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.Continue Reading Bass Riffs