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The Un-Dead on "Parallel Requirements," Preemption, and Punitive Damages

By James M. Beck and Mark Herrmann

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 Of The Parallel Requirements Exception Under Lohr And Riegel," 65 N.Y.U. Ann. Survey of Am. L. 545 (2010).  It's also on Westlaw at 65 NYUANSAL 545.  The article discusses a lot of what we've already said here about parallel violation claims, and preemption:  (a) discussing Lohr, Buckman, Bates, and Riegel on the subject, (b) that parallel violation claims can't just be disguised private attempts to enforce the FDCA without falling afoul of Buckman, since implied preemption can work independently of express preemption (c) to avoid interference with the FDA's prosecutorial discretion, private parallel claims can't be brought where the FDA hasn't acted., (d) warning letters and the like aren't enforcement, and thus don't without more count as parallel claims, (e) negligence per se claims, in addition to being subject to implied Buckman preemption, have a lot of other drawbacks, such as being contrary to the congressional purpose of 21 U.S.C. §337(a), (f) parallel claims aren't parallel if the FDA wouldn't enforce the relevant regulation in the same fashion, and (g) manufacturing claims can't survive without a concrete violation of a specific regulation that applied to the device at issue.

The big advantage of Herrmann's article is that, while you can't cite one of our blog posts in a brief, you can cite a law review article.  The new Herrmann article is worth a read for that reason alone.

But there's more.  The last part of the article (pages 579-83) is a thought-provoking discussion of the "relatively uncharted" intersection between preemption and punitive damages.  The article explores a conflict between punitive damages and 21 U.S.C. §331(f), which deals with civil liability under the FDCA.  Specifically, §331(f) requires certain determinations in assessing civil penalties, which juries don't, and can't, do.  Also, it sets caps on civil penalties ($15,000 for a single violation and no more than $1,000,000 in the aggregate), and precludes them altogether in a number of circumstances - all of which under Due Process mandates receive substantial deference in a punitive context.  Finally, §331(f) provides a "safe harbor" under certain circumstances.  Thus, the Herrmann article concludes:

If a jury assessing punitive damages relating to a state law claim that parallels federal good manufacturing requirements is not required to assess whether there was ?a significant and knowing departure from [those] requirements? or ?a risk to public health,? then the state law damages remedy may impose requirements that go beyond federal requirements, and §333(f)(1)(B)(i)?s ?safe harbor? is nullified.  Furthermore, even if the jury does make those assessments, there is no guarantee that the jury?s determinations will track what the FDA?s decisions would have been.

Id. at 583.  We don't know if we've ever seen punitive damages assessed on an unpreempted parallel claim in a medical device case (at least since these concepts were created), but if we do, now we've got a new argument.

If Mark ever gets tired of his in-house job, we'd be happy to take him on as a blogger again.

Full post as published by Drug and Device Law on April 23, 2010 (boomark / email).