KAKU et al v. ALPHATEC SPINE INC
ORDER finding as moot 7 Motion to Dismiss Complaint; denying 13 Motion to Dismiss Complaint. Ordered by US DISTRICT JUDGE HUGH LAWSON on 3/28/2017. (aks)
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF GEORGIA
JESSICA KAKU and EMILLIANO
Civil Action No. 7:16-CV-9 (HL)
ALPHATEC SPINE, INC.,
Before the Court is Defendant Alphatec Spine, Inc.’s Motion to Dismiss
(Doc. 7) and Defendant’s Motion to Dismiss Plaintiffs’ First Amended Complaint.
(Doc. 13). For the reasons discussed herein, Defendant’s Motion to Dismiss
Plaintiffs’ First Amended Complaint (Doc. 13) is denied, and Defendant’s Motion
to Dismiss (Doc. 7) is deemed moot.
This is a product liability action arising out of the alleged failure of two
Alphatec Zodiac® polyaxial pedicle screws, implanted into Plaintiff Jessica
Kaku’s vertebrae, to remain intact following a transforaminal lumbar interbody
fusion (“TLIF”).1 In January of 2014, Jessica Kaku sought treatment for lower
back pain from Dr. James Goss at Valdosta Orthopedic Associates. Following a
The facts are taken from the allegations in the First Amended Complaint (Doc.
10) and are accepted as true for purposes of this motion.
diagnosis of spondylolisthesis, Dr. Goss recommended that Mrs. Kaku undergo
TLIF, a type of surgical spinal fusion. The goal of lumbar fusion is to create solid
bone between two or more vertebrae to reduce pain from motion and nerve root
inflammation. Pedicle screws are used to add extra support and strength to the
fusion by locking the spine in place while the fusion heals.
Dr. Goss performed the TLIF procedure on Jessica Kaku on February 10,
2014. During the procedure, four pedicle screws were surgically implanted into
two of Mrs. Kaku’s vertebrae.
The screws were designed, manufactured,
marketed, distributed, sold, and supplied by Defendant. Following the surgery,
Jessica Kaku experienced relief from her lower back and sciatic pain almost
immediately and was able to return to work in the United States Air Force within
On March 21, 2014, while sitting at her desk, Mrs. Kaku turned in her chair
to throw a piece of paper in the trashcan and felt a sudden pop in her back,
followed by the feeling of metal grinding. She later learned that the pop she felt
was the sound of two of the pedicle screws breaking. The failure of the screws
compromised the progress of Mrs. Kaku’s fusion, and she was forced to undergo
a second surgery on June 23, 2014 to remove the pedicle screws. Three of the
screws were removed, but one of the screws could not be removed safely. As a
result, that screw remains in Mrs. Kaku’s vertebra. Since the second surgery,
Mrs. Kaku has experienced continuous low back pain, more excruciating than the
pain she endured prior to her first surgery.
The pedicle screws at issue in this lawsuit are Class II medical devices.
Prior to marketing a Class II device, Section 510(k) of the Food, Drug and
Cosmetic Act requires the submission of a premarket notification to the Food and
Drug Administration (“FDA”). The 510(k) process allows the FDA to classify the
device and determine whether it is substantially equivalent to another device
already on the market. Thus, prior to marketing its pedicle screws, Defendant
filed a premarket notification with the FDA.
On July 16, 2015, the FDA issued a warning letter to Defendant. The
warning letter claims that an inspection revealed that pedicle screw implants and
stainless steel instruments used during implant installation procedures were
“adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 321(h),
in that the methods used in, or the facilities or controls used for, their
manufacture, packing, storage, or installation are not in conformity with the
current good manufacturing practice requirements of the Quality System
regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.”
Plaintiffs have not alleged that the warning letter pertains to the pedicle screws
that were implanted in Jessica Kaku. However, Plaintiffs make clear that the
deficiencies outlined in the letter were present at Defendant’s manufacturing
facilities at the time the pedicle screws implanted in Mrs. Kaku were
Plaintiffs Jessica Kaku and Emilliano Kaku filed this lawsuit, alleging that
Defendant is strictly liable for defectively designing, developing, engineering,
and/or manufacturing the pedicle screws that were implanted in Jessica Kaku. In
addition to their strict liability claim, Plaintiffs have stated a claim for loss of
consortium, punitive damages, and attorneys’ fees. Defendant filed a Motion to
Dismiss (Doc. 7) on March 22, 2016. Plaintiffs then filed their First Amended
Complaint (Doc. 10) on April 4, 2016. Defendant now moves to dismiss Plaintiffs’
First Amended Complaint, arguing that Plaintiffs have failed to state a claim upon
which relief may be granted, that Plaintiffs’ strict liability claim is preempted by
the Medical Device Amendments of 1976 (“MDA”), and that the remaining claims
must be dismissed because they are derivative of Plaintiffs’ strict liability claim.
STANDARD OF REVIEW
When reviewing a claim pursuant to a Rule 12(b)(6) motion, the Court
accepts the allegations in the claim as true and construes them in the light most
favorable to the party asserting the claim.
See Jackson v. BellSouth
Telecomms., 372 F.2d 1250, 1262 (11th Cir. 2004). “While a complaint attacked
by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a
plaintiff’s obligation to provide the grounds of his entitlement to relief requires
more than labels and conclusions, and a formulaic recitation of the elements of a
cause of action will not do.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555
(2007) (internal quotations and citations omitted). Instead, the complaint must
set forth factual allegations “plausibly suggesting (not merely consistent with)” a
violation of the law. Id. at 557.
Accordingly, “[t]o survive a motion to dismiss, a complaint must contain
sufficient factual matter, accepted as true, to ‘state a claim to relief that is
plausible on its face.’”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting
Twombly, 550 U.S. at 570). The Iqbal Court explained as follows:
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. The plausibility
standard is not akin to a probability requirement, but it asks for more
than a sheer possibility that a defendant has acted unlawfully.
Where a complaint pleads facts that are merely consistent with a
defendant’s liability, it stops short of the line between possibility and
plausibility of entitlement to relief.
556 U.S. at 678 (internal quotes and citations omitted).
“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 (citation omitted). “But where the
well-pleaded facts do not permit the court to infer more than the mere possibility
of misconduct, the complaint has alleged—but it has not ‘show[n]’—‘that the
pleader is entitled to relief.’” Id. (quoting Fed. R. Civ. P. 8(a)(2)).
Defendant moves to dismiss Plaintiffs’ First Amended Complaint, arguing
that Plaintiffs’ strict liability claim fails for lack of factual support. Even if the facts
alleged were sufficient to state a claim for strict products liability, Defendant
argues that this claim is preempted by the MDA. Finally, Defendant moves to
dismiss Plaintiffs’ claims for loss of consortium, punitive damages, and attorneys’
fees because they are derivative of Plaintiffs’ strict liability claim.
Plaintiffs have stated a claim for relief for strict products
Defendant moves to dismiss Plaintiffs’ strict liability claim, arguing that
Plaintiffs have failed to state specific facts showing a product defect or causation.
To state a claim for strict products liability, a plaintiff must allege that: (1) the
defendant manufactured the allegedly defective product; (2) the allegedly
defective product was not merchantable and reasonably suited for its intended
use when the defendant sold it; and (3) the defective product proximately caused
the plaintiff’s injuries. Chi. Hardware & Fixture Co. v. Letterman, 510 S.E.2d 875,
877–78 (Ga. Ct. App. 1999).
Under Georgia law, “[t]here are three general
categories of product defects: manufacturing defects, design defects, and
marketing/packaging defects.” Banks v. ICI Americas, Inc., 450 S.E.2d 671, 672
In all cases, the inquiry is the same: “whether a product was
defective, and if so, whether the defect was the proximate cause of a plaintiff’s
injury.” SK Hand Tool Corp. v. Lowman, 479 S.E.2d 103, 106 (Ga. Ct. App.
Count I of Plaintiffs’ First Amended Complaint, for strict products liability,
contains the following allegation:
The Alphatec pedicle screws implanted in Plaintiff, as designed,
developed, engineered, manufactured, distributed, marketed, and
sold by Alphatec, were not merchantable or reasonably suited for
their intended use at the time said screws were sold. Specifically,
the Alphatec pedicle screws failed to perform as intended and
designed by breaking within six (6) weeks of implantation into
Plaintiff Jessica Kaku’s vertebrae. 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.
(Doc. 10, ¶ 31).
Defendant argues that Plaintiffs have not identified whether the allegedly
defective pedicle screws suffered from a design defect, a manufacturing defect,
some failure to warn-based theory of liability, or all three.2 As a result, Defendant
contends that it has been put “in the untenable position . . . of trying to guess at
the varying potential claims and facts in support, and swat them down on a
piecemeal basis.” (Doc. 17, p. 2). Defendant believes that Plaintiffs’ allegations
fall short of the requirements of Twombly, Iqbal, and their progeny.
The Court disagrees.
Contrary to Defendant’s assertion that Plaintiffs
have failed to identify a specific defect in the pedicle screws, Plaintiffs have
alleged that Defendant defectively designed and manufactured the pedicle
screws. (Doc. 10, ¶ 30). Plaintiffs claim that the screws broke within six weeks
of implantation, and were thus unable to serve their intended purpose of
providing the necessary stability to Jessica Kaku’s vertebral column during this
critical period of recovery. (Doc. 10, ¶ 31). This is not a situation where, as
Defendant contends, the First Amended Complaint is so completely devoid of
There is no mention of any failure to warn-based theory of liability in the First
Amended Complaint (Doc. 10) or in Plaintiffs’ Response to Defendant’s Motion to
Dismiss (Doc. 15). As a result, the Court concludes that Plaintiffs are proceeding
on theories of defective design and defective manufacturing.
reference to a specific defect that Defendant is left “guess[ing] at the varying
potential claims and facts in support.” (Doc. 17, p. 2).
A bald assertion that the pedicle screws were defective in design and
manufacture when they left Defendant’s hands, that they were unreasonably
dangerous, and that the foreseeable risks outweighed the benefits of using them
during fusion would be insufficient to survive a motion to dismiss. See, e.g.,
Moore v. Mylan, Inc., 840 F.Supp.2d 1337, 1344–45 (N.D. Ga. 2012).
Plaintiffs have done much more here.
They have alleged that four pedicle
screws, manufactured by Defendant, were implanted into Jessica Kaku’s
vertebrae; that two of the screws broke within six weeks of the surgery; that the
screws broke while Mrs. Kaku was turning in her chair to throw away a piece of
paper; that the purpose of the screws was to provide the necessary stability to
the vertebral column so that fusion could occur; and that because the screws
were defective in design and manufacture, the screws were “incapable of serving
their intended purpose.” (Doc. 10, ¶¶ 13, 15–17, 31).
Although it is not clear from the allegations whether Plaintiffs believe it was
a design defect or a manufacturing defect that caused the screws to break, when
“[t]he very nature of a products liability action” makes it not obvious which of
many alleged defects might have caused the plaintiff’s injury, the plaintiff may set
out various alternative or hypothetical sources of his injury.
See Bailey v.
Janssen Pharmaceutica, Inc., 288 F. App’x 596, 605 (11th Cir. 2008). “Nothing
in Rule 8(a), Twombly, Iqbal, or any other binding precedent requires a plaintiff to
specifically plead facts that establish every element (e.g. causation) in order to
state a claim.” Edwards v. Wis. Pharmacol Co., 987 F.Supp.2d 1340, 1345–46
(N.D. Ga. 2013). What is required, under both Georgia law and the Federal
Rules of Civil Procedure, is an allegation of specific defects from which the Court
can draw a reasonable inference that at least one of the defects caused the
plaintiff’s injuries. Cf. Coney v. Mylan Pharm., Inc., No. 6:11-cv-35, 2012 WL
170143, at *6 (S.D. Ga. Jan. 19, 2012) (dismissing plaintiff’s claims because he
failed to assert any specific defects from which the court could draw a reasonable
inference of causation). Plaintiff has satisfied that requirement here.
Defendant argues that, in evaluating whether Plaintiffs have alleged facts
sufficient to state a claim for strict products liability, the Court should disregard
the FDA Warning Letter discussed in the First Amended Complaint. (Doc. 13, p.
7). Defendant notes that Plaintiffs have not alleged that the products at issue in
the letter are the same as those which were used in Jessica Kaku’s surgery, and
as a result Defendant believes the letter is irrelevant to this lawsuit. (Doc. 13, p.
7). Although Plaintiffs do not contend that the pedicle screws implanted in Mrs.
Kaku are the subject of the warning letter, Plaintiffs do assert that “[t]he
deficiencies noted in the Warning Letter existed at Alphatec’s manufacturing
facilities . . . at the time the Alphatec screws implanted into Plaintiff Jessica Kaku
were manufactured.” (Doc. 10, ¶ 29). This allegation “permit[s] the [C]ourt to
infer more than the mere possibility of misconduct.” Iqbal, 556 U.S. at 678.
Defendant further argues that the facts in the First Amended Complaint are
insufficient to state a claim for strict products liability because they rely on a
theory of res ipsa loquitur.
Defendant asserts that res ipsa loquitur “is
inapplicable in a case like this because Alphatec did not have exclusive control
over the pedicle screws.” (Doc. 13, p. 6).
Res ipsa loquitur is a rule of evidence to be applied in cases where
there is no evidence of consequence showing negligence on the part
of the defendant. The doctrine authorizes, but does not require, the
jury to infer facts from the circumstances in which the injury
occurred, thereby filling the evidentiary gap.
Kmart Corp. v. Larsen, 522 S.E.2d 763, 765 (Ga. Ct. App. 1999).
preliminary matter, res ipsa loquitur is a negligence doctrine and has “no
application” in a strict liability case such as this one. Lang v. Federated Dept.
Stores, Inc., 287 S.E.2d 729, 731 (Ga. Ct. App. 1982). However, “the inferences
which are the core of the doctrine” are still applicable in strict liability cases; “the
plaintiff is not required to eliminate all other possibilities or to prove the case
beyond a reasonable doubt.” Id.
It is true that, in order to impose strict liability against a manufacturer of a
defective product, the product must “reach the user or consumer without
substantial change in the condition in which it is sold.” Talley v. City Tank Corp.,
279 S.E.2d 264, 269 (Ga. Ct. App. 1981) (citation and internal quotation marks
omitted). However, the fact that a manufacturer did not have exclusive control
over a product before its defect became apparent is not a bar to recovery for
strict products liability. See id. (“In some cases it may be a jury question as to
whether the product’s original design has been merely slightly or somewhat
In such cases, the jury must determine whether the original
manufacturer’s design was defective and, if so, whether the proximate cause of
the injuries sustained was the original defective design or the subsequent
Because Plaintiffs have adequately alleged that the pedicle screws
suffered from a design or manufacturing defect, and because Plaintiffs have
provided facts from which the Court can draw a reasonable inference that at least
one of the defects caused Jessica Kaku’s injuries, Plaintiffs have stated a claim
for relief for strict products liability.
Defendant is not entitled to dismissal of
Count I of Plaintiffs’ First Amended Complaint on this ground.
Plaintiffs’ strict liability claim is not preempted by the
Medical Device Amendments of 1976
In 1976, Congress enacted the MDA to address the perceived inadequacy
of existing law to protect consumers from “increasingly complex devices which
pose serious risk if inadequately tested or improperly designed or used.” S.Rep.
No. 33, 94th Cong., 2d Sess. 5, reprinted in 1976 U.S. Code Cong. & Admin.
News 1070, 1075. The Act classifies devices into one of three categories based
on the risk that the device poses to the public.
Devices that present no
unreasonable risk of illness or injury are designated Class I and are subject only
to minimal regulation by “general controls.” 21 U.S.C. § 360c(a)(1)(A). Devices
that are potentially more harmful are designated Class II devices. Although they
may be marketed without advance approval, manufacturers of such devices must
comply with federal performance regulations known as “special controls.”
360c(a)(1)(B). Finally, devices that either “presen[t] a potential unreasonable risk
of illness or injury,” or which are “purported or represented to be for a use in
supporting or sustaining human life or for a use which is of substantial
importance in preventing impairment of human health,” are designated Class III.
§ 360c(a)(1)(C). The Alphatec Zodiac® polyaxial pedicle screws are Class II
devices. (Doc. 10, ¶ 21).
Class II devices are subject to the requirements of 21 U.S.C. § 360(k),
which “imposes a limited form of review on every manufacturer intending to
market a new device by requiring it to submit a ‘premarket notification’ to the FDA
(the process is also known as a ‘§ 510(k) process,’ after the number of the
section in the original Act).” Medtronic, Inc. v. Lohr, 518 U.S. 470, 478 (1996).
“If the FDA concludes on the basis of the § 510(k) notification that the device is
‘substantially equivalent’ to a pre-existing device, it can be marketed without
further regulatory analysis . . . .” Id. Notably, the Supreme Court has held that
“[t]he 510(k) process is focused on equivalence, not safety.” Id. at 493 (citation
and quotation marks omitted) (emphasis in original). “As a result, substantial
equivalence determinations provide little protection to the public.” Id. (citation
and quotation marks omitted).
The MDA includes an express preemption clause:
(a) General rule. Except as provided in subsection (b)3 of this
section, no State or political subdivision of a State may establish or
continue in effect with respect to a device intended for human use
(1) which is different from, or in addition to, any requirement
applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any
other matter included in a requirement applicable to the device
under this chapter.
21 U.S.C. § 360k(a). The FDA’s regulation interpreting section 360k, issued in
1978, advises that:
State or local requirements are preempted only when the [FDA] has
established specific counterpart regulations or there are other
specific requirements applicable to a particular device under the act,
thereby making any existing divergent State or local requirements
applicable to the device different from, or in addition to, the specific
21 C.F.R. § 808.1(d).
Defendant argues that Plaintiffs’ strict liability claim imposes duties
inconsistent with the MDA, and is thus preempted. (Doc. 13, p. 10). Specifically,
Defendant contends that this claim imposes a duty on Defendant to “create an
‘indestructible’ pedicle screw that could not fracture or cause injury.” (Doc. 13, p.
10). Such a duty “would create a state law requirement that is different from, and
in addition to, the federal requirements” governing Class II medical devices.
Subsection (b) provides a means for a state or political subdivision thereof to
apply for an exemption to preemption when compelling local conditions require a
more stringent requirement. See 21 U.S.C. § 360k(b).
(Doc. 13, p. 11). As a result, Defendant argues that Plaintiffs’ strict liability claim
Defendant’s argument is unpersuasive. As a preliminary matter, Plaintiffs’
strict liability claim does not impose a duty on Defendant to create an
“indestructible” pedicle screw. Rather, Plaintiffs allege that the pedicle screws
implanted into Jessica Kaku’s vertebrae were defective in that they broke during
the fusion process, in which “it is critical that the screws remain intact.” (Doc. 15,
p. 13). Plaintiffs argue that the defective screws were “not merchantable and
reasonably suited to the use intended,” and accordingly, Defendants are strictly
liable for the injuries sustained as a result of the failed pedicle screws. There is
nothing in Georgia law or in the First Amended Complaint that requires a product
manufacturer to produce an “indestructible” product.
Further, as Plaintiffs argue in their response to Defendant’s Motion to
Dismiss, Defendant’s preemption argument is belied by the United States
Supreme Court’s decision in Medtronic, Inc. v. Lohr. Lohr, which reached the
Supreme Court on appeal from the Eleventh Circuit Court of Appeals, held that
the requirements of the § 510(k) process “were not sufficiently concrete to
constitute a pre-empting federal requirement.”
518 U.S. at 493.
reasoned that the 510(k) process does not “require” medical devices “to take any
particular form for any particular reason.” Id. Further, in examining the text of
the statute and the legislative history, the Court explained that “[t]here is no
suggestion in either the statutory scheme or the legislative history that the §
510(k) exemption process was intended to do anything other than maintain the
status quo with respect to the marketing of existing medical devices and their
substantial equivalents.” Id. at 494.
In its Reply Brief (Doc. 17), Defendant attempts to distinguish Lohr from
the facts at issue in this case.
Defendant argues that Lohr was an express
preemption case and that the Supreme Court “made no pronouncement
regarding whether there was a conflict between the state and federal
requirements.” (Doc. 17, p. 9). Here, Defendant contends that Plaintiffs’ strict
liability claim is preempted by “implied impossibility.” (Doc. 17, p. 5) (emphasis
added). Defendant cites two cases in support of its argument: PLIVA v. Mensing,
564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466
Both PLIVA and Bartlett concern “complex” federal drug labeling
requirements. PLIVA, 564 U.S. at 612; see also Bartlett, 133 S.Ct. at 2470.
PLIVA considered whether laws in Minnesota and Louisiana were preempted by
drug labeling requirements promulgated under federal law. PLIVA, 563 U.S. at
611–12. At the heart of the Court’s analysis was “whether, and to what extent,
generic manufacturers may change their labels after initial FDA approval.” Id. at
613. The Court summarized the state and federal requirements as follows:
State tort law places a duty directly on all drug manufacturers to
adequately and safely label their products. . . . [T]his duty required
the Manufacturers to use a different, stronger label than the label
they actually used. Federal drug regulations, as interpreted by the
FDA, prevented the Manufacturers from independently changing
their generic drugs’ safety labels.
Id. at 617.
Ultimately, the Court concluded that the state law labeling
requirements were preempted, because “state law imposed a duty on the
Manufacturers to take certain action, and federal law barred them from taking
that action.” Id. at 624.
In Bartlett, the Supreme Court considered whether federal regulations
preempted New Hampshire law which “imposes a duty on manufacturers to
ensure that the drugs they market are not unreasonably unsafe.” 133 S.Ct. at
2470. The Court held that the New Hampshire law was preempted because
“state-law design-defect claims that turn on the adequacy of a drug’s warnings
are pre-empted by federal law under PLIVA.” Id.
Defendant argues that the facts at issue here are more akin to those at
issue in PLIVA and Bartlett than they are to Lohr. As previously discussed, Lohr
held that the requirements of the § 510(k) premarket notification process were
not sufficiently concrete to constitute a pre-empting federal requirement.
Defendant asserts that the Court’s holding in Lohr concerned whether state law
defective design claims were expressly preempted by the requirements of federal
law. Here, Defendant urges, the Court should consider whether Plaintiffs’ strict
liability claim is impliedly preempted, due to the impossibility of complying with
both state and federal law.
Defendant points the Court to 21 C.F.R. § 807.81(a)(3), which requires that
a manufacturer submit a premarket notification submission to the FDA 90 days
before the manufacturer proposes to introduce an altered product into the market
(3) The device is one that the person currently has in commercial
distribution or is reintroducing into commercial distribution, but that is
about to be significantly changed or modified in design, components,
method of manufacture, or intended use. The following constitute
significant changes or modifications that require a premarket
(i) A change or modification in the device that could significantly
affect the safety or effectiveness of the device, e.g., a significant
change or modification in design, material, chemical composition,
energy source, or manufacturing process.
(ii) A major change or modification in the intended use of the device.
21 C.F.R. § 807.81(a)(3) (emphasis added). Defendant’s position is that this
regulation requires prior FDA approval of any change that might be required in
order to comply with state law.
Defendant argues that the Supreme Court’s
decision in PLIVA established that “there is a federal-state law conflict where
state law ‘demand[s] a safer label’ and the only unilateral step a manufacturer
can take is to ‘communicate with the FDA about the possibility of a safer label.’”
(Doc. 17, pp. 9–10) (citing PLIVA, 564 U.S. at 619). According to Defendant,
“[t]hat same irreparable conflict exists [here,] where state law demands a safer
design and the only unilateral step a § 510(k) device manufacturer can take is to
submit a notification to the FDA requesting approval for a design change.” (Doc.
17, p. 10). Because Defendant could not independently do under federal law
what Georgia law requires of it, Defendant argues that Plaintiffs’ strict products
liability claim is impliedly preempted by impossibility.
The Court disagrees. The Court concedes that 21 C.F.R. § 807.81(a)(3)
concerns a situation where safety is inherently at issue, unlike the premarket
notification submission under § 510(k). However, it is not clear that 21 C.F.R. §
807.81(a)(3) applies under the circumstances.
Whether any changes to the
pedicle screws, made to comply with Georgia law, would “significantly affect the
safety” of the screws is a question of fact, not of law. There are no facts in the
First Amended Complaint suggesting that changes which “significantly affect the
safety” of the screws needed to be made in order to comply with Georgia’s strict
products liability statute. As a result, the Court cannot say that it was impossible
for Defendant to comply with both state and federal law.
Defendant is not
entitled to dismissal of Plaintiffs’ strict products liability claim on these grounds.
Plaintiffs have stated a claim for relief for loss of consortium,
punitive damages, and attorneys’ fees
Defendant moves to dismiss Counts II, III, and IV of the First Amended
Complaint. Defendant’s sole argument in support of dismissing these claims is
that they are all derivative of Plaintiffs’ strict liability claim. (Doc. 13, p. 10 n.4).
The Court has determined that Plaintiffs have stated a claim for relief for strict
products liability. Accordingly, Defendant is not entitled to dismissal of Counts II,
III, and IV.
For the reasons discussed, Defendant’s Motion to Dismiss Plaintiffs’ First
Amended Complaint (Doc. 13) is DENIED. Defendant’s Motion to Dismiss (Doc.
7) is deemed MOOT.
Plaintiffs’ claims may proceed for further factual
SO ORDERED, this the 28th day of March, 2017.
/s/ Hugh Lawson_________________
HUGH LAWSON, SENIOR JUDGE
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