Legal News

Do Newly-Released FDA Memos Hurt Wyeth?s Preemption Argument?

By Dan Slater

The Law Blog is gearing up big-time for Monday. That’s when lawyers will square off before the High Court to argue Wyeth v. Levine, a preemption case with major implications for the business community. (Here’s recent LB coverage, and here are all the docs, via Scotus Wiki.)

At issue in Wyeth: Whether, despite a state-court verdict that Wyeth hadn’t sufficiently warned of dangers related to anti-nausea drug, the company is protected because the FDA approved its label? In other words, does preemption — the notion that federal laws or rulemaking can trump state tort law — protect the company against state tort suits?

Now, in the run-up to the arguments, documents released yesterday in a congressional investigation show that career officials at the FDA have dissented on the issue of the FDA blocking consumer lawsuits against drug makers.

As the WSJ reports, internal memos contradict the FDA’s position in the Wyeth case. The FDA says federal drug-approval and warning-label standards should trump stricter state laws. But two FDA officials said in the memos that it’s wrong to assume that FDA-approved drug labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers.

“[M]uch of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis,” wrote John Jenkins, the top official in the drug approval section, in 2003. At the time, the FDA was debating a rule, later adopted, that enshrined the concept of preempting state suits.

An FDA spokeswoman told the WSJ: “As in any organization, there is rarely unanimity of opinion.”

Rep. Henry Waxman (D., Calif.) released the documents. The WSJ notes that they’re likely to encourage him and other Democrats in Congress who want to pass bills reversing the Bush administration’s preemption policy.

Full post as published by Law Blog - WSJ.com on October 30, 2008 (boomark / email).