[DO NOT PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

________________________

No. 19-13380

________________________

D.C. Docket No. 1:17-cv-03181-SCJ

WENDY SHARP, 

Individually and as administrator of the 

estate of Estate of Milton Sharp, 

 Plaintiff-Appellant,

 versus

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.

________________________

Appeal from the United States District Court

for the Northern District of Georgia

________________________

(December 23, 2020)

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Before WILSON, NEWSOM, and ANDERSON, Circuit Judges.

WILSON, Circuit Judge:

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 support 

1 Ms. Sharp brought claims against St. Jude Medical, Inc., St. Jude Medical S.C., Inc., Pacesetter, 

Inc. d.b.a. St. Jude Medical Cardiac Rhythm Management Division, and St. Jude Medical LLC. 

Throughout this opinion they are collectively referred to as “St. Jude Medical” or “Defendants.”

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her negligence and strict liability claims. We reverse the district court’s dismissal 

of those claims.

I.

A. Procedural History

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 were 

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preempted.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. 

B. Standard of Review

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).

2 The district court noted that Ms. Sharp’s failure to state a claim was determinative of the case, 

but that the court considered Defendants’ preemption arguments “in the interest of caution.”

Because preemption is a principle derived from the Supremacy Clause, U.S. Const. Art. VI, cl. 2, 

it was inappropriate for the district court to reach preemption after finding that the state law 

claims were not viable. See Godelia v. Doe 1, 881 F.3d 1309, 1317 (11th Cir. 2018). 

Accordingly, the district court’s preemption analysis was not determinative, and we need reverse 

today only on the question of whether Ms. Sharp stated a claim. Though not determinative, the 

district court’s preemption analysis is flawed, nonetheless. Our precedent in Mink v. Smith & 

Nephew, Inc., 860 F.3d 1319, 1327 (11th Cir. 2017) and Godelia, 881 F.3d at 1317, 1319–20, 

clearly allows for parallel claims that fit in the “narrow gap” of cases that avoid both express and 

implied preemption. That precedent should govern any preemption analysis of these claims.

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II.

A. Factual Allegations

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.

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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 of 

3 Mr. Sharp initially had his ICD implanted in October of 2004. In September of 2011, Mr. Sharp 

had an operation to replace his then-existing generator with a St. Jude Fortify DR generator. The 

Riata lead remained intact. 

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defective 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., 

4 The dissent asserts that Ms. Sharp’s PMA claims suffer from a “timing issue.” We disagree. 

While Ms. Sharp’s complaint does discuss certain PMA amendments that St. Jude Medical 

applied for beginning in 2005—which necessarily cannot govern Mr. Sharp’s ICD that was 

implanted in 2004—not all discussions of the PMA violations specifically relate to these post2005 PMAs. In fact, the complaint also alleges that St. Jude Medical applied for 14 supplements 

to the original PMA that were approved between 1996 and 2002, and additional applications for 

PMA supplements that were approved “[o]ver the next several years.”

The complaint alleges defects like “inconsistent insulation diameters” that are “required 

by the PMA. . . to be consistent.” There is no indication that the PMA discussed there was 

imposed only after 2004. Reasonable inferences can be made from the complaint that there were 

PMA insulation requirements based on the original PMA or the pre-2005 supplements. At this 

stage, we must make all reasonable inferences in favor of Ms. Sharp. Accordingly, she has 

plausibly alleged a PMA violation that affected Mr. Sharp’s device. 

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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) (“A product recall can serve as 

circumstantial evidence of an original defect ... when there is first introduced some 

independent proof that the particular product in question suffered from the same 

defect.” (internal quotation mark omitted)). Ms. Sharp argues that the postmortem 

inspection of Mr. Sharp’s ICD shows that his particular device suffered from this 

same insulation abrasion defect. 

5 The dissent notes that the violations in the Form 483 report seem to allege design defects, not 

manufacturing defects. However, there is no reason that the report cannot be relevant to both 

types of claims. For example, plaintiffs alleged that “Defendants failed to define procedures for 

implementing corrective and preventative actions.” This could support a claim that the design 

was unsafe and can also support a claim that because of those failures, nonconforming products 

were produced. 

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B. Georgia Law

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 1358. “Thus, by 

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definition, a manufacturing defect will always be identifiable as a deviation from 

some objective standard or a departure from the manufacturer’s specifications 

established for the creation of the product.” Id. At the motion to dismiss stage, a 

plaintiff “need only allege [ ] a deviation and that the deviation was the proximate 

cause of the injury.” Morgan v. Dick’s Sporting Goods, Inc., 359 F. Supp. 3d 1283, 

1292 (N.D. Ga. 2019).

Georgia also recognizes negligence claims in relation to manufacturing 

defects. See O’Shea v. Zimmer Biomet Holdings, Inc., 342 F. Supp. 3d 1354, 1358 

(N.D. Ga. 2018). Under Georgia law, a plaintiff asserting a negligence claim must 

prove: (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. See Henderson v. Sun Pharms. Indus., Ltd., 809 F. Supp. 2d 1373, 1380 

(N.D. Ga. 2011). “[A] manufacturer has a duty to exercise reasonable care in 

manufacturing its products so as to make products that are reasonably safe for 

intended or foreseeable uses.” Morgan, 359 F. Supp. 3d at 1289 (citing Battersby 

v. Boyer, 526 S.E.2d 159, 162 (Ga. Ct. App. 1999)).

C. Analysis

Here, Ms. Sharp has alleged a strict liability claim. She alleged (1) that St. 

Jude Medical manufactured her husband’s ICD, (2) that the ICD was defective, 

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and (3) that those defects caused Mr. Sharp’s death. Specifically, Ms. Sharp says

that Defendants manufactured Riata leads that were not consistent with the FDAapproved PMA specifications mentioned above. These types of defects increase the 

risk of abrasion, which can cause short circuiting and an inability to deliver 

therapy—making the device not suitable for its reasonably intended use. 

St. Jude Medical’s postmortem inspection of Mr. Sharp’s device revealed 

that circuit damage prevented it from delivering the necessary charges. The FDA 

recall of Riata leads and the 483 report, despite occurring after Mr. Sharp’s lead 

was manufactured, allow for a plausible inference that his particular device 

suffered from these defects. Because the existence of a defect can be shown 

through circumstantial evidence alone, taking all of the allegations together, Ms. 

Sharp has alleged enough at this stage. See Firestone Tire & Rubber Co. v. King, 

244 S.E.2d 905, 909 (Ga. Ct. App. 1978). Finally, Ms. Sharp alleged that the defect

prevented Mr. Sharp’s device from administering therapy and caused his death. 

Ms. Sharp also alleged a negligence claim. Relying on the same facts, Ms. 

Sharp asserted that St. Jude Medical has a duty to exercise reasonable care in 

manufacturing ICDs to make them reasonably safe for their intended use. That 

duty includes strictly adhering to the protocols contained in the PMA and 

applicable federal regulations. St. Jude Medical breached their duty by failing to 

adhere to the requirements and PMAs. Ms. Sharp alleged that Defendants knew or 

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should have known that failure to strictly adhere to the requirements was likely to 

result in the production of a device with a latent defect. As a direct and proximate 

result of the manufacturing defect, Mr. Sharp died. 

Similar allegations have been found sufficient to state claims for negligence 

and strict liability manufacturing defects in Georgia. See e.g., Williams v. St. Jude 

Med., S.C., Inc., No. 16–CV–04437, slip op. at 2–3 (N.D. Ga. Oct. 19, 2017) 

(failing to dismiss these claims when plaintiff alleged that: an ICD was defectively 

manufactured because it deviated from the manufacturing standards, the defect 

existed at the time the product left defendant’s control, the defect was the result of 

defendant’s negligence, and the defect caused decedent’s death). 

III.

Ms. Sharp pleaded sufficient facts to allow this court to reasonably infer that 

St. Jude Medical’s violations of federal regulations caused Mr. Sharp’s device to 

fail. Accordingly, she sufficiently stated both strict liability and negligence 

manufacturing defect claims under Georgia law. Because the allegations in Ms. 

Sharp’s complaint are sufficient to plausibly allege these claims, we reverse the 

district court’s dismissal of both claims and remand for further proceedings 

consistent with this opinion. 

REVERSED and REMANDED.

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NEWSOM, Circuit Judge, concurring in part and dissenting in part:

I see part of this appeal differently than my colleagues do.1

 Although I have 

little doubt that something was amiss with Riata leads in general, I don’t think that 

Ms. Sharp’s complaint sufficiently alleged manufacturing-defect claims regarding 

this lead in particular. I write separately (and briefly) to explain why.

I

A

Having no quibble with the majority’s recitation of the facts and procedural 

history, I’ll skip straight to the point of divergence: whether Ms. Sharp sufficiently 

alleged claims for a manufacturing defect. I don’t think she did. 

First, a word on the taxonomy of product-defects claims under Georgia law. 

In Georgia, “[t]here are three general categories of product defects: manufacturing 

defects, design defects, and marketing/packaging defects.” Banks v. ICI Americas, 

1 A brief word on what I take to be common ground. In addition to her arguments about her 

manufacturing-defect claims, Ms. Sharp’s briefing before us includes a few references to, and 

one argument about, her negligence-per-se claim. But Sharp’s lone argument about her 

negligence-per-se claim challenges only the district court’s determination that the claim was 

preempted by federal law. By failing to address the district court’s antecedent determination that 

she failed to state a negligence-per-se claim as a matter of state law, Sharp “abandoned any 

challenge of that ground, and it follows that the judgment [in that respect] is due to be affirmed.” 

Sapuppo v. Allstate Floridian Ins. Co., 739 F.3d 678, 680 (11th Cir. 2014). The majority opinion 

discusses only Ms. Sharp’s manufacturing-defect claims in its analysis, see Maj. Op. at 10–12, 

and I understand that to mean that it also considers any issue regarding Sharp’s negligence-per-se 

claim to be abandoned. I concur in that much of the majority’s decision, and I take the 

majority’s reversal and remand to refer only the portion of the judgment that Sharp effectively 

challenged on appeal—that which concerned her manufacturing-defect claims regarding the 

Riata lead. 

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Inc., 450 S.E.2d 671, 672 (Ga. 1994); see also Ga. Code. Ann. § 51-1-11. A 

manufacturing-defect claim involves a product that falls short of “a built-in 

objective standard or norm of proper manufacture or design”—in short, it pertains 

to a particular product that came off the assembly line in bad shape. Banks, 450 

S.E.2d at 673 n.2 (quotation marks and emphasis omitted). In contrast, “a design 

defect claim posits that there is a problem with the entire product line[.]” In re 

Mentor Corp. ObTape Transobturator Sling Prod. Liab. Litig., 711 F. Supp. 2d 

1348, 1365 (M.D. Ga. 2010). Another piece of the background: manufacturingdefect claims can be premised on theories of strict liability or negligence. See 

Boswell v. OHD Corp., 664 S.E.2d 262, 263 (Ga. Ct. App. 2008). Both the strictliability- and negligence-based species of the manufacturing-defect genus require 

two things. A plaintiff must allege both “a defect in the product” and “a causal 

connection between the alleged . . . manufacturing defect and [the plaintiff’s] 

injury.” Id.2

 

With that in mind, I’ll turn to the sources that Ms. Sharp relied on in arguing 

that she sufficiently alleged manufacturing-defect claims in her late husband’s 

Riata lead. Start with the FDA’s 2011 recall of Riata leads. I don’t think that 

2 Because these two requirements are common to both kinds of manufacturing-defect claims at 

issue here, I address them jointly. And, because I would conclude that Sharp’s complaint failed 

to state a manufacturing-defect claim of either kind, I have nothing to say about preemption. Cf.

Maj. Op. at 4 n.2.

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source supports a manufacturing-defect claim—of either kind—because the 

problems that led to the recall seem to have been caused by a design defect. The 

FDA’s Recall Notice listed the “FDA Determined Cause” of the recall as “Device 

Design.” In Sharp’s operative complaint, she discusses the recall at some length 

and mentions both design and manufacturing defects in relation to the recall. But 

allegations that might support a claim of one kind won’t necessarily support the 

other. Sharp may be right to say that her complaint “clearly alleges Mr. Sharp’s 

leads had the same defect identified in the recalled leads,” and that under Georgia 

law, the recall is, by itself, sufficient to indicate some defect in the product. See 

Miller v. Ford Motor Co., 653 S.E.2d 82, 84 (Ct. App. Ga. 2007). But, insofar as

the defect that spawned the recall was a design defect, that allegation doesn’t 

support manufacturing-defect claims.

Next, Sharp’s allegations of a manufacturing defect assert various violations 

of certain federal requirements. Broadly speaking, I think those requirements can 

be put in two classes: (1) those related to the PMAs issued for the Riata lead, and 

subsequent supplements to those PMAs; and (2) CGMP regulations.

As I see it, the PMA-related allegations suffer from a timing issue. 

Specifically, Sharp’s allegations concern failures to live up to standards that the 

FDA set after Mr. Sharp’s lead had been implanted. For example, the complaint 

said that during the time from “2005-2010 St. Jude applied for at least 27 

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manufacturing or process changes to the Riata leads” that the FDA approved, but 

that “St. Jude failed to manufacture the Riata leads in a manner consistent with 

these approved changes . . . .” And then it details various alleged violations of 

those standards. On appeal, those alleged violations formed the centerpiece of Ms. 

Sharp’s argument, and each details how a particular deviation from a particular 

PMA requirement led to a problem with the insulation in Riata leads. In a vacuum,

it’s clear enough that alleged violations of those standards support a

manufacturing-defect claim. But not these claims—that’s because those 

allegations involve standards set in 2005 (at the earliest), and Mr. Sharp’s lead was 

implanted in his chest in 2004, which means it was manufactured in 2004 (at the 

latest). I don’t see how standards from 2005 and thereafter can provide the 

standard by which one judges such a lead. 

With respect to the allegations involving CGMPs, the problem isn’t so much 

one of timing as it is of causation. For a bit of context, CGMPs “govern the 

methods used in, and the facilities and controls used for, the design, manufacture, 

packaging, labeling, storage, installation, and servicing of all finished devices 

intended for human use.” 21 C.F.R. § 820.1(a). And Sharp’s complaint points out 

that the FDA issued a Form 483 letter in 2009 detailing potential violations of 

these regulations. But I don’t understand how these alleged violations relate to a 

manufacturing defect. For instance, the complaint alleges that “[St. Jude] failed to 

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perform design reviews at appropriate times” and that “team meeting minutes were 

not maintained as required.” It’s not self-evident to me what those failures have to 

do with manufacturing-defect claims, and Sharp doesn’t do much to help us 

connect the dots. The same is true for an alleged failure to “resolve discrepancies 

noted at the completion of design verification.” So too with respect to the 

allegations about risk analysis and reporting requirements—those might have 

supported other claims Sharp made (like failure-to-warn claims), but I don’t see 

how they relate to Sharp’s manufacturing-defect claims.

* * *

In sum: I think that (1) the FDA’s recall points to a different kind of defect, 

(2) the PMA and PMA supplements that Sharp connects to a manufacturing-defect 

postdate the making of this particular device, and (3) Sharp didn’t link the alleged 

violations of CGMPs to a manufacturing-defect. As a result, I don’t think the 

complaint here stated a claim for a manufacturing defect and I would affirm the 

district court’s judgment on that basis. Because my colleagues conclude otherwise, 

I must respectfully dissent from that much of the majority’s judgment.

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