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We’re predictably pleased with yesterday’s Eleventh Circuit opinion in Wolicki-Gables v. Arrow International, Inc., No. 09-14342, slip op. (11th Cir. March 8, 2011).  After all, the defense won, didn’t it?  By the way, a tip of the old cyberhat to Joe Lang, who won it, and Wendy Lumish, who sent it to us – both from Carlton Fields.
We’re particularly pleased because the Eleventh Circuit came squarely down on the side of holding that the Supreme Court actually meant what it said in TwIqbal (take that, Bausch).
W-G involved a Class III PMA device (as usual), a spinal pain pump.  The device – like Gaul – was in three parts, a pump that moved the medication, a catheter that provided access to the spinal cord, and a tube that connected the two.  Somehow the device implanted in the plaintiff became clogged, as revealed by test dye that showed failure to diffuse.  Slip op. at 3.  A physical inspection, however, could find nothing wrong with any of the device’s components.  Slip op. at 4.  The pump was reimplanted with a new tube.  Id.
But of course, something else went wrong – or else there wouldn’t have been a lawsuit.
For one thing, the old tube was returned to the manufacturer, which later disposed of it.  Keep that in mind as our little drama unfolds.
Two weeks later, the plaintiff is back in the hospital with paralysis.  The doctors diagnosed transverse myelitis, but looked for, and didn’t find, any infection.  Slip op. at 5.  But a few days later an infection did turn up, around the incision site for the surgery to inspect the device.  The infection, however, did not involve the device in any way – only the plaintiff’s skin.  Id.  The plaintiff ended up permanently paralyzed.
Being the only product in the vicinity, when plaintiff went looking for somebody to sue, the pump was fingered.  But only barely.  The plaintiff alleged nothing but boilerplate – that the defendant:

(a) fail[ed] to reasonably design the [fill in the blank with the product] in a manner which would have prevented injury to those like [fill in the blank with plaintiff’s name]; (b) fail[ed] to reasonably manufacture the [fill in the blank with the product] in a reasonable manner; [and] (c) fail[ed] to reasonably provide adequate warnings regarding the defective and unreasonably dangerous [fill in the blank with the product], having actual or constructive knowledge of the hazards associated with the product.

Slip op. at 11-12 (quoting complaint).
Before TwIqbal plaintiffs could get away with such dross.  But no longer – especially when preemption also comes into play.  Preemption forced plaintiffs to resort to argue that they had somehow pleaded a “parallel” FDCA violation claim when they plainly had not.
Unlike Bausch the court in W-G took TwIqbal seriously:

[W]e must first consider whether [plaintiffs] have demonstrated that they have alleged a parallel claim.  Plaintiffs cannot simply incant the magic words ‘[Appellees] violated FDA regulations’ in order to avoid preemption.  Parallel claims must be specifically stated in the initial pleadings.  A plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue.  To properly allege parallel claims, the complaint must set forth facts pointing to specific PMA requirements that have been violated.

Slip op. at 11-12 (citations and quotation marks omitted).
Because W-G took TwIqbal seriously, plaintiffs lost.  Their sparse, boilerplate allegations “d[id] not set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged,” so having “failed to allege facts in their complaint demonstrating the presence of the elements of a parallel claim,” plaintiffs’ claims – all of them were preempted.  Slip op. at 13.
Note also that, although the court did not discuss him separately in the legal analysis, the plaintiff also raised claims against a sales representative (Nelson) based upon alleged knowledge of off-label use and sending to the manufacturer the part that was disposed of.  See Slip op. at 6-7.  Thus, the court’s preemption/pleading analysis also applies to claims against sales representatives.
Finally, remember that little factoid about the manufacturer discarding the tube?  Well plaintiffs tried to turn that into some sort of spoliation claim.  They claimed that they were somehow entitled to an “inference” of defect simply because the product had been destroyed.  Slip op. at 14 (citing Worsham v. A.H. Robins Co., 734 F.2d 676 (11th Cir. 1984)).  However, any such inference is dependent upon the plaintiff sufficiently excluding “alternative possible causes” so that a defect is left as the “most probable” cause of injury.  Id.  Their expert was “unable to exclude” possibilities such as “idiosyncratic complication,” “natural bodily rejection,” and “clogging.”   Slip op. at 15.
Bye-bye presumption.
Hello affirmance.