USCA11 Case: 19-13380 Date Filed: 12/23/2020 Page: 1 of 17
[DO NOT PUBLISH]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) USCA11 Case: 19-13380 Date Filed: 12/23/2020 Page: 2 of 17
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
3 USCA11 Case: 19-13380 Date Filed: 12/23/2020 Page: 4 of 17
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. 6 USCA11 Case: 19-13380 Date Filed: 12/23/2020 Page: 7 of 17
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 post- 2005 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. 7 USCA11 Case: 19-13380 Date Filed: 12/23/2020 Page: 8 of 17
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. 8 USCA11 Case: 19-13380 Date Filed: 12/23/2020 Page: 9 of 17
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,
10 USCA11 Case: 19-13380 Date Filed: 12/23/2020 Page: 11 of 17
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 FDA-
approved 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. 13 USCA11 Case: 19-13380 Date Filed: 12/23/2020 Page: 14 of 17
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: manufacturing-
defect 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 strict-
liability- 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. 14 USCA11 Case: 19-13380 Date Filed: 12/23/2020 Page: 15 of 17
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.