Last week saw the birth of the seven billionth current human on the planet. This week sees us comment on the parallel claim exception to Riegel preemption for what feels like the seven billionth time. It puts us in mind of Nietzsche’s theory of the eternal return, where everything we’ve done we’ll do again an infinite number of times. Really? We’ve got to go through that junior prom again, with all the plaid bell-bottoms and the awful Peter Frampton “tribute” band playing “Show Me the Way” as we fought off the effects of smuggled-in Southern Comfort?
We wish courts would do a better job of showing us the way on the parallel claim exception. Is it possible that the parallel claim exception is poorly conceived and poorly described, thereby prompting plaintiffs to parade various attempts to plead around it, leading to courts issuing rulings on the issue that are inconsistent and opaque? Yes, it is. Some parallel claims decisions have been reasonably coherent; others have blessed complaints resembling mackerels in the moonlight — they shine, they stink. Bausch is an example of the latter, and yet the Seventh Circuit waved it by. We’ll not regale you again with our Why We Hate Bausch litany, though the U.S. Supreme Court’s recent refusal to review it led to a marathon teeth-grinding session here on the West Bank of the Schuylkill.
Can our BFF TwIqbal save us from the craziness? Sometimes yes and sometimes no. Here is how we think the analysis ought to play out:
(1) What exactly is the alleged violation of federal law? Cite the specific regulation and the specific problem with the product.
(2) How exactly does state law make such violation actionable? (And here we will confess our esurient desire to appropriate Judge Posner’s identicalness test from the Turek case we blogged about a couple of weeks ago. Yeah, yeah, it’s a different statute. That being said…. Oh, heck, maybe it’s asking too much for drug-and-device law to make sense.)
(3) How exactly did the alleged infraction cause the plaintiff’s alleged injury?Continue Reading Why Does the Parallel Violation Exception Remind us of Nietzsche and Frampton?

Sometimes repeated litigation concerning a particular product can help establish legal standards applicable to all cases, especially if many people received the product and try to bring suits. Plaintiffs try one theory after another; courts reject most of those theories; and the resultant mosaic of decisions forms a comprehensive picture of which claims are viable

Two recent cases, one good and the other not, have us thinking about the presumption against preemption in the context of “parallel” claims – that would be medical device preemption – and allegations of fraud on the FDA, which could be either.  We think it would be a good idea for defense counsel to review

Just before the new year Medtronic’s litigation team brought home yet another preemption win that bears discussion.  In Ilarraza v. Medtronic, Inc., slip op. (E.D.N.Y. Dec. 28, 2009), the plaintiff took one look at the law of preemption (but only after filing suit); filed an amended complaint that dropped all his prior claims (the