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Cantwell v. De La Garza

United States District Court, W.D. Oklahoma

May 17, 2019

MARY A. CANTWELL, et al., Plaintiffs,
SCOTT M. DE LA GARZA, M.D., et al., Defendants.



         Before the Court is Defendant Ulrich Medical USA, Inc.'s Motion to Dismiss Plaintiffs' First Amended Complaint [Doc. No. 52], filed pursuant to Fed.R.Civ.P. 12(b)(6) and 9(b).[1] Plaintiffs have filed a timely response [Doc. No. 55], and the movant has replied [Doc. No. 56]. Upon consideration, the Court rules on the Motion as follows.

         Factual and Procedural Background

         Plaintiff Mary Cantwell claims she suffered personal injuries as a result of medical malpractice by Defendant Scott De La Garza, M.D.[2] Dr. De La Garza is an orthopedic surgeon who implanted in Plaintiff's cervical spine a medical device designed, manufactured, and marketed by Defendant Ulrich Medical USA, Inc. (“Ulrich”). Plaintiff alleges the device was not approved for use in the cervical spine by the United States Food and Drug Administration (“FDA”) and the unapproved nature of the use, together with an unspecified financial relationship between Defendants and risks posed by the unapproved use, were not disclosed to her. Plaintiff reasserts in the Amended Complaint [Doc. No. 46] common law tort theories of recovery against Ulrich that were not sufficiently pleaded in her original complaint - fraudulent concealment or constructive fraud, and negligence per se. See 11/13/18 Order [Doc. No. 45] (hereafter “Order”) at 6-7, 9-11. She adds two new theories of Ulrich's liability - lack of informed consent and breach of an implied warranty. Because the Court's prior Order states the applicable standards of decision, the Court proceeds directly to the merits of Ulrich's renewed Motion.


         1. Constructive Fraud

         Plaintiff argues in general terms that the Amended Complaint adequately states a constructive fraud claim because Ulrich has sufficient notice of the claim, citing “bullet points” in Ulrich's brief summarizing the factual allegations on which the fraud claim is based. See Pls.' Resp. Br. at 8; Mot. Dismiss at 4-5. Plaintiff contends the alleged facts that Ulrich's medical device was implanted “for an undisclosed, experimental, off-label purpose by Dr. De La Garza acting in concert with Ulrich for the financial gain of each of them” and that “[a]n employee of Ulrich was present for the surgery” are sufficient to satisfy the specificity requirement of Rule 9(b). See Pls.' Resp. Br. at 8.

         For the reasons previously stated in the November 13 Order, the Court disagrees with Plaintiff's position and finds that she has failed to cure the deficiencies in her fraud claim. Plaintiff “do[es] not identify any facts that would establish Ulrich owed Mrs. Cantwell a duty of disclosure or withheld information from her.” See Order at 7. Nor does Plaintiff explain how alleged “collusion between the parties” (Pls.' Resp. Br. at 7) could satisfy the requirement of showing Ulrich's involvement in fraudulent activity.[3]Therefore, the Court finds that Plaintiff has failed to state a fraud claim against Ulrich.

         2. Negligence Per Se

         The deficiency previously found in Plaintiff's pleading regarding negligence per se was the failure to identify “the statute or regulation allegedly violated, and thus the duty allegedly breached, by the defendant's conduct.” See Order at 10. The Court rejected Plaintiff's position that she “need not plead the violation of a particular statute or regulation to state a claim of negligence per se.” Id. Following the amendment of her pleading, Plaintiff's argument to show that the Amended Complaint sufficiently states a negligence per se claim consists of a single sentence in her brief: “The paragraphs of the Amended Complaint (§§ 24-38) 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.” See Pls.' Resp. Br. at 12.

         An examination of the Amended Complaint reveals that, like the original pleading, Plaintiff refers generally to federal statutes requiring FDA approval of new medical devices, citing “[t]he Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., via the Medical Devices Amendments of 1976 (MDA). 21 U.S.C. § 360c et seq.” See Am. Compl., ¶ 24. Plaintiff adds citations to “parallel” statues in Article 14 of the Oklahoma Public Health Code, Okla. Stat. tit. 63, § 1-1401 et seq., and identifies specifically “63 O.S. § 1-1402(a)-(d), 63 O.S. § 1-1408, and 63 O.S. § 1-1409.” See Am. Compl., ¶ 25. She also adds allegations that Ulrich designed its device “for use in cervical spines despite Ulrich's representations to the FDA during the premarket approval process pursuant to 21 U.S.C. § 360e, ” and marketed the device “for cervical indications, despite the labeling of the product and despite their [sic] contrary representations to the FDA in the premarket approval process, all in violation of 21 U.S.C. § 331 and parallel state laws, statutes and regulations.” See Am. Compl., ¶¶ 26, 29. 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. ¶ 32.

         Although Plaintiff has now included in the Amended Complaint citations to federal and state statutes that allegedly were violated, the Court finds that Plaintiff has failed to cure the deficiency in her pleading. The Court previously ruled that a claim of negligence per se, particularly in the context of federal regulation of medical devices, requires “the identification of a particular statute or regulation that provides the duty allegedly violated” so Ulrich receives sufficient notice of the conduct at issue to permit the assertion of the federal preemption defense provided by the FDCA, if appropriate. See Order at 10-11. The 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).[4] Plaintiff's factual allegations seem to focus on Ulrich's conduct in the FDA approval process, and she argues in her brief that “Ulrich manipulated the FDA's preapproval process.” See Pls.' Resp. Br. at 13. But she disclaims any intention of bringing a “fraud on the FDA claim.” Id.

         Upon consideration of Plaintiff's arguments, the Court is left to wonder what duty of care established by any statute or regulation was allegedly breached by the conduct of which Plaintiff complains, namely, Ulrich's designing and marketing its device for an off-label use. The statutory citations added to the Amended Complaint provide no useful assistance. Further, Plaintiff expressly argues that she is not “attempt[ing] to enforce any FDA regulation” and “federal law does not supply any elements of the claim.” Id. at 14. Under these circumstances, the Court finds that Plaintiff has failed to state a plausible claim of negligence per se.

         3. Lack of ...

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