Wyeth v. Levine was decided this morning and the Court rejected preemption by a 6-2 vote, Justice Stevens writing for the majority.
The basics. (1) there is no premption by impossibility because the FDA's changes being effected ("CBE" ) regulation permits certain preapproval labeling changes that add or strengthen a warning to improve drug safety. There was no evidence the FDA would have rejected such a change. (2) as for ordinary conflict preemption, there is no evidence of congressional intent to preempt state tort inadequate warning actions. The FDA's 2006 preemption preamble, entitled to only Skidmoore deference, is not persuasive in light of several factors. (3) Geier is distinguishable because it involves actual notice-and-comment rulemaking - which may present a different situation.
As regular readers of this blog know, Diana Levine was a children's guitarist in Vermont. In April 2000, she went to a clinic for treatment of a severe migraine headache and associated nausea. She was originally treated with intramuscular injections of Demerol (for headache) and Wyeth's drug, Phenergan (for nausea). Intramuscular injection was the preferred method for administering Phenergan identified in the product's labeling.
When that treatment did not provide relief, Levine returned to the clinic, and a physician's assistant administered a second dose of Demerol and Phenergan intravenously by IV push injection -- injecting the medication into the tubing of an IV infusion set that led to a needle inserted into what the assistant thought was a vein.
At the time of Levine's treatment, the package insert for Phenergan warned in four separate places about the risk of gangrene arising from inadvertent exposure of arterial blood to the drug. Among other things, the "Adverse Reactions" section of the label said, in bold, upper-case letters: "INTRA-ARTERIAL INJECTION [CAN] RESULT IN GANGRENE OF THE AFFECTED EXTREMITY."
The FDA had regularly reviewed Wyeth's labeling for Phenergan, and the Agency was aware of the risk of gangrene if arterial blood was exposed to the drug. In 1997 (the last review before Levine's treatment) the FDA ordered Wyeth to make various changes to the labeling of Phenergan, but directed the company to "[r]etain verbiage in current label" about inadvertent intra-arterial injection.
Unfortunately, after Levine's treatment, she developed the symptoms of arterial exposure and gangrene, requiring amputation of her forearm.
Levine sued the health clinic, physician's assistant, and supervising physician for malpractice, and she settled those claims for $700,000. She then sued Wyeth in state court in Vermont, pleading state law claims for inadequate warning. At trial, Levine's lawyer and expert witness both argued that Wyeth should have contraindicated intravenous injection of Phenergan on the drug's label, forbidding that method of administration -- even though the FDA never required such a contraindication and instead required Wyeth to use only the language the Agency had approved.
Wyeth argued in motions for summary judgment and judgment as a matter of law in the trial court that Levine's claims were preempted -- because the FDA dictated the warnings included on Phenergan's labeling as a matter of federal law, state law could not require Wyeth to give different warnings that would have conflicted with federal law.
The trial court rejected that argument, and the jury entered a verdict of $7.4 million against Wyeth. The judgment was later reduced to $6,774,000 to account for prejudgment interest and the settlement of the earlier malpractice suit.
On appeal to the Vermont Supreme Court, Wyeth again explained that Levine's claims were preempted because Wyeth could not comply with both its federal duty to distribute Phenergan only under the precise labeling approved by the FDA and its Vermont common-law duty to give different warnings. In a split decision, the Vermont Supreme Court affirmed, rejecting Wyeth's preemption argument.
The United States Supreme Court granted certiorari in Wyeth v. Levine on January 18, 2008, and heard argument on November 3.
For those who are curious, we've previously posted about Wyeth v. Levine many times, including here (analyzing the transcript of the argument), here (describing the defense amicus briefs), and here (collecting our thoughts after the grant of cert last January).
The Supreme Court issued its decision just moments ago.
After we've had a chance to read the opinion, we'll publish a post analyzing the legal implications of Wyeth v. Levine. (We won't take too long to do that. We promise!)