Opinion
SA-20-CV-1267-FB (HJB)
01-06-2023
GEORGANN OGLESBY, and STEPHEN OGLESBY, Plaintiffs, v. MEDTRONIC, INC., MEDTRONIC USA, INC., and INTEGRA LIFESCIENCES CORPORATION, Defendants.
To Honorable Fred Biery, United States District Judge:
REPORT AND RECOMMENDATION OF UNITED STATES MAGISTRATE JUDGE
Henry J. Bemporad, United States Magistrate Judge.
This Report and Recommendation concerns the motions for summary judgment filed by Defendants Medtronic, Inc., (“Medtronic”) and Integra LifeSciences Corporation (“Integra”).(Docket Entries 104 and 105.) Pretrial matters in this case have been referred to the undersigned for consideration. (See Docket Entry 39.) For the reasons set out below, I recommend that Defendants' motions for summary judgment (Docket Entries 104 and 105) be GRANTED.
Medtronic and Integra present substantially the same arguments and will be referred to collectively as “Defendants.”
I. Jurisdiction.
Defendants removed this case from state court to this Court, alleging diversity jurisdiction pursuant to 28 U.S.C. § 1332 and 1441(a). I have authority to issue this Report and Recommendation pursuant to 28 U.S.C. § 636(b)(1)(B).
II. Background.
This case involves causes of action arising from the use of an allegedly defective medical device, the Durepair Dura Regeneration Matrix. (See Docket Entry 98, at 2.) The background summary that follows describes the medical procedures involved, the device, and the procedural history of the case.
A. The Surgeries.
Doctors discovered a large cyst on Plaintiff Georgann Oglesby's cervical spine. (Docket Entry 119-1, at 13-14.) On July 11, 2019, Dr. G. Alexander West surgically removed the cyst. (Docket Entry 119-1, at 24-25.) As part of that procedure, Dr. West implanted the Durepair device and used an Adherus dural sealant spray in conjunction with the implant. (Docket Entry 119-1, at 28-29; Docket Entry 104-2, at 83.) Dr. West did not recall ever reading the Instructions for Use (“IFU”) for either the Durepair device or the sealant spray. (Docket Entry 119-1, at 75, 83.)
Two or three weeks after her surgery, Georgann began experiencing “headaches, discomfort, [and] other symptoms” that prompted Dr. West to conduct a workup. (Docket Entry 119-1, at 33.) Dr. West discovered a cerebrospinal fluid (“CSF”) leak and attempted a blood patch to resolve it. (Id. at 33-34.) When the blood patch did not work, Dr. West conducted a second surgery on September 14, 2019. (Id. at 34-35.) During the second surgery, doctors discovered that the Durepair device had largely disintegrated and that Georgann was leaking cerebrospinal fluid from the patch. (Docket Entry 119-1, at 38.) Dr. West reported the event to the FDA because he believed the device was defective based on his experience as a neurosurgeon. (Docket Entry 119-1, at 38, 45.)
B. The Device.
The Durepair device is a dura substitute used to repair the dura matter that covers the brain and spinal cord. (See Docket Entry 104-3, at 3.) Defendant Medtronic is responsible for the Durepair's design and the warnings contained in the IFU. (See Docket Entry 104-7.) Defendant Integra manufactures Durepair devices in accordance with Medtronic's specifications. (Docket Entry 104-6, at 5.) The device history and “Final Release” form indicates the Durepair device used in Georgann's surgery “met all manufacturing specifications, passed all testing, and contained no non-conformities and no deviations,” and Plaintiffs have provided no evidence that the device used in the surgery deviated from the design. (See Docket Entries 104-1 and 104-9.)
C. Procedural History.
On August 31, 2020, Plaintiffs filed suit against Medtronic in the 433rd Judicial District of Comal County, Texas. (Docket Entry 1, at 11.) Plaintiffs brought causes of action based on theories of negligence, breach of warranty, manufacturing defect, and res ipsa loquitur. (Id. at 1119.) Defendant Medtronic removed the case to this Court. (Docket Entry 1.) Plaintiffs subsequently amended their complaint to comply with federal pleading standards. (Docket Entry 6.) Thereafter, Plaintiffs sought leave to file their second amended complaint, adding Integra as a party. (Docket Entry 19.) After completing some discovery, Plaintiffs were granted leave to file a third amended complaint. (See Docket Entries 97 and 98.) Both Defendants moved for summary judgment. (Docket Entries 104 and 105.) Plaintiffs responded in opposition (Docket Entries 118 and 119), and Defendants replied (Docket Entries 126 and 127).
III. Legal Standard.
A party is entitled to summary judgment under Federal Rule of Civil Procedure 56 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). “A fact is material if it might affect the outcome of the suit under the governing law, while a dispute about that fact is genuine if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Owens v. Circassia Pharms., Inc., 33 F.4th 814, 824 (5th Cir. 2022) (internal quotation marks omitted).
The moving party “always bears the initial responsibility of demonstrating the absence of a genuine issue of material fact.” Jones v. United States, 936 F.3d 318, 321 (5th Cir. 2019) (alterations omitted). When the movant would not bear the burden of persuasion at trial, he may satisfy his initial summary judgment burden “by pointing out that the record contains no support for the non-moving party's claim.” Wease v. Ocwen Loan Serv., L.L.C., 915 F.3d 987, 997 (5th Cir. 2019). If the moving party satisfies his initial burden, the nonmovant “must go beyond the pleadings and designate specific facts showing that there is a genuine issue for trial.” Jones, 936 F.3d at 321.
IV. Analysis.
Plaintiffs assert the following claims: strict liability manufacturing defect, negligence, and negligent failure to warn. They also assert the doctrine of res ipsa loquitur, seek punitive damages, and seek loss of consortium damages for Plaintiff Stephen Oglesby. (Docket Entry 98.) Defendants seek summary judgment on all claims. Each of Plaintiffs' claims are addressed below.
A. Strict Liability Manufacturing Defect.
“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.” Cooper Tire & Rubber Co. v. Mendez, 204 S.W.3d 797, 800 (Tex. 2006) (quoting Ford Motor Co. v. Ridgway, 135 S.W.3d 598, 600 (Tex. 2004). To prevail on a manufacturing-defect claim. “[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.
Defendants argue that Plaintiffs have failed to provide evidence of a manufacturing defect. (Docket Entry 104, at 13-14; Docket Entry 105, at 10-11.) Specifically, Defendants rely on Integra's 30(b)(6) corporate witness to assert that the Durepair device met its manufacturing specifications and therefore a defect did not exist. (Docket Entry 104, at 14; Docket Entry 105, at 11.) Plaintiffs respond that the defect in this case was a latent defect not visible to the naked eye; the Durepair device was “designed to act as a patch and not dissolve in a patient's body”; and the device malfunctioned when it disintegrated inside Georgann Oglesby's body. (Docket Entry 118, at 14-16; Docket Entry 119, at 18-20.)
“Texas law does not generally recognize a product failure or malfunction, standing alone, as sufficient proof of a product defect.” Ford Motor Co. v. Ledesma, 242 S.W.3d 32, 42 (Tex. 2007) (citing Cooper Tire & Rubber Co., 204 S.W.3d at 807). “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.” Gharda USA, Inc. v. Control Sols., Inc., 464 S.W.3d 338, 352 (Tex. 2015). “[E]xpert testimony is generally encouraged if not required to establish a products liability claim.” Ledesma, 242 S.W.3d at 42.
Plaintiffs contend that they provide evidence creating a genuine issue as to the existence of a manufacturing defect and resulting damage because their expert, Dr. Jahan Rasty, testified that the disintegration of the device “was more likely than not caused by a manufacturing defect.” (Docket Entry 118, at 16; Docket Entry 119, at 20.) In reply, Defendants point out that Plaintiff's recitation omits key statements in Dr. Rasty's affidavit regarding the cause of the disintegration. (Docket Entry 127, at 3; Docket Entry 126, at 7.) As shown by Defendants, the language as to causation cited by Plaintiffs does not appear in the affidavit of Dr. Rasty that was attached as an exhibit to Plaintiffs' response. In that affidavit, Dr. Rasty testified that “within a reasonably [sic] degree of engineering and scientific probability, and on a more-likely-than-not basis, the Subject Durepair contained a manufacturing defect and/or reacted adversely with the Adherus sealant which led to its ‘disintegration.'” (Docket Entry 119-2, at ¶ 11.) Therefore, Plaintiffs' own expert presented two equally likely causes of the disintegration: a manufacturing defect “and/or” an adverse reaction with the sealant. When the plaintiff's own evidence shows an equally likely alternative cause of the alleged damages, a manufacturing defect is not shown by a preponderance of the evidence.Because Plaintiffs have not presented competent evidence of a specific manufacturing defect that led to the alleged injuries, summary judgment on this claim should be granted. See Ridgway, 135 S.W.3d at 601 (finding defendant entitled to summary judgment when plaintiffs' expert could not rule out other possible cause of malfunction and there was no proof of defect in product when it left the manufacturer).
After briefing on the motion for summary judgment, Plaintiffs filed an advisory explaining that their response quotes Dr. Rasty's October 2021 affidavit, which was prepared before additional discovery was taken; after discovery, he updated the affidavit, and it is this updated affidavit that is attached to Plaintiffs' response. (See Docket Entry 133.) The undersigned relies on the updated affidavit in reaching the conclusions below.
Plaintiffs also contend that Dr. West's opinion testimony shows a defect existed because the device failed. (Docket Entry 118, at 16; Docket Entry 119, at 20.) Defendants have moved to strike Dr. West's opinions regarding alleged defects. (See Docket Entry 128.) Even if the Court considers Dr. West's testimony, it is not enough to show the existence of a manufacturing defect that caused the failure here: Dr. West did not have an opinion as to why the Durepair device failed. (See Docket Entry 104-2, at 4-5 (“Q. And do you any idea why, as you sit here today, the Medtronic dura patch failed? A. I do not.”)).
B. Negligence.
Defendants seek summary judgment on Plaintiffs' negligence claims. A negligence claim is a distinct cause of action from a strict products liability claim. Am. Tobacco Co. v. Grinnell, 951 S.W.2d 420, 437 (Tex. 1997). “Strict liability looks at the product itself and determines if it is defective. Negligence looks at the acts of the manufacturer and determines if it exercised ordinary care in design and production.” Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 384 (Tex. 1995). “To prevail on a claim of negligence against the supplier of an allegedly defective product, a plaintiff must prove a legal duty owed to the plaintiff by the defendant, breach of that duty, and damages to the plaintiff proximately caused by the breach of that duty.” Cofresi v. Medtronic, Inc., 450 F.Supp.3d 759, 765 (W.D. Tex. 2020) (quoting Dewayne Rogers Logging, Inc. v. Propac Indust., Ltd., 299 S.W.3d 374, 385 (Tex. App. 2009)).
Defendants argue that Plaintiffs' negligence claims fail because they are based on an alleged manufacturing defect and Plaintiffs have provided no evidence of a defect. (Docket Entry 104, at 16; Docket Entry 105, at 12.) Plaintiffs respond that there remains a genuine issue of material fact as to whether Defendants “knew or should have known about the defects in the Durepair device but did not fix it,” and that Defendants “breached the duty of ordinary care by negligently creating a manufacturing defect ... which caused the Durepair to dissolve” and by “failing to properly test, inspect, and manufacture the Durepair.” Plaintiffs also assert the doctrine of res ipsa loquitor asserting that “the character of the accident is such that it would not ordinarily occur absent negligence related to a manufacturer's defect.” (Docket Entry 118, at 28-29; Docket Entry 119, at 28-29.)
“[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). As discussed above, Plaintiffs have failed to show a manufacturing defect. Absent a specific defect, their negligence claims, including the res ipsa loquitur theory, similarly fail. See Elmazouni v. Mylan, Inc., 220 F.Supp.3d 736, 743 (N.D. Tex. 2016) (“Whether Plaintiffs seek recovery based on a negligence theory or a strict liability theory, they must establish that [the] injury resulted from a defect in the [product].”) Accordingly, summary judgment should be granted on Plaintiffs' negligence claims.
Plaintiffs' negligence claims additionally fail because they have not shown an alternative design. Texas courts have required such a showing for negligent manufacturing claims. See Am. Tobacco Co. v. Grinnell, 951 S.W.2d at 437 (“Absent an alternative design, a claim for negligent design or manufacturing fails as a matter of law.”); accord Ridgway v. Ford Motor Co., 82 S.W.3d 26, 32 (Tex. Ct. App. 2002) (“Negligent manufacturing claims must be accompanied by a safer alternative design.”), reversed on other grounds, 135 S.W.3d 598 (Tex. 2004). Plaintiffs rely on Ledesma, 242 S.W.3d 32, to dispute this requirement. However, Ledesma involved a strict liability claim and not a negligence claim. See id. at 42-43.
C. Failure to Warn.
Defendants seek summary judgment on Plaintiffs' failure-to-warn claims, arguing that the Durepair's warnings were adequate as a matter of law and that Plaintiffs failed to establish causation. (Docket Entries 104, at 2; Docket Entry 105, at 13-14.) Integra also argues that because it serves as Medtronic's contract manufacturer, its only responsibility relating to warnings was to include Medtronic's IFU in the Durepair packaging. (Docket Entry 105, at 13.) Because Defendants' causation argument is well-taken, the Court need not consider the additional arguments.
“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). To prevail on a failure-to-warn claim, a plaintiff must show: “(1) the warning was defective; and (2) the failure to warn was a producing cause of the plaintiff's condition or injury.” Perez v. Am. Med. Sys. Inc., 461 F.Supp.3d 488, 506 (W.D. Tex. 2020) (quoting Porterfield v. Ethicon, Inc., 183 F.3d 464, 468 (5th Cir. 1999)). In “medical products liability actions” like this one, the learned-intermediary (“LI”) doctrine requires that the warning be provided to the doctor, “who then assumes the duty to pass on the necessary warnings to the end user”-the patient. Centocor, 372 S.W.3d at 142. Causation in the LI context “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., Pinnacle Hip Implant Prod. Liab. Litig., 888 F.3d 753, 775 (5th Cir. 2018).
Defendants argue that any failure to warn could not have caused Plaintiffs' injury because Dr. West “did not recall ever reading” the Durepair's warnings, nor did he rely on them to inform himself of the risks associated with the surgery. (Docket Entry 104, at 11; Docket Entry 105, at 14-15 (emphasis in original).) Plaintiffs respond that even if Dr. West had read the warnings, he would not have been informed of the risk of disintegration. (Docket Entry 118, at 22-23; Docket Entry 119, at 16.) This response misses the point. To prove that the allegedly inadequate warning caused the injury, Plaintiffs must show that if an adequate warning had been provided, Dr. West “would have read or encountered” it. See Pinnacle Hip Implant, 888 F.3d at 775. Without evidence that Dr. West would have read or encountered an adequate warning, Plaintiffs cannot demonstrate that the allegedly inadequate warning was the producing cause of the injury. See, e.g., Isaac v. C.R. Bard, Inc., No. A-19-CV-895-LY, 2021 WL 1177882, at *5-6 (W.D. Tex. Mar. 29, 2021) (granting summary judgment where plaintiff provided no evidence that physician would have read or encountered the adequate warning); Pustejovsky v. Pliva, Inc., 623 F.3d 271, 277 (5th Cir. 2010) (physician's failure to recall ever reading the warnings could not sustain plaintiff's summary judgment burden). Accordingly, summary judgment should be granted on this claim.
D. Remaining Issues.
Plaintiffs seek punitive damages and loss of consortium damages for Mr. Oglesby. (See Docket Entry 98, at 10-12.) The parties dispute whether these specific damages may be awarded. (See Docket Entry 104, at 16, 20; Docket Entry 105, at 16, 20; Docket Entry 119, at 23, 29.) As the undersigned has recommended that summary judgment be granted in Defendants' favor on all of Plaintiffs' claims relating to Georgann's injuries, Plaintiffs are not entitled to punitive damages, and the derivative loss of consortium claim fails.
V. Conclusion and Recommendation.
Based on the foregoing, I recommend that Medtronic's and Integra's motions for summary judgment (Docket Entries 104 and 105) should be GRANTED.
VI. Instructions for Service and Notice of Right to Object.
The United States District Clerk shall serve a copy of this Report and Recommendation on all parties by either (1) electronic transmittal to all parties represented by attorneys registered as a “filing user” with the clerk of court, or (2) by mailing a copy to those not registered by certified mail, return receipt requested. Written objections to this Report and Recommendation must be filed within fourteen (14) days after being served with a copy of same, unless this time period is modified by the district court. 28 U.S.C. § 636(b)(1); FED. R. CIV. P. 72(b). The party shall file the objections with the clerk of the court, and serve the objections on all other parties. A party filing objections must specifically identify those findings, conclusions or recommendations to which objections are being made and the basis for such objections; the district court need not consider frivolous, conclusive or general objections. A party's failure to file written objections to the proposed findings, conclusions and recommendations contained in this report shall bar the party from a de novo determination by the district court. Thomas v. Arn, 474 U.S. 140, 149-52 (1985); Acuna v. Brown & Root, Inc., 200 F.3d 335, 340 (5th Cir. 2000). Additionally, failure to file timely written objections to the proposed findings, conclusions and recommendations contained in this Report and Recommendation shall bar the aggrieved party, except upon grounds of plain error, from attacking on appeal the unobjected-to proposed factual findings and legal conclusions accepted by the district court. Douglass v. United Servs. Auto. Ass'n, 79 F.3d 1415, 1428-29 (5th Cir. 1996) (en banc).