Like a bad penny, this Heisner v. Genzyme complaint keeps turning up, getting dismissed for lack of facts, and coming back again in yet another iteration.  Now at the “third amended” stage, it’s been dismissed again.  See Heisner v. Genzyme Corp., No. 08-C-593, slip op. (N.D. Ill. March 8, 2010).  As you’ll see from our device preemption scorecard, previous versions were dismissed at Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008) (plaintiff didn’t pleas any parallel claims), and Heisner v. Genzyme Corp., 2009 WL 1210633 (N.D. Ill. April 30, 2009) (negligence per se claims weren’t parallel).  Heisner has now been around for some two years and the plaintiffs haven’t mustered a decent complaint yet.

Strike three and you’re out?  Yes.  This time the court dismissed the complaint with prejudice.  Slip op. at 8.

Anyway, the latest decision, which we’ll call “Heisner III,” found essentially more of the same.  Each time plaintiff gets told to go back to the drawing board, he comes back with more words and less (or at least no more) substance.  There doesn’t seem to be any way around preemption in this case, as much as plaintiff has tried.  You can’t have a “parallel” claim that isn’t really parallel – or as the court puts it, “state and federal requirements are not equivalent if a manufacturer could be held liable under state law while complying with federal requirements.”  Slip op. at 5 (citation omitted).

This time the plaintiff tried to equate the FDA’s CBE warning update regulations with a common law claim for post-sale duty to warn.  But that didn’t fare any better (even after plaintiff belated discovered that the CBE regulation for devices was different than the one for drugs), because the CBE regulation is voluntary, whereas the tort claim would make it mandatory.  Slip op. at 5-6.

Everything else in the plaintiff’s, longer complaint remained too vague and devoid of facts. “Plaintiff utilizes more words, but verbosity cannot substitute for factual allegations.”  Slip op. at 7.

A claimed failure to file adverse reaction reports didn’t constitute a product defect.  Slip op. at 6 (“failure to report adverse events to the FDA may violate the FDCA, but does not constitute a product “condition” or defect”).  Negligence per se claims still couldn’t possibly be causal, since they postdated the alleged injury.  Id.

We thank another of our anonymous (by request) readers for passing Heisner III along.