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Kaku v. Alphatec Spine Inc.

United States District Court, M.D. Georgia, Valdosta Division

March 28, 2017

JESSICA KAKU and EMILLIANO KAKU, Plaintiffs,
v.
ALPHATEC SPINE, INC., Defendant.

          ORDER

          HUGH LAWSON, SENIOR JUDGE

         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.

         I. FACTUAL BACKGROUND

         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 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 three weeks.

         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 manufactured.

         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.

         II. 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)).

         III. ANALYSIS

         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.

         A. Plaintiffs have stated a claim for relief for strict products liability

         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 (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 (Ga.Ct.App. 1996).

         Count I of Plaintiffs' First Amended Complaint, for strict products liability, ...


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