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Bexis has just submitted revisions and updates to Chapter 4 of his treatise, Drug and Medical Device Product Liability Deskbook.  Chapter 4 is “The Federal Framework,” and one of the topics it covers is the use of claimed FDCA violations as the basis for state-law claims, including, most prominently, negligence per se.  Bexis addresses in depth a number of non-FDCA-based common-law defenses to negligence per se: (1) consistency with legislative intent; (2) the force-of-law requirement; (3) prohibition on creation of novel tort duties; (4) inapplicability of licensing statutes; (5) requirement of a specific standard; and (6) causation issues.  That means Bexis has been reading a lot (hundreds) of recent non-FDCA negligence per se cases, involving everything from traffic accidents to firearms to data breaches.

These updates will be available online, for those who buy the book, in a couple of months.

One thing that Bexis’ chapter 4 does not go into is general pleading of negligence per se claims.  But TwIqbal, and analogous state-law, challenges to negligence per se pleading are common and there are a lot of opinions on this topic out there in just about every jurisdiction.  Because pleading negligence per se has implications for pleading FDCA-based negligence per se, Bexis saved a couple of these non-drug/device pleading cases that he ran across.

The first one is Cenatiempo v. Bank of America, N.A., 219 A.3d 767 (Conn. 2019), in which the Connecticut Supreme Court held that the plaintiff’s negligence per se claim involving alleged mortgage-related violations against a lending bank failed for lack of specificity.  Among other things, the defendants challenged the sufficiency of the plaintiffs’ pleading because “their complaint . . . did not allege the violation of any specific statute by the defendant that would support a negligence per se claim.”  Id. at 814.  The plaintiffs responded, claiming that their allegation that the defendant “breached a duty imposed by federal regulations and state statutes” was sufficient.  Id.  The court agreed with the defendants that a negligence per se allegation must “identify particular legal provisions that the defendant violated.”  Id. at 815.

Even in their opposition to the defendant’s motion to strike, on which the plaintiffs rely, they did not identify which statutory provisions established the standard of care that the defendant violated.  The plaintiffs were required to plead their claim of negligence per se with greater specificity.

Id. (citation and footnote omitted).  Vague allegations that the defendants violated some unspecified part of a statute, or unspecified statutes were also insufficient to state a negligence per se claim:

The plaintiffs’ simple assertion in their opposition to the defendant’s motion to strike that the defendant violated [a federal real estate statute] and this state’s foreclosure mediation statutes was not sufficient to put the defendant and the trial court on notice that they were advancing a theory of negligence per se.


The second case is federal, Collins-Myers v. Triangle Trucking, Inc., 2020 WL 1445703 (E.D. Mo. March 25, 2020), decided under TwIqbal.  Again, it has nothing to do with drugs and devices and is simply representative of federal courts’ attitudes to the pleading of negligence per se generally.  Collins-Myers involved an auto accident, and the defendants moved to strike the plaintiff’s negligence per se claim for being too vague about the purported violation to state a claim:

The legal issue turns on whether a plaintiff must allege a violation of a specific statute or regulation to state a negligence per se claim.  [Plaintiff] asserts she does not have to plead a specific statute or regulation but instead that she need allege only a general reference to the applicable federal regulations and enough underlying factual predicate to support a claim.

Id. at *4.

Again, the court did not agree.  Plaintiff merely alleged that the defendant “violated multiple regulations issued by [a federal agency] in the U.S. Code of Federal Regulations,” but “does not identify a specific statute or regulation she believes Defendants violated.”  Id. at *5.  That wasn’t near enough to satisfy TwIqbal:

Without identification of a specific statute or regulation, neither Defendants, nor the Court, can determine if the statute at issue is one on which negligence per se may be based, if the class of persons intended to be protected by the statute includes [plaintiff], or if the injury is one of the nature the statute was designed to prevent.  Consequently, [plaintiff] fails to state a claim for negligence per se.


We are offering these two cases as representative of a lot more precedent involving the application of general pleading standards, both state and federal, applicable to the pleading of negligence per se We think these cases provide another useful source of precedent relevant to the vague versus specific pleading battle that commonly arises in so-called “parallel violation claims” in medical device preemption cases.  In the preemption context, some courts have held that plaintiffs don’t have to plead any specifics about the violation they allege – the decision in Bausch v. Stryker Corp., 630 F.3d 546, 555 (7th Cir. 2010), being the primary example. Such courts do not have as much of a clean slate to allow vague pleadings of statutory violations as they might think.

The specificity of pleading statutory and/or regulatory violations is exactly the same issue presented in the general negligence per se cases – except that with the preemption overlay removed. While some courts are, unfortunately, openly hostile to preemption, in practically all the non-preemption negligence per se cases we’ve seen, courts require specific pleading of at least the exact provisions of the statute that are violated.

So we recommend to our defense colleagues that, in asserting specificity-based pleading challenges to supposedly parallel claims, that they search for and rely on these general negligence per se cases from the pertinent jurisdictions. Even if precedent supporting specificity in the pleading of parallel violation claims isn’t precisely available, it’s quite likely that defendants can get at least half-way there, with non-preemption cases imposing similar specificity requirements in the pleading of other violation-based causes of action. These require, at least, specific pleading of what statutes or regulations a plaintiff claims that the defendant violated.

Half a pleading loaf is still better than none at all.