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Recently, within the course of a couple of weeks, two different courts reached the same conclusion – that a plaintiff’s negligence per se claims, largely based on purported violations of the Food, Drug & Cosmetic Act (“FDCA”), failed to state a claim.  See Disarro v. Ezricare, LLC, 2023 WL 6619445 (M.D. Fla. Oct. 11, 2023), and Alcozar v. Orthopedic & Sports Medical Center, ___ N.E.3d ___, 2023 WL 6302337 (Ind. App. Sept. 28, 2023).  Another thing that these two opinions share is that neither of them relied on federal preemption in disposing of the FDCA-related negligence per se claims.

These decisions, and the way they were reached, raise nostalgic feelings in those of us bloggers who are Orthopedic Bone Screw veterans.  That’s exactly how we attacked – and usually beat – FDCA-based negligence per se claims before we won the preemption ruling in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) (a Bone Screw case).  Indeed, one of Bexis’ very first blogposts, back in 2007, was a comprehensive review of non-preemption defenses to negligence per se.

The very first non-preemption defense to negligence per se mentioned in Bexis’ 2007 post was legislative intent.  That was the ground on which Disarro was decided.  The negligence per se allegations in Disarro claimed violations of FDCA provisions “intended to ensure the purity and safety of [defendant’s] products.”  2023 WL 6619445, at *1. 

Disarro “agree[d] with Defendants” that the negligence per se claims “must be dismissed because there is no private right of action under the FDCA”:

In Florida, legislative intent should be the primary factor considered by a court in determining whether a cause of action exists when a statute does not expressly provide for one. . . .   The FDCA does not expressly provide a private cause of action.  Legislative intent, as evidenced by the language and structure of the Act, does not support the conclusion that the Florida Drug and Cosmetic Act impliedly provides a private cause of action.  The FDCA expressly prohibits private claims for violations of that statute, 21 U.S.C. §337(a), strongly evidencing a legislative intent not to create a private cause of action.  Under Florida law, therefore, Plaintiff cannot use a negligence per se claim to create a private cause of action for Defendant’s alleged violations of the FDCA.”

Id. at *1-2 (citations and quotation marks omitted).  The primary citation omitted, Blinn v. Smith & Nephew Richards, Inc., 55 F. Supp. 2d 1353, 1361 (M.D. Fla. 1999), was a Bone Screw case.  Because of the legislative intent embodied in the absence of any private FDCA cause of action, the negligence claims were dismissed.  2023 WL 6619445, at *2.

The second recent decision, Alcozar, exemplifies another frequent problem with FDCA-based negligence per se.  Plaintiffs constantly seek to create FDCA violations that do not exist, often through bizarre interpretations of FDA regulations that the FDA has never followed.  Alcozar, like Disarro, involved claims relating to drug impurities, what the FDA calls “adulteration.”  In Alcozar, the contamination being alleged arose from the notorious NECC compounded drug incident – yes, the case had been around for over a decade in one incarnation or another.  2023 WL 6302337, at *1-2.  The biggest problem for the dozens of plaintiffs in the consolidated Alcozar appeal was finding a deep pocket, since the truly responsible party, the drug compounder, was long since bankrupt.  Thus, the plaintiffs in Alcozar were now suing a variety of clinics and health care providers.

Plaintiffs in Alcozar asserted negligence per se claims based in alleged FDCA violations, as well as violations of the largely parallel Indiana “little FDCA” statute.  Id. at *1.  Unfortunately for them, the enactments they claimed were violated did not apply to this set of defendants.  “Put simply, [the statutory] labeling requirements do not apply to the actions of Defendants in this case.”  Alcozar, 2023 WL 6302337, at *5.  Applying regulations intended for manufacturers (or, here, compounders) instead to health care providers would have made a mockery of the FDA’s regulatory scheme.

Plaintiffs are asking us to apply a requirement from a completely different scenario to one in which it makes no sense.  It is, of course, true that had [the compounder] been administering the [drug] to Plaintiffs instead of Defendants, Defendants would have had to issue prescriptions to [the compounder] with a specific patient’s name, but that never occurred.  Plaintiffs point to no FDCA requirement that such information be included in an order for medicine to be delivered to the doctor who ordered it.

Id.  Moreover, “it would be nonsensical to require directions for patient use for a drug that is injected into the patient by a doctor in a clinical setting.”  Id.  Plaintiffs’ reliance on FDCA dispensing regulations similarly failed, because they had:

no relevance to what occurred in this case:  no [drug] was “dispensed” by anyone − it was administered by Defendants.  Consequently, the requirements for dispensing drugs to a patient did not have to be met in this case.

Id. at *6.

The provisions of the Indiana state statute plaintiffs claimed could support negligence per se were similarly far afield.  Id. at *6-7.  Further, because the regulations were irrelevant to these defendants, none of the purported violations – assuming that they all occurred – could possibly have resulted in harm to the plaintiffs, since the contamination that was the source of their injury had already been introduced upstream by the bankrupt compounder.

None of these provisions, whatever their purpose or utility, have any connection whatsoever with the undisputed cause of the injuries in this case − contaminated [drugs].  Had Defendants done any − or all − of the things that Plaintiffs argue they were required to do, it would have changed nothing, as none of the alleged requirements have anything to do with the compounding of the [drug] or its handling.

Id. at *4.  Thus, the negligence per se claims in Alcozar failed because, depending on how one views the opinion’s holdings, plaintiffs proved no violation (since the regulations were inapplicable to these defendants), or because none of the purported violations were causal.

Disorra and Alcozar are reminders that, with FDCA-based negligence per se claims, in most states there is no reason for a defendant to put all of its eggs in the Buckman basket.  Most such claims also fail for independent state-law grounds.  Defendants just have to familiarize themselves with what works in any particular state.  Bexis’ 2007 post, though dated, is a good place to begin that familiarization.