Elowson v. Alphatec Spine Incorporated et al

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WO
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
Lisa Elowson,
Plaintiff,
v.
Alphatec Spine Incorporated, et al.,
Defendants.
No. CV-25-00561-PHX-DJH
ORDER
Defendant Alphatec Spine Incorporated (“Defendant”) filed a Motion to Dismiss
Plaintiff’s Complaint under Fed. R. Civ. P. 12(b)(6). (Doc. 16).1 Thereafter, Plaintiff Lisa
Elowson (“Plaintiff”) filed a Response in Opposition (Doc. 22), and Defendant filed a
Reply. (Doc. 23).
I. Background
Defendant designs and manufactures products used in surgical procedures on the
spine. (Doc. 7 at ¶ 9). Plaintiff alleges, generally, that Defendant’s medical device was
surgically implanted in her spine, but, due to the product’s defects, her spine did not heal
properly, causing her “harm, pain, and suffering.” (Id. at ¶ 1).
After experiencing pain in her back from a slip and fall in April of 2019, Plaintiff
visited her primary care physician, who ultimately referred her to Barrow Neurological
Brain and Spine. (Id. at ¶¶ 13, 15–18). On June 12, 2019, a CT scan was performed on
1 Defendant seeks dismissal of the entire Amended Complaint but only challenges two of
Plaintiff’s claims in the Amended Complaint. (See generally id.). The Motion therefore
only seeks partial dismissal of the Amended Complaint.
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Plaintiff’s lumbar spine. (Id. at ¶ 19). The scan revealed a “meningioma tumor spanning
from [her] L2 through L5 vertebrae[.]” (Id. at ¶ 20). The following month, Plaintiff
underwent “a complex surgery involving multiple procedures” to remove the tumor. (Id.
at ¶ 21).
During the surgery, “a spinal fixation procedure was performed to stabilize
Plaintiff’s spine.” (Id. at ¶ 22). This procedure employed Defendant’s “Arsenal Spinal
Fixation System.” (Id.) Initially, “Defendant’s pedicle screws were implanted on the right
side at the L2, L3, L4, and L5 levels and on the left side at the L2 and L5 levels,” then the
screws were connected on either side with rods. (Id.) Following laminectomy and
facetectomy procedures, Plaintiff’s tumor was excised. (Id. at ¶¶ 23–25).
In April 2024, Plaintiff began experiencing severe back pain in her lumbar region,
and an X-ray revealed that Defendant’s pedicle screw at L4 had broken prior to fusion. (Id.
at ¶ 27). An MRI confirmed that one or more of Defendant’s pedicle screws had failed.
(Id. at ¶ 28).
As a result of the product failures, Plaintiff alleges that she continues to suffer
consequences, such as permanent bodily injury, pain and suffering, and disability and
impairment. (Id. at ¶ 39). She has now brought design defect, negligence per se, and
breach of the implied warranty of merchantability claims against Defendant.
II. Standard of Review
A motion to dismiss under Rule 12(b)(6) tests the legal sufficiency of a claim.
Cook v. Brewer, 637 F.3d 1002, 1004 (9th Cir. 2011). Complaints must make a short and
plain statement showing that the pleader is entitled to relief for its claims.
Fed. R. Civ. P. 8(a)(2). This standard does not require “‘detailed factual allegations,’ but
it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation.”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S.
544, 555 (2007)). There must be “more than a sheer possibility that a defendant has acted
unlawfully.” Id. A plaintiff must allege facts sufficient to “raise a right to relief above the
speculative level.” Twombly, 550 U.S. at 555. A complaint must “state a claim to relief
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that is plausible on its face.” Id. at 570. “A claim has facial plausibility when the plaintiff
pleads factual content that allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. “Determining
whether a complaint states a plausible claim for relief will . . . be a context-specific task
that requires the reviewing court to draw on its judicial experience and common sense.”
Id. at 679.
Dismissal of a complaint for failure to state a claim may be based on either the “lack
of a cognizable legal theory or the absence of sufficient facts alleged under a cognizable
legal theory.” Balistreri v. Pacifica Police Dep’t, 901 F.2d 696, 699 (9th Cir. 1990). In
reviewing a motion to dismiss, courts will “accept factual allegations in the complaint as
true and construe the pleadings in the light most favorable to the nonmoving party.”
Manzarek v. St. Paul Fire & Marine Ins. Co., 519 F.3d 1025, 1031 (9th Cir. 2008). But
courts are not required “to accept as true a legal conclusion couched as a factual allegation.”
Twombly, 550 U.S. at 555 (quoting Papasan v. Allain, 478 U.S. 265, 286 (1986)).
III. Discussion
Defendants argue that Plaintiff’s First Amended Complaint should be dismissed
because 1) Plaintiff’s negligence per se claim is impliedly preempted and 2) Plaintiff’s
design defect claim is barred under Arizona law and inadequately pled. (Doc. 16 at 1).
A. Plaintiff’s Negligence Per Se Claim and Implied Preemption
Under Arizona law, “negligence per se applies when there has been a violation of a
specific requirement of a law or an ordinance.” Griffith v. Valley of Sun Recovery and
Adjustment Bureau, Inc., 613 P.2d 1283, 1285 (Ariz. Ct. App. 1980). “A person who
violates a statute enacted for the protection and safety of the public is guilty of negligence
per se.” Alaface v. Natl. Inv. Co., 892 P.2d 1375, 1385 (Ariz. Ct. App. 1994).
Plaintiff’s negligence per se claim is based upon Defendant’s outdated pedicle screw
design. Plaintiff alleges that “[t]he Alphatec lumbar pedicle spinal screws implanted into
Plaintiff contain an outdated and defective European style of design in which there is a
‘sharp edge’ between the thread pattern and the minor diameter of the screw shaft.” (Id. at
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¶ 54). This “sharp edge” allegedly “makes the screws prone to fractures at the joint
between the thread and screw.” (Id. at ¶ 55). Plaintiff says that “Spinal screws
manufactured in the United States generally employ a smooth radius and transition between
the screw thread and minor diameter to eliminate this sharp edge and provide for a smooth
transition to reduce the potential for crack initiation and propagation.” (Id. at ¶ 56).
Plaintiff says her injuries were caused because Defendant maintained the outdated design
in its screws. (Id. at ¶¶ 57, 59–60).
Plaintiff says the source of Defendant’s duty to update its screw design can be found
in the Federal Food, Drug, and Cosmetic Act (“FDCA”) and its regulations, which impose
certain obligations on manufacturers of Class II medical devices like the Alphatec screws.
(Doc. 7 at ¶ 42). 21 C.F.R. § 820.1(a)(1) is a federal regulation that governs “methods used
in, and the facilities and controls used for, the design, manufacture, packaging, labeling,
storage, installation, and servicing of all finished devices intended for human use” and
establishes “basic requirements applicable to manufacturers of finished medical devices.”
Plaintiff says that under these regulations, Defendant is obligated to: “ ‘establish and
maintain procedures to control the design of the subject devices ‘in order to ensure that
specified design requirements are met’ ”; establish and maintain “ ‘procedures to ensure
that formal documented reviews of the design results’ for the subject devices ‘are planned
and conducted at appropriate stages of the device’s design development’ ”; and ensure that
Defendant’s design history file “contain[s] or reference[s] the records necessary to
demonstrate that the design was developed in accordance with the approved design plan
and the requirements of’ 21 C.F.R. part 820.” (Id. at ¶¶ 47–48, 52 (citing 21 C.F.R.
§§ 820.30(a), (e) and (j))).
Plaintiff claims that “[h]ad Alphatec performed its duties imposed by federal law, it
would not have sold the Arsenal Spinal Fixation System without altering the screw thread
design to contain a more suitable smooth radius and transition between the thread and
screw.” (Id. at ¶ 58).
In its Motion to Dismiss, Defendant argues that Plaintiff’s negligence per se claim
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is impliedly preempted2 because it is entirely premised upon Defendant’s alleged failure to
comply with FDA regulations. (Doc. 16 at 5–6).
The Supreme Court addressed the issue of implied preemption under the FDCA in
Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). There, the Court
held that if establishing the defendant’s liability for the plaintiff’s state law claim requires
demonstrating that the FDCA has been violated, then prosecution of the state law action
intrudes upon the FDA’s exclusive province to enforce the FDCA, rendering the suit
impliedly preempted. Id. at 349–53. The Supreme Court, however, was clear that implied
preemption is not absolute; that is, a plaintiff may rely on a violation of an FDCA
requirement as a predicate for a state tort claim where the plaintiff brings a claim under
“traditional state tort law which [ ] predated the federal enactments in question[.]” Id. at
353. By contrast, if the state law claim would not exist in the absence of the FDCA, “then
the plaintiff is effectively suing for a violation of the FDCA (no matter how the plaintiff
labels the claim), and the plaintiff’s claim is thus impliedly preempted under Buckman.”
Riley v. Cordis Corp., 625 F.Supp.2d 769, 777 (D. Minn. 2009) (citation omitted).
In other words, “[i]mplied preemption under the MDA bars claims seeking to
enforce an exclusively federal requirement not grounded in traditional state tort law.”
Kashani–Matts v. Medtronic, Inc., 2014 WL 819392, at *2 (C.D. Cal. 2014) (citing
Buckman, 531 U.S. at 352–53). “Claims not tied to state law tort duties are essentially
2 Though the Medical Device Amendments (“MDA”) to the FDCA contains an express
preemption provision, 21 U.S.C. § 360k(a), Defendant does not argue that Plaintiff’s
negligence per se claim is expressly preempted, and indeed, the facts do not support such
an argument. There is no dispute that Defendant’s Arsenal Spinal Fixation System
underwent the more limited 510(k) review process as opposed to the more rigorous
premarket approval process. As a result, it cannot be said that the FDA has “established
requirements applicable to the medical device at issue” — the first condition of the test for
express preemption under the statute. See e.g., Duggan v. Medtronic, Inc., 840 F. Supp.
2d 466, 469 (D. Mass. 2012) (“[C]laims involving a device that received premarket
approval satisfy the first condition of the test for preemption while claims involving a
device that received § 510(k) approval do not.”). Accordingly, Plaintiff’s contentions that
her negligence per se claim is not preempted because the legal requirements of her claim
are not “different from, or in addition to” the federal law requirements imposed on
Defendant are irrelevant to the issue. (Doc. 22 at 5). Whether state law requirements are
“different from, or in addition to,” federal law requirements is a consideration in express
preemption, not implied preemption. See Riegel v. Medtronic, Inc., 552 U.S. 312, 321–22
(2008).
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private actions to enforce the FDCA and are barred by Section 337(a).” Hawkins v.
Medtronic, Inc., 2014 WL 346622, *4 (E.D. Cal. 2014). “To avoid implied preemption, a
cause of action must rely on traditional state tort law.” Id.
Here, Plaintiff alleges that Defendant breached its duties under federal law to
“review, validate, and otherwise ensure that the design of the bone screws it distributes” is
reasonably safe for its intended use. (Doc. 7 at ¶ 57). Her claim relies on and cites to
multiple federal regulations that impose design review obligations on Defendants. (See id.
at ¶¶ 41–52)
The Court finds that Plaintiff’s negligence per se claim, as pled, is impliedly
preempted. Unlike a design defect claim based on a negligence theory, “[n]egligence per
se is limited to situations involving a violation of a specific legal requirement, not a general
standard of care.” Ibarra v. Gastelum, 471 P.3d 1028, 1030 (Ariz. Ct. App. 2020); Kapps
v. Biosense Webster, Inc., 813 F. Supp. 2d 1128, 1152 (D. Minn. 2011) (“In a typical
negligence case, the plaintiff seeks to hold the defendant liable because the defendant acted
carelessly. In a negligence per se case, the plaintiff seeks to hold the defendant liable
because the defendant violated a statute.”). Here, Plaintiff’s claim could not exist without
the specific requirements set out in the MDA; indeed, she does not identify a state law or
statute that otherwise provides the basis for the alleged violations. Her claim does not,
therefore, exist independently under Arizona state law and is preempted. See Brooks v.
Mentor Worldwide LLC, 985 F.3d 1272, 1279 (10th Cir. 2021) (“When we ask whether
liability under negligence per se exists independently under state law, regardless of the
FDCA or MDA, we must answer ‘no.’ ”). Even construing the Amended Complaint in
light most favorable to Plaintiff, the negligence per se claim could not exist without the
MDA and, therefore, is impliedly preempted.
Other courts, addressing similar negligence per se claims, have reached the same
conclusion. See, e.g., id. at 1280 (“Any negligence per se action premised on an MDA
violation necessarily seeks to enforce the MDA rather than a parallel state-law duty.”);
Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977, 1000 (D. Ariz. 2013), clarified on denial
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of reconsideration (Oct. 24, 2013) (“[A] claim for negligence that is premised solely on a
manufacturer’s violation of a federal standard—here the FDCA and MDA—is impliedly
preempted.”); Hafer v. Medtronic, Inc., 99 F. Supp. 3d 844, 862 (W.D. Tenn. 2015) (“If
Plaintiffs claim negligence based solely on Defendants’ failure to comply with federal law
or solely on illegal off-label promotion (i.e. negligence per se), Plaintiffs’ claims are
impliedly preempted under Buckman.”); see also Kapps, 813 F. Supp. 2d at 1152 (“A
negligence-per-se claim that is predicated on an alleged violation of the FDCA is, by
definition, a claim that would give rise to liability under Minnesota law only because of
the FDCA’s enactment.”). In essence, a negligence per se claim based solely on MDA
violations is an attempt to enforce the MDA through a private cause of action. C.f. 21
U.S.C. § 337(a) (“[A]ll such proceedings for the enforcement, or to restrain violations, of
this chapter shall be by and in the name of the United States.”). Plaintiff’s Count II,
negligence per se claim, is necessarily dismissed.
B. Design Defect
Plaintiff alleges that Defendant’s “Arsenal Spinal Fixation System and associated
pedicle screws implanted in Plaintiff were in fact defectively designed, developed,
engineered, and/or manufactured and were not merchantable or reasonably suited for their
intended use[.]” (Doc. 7 at ¶ 37).
Specifically, the Alphatec “Arsenal Spinal Fixation System and associated
pedicle bone screws used in Plaintiff’s lumbar spine failed to perform as
intended and designed by breaking before fusion could occur in Plaintiff’s
lumbar spine. Because said failure occurred prior to the fusion healing fully,
the screws were incapable of serving their intended purpose of providing the
necessary stability to the vertebral column during this critical period of
recovery.
(Id. at ¶ 38). Plaintiff also alleges that these defects existed at the time it left Defendant’s
control and were the direct and proximate cause of her injuries. (Id. at ¶¶ 36, 39).
Defendant argues that Plaintiff’s strict liability design defect claim is barred under
Arizona law and is inadequately pled. (Doc. 16 at 6–8).
1. Whether Arizona Law Bars Plaintiff’s Design Defect Claim
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As to its first contention, Defendant states that “Arizona follows either the
Restatement (Second) or (Third) of Torts, and [] both of these reject strict liability design
defect claims involving medical devices.” (Doc. 23 at 8 (emphasis omitted)).
To the extent Arizona follows the Second Restatement, Defendant argues that it
prohibits design defect claims “for those important products that are ‘incapable of being
made safe for [its] intended and ordinary use.’” (Doc. 16 at 7 (citing Restatement (Second),
§ 402A cmt. k)). The Court agrees with Plaintiff that whether the Arsenal device is
incapable of being safe for its intended and original use is a factual issue that cannot be
resolved on a motion to dismiss. Whitewater West Industries, Ltd. v. Pacific Surf Designs,
Inc., 2017 WL 4518526, *3 (S.D. Cal. 2017) (“Defendants’ arguments require the Court to
weigh evidence and draw inferences against the non-moving party. That is improper on a
motion to dismiss.”). This argument is, therefore, rejected.
The Court also rejects Defendant’s contention that § 6c of the Third Restatement
applies to Plaintiff’s strict liability design claim, rendering it deficiently pled. Section 6(c)
provides that
[a] prescription drug or medical device is not reasonably safe due to defective
design if the foreseeable risks of harm posed by the drug or medical device
are sufficiently great in relation to its foreseeable therapeutic benefits that
reasonable health-care providers, knowing of such foreseeable risks and
therapeutic benefits, would not prescribe the drug or medical device for any
class of patients.
Restatement (Third) of Torts: Products Liability § 6(c) (1998). Defendant’s position is that
under Restatement § 6c, which articulates a risk/benefit assessment for a juror, Plaintiff
has not and cannot plausibly plead that a provider would not prescribe the Arsenal device
for any class of patients. Section 6c, however, is not consistent with the standard
articulated in Dart v. Wiebe Mg., Inc., 709 P.2d 876, 880–81 (Ariz. 1985), the applicable
standard for a strict liability design defect claim in Arizona.
In Dart, the Arizona Supreme Court explained that “there is a fundamental
difference in the application of a risk/benefit analysis in a negligent design
case and the same analysis in a strict liability design case. The difference is
significant, for it shifts the central focus of the inquiry from the conduct of
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the manufacturer (negligence) to the quality of the product (strict liability).”
Id. at 880 (emphasis in original). The court elaborated that “[t]he true
distinction. . . between negligent design cases applying the risk/benefit
analysis and strict liability cases applying the same word formulation is the
time frame in which this determination is made.” Id. In negligence cases, the
reasonableness of the manufacturer’s conduct is assessed “at the time of
manufacture or design of the product.” Id. at 880-81 (noting that “[t]his test
is ‘nothing more than the familiar negligence standard’ ”). In strict liability
cases, however, the product is the focus of the inquiry, and “[t]he quality of
the product may be measured not only by the information available to the
manufacturer at the time of design, but also by the information available to
the trier of fact at the time of trial.” Id. at 880-81. The court noted that “[t]his
‘hindsight’ test is generally recommended by the commentators, and by
precedent, if the case is to be pursued in strict liability.” Id. at 881 (citations
omitted).
McBroom v. Ethicon, Inc., No. CV-20-02127-PHX-DGC, 2022 WL 675813, *2 (D. Ariz.
Mar. 6, 2022). As the court in McBroom noted, Dart remains good law in Arizona.
Applying Restatement § 6(c) to Plaintiff’s strict liability design defect claim would be a
departure from Arizona law in light of the distinctions between strict liability design defect
claims and negligent design claims noted by the Dart court. The Court therefore declines
to apply § 6(c) in assessing the sufficiency of Plaintiff’s claim.
Contrary to Defendant’s assertion, neither Restatement acts as an outright
prohibition on Plaintiff’s strict liability design defect claim. The Court will proceed to
determine if a strict products liability design defect claim has been properly alleged.
2. Sufficiency of Plaintiff’s Design Defect Claim
To establish a strict products liability claim under Arizona law, a plaintiff must
demonstrate that 1) the product is defective and unreasonably dangerous, 2) the dangerous
condition existed at the time it left defendant’s control, and 3) the defective condition is
the proximate cause of the plaintiff’s injuries and property loss. Dietz v. Waller, 685 P.2d
744 (Ariz. 1984) (citation omitted). Defendant summarily argues the claim is deficient
because it “does not allege any specific defect in the design” or “how such design caused
Plaintiff’s injury.” (Doc. 16 at 8). But to find the Amended Complaint deficient in this
regard would ignore allegations of the Amended Complaint. (See e.g., Doc. 7 ¶¶ 38, 54–
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56); Securities and Exch. Comm’n v. Timetrust, Inc., 28 F. Supp. 34, 44 (N.D. Cal. 1939)
(“Courts should deal with the substance, and not the form of the language of the
pleadings.”).
Plaintiff describes the design defect as follows: “The Alphatec lumbar pedicle spinal
screws implanted into Plaintiff contain an outdated and defective European style of design
in which there is a ‘sharp edge’ between the thread pattern and the minor diameter of the
screw shaft.” (Doc. 7 at ¶ 54). “The ‘sharp edge’ makes the screws prone to fractures at
the joint between the thread and screw,” whereas “a smooth radius and transition between
the screw thread and minor diameter…provide for a smooth transition to reduce the
potential for crack initiation and propagation.” (Id. at ¶¶ 55–56). The defective design
resulted in the screw “breaking before fusion could occur in Plaintiff’s lumbar spine.” (Id.
at ¶ 38). She then says Defendant’s failure to design screws that remain intact and do not
break caused her injuries, including “debilitating pain as a result of (a) the breakage itself;
(b) a recommendation to undergo a second spinal surgery to (i) remove and (ii) replace the
Alphatec screws and (iii) implant titanium interbody devices between Plaintiff’s vertebrae;
(c) the inability to fully remove a broken Alphatec screw from her vertebrae; and (d) having
to undergo a second recovery period following the second spinal surgery.” (Id. at ¶ 39).
Plaintiff has sufficiently alleged a design defect claim capable of withstanding a
12(b)(6) challenge.
Accordingly,
IT IS ORDERED that Defendant’s Motion to Dismiss (Doc. 16) is GRANTED IN
PART AND DENIED IN PART. Plaintiff’s Count II Negligence Per Se claim is
impliedly preempted and therefore dismissed.
Dated this 26th day of January, 2026.
Honorable Diane J. Humetewa
United States District Judge
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