United States Court of Appeals 

for the Fifth Circuit ____________ 

No. 23-50274 

____________ 

GeorgAnn Oglesby; Stephen Oglesby, 

Plaintiffs—Appellants, 

versus

Medtronic, Incorporated; Medtronic USA, 

Incorporated; Integra LifeSciences Corporation, 

Defendants—Appellees. 

______________________________ 

Appeal from the United States District Court 

for the Western District of Texas 

USDC No. 5:20-CV-1267 

______________________________ 

Before King, Ho, and Engelhardt, Circuit Judges.

Per Curiam:*

GeorgAnn Oglesby sued Medtronic, Inc., Medtronic USA, Inc., and 

Integra LifeSciences Corporation, asserting manufacturing defect, negligence, and failure-to-warn claims after a medical device implanted in 

Oglesby’s body disintegrated. The district court granted summary judgment 

in favor of Medtronic and Integra. We affirm. 

_____________________ 

*

 This opinion is not designated for publication. See 5th Cir. R. 47.5. 

United States Court of Appeals 

Fifth Circuit 

FILED 

March 26, 2024 

Lyle W. Cayce 

Clerk 

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No. 23-50274 

2 

In July 2019, Oglesby had surgery to address a cyst on her cervical 

spine. During the surgery, Oglesby’s physician implanted a Durepair Dura 

Regeneration Matrix—a medical device designed to be used as a patch to repair dura matter, which is a membrane protecting the brain and spinal cord. 

The Durepair device was manufactured by Integra and sold by Medtronic. 

Soon after the surgery, Oglesby experienced severe headaches and 

other serious symptoms. Oglesby underwent another surgery in which her 

physician discovered that the Durepair patch had largely disintegrated, causing a cerebrospinal fluid leak. 

Oglesby and her husband sued Medtronic in Texas state court. 

Medtronic removed the case to federal court, and Oglesby later amended her 

complaint to include Integra as a defendant. She asserts manufacturing 

defect, negligence, and failure-to-warn claims. 

Medtronic and Integra both filed motions for summary judgment. 

The magistrate judge’s report and recommendation concluded (1) that 

Oglesby’s manufacturing defect and negligence claims failed because she did 

not identify a specific defect in the Durepair product and (2) that Oglesby’s 

failure-to-warn claim failed because Oglesby could not show that her doctor 

would have read the warning even if an adequate warning was provided. The 

district court adopted the magistrate judge’s report and recommendation, 

granted both summary judgment motions, and dismissed the case. Oglesby 

appealed. 

We review a district court’s grant of summary judgment de novo. 

Norman v. Bodum USA, Inc., 44 F.4th 270, 272 (5th Cir. 2022). Courts grant 

summary judgment “if the movant shows that there is no genuine dispute as 

to any material fact and the movant is entitled to judgment as a matter of 

law.” Fed. R. Civ. P. 56(a). Summary judgment is inappropriate, 

however, if, viewing the evidence in the light most favorable to the 

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3 

nonmovant, “a reasonable jury could return a verdict for the nonmoving 

party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). 

Oglesby’s claims are governed by Texas law. We first address her 

manufacturing defect claim. “A manufacturing defect exists when a product 

deviates, in its construction or quality, from the specifications or planned 

output in a manner that renders it unreasonably dangerous.” Ford Motor Co. 

v. Ridgway, 135 S.W.3d 598, 600 (Tex. 2004). “A plaintiff must prove that 

the product was defective when it left the hands of the manufacturer and that 

the defect was a producing cause of the plaintiff’s injuries.” Id. 

While “[a] manufacturing defect may be established exclusively 

through circumstantial evidence,” Norman, 44 F.4th at 272, product failure 

alone is not enough to prevail on a manufacturing defect claim. See Ford 

Motor Co. v. Ledesma, 242 S.W.3d 32, 42 (Tex. 2007). Instead, the plaintiff 

must identify a specific defect in how the product was manufactured. See 

Gharda USA, Inc. v. Control Sols., Inc., 464 S.W.3d 338, 352 (Tex. 2015) (“To 

be successful on a manufacturing defect claim, the plaintiff must identify a 

specific defect by competent evidence and rule out other possible causes of 

the damage.”); Ledesma, 242 S.W.3d at 42 (“While a products liability claim 

does not of course require proof of manufacturer negligence, the deviation 

from design that caused the injury must be identified.”). 

However, Oglesby has not attempted to identify any specific way in 

which the Durepair product deviated from its design. She acknowledges as 

much in her briefing, which states that she “has not pointed to the specific 

mechanism by which the Durepair device was defective.” Instead, she 

argues that the law does not require her to allege a specific defect, relying 

heavily on older cases from this court and the Texas courts of appeals. See 

Ayres v. Sears, Roebuck & Co., 789 F.2d 1173, 1175 (5th Cir. 1986) (stating that 

plaintiffs “need not establish the specific feature which made the product 

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4 

defective”). See also Bell Aerospace Corp. v. Anderson, 478 S.W.2d 191, 197 

(Tex. Civ. App.—El Paso 1972, writ ref’d n.r.e.); Baxter Healthcare Corp. v. 

Grimes, No. 05-95-01682-CV, 1998 WL 548729, *10 (Tex. App.—Dallas 

Aug. 31, 1998, no pet.). 

But “[t]o determine Texas law, this court looks first to the final 

decisions of the Texas Supreme Court.” Austin v. Kroger Tex. L.P., 746 F.3d 

191, 196 (5th Cir. 2014). In recent years, the Texas Supreme Court has 

repeatedly stated that identifying a specific defect is essential to a 

manufacturing defect claim. See Gharda USA, 464 S.W.3d at 352; Ledesma, 

242 S.W.3d at 42; Nissan Motor Co. v. Armstrong, 145 S.W.3d 131, 137 (Tex. 

2004) (“[A] specific defect must be identified by competent evidence.”). See 

also Norman, 44 F.4th at 272 (“[P]laintiffs must allege a specific deviation 

from the product’s intended design that allegedly caused the injury.”). 

Oglesby points to evidence indicating that the Durepair patch was not 

designed to dissolve, but that it nevertheless sometimes disintegrates. But 

none of this evidence establishes a specific manufacturing defect. See

Ledesma, 242 S.W.3d at 42 (noting that deviation from design “serves the 

essential purpose of distinguishing a manufacturing defect from a design 

defect”); Norman, 44 F.4th at 272 (“In a manufacturing defect case, . . . the 

plaintiff must present proof of a manufacturer’s intended design, from which 

the actual product in question deviated as a result of a defect in the 

manufacturing process.”). 

Oglesby also cites expert testimony that, “within a reasonabl[e] 

degree of engineering and scientific probability, and on a more-likely-thannot basis, the Subject Durepair contained a manufacturing defect and/or 

reacted adversely with the Adherus sealant which led to its ‘disintegration,’ 

as noted by [Oglesby’s physician].” But this testimony also does not 

establish the specific manufacturing defect that allegedly caused the 

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5 

disintegration. Nor does it support an inference that such a defect, as 

opposed to an adverse reaction with the sealant, more likely than not caused 

the disintegration. “When the circumstances are equally consistent with 

either of two facts, neither fact may be inferred.” City of Keller v. Wilson, 168 

S.W.3d 802, 813 (Tex. 2005) (internal quotation omitted).1

While a specific defect may be proven by circumstantial evidence, that 

does not eliminate the requirement to allege the existence of a specific defect 

in the first place. Oglesby failed to do so. Under Texas law, this fact alone 

means that her manufacturing defect claim cannot succeed. The district 

court therefore correctly granted summary judgment for Integra and 

Medtronic on Oglesby’s manufacturing defect claim. 

Oglesby’s negligence claim fails for the same reason. “While strict 

liability focuses on the condition of the product, negligence looks at the acts 

of the manufacturer and determines if it exercised ordinary care in design and 

production.” Am. Tobacco Co. v. Grinnell, 951 S.W.2d 420, 437 (Tex. 1997) 

(cleaned up). But “a manufacturer logically cannot be held liable for failing 

to exercise ordinary care when producing a product that is not defective.” 

Garrett v. Hamilton Standard Controls, Inc., 850 F.2d 253, 257 (5th Cir. 1988). 

Oglesby points to the doctrine of res ipsa loquitor, but this doctrine does not 

relieve plaintiffs of their burden to allege a specific defect. See Funk v. Stryker 

Corp., 631 F.3d 777, 782 (5th Cir. 2011) (holding that the plaintiff failed to 

state a manufacturing defect claim because the complaint “d[id] not specify 

the manufacturing defect,” notwithstanding the plaintiff’s invocation of the 

res ipsa loquitor doctrine).

_____________________ 

1

 Oglesby contends that the district court improperly weighed the evidence under 

the merits-stage preponderance-of-the-evidence standard instead of using the proper 

summary judgment standard under Rule 56. But, as explained above, under Texas law, 

Oglesby’s evidence is legally insufficient for a reasonable jury to find in her favor. 

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6 

That leaves Oglesby’s failure-to-warn claim. Because she didn’t 

object to the magistrate judge’s recommendation on this issue, we review for 

plain error. See Wallace v. Mississippi, 43 F.4th 482, 494–95 (5th Cir. 2022) 

(“[I]t has long been established that, when the district court has not made an 

independent review of the record, failure to object to an issue in the R & R, 

when warned of the requirement to file timely objections, results in plainerror review applying to that issue when raised in our court.”) (citation 

omitted). Under plain-error review, among other requirements, “the legal 

error must be clear or obvious, rather than subject to reasonable dispute.” 

Puckett v. United States, 556 U.S. 129, 135 (2009). 

“Generally, a manufacturer is required to provide an adequate 

warning to the end users of its product if it knows or should know of any 

potential harm that may result from the use of its product.” Centocor, Inc. v. 

Hamilton, 372 S.W.3d 140, 153–54 (Tex. 2012). Under the learned 

intermediary doctrine, which “generally applies within the context of a 

physician-patient relationship,” the manufacturer “fulfill[s] its duty to warn 

end users of its product’s potential risks by providing an adequate warning to 

the prescribing physician.” Id. at 142. However, even if a warning is 

inadequate, the plaintiff must still show that the failure to warn was the 

“producing cause” of the plaintiff’s injuries. Id. at 170. “In the [learned 

intermediary] context, causation entails two distinct factual predicates: first, 

that the doctor would have read or encountered the adequate warning; and 

second that the adequate warning would have altered his treatment decision 

for, or risk-related disclosures to, the patient.” In re DePuy Orthopaedics, Inc., 

888 F.3d 753, 775 (5th Cir. 2018) (emphasis and footnote omitted). 

We agree with Medtronic and Integra that Oglesby did not establish a 

genuine dispute of material fact on causation. Oglesby’s physician testified 

that he could not recall reading a product manual or any other Medtronic 

resources about the Durepair product, that he “probably” did not read the 

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Durepair product’s instructions for use when preparing for Oglesby’s 

surgery or when he first learned about Durepair, and that he “maybe” had 

not ever read the instructions for use. 

Oglesby therefore cannot show that an adequate warning would have 

prevented her physician from using the product. See Pustejovsky v. Pliva, Inc., 

623 F.3d 271, 277 (5th Cir. 2010) (“Dr. Collini did not recall ever reading the 

package insert for the drug or consulting the Physician’s Desk Reference. 

Her lack of memory, of course, does not preclude the possibility that she had 

read these materials, but neither can it sustain Pustejovsky’s [summary 

judgment] burden.”). Oglesby nonetheless contends that she has established 

a genuine dispute of material fact because her physician cut the Durepair 

device to size before implanting it in Oglesby’s body. According to Oglesby, 

this indicates that he did read the Durepair instructions. But her physician 

testified that cutting the device is merely “standard operating procedure” 

since “[t]hey come in standard sizes.” The fact that he cut the device 

therefore does not create a genuine dispute of material fact as to whether he 

read the instructions for the Durepair product. 

For these reasons, we affirm the district court’s decision to grant the 

defendants’ motions for summary judgment. 

 

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