the agency and that the report simplified the 2006 changes in drug labeling regulations--changes that included an explicit endorsement of preemption. The new labeling requirements essentially created a "highlights" section on the first page of every drug label (which can sometimes run 30 pages long), where manufacturers must detail the most important warnings about the drug. The new rules banned drug companies from adding warnings to the highlights section without the FDA's approval--a change internal critics suggested was meant to protect drug companies from lawsuits, since the FDA was taking on the full burden of updating the warning label.

Waxman's letter, penned in response to another letter sent to the Court Thursday by plaintiff's attorney David Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel, also points out that the report was not endorsed by the full House committee.

The good news is that all the jockeying ends Monday, when the arguments will finally happen. Stay tuned.

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