In the last few days it seems that we can’t stick our head out the blog's front door in the morning without a court hitting us in the head with a bad decision like a wild-armed paperboy. Stengel, Weeks, boom, thwack! Well, we’ve had enough and we’re not going to take it anymore! No, wait. Let’s rethink that. Let’s be understated. We don’t want to invite more bad decisions. So let’s be quiet. Like it’s rabbit season. Shhhhhhh. OK, we found a good decision. It’s called Abicht v. PLIVA, Inc., 2013 U.S. Dist. LEXIS 3670 (D. Minn. Jan. 9, 2013). It’s nice. Sure, it has generic preemption, but it comes with a “no private right of action under the FDA” dismissal too. So it’s pretty darn good . . . . No, wait. Shhhhhhh. Take it down a notch again. It’s just OK. (Wink.)
Plaintiffs brought a slew of claims based on an allegedly inadequate warning on the generic drug metoclopramide. We know how this goes, and it’s nothing new and nothing really to be quiet about. They’re preempted. The court put it nicely:
[M]ost of Plaintiffs’ claims in these two cases are just the sort of failure-to-warn claims that Mensing prohibits, whether couched as strict liability, breach of warranties, negligence, misrepresentation, fraud, negligence per se, Minnesota Deceptive Trade Practices Act, Minnesota Prevention of Consumer Fraud Act, or negligent infliction of emotional distress, and those claims must be dismissed as preempted by Mensing.
Id. at *5. Nice.
But, Shhhhhhh. Here’s the good part. Plaintiffs argued, as many plaintiffs do these days, that they still had a state-law claim against the generic manufacturer for failing to update its label to match that of the branded manufacturer. But where does that obligation come from?, the court quietly asked. Federal law and the FDCA, it even more quietly answered. And only the federal government can enforce that obligation, not private litigants:
Federal law is the gravamen of Plaintiffs’ failure-to-update claim here. They contend that PLIVA violated its duties under the FDCA by failing to include on the metoclopramide label the information the FDA approved for Reglan’s label. But the enforcement of such a duty is exclusively the province of the federal government, not of state tort law. ‘[A] private litigant cannot bring a state-law claim against a defendant when the state-law claim is in substance (even if not in form) a claim for violating the FDCA--that is, when the state claim would not exist if the FDCA did not exist.
Id. at *6-7. We must say, quietly and respectfully, that that’s pretty darn sweet.
But, Shhhhhhh. There’s more. Shhhhhhh. Shhhhhhh. Shhhhhhh. Plaintiffs argued that, like the court found in Fisher v. Pelstring, 817 F. Supp. 2d 791, 805 (D.S.C. 2011), their action is really based in state negligence law, not federal law. Their state-law negligence action merely borrows the federal obligation as the standard of care. Sure. Well, the Abicht court wasn’t having any of it:
This Court respectfully disagrees with the Fisher court’s analysis. Where federal law supplies the duty, a state claim to enforce that duty is, in substance if not in form, a cause of action under federal law. And such private actions are not allowed under the FDCA. As such, Plaintiffs’ failure-to-update claim fails as a matter of law.
Id. at *9. Wow! Uh, well, we mean, um, that was interesting. Nothing to see here. Just another boring legal decision. Move on. No need to hit us in the head with a bad decision or anything.
(OK, that feels better.)