A little more than a year ago we posted about Longs v. Wyeth, 536 F. Supp.2d 843 (N.D. Ohio 2008), a fen-phen decision that, among other things, held preempted a claim that the drug in question was so dangerous that there was no adequate warning that could make it “safe” enough for state tort law. As we reported then:
It’s one thing to say that the warning was inadequate. . . . But it’s quite another thing to say that there isn’t any warning on the face of the earth that could make an FDA-approved drug “safe” under state law. That’s the same thing as saying that, as far as state law is concerned, notwithstanding the FDA’s approval, the defendant should never have sold the product.And for a state to tell the FDA that its approval should
never have happened – well, that’s preempted.
Well we’re happy to report that last Friday, the same judge on reconsideration after Wyeth v. Levine, held that nothing had changed. Even after Levine, a claim (analogous to the failure-to-contraindicate claim that we thought Levine was about) is still preempted. It could hardly be otherwise if the FDA is to retain any real authority at all. In Longs v. Wyeth, No.: 1:03 CV 2042 (N.D. Ohio March 20, 2009), the court drew a distinction between “pre-approval” and “post-approval” tort claims and observed that Levine dealt with “the postmarketing phase [when] new risks emerge. Slip. op. at 5 (quoting Levine, 2009 WL 529172, at *12). The court accordingly held that the plaintiffs too-dangerous-for-warnings claim was still preempted:
The instant case is distinguishable from Wyeth as this case does not involve a failure to warn claim, which served as the basis for the Supreme Court’s determination. Furthermore, the court, in holding that a failure to warn claim is not preempted, focused on the fact that the claim arises out of the actions of the manufacturer post-FDA approval. The Court found that after the FDA approves a product for the market, manufacturers maintain a duty to update warning labels because of their superior knowledge of new risks concerning their products. This post-FDA approval duty is distinguishable from a manufacturer’s duty prior to approval by the FDA, a circumstance that the Court does not explicitly address. While Wyeth may stand for the proposition that post-FDA approval claims are [sic not?] preempted, it does not purport to hold that the same is true for pre-FDA approval claims. Thus, Plaintiff fails to demonstrate that this court erred in its holding that Plaintiff’s pre-FDA approval claims are preempted.
Slip op. at 7.
That distinction makes sense to us, particularly in light of what the Supreme Court did not decide in Levine, which was the failure-to-contraindicate claim. A claim that a drug cannot be made reasonably safe by warnings is a direct challenge to the power of the FDA to approve drugs in first place. The same thing goes for indications vs. contraindications. Since any new indication requires FDA approval (that’s what the off-label use debate is all about), then a failure to contraindicate claim is the same thing – a direct challenge to the FDA’s power to approve uses of drugs.
We think that the plaintiffs in Longs overreached even the broadest possible scope of the common law in Levine – we doubt they will be the last to do so.