Gutierrez v. Ethicon, Inc.

Full title: Debra GUTIERREZ and Raymond Gutierrez, Plaintiffs, v. ETHICON, INC. and…

Court: United States District Court, W.D. Texas, San Antonio Division.

Date published: Apr 23, 2021

535 F. Supp. 3d 608 (W.D. Tex. 2021)

Opinion

Case No. 5:20-cv-00093-RCL

2021-04-23

Debra GUTIERREZ and Raymond Gutierrez, Plaintiffs, v. ETHICON, INC. and Johnson & Johnson, Defendants.

Paul L. Sadler, Sadler & Sadler, San Antonio, TX, for Plaintiffs. Anita Modak-Truran, Butler Snow LLP, Nashville, TN, Christopher R. Cowan, Butler Snow LLP, Katherine Ann Fillmore, Duane Morris LLP, Paige Arnette Amstutz, Stephen E. McConnico, Scott, Douglass & McConnico, LLP, Austin, TX, for Defendants.

ROYCE C. LAMBERTH, U.S. DISTRICT JUDGE

Paul L. Sadler, Sadler & Sadler, San Antonio, TX, for Plaintiffs.

Anita Modak-Truran, Butler Snow LLP, Nashville, TN, Christopher R. Cowan, Butler Snow LLP, Katherine Ann Fillmore, Duane Morris LLP, Paige Arnette Amstutz, Stephen E. McConnico, Scott, Douglass & McConnico, LLP, Austin, TX, for Defendants.

MEMORANDUM OPINION

ROYCE C. LAMBERTH, U.S. DISTRICT JUDGE

In July 2007, a physician surgically implanted a polypropylene mesh device called a "TVT-O" into the thighs and vagina of the co-plaintiff, Debra Gutierrez, to mitigate her stress urinary incontinence ("SUI"). Opp'n at 2, 36, ECF No. 50. Defendant Ethicon, a division of defendant Johnson & Johnson, developed the TVT-O and trained and advised physicians about its use. Id. at 1, 31. Though the defendants marketed the device as safe and effective, Mrs. Gutierrez experienced serious complications. The TVT-O, she says, damaged her nerves, eroded her vaginal wall, failed to mitigate her SUI, leached chemicals into her body, and scraped her husband's penis during intercourse. Id. at 6-10. Given the other TVT-O recipients reporting similar issues, the Judicial Panel on Multidistrict Litigation consolidated extant suits into the U.S. District Court for the Southern District of West Virginia ("SDWV") for management as multidistrict litigation ("MDL"). The SDWV also invited eligible plaintiffs to "direct file" complaints there for later transfer to the otherwise-proper jurisdiction. Mrs. Gutierrez direct-filed in January 2014. See Short Form Complaint, ECF No. 1. After managing pre-trial discovery, the MDL court then transferred Mrs. Gutierrez's case here in January 2020. Notice of Transfer, ECF No. 35. The parties agreed that some of Mrs. Gutierrez's original claims should be dismissed, so the Court entered partial summary judgment for the defendants on those claims in February 2020. Order, ECF No. 39. The defendants now move for summary judgment on the plaintiffs’ remaining claims.¹ Mot., ECF No. 49. They argue, first, that those claims were untimely filed, and second, that even if timely, the defendants are still entitled to summary judgment. Id. at 1–2. Though the Court holds that genuine factual issues persist regarding the claims’ timeliness, it concludes that the defendants are still entitled to summary judgment on all them. Thus, the Court will GRANT the defendants’ motion for summary judgment.

1 As discussed below, the plaintiffs’ remaining claims comprise strict liability/failure to warn, negligence, gross negligence, common-law fraud, negligent misrepresentation, violation of consumer-protection laws, strict liability/design defect, and loss of consortium. See Short Form Complaint at 4, ECF No 1; Order, ECF No. 39.

I. BACKGROUND

Co-plaintiff Debra Gutierrez has long suffered from SUI—"the involuntary leakage of urine during moments of physical activity that increase[ ] abdominal pressure, such as coughing, sneezing, laughing, or exercise." Opp'n at 2, ECF No. 50.² SUI is relatively common among women and "may be treated non-surgically or surgically." Id. In July 2007, Mrs. Gutierrez opted for the latter approach. Id. at 36. She had her gynecologist, Dr. Alan Braid, implant an Ethicon-made TVT-O device into her thighs and vagina to address her SUI. As she describes the procedure,

2 In its recitation of this case's background facts, the Court draws all justifiable inferences in favor of the non-movant plaintiffs. See Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

The [TVT-O] mesh (which looks much like a window screen) [is] placed into the non-sterile vagina and placed under the urethra. An incision is made below the urethra meatus inside the vagina. The surgeon then dissects/tunnels into the obturator foramen, which is described as an anatomical spot in the pelvis, and then through the thighs of the woman for placement of supports. The supports also made of the mesh are tunneled through the thighs and are used to pull the sling into place under the urethra. These supports through the thighs are then cut just below the surface of the skin and the incisions in the thighs are closed[,] leaving the mesh in the vagina and the thighs. Essentially, the design entails taking a sterilized product, placing

it through the unsterilized vagina[,] and then pulling two supports through the sterilized thighs. The mesh[,] with its window-screen or strainer-appearing construction[,] is intended to be permanently placed in the woman's body.

Id. at 2.

After the device was so placed into Mrs. Gutierrez, she appeared to heal normally. Id. at 8. She reported that "sexual intercourse at the time was not painful for her" and that her only side effect was difficulty inserting a tampon. Id. "She believed" that issue, though, "was just part of the healing process." Id. Otherwise, "that was it." Id.

Unfortunately, Mrs. Gutierrez eventually noticed issues developing with her TVT-O. In the first year after its implantation, her husband reported that he could feel something "sticking [his] penis" during sex. Id. at 7. It turned out that portions of TVT-O mesh were "extruding" into Mrs. Gutierrez's vagina. Id. Dr. Braid understood "this to be a known complication," however, "that was easily resolved by simply cutting off" the small piece of extruded mesh. Id. Thus, on April 4, 2008, Dr. Braid performed a brief, twenty-five-minute surgery to remove the mesh "sticking out of the vagina mucosa." Id. Mrs. Gutierrez recalled Dr. Braid telling her that he "just [needed to] go in there and snip it off and you'll be fine." Id. at 7 (citing Gutierrez Dep. at 88:18-21). Follow-up visits with Dr. Braid seemed to confirm that "everything went well," and she was then "feeling fine." Id. (citing Gutierrez Dep. at 95:2-7; 98:10-17).

Mrs. Gutierrez continued to see Dr. Braid for follow-up visits until 2010 or 2012.³ In those annual visits after her 2008 revision surgery, she began to report new concerns to Dr. Braid. Id. at 8. Her SUI eventually recurred, and she noted "pain in her pelvic region and back." Id. Mr. Gutierrez also claimed that Mrs. Gutierrez did not "feel the same" during sex. Id. Yet Dr. Braid informed Mrs. Gutierrez that her "tests and [ ] exams were normal," that she was "healthy," and that her pains were simply age-related. Id. (citing Gutierrez Dep. at 106:18-23). Dr. Braid also encouraged Mrs. Gutierrez to remind her husband that "he was not having sex with a 20 year old anymore" and that she was not a "spring chicken." Id. at 9 (citing Gutierrez Dep. at 107:22–108:2). Because Mrs. Gutierrez has had six children, she "figured [that Dr. Braid] was right" and that her pains came from age and childbirth, rather than the TVT-O. Id.

3 Mrs. Gutierrez says she continued to see Dr. Braid until either 2010 or 2012, Opp'n at 8, ECF No. 50, but Dr. Braid says he closed his practice in 2010. See Braid Dep. at 58:3-5, ECF No. 49-2. Nothing hinges on this distinction.

Some time in early January 2014, however, Mrs. Gutierrez says she saw "a commercial about the mesh product" and the related lawsuits. Id. (citing Gutierrez Dep. at 116:22–117:12). "[A]s soon as she saw the commercial," she "knew that those were [her] symptoms," and thus she realized that she might have a legal claim. Gutierrez Dep. at 118:12-15, ECF No. 50-8. She contacted plaintiffs’ counsel shortly after, and together they filed the complaint in the MDL court that was ultimately transferred to this jurisdiction. Opp'n at 9, ECF No. 50.

Though Mrs. Gutierrez had thrown her hat into the MDL ring by early 2014, she continued to seek medical advice about resolving her ongoing medical issues. Id. After Dr. Braid retired, Mrs. Gutierrez began to see a new gynecologist, Dr. James Lovell. Gutierrez Dep. at 108:15-20, ECF No. 50-8. She hoped to get "a second opinion" from Dr. Lovell about the cause of her symptoms. Id. In particular, Mr. Gutierrez began to report around July or August 2014 that he could feel "something sharp ... like needle pricks" in his penis during sex, and Mrs. Gutierrez continued to feel pain. Id. at 115:11-17. Dr. Lovell examined Mrs. Gutierrez's vagina but "said he couldn't feel anything." Id. at 116:9. Mrs. Gutierrez recalled him recommending no other "procedure or treatment" for the issues, and he seemed to concur with Dr. Braid that Mrs. Gutierrez was healthy. Id. at 117:18–118:8. He reiterated that her husband's complaints about her vagina likely stemmed from her six childbirths, and he suggested that they "use some lubricant." Id. at 118:1–8.

During a follow-up visit in November, Dr. Lovell at last deduced the source of Mr. Gutierrez's complaints: pieces of mesh visibly protruding into Mrs. Gutierrez's vagina. Id. at 119:9-11. (Mrs. Gutierrez, too, reported feeling "something protruding out of there." Id. at 119:7.) Dr. Lovell recalled using a hemostat to latch onto the exposed mesh, which he described as blue in color and like "a whisker." Lovell Dep. at 38:2-4; 39:8, ECF No. 50-9. Dr. Lovell told Mrs. Gutierrez that another revision surgery "should be an easy fix" that could be done "here at the office," but he let Mrs. Gutierrez go home and "th[ink] about it." Gutierrez Dep. at 119:10-11, ECF No. 50-8; Lovell Dep. at 40:6-9, ECF No. 50-9. She returned in December, and Dr. Lovell excised the protruding mesh. Lovell Dep. at 39:25–40:21, ECF No. 50-9.

Still, however, Mrs. Gutierrez's problems persisted. She continued to report pain in her pelvis and back. But Dr. Lovell told Mrs. Gutierrez that "he thought that he [had] gotten the piece of the mesh or the stitches out that were causing [her] problems." Gutierrez Dep. at 121:21-24, ECF No. 50-8. So Mrs. Gutierrez sought a third opinion from another gynecologist, Dr. Carlos Cardenas. Opp'n at 9, ECF No. 50. Dr. Cardenas opined that Mrs. Gutierrez "might be experiencing pain because [she] might be menopausal." Gutierrez Dep. at 125:8-9, ECF No. 50-8. Thinking that "maybe [Mrs. Gutierrez's] hormones are out of whack," Dr. Cardenas suggested various tests and, eventually, hormone replacement therapy. Id. at 125:9-19. Mrs. Gutierrez apparently began hormone treatment, but she says that her symptoms never improved. Id. at 125:22-25.

In 2019, Mrs. Gutierrez was then "examined at the University Health System Clinic," which referred her to yet a fourth physician, Dr. Sylvia Botros-Brey. Opp'n at 10, ECF No. 50. In another procedure in December 2019, Dr. Brey removed as much of the mesh device from Mrs. Gutierrez as was possible. Id. Dr. Brey explained that "one side" of the vaginal wall "was eroded," that she "found the mesh on both sides," and that she managed to remove much of the TVT-O. Botros-Brey Dep. at 29:3-6; 28:3-9, ECF No. 50-7. Mrs. Gutierrez notes, though, that "[t]o this day[,] part of the TVT-O device remains in [her body] and cannot be removed." Opp'n at 10, ECF No. 50.

The defendants do not dispute this chronology. Mot. at 2–3, ECF No. 49. Indeed, they recite it (in somewhat abbreviated form) in paragraphs seven and eight of their summary judgment brief, in a section entitled "undisputed material facts." Id. Defendants’ argument is, instead, that given this undisputed chronology, Mrs. Gutierrez did not timely assert her claims. Id. at 4. They argue that her causes of action accrued, and thus, that "[t]he statute of limitations began to run in this case," when Dr. Braid performed the first revision surgery on April 4, 2008. Id. at 5 n.1. The plaintiffs sharply dispute that conclusion. Opp'n at 6, ECF No. 50. Mrs. Gutierrez's diligent pursuit of an accurate diagnosis, they say, tolled the statute of limitations until she discovered that her TVT-O device was the root of her symptoms. Id.

Separately, the defendants argue, even if the plaintiffs’ claims were timely filed, defendants still should receive summary judgment. Mot. at 6–10, ECF No. 49. As for the plaintiffs’ design defect claims, defendants contend that plaintiffs have not shown (1) a causal link between a design defect and Mrs. Gutierrez's alleged injuries, (2) no proof of a safer alternative design, and (3) no proof that any safer design would have prevented her alleged injuries. Id. at 6–7. As for the plaintiffs’ strict liability/failure to warn claims, defendants argue that Dr. Braid's status as a "learned intermediary" alleviates any further duty of Ethicon's to have warned Mrs. Gutierrez about the product. Id. at 7–9. And the defendants argue that the learned intermediary doctrine defeats the plaintiffs’ claims for fraud, consumer fraud, and negligent misrepresentation as well. Id. at 9–10. Last, because Mr. Gutierrez's loss of consortium claim is "derivative" of these allegedly failed claims, it falls along with them. Id. at 10.

The plaintiffs, inversely, dispute all those assertions. They argue that design flaws with the TVT-O caused Mrs. Gutierrez's injuries and that Ethicon knew of safer designs. Opp'n at 19–27, ECF No. 50. They also argue that to the extent Dr. Braid was an intermediary, he was himself not adequately warned by Ethicon about potential complications with its product. Id. at 27–36. Thus, he could not have apprised Mrs. Gutierrez of the procedure's true risks. Id. And, she says, had she known those risks, she would have chosen different treatments. Id. at 37–38 (citing Gutierrez Aff., ECF No. 50-21).

II. LEGAL STANDARDS

This Court has jurisdiction under 28 U.S.C. § 1332(a)(1). Section 1332(a)(1)—part of the diversity jurisdiction statute—provides that "[t]he district courts shall have original jurisdiction of all civil actions where the matter in controversy exceeds the sum or value of $75,000, exclusive of interest and costs," and where the parties are "citizens of different states." § 1332(a)(1). This case satisfies those conditions. The plaintiffs, Mr. and Mrs. Gutierrez, are citizens of the state of Texas. Short Form Complaint at 1, ECF No. 1. Defendant Johnson & Johnson, by contrast, admits that both its state of incorporation and its principal place of business are New Jersey. Master Answer at 1, ECF No. 39-2. Defendant Ethicon, Inc., too, admits that both its state of incorporation and its principal place of business are also New Jersey. Id. at 1–2. So the parties are completely diverse, satisfying the diversity-of-citizenship requirement.⁴

4 The Court notes that another entity, Ethicon LLC, was also originally a defendant in this action. Its presence might have complicated the jurisdictional determination, since LLCs are citizens for diversity purposes in all the domiciles of their members. See Harvey v. Grey Wolf Drilling Co. , 542 F.3d 1077, 1080 (5th Cir. 2008). But the parties earlier agreed to voluntarily dismiss Ethicon LLC from the action, negating any effect on the jurisdictional analysis. See Mem. of Law at 1 n.1., ECF No. 25.

The amount-in-controversy requirement is more complicated. The plaintiffs’ original short-form complaint said that the requirement was satisfied for the reasons set forth in paragraphs 9–11 of the Master Complaint. Short Form Complaint at 2, ECF No. 1. The Master Complaint, in turn, said that the requirement was satisfied because "in each of the constituent actions ... the amount in controversy exceeds $75,000." First Amended Master Complaint (FAMC) at ¶ 9, ECF No. 32-1. So the Gutierrezes simply incorporated by reference the Master Complaint's conclusory allegation that the requirement was, in their individual case, satisfied. But the Court has found no particularized allegation by the Gutierrezes about the specific amount they wish to put in controversy. That's a problem, because federal courts must presume the absence of subject-matter jurisdiction, and they are duty-bound to investigate sua sponte whether it truly exists. See Gonzalez v. Thaler , 565 U.S. 134, 141, 132 S.Ct. 641, 181 L.Ed.2d 619 (2012) ; Howery v. Allstate Ins. Co. , 243 F.3d 912, 916 (5th Cir. 2001). Ordinarily, asserting "in a conclusory manner ... that the matter in controversy exceeds the sum or value of $75,000" won't cut it. Posada v. Dolgencorp of Tex., Inc. , No. C-10-98, 2010 WL 1798826, at *2 (S.D. Tex. May 5, 2010) (citing Allen v. R&H Oil & Gas Co. , 63 F.3d 1326, 1335 (5th Cir. 1995) ). Rather, if particularized allegations are lacking, the Court must independently survey the record to determine whether it is more likely than not that the requirement is, in fact, satisfied. Manguno v. Prudential Prop. & Cas. Ins. Co. , 276 F.3d 720, 723 (5th Cir. 2002).

Having completed that survey, however, the Court finds that the Gutierrezes have more likely than not satisfied the requirement. They allege that Mrs. Gutierrez will have potentially lifelong urological and sexual dysfunction because of her TVT-O device. Problems associated with the device required multiple revision surgeries, and they may necessitate "additional therapies such as trigger point injections with local anesthetics, steroids, and/or Botox." Peacher Report at 18, ECF No. 50-16. Mrs. Gutierrez also may need "additional surgery to remove all the mesh," along with "long-term psychotherapy and medications for her associated depression." Id. And Mr. Gutierrez, of course, levies an additional claim for loss of consortium based on his wife's injuries. "[A]pplying [its] common sense," the Court finds that if the plaintiffs prevailed at trial, they more likely than not could collect over $75,000. Allen , 63 F.3d at 1336.⁵ So with the amount-in-controversy requirement satisfied, the Court has diversity jurisdiction over the action.

5 Moreover, when the Court cannot determine on the complaint's face whether the amount-in-controversy requirement is satisfied, it may "require [the] parties to submit summary-judgment type evidence [ ] relevant to the amount in controversy." Allen , 63 F.3d at 1336. Here, of course, the Court is already in possession of such evidence, since it now decides this case in a summary-judgment posture in light of the parties’ evidentiary submissions.

Because the Court's jurisdiction rests on diversity, the doctrine of Erie Railroad Co. v. Tompkins applies. 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938). Under Erie and its progeny, federal law generally governs the "procedural" aspects of a diversity suit, while state law governs its "substantive" aspects. See Hanna v. Plumer , 380 U.S. 460, 465, 85 S.Ct. 1136, 14 L.Ed.2d 8 (1965). As relevant here, the summary judgment standard is "procedural," and a valid Federal Rule of Civil Procedure—Rule 56 —is on point. See FDIC v. Shrader & York , 991 F.2d 216, 220 (5th Cir. 1993) ; see also Gasperini v. Ctr. for Humanities , 518 U.S. 415, 427 n.7, 116 S.Ct. 2211, 135 L.Ed.2d 659 (1996). Thus, Rule 56 controls. As that Rule provides, "[t]he court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and [that] the movant[s]"—here, the defendants—are "entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). While the defendants bear the burden of showing their entitlement to summary judgment, they must simply show that the plaintiffs have not produced enough evidence to meet their burden at trial. See Celotex v. Catrett , 477 U.S. 317, 322–23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

State statutes of limitation, by contrast, are classically "substantive" under the Erie doctrine. Guaranty Trust Co. of N.Y. v. York , 326 U.S. 99, 110, 65 S.Ct. 1464, 89 L.Ed. 2079 (1945) ; see also West v. Conrail , 481 U.S. 35, 39 & 39 n.4, 107 S.Ct. 1538, 95 L.Ed.2d 32 (1987). When applied to state causes of action, state statutes of limitation bear "vitally ... on a state-created right." Guaranty Trust Co. of N.Y. , 326 U.S. at 110, 65 S.Ct. 1464. Here, indeed, the plaintiffs assert causes of action under the law of Texas. Short Form Complaint at 4, 6, ECF No. 1. So the relevant Texas statutes of limitation govern whether plaintiffs’ claims are timely. As the parties agree, the relevant Texas statute, § 16.003 of the Texas Civil Practice & Remedies Code, imposes a two-year statute of limitations on personal injury claims. Tex. Civ. Prac. & Rem. Code § 16.003 ; see also Mot. at 4, ECF No. 49; Opp'n at 6, ECF No. 50. As that provision says, persons must bring suit for personal injury "not later than two years after the day the cause of action accrues." Tex. Civ. Prac. & Rem. Code § 16.003. And Texas courts have held that this two-year window applies to products-liability actions as well. Heckel v. Allen Samuels Chevrolet , No. 14-07-00254-CV, 2008 WL 4308406, at *3 (Tex. Ct. App. Aug. 28, 2008) ; Ogbolu v. Colgate-Palmolive Co. , No. 05-06-01480-CV, 2008 WL 171228, at *1 (Tex. Ct. App. Jan. 22, 2008). So under Texas law, the plaintiffs had to bring their action no later than two years after that action accrued.

The parties’ real dispute concerns whether Texas's so-called "discovery rule" tolls that ordinary, two-year limit. Compare Opp'n at 6, ECF No. 50, with Reply at 1–3, ECF No. 51. The Court will discuss that issue at length below, but for now it will give an overview of the relevant doctrine. Put simply, the discovery rule permits plaintiffs to sue after the two-year limitations period if they could not have discovered their injuries (with reasonable diligence) within that period. Childs v. Haussecker , 974 S.W.2d 31, 40 (Tex. 1998). In other words, "the discovery rule delays accrual [of a resultant cause of action] until the plaintiff knew[,] or in the exercise of reasonable diligence should have known[,] of the wrongful act and resulting injury." Schlumberger Tech. Corp. v. Pasko , 544 S.W.3d 830, 834 (Tex. 2018) (citing S.V. v. R.V. , 933 S.W.2d 1, 4 (Tex. 1996) ). Under Texas law, such injuries that cannot be discovered through ordinary diligence are termed "inherently undiscoverable." Comput. Assoc. Int., Inc. v. Altai, Inc. , 918 S.W.2d 453, 456 (Tex. 1996). And besides being "inherently undiscoverable," injuries subject to the discovery rule must also be "verifiable" through objective evidence. Id.

When "the plaintiff pleads the discovery rule, the defendant moving for summary judgment on limitations bears the additional burden of negating the rule." Schlumberger Tech. Corp. , 544 S.W.3d at 834. "Inquiries involving the discovery rule usually entail questions for the trier of fact." Haussecker , 974 S.W.2d at 44. Only "if reasonable minds could not differ about the conclusion to be drawn from the facts in the record" may the Court determine "commencement of the limitations period ... as a matter of law." Id. ; accord Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 250-51, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) (noting that courts may award summary judgment when "reasonable minds could [not] differ" about the case's facts). Moreover, "all evidence favorable" to the non-movants—here, the plaintiffs—"must be taken as true, and all reasonable inferences and doubts must be resolved in their favor." Haussecker , 974 S.W.2d at 44 ; accord Waste Mgmt. of La., LLC v. River Birch, Inc. , 920 F.3d 958, 964 (5th Cir. 2019).

Last, this case involves several claim-specific legal standards, such as each cause of action's legal elements and the requisite evidence required to prove them. The Court will detail those standards claim-by-claim as it examines them below.⁶

6 The Court notes at the outset that the defendants have raised no federal preemption arguments in their present motion for summary judgment, and thus the Court does not address preemption in this Opinion.

III. DISCUSSION

The Court now undertakes three tasks in its Discussion section. First, it explains why there are genuine issues of material fact about when Mrs. Gutierrez's causes of action accrued and why the discovery rule precludes holding that her claims are untimely as a matter of law. Second, it explains why the defendants are still entitled to summary judgment on Mrs. Gutierrez's various claims. And third, it explains why the defendants are also entitled to summary judgment on Mr. Gutierrez's loss of consortium claim and the issue of punitive damages.

1. There Are Genuine Issues of Material Fact About When Mrs. Gutierrez's Cause of Action Accrued, and the Discovery Rule Precludes Finding that Her Claims Are Untimely as a Matter of Law

As the Court mentioned above, the parties do not dispute that Texas law ordinarily would subject the plaintiffs’ claims to a two-year statute of limitations. The only issue is whether Texas's "discovery rule" tolls that limitations period, which hinges on whether a genuine dispute of material fact exists about when the plaintiffs’ claims accrued. Haussecker , 974 S.W.2d at 44. In the defendants’ view, Mrs. Gutierrez needed to file her suit—at the latest—within two years of her first revision surgery, which took place on April 4, 2008. Mot. at 2, 5 n.5, ECF No. 49. The plaintiffs counter that her cause of action really accrued in early 2014, when she saw a vaginal mesh litigation commercial and realized that her complications might have stemmed from the defendants’ allegedly wrongful acts. Opp'n at 9, ECF No. 50; Reply at 1–2, ECF No. 51. So in the plaintiffs’ view, Mrs. Gutierrez could have filed her suit within two years after seeing the commercial and discovering the true cause of her injuries. Opp'n at 6–9, ECF No. 50. And, they say, she easily satisfies that timeline, since she direct-filed into the MDL just a few days or weeks after seeing the commercial. Id. at 9; Short Form Complaint, ECF No. 1. The defendants counter that while Mrs. Gutierrez might have discovered the extent of her injuries as time went on, she at least knew that she was injured by April 2008, which is enough to trigger the statute of limitations. Mot. at 4–5, 5 n.5, ECF No. 49.

In combination, the record and relevant Texas law show that—at the very least—there is a genuine factual dispute about when Mrs. Gutierrez learned of her injury's cause, and thus when the limitations period began. In other words, because "reasonable minds could ... differ" about when the plaintiffs’ causes of action accrued, the Court cannot say as a matter of law precisely when the statute of limitations began to run. Haussecker , 974 S.W.2d at 44. Rather, that inquiry "entail[s] questions for the trier of fact." Id. And thus, summary judgment is inappropriate. That fact becomes readily apparent when comparing two of the Supreme Court of Texas's leading cases on the discovery rule: Schlumberger Technology Corporation v. Pasko and Childs v. Haussecker . 544 S.W.3d 830 (Tex. 2018) ; 974 S.W.2d 31 (Tex. 1998). Starting with Schlumberger , its facts were as follows: Plaintiff Michael Pasko served as a contractor at a "location where an oil well was being drilled." Schlumberger , 544 S.W.3d at 832. On "May 6, 2013, a Schlumberger employee instructed him to clean up a spill of fracking liquid backflow but did not provide him with protective equipment." Id. As Pasko cleaned up the chemicals, "most of his body came into contact with the liquid." Id. "[W]ithin hours, he was in severe pain" from chemical burns to his skin. Id. He was admitted to several hospitals for treatment and continued to suffer from "severe ... symptoms." Id. Then, "[o]n September 12, 2013, a little over four months after being exposed to the liquid, Pasko was diagnosed with squamous cell carcinoma [.]" Id.

Pasko timely sued several defendants for his injuries on May 5, 2015, beating the statute of limitations by a day. Id. But he did not add Schlumberger as a defendant until August 13, 2015, after the passage of another three months. Id. Schlumberger moved for summary judgment on statute-of-limitations grounds. Id. Pasko responded that the two-year limit to add Schlumberger should be tolled under the discovery rule. Id. The trial court ruled for Schlumberger on those grounds, but the Texas Court of Appeals reversed. Id. The Court of Appeals held that under the discovery rule, a genuine factual issue remained about whether Pasko knew, as of May 6, that he suffered from an illness. Id. at 832–33.

The Supreme Court of Texas then reversed the Court of Appeals, affirming the trial court's original grant of summary judgment to Schlumberger. Id. at 836. As the Supreme Court noted, Pasko might not have known that he would develop cancer on May 6, but he at least knew that he had been injured on May 6. Id. at 834-35. Unlike a true latent-injury case, Pasko's involved "a known, acute injury" that Pasko discerned contemporaneous with its occurrence. Id. at 833–34. Specifically, Pasko already knew by May 6 that a Schlumberger employee had directed him to clean up caustic chemicals without protective equipment and that those same chemicals inflicted his "severe burn injuries." Id. at 834. So while Pasko might not have known the extent of his injuries on May 6, the Court held that his contemporaneous knowledge that he had been injured was enough to start the limitations period. Id. at 834–35. Indeed, "[t]here was nothing latent about what was happening to Pasko or his injury." Id. at 835. Instead, "he immediately knew that the fluids were burning him, even though the full effects of his exposure were not immediately known." Id.

Schlumberger stands in contrast to the Supreme Court's earlier decision in Childs v. Haussecker . ⁷ 974 S.W.2d at 31. There, plaintiff Joseph Haussecker began work as a sandblaster in 1961 for a company called AMF Tuboscope. Id. at 34. "Two years later, AMF transferred him to its ‘pipe pickling’ operation because he complained about spitting up blood. Haussecker's pipe-pickling duties involved cleaning used pipe with paraffin, sulphur [sic], oil, and acid." Id. Later, Haussecker returned to his sandblasting duties. Id. Thus, "[d]uring his time at AMF, Haussecker was exposed to and inhaled significant quantities of silica dust and sand, as well as toxic fumes." Id.

7 Haussecker was a companion case to Humble Sand & Gravel Inc. v. Martinez , decided on the same day and in the same opinion. Haussecker , 974 S.W.2d at 31. In both Haussecker and Humble Sand , the Supreme Court of Texas tolled the respective plaintiffs’ statutes-of-limitations periods because of the discovery rule. Id. at 47.

Unfortunately, Haussecker's lung troubles continued. In September 1967, he visited a family physician, Dr. McCullough, complaining of "shortness of breath, wheezing, coughing, and a general feeling of being ill." Id. After taking chest x-rays, his doctor prescribed some "pills to alleviate Haussecker's wheezing." Id. Three months later, Haussecker visited another physician, Dr. Huffman, who performed additional x-rays and a sputum test. Id. at 34-35. "Dr. Huffman informed Haussecker that something was seriously wrong with him and that he would receive a letter in the mail," but he gave Haussecker no specific diagnosis. Id. at 35. And his "letter never arrived." Id. Haussecker then returned to Dr. McCullough in May 1968, who opined that Haussecker's problems stemmed from "his prostate gland." Id. "That same month, Haussecker reported to Midland Hospital because he had a prolonged fever and was coughing up blood and pus." Id. Dr. McCullough then suggested "that Haussecker suffered from lymphoma or Hodgkin's disease." Id. Haussecker next visited a lung specialist named Dr. Morales. Id. Dr. Morales performed "a bronchoscopy on Haussecker's lung in June 1968" and thereafter diagnosed Haussecker "with granuloma of the right lung." Id.

Though Haussecker clearly understood that he was injured, he struggled to discern "the cause of his injuries." Id. at 34. "Both Dr. Morales and Dr. McCullough told Haussecker that his illness was not work-related," though Dr. McCullough apparently "did advise Haussecker not to return to his job at AMF." Id. at 35. "Further, because one of Haussecker's co-workers had died of work-related silicosis and others had health problems similar to his own, Haussecker formed his own opinion that he too suffered from silicosis." Id.

Suspecting that his injury might be work-related, Haussecker "filed a worker's-compensation claim with the Industrial Accident Board, alleging that he had a work-related disease." Id. But "[t]he IAB denied his claim," apparently finding it unsubstantiated. Id. On November 6, 1968, Haussecker then "sued AMF's worker's compensation carrier, Liberty Mutual Insurance Company." Id. Haussecker's suit alleged that he suffered severe lung damage and "the disease of silicosis" because of his work with AMF. Id. But Haussecker's lawyer, Jerry Childs, eventually told Haussecker that "he could no longer continue the representation in good faith." Id. Childs could find no evidence "relating Haussecker's health problems to his employment at AMF," nor could he find any doctor "who would provide a diagnosis of silicosis." Id. Thus, Haussecker's "suit was dismissed for want of prosecution in 1972." Id.

In 1988, Haussecker then visited the hospital for a hand infection. Id. While there, he was examined by a lung specialist named Dr. McKenna. Id. Dr. McKenna told Haussecker that, "based on his symptoms and from Dr. McKenna's experience with other employees at AMF, he believed Haussecker had silicosis." Id. Dr. McKenna then "performed a lung biopsy in February 1990," and he "diagnosed Haussecker with work-related silicosis in April 1990." Id. At last, Haussecker had gained a "confirmed diagnosis" about the cause of his injuries. Id.

"Armed with a confirmed diagnosis," Haussecker met with his old lawyer, Childs, on April 29, 1990, to discuss re-opening his 1972 lawsuit against Liberty Mutual. Id. Yet Childs advised Haussecker "that too much time had passed for him to be able to do anything about a claim ... filed twenty years ago." Id. So Haussecker recruited a new lawyer, Mike Martin, who filed a products liability lawsuit for Haussecker in April 1993. Id. at 35–36. But the trial court granted summary judgment to the defendants on statute-of-limitations grounds, since Haussecker had filed his suit more than two years after receiving his "confirmed diagnosis" of work-related silicosis. Id. at 36.

Haussecker then sued Childs and his law firm for legal malpractice. Id. at 36. The core issue regarding Childs's potential liability was whether the statute of limitations had indeed expired in the 1970s, as Childs first advised Haussecker, or whether the statute of limitations instead only began to run with Haussecker's "confirmed diagnosis" in April 1990, so that Childs could have timely filed Haussecker's personal injury action. Id. at 36, 44–46. The trial court granted summary judgment to Childs on that issue, but the Texas Court of Appeals reversed. Id. at 36. It held that "the Hausseckers had raised a fact issue about whether the discovery rule" prevented their claims from being time-barred when they consulted Childs. Id.

On review, the Supreme Court of Texas affirmed. Id. at 47. At the outset, the court noted that Texas's discovery rule tolls a claim's accrual "until a claimant discovers[,] or in the exercise of reasonable diligence should have discovered[,] the injury[,] and that it was likely caused by the wrongful acts of another." Id. at 40. Applying those principles, the court held that genuine factual issues about when "Haussecker knew or should have known in the exercise of reasonable diligence that he likely suffered from an occupational illness" precluded summary judgment. Id. at 44. To be sure, "Haussecker certainly knew he was injured long before" he asked Childs about re-opening his 1972 lawsuit. Id. But the date on which Haussecker discerned that his work at AMF had caused those injuries was "not so clear." Id. at 45. Haussecker had diligently consulted doctors, but they had offered wide-ranging theories that discounted the possibility that his injuries were work-related. Id. As the court said,

When medical experts consistently reject a lay-person's suspicions concerning the cause of symptoms by expressly refuting an occupational connection or by suggesting exclusively causes that are not work-related, a fact question ordinarily arises about what reasonably should be known by the plaintiff and what further action the plaintiff should have taken[.]

Id.

Further, Haussecker had abandoned his earlier workers’-compensation claim and 1972 lawsuit precisely because he had no hard evidence that his injury was work-related. Id. at 46. And the court put little weight on Haussecker's "mere suspicion" before 1990 that his injuries stemmed from AMF. Id. at 43. Indeed, the court explained that a plaintiff's personal, "subjective belief that a causal connection exists between his exposure and his symptoms is, standing alone, insufficient to establish accrual [of a claim] as a matter of law." Id. Thus, "because reasonable minds could differ about when Haussecker knew or should have known through the exercise of reasonable diligence about a likely causal connection between his symptoms and his occupational exposure, Childs was not entitled to judgment as a matter of law" regarding the statute of limitations. Id. at 46.

In tandem, Schlumberger and Haussecker set forth a few principles of Texas law that dispose of the defendants’ statute-of-limitations argument. According to Schlumberger , causes of action for "known, acute" injuries, the causes of which laymen can discern contemporaneous with the injuries’ occurrence, will accrue on the date of that occurrence. Schlumberger , 544 S.W.3d at 833–34. By contrast, when a plaintiff struggles to uncover a known injury's true cause, diligently pursues a diagnosis, yet only manages to establish "mere suspicion" about those causes, the date on which any corresponding action accrued remains a question for the trier of fact. Haussecker , 974 S.W.2d at 43–46. And to the extent the latter sort of "inherently undiscoverable" injuries are also capable of verification by "objective" evidence, the trier of fact may conclude that the statute of limitations was tolled until the injured party discovered her injury's true cause. Id. at 36–37.

The Gutierrezes’ suit more clearly fits the latter, Haussecker - type situation than it does the former, Schlumberger - type situation. After receiving her TVT-O implant, Mrs. Gutierrez reported that she was healing normally and had no problems with sex. Opp'n at 7, ECF No. 50 (citing Gutierrez Dep. at 95:2-7; 98:10-17). Nothing "acute" about the implantation contemporaneously suggested "a wrongful act and resulting injury." Schlumberger , 544 S.W.3d at 833 ; Haussecker , 974 S.W.2d at 37. Her only apparent problem was difficulty inserting a tampon, which "she believed was just part of the healing process." Opp'n at 8, ECF No. 50. After Mr. Gutierrez reported that something was "sticking [his] penis" during sex, Dr. Braid wrote this off as a "known complication" and purported to resolve it with a brief, April 2008 revision surgery. Id. at 7-8. Follow-up visits with Dr. Braid seemed to confirm that "everything went well," and Mrs. Gutierrez was "feeling fine." Id. at 8 (citing Gutierrez Dep. at 95:2-7; 98:10-17). After Mrs. Gutierrez noticed recurrent SUI and pain during sex, Dr. Braid told Mrs. Gutierrez that her "tests and [ ] exams were normal," that she was "healthy," and that any pain was simply age-related. Id. (citing Gutierrez Dep. at 106:18-23). Mrs. Gutierrez "figured [that Dr. Braid] was right," and that any pains arose from age and childbirth. Id. at 8-9 (citing Gutierrez Dep. at 106:18-23; 107:8-11; 107:22–108:2). So, like Joseph Haussecker, Mrs. Gutierrez struggled to discern the true cause of her issues, despite continued consultation with her medical providers.

For that matter, even after Mrs. Gutierrez direct-filed into the MDL action, she continued to get mixed messages from her physicians. Id. at 9. Dr. Lovell at first told her that she was healthy and needed no further procedures. Id. ; see also Gutierrez Dep. at 117:18-21. Later, after another revision surgery, he continued to suggest that her problems were resolved. Id. at 117:18–118:8. Dr. Cardenas suggested that all Mrs. Gutierrez's symptoms were hormonal, rather than results of the TVT-O device. Id. at 125:8-19. Only after consulting with Dr. Botros-Brey in 2019 did Mrs. Gutierrez appear to gain confirmation that her TVT-O implant needed to go. Opp'n at 10, ECF No. 50. On those facts, Haussecker strongly suggests that genuine factual issues persist regarding the date on which Mrs. Gutierrez's claims accrued. Setting an accrual date as a matter of law, in other words, would contravene both Texas law and Rule 56 of the FRCP.

The defendants’ two counterarguments are clearly wrong. First, they ignore the plaintiffs’ arguments about Haussecker , instead dismissing the relevant portions of that opinion as "dicta." Reply at 2, ECF No. 51. "This dicta," they claim, "has not been followed by other courts and is not good law in Texas." Id. Yet the defendants cite no Texas case construing the relevant portions of Haussecker as dicta, and they offer no arguments about why those portions do not constitute a binding holding. Nor can this Court discern what the defendants are talking about. Traditionally, courts have distinguished between non-binding digressions in judicial opinions—so-called obiter dictum —and those portions of the opinion necessary to reach the result—the case's binding ratio decidendi. See Bryan A. Garner et al., The Law of Judicial Precedent 44–47 (2016). Haussecker's treatment of the discovery rule falls neatly into the latter camp. The view that Haussecker's inability to get a clear diagnosis could toll the statute of limitations was necessary to the court's holding that Haussecker was entitled to present his malpractice claims to the jury. Haussecker , 974 S.W.2d at 45–46. Precisely for those reasons, the Supreme Court affirmed the lower court's denial of summary judgment to Childs. Id. at 45–47. And because those discovery rule issues were actually presented to and necessarily decided by the Haussecker Court, they constitute binding portions of its opinion. Accord Garner et al., supra , at 44 ("The holding of an appellate court constitutes the precedent, as a point necessarily decided.").

A quick Westlaw search provides a clue about what the defendants may be hinting at. According to that database, Haussecker was "not followed as dicta" in the Texas Court of Appeals case Pustejovsky v. Pittsburgh Corning Corp. , 980 S.W.2d 828 (Tex. Ct. App. 1998). Pustejovsky concerned whether separate diagnoses for separate but related diseases, like asbestosis and mesothelioma, entails accrual of two separate causes of action (and thus, two distinct limitations periods), or whether only a single cause of action accrues under Texas law. Id. at 829. The Pustejovsky court noted Haussecker ’s statement that

[W]hen more than one separate disease results from a particular exposure, many courts have concluded that allowing the statute of limitations to run separately for each distinct disease benefits plaintiffs, defendants, and the judicial system by deterring uneconomical anticipatory lawsuits. Although the issue is not before us , we note that our formulation of the discovery rule for latent disease cases does not necessarily preclude a plaintiff from recovering damages for every disease that ultimately manifests itself as a result of the occupational exposure.

Id. at 832 (citing Haussecker , 974 S.W.2d at 31, 40–42 ) (internal quotation marks omitted) (emphasis added).

The Pustejovsky court correctly rejected that portion of Haussecker as dictum, since the question whether multiple causes of action may accrue from distinct diseases with a related source was not actually raised and necessarily decided in Haussecker —as the Haussecker Court itself pointed out. Haussecker , 974 S.W.2d at 41.⁸ Again, Haussecker decided only whether the discovery rule could toll the statute of limitations's start date until the advent of a diligently pursued "confirmed diagnosis." Id. at 35, 46. But that portion of Haussecker , being necessarily decided, was a binding portion of its holding. Accord Garner et al., supra at 44–47.

8 And for that matter, the Texas Court of Appeals's decision in Pustejovsky that multiple causes of action and statutes of limitation could not ensue from the advent of separate but related diseases was itself rejected by the Supreme Court of Texas. See Pustejovsky v. Rapid-Am. Corp. , 35 S.W.3d 643 (Tex. 2000).

The defendants’ second counterargument is more comprehensible, though also unavailing. They say, essentially, that while Mrs. Gutierrez might not have always known the full extent of her injuries, she knew many years before commencing her present suit that she was at least injured. Mot. at 4–5, 5 n.5, ECF No. 49. Indeed, as the defendants say in their reply brief, Mrs. Gutierrez "was aware of the symptoms" from her TVT-O "following the initial implant and the 2008 revision." Id. at 5 n.5. And that's all, they say, that "Texas law requires" to start the statute-of-limitations period. Id.

But as the Court has already explained, that is not all that Texas law requires. The defendants’ characterization would be true had Mrs. Gutierrez suffered a "known, acute" injury with a cause contemporaneously patent to a layperson. Schlumberger , 544 S.W.3d at 833. Under Schlumberger , she would have had to sue within two years of that acute occurrence, which explains why the defendants so heavily rely on Schlumberger in their untimeliness arguments. See, e.g. , Mot. at 4, ECF No. 49 (citing Schlumberger ); id. at 5 n.5 (same); Reply at 2, ECF No. 51 (same). But Mrs. Gutierrez's latent injuries, which evaded a clear diagnosis despite her diligent pursuit of one, are distinguishable from the "known, acute" injury scenario. Cf. Schlumberger , 544 S.W.3d at 833. She might have known well before 2014 that she was experiencing "symptoms," as the defendants call them, from her TVT-O device. Mot. at 5 n.5, ECF No. 49. But she apparently had no specific knowledge that those symptoms were, in fact, injuries caused by the wrongful acts of another. For that reason, Haussecker governs. And under that precedent, the defendants are not entitled to judgment as a matter of law on the timeliness issue.

2. The Defendants are Entitled to Summary Judgment on the Plaintiffs’ Various Causes of Action

Having explained why the plaintiffs’ claims are not untimely, the Court will now explain why the defendants are still entitled to summary judgment on all the plaintiffs’ claims. Once again, their suit comprises claims for strict liability/failure to warn, negligence, gross negligence, common law fraud, negligent misrepresentation, violation of consumer-protection laws, strict liability/design defects, and loss of consortium. Short Form Complaint at 4, ECF No. 1; Order, ECF No. 39. The Court addresses the plaintiffs’ causes of action in that order.

2.A The Defendants are Entitled to Summary Judgment on the Plaintiffs’ Strict Liability/Failure to Warn Claim, as Well as on the Plaintiffs’ Negligence and Gross Negligence Claims to the Extent the Latter are Predicated on Failure-to-Warn Theories

The first theory of recovery the Court turns to is the plaintiffs’ "failure to warn" theory. The First Amended Master Complaint's Count III is labeled "strict liability—failure to warn." FAMC at 28, ECF No. 32-1. It alleges, in relevant part, that the defendants "failed to properly and adequately warn and instruct the Plaintiffs and their healthcare providers" of various pertinent information, such as the "proper candidates" for surgery, "the safest and most effective methods of implantation," "research and testing," and the "risks and benefits" associated with the device. Id. at ¶¶103–105. The plaintiffs’ negligence count (Count I) also incorporates failure-to-warn theories. Id. at 24. It alleges, for instance, that the "Defendants breached their duty of care and were negligent" regarding their "warning," and that they "fail[ed] to use reasonable care in instructing and/or warning healthcare providers, the FDA[,] and the public as set forth herein of risks associated with the Products." Id. at ¶¶ 90–94. Later on, the plaintiffs also present a gross negligence theory of recovery, Count XIV. Id. at 54. They do not specifically allege failure to warn (or any other particular gross negligence theory) under Count XIV, suggesting only that the plaintiffs were "subjectively aware" of "an extreme degree of risk" and yet continued to sell their product. Id. at ¶ 217. The Court's present discussion of their gross negligence claim, then, applies to the extent that the plaintiffs are relying on a failure-to-warn theory of gross negligence.

Failure to warn under Texas law requires the plaintiff to establish two basic elements: that "(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. Ct. App. 1989) ; accord Perez v. Am. Med. Sys., Inc. , 461 F. Supp. 3d 488, 506 (W.D. Tex. 2020). Though the plaintiffs purport to have evidence for both elements, the defendants dispute that assertion. Compare Opp'n at 27–40, ECF No. 50, with Mot. at 7, ECF No. 49. Specifically, the defendants rely on Texas's "learned intermediary doctrine." Mot. at 7, ECF No. 49. Under that doctrine, "the manufacturer of a pharmaceutical product satisfies 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). Though "the most common use of this doctrine is in prescription drug cases," Texas courts have also extended it to scenarios analogous to the present suit. Wyeth-Ayerst Lab'y Co. v. Medrano , 28 S.W.3d 87, 91 (Tex. Ct. App. 2000). For instance, the Texas Court of Appeals has applied the doctrine to a claim concerning an implanted contraceptive device. Id. 94–95. So logically it would apply in a case concerning an implanted mesh device as well.

In the context of this suit, the learned intermediary doctrine places two specific burdens on the plaintiffs. They must show, first, that Mrs. Gutierrez's intermediary—Dr. Braid—received inadequate warnings from the defendants about the risks associated with the TVT-O. Stewart , 780 S.W.2d at 911. But second, they must show that if Dr. Braid had received adequate warnings about the device that he would not have recommended it. Wyeth-Ayerst Lab'y Co. , 28 S.W.3d at 95 ("In order to prove causation, the plaintiff must show that a proper warning would have changed the decision of the intermediary to prescribe the product."); see also Centocor, Inc. , 372 S.W.3d at 170 ("[W]here the physicians were unequivocal that new information about the risks would not have changed their decision to prescribe the medication, an inadequate warning was not the proximate cause of plaintiff's injury ... [I]t is ... the plaintiff's burden to prove that a different warning would have changed the physician's decision to prescribe the medication."); In re Norplant Contraceptive Prod. Liab. Litig. , 955 F. Supp. 700, 709 (E.D. Tex. 1997) ("Plaintiffs must demonstrate that a proper warning would have changed the decision of the treating physician, i.e., that but for the inadequate warning, the treating physician would not have used or prescribed the product.") (applying Texas law). And if the plaintiff fails to show that the intermediary, when presented with an adequate warning, would have changed his recommendation, "then, as a matter of law, he or she has failed to prove causation." Wyeth-Ayerst Lab'y Co. , 28 S.W.3d at 95.

Turning to the warning's adequacy, the plaintiffs appear to have established genuine factual issues about whether Ethicon's warnings adequately apprised Dr. Braid of the TVT-O's risks. Generally, Texas law dictates that "[t]he adequacy of a warning is a question of fact to be determined by the jury." Alm v. Aluminum Co. of Am. , 717 S.W.2d 588, 592 (Tex. 1986) (citation omitted). The defendants attempt to argue that Ethicon's warnings were sufficient by pointing to several statements from Dr. Braid's deposition. They note that

Dr. Braid, the physician who implanted [the] TVT-O in Ms. Gutierrez, testified that he knew of the risks Plaintiffs now complain of. Ms. Gutierrez complains of pelvic and pain [sic], urinary problems, pain with sex (for both Ms. Gutierrez and her husband), and recurrence of her symptoms (stress urinary incontinence ) as injuries from implantation of her TVT-O. Ex. A, PFS at 7. Dr. Braid knew about each of these risks from TVT-O implantation. Ex. B, Depo. of Alan Braid, M.D., at 40:16-41:2; 46:2-47:22; 48:7-49:23; 54:9-55:5; 62:1-63:20. Dr. Braid even went into great detail about how these various injuries warned about could occur during TVT-O implantation and also listed the risks of those injuries on the consent forms for the surgical procedures he performed on Ms. Gutierrez. Id. at 39:19-41:2.

Mot. at 8, ECF No. 49.

The plaintiffs respond that Dr. Braid relied on information in Ethicon's literature and from an Ethicon conference, and that the literature omitted mention of several complications from which Mrs. Gutierrez now suffers. Opp'n at 31–35, ECF No. 50. At his deposition, for instance, Dr. Braid testified that he "read journal [sic] and information supplied by the manufacturer" to learn about TVT-O devices. Id. at 31 (citing Braid Dep. at 64:11-19). Though he did not specifically recognize the Ethicon pamphlet he was presented at his deposition, he remarked that he "recognize[d] the information within the pamphlet." Id. (citing Braid Dep. at 64:21-25; 66:20-25). (Elsewhere, he re-affirmed that he would have read and relied on safety information from the manufacturer before performing surgeries. Id. at 32 (citing Braid Dep. at 64:15-19; 72:15-17).) At the time of Mrs. Gutierrez's first surgery, that pamphlet—referred to as the TVT-O's "Instructions for Use" (IFU)—did not include information about "chronic infection, antibiotic resistant infections, chronic pain, abscess, vaginal perforation, vaginal scarring, foreign body reaction, bridging fibrosis, shrinkage contraction of the mesh device, curling, roping, or deformation of the mesh, nerve entrapment, dyspareunia [, or] complications requiring mesh removal." Id. at 32 (citing Rosenzweig Report at 66–81, ECF No. 50-2).

Concomitantly, the plaintiffs say, these gaps in the literature created gaps in Dr. Braid's knowledge. Opp'n at 33–34, ECF No. 50. For instance, he was unaware that vaginal erosion could continue for the rest of Mrs. Gutierrez's life, and nothing in Ethicon's documents so warned him. Id. He was also not apprised that the mesh could continue to degrade. Id. Nor did he realize that the device could lead to chronic irritation. Id. (Indeed, Ethicon's literature referenced only "transitory local irritation of the wound site," and Dr. Braid testified that he understood the term "transitory" to refer only to "temporary" irritation. Id. ) Additionally, nothing in Ethicon's literature revealed that the device was intended to remain permanently within the body, nor did it inform Dr. Braid that it posed a risk of cytotoxicity. Id.

But even assuming the plaintiffs have established a genuine issue of material fact about the warnings’ adequacy, the plaintiffs’ failure-to-warn claims still fail on the second, "causation" prong. Wyeth-Ayerst Lab'y Co. , 28 S. W.3d at 95 ("[E]ven if we assume that the plaintiff can prove that the given warnings were inadequate, the plaintiff still must prove causation."). Again, merely showing a warning's defectiveness does not suffice for a failure-to-warn claim under Texas law. Plaintiffs must also put forth evidence that Mrs. Gutierrez's intermediary, Dr. Braid, would have changed his decision to recommend the TVT-O had he known the additional risks omitted from the original warnings. Id. at 95 ("In order to prove causation, the plaintiff must show that a proper warning would have changed the decision of the intermediary to prescribe the product.... If the plaintiff fails to sustain this burden, then, as a matter of law, he or she has failed to prove causation."). In other words, the plaintiffs must put forth evidence that Dr. Braid would not have recommended the TVT-O had he received an adequate warning.

Yet Dr. Braid's testimony actually shows the opposite—that he still would have recommended the TVT-O to Mrs. Gutierrez even after being apprised of its additional risks. The relevant portions of Dr. Braid's deposition are instructive. That questioning proceeded as follows:

By Mr. Wingard:

Q. Dr. Braid?

A. Yeah.

Q. In this case, Ms. Gutierrez's case, with all the information you've received up to the present, including the questioning that you just went through, would you still recommend TVT-O to Mrs. Gutierrez in 2007?

A. I still believe TVT-O has fewer complications overall than more invasive kinds of surgeries for stress urinary incontinence like MMK or A&P repair.

Q. And so, specifically, would you have recommended TVT-O for Ms. Gutierrez, but not having a crystal ball to know what if any complications might ensue?

A. I think based on—on what I knew at the time she had her surgery, I would have recommended TVT-O.

Q. And knowing everything you know today, if—if a patient presented to you today and you were still active in the management of stress urinary incontinence, would you still prescribe TVT-O today?

A. After informed consent and decision-making with the patient, giving her all the information that I had before and I have now, yes.

Braid Dep. at 111:23–112:20, ECF No. 50-6.

Later on, the exchange continued:

Q. Okay, and do you second-guess your decision to use TVT-O in Ms. Gutierrez?

A. No.

Id. at 114:1-3.

Plaintiffs’ counsel then sought to rehabilitate Dr. Braid with the following sequence of questions:

By Mr. Sadler:

Q. Just one area, Doctor. You were asked very carefully, and your response, I noticed, was very carefully about whether or not you would have recommended Ms. Gutierrez's surgery, and you said from what I knew at the time of the surgery in 2007—

A. Right.

Q. —you would have made that decision?

A. Right.

Q. And then asked, well, would you still today, you said I would have—after informed consent and

after giving her all of the data and information—

A. Right.

Q. —in other words, the information, you didn't know in 2007, correct, about chronic foreign body response and the erosion response and the Ethicon internal data.

Mr. Wingard: Objection, form.

A. Yeah, that's true, but—but also knowing about the chronic response that we discussed, I would have been able to inform Ms. Gutierrez of that possibility and put that in the risk column for her to decide whether that risk was worth the benefit of being cured of stress urinary incontinence.

Q. (By Mr. Sadler) That was exactly my next question. And that's a good standard of medical care, correct?

A. Yes.

Q. Because it's—

A. I believe so.

Q. —ultimately her choice?

A. I believe so.

Q. She can decide whether or not she wants a polypropylene mesh in her body—

A. Right.

Q. —or if she wants to use her own natural tissue to try to fix her problem, correct?

A. That's correct.

Q. Thank you.

Id. at 114:17–116-5.

Defense counsel then continued:

By Mr. Wingard:

Q. But, Doctor, knowing everything that you know today, as you here right now [sic], you would still recommend, I'm not saying you would force, but you would recommend TVT-O for Ms. Gutierrez?

A. I would present that as a—a procedure to treat her stress incontinence, give her all the information for her to make an informed decision about what procedure, if any, she wanted to go forward with, with her ability to weigh the risks and the benefits, and if she chose TVT-O, I would have done that procedure knowing all that I know today.

Q. Do you believe it's still the gold standard treatment for the treatment of stress urinary incontinence ?

Mr. Sadler: That's asked and answered.

By Mr. Wingard:

Q. You're allowed to answer.

Mr. Sadler: He said he didn't know today.

A. Right, I—I—I have not followed the literature since 2010 on that subject. I believe back then it was the gold standard. There's no information I have now that would lead me to believe anything else.

Q. (By Mr. Wingard) Right. So if the American College of Obstetrics and Gynecology has recently put out a statement saying—

A. Uh-huh.

Q. —that TVT slings still are the gold standard treatment for the treatment of stress urinary incontinence, do you have any reason to dispute that?

A. No.

Q. Okay. Thank you.

Id. at 116:8-25, ECF No. 50-6; Braid Dep. at 117:1-14, ECF No. 49-2. In combination, then, these portions of Dr. Braid's testimony establish several salient points. First, he still believes that the TVT-O device has "fewer complications overall" than competing treatments. Braid Dep. at 112:5-7, ECF No. 50-6. Second, "knowing everything [he] know[s] today," i.e., all of the TVT-O's additional potential risks, he would still prescribe TVT-Os. Id. at 116:8-18. Third, he does not "second guess" his decision to prescribe a TVT-O to Mrs. Gutierrez. Id. at 114:1-3. Fourth, despite learning of its additional risks, he still would have "present[ed]" it to her today as a viable option, and he still "would have done that procedure knowing all that I know today." Id. at 116:12-18. And fifth, Dr. Braid explained that he has no reason to conclude, even today, that TVT-O is not the "gold standard" for treating SUI. Braid Dep. at 117:2-14, ECF No. 49-2.

In rebuttal, the plaintiffs do not even contest that Dr. Braid's TVT-O recommendation would remain the same today. Opp'n at 35–40, ECF No. 50. Instead, they hammer the legally irrelevant point that Dr. Braid would have mentioned additional risks to Mrs. Gutierrez, which would have caused Mrs. Gutierrez to change her mind. Id. But under the learned intermediary doctrine, whether Mrs. Gutierrez might have changed her mind does not bear on the causation element of a failure-to-warn claim under Texas law. Again, "[i]n order to prove causation, the plaintiff must show that a proper warning would have changed the decision of the intermediary to prescribe the product." Wyeth-Ayerst Lab'y Co. , 28 S.W.3d at 95 ; accord Centocor, Inc. , 372 S.W.3d at 170 (emphasis added). Dr. Braid's testimony reveals that he would not have changed his mind about recommending the TVT-O to Mrs. Gutierrez. To the contrary, he remarked that despite everything he learned about the TVT-O during the litigation, he still considered it the "gold standard," still would have recommended it to Mrs. Gutierrez, and still would have performed exactly the same procedure. See supra pages 628–31. Thus, the plaintiffs cannot show that Ethicon's allegedly inadequate warnings caused their injuries, and so their failure-to-warn claims fail as a matter of law.

Seeking to rebut that conclusion, the plaintiffs quote a 2006 case from the Fifth Circuit, McNeil v. Wyeth , 462 F.3d 364 (5th Cir. 2006) ; Opp'n at 37, ECF No. 50 (citing McNeil ). There, the Fifth Circuit remarked that "[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." McNeil , 462 F.3d at 373. The plaintiffs then reason as follows: Dr. Braid testified that had Ethicon made him aware of the TVT-O's additional risks, though he still would have recommended the device to Mrs. Gutierrez, he also would have informed her of those additional risks. Opp'n at 37–38, ECF No. 50. And Mrs. Gutierrez testified that had she known of those additional risks, she never would have agreed to receiving a TVT-O. Id. (citing Gutierrez Affidavit). Thus, following McNeil , because Ethicon "sabatoge[d]" Dr. Braid's role as an intermediary, the jury could find the inadequate warning "a ‘producing’ cause of the injury." Id.

Respectfully, the Fifth Circuit's McNeil decision is not an accurate statement of Texas law. The Fifth Circuit itself cited no on-point Texas case for its analysis, and McNeil conflicts with the Supreme Court of Texas's more recent treatment of the learned intermediary doctrine. The 2012 case Centocor, Inc. v. Hamilton is instructive. 372 S.W.3d 140 (Tex. 2012). There, plaintiffs Patricia and Thomas Hamilton sued Centocor, a prescription drug manufacturer, along with Patricia's prescribing physicians, for injuries Patricia sustained after being prescribed a Centocor-made drug called Remicade. Id. at 143. The Hamiltons argued that Centocor gave "inadequate and inappropriate warnings and instructions for use" and that after taking Remicade, Patricia suffered "a serious drug-induced side effect called lupus-like syndrome." Id. But the Supreme Court of Texas ruled for the defendants because the Hamiltons failed to show that additional warnings "would have changed [the physicians’] decision to prescribe Remicade to Patricia." Id. at 172. Because the plaintiffs "failed to present any evidence that including additional post-approval reports [about the drug's side effects] in the warning would have caused Patricia's physicians to change their prescription, the Hamiltons failed to meet their burden of proof." Id. at 173. "Accordingly," the Supreme Court stated, "because there is no causation evidence to support the Hamiltons’ claims, all of which are premised on Centocor's alleged failure to warn, the Hamiltons’ claims must fail." Id.

In so holding, the Supreme Court of Texas cited with approval similar cases requiring evidence that additional warnings would have changed the prescribing physician's recommendation. For instance, the Supreme Court endorsed a Southern District of Texas case that explained, "[W]here the physicians were unequivocal that new information about the risks would not have changed their decision to prescribe the medication, an inadequate warning was not the proximate cause of plaintiff's injury." Id. at 170 (citing Ebel v. Eli Lilly & Co. , 536 F. Supp. 2d 767, 780 (S.D. Tex. 2008) ). In other words, "it is ... the plaintiff's burden to prove that a different warning would have changed the physician's decision to prescribe the medication." Id. The Supreme Court then contrasted this rule—the one it deployed to reject the Hamiltons’ claims—with the Fifth Circuit's McNeil holding. Id. Though it quoted the relevant paragraph of McNeil that the Gutierrezes now cite, the Supreme Court set it off with a "cf. " signal, indicating that it was "a proposition different from the main proposition." See THE BLUEBOOK 63 (21st ed. 2020). And that the Supreme Court believes that McNeil stands for a "different ... proposition" from Texas law is unsurprising, given that McNeil conflicts with Centocor's holding. Id.⁹

9 For instance, Centocor and McNeil would produce divergent results where, as here, a warning is allegedly inadequate, but a physician states that he would have prescribed the same treatment even if the manufacturer had given him an adequate warning. Under Centocor , the plaintiff's showing of causation fails as a matter of law in that scenario, since the new warning wouldn't have changed the physician's mind. Centocor , 372 S.W.3d at 170. By contrast, McNeil lets the suit continue: the plaintiff can create a genuine issue of material fact by claiming that, even though her doctor would have prescribed the same treatment, she would have rejected his recommendation. McNeil , 462 F.3d at 373. So whatever the wisdom of the McNeil rule, it is not the law of Texas and thus not the rule of decision in a diversity suit. See Erie R.R. Co. , 304 U.S. at 78, 58 S.Ct. 817.

Having established an inconsistency between the Supreme Court of Texas's view of Texas law and the view earlier espoused by the Fifth Circuit, it nearly goes without saying that this Court, sitting in diversity, must defer to the former. As Erie itself recognized, "the law to be applied in any [diversity] case is the law of the state." Erie R.R. Co. , 304 U.S. at 78, 58 S.Ct. 817. And that law is determined by either the state's legislature "or by its highest court." Id. Because that highest court—the Supreme Court of Texas—has construed its learned intermediary doctrine to require evidence that the intermediary would have changed his recommendation had he seen an augmented warning, and because the plaintiffs have produced no such evidence, their failure-to-warn claims will be denied as a matter of law. Thus, the defendants are entitled to summary judgment on the plaintiffs’ strict liability/failure-to-warn claim, as well as on the plaintiffs’ negligence and gross negligence claims to the extent that they rely on failure-to-warn theories.

2.B Defendants Are Also Entitled to Summary Judgment on the Plaintiffs’ Common-Law Fraud, Negligent Misrepresentation, and Violation-of-Consumer-Protection-Law Claims, Which Rehash the Plaintiffs’ Failure-to-Warn Theory

The plaintiffs also assert claims for common-law fraud, negligent misrepresentation, and violation of consumer-protection laws. Short Form Complaint at 4, ECF No. 1; FAMC at 33, 44, 50, ECF No. 32-1. Really, though, each of these three claims relies on the same failure-to-warn theory that the Court just rejected under the learned intermediary doctrine. For instance, regarding common-law fraud, the plaintiffs’ complaint states that the defendants’ allegedly false representations

were made by Defendants with the intent of defrauding and deceiving the medical community , Plaintiffs, and the public, and also inducing the medical community , Plaintiffs, and the public, to recommend, prescribe , dispense, and purchase the Pelvic Mesh Products for use as a means of treatment for stress urinary incontinence and/or prolapse, all of which evinced a callous, reckless, willful, and depraved indifference to the health, safety, and welfare of Plaintiffs.

FAMC at ¶ 122, ECF No. 32-1 (emphases added).

The same common-law fraud count then details how the defendants deployed these "misrepresentations" to "induce ... the medical community to request, recommend, prescribe, dispense, purchase, and continue to use the Defendant's Pelvic Mesh Products." Id. at ¶ 137. The negligent misrepresentation count, too, alleges that the "Defendants failed to exercise ordinary care in the representations concerning the Pelvic Mesh Products while they were involved in their manufacture, sale, testing, quality assurance, quality control, and distribution in interstate commerce, because Defendants negligently misrepresented the Pelvic Mesh Products’ high risk of unreasonable, dangerous, adverse side effects," and thus deprived the plaintiffs of "adequate and accurate warnings. " Id. at ¶¶ 166, 168 (emphasis added). And the violation-of-consumer-protection-laws count also rests on a failure-to-warn theory. The defendants’ "fraudulent or deceptive conduct," it says, caused "Plaintiffs and the medical community [to] rel[y] upon Defendants’ misrepresentations and omissions in determining which product and/or procedure to undergo and/or perform (if any)." Id. at ¶¶ 201, 212 (emphases added).

Yet Texas law forecloses the deployment of creative pleading to circumvent the learned intermediary doctrine. As the District Court for the Eastern District of Texas explained (in an opinion the Supreme Court of Texas later endorsed) Texas courts must discern the "gravamen" of claims to determine whether they, in truth, simply rehash failure-to-warn theories. In re Norplant , 955 F. Supp. at 709. Doing so is necessary because if the learned intermediary doctrine "could be avoided by casting what is essentially a failure-to-warn claim under a different cause of action such as the DTPA¹⁰ [i.e., a consumer-protection law] or a claim for misrepresentation, then the doctrine would be rendered meaningless." Id. As the Supreme Court of Texas explained in Centocor , where the "crux" of a common-law claim is really a failure-to-warn theory, the learned intermediary doctrine applies with equal force. Centocor, Inc. , 372 S.W.3d at 169 (citing In re Norplant with approval).

10 The Norplant court was here referring to the Deceptive Trade Practices Act, a Texas consumer-protection law intended to protect consumers from fraudulent and deceptive business practices. See In re Norplant , 955 F. Supp. at 703.

Applied to the plaintiffs’ present claims, the Court holds that the learned intermediary doctrine defeats the common-law fraud, negligent misrepresentation, and violation-of-consumer-protection-law claims as a matter of law. The "gravamen" or "crux" of these claims, as detailed above, is that the defendants furnished inadequate warnings to physicians and the public, and that physicians and the public "relied upon [those] misrepresentations and omissions in determining which product and/or procedure to undergo and/or perform[.]" FAMC at ¶ 212; see also FAMC at ¶ 168, ECF No. 32-1 (alleging that defendants’ negligent misrepresentations left physicians and the public "lack[ing] adequate and accurate warnings."); id. at ¶ 122 (alleging, under common-law fraud theory, that defendants "induce[d] the medical community ... to recommend [and] prescribe" the mesh product). Because these are really failure-to-warm claims masquerading as distinct causes of action, Texas law obliges the Court to treat them as failure-to-warn claims, and thus to apply the learned intermediary doctrine. And because, as the Court has explained, that doctrine defeats this case's failure-to-warn theory, the plaintiffs’ common-law fraud, negligent misrepresentation, and violation-of-consumer-protection-law claims also fail as matter of law.

The plaintiffs’ only real response to this point is to contend that their pleadings did not "simply repurpose the failure to warn claim." Opp'n at 40, ECF No. 50. "While the same or similar conduct may support each of these theories," they say, "the inquiries and proof are different. Strict liability failure to warn focuses on the warning defect of the product. Negligence, gross negligence, fraud[,] and consumer protection laws focus on the conduct of the manufacturer. Each are distinct causes of action with different standards of conduct." Id. For instance, they continue, "the conduct of hiding the data ... may constitute an independent action of [sic] fraud." Id. at 41.

Tellingly, though, the plaintiffs make no attempt to distinguish In re Norplant or Centocor . The former extended the learned intermediary doctrine to misrepresentation and consumer-protection-law claims after concluding that their "gravamen" was really failure-to-warn. In re Norplant , 955 F. Supp. at 709. And the Supreme Court of Texas both approved Norplant and extended it in Centocor , where it similarly applied the learned intermediary doctrine to a fraud claim. Centocor, Inc. , 372 S.W.3d at 169. So how can the Gutierrezes say that they may pursue "an independent action of [sic] fraud" when the Supreme Court of Texas denied just such a fraud claim in similar circumstances under the learned intermediary doctrine? Their brief, which does not even mention Centocor , leaves the answer mysterious. 2.C The Defendants Are Also Entitled to Summary Judgment on the Plaintiffs’ Strict Liability/Design Defect Claim, as Well as on the Plaintiffs’ Negligence and Gross Negligence Claims to the Extent That the Latter are Also Predicated on Design-Defect Theories

That leaves the plaintiffs’ strict liability/design defects claim, along with, to the extent that they do not rely on a failure-to-warn theory, their negligence and gross negligence claims. See Short Form Complaint at 4, ECF No. 1; Order, ECF No. 39. The Court has found no Texas case extending the learned intermediary doctrine to design-defect claims, and the defendants do not contend that it so applies. Thus, the Court turns to Texas's general principles on design defects. Such claims are governed by § 82.005 of the Texas Civil Practice and Remedies Code. As that statute provides, "[i]n a products liability action in which a claimant alleges a design defect, the burden is on the claimant to prove by a preponderance of the evidence that: (1) there was a safer alternative design; and (2) the defect was a producing cause of the personal injury[.]" Tex. Civ. Prac. & Rem. § 82.005. Further, the statute requires the plaintiff to show that this "safer alternative design ... in reasonable probability: (1) would have prevented or significantly reduced the risk of the claimant's personal injury [and] (2) was economically and technologically feasible at the time the product left the control of the manufacturer or seller by the application of reasonably existing or reasonably achievable scientific knowledge." Id. These elements generally present issues of fact "for the jury." Genie Indus. Inc. v. Matak , 462 S.W.3d 1, 3 (Tex. 2015). But where the plaintiff fails to offer evidence of an element, the design-defect claim fails as a matter of law. Smith v. Aqua-Flo, Inc. , 23 S.W.3d 473, 477 (Tex. Ct. App. 2000).

The defendants attack the plaintiffs’ attempt to prove those elements on three distinct grounds. First, the defendants say, there is "[n]o causative link between [the] defect and alleged injury." Mot. at 6, ECF No. 49. They argue, specifically, that the plaintiffs have adduced no expert testimony that a TVT-O design defect caused Mrs. Gutierrez's injuries. Id. Second, the defendants contend that the plaintiffs have presented "[n]o proof of a safer alternative design." Id. The plaintiffs’ expert, Dr. Jorge Peacher, "did not identify any safer alternative designs to TVT-O in his expert report." Id. And third, the defendants argue that there is "[n]o proof that any safer alternative design would have prevented [the] alleged injuries." Id. at 7. So because the plaintiffs have no "case-specific expert testimony ... that a proposed alternative was available [and] was scientifically, economically, and technologically feasible, and that the alternative [design] would have prevented their injuries," their design-defect claims fail as a matter of law. Id. Because the defendants’ last argument disposes of this case, the Court addresses it first.

2.D. The Plaintiffs Have Failed to Put Forth Case-Specific Evidence That a Safer Alternative Design, In Reasonable Probability, Would Have Prevented Mrs. Gutierrez's Injuries

As the Supreme Court of Texas has explained, § 82.005 requires "a claimant to prove that an alternative design ... would in reasonable probability have prevented or significantly reduced the risk of the claimant's injury or damage." Hernandez v. Tokai Corp. , 2 S.W.3d 251, 258 (Tex. 1999). Plaintiffs must adduce case-specific evidence for this element of their claims. Id. "The relevant risk of injury or damage," as the Supreme Court has explained, "is the risk to the claimant ." Id. (emphasis added). In other words, just as the plaintiff must make a "specific causation" showing that a design defect actually "caused [that] particular individual's injury," the plaintiff must make a similarly specific showing that an alternative design likely would have prevented that injury. Merck & Co. v. Garza , 347 S.W.3d 256, 262 (Tex. 2011). When the plaintiff fails to make such a showing, her case has omitted a "necessary" element of "a defective-design claim" under Texas law. Hernandez , 2 S.W.3d 251 at 258.

In response to the defendants’ argument that no case-specific testimony supports concluding that an "alternative [design] would have prevented [the plaintiffs’] injuries," the plaintiffs marshal no on-point evidence. Mot. at 7, ECF No. 49. They simply offer up the "case specific reports" of their two case-specific experts, Drs. Jorge Peacher and Paul J. Michaels. Opp'n at 20, ECF No. 50 (directing the Court to the "Michael [sic] and Peacher case specific reports"). But neither of these experts has suggested that a proposed alternative design would have prevented Mrs. Gutierrez's injuries. In his scant, four-and-a-half-page declaration, Dr. Peacher simply recites Mrs. Gutierrez's case history, mentions some mesh studies, and then opines that "it is my opinion to a reasonable degree of medical probability that the cause of Debra Gutierrez's pelvic pain and pain with intercourse was a direct result of the implantation of the Ethicon Gynecare TVT-O." Peacher Report at 1–5, ECF No. 50-16. As an initial matter, Dr. Peacher's declaration borders on the sort of "mere ipse dixit of a credentialed witness" that Texas and federal courts have specifically disapproved. Genie Indus., Inc. , 462 S.W.3d at 8 ; Ellis v. United States , 673 F.3d 367, 373 (5th Cir. 2012). But even if the Court assumes that Dr. Peacher could testify to everything in his declaration and its various addenda at trial, his comments tell the Court nothing about whether an alternative design likely would have prevented Mrs. Gutierrez's injuries.

Dr. Michaels's case-specific report is no more helpful in that regard. Dr. Michaels is a pathologist who, in preparation for this case, microscopically reviewed tissue slides taken from Mrs. Gutierrez's vagina. Michaels Report, ECF No. 50-11.¹¹ (He attaches several of those slides to his expert report, along with his commentary on what they reflect. Id. at 8–48.) Dr. Michaels's report is significantly more thorough than Dr. Peacher's, to be sure. But Dr. Michaels, like Dr. Peacher, has offered the Court no evidence on whether the plaintiffs’ proposed alternative designs would have prevented Mrs. Gutierrez's injuries. His expert report, for example, describes his "summary of opinions" as follows:

11 The Court notes that plaintiffs’ counsel uploaded twenty-five exhibits to the ECF system along with its opposition brief. Instead of assigning those exhibits labels within the ECF system, counsel left them as "Exhibit 1," "Exhibit 2," "Exhibit 3," and so on. Apparently attempting to aid the Court in discerning which exhibits those generic labels referred to, counsel also uploaded an "exhibit list" along with the exhibits. But counsel uploaded the exhibit list itself as "Exhibit 1," which caused the exhibit list to be inaccurate for every single exhibit it mentions. For instance, the exhibit list calls the Rosenzweig Report "Exhibit 1" when it's really Exhibit 2, the mesh revision history "Exhibit 2" when it's really Exhibit 3, the fact sheet "Exhibit 3" when it's really Exhibit 4, and so on. Suffice it to say that the Court would have preferred accurately labeled exhibits.

1. Polypropylene surgical mesh, including the Ethicon Gynecare TVT Obdurator device, elicits a chronic foreign body inflammatory reaction in tissue;

2. Certain design features of polypropylene surgical mesh, including the Ethicon Gynecare TVT Obturator device, lead to scar bridging between

polypropylene fibers and scar plating with encapsulation;

3. During repair of the tissue damaged by placement of the mesh device, the wound site contracts and shrinks the implant area;

4. Bridging fibrosis, scar plating/encapsulation, and shrinkage lead to a hardened, rigid device that is damaging to the surrounding vaginal mucosa;

5. The foreign body inflammatory reaction and resultant scarring and mesh contraction can lead to mesh-related complications like nerve entrapment (pain), erosion and extrusion, sexual pain, and urinary/bowel dysfunction.

6. Histopathological analysis of pathological specimens of Mrs. Gutierrez's explanted vaginal mesh demonstrated a prominent inflammatory and fibrosing reaction secondary to the mesh, including scar plate formation, bridging fibrosis, chronic inflammation, vascular congestion and hemorrhage, nerve proliferation and distortion, polypropylene bark degradation, and granuloma formation.

7. Mrs. Gutierrez's reported signs and symptoms of mesh erosion, pelvic/thigh pain, and dyspareunia were the direct result of these pathological features noted in my observations above.

Id. at 2.

But even if Dr. Michaels could testify to all those points at trial,¹² nothing in his declaration addresses the critical question whether the proposed alternative designs would have prevented those harms. In other words, it is not sufficient for the plaintiffs merely to put forth case-specific evidence that the TVT-O injured Mrs. Gutierrez; they must also show in a case-specific manner that their alternative designs likely would not have so injured her. Hernandez , 2 S.W.3d at 258. But all the plaintiffs have mentioned on that inquiry comes from the general opinions of Drs. Uwe Klinge, Bruce Rosenzweig, and Michaels. Opp'n at 20, ECF No. 50. Such generalized opinions that apply to the entire MDL suit obviously do not suffice to show that alternative designs would have prevented specifically Mrs. Gutierrez's injuries. Thus, the plaintiffs have failed to put forth evidence supporting the "necessary" showing that alternative designs could have prevented the harms to Mrs. Gutierrez. Hernandez , 2 S.W.3d at 258.

12 As the Court was adjudicating this motion, the defendants separately filed a motion "to limit the case-specific opinions of Dr. Paul J. Michaels." Mot., ECF No. 53. The Court need not rule on that motion, and it will dismiss it as moot via a separate Order issued this date. For even if Dr. Michaels's opinions as to Mrs. Gutierrez are considered in full, they do not show (or even address) whether and how alternative devices would have prevented Mrs. Gutierrez's injuries, and thus they do nothing to help the plaintiffs survive summary judgment.

Ironically, Dr. Michaels's own expert report underscores just how damaging that omission is for the plaintiffs. Corroborating Dr. Braid's comment that Mrs. Gutierrez is no longer a "spring chicken," Dr. Michaels notes that Mrs. Gutierrez has been pregnant eight times and has experienced six vaginal deliveries (at ages 17, 21, 28, 31, 35, and 40), along with multiple liposuction procedures, breast augmentations, and endometrial dilation and curettage. Michaels Report at 2, ECF No. 50-11. She is now almost sixty years old. Id. She also has significant comorbidities, including hyperlipidemia and diabetes. Id. And she was a smoker for a quarter-century. Id. With so many factors complicating her medical history, it was especially important for the plaintiffs to elicit evidence showing that some product other than the TVT-O actually would have made a difference to Mrs. Gutierrez's outcome.

But that they did not do. Without case-specific evidence that some alternative design "would in reasonable probability have prevented or significantly reduced the risk of [Mrs. Gutierrez's] injury or damage," the Court must conclude that the plaintiffs have omitted a "necessary" showing under Texas law. Hernandez , 2 S.W.3d at 258. Thus, the Court will also award summary judgment to the defendants on the plaintiffs’ strict liability/design defect claims, and on their negligence and gross negligence claims to the extent that they rely on design-defect theories.

2.E Because Mrs. Gutierrez's Claims Fail as a Matter of Law, Mr. Gutierrez Cannot Seek a Derivative Award for Loss of Consortium, and Neither Plaintiff May Seek Punitive Damages

As the Supreme Court of Texas has explained, loss of consortium claims are "derivative" claims that presuppose the ability to show "the tortfeasor's liability for [the other spouse's] physical injuries." Reed Tool Co. v. Copelin , 610 S.W.2d 736, 738 (Tex. 1980). Thus, where a defense defeats "the tortfeasor's liability to the injured [spouse]," it "will have the same effect on the [other spouse's] consortium claim." Id. at 738-39. In other words, where the tortfeasor is not liable to the injured spouse, there can be no derivative liability under a loss-of-consortium theory to the uninjured spouse. Barker v. Halliburton Co. , 645 F.3d 297, 299–300 (5th Cir. 2011) (citing Reed Tool Co. , 610 S.W.2d at 738 ); see also Motor Express, Inc. v. Rodriguez , 925 S.W.2d 638, 640 (Tex. 1996) ("Because Rodriguez cannot recover mental anguish damages as a matter of law under his negligence claim, Rodriguez's wife's claims likewise are barred. Claims for loss of consortium are derivative.").

Mrs. Gutierrez's claims have already failed as a matter of law. Because Mr. Gutierrez's loss-of-consortium claim is derivative of his wife's failed claims, his loss-of-consortium claim also fails as a matter of law. Thus, the defendants will receive summary judgment on that cause of action as well.

Last, as the defendants point out, the plaintiffs’ request for punitive damages is not a separate cause of action, but a type of additional relief above and beyond ordinary compensatory damages. See Owens-Corning Fiberglas Corp. v. Malone , 972 S.W.2d 35, 39–40 (Tex. 1998). Because the defendants are entitled to summary judgment on all the plaintiffs’ claims, the plaintiffs have no right to collect any damages, much less punitive damages.

IV. CONCLUSION

For the reasons set forth above, the defendants are entitled to summary judgment on all the plaintiffs’ remaining claims in this action. A separate Order consistent with this Memorandum Opinion shall issue this date.