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There’s an important new opinion, Bass v. Stryker Corp., No. 11-10076, slip op. (5th Cir Jan. 31, 2012), that provides a pretty decent rundown of what a plaintiff has to have to plead, under TwIqbal, an unpreempted “parallel violation” claim of the manufacturing defect variety.
Here are the elements that must be pleaded under Bass (which the court held that the plaintiff did):

  • (1) The particular product that the plaintiff claims caused injury (“he received a Shell implant”);
  • (2) The nature of the claimed “parallel” violation (“the FDA had previously warned [defendant] of bioburden in excess of FDA regulations in its final rinse of the Shells”);
  • (3) That the violation could be causal in that it pertained to the plaintiff’s device (“after [plaintiff’s] surgery, [defendant] ultimately voluntarily recalled those Shells, including the Shell specifically used in [plaintiff’s] implant”);
  • (4) The nature of the plaintiff’s injury (“[plaintiff] suffered from a loose Shell due to a lack of bony ingrowth”); and
  • (5)  That the violation could be causal in that it bore a relation to the plaintiff’s claimed injury (“the lack of bony ingrowth is a known effect of an excess of bioburden and manufacturing residuals on Shells”).

Bass, slip op. at 10.  Where we find plaintiffs falling down is usually on items (2), by failing to plead that the FDA action pertained to the device the plaintiff had, (3) by pleading scattershot FDA actions that, giving timing or location, have nothing to do with the case, and (5) claiming violations that don’t have anything to do with the injury in the case.
One more thing:  the plaintiff must plead the violation of a sufficiently specific FDA requirement.  Bass, slip op. at 12-13.  That can be done by alleging that the defendant either a specific regulation, or a more general regulation (such as certain Good Manufacturing Practices), as applied to the device by particular specifications in the PMA that the FDA actually approved.  Id. at 13 (“The PMA application that is approved by the FDA is more specific than the regulations”).
Do all that, and there’s a properly pleaded violation claim that entitles the plaintiff to discovery.  Bass, slip op. at 12.
Remembering that this is only at the pleading stage, where a preliminary FDA warning letter, while it might be “plausible” as an allegation, id. at 15, but would be admissible as proof, we’re not terribly offended by these pleading requirements.
That’s particularly so because Bass goes out of it’s way to specify that a plaintiff can’t argue that the specifications themselves should have been different from what the FDA approved:

[I]f the plaintiff challenges the suitability of the precise processes or procedures chosen by the maker, and approved by the FDA, to achieve the broader regulatory goals, such a claim could not proceed.

Id. at 14; see also id. (example that demanding something more or different would be preempted, but not failure to meet what the FDA approved).
There’s other good stuff in Bass, too.  The court rejects the rather ridiculous parsing arguments that we’ve seen with various multi-component devices, holding that the PMA covers all of the device’s components.  Slip op. at 6-7.  More broadly favorable, is the court’s affirmation of the district court’s using judicial notice of FDA documents to establish the fact and scope of the PMA approval on a motion to dismiss.  Id. at 5-6.  The scope of the FDA’s approval is a question of law, and thus a plaintiff’s allegations on this issue need not be treated as true.  Id. at 5-6.
We’re less sanguine about Bass‘ handling of whether Texas common law would allow “negligence per se” based on FDA violations.  The court dodges that main point, and in another stretch of Erie principles, equates cases saying such claims “aren’t preempted” with the recognition of an underlying cause of action.  Bass, slip op. at 17.  Still, the court in Bass didn’t go all the way and hold there was a negligence per se claim, but that the allegations might support “negligence.”  Id. at 17.
Bass closes with a detailed (one of the most detailed we’ve ever seen) specification of what’s in and not in.  Slip op. at 18-23.  Everything that’s left in relates to the manufacturing-related claim predicated on the FDA’s warning letter and recall, whether it’s called “strict liability,” “negligence,” “warranty” or whatever.  All warning/marketing claims are out – preempted – as are any other claims that would impose liability despite compliance with FDA regulations.  See id. at 22 (discussing implied warranty).
Bass isn’t the greatest decision in the world, but it’s not horrible either.  Remember, this is just at the pleading stage.  The plaintiff still has to prove the violation allegations with admissible evidence.  The linchpin to Bass seems to be that the plaintiff pleaded the link between the FDA violation and that plaintiff’s actual injuries.  If, either in Bass or some other case, that allegation is actually baseless (such as a false statement that a recall applied to the plaintiff’s device), such bad-faith pleading would be a situation where Rule 11 and other cost-shifting would be appropriate, TwIqbal is based in large part on preventing unnecessary imposition of cost.