A longtime correspondent (who wishes to remain nameless – but we thank you anyway) sent along overnight a new medical device preemption win, Wheeler v. DePuy Spine, Inc., No. 06-21245, slip op. (S.D. Fla. March 9, 2010).
You know the drill. Class III PMA Device = preemption. The Charite Artificial Disc (a spinal implant) is that. So essentially the only thing left would be a “parallel violation” claim. Concerning a implied warranty/product liability claim, the plaintiff didn’t even try. Rather, plaintiff “specifically disavows any reliance on a statutory violation claim as to his strict liability claim.” Slip op. at 5. Why bother then? After Riegel, that’s sort of like leaning in to your opponent’s best punch. The result was predictable – summary judgment granted. Id.
The plaintiff put up a little more fight on the negligence claim. At least there was an allegation that the defendant violated something – although the allegations were maddeningly vague. Wheeler was a 2006 filing – these days that kind of claim would be likely be knocked out of the starting box by a Twombly/Iqbal motion. Again, however, plaintiff’s argument wasn’t very good. The complaint “states that [plaintiff] seeks to ‘enforce the requirements of the FDA.'” Slip op. at 6. Oops. Rarely has a plaintiff been so up front about doing something that he’s not allowed to do. There is no private right of action to “enforce” the FDCA. Not only that, Florida law is quite explicit that negligence per se isn’t available unless there was legislative intent to allow private enforcement. Id. at 6-7. So plaintiff’s “enforcement”-based violation claim goes by the boards for both federal and state-law related grounds. Id. at 9.
All of that is relatively routine by now – defendants have been successfully mating general Florida negligence per se standards with the FDA’s prohibition of private enforcement since Bone Screw days over a decade ago. And you know what? When summary judgment forced plaintiff here to put some meat on the bones of his violation allegations, the claim turned out to be almost exactly like Bone Screw: the purported “violation” was “that Defendant failed to comply with the conditions of the PMA by permitting usage of two discs in the patient.” Slip op. at 8. That was, we gather, an off-label use. That means the alleged violation was “permitting” an off-label use to occur. Also plaintiff argued that the defendant “did not accurately disclos[e] to the FDA” adverse events. Id. Again that was like leaning into a left hook – this particular punch being called Buckman. Citing Buckman for both propositions, the court found the off-label and disclosure allegations were preempted. “Although plaintiff states that he is not bringing a fraud-on-the-FDA claim, the claim described by Plaintiff appears to be such a claim.” Id. at 8 n.4.
Plaintiff’s last stand is on a vague express warranty claim that the product was “not proven” to be safe effective or durable. Slip op. at 9. It’s another claim that Twombly/Iqbal should take care of today, should the same complaint be filed. Express warranty, of course, was not addressed specifically in Riegel. Wheeler recognized the majority rule that any supposed express warranty arising from FDA-approved material was preempted. Id. at 10-11. There also wasn’t privity, and (as mentioned) the claim was vague. Id. The court, however, decided to hold a hearing on express warranty, so at this moment, plaintiff is still hanging on by a thread.
Keep those wins coming.