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Why Does the Parallel Violation Exception Remind us of Nietzsche and Frampton?
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?
Thin Pleadings Doom Another Not-So-Parallel Claim
Today is the birthday of Adam West, the great television Batman, so we are pleased to see a court deliver a Bam! Pow! and Socko! to another attempt to escape Riegel preemption via a bogus parallel claim. The case is called DeSabio v. Howmedica Osteonics Corp., 2011 U.S. Dist. LEXIS 103288 (W.D.N.Y. September 13,…
Get rid of parallel violation claims without supporting facts
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…
Preemption, Presumption, And Parallel Claims
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…
Another parallel violation claim is blocked by § 337(a)
We have been saying for a long time that parallel violation claims that avoid preemption under 21 U.S.C. § 360k pursuant to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), may nonetheless be preempted by 21 U.S.C. § 337(a)’s ban on private actions to enforce the FDCA. It took the judiciary a little time…
The Un-Dead on “Parallel Requirements,” Preemption, and Punitive Damages
He may be gone – dead in the blogging sense – but Herrmann continues to provide scholarly commentary about issues we care about from beyond the cyber-grave. Dave Alden, Mark’s former colleague at Jones Day, just sent us a copy of an article the he, Herrmann, and Brad Harrison wrote entitled “The Meaning…
Negligence Per Se Does Not Equal “Parallel”
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…
Riegel At 1 1/2 : What Do We Know Now About Parallel Violation Claims?
Our last preemption-related post was more than three weeks ago, on July 2. Can you believe it? What ever happened to “all preemption, all the time,” as we used to be called?
The Supreme Court decided all of its pending cases, that’s what. Device preemption is pretty much settled, unless Congress upsets the applecart. Drug…
DoJ/FDA Take Positions On §337(a), “Parallel” Requirements Litigation
We’ve been following the long migration of Farm Raised Salmon for some time now. Our prior posts on the California Supreme Court’s decision and on the Supreme Court’s request for the government’s views on the defendants’ certiorari petition are here, here, here, and here, respectively.
While Farm Raised Salmon is a…