Cantwell et al v. De La Garza et al

Filing 57

ORDER granting 52 Ulrich Medical USA's Motion to Dismiss Amended Complaint. IT IS FURTHER ORDERED that the remaining parties shall show cause within 14 days from the date of this Order why the case should not be remanded to the District Court of Oklahoma County, Oklahoma. Signed by Honorable Timothy D. DeGiusti on 5/17/2019. (mb)

IN THE UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF OKLAHOMA
MARY A. CANTWELL, et al.,
Plaintiffs,
v.
SCOTT M. DE LA GARZA, M.D.,
et al.,
Defendants.

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Case No. CIV-18-272-D

ORDER
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,

1

The Motion does not expressly move for dismissal under these rules but renews
arguments raised in a prior motion [Doc. No. 28], which was granted by Order of November 13,
2018 [Doc. No. 45]. The instant Motion challenges whether Plaintiffs’ amended pleading cures
the prior deficiencies, and whether newly-asserted theories of recovery are sufficiently pleaded.
The reader’s familiarity with the November 13 Order is assumed.
2

Plaintiff William Cantwell claims a loss of consortium based on injuries suffered by his
wife. The parties agree Mr. Cantwell asserts derivative claims that depend on the sufficiency of
Mrs. Cantwell’s claims. See Def.’s Mot. at 14; Pls.’ Resp. Br. at 7 n.1 Thus, the Court discusses
only the primary claims, and references in this Order to “Plaintiff” mean Mrs. Cantwell.

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.
Discussion
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.

2

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

3

The Court previously found that Plaintiffs failed to plead a plausible claim of conspiracy
to commit fraud. See Order at 7-8.
3

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.
4

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 offlabel 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 Informed Consent
Plaintiff makes no effective response to Ulrich’s assertion that it had no duty to

obtain her informed consent to the procedure and did not breach any such duty. She argues
that “[t]he combined actions of Ulrich and Dr. De La Garza resulted in Mrs. Cantwell[’s]
uninformed consent to the improper use of the Ulrich device” and explains that the claim

4

Plaintiff cites state statutes that prohibit generally the manufacture and sale of adulterated
or misbranded drugs and devices, and false advertising. See Okla. Stat. tit. 63, §§ 1-1402(a)-(d)
1-1408, 1-1409.

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against Ulrich is based on the “conspiratorial nature of the relationship between Dr. De La
Garza and Ulrich.” See Pls.’ Resp. Br. at 11. Plaintiff cites no legal authority for the
existence of such a combined duty; the Court has previously found that Plaintiffs’ have
failed to plead a civil conspiracy claim. See Order at 7-8. Therefore, the Court finds that
Plaintiff’s claim against Ulrich based on an alleged lack of informed consent fails as a
matter of law.
4.

Breach of Implied Warranty
Plaintiff has added to the Amended Complaint allegations that “[p]rior to the

surgical procedure, Ulrich . . . impliedly warranted to Plaintiffs that the [implanted device]
was fit for the use for which it was intended” and that unspecified “actions” constitute “a
breach of implied warranty, including but not limited to the warranty of implied fitness.”
See Am. Compl. ¶¶ 44, 45. Ulrich asserts that these conclusory allegations fail to identify
what warranty was made, and fail to state a plausible breach of warranty claim. Ulrich also
asserts that Plaintiff’s only remedy for a breach of warranty under Oklahoma law is
provided by the Uniform Commercial Code (UCC), but the surgical procedure at issue did
not constitute a sale of goods and so was not governed by the UCC. See Def.’s Mot. at 7.
Plaintiff responds, without any citation of legal authority, that the UCC should apply
where “the implantation of the device was a critical component of the surgery” and “that
the ‘labor or service’ required to install, implant or replace any manufactured part should
[not] outweigh responsibility for the sale of the device or part.” See Pls.’ Resp. Br. at 10.
Regarding the nature of the warranty allegedly given by Ulrich, Plaintiff refers to “the
warranty of implied fitness for use and fitness for purpose.” Id. She also argues that “the
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device installed in Mrs. Cantwell was not fit for the purposes of the surgery because the
device failed to comply with the numerous federal statutes, regulations, and laws
specifically cited in the complaint.” Id.
Setting aside whether the UCC applies to an alleged sale of Ulrich’s device to
Plaintiff, Oklahoma law is clear that to prove a breach of warranty claim, Plaintiff must
show: (1) “the existence of the warranty;” (2) “the warranty was broken;” and (3) “the
breach was the proximate cause of the loss sustained.” See Am. Fertilizer Specialists, Inc.
v. Wood, 635 P.2d 592, 595 (Okla. 1981) (footnote omitted) (citing U.C.C. § 2-314
cmt. 13). Although unclear from Plaintiff’s argument, it appears that the implied warranty
at issue is one of fitness for a particular purpose. See id. at 595 & n.8 (implied warranty
of merchantability requires that goods operate for their ordinary purpose; implied warranty
of fitness for a particular purpose “envisages a specific use by the buyer which is peculiar
to the nature of his business”) (quoting U.C.C. § 2-315 cmt. 2); see Okla. Stat. tit. 12A,
§§ 2-314(2)(c); 2-315.
Upon consideration, the Court finds that Plaintiff fails to allege sufficient facts to
establish the existence of an implied warranty of fitness for a particular purpose with
respect to a sale of Ulrich’s device to Plaintiff. Thus, the Amended Complaint necessarily
fails to show that the warranty was breached or that the breach was the proximate cause of
Plaintiff’s injury. Therefore, the Court finds that Plaintiff has failed to state a plausible
breach of warranty claim.

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Conclusion
For these reasons, the Court finds that Plaintiffs have failed to state any claim
against Ulrich on which relief can be granted. 5 Further, because Plaintiffs indicate that
they wish to stand on the Amended Complaint, the Court finds that further amendment of
Plaintiffs’ pleading would be futile and should not be permitted. 6
Supplemental Jurisdiction
This case was removed to federal court based on federal question jurisdiction under
28 U.S.C. § 1331 and issues arising under the FDCA. See Notice of Removal [Doc. No. 1],
¶ 3. Having determined that Plaintiffs do not assert a negligence claim based on a violation
of the FDCA, the Court questions whether it should exercise supplemental jurisdiction over
this case. Tenth Circuit law is clear “that if federal claims are dismissed before trial,
leaving only issues of state law, the federal court should decline the exercise of jurisdiction
by dismissing the case without prejudice” or, in a removed case, remanding the case to
state court. See Brooks v. Gaenzle, 614 F.3d 1213, 1229-30 (10th Cir. 2010) (internal
quotation omitted); Bauchman v. West High Sch., 132 F.3d 542, 549-50 (10th Cir. 1997)

5

As previously noted, the parties agree that if Mrs. Cantwell fails to state a claim, the
Amended Complaint also fails to state a claim on which Mr. Cantwell can obtain relief. See supra
note 1.
6

Plaintiffs state they “object to defendant’s request that Plaintiffs be required to submit a
second Amended Complaint repleading any cause of action” and the case should “proceed to the
discovery stage of the proceedings.” See Pls.’ Resp. Br. at 7 n.1. But the federal pleading standard
of Rule 8 “does not unlock the doors of discovery for a plaintiff armed with nothing more than
conclusions.” See Ashcroft v. Iqbal, 556 U.S. 662, 678-79 (2009). Also, a district court does not
err by failing to authorize a plaintiff to amend a deficient complaint if the plaintiff fails to move
for leave to amend. See Garman v. Campbell Cty. Sch. Dist. No. 1, 630 F.3d 977, 986 (10th Cir.
2010); Burnett v. Mortg. Elec. Registration Sys., Inc., 706 F.3d 1231, 1238 n.4 (10th Cir. 2013).
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(dismissal); Roe v. Cheyenne Mountain Conference Resort, Inc., 124 F.3d 1221, 1237 (10th
Cir. 1997) (remand); see also United States v. Botefuhr, 309 F.3d 1263, 1273-74 (10th Cir.
2002); 28 U.S.C. § 1367(c)(3).
IT IS THEREFORE ORDERED that Defendant Ulrich Medical USA, Inc.’s Motion
to Dismiss Plaintiffs’ Amended Complaint [Doc. No. 52] is GRANTED. Plaintiffs’ action
against Defendant Ulrich Medical USA, Inc. is dismissed with prejudice.
IT IS FURTHER ORDERED that the remaining parties shall show cause within
14 days from the date of this Order why the case should not be remanded to the District
Court of Oklahoma County, Oklahoma.
IT IS SO ORDERED this 17th day of May, 2019.

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