Barnes v. Medtronic, Inc.
| Decision Date | 24 August 2021 |
| Docket Number | Civil Action 1:20-CV-04310-JPB |
| Parties | REGINA BARNES, AS NEXT FRIEND OF TIANA GIBSON, AN INCAPACITATED ADULT, Plaintiff, v. MEDTRONIC, INC., et al., Defendants. |
| Court | U.S. District Court — Northern District of Georgia |
This matter is before the Court on Medtronic, Inc., Medtronic USA Inc., Medtronic Logistics, LLC, and Medtronic Puerto Rico Operations, Co.'s (collectively “Defendants”) Motion to Dismiss Plaintiff's Amended Complaint [Doc. 17]. This Court finds as follows:
BACKGROUND AND FACTUAL ALLEGATIONS
This is a products liability action involving a SynchroMed II Programmable Implantable Infusion Pump System (“SynchroMed Device”), a Class III medical device manufactured by Defendants. [Doc. 14, pp.1-2]. Like its name suggests, the SynchroMed Device is a programmable drug infusion system that is implanted in the body to deliver medication into the intrathecal space (spinal canal) of the patient. Id. at 4-5. In 1988, the Food and Drug Administration (“FDA”) approved the SynchroMed Device through the Premarket Approval (“PMA”) process. Id. at 5.
Tiana Gibson (“Plaintiff”)[1] was in a car accident in 2011 and as a result, suffers from spasticity of the bilateral upper extremities, lower extremity weakness and seizure disorder. Id. To reduce both the muscle spasticity associated with her condition and her need to take oral medications, Plaintiff elected to have a SynchroMed Device implanted to deliver baclofen, a muscle relaxer, into the intrathecal space of her spine. Id. at 7. Plaintiff has had at least three SynchroMed Devices implanted since 2011.[2] Plaintiff's third SynchroMed Device is the only product at issue in this suit. Id.
On January 16, 2018, Plaintiff underwent surgery and had her third SynchroMed Device implanted. Id. For several months thereafter, Plaintiff experienced vomiting in between her doctor's visits. Id. At the end of October 2018, Plaintiff suffered six seizures in a handful of days. Id. Then, from October 2018 to December 2018, Plaintiff's muscle spasticity significantly worsened, and Plaintiff experienced dramatic changes in mood. Id. at 8. Based on these symptoms, in December 2018, Plaintiff's physicians determined that the SynchroMed Device had malfunctioned and failed. Id. The device was thereafter removed and replaced on January 2, 2019. Id.
Contending that the device was defective and that she was injured as a result, Plaintiff filed this action against Defendants on October 20, 2020. [Doc. 1]. On February 5, 2021, Plaintiff filed her Amended Complaint asserting the following causes of action: (1) Strict Liability Manufacturing Defect; (2) Negligent Manufacturing Defect; (3) Breach of Implied Warranty of Merchantability; (4) Negligence Per Se; (5) Breach of Express Warranty; (6) Punitive Damages; and (7) Attorney's Fees and Expenses of Litigation. [Doc. 14]. Shortly thereafter, on February 19, 2021, Defendants filed the instant Motion to Dismiss Plaintiff's Amended Complaint. [Doc. 17]. The motion is now ripe for review.
In evaluating a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), the court “accept[s] the allegations in the complaint as true and constru[es] them in the light most favorable to the plaintiff.” Traylor v. P'ship Title Co., LLC, 491 Fed.Appx. 988, 989 (11th Cir. 2012). Federal Rule of Civil Procedure 8(a)(2) provides that a pleading must contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Although detailed factual allegations are not necessarily required, the pleading must contain more than “labels and conclusions” or a “formulaic recitation of the elements of a cause of action.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). Importantly, “a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.'” Id. (citation omitted). At bottom, the complaint must contain more than “an unadorned, the-defendant-unlawfully-harmed-me accusation” (id.) and must “plead[] factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Traylor, 491 Fed.Appx. at 990 (quoting Iqbal, 556 U.S. at 678).
In their Motion to Dismiss, Defendants assert that Plaintiff's claims are preempted by federal law. Defendants also assert that Plaintiff's claims are inadequately pled. Because preemption is a principle derived from the Supremacy Clause of the United States Constitution this Court “must first analyze whether each claim can stand under state law, and only then decide the preemption questions where necessary.” Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1328 (11th Cir. 2017).
As explained in the rule immediately above, before this Court can analyze whether Plaintiff's claims are preempted, the Court must first determine whether Plaintiff's claims are properly pled. Each claim will be addressed in turn.
In Count 1, Plaintiff asserts a claim for strict liability manufacturing defect. Georgia statutes provide for strict liability for defective products. Specifically, O.C.G.A. § 51-1-11(b)(1) states that a manufacturer of personal property sold as new is liable in tort to “any natural person who may use, consume, or reasonably be affected by the property” and who suffers an injury to her person or property “because the property when sold by the manufacturer was not merchantable and reasonably suited to the use intended, and its condition when sold is the proximate cause of the injury sustained.” Thus, to state a claim for strict liability manufacturing defect, the plaintiff must allege that “(1) the defendant was the manufacturer of the product; (2) the product, when sold, was not merchantable and reasonably suited to the use intended, and (3) the product's defective condition proximately caused plaintiff's injury.” Sharp v. St. Jude Med., S.C., Inc., 838 Fed.Appx. 462, 466 (11th Cir. 2020) (quoting Brazil v. Janssen Rsch. & Dev. LLC, 196 F.Supp.3d 1351, 1357 (N.D.Ga. 2016)). A plaintiff can show that a product was “not merchantable” through any of three variations of product defects: manufacturing defects, design defects or marketing/packaging defects. Id.
As already stated, Plaintiff asserts a manufacturing defect. Where a manufacturing defect is asserted, a plaintiff must “allege the existence of a specific manufacturing defect that proximately caused the harm.” Id. (quoting Brazil, 196 F.Supp.3d. at 1358). Manufacturing defects will always be identifiable as a deviation from some objective standard or a departure from the manufacturer's specification established for the creation of the product. At bottom, a plaintiff only needs to allege a deviation that was the proximate cause of an injury. Id.
In the present case, Plaintiff sufficiently states a claim for strict liability manufacturing defect. Plaintiff's Amended Complaint alleges that: (1) her SynchroMed Device, which was manufactured by Defendants, was not reasonably suited for its intended use due to manufacturing defects; and (2) those defects were the proximate cause of her injury. Specifically, Plaintiff alleges that defects in the manufacture of the SynchroMed Device caused a motor stall, resulting in baclofen withdrawal symptoms and necessitating an invasive removal surgery. In her allegations, Plaintiff asserts that Defendant violated numerous federal statutes and regulations that are designed to prevent the manufacture and distribution of adulterated products, including: 21 C.F.R. §§ 820.30(c), 820.30(g), 820.70(a), 820.75(a), 820.100(a), 820.100(a)(2), 820.100(a)(3) 820.100(a)(5), 820.824, 820.198(a), 820.198(a)(3) and 820.198(c). Moreover, Plaintiff identifies an August 9, 2017 recall which was initiated to address motor stall issues. These are sufficient facts to allow this Court to reasonably infer that Defendants' violations of federal regulations caused Plaintiff's device to fail. Ultimately, this Court finds that the allegations provide sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face. Therefore, under Georgia law, Plaintiff has properly pled this claim. See Cooksey v. Medtronic, Inc., No. 1:20-CV-00805, 2020 WL 10090793, at *3 (N.D.Ga. Dec. 16, 2020) (); Green v. Medtronic, Inc., No. 1:19-CV-3242, 2020 WL 4577713, at *3 (same).
In Count II, Plaintiff asserts a claim for negligent manufacturing defect. This claim is recognized under Georgia law. Sharp, 838 Fed.Appx. at 466. A plaintiff must allege the following to state a claim for negligent manufacturing: “(1) a legal duty to conform to a standard of conduct for the protection of others against an unreasonable risk of harm; (2) breach of that standard; (3) causation; and (4) some loss or damage as a result of the alleged breach of the legal duty.” Id. Ultimately, to avoid liability for negligent manufacturing, a manufacturer must exercise reasonable care in manufacturing its products so that the products are reasonably safe for intended or foreseeable uses. Id.
After reviewing Plaintiff's Amended Complaint, this Court finds that Plaintiff's allegations are sufficient to establish a negligent manufacturing claim. Specifically, Plaintiff asserts that Defendants had a duty to individuals, including Plaintiff, to use reasonable care in manufacturing the SynchroMed Device and Defendants breached that duty when they failed to comply with federal regulations. Like Plaintiff's strict liability...
To continue reading
Request your trial