Our days of the week are mostly named based on Norse mythology, but our months are firmly Roman. May is named after the deity Maia, whose Roman version was honored for her role in the growth of plants. Her cousin Juno, the queen of the Roman gods, gave us the name for June. In their rituals, the Romans offered up a variety of burnt animals depending on the time of year, deity being honored, and purpose of the offering. Maia might get a pregnant sow consigned to flames, while Juno might get a bull. The growth of greenery in our area and our more controlled use of flames over the last month made us think of these rituals. (Not really, but play along.) The Romans did not eat their sacrifices. Nor did they sacrifice turkeys. They definitely did not slow cook a turkey over smoking embers.
So, what is with the convoluted intro here? Well, the day after last Thanksgiving, we wrote a post that predictably talked about leftover turkey. The case, Cantwell, involved the attempt to plead a claim under Oklahoma law for per se negligence based on an alleged violation of FDA law or regulation in connection with the alleged off-label use of the PMA device at issue. The turkey was the Oklahoma Supreme Court's decision in Howard that endorsed such a claim in the abstract. When the Cantwell court held that plaintiffs had not come close to pleading the elements of such a claim, it gave the plaintiffs a chance to cure with an amended complaint. We predicted "plaintiffs will try again. If they do, then we would not be surprised if Justice Gorsuch's former colleagues on the Tenth Circuit get another chance to weigh in on express preemption with a re-heated version of Howard." About six months later, plaintiffs tried again and we are back with Cantwell and its fowl history. Cantwell v. De La Garza, No. CIV-18-272-D, 2019 WL 2166541 (W.D. Okla. May 17, 2019).
Plaintiffs' amended complaint re-urged constructive fraud and negligence per se with minor changes and added claims for lack of informed consent and breach of implied warranty. Constructive fraud fell for the same reasons it did before, the manufacturer had no duty to obtain informed consent with a prescription medical device, and plaintiff failed to alleged facts establishing an implied warranty was made.
That leaves us with the re-packaged negligence per se claim. Anticipating the express preemption issue that had not been addressed as to the prior complaint, plaintiffs argued that fifteen paragraphs of the current complaint "are very clear with respect to the protection provided to a consumer of a medical device and the parallel state law enactments applicable to this cause of action." Id. at *2 (emphasis added). Those paragraphs now included references to the Oklahoma Public Health Code, including its provisions prohibiting the adulteration and/or misbranding of drugs and devices. Id. & n.4. They also alleged that the device was designed and marketed for a specific use different than how it was approved and labeled, citing parts of the FDCA and unspecified "parallel state laws." Id.
Regarding Ulrich's conduct in relation to these statutes, Plaintiff alleges only that "Ulrich's violations during FDA's premarket approval process and subsequent misrepresentation of its product in advertisements and to its patients constitutes [sic] violations of the abovementioned Federal and State laws, regulations and statutes."
Id. We threw that in a block quote mostly to point out that a court calling you out with a "[sic]" is often not a favorable sign on how it will rule.
While Plaintiffs were required to identify the particular statute or regulation violated to allow for evaluation of express preemption, "federal statues cited in the Amended Complaint encompass multiple subject areas and broad categories of conduct (21 U.S.C. § 331) and mandate the process for premarket approval of certain medical devices (21 U.S.C. § 360e)." Id. Plaintiffs also argued that the manufacturer "manipulated the preapproval process," while disclaiming that she was pursuing a claim based on fraud on FDA. Id. Thus, the court could not identify from the amended complaint the statute or regulation alleged breached by the alleged misconduct of "designing and marketing its device for an off-label use." Id. at *3. In attempting to avoid express preemption under the FDCA and implied preemption under Buckman—they stated "federal law does not supply any elements of the claim" and disclaimed "attempt[ing] to enforce any FDA regulation"—plaintiffs were left with nothing supporting a "plausible claim of negligence per se." Id.
Thus, the court smoked plaintiffs' claims against the manufacturer and dismissed them with prejudice. Preemption, while providing the indirect heat here, was not directly decided. So, while we would like to claim prescience in November's augury, it does not look like that issue will be before the Tenth Circuit should plaintiffs pursue a bird-brained appeal.
This article is presented for informational purposes only and is not intended to constitute legal advice.
