Sharp v. St. Jude Med., S.C., Inc.
| Decision Date | 23 December 2020 |
| Docket Number | No. 19-13380,19-13380 |
| Parties | WENDY SHARP, Individually and as administrator of the estate of Estate of Milton Sharp, Plaintiff-Appellant, v. ST. JUDE MEDICAL, S.C., INC., ST. JUDE MEDICAL, INC., PACESETTER, INC., d.b.a. St. Jude Medical Cardiac Rhythm Management Division, ST. JUDE MEDICAL, LLC, ABBOTT LABORATORIES, Defendants-Appellees. |
| Court | U.S. Court of Appeals — Eleventh Circuit |
[DO NOT PUBLISH]
D.C. Docket No. 1:17-cv-03181-SCJ
Appeal from the United States District Court for the Northern District of Georgia Before WILSON, NEWSOM, and ANDERSON, Circuit Judges.
Wendy Sharp appeals the district court's dismissal of her case against St. Jude Medical for failure to state a claim.1 Ms. Sharp brought negligence and strict liability manufacturing defect claims, among others, under Georgia law. Ms. Sharp sues individually and as the personal representative of the estate of Milton Sharp, her late husband.
Mr. Sharp had a heart condition and relied on an implantable cardiac defibrillator (ICD) manufactured by St. Jude Medical to monitor and regulate his heartrate. ICDs are implanted under the skin of the chest wall; the device's power source (a pulse generator) connects to the heart through a lead (a wire that transmits electrical impulses from the generator). The lead monitors the heart rhythm and delivers an electric shock to the heart to restore its normal rhythm when an arrhythmia is detected.
On August 23, 2015, Mr. Sharp died after suffering a ventricular fibrillation. The claims against St. Jude Medical relate to the operation (or failure to operate) of Mr. Sharp's ICD. After careful consideration, and with the benefit of oral argument, we determine that Ms. Sharp pleaded enough facts to plausibly supporther negligence and strict liability claims. We reverse the district court's dismissal of those claims.
On August 22, 2017, Ms. Sharp filed a complaint against St. Jude Medical in the Northern District of Georgia for the wrongful death of her husband. The complaint alleged negligence, negligence per se, strict liability, and failure to warn. Ms. Sharp filed her First Amended Complaint on September 7, 2017 and Defendants moved to dismiss. Ms. Sharp was granted leave to amend and filed her Second Amended Complaint on September 14, 2018, alleging that Mr. Sharp's device failed because of manufacturing defects.
Specifically, Ms. Sharp alleged that defects caused the insulation around the lead to erode, thereby exposing the conductive wire. Erosion of the lead—called lead abrasion—can cause short circuiting and prevent delivery of high voltage therapy. Ms. Sharp stated that her claims arose out of Defendants' violation of FDA regulations and policies applicable to the manufacture and sale of the device.
Defendants again moved to dismiss Ms. Sharp's complaint, asserting that federal law preempted her claims and that she failed to state a claim under state law. The district court granted Defendants' motion to dismiss on August 14, 2019, finding that Ms. Sharp failed to state any claim and that her claims werepreempted.2 This appeal followed. Though the district court dismissed all claims, Ms. Sharp appeals only the dismissal of her negligence and strict liability manufacturing defect claims.
We review de novo a dismissal for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). Echols v. Lawton, 913 F.3d 1313, 1319 (11th Cir. 2019). We must reverse the dismissal if the complaint "state[s] a claim to relief that is plausible on its face," Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009), after we accept all factual allegations in the complaint as true and draw all reasonable inferences in favor of the claimant. See Spanish Broad. Sys. of Fla., Inc. v. Clear Channel Commc'ns, Inc., 376 F.3d 1065, 1070 (11th Cir. 2004). We review de novo the district court's interpretation of state law. Tampa Bay Water v. HDR Eng'g, Inc., 731 F.3d 1171, 1177 (11th Cir. 2013).
Ms. Sharp appeals the dismissal of two claims based on a manufacturing defect: strict products liability and negligence. She argues that she adequately stated claims for each of these causes of action in her Second Amended Complaint. Because we are reviewing the district court's ruling based on the pleadings, we accept the factual allegations in the complaint as true and construe them in the light most favorable to the plaintiff. See Hill v. White, 321 F.3d 1334, 1335 (11th Cir. 2003) (per curiam). Accordingly, our account of the facts comes from Ms. Sharp's Second Amended Complaint.
Mr. Sharp suffered from tachycardia, a serious heart condition involving an irregular heartbeat. Patients with potentially fatal heart rhythms commonly receive ICDs when medication cannot adequately control their condition. ICDs are Class III medical devices—the highest category of risk—and are regulated by the Food and Drug Administration (FDA). All Class III devices must go through a rigorous premarket approval (PMA) process before being distributed to the public. After approval, the manufacturer must fully comply with the PMA's specifications and may not make any changes to the product or manufacturing process without submitting a supplemental PMA application to the FDA.
Mr. Sharp had an ICD implanted in his chest in 2004. His ICD consisted of a Fortify pulse generator and a Riata lead.3 St. Jude Medical manufactured both parts of his ICD.
On August 23, 2015 between 6:45 and 7:00 a.m., Mr. Sharp suffered a cardiac arrest while driving. His ICD failed to deliver an appropriate shock to his heart to correct the arrhythmia. Mr. Sharp was pronounced dead soon after.
Mr. Sharp's doctors returned his ICD to St. Jude Medical for inspection and testing. St. Jude Medical's inspection revealed that the device had delivered high voltage therapy on August 23, 2015 at 6:56 a.m. However, the therapy was ineffective in reducing the arrhythmia because of damage to the device. Four subsequent attempts to deliver therapy were aborted due to detection of possible circuit damage. As a result, Mr. Sharp's ICD did not deliver the electrical shock his heart needed to keep him alive.
In her complaint, Ms. Sharp alleged that St. Jude Medical's manufacturing process violated federal regulations and failed to "adhere to the commitments made to the FDA in the PMA and supplemental PMA." St. Jude Medical's failure to manufacture in line with these requirements resulted in the "production ofdefective Riata leads," like Mr. Sharp's, that "render[ed] the device unreasonably dangerous for its intended use."
For example, Ms. Sharp alleged that St. Jude Medical's approved PMA required consistent insulation diameters.4 Yet the products were manufactured with inconsistent insulation diameters—leaving some products with too much and others with too little insulation. This inconsistency increased the risk of abrasion and externalization of the wires.
Ms. Sharp alleged that externalization can cause a lead to short circuit and prevent the device from delivering life-saving treatment. Abrasion is also associated with an inability of the ICD to deliver high voltage therapy. Despite five attempts to deliver high voltage therapy, Mr. Sharp's device failed to successfully do so.
Ms. Sharp also alleged that St. Jude Medical violated Current Good Manufacturing Practices and Quality System Regulations, 21 C.F.R. § 820 et seq.,in addition to the device-specific manufacturing parameters in the PMAs. She pointed to a 2009 FDA inspection of St. Jude Medical's manufacturing facility as evidence. After the inspection, the FDA issued a Form 483 report which documents conditions that may constitute violations of the Food and Drug Cosmetic Act and the Medical Devices Act. The 483 report issued for Defendants identified numerous potential violations that could affect the manufacturing process and lead to defective products.5
Additionally, Ms. Sharp identified a September 2011 FDA recall of Riata leads—because of failures associated with lead insulation abrasion—as circumstantial evidence of a defect under Georgia law. See Miller v. Ford Motor Co., 653 S.E.2d 82, 84 (Ga. Ct. App. 2007) . Ms. Sharp argues that the postmortem inspection of Mr. Sharp's ICD shows that his particular device suffered from this same insulation abrasion defect.
Georgia's statutes provide for strict liability for defective products. 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 suffers an injury to his 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." O.C.G.A. § 51-1-11(b)(1).
Accordingly, to state a claim for strict liability the plaintiff must show 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 plaintiffs injury." Brazil v. Janssen Rsch. & Dev. LLC, 196 F. Supp. 3d 1351, 1357 (N.D. Ga. 2016); see also Chicago Hardware & Fixture Co. v. Letterman, 510 S.E.2d 875, 877 (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). To allege a manufacturing defect, a plaintiff must "allege the existence of a specific manufacturing defect that proximately caused the harm." Brazil, 196 F. Supp. 3d at...
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