United States District Court, M.D. Georgia, Valdosta Division
LAWSON, SENIOR JUDGE
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
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”). In January of 2014, Jessica Kaku
sought treatment for lower back pain from Dr. James Goss at
Valdosta Orthopedic Associates. Following a 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.
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 three weeks.
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.
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.
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 manufactured.
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
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.
“[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).
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.
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
Plaintiffs have stated a claim for relief for strict products
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 (Ga. 1994). 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
of Plaintiffs' First Amended Complaint, for strict
products liability, ...