Opinion
CIVIL ACTION NO. SA-20-CA-920-FB
2023-03-06
Danielle BAKSIC, and Brian Baksic, Plaintiffs, v. ETHICON INC., and Johnson & Johnson, Defendants.
Alicia D. O'Neill, Francisco Guerra, IV, Paige Boldt, Watts Guerra LLP, San Antonio, TX, Laurel Li Harris, Pro Hac Vice, Sheila M. Bossier, Pro Hac Vice, Bossier & Associates, PLLC, Jackson, MS, for Plaintiffs. Anita Modak-Truran, Butler Snow LLP, Nashville, TN, Chad R. Hutchinson, Pro Hac Vice, ButlerSnow, LLP, Ridgeland, MS, Christopher R. Cowan, Jordan Jarreau, Butler Snow LLP, Austin, TX, Kari L. Sutherland, Pro Hac Vice, Butler Snow LLP, Oxford, MS, Pamela Lawrence Ferrell, Pro Hac Vice, Butler Snow LLP, Atlanta, GA, Michael B. Hewes, Pro Hac Vice, Butler Snow LLP, Gulfport, MS, for Defendants.
Alicia D. O'Neill, Francisco Guerra, IV, Paige Boldt, Watts Guerra LLP, San Antonio, TX, Laurel Li Harris, Pro Hac Vice, Sheila M. Bossier, Pro Hac Vice, Bossier & Associates, PLLC, Jackson, MS, for Plaintiffs. Anita Modak-Truran, Butler Snow LLP, Nashville, TN, Chad R. Hutchinson, Pro Hac Vice, ButlerSnow, LLP, Ridgeland, MS, Christopher R. Cowan, Jordan Jarreau, Butler Snow LLP, Austin, TX, Kari L. Sutherland, Pro Hac Vice, Butler Snow LLP, Oxford, MS, Pamela Lawrence Ferrell, Pro Hac Vice, Butler Snow LLP, Atlanta, GA, Michael B. Hewes, Pro Hac Vice, Butler Snow LLP, Gulfport, MS, for Defendants. ORDER ACCEPTING REPORT AND RECOMMENDATION OF UNITED STATES MAGISTRATE JUDGE FRED BIERY, UNITED STATES DISTRICT JUDGE
Before the Court are the Report and Recommendation of United States Magistrate Judge (docket no. 98) concerning the Motion for Summary Judgment filed by Defendants Ethicon Inc. and Johnson & Johnson (sometimes collectively referred to as "Ethicon") (docket no. 74) and the Motion for Partial Summary Judgment filed by Plaintiffs Danielle Baksic and Brian Baksic (docket no. 75), along with Plaintiffs' written objections (docket no. 99) thereto and Defendants' response (docket no. 100) to Plaintiffs' objections.
Where no party has objected to a Magistrate Judge's Report and Recommendation, the Court need not conduct a de novo review of the Report and Recommendation. See 28 U.S.C. § 636(b)(1) ("A judge of the court shall make a de novo determination of those portions of the report or specified proposed findings and recommendations to which objection is made."). In such cases, the Court need only review the Report and Recommendation and determine whether it is clearly erroneous or contrary to law. United States v. Wilson, 864 F.2d 1219, 1221 (5th Cir.), cert. denied, 492 U.S. 918, 109 S.Ct. 3243, 106 L.Ed.2d 590 (1989).
On the other hand, any Report and Recommendation to which objection is made requires de novo review by the Court. Such a review means that the Court will examine the entire record, and will make an independent assessment of the law. The Court need not, however, conduct a de novo review when the objections are frivolous, conclusive, or general in nature. Battle v. United States Parole Comm'n, 834 F.2d 419, 421 (5th Cir. 1987).
The Court has thoroughly analyzed the parties' submissions in light of the entire record. As required by Title 28 U.S.C. § 636(b)(1)(c), the Court has conducted an independent review of the entire record in this cause and has conducted a de novo review with respect to those matters raised by the objections. After due consideration, the Court concludes the objections lack merit.
This Court agrees with the Magistrate Judge that judgment as a matter of law is warranted for Defendants on Plaintiffs' failure-to-warn claim, whether the claim is based in strict liability or negligence, because there is no genuine issue of fact as to whether an inadequate Ethicon warning caused Plaintiff Danielle Baksic's injuries. Judgment as a matter of law is likewise warranted in favor of Defendants on the design defect claim, whether that claim is based in strict liability or negligence, because there is no genuine issue of fact as to whether a "safer alternative design" was available at the time of Ms. Baksic's surgery. Plaintiff Brian Baksic's loss of consortium claim also fails as a matter of law because it is wholly derivative of those other failed claims. Finally, because it is unclear to the Court whether Plaintiffs have sufficiently asserted negligence claims in the complaint other than the negligent-design-defect and negligent-failure-to-warn claims, this case remains referred to the Magistrate Judge for further proceedings on this issue.
IT IS THEREFORE ORDERED that the Report and Recommendation of United States Magistrate Judge (docket no. 98) is ACCEPTED pursuant to 28 U.S.C. § 636(b)(1) such that Defendants' Motion for Summary Judgment (docket no. 74) is GRANTED and Plaintiffs' Motion for Partial Summary Judgment (docket no. 75) is DISMISSED AS MOOT. This case continues to be referred to the Magistrate Judge for further proceedings on the issue of whether Plaintiffs have sufficiently asserted negligence claims in the complaint other than the negligent-design-defect and negligent-failure-to-warn claims.
It is so ORDERED.
REPORT AND RECOMMENDATION OF UNITED STATES MAGISTRATE JUDGE
To the Honorable United States District Judge Fred Biery:
RICHARD B. FARRER, UNITED STATES MAGISTRATE JUDGE
This Report and Recommendation concerns the Motion for Summary Judgment filed by Defendants Ethicon Inc. and Johnson & Johnson (collectively, "Ethicon"), see Dkt. No. 74, and the Motion for Partial Summary Judgment filed by Plaintiffs Danielle Baksic and Brian Baksic, see Dkt. No. 75. All pretrial matters have been referred for resolution, pursuant to Rules CV-72 and 1 of Appendix C to the Local Rules for the United States District Court for the Western District of Texas. See Dkt. No. 16. Authority to enter this recommendation stems from 28 U.S.C. § 636(b)(1)(B).
For the reasons set forth below, Ethicon's Motion for Summary Judgment, Dkt. No. 74, should be GRANTED in its entirety. The Baksics' Motion for Partial Summary Judgment, Dkt. No. 75, should be DISMISSED AS MOOT.
Factual and Procedural Background
In July of 2010, Plaintiff Danielle Baksic underwent surgery to treat stress urinary incontinence. The surgery, performed by Danielle's physician Dr. Bruce Akright, involved the implantation of an Ethicon Gynecare TVT Obturator mesh sling device ("TVT-O"). Following the surgery, Danielle allegedly suffered an array of complications. To alleviate them, she underwent multiple mesh-removal surgeries. She claims she continues to suffer from adverse side effects due to the implantation of the device, including dyspareunia, pelvic and groin pain, and scarring, among others. See Complaint (Dkt. No. 1).
It is undisputed that Ethicon's TVT-O device is a mesh sling made from polypropylene (Ethicon's version of this material is called Prolene ®). There's no dispute that Ethicon provides "Instructions for Use" ("IFU") for the TVT-O device, or that the IFU includes information about possible adverse reactions. All agree the IFU was revised in 2015 and that following investigations by various attorneys general Ethicon entered into a settlement agreement in 2019 that required it to further revise the IFU to include additional information about risks associated with the device. See Ex. S, App'x to Pl. Resp. to Mot. for Summ. J. at 1583 (Dkt. No. 81-1) ("Pl. App'x"); Akright Dep. 50:1-52:19, Pl. App'x at 1711-13 (comparing IFU in place in 2010 to 2015 IFU). Ethicon released that revised IFU in 2021. See Ex. T, Pl. App'x at 1597-60.
On August 6, 2020, Danielle and her husband Brian sued Ethicon and its parent company Johnson & Johnson. Their Complaint raises claims for strict liability premised on a theory of failure to warn (Count I), strict liability premised on design defect (Count II), negligence (Count III), and loss of consortium (Count IV). Ethicon answered, asserting dozens of defenses. Ethicon now moves for summary judgment on the Baksics' claims. The Baksics, in turn, move for partial summary judgment on various of the defenses raised in answer to the lawsuit, arguing in essence the defenses are unavailable as a matter of law.
Analysis
Judgment as a matter of law is warranted for Ethicon on the Baksics' failure-to-warn claim, whether the claim is based in strict liability or negligence, because there is no genuine issue of fact as to whether an inadequate Ethicon warning caused Danielle's injuries. Judgment as a matter of law is likewise warranted in favor of Ethicon on the design-defect claim, whether that claim is based in strict liability or negligence, because there is no genuine issue of fact as to whether a "safer alternative design" was available at the time of Danielle's surgery. Brian's loss-of-consortium claim fails as a matter of law because it is wholly derivative of those other failed claims.
Finally, it is unclear to the Court whether the Baksics have sufficiently asserted negligence claims in the Complaint other than the negligent-design-defect and negligent-failure-to-warn claims, and neither Ethicon's Motion for Summary Judgment nor the Baksics' response thereto adequately addresses this issue. Accordingly, Ethicon will be afforded the opportunity to file a brief addressing whether and to what extent the Complaint sufficiently alleges any claim for negligence other than ones for negligent design defect and negligent failure to warn. Should any negligence claim survive this process, the Court will re-evaluate Brian's loss-of-consortium claim to the extent it may be derivative of any such remaining claims.
A. Claims Premised on a Failure to Warn Fail Because the Baksics Cannot Show a Failure to Warn Was a Producing Cause.
The Baksics' claim in Count I seeks to impose strict liability on the basis of a failure to warn. Count III invokes a negligent failure to warn. See Complaint ¶ 60. Under Texas law, a failure-to-warn products-liability claim involves the following two elements: "(1) [t]he warning was defective, and (2) [t]he failure to warn was a producing cause of the plaintiff's condition or injury." Stewart v. Janssen Pharmaceutica, Inc., 780 S.W.2d 910, 911 (Tex. App.—El Paso 1989, writ denied) (citation omitted). Although "conceptually different," failure to warn claims based both in negligence and in strict liability involve the same "essential question [of] whether an inadequate warning caused the plaintiff's injuries." See Sprankle v. Bower Ammonia & Chem. Co., 824 F.2d 409, 413-14 (5th Cir. 1987) (citation omitted) (applying Mississippi law). While courts differ on the precise distinction between the two theories, the general consensus is that negligence requires at least an equal showing of proof as to a defendant's wrongdoing. Sprankle, 824 F.2d at 413 n.5 (providing overview of different views on distinction between strict liability versus negligent failure-to-warn). Accordingly, a " 'finding against strict liability for failure to warn necessarily precludes a finding [of liability] on a negligence theory.' " Cox v. Ethicon, Inc., No. 4:20-CV-01172-O, 2020 WL 10817782, at *5 (N.D. Tex. Dec. 22, 2020) (quoting Sprankle, 824 F.2d at 4l3 n.5). A failure-to-warn claim based in the so-called "learned intermediary doctrine" can affect the liability inquiry because a pharmaceutical-product manufacturer can satisfy its duty to warn "the end user of its product's potential risks by providing an adequate warning to a 'learned intermediary,' who then assumes the duty to pass on the necessary warnings to the end user." Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 142 (Tex. 2012) (citation omitted).
The paragraph mistakenly labeled "60" in the Complaint is in between paragraphs 63 and 64.
As pertinent here, the learned-intermediary doctrine intersects with the producing-cause element of a failure-to-warn claim because an inadequate warning is not the producing cause of an injury when a learned intermediary (1) was already aware of the risks at issue but chose to recommend the medical product anyway and (2) where there is no evidence that a proper warning would have changed the decision of the learned intermediary to recommend the product. See Centocor, 372 S.W.3d at 170 (citing, e.g., Stewart, 780 S.W.2d at 912; Ebel v. Eli Lilly & Co., 536 F. Supp.2d 767, 780 (S.D. Tex. 2008), aff'd, 321 F. App'x 350 (5th Cir. 2009)); see also Centocor, 372 S.W.3d. at 173 ("Because [plaintiff's] prescribing physicians were aware of the potential risk . . . but chose to prescribe [the medication] in spite of those risks, and because [plaintiffs] failed to present any evidence that including [additional warnings] would have caused [plaintiff's] physicians to change their prescription, [plaintiffs] failed to meet their burden of proof" for their failure-to-warn claim.). It is not entirely clear to the Court at present whether a showing as to both issues is required or if a showing of either will suffice to show no producing cause in this summary-judgment posture. Here, it does not matter because both are demonstrated as a matter of law, thereby precluding the claim from proceeding past summary judgment. See Ackermann v. Wyeth Pharms., 526 F.3d 203, 209, 212 (5th Cir. 2008) (explaining, that to defeat summary judgment "[t]here must be a genuine issue of material fact whether [the doctor] would have prescribed [the drug] had the warning been 'adequate' and holding plaintiff failed to meet burden because prescribing physician knew of the relevant risks and was unequivocal that a stronger warning would not have changed his decision).
As will be discussed in more detail below, Dr. Akright clearly and unequivocally stated in sworn testimony that he knew of the risks at issue but recommended the device anyway. He likewise testified that a different warning would not have changed his decision. Indeed, in his testimony he explained that he continues to recommend the device to similar patients in spite of the revised warnings in the IFU.
To provide more detail, first, as to Dr. Akright's knowledge of the risks, the Court notes the Baksics listed the following physical symptoms on their Plaintiff Fact Sheet: abdominal/pelvic pain, lower back pain, vaginal pain, dyspareunia (painful intercourse), erosion, stress urinary incontinence, urinary problems, transvaginal product removal, scar tissue, bladder spasms, muscle ligament stiffness, nerve pain, and chronic pain. Ex. A, App'x to Def. Mot. for Summ. J. at 6, 9 (Dkt. No. 74-1) ("Def. App'x"). Danielle also allegedly suffers from chronic groin pain. Pl. Resp. to Mot. for Summ. J. at 12 (Dkt. No. 81) ("Pl. Resp."). Dr. Akright testified at his deposition that at the time of Danielle's surgery he was aware of the many potential side effects of using polypropylene-mesh products, such as the TVT-O device, to treat stress urinary incontinence, including the following:
See Ex. C, Def. App'x at 39-64 (Margolis Report), cited in the Baksics' Response, for a complete list of Danielle's alleged injuries described in medical terms.
Acute and/or Chronic Pain with Intercourse, Acute and/or Chronic Pain, Vaginal Scarring, Infection, Urinary Problems . . . Organ/Nerve Damage . . . Inflammation, Fistula Formation, Neuromuscular Problems, including any pelvic floor muscles, lower extremities and/or abdominal area, One or more surgeries to treat an adverse event, Recurrence or Failure, Foreign Body Response [(mesh)], Erosion/Exposure/Extrusion [(mesh)], [and] Contraction/Shrinkage of tissues.Akright Dep. 104:19-105:24, Def. App'x at 23-24 (listing side effects of non-mesh procedures and Dr. Akright testifying he was aware of these risks) (internal quotations omitted) and id. at 108:4-109:24 (acknowledging list also applies to mesh procedures with the only change being reference to mesh rather than sutures, and testifying he was aware of these risks at the time). Dr. Akright also had brochures at the time of the surgery that listed possible complications of the procedure, including "difficulty urinating, pain, scarring, pain with intercourse, bladder and bowel injury" and "mesh material becoming exposed" which "may require treatment." Id. at 92:25-93:3. Danielle's alleged injuries are encompassed by these extensive lists of risks.
While it is true that Dr. Akright acknowledged that he has changed his consent procedure since Danielle's surgery, that fact doesn't undermine his clear testimony regarding his knowledge of the risks and recommendation of the procedure and device. Nothing in Dr. Akright's testimony regarding his consent procedures directly addresses whether the changes to the IFU informed Dr. Akright of risks he was previously unaware of, or whether the changes would have altered his decision to recommend the device at all. For example, the Baksics claim Dr. Akright was:
[U]naware of many of the risks that Plaintiffs' experts have opined about, including the following: dyspareunia [(Akright Dep.) at 50:22-51:2; 52:11-21]; chronic groin pain [Id. at 53:5-54:4.]; need for multiple revision surgeries and difficult surgeries to remove mesh [Id. at 54:13-21; 55:11-21]; and exposed mesh causing injury or discomfort to patient's partner [Id. at 56:10-19].Pl. Resp. ¶ 23. But Dr. Akright specifically testified that he was aware of those risks, see supra pg. 6, and the citations the Baksics' briefing provides all lead back to the discussion about Dr. Akright's consent procedures, not his knowledge. To the extent Dr. Akright's consent process changed over time due to a change in his underlying knowledge, he primarily presents it as stemming from his growing body of experience, his independent reading of the literature, and discussions with colleagues, not risks newly revealed to him through the revised IFU. See Akright Dep. 50:11-21, Pl. App'x at 1711 (explaining change is due primarily to experience and reading literature rather than newly available information); Id. at 52:5-10 ("Certainly based on my experience now, I discuss pain afterwards," but not necessarily as a chronic phenomenon); Id. at 107:2-8 (discussing factors used to assess frequency and severity of risks, including experience, review of literature, and discussions with colleagues).
The Court recognizes the list of possible adverse effects on page 6 does not explicitly reference discomfort to the patient's partner. However, it does include dyspareunia generally as well as the risk of exposed mesh, which is the underlying cause of discomfort to a patient's partner as noted in Plaintiffs' Response.
Dr. Akright's testimony—read in the light most favorable to the Baksics, as it must be in this summary-judgment posture—suggests only that the quality and breadth of his knowledge has increased over time through a variety of sources, leading him to change somewhat his consent procedures. This, however, does not run counter to his testimony that he knew of the relevant risks when he recommended the device to Danielle, and therefore points to no disputed issue of fact surrounding whether he knew of the product's risks and recommended it anyway.
Turning next to the details surrounding whether Dr. Akright would have changed his recommendation to undergo the procedure, we need look no further than the doctor's testimony. Dr. Akright unequivocally testified that even if he had been provided a different warning from the manufacturer, it would not have changed his decision to recommend the product and procedure. It is a "critical element" of a failure-to-warn claim that an adequate warning would have changed the physician's decision to recommend the product. See Centocor, 372 S.W.3d at 172. And when the doctor's testimony is "unequivocal" that an adequate warning would not have changed his decision, the claim fails as a matter of law for lack of causation. Id. at 170 ("[W]hen the prescribing physician is aware of the product's risks and decides to use it anyway, any inadequacy of the product's warning, as a matter of law, is not the producing cause of the patient's injuries" (citing inter alia Ebel, 536 F. Supp. 2d at 780)); Ackermann, 526 F.3d at 210. Such is the case here.
The Baksics misunderstand Dr. Akright's testimony when they argue the testimony "strongly suggests that, had he known of the specific issues associated with the TVT-O, he would have at the very least altered his risk-related disclosures to Mrs. Baksic and most likely altered his treatment decision in order to provide the best options for his patient." Pl. Resp. at 16. Dr. Akright explicitly stated that he would have recommended the device to Danielle even if the revised 2015 IFU had been in place at the time. Akright Dep. 110:24-112:11, Pl. App'x at 1771-73. He unequivocally stood by his treatment decision and stated that he continues to use the device today:
Q: Based on what you know today, you still stand by your decision to recommend using a TVT-O to treat Ms. Baksic's stress urinary incontinence?Id. at 112:18-24.
. . .
A: Yes. And I still use the same device still with similar patients today. So, yes, I still stand by that.
The Baksics also miss the mark by pointing to Danielle's testimony that she would not have consented had she received additional warnings, and then to Dr. Akright's testimony that he would have recommended an alternative procedure or no procedure at all had she not consented. Pl. Resp. at 15. This argument focuses improperly on Danielle's state of mind, not Dr. Akright's. In other words, that Dr. Akright wouldn't have forced Danielle to undergo a procedure she didn't want doesn't speak to whether or not he would have recommended it in the first place. And Dr. Akright never testified he wouldn't have recommended the device in the first place. His testimony unequivocally indicates the opposite. In short, there is no evidence that additional warnings from Ethicon would have altered Dr. Akright's decision. Any attempted insinuations to the contrary are flatly contradicted by Dr. Akright's unequivocal testimony and continued use of polypropylene devices.
Finally, the Court addresses the Baksics' arguments based on the Fifth Circuit's decision in McNeil v. Wyeth, 462 F.3d 364 (5th Cir. 2006). According to McNeil, which applies Texas law, "[w]here the physician would have adequately informed a plaintiff of the risks of a disease, had the label been sufficient, but fails to do so on that account, and where the plaintiff would have rejected the drug if informed, the inadequate labeling could be a 'producing' cause of the injury, because it effectively sabotages the function of the intermediary." 462 F.3d at 373. Under McNeil's application of Texas law, in other words, causation could possibly be established even if there is no evidence that the doctor would have changed the recommendation.
This argument fails because McNeil is not a reliable statement of Texas law on the learned-intermediary doctrine. After McNeil, the Texas Supreme Court decided Centocor. And Centocor's holding restates the Texas rule on causation in the context of the learned intermediary doctrine, and it does not embrace the broader reading of causation set forth in McNeil. See Gutierrez v. Ethicon, Inc., No. 5:20-CV-00093-RCL, 535 F.Supp.3d 608, 631 (W.D. Tex. Apr. 23, 2021) (In light of Centocor, "the Fifth Circuit's McNeil decision is not an accurate statement of Texas law."). In Centocor, the Texas Supreme Court explained that where the physician knew of the risks but prescribed the drug anyway, and where there was no evidence an adequate warning would have changed the physician's decision, a failure-to-warn claim must fail. Centocor, 372 S.W.3d at 173. The Centocor Court offered no caveats or exceptions.
A federal court sitting in diversity must apply the substantive law of the state in which it sits. Erie R.R. Co. v. Tompkins, 304 U.S. 64, 78 (1938). The Texas Supreme Court has never endorsed the exception formulated in McNeil, and it has unequivocally ruled that where there is no evidence an adequate warning would have changed a doctor's recommendation, there can be no causation. Dr. Akright knew the risks associated with the device when he recommended it, and he was unequivocal that another warning would not have changed his decision. As a matter of law under Centocor, the Baksics cannot show the allegedly inadequate warning caused Danielle's injuries. Accordingly, judgment as a matter of law is warranted on the Baksics' failure-to-warn claim, whether based in strict liability (Count I) or negligence (Count III).
B. The Design-Defect Claims Fail Because Baksic Cannot Show There Was a Safer Alternative Design Available.
The Baksics' claim in Count II is based on a design-defect theory invoking strict liability. Count III also states a design-defect claim but invokes negligence. See Complaint ¶ 63(a)-(l) (listing the "reasons Defendants' negligence caused the Pelvic Mesh Device to be unreasonably dangerous and defective"). To ultimately succeed on a design-defect claim, a plaintiff must prove that " '(1) the product was defectively designed so as to render it unreasonably dangerous; (2) a safer alternative design existed; and (3) the defect was a producing cause of the injury for which the plaintiff seeks recovery.' " In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Prod. Liab. Litig., 888 F.3d 753, 765 (5th Cir. 2018) (quoting Casey v. Toyota Motor Eng'g & Mfg. N.A., 770 F.3d 322, 330 (5th Cir. 2014)) (applying Texas law). Design-defect claims based in negligence are also "predicated on the existence of a safer alternative design," and "[a]bsent an alternative design, a claim for negligent design or manufacturing fails as a matter of law." Am. Tobacco Co. v. Grinnell, 951 S.W.2d 420, 437 (Tex. 1997) (citation omitted) (superseded by statute on other grounds).
Ethicon argues that the Baksics' design-defect claim should fail as a matter of law because the Baksics cannot establish the second element, namely that a safer alternative design existed at the time of Danielle's surgery. The Baksics counter by pointing to multiple safer alternative designs identified in their expert reports. These include the Burch procedure, autologous fascia slings, allograft slings, retropubic slings, and slings made of lighter weight, larger pore synthetic mesh material such as Ultrapro or PVDF. Pl. Resp. at 5. Because none of the safer alternative designs identified by the Baksics can support a claim, and because none involves a disputed question of fact, the design-defect claim fails as a matter of law. Brockert v. Wyeth Pharms., Inc., 287 S.W.3d 760, 769 (Tex. App.—Houston [14th Dist.] 2009, no pet.) (citing Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 384 (Tex. 1995)).
1. Three of the Baksics' proposed safer alternatives fail because they're alternative procedures or substantially different products rather than alternative designs. Under Texas law, a " 'substantially different product' cannot constitute a safer alternative design." DePuy, 888 F.3d at 766 (citing Brockert, 287 S.W.3d at 770; Caterpillar, 911 S.W.2d at 385). The Baksics' proposed alternative designs are in fact alternative procedures or products, and so the design-defect claim fails as a matter of law with respect to each of these proffered alternatives.
The Burch procedure is not a safer alternative design because it involves an entirely different procedure. The Burch procedure is a surgery used to treat stress urinary incontinence. It uses sutures and does not involve the implantation of any medical device or organic tissue. Margolis Dep. 82:12-18, Def. App'x at 79. It is an entirely different procedure from the implantation of a TVT-O device, and therefore cannot, as a matter of law, be considered a "safer alternative design" for that device. See Brockert, 287 S.W.3d at 770 ("a plaintiff who contended that pedicle screws were defectively designed was required to demonstrate a safer alternative design that involved pedicle screws . . . [t]hus, a safer alternative design must be one for the product at issue") (discussing and applying holding in Theriot v. Danek Med., Inc., 168 F.3d 253 (5th Cir. 1999) (applying Louisiana law))). Multiple district courts in Texas have likewise concluded that non-mesh treatments like the Burch procedure are not alternative designs to mesh implants. See, e.g., Castillo v. Boston Sci. Corp., No. 1-20-CV-513-RP, 2020 WL 2771193, at *4 (W.D. Tex. May 28, 2020); Fearrington v. Boston Sci. Corp., 410 F. Supp. 3d 794, 804 (S.D. Tex. 2019).
Autologous fascia slings also involve a different procedure that doesn't involve a medical device . Autologous fascia slings are created from tissue taken from other parts of the patient's body, which are surgically implanted in the pelvic area to treat stress urinary incontinence. Margolis Dep. 82:23-83:2, Def. App'x at 79-80. Like the Burch procedure, this is an entirely different procedure that does not involve a medical device, and so it is not an alternative design for much the same reasons. See, e.g., Castillo, 2020 WL 2771193, at *4; Fearrington, 410 F. Supp. at 804.
Allograft slings involve a substantially different product. Allograft slings, such as Repliform, are made from cadaverous tissue and sold in a sheet. Margolis Report, Def. App'x at 55; Margolis Dep. 83:3-12, Def. App'x at 80. They are a substantially different product from the entirely synthetic TVT-O device. In Brockert v. Wyeth, the court rejected a proposed "alternative" to a drug that involved a combination of synthetic progestin added to estrogen because the so-called alternative effectively required that the drug should not exist and should instead be transformed into a different product. 287 S.W.3d at 770-71. Texas law "does not recognize this sort of categorical attack on a product." Id. at 771 (citing Caterpillar, 911 S.W.2d at 384-85). An entirely organic mesh cannot be an alternative to a synthetic mesh because organic and synthetic mesh are different products. Multiple district courts have reached this same conclusion. See, e.g., Confresi v. Meditronic, Inc., 450 F. Supp. 3d 759, 766 (W.D. Tex. 2020); LaBiche v. Johnson & Johnson, No. H-20-4249, 2021 WL 3719554, at *2 (S.D. Tex. Aug. 19, 2021); Castillo, 2020 WL 2771193, at *4.
2. Two of the Baksics' remaining proposed safer alternatives fail because they were not available at the time of Danielle's surgery. A plaintiff must show that its proposed safer alternative design existed at the time of the alleged injury and was technologically and economically feasible. Casey, 770 F.3d at 331 (citation omitted). The Baksics propose two safer alternatives called Ultrapro and PVDF. They are synthetic mesh materials that contain less polypropylene than the TVT-O (Ultrapro) or contain a different synthetic material (PVDF). They are generally lighter and have a larger pore size. The issue here with respect to these two potential alternatives is that at the time of Danielle's surgery, these alternatives existed but were not yet cleared by the FDA for the purpose of treating stress urinary incontinence.
Ethicon argues that the lack of FDA clearance rendered the proposed alternatives "unavailable" at the time of Danielle's surgery. This is a question of law that has not been addressed by the Fifth Circuit, and different courts in this District have reached different conclusions on it. See, e.g., Pizzitola v. Ethicon, Inc., No. 4:20-CV-2256, 2020 WL 6365545, *4-5 (S.D. Tex. Aug. 31, 2020) (noting, "any alternative designs . . . that had not been cleared by the FDA at the time of implantation cannot be considered safer alternative designs"); Robinson v. Ethicon Inc., No. CV H-20-3760, 2021 WL 5054648, *7 (S.D. Tex. Nov. 1, 2021); Labiche, 2021 WL 3719554, *2. But see, e.g., Castillo, 2020 WL 2771193, *4 (noting, that the existence of "extant product as an example of the proposed alternative design [using Ultrapro]" was sufficient to raise issue of fact as to design-defect claim); Bell v. Ethicon Inc., No. 4:20-CV-3678, 2021 WL 1111071, at *7 (S.D. Tex. Mar. 23, 2021) (rejecting argument that "lack of FDA approval precludes an alternative design"); Cox, 2020 WL 10817782, *4 (same, and finding sufficient question of fact as to whether design similar to Ultrapro was "capable of being developed" to survive summary judgment).
A device must be approved or cleared by the FDA before it can be sold in the United States. Because mesh such as Ultrapro and PVDF were not cleared by the FDA for treatment of stress urinary incontinence at the time of Danielle's surgery, they were not legally available at the time and, in this Court's view, they do not qualify as safer alternative designs as a matter of law. Moreover, a safer alternative design may be considered available if it was technologically and economically feasible at the time and "capable of being developed." Casey, 770 F.3d at 334 (citation omitted). District courts that have found FDA approval is required to show availability have nevertheless suggested that a design may still be "capable of being developed" if a plaintiff shows that the FDA would have approved the design had an application been made. See Robinson, 2021 WL 5054648, *7 (discussing potential to find unapproved product "available" if FDA regulatory expert could testify as to the regulatory process and how an application would have been viewed by the FDA). Here, however, the Baksics fail to present any evidence to support such an argument, which further bolsters the Court's conclusion on this issue.
The Baksics instead insist that approval of the alternative mesh materials for other purposes and in other countries is sufficient to make them available as alternatives here, or at least to present enough of an issue to move beyond summary judgment. Danielle's surgery was in 2010. Ethicon got clearance from the FDA to use an Ultrapro mesh device to treat hernias in 2004, and pelvic organ prolapse in 2008. See Pl. Resp. at 5-6 and accompanying citations. Mesh products containing PVDF were cleared by the FDA for hernia repair in 2008, with fully PVDF meshes approved in 2013. Id. at 8. Dynamesh is a PVDF product that is used in Europe to treat stress urinary incontinence. Id. Plaintiff's expert opined that "[a]lthough Ethicon recognized the benefits of lighter-weight mesh . . . Ethicon never transitioned the TVT product to a lightweight mesh." Pence Report, Pl. App'x at 1411.
But none of this creates a genuine fact issue concerning whether these alternative meshes would have been cleared to treat stress urinary incontinence in the United States had Ethicon sought such approval. The Baksics note that a randomized clinical trial was conducted in 2005-07 to compare Ultrapro to the Prolene used in TVT-O for treatment of stress urinary incontinence. Pl. Resp. at 5. But the results of the trial were not published until 2013, three years after Danielle's surgery. Id. Moreover, the Baksics point to no evidence regarding the FDA's regulatory requirements and clearance procedures as they related to the likelihood that Ultrapro or PVDF slings would have satisfied those requirements in 2010 for the purpose of treating stress urinary incontinence. Even assuming arguendo that Ultrapro and PVDF mesh were alternative designs and were safer, there is no genuine issue of material fact presented regarding their availability in 2010 at the time of Danielle's surgery. As a result, the Baksics fail to meet their summary judgment burden.
3. The Baksics' proposed safer alternative fails with respect to the retropubic sling because it is a different procedure, and Plaintiff did not present material facts supporting a finding that it is "safer." The Baksics' efforts to proffer as a safer alternative design a retropubic sling device fail for two reasons. First, the use of retropubic slings involves a different procedure from the surgery used to implant the TVT-O device. A retropubic sling is placed in a different part of the body using a different surgical method. See Rosenzweig Report, Pl. App'x at 14 (describing development of the procedure using obturator membrane and inner thigh for passage of sling to avoid retropubic space, eventually resulting in "inside-out" method for placement of sling used for TVT-O); see also Robinson, 2021 WL 5054648, at *5, *5 n.4 (finding retropubic sling is not a "safer alternative" on other grounds, but noting evidence also suggested it is an "entirely different procedure"). Thus, implantation of a retropubic sling, regardless of the material it is made of, involves a different surgical procedure and is therefore not an "alternative design."
Second, although a closer call, the Baksics fail to point to a triable issue on the retropubic sling's safety, which provides an independent basis to reject this alternative. The Baksics contend that retropubic slings avoid or significantly reduce the risk of pain related to obturator neuralgia and pudendal neuralgia due to placement in a different part of the body. Margolis Report, Def. App'x at 55-56. See also Rosenblatt Report, Pl. App'x at 1261-66 (acknowledging greater risk of neurologic symptoms, groin pain, and thigh pain). The UK's National Institute for Health and Care Excellence recommend the retropubic approach over the transobturator approach. See Margolis Report, Def. App'x at 53-54; 2019 NICE Guidelines, Pl. App'x at 1328. This argument fails, however, because it doesn't address other factors that necessarily come into play when assessing whether an alternative is actually a "safer" one overall.
That one of the specific types of pain the Baksics allege would have been reduced or avoided by use of a retropubic sling is only one of a number of symptoms and side effects that must be assessed when determining the relative safety of the retropubic sling. The Baksics expert Dr. Margolis listed retropubic slings as a safer alternative only due to the reduced risk of obturator neuralgia and pudendal neuralgia. Margolis Report, Def. App'x at 55-56. But he also testified at his deposition that a TVT retropubic sling (also made of polypropylene) has many of the same side effects as the TVT-O device, including many of the ones afflicting Danielle. Margolis Dep. 12:22-17:18, Def. App'x at 71-76. In fact, he testified that he does not consider polypropylene retropubic slings safe and would not recommend them to patients "[b]ecause the risks outweigh the benefits." Id. at 12:22-13:10. He testified "I do not implant transvaginal mesh systems for stress incontinence or prolapse, and never have." Id. at 13:3-5. His testimony is therefore hardly probative on the question of the retropubic sling's overall safety as compared to the TVT-O, nor does it address the relative efficacy of the retropubic approach.
And at the same time, the Baksics fail to address whether there are additional complications that can arise from a retropubic sling. Dr. Margolis testified to a long list of adverse effects associated with polypropylene retropubic slings, and the doctor did not testify that the retropubic approach is safer overall. See Mot. for Summ. J. at 15 and accompanying citations to the record. A safer design must be one that "would have prevented or significantly reduced the risk of the [plaintiff]'s personal injury . . . without substantially impairing the product's utility." DePuy, 888 F.3d at 765; see also Casey, 770 F.3d at 331. The design cannot, "under other circumstances, impose an equal or greater risk of harm." Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 337 (Tex. 1998)). With at most evidence that one category of pain could be reduced, no evidence that other complications or adverse effects wouldn't be increased or introduced with the use of a retropubic sling, and no case-specific evidence favorably weighing the benefits of the retropubic approach against its possible drawbacks, the Baksics fail to demonstrate a triable issue on whether a retropubic sling was a safer alternative.
C. Mr. Baksic's Loss-of-Consortium Claim Fails Because There Is No Liability.
A loss-of-consortium claim is a derivative claim belonging to Brian—i.e., Mr. Baksic—that is reliant on the tortfeasor's liability for Danielle's injuries. Reed Tool Co. v. Copelin, 610 S.W.2d 736, 738 (Tex. 1980). If all of the Baksics' liability claims fail, the loss-of-consortium claim fails as well. Barker v. Halliburton Co., 645. F.3d 297, 299-300 (5th Cir. 2011). This claim, therefore, appears to fail, unless there is some negligence claim that survives and is capable of supporting a demand for loss of consortium, as discussed next.
D. Other Negligence Claims, Apart from the Negligent Failure-to-Warn and Design-Defect Claims, Appear to Fail But the Court Will Direct More Briefing on the Issue.
In addition to the negligent failure-to-warn claim and the negligent design-defect claim discussed above, the Baksics' Response also invokes negligence claims premised on the "manufacture, marketing, testing, advertisement, supply, promotion, packaging, sale, and distribution" of the TVT-O device. Pl. Resp. at 25 n.24; see also Complaint ¶ 62. Ethicon's Motion for Summary Judgment only addresses the Baksics' negligence claims as they pertain to failure to warn and design defect. Ethicon has the burden as the party moving for summary judgment to show there is no dispute of material fact on a particular claim. But here, the Baksics do not appear to have sufficiently alleged negligence claims under this laundry list of negligence theories.
To survive a motion to dismiss on any additional negligence claims, the Baksics' Complaint must identify more than a subjective belief that the defendant was negligent. It must describe specific facts that, if accepted as true, are sufficient "to state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555-56, 570 (2007). The allegations pleaded must show "more than a sheer possibility that a defendant has acted unlawfully." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). A conclusory complaint—one that fails to state material facts or merely recites the elements of a cause of action—may be dismissed for failure to state a claim. See Twombly, 550 U.S. at 555-56. The Baksics' Complaint lists numerous possible negligence claims, see ¶ 62, but the facts provided predominantly relate to a claim of negligent design defect, see ¶ 63, or negligent failure to warn, see ¶ 60 (sic). Accordingly, it is unclear what, if any, negligence theories are sufficiently pleaded in the Complaint but not addressed in the summary judgment briefing. The Court will order further briefing on this issue, as provided below.
Conclusion and Recommendation
For the reasons discussed above, it is recommended that Defendants' Motion for Summary Judgment, Dkt. No. 74, be GRANTED as set forth herein, and that Plaintiffs' Motion for Partial Summary Judgment, Dkt. No. 75, be accordingly DISMISSED AS MOOT.
Further, Ethicon is ORDERED to file a memorandum of no more than 20 pages in length, on or before 30 days after entry of this Order onto the docket, to address whether and to what extent Plaintiffs' Complaint sufficiently alleges any claim for negligence other than claims for negligent design or negligent failure to warn. The status of the loss-of-consortium claim should also be briefly addressed. A Response should be filed within 30 days after Defendants' memorandum, and any Reply within 14 days after the Response. Should any negligence claims survive this process, Plaintiffs will be permitted to re-urge their Motion for Partial Summary Judgment to the extent it is applicable to those remaining claims.
Instructions for Service and Notice of Right to Object/Appeal
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 by certified mail, return receipt requested, to those not registered. 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). Objections, responses, and replies must comply with the same page limits as other filings, unless otherwise excused by the district court's standing orders. See Rule CV-7. The objecting 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, conclusory, 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); Acuña v. Brown & Root, Inc., 200 F.3d 335, 340 (5th Cir. 2000). Additionally, failure to timely file 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).
IT IS SO ORDERED.