Law

Bexis is updating chapter 4 of his book, which includes a thorough discussion of negligence per se.  Negligence per se in the context of the Food, Drug & Cosmetic Act ("FDCA") has taken on increased salience, particularly in preemption cases where courts leave an "out" for parallel claims.  Because there must be a pre-existing state-law tort claim for an FDCA violation claim to be "parallel" to (since the FDCA expressly bars private rights of action), state-law precedent that independently bars FDCA-based negligence per se claims can shut the "parallel claim" door in preemption cases.

There are, of course, the big five:  (1) no negligence per se when it would violate the "intent" of the legislature to preclude private causes of action; (2) no negligence per se for non-statutory violations; (3) no negligence per se that establishes novel duties; (4) no negligence per se where the enactment is too vague to provide a meaningful replacement to the "reasonable man" standard; and (5) no negligence per se for mere failure to have a required permit/license (which we've covered at length before), but did you know:

In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the FDCA) are prohibited.  St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529, 534 & n.14 (Ky. 2011); T & M Jewelry, Inc. v. Hicks, 189 S.W.3d 526, 530 (Ky. 2006).

In Louisiana, Kansas and Ohio, comprehensive tort reform statutes have abrogated negligence per se in product liabilty cases.  Mattos v. Eli Lilly & Co., 2012 WL 1893551, at *3 (D. Kan. May 23, 2012); Tolliver v. Bristol-Myers Squibb Co., 2012 WL 3074538, at *2 (N.D. Ohio July 30, 2012); Boroff v. ALZA Corp., 685 F. Supp.2d 704, 711 (N.D. Ohio 2010) (applying Ohio law); King v. Bayer Pharmaceuticals Corp., 2009 WL 2135223, at *3-4 (W.D. La. July 13, 2009); In re Air Bag Products Liability Litigation, 7 F. Supp.2d 792, 800 (E.D. La. 1998)

. In Montana, you can't have negligence per se at all without an express statutory private right of action. 
Doyle v. Clark, 254 P.3d 570, 577 (Mont. 2011).

In South Carolina, you can't have negligence per se at all without at least an implied statutory private right of action.  Salley v. Heartland-Charleston, LLC, 2011 WL 2728051, at *3 (D.S.C. July 12, 2011) (applying Court v. Ash factors).

  That's six states (two by their supreme courts) where, if we can't kill purported parallel FDCA-based claims on the front end with implied preemption under Buckman, we can try killing them on the back end as simply not stating a cause of action under existing state law (and if we're in federal court, we can add the Erie point about not reaching for novel, expansive state-law liability) - all by relying on state-specific peculiarities of negligence per se law.  Most of these states (except Ohio) aren't particularly large, but these quirks are things we'd definitely want to know if we happened to have a case originating there.

State-law specific quirks - that's one reason why folks like us, who practice in "big firms," need to have local counsel.  So we'd like to hear from our "local counsel" readers - anybody out there know of any other state-specific negligence per se peculiarities that can defeat purported "parallel" FDCA-based claims?

As always, we'll give name and firm credit to our readers.

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Posted By Bexis to Drug and Device Law at 1/30/2013 04:47:00 PM

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