Opinion
Case No.: 1:18-cv-23643-UU
2019-09-10
Charlotte SALINERO, et al., Plaintiffs, v. JOHNSON & JOHNSON, et al., Defendants.
James L. Ferraro, James Louis Ferraro, Jr., Daniel J. DiMatteo, Leslie Rothenberg, Mathew Daniel Gutierrez, The Ferraro Law Firm, Miami, FL, Gabriel Santiago Saade, The Saade Law Firm, P.A., Coral Gables, FL, for Plaintiffs. Andrew Russell Kruppa, Beatriz E. Jaramillo, Amanda Elizabeth Preston, Squire Patton Boggs (US) LLP, Andrea Cox, Arnstein & Lehr LLP, Miami, FL, Chad R. Hutchinson, Pro Hac Vice, Butler Snow LLP, Ridgeland, MS, Kari L. Sutherland, Pro Hac Vice, Paul V. Cassisa, Jr., Pro Hac Vice, Butler Snow LLP, Oxford, MS, Michael Andrew Snowden, Pro Hac Vice, Butler Snow LLP, Shayna S. Cook, Pro Hac Vice, Goldman Ismail Tomaselli Brennan & Baum LLP, Chicago, IL, Nils Burton Snell, Pro Hac Vice, Butler Snow LLP, Fort Washington, PA, Philip J. Combs, Pro Hac Vice, Thomas Combs & Spann, PLLC, Charleston, WV, for Defendants.
James L. Ferraro, James Louis Ferraro, Jr., Daniel J. DiMatteo, Leslie Rothenberg, Mathew Daniel Gutierrez, The Ferraro Law Firm, Miami, FL, Gabriel Santiago Saade, The Saade Law Firm, P.A., Coral Gables, FL, for Plaintiffs.
Andrew Russell Kruppa, Beatriz E. Jaramillo, Amanda Elizabeth Preston, Squire Patton Boggs (US) LLP, Andrea Cox, Arnstein & Lehr LLP, Miami, FL, Chad R. Hutchinson, Pro Hac Vice, Butler Snow LLP, Ridgeland, MS, Kari L. Sutherland, Pro Hac Vice, Paul V. Cassisa, Jr., Pro Hac Vice, Butler Snow LLP, Oxford, MS, Michael Andrew Snowden, Pro Hac Vice, Butler Snow LLP, Shayna S. Cook, Pro Hac Vice, Goldman Ismail Tomaselli Brennan & Baum LLP, Chicago, IL, Nils Burton Snell, Pro Hac Vice, Butler Snow LLP, Fort Washington, PA, Philip J. Combs, Pro Hac Vice, Thomas Combs & Spann, PLLC, Charleston, WV, for Defendants.
ORDER ON MOTION FOR SUMMARY JUDGMENT (AS TO LIABILITY ONLY)
URSULA UNGARO, UNITED STATES DISTRICT JUDGE
THIS CAUSE is before the Court upon the Motion for Summary Judgment (the "Motion") filed by Defendants Johnson & Johnson ("J&J") and Ethicon, Inc. ("Ethicon") (collectively, "Defendants"). D.E. 92. The Court has reviewed the Motion and the pertinent portions of the record and is otherwise fully advised of the premises. For the reasons set forth below, the Motion is GRANTED IN PART and DENIED IN PART with respect to the Motion's liability grounds, and the Court RESERVES RULING IN PART as to the Motion's punitive damages argument.
I. FACTUAL BACKGROUND
Unless otherwise indicated, the following facts are undisputed. A. Mrs. Salinero's Prolapse Diagnosis and Implantation of Artisyn Mesh
Pelvic organ prolapse ("POP") is a potentially debilitating condition where one or more of a woman's pelvic organs (bladder, rectum, and uterus) prolapse into her vagina. D.E. 134 at 7 ¶ 5(g). At age 56, Plaintiff Charlotte Salinero ("Mrs. Salinero") was diagnosed with stage IV POP. Id. at 7 ¶ 5(b).
On December 3, 2012, Mrs. Salinero underwent a cystoscopy and three simultaneous abdominal surgeries: (1) a supracervical hysterectomy ; (2) a bilateral salpingo-oophorectomy ; and (3) an abdominal sacrocolpopexy. Id. at 7 ¶ 5(c). Abdominal sacrocolpopexy is a surgery for treatment for uterovaginal prolapse. Id. at 7 ¶ 5(h). During the sacrocolpopexy, Mrs. Salinero's surgeon implanted Defendants' Artisyn Mesh product, a "bridging material," to treat her significant POP. D.E. 93 ¶ 1; D.E. 134 at 7 ¶ 5(c), (h); see also D.E. 20 ¶ 19. Artisyn Mesh is a prescription medical device that contains polypropylene. D.E. 93 ¶¶ 2, 9. Defendant Ethicon designed and manufactured Artisyn Mesh. D.E. 134 at 7 ¶ 5(f). Ethicon is a wholly owned subsidiary of Defendant J&J. D.E. 20 ¶ 4; D.E. 26 ¶ 4.
In Plaintiffs' response to Defendants' statement of material facts (D.E. 164), Plaintiffs did not controvert paragraphs 1–5, 8, 24–25, and 30 of Defendants' statement (D.E. 93); these facts are supported by record evidence and are therefore deemed admitted. S.D. Fla. L.R. 56.1(b).
Plaintiffs controvert other portions of paragraph 9 of Defendants' statement, but all parties agree that Artisyn Mesh contains polypropylene. Compare D.E. 93 ¶ 9 with D.E. 164 at 2 ¶ 9; see also D.E. 20 ¶ 29; D.E. 26 ¶ 29; D.E. 27 ¶ 29.
Mrs. Salinero's implant surgery was performed by Dr. Jaime Sepulveda, a surgeon who is board-certified in both gynecology and female pelvic medicine and reconstructive surgery, at South Miami Hospital in Miami, Florida. D.E. 93 ¶ 3. According to Dr. Sepulveda, Mrs. Salinero's POP was at Stage IV, the most serious stage of prolapse, at the time of her surgery. Id. ¶ 4; see also D.E. 134 at 7 ¶ 5(c). A prolapse of this extent meant that Mrs. Salinero's anterior vaginal wall was protruding through her vaginal opening because her uterus had dropped. D.E. 93 ¶ 5. Dr. Sepulveda decided to perform an abdominal robotic sacrocolpopexy, a surgery that brings support to the apex of the vagina by placing an implant over the top of the vagina. Id. ¶ 8.
B. Dr. Sepulveda's Testimony About the Decision to Implant Artisyn Mesh
In his deposition, Dr. Sepulveda testified that, when deciding what type of surgery to do to treat a particular patient's prolapse, he relies on "the published data, obviously on my training, my textbooks, journals, Cochrane reviews[ ]...society recommendation, society opinions" and his own clinical experience. D.E. 165-1 ("Sepulveda Dep.") at 20:14–24, 21:6–12. As to Mrs. Salinero, he testified that his impression was that her POP was "not going to go away" absent surgery and that conservative measures would not have been able to treat her prolapse at that time. Id. at 40:12–41:1.
According to Dr. Sepulveda, a "Cochrane review" is "a scientific collaboration that examines the efficacy and the safety complications of the different procedures that we have." Id. at 21:1–5.
Dr. Sepulveda testified that back in 2012, at the time of Mrs. Salinero's implant surgery, he could have "use[d] may other implants, but the implants that [he] used for sacrocolpopexy is polypropylene." Id. at 30:8–14. He testified that he viewed polypropylene mesh implants as "available or appropriate" for a sacrocolpopexy "[b]ecause it offers durability, and it offers the surgical flexibility, and it offers the best results in – that's it. Offers the best results." Id. at 30:19–24. He explained:
Q : When you say that the polypropylene mesh used in sacrocolpopexy offers the best results, what do you mean by best results?
A : Well, it's – well, the first issue is an issue of durability. You want to make sure that something is going to last. And to be able to do that, you use – to be able to do a sacrocolpopexy, you will have to use an implant. So when you do a sacrocolpopexy, you have the option of having implants that will be absorbed, and you have the option of implants that will not be absorbed.
In the implants that will be absorbed, we use[d] those many years ago, and we know they don't work in durability. They don't last. The ones that are not absorbable have improved durability. On the ones that will not be absorbed, we have had different materials. And as early as 2004, it was examined, examined what are the materials, and the consensus is that polypropylene offers the best durability when used in a macroporous monofilament open knit.
Id. at 31:1–20. Dr. Sepulveda testified that, by the time he treated Mrs. Salinero in 2012, he had been using polypropylene mesh in sacrocolpopexy surgery since 1992 and had found polypropylene mesh to be a safe and effective treatment for prolapse patients. Id. at 32:2–9, 44:7–15. He stated that he considered polypropylene mesh to be the current clinical standard at that time. Id. at 33:2–6.
As to alternatives, Dr. Sepulveda testified that he did not believe Gore-Tex mesh to be a better alternative to polypropylene mesh for treatment of POP, because Gore-Tex mesh is dense, lacks porosity, is not biocompatible, and has a higher rate of revision surgery. Id. at 33:20–35:13. Dr. Sepulveda also testified that he could not have performed a sacrocolpopexy using Mrs. Salinero's own tissue or a cadaver's tissue, "[b]ecause [he] tried in the past. [He] tried that 28 years ago, and it did not work." Id. at 35:19–25. He also testified that he could not use a transvaginal implant because, as of 2012, there were no transvaginal meshes anymore. Id. at 36:1–10, 37:7–15.
Dr. Sepulveda did not recommend Artisyn Mesh specifically to Mrs. Salinero; he testified that he chose to use Artisyn Mesh "based on [his] experience and training." Id. at 44:21–45:1. Dr. Sepulveda testified that, prior to Mrs. Salinero's implant surgery, he was aware of the following risks associated with Artisyn Mesh: exposure of mesh into the vagina (id. at 45:2–16); mesh erosion into other organs (id. at 45:17–22); urinary tract infections (id. at 45:23–46:10); dyspareunia (pain with sexual intercourse) (id. at 45:11–20); fistula formation (id. at 47:2–6); a need for explant surgery to remove of the mesh (id. at 47:15–19); formation of scar tissue or adhesions (id. at 47:20–48:3); bowel obstruction (id. at 48:7–10); urinary or fecal incontinence (id. at 48:15–20); chronic pelvic pain (id. at 48:25–49:3); and vaginal shortening (id. at 49:7–14). Dr. Sepulveda also testified that "[a]t some point" he read the Artisyn Mesh Instructions for Use ("IFU"), which warn of potential risks, in addition to the above and among others, of "infection potentiation,...recurrent prolapse, [and] inflammation...." Id. at 50:3–19, 51:9–21. He testified that he believed the IFU information to be appropriate and adequate in terms of the risks of the product and the surgery, such that a revised IFU would not have changed his decision to use Artisyn Mesh with Mrs. Salinero. Id. at 52:13–25, 210:22–25. Later in his deposition, Dr. Sepulveda again testified that, in December 2012, he was aware of the potential risks associated with Artisyn Mesh such as extrusion, erosion, exposure, fistula formation, inflammation, risk of infection, risk of necessary revision surgery, and/or required associated tissue dissection. Id. at 209:20–210:18. According to Dr. Sepulveda, his knowledge of the risks was not primarily based on the IFU but rather what he knew "about polypropylene from before" from training, journals, textbooks and reviews, and his experience. Id. at 49:15–50:2, 50:20–51:8.
Dr. Sepulveda describes a fistula as "[a] communication between two organs." Id. at 46:25–47:1.
Dr. Sepulveda testified that, in December 2012 when he performed Mrs. Salinero's implant surgery, he believed he was fully informed about all the potential risks of Artisyn Mesh—including the problems that Mrs. Salinero actually experienced after the surgery—but considered the risks to be "highly, highly infrequent." Id. at 53:1–15. He testified that he considered other surgical options for Mrs. Salinero but concluded that every option had a potential risk of fistula formation, scar tissue formation, dyspareunia and/or pelvic pain. Id. at 59:3–24. Further, he testified that he believed there was no safer surgical option to treat Mrs. Salinero's POP in December 2012, and that he believes to this day that the surgery he performed in December 2012 was Mrs. Salinero's best option. Id. at 59:25–60:4, 61:5–10, 103:6–18. He testified that he determined that the benefits of implanting Artisyn Mesh to treat Mrs. Salinero's POP outweighed the potential risks and that he continues to believe that, even knowing what he knows now. Id. at 60:11–61:10, 103:20–25. Dr. Sepulveda testified that he continues to use Artisyn Mesh when he performs sacrocolpopexy surgeries to this day. Id. at 102:14–103:5, 210:3–5.
Plaintiffs do not dispute that Dr. Sepulveda testified as reflected above; they do, however, challenge the credibility of Dr. Sepulveda's testimony because of his relationship with the Defendants (see infra Section D). See generally D.E. 164 at 1–6.
C. Complications and Explant Surgery
Though causation is disputed, it is undisputed that in 2017, Dr. Marcos Szomstein diagnosed Mrs. Salinero with a rectovaginal vesical fistula. D.E. 134 at 7 ¶ 5(d). On April 24, 2017, Mrs. Salinero underwent mesh explant surgery, which was performed by a team of surgeons consisting of Dr. Sepulveda, Dr. Szomstein, and Dr. John Mekras. Id. at 7 ¶ 5(e). Dr. Sepulveda testified that he separated the adhesion within Mrs. Salinero's bladder and rectum, identified the implant, disconnected the implant, dissected and lifted it out in one piece, and there were "two little segments underneath that [he] took later on." Sepulveda Dep. at 95:5–96:14.
See, e.g. , Sepulveda Dep. at 103:23–104:9 ("I never wish that she will have any risk or she would not have had a colovesical fistula, but I am not convinced that that mesh is what caused it.... [A]s a clinician, obviously, I try to figure out within myself that what could have caused this compli – this complication. I am not completely certain that that's the – that that is the polypropylene itself.").
In their Complaint, Mrs. Salinero and her co-plaintiff, husband Dr. Efren Salinero, allege that Mrs. Salinero's injuries include "a urinary-genital tract fistulae, severe and permanent pain, [and] gas and stool in [her] vagina." D.E. 93 ¶ 25 (citing D.E. 20 ¶¶ 92, 98, 106, 110, 128, 132)). They also allege "loss of enjoyment of life, loss of care, comfort and consortium, [and] economic damages." See id. Plaintiffs have not provided any medical records pertaining to Efren Salinero. Though Defendants filed an excerpt of Efren Salinero's deposition testimony in connection with briefing on Plaintiffs' motion in limine , see D.E. 136-15, this testimony lacks any discussion of Dr. Salinero's own physical injuries (as distinct from Mrs. Salinero's).
The Complaint spells Dr. Salinero's first name as "Efrain," see D.E. 20, but the deposition testimony in the record reflects the spelling "Efren," see D.E. 136-15.
D. Dr. Sepulveda's Relationship with Defendants
In its internal documents, Ethicon has identified Dr. Sepulveda as a "key surgeon." D.E. 164 at 7 ¶ 1. Dr. Sepulveda also has served and continues to serve as both an expert witness and a consultant for Ethicon. See D.E. 164 at 7–8 ¶¶ 2, 7. Specifically, Dr. Sepulveda first testified for Ethicon "just after the Prolift® litigation for transvaginal mesh." Sepulveda Dep. at 110:19–23. Dr. Sepulveda had done cadaver dissections and developed a "subspecialty" on transvaginal meshes. Id. at 114:11–21. At least as early as 1994, Dr. Sepulveda put on presentations for the Ethicon sales force to demonstrate his surgical procedures and uses for various products. See id. at 116:8–119:9. For example, in 1994, he taught a course to demonstrate procedures involving laparoscopic surgery. See id. at 115:10–12, 118:21–119:5. Later, beginning in approximately 2003, he began teaching courses regarding transvaginal mesh products and procedures. See id. at 119:10–22. Ethicon has paid Dr. Sepulveda to train other doctors on how to use polypropylene mesh in surgery. D.E. 164 at 8 ¶ 5; Sepulveda Dep. at 21:21–23:16. However, Dr. Sepulveda testified that he performs such training not only to receive compensation, but because it "allow[s] me to continue training myself...[,] to understand the anatomy better and to keep [my]self in shape for all the surgeries." Sepulveda Dep. at 22:14–23:9.
As permitted by Local Rule 56.1(a), Plaintiffs (as the parties opposing summary judgment) submitted additional facts that they contend are material pertaining to Dr. Sepulveda. See D.E. 164 at 7–8 & Exs. 1–2. Defendants, in their reply, did not controvert Plaintiffs' "additional facts" numbered 1, 3, 5, 7, 9, and 11. See D.E. 178 at 6–8. These uncontroverted additional facts are supported by record evidence and are therefore deemed admitted. S.D. Fla. L.R. 56.1(b).
Defendants do not present evidence to controvert that Dr. Sepulveda has worked and continues to work as both a consultant and an expert witness for Ethicon. Instead, Defendants state that "[t]he implication that Dr. Sepulveda's work as a consultant and his work as an expert are connected is incorrect. Dr. Sepulveda's consulting work was ‘purely medical work.’ " D.E. 178 at 6 ¶ 2.
Dr. Sepulveda began serving as a consultant for Ethicon in the early 2000s. See id. at 126:5–10. In this role, Dr. Sepulveda has performed many tasks: "I evaluated products. I sat on committees in which I evaluated the adequacy of the product. I considered the options of other doctors. I dissected cadavers. I ran – I participated on the different trials of seeing the elasticity of the mesh, the details of the mesh, the porosity. I was – I was involved also in reviewing the standards for slings and meshes for prolapse, the validity of the training, professional education, evaluation of publications." Id. at 126:15–24.
Dr. Sepulveda charges Ethicon $500 per hour or $3,500 per day for his expert services. D.E. 164 at 7 ¶ 3; Sepulveda Dep. at 131:5–21. He testified that the $3,500 per-day rate includes work done reviewing records, writing reports, and testifying in depositions, as well as for professional education. Sepulveda Dep. at 131:18–132:1. He has reviewed approximately 20 to 25 cases for Ethicon as an expert and has testified in dozens of depositions defending Ethicon's products in court. D.E. 164 at 8 ¶ 7. Dr. Sepulveda has also worked for Defendant J&J since 1994 doing "all sorts of different work," including reviewing cases. Sepulveda Dep. at 141:9–20. Dr. Sepulveda did not dispute that he was paid $388,000 by J&J for in 2009 for consulting and testifying. See id. at 137:9–141:4. Likewise, Dr. Sepulveda did not dispute that he was paid $286,650 by J&J in 2010. See id. at 142:5–144:7. And Dr. Sepulveda did not dispute that, through the calendar year 2010, he had earned approximately $2 million from J&J. D.E. 164 at 8 ¶ 11; see also Sepulveda Dep. at 144:8–23.
Dr. Sepulveda testified that his decision to use Artisyn Mesh in Mrs. Salinero's surgery did not have anything to do with any consulting work he had done for Ethicon. Sepulveda Dep. at 43:5–8. Rather, he testified that he "ha[d] enough evidence to use polypropylene, and [he was] going to use the largest pore, ... monofilament and the one that provides the best support with the best data behind it." Id. at 43:11–14. He also testified that his expert witness work for Ethicon did not impact his treatment of Mrs. Salinero at all. Id. at 105:24–106:1.
II. PROCEDURAL HISTORY
Plaintiffs assert claims against both Ethicon and J&J for: Negligence (Count I); Strict Liability – Manufacturing Defect (Count II); Strict Liability – Failure to Warn (Count III); Strict Liability – Design Defect (Count IV); False Information Negligently Supplied for the Guidance of Others (Count V); Negligent Infliction of Emotional Distress (Count VI); Gross Negligence (Count VII); and Loss of Consortium (Count VIII). D.E. 20; D.E. 93 ¶ 25. They also seek punitive damages. D.E. 20; D.E. 93 ¶ 25.
On May 3, 2019, Defendants moved for summary judgment on the following grounds: (1) Plaintiffs lack admissible expert testimony that could prove that the Artisyn Mesh was defective and that the defect caused Plaintiffs' injuries; (2) Plaintiffs lack evidence of any manufacturing defect; (3) Plaintiffs' failure to warn claims fail under the "learned intermediary" doctrine; (4) the False Information Negligently Supplied for the Guidance of Others claim is simply a re-labelled failure to warn claim and fails for the same reasons; (5) Plaintiffs have neither pleaded nor proved their negligent infliction of emotional distress claim; and (6) should any of Plaintiffs' claims survive summary judgment, their request for punitive damages should be dismissed. D.E. 92. The Motion is now ripe for adjudication.
III. LEGAL STANDARD
Summary judgment is authorized only when the moving party meets its burden of demonstrating that "the pleadings, depositions, answers to interrogatories and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed. R. Civ. P. 56. When determining whether the moving party has met this burden, the Court must view the evidence and all factual inferences in the light most favorable to the non-moving party. Adickes v. S.H. Kress & Co. , 398 U.S. 144, 157, 90 S.Ct. 1598, 26 L.Ed.2d 142 (1970) ; Rojas v. Florida , 285 F.3d 1339, 1341-42 (11th Cir. 2002).
The party opposing the motion may not simply rest upon mere allegations or denials of the pleadings; after the moving party has met its burden of proving that no genuine issue of material fact exists, the non-moving party must make a showing sufficient to establish the existence of an essential element of that party's case and on which that party will bear the burden of proof at trial. See Celotex Corp. v. Catrett , 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) ; Poole v. Country Club of Columbus, Inc. , 129 F.3d 551, 553 (11th Cir. 1997) ; Barfield v. Brierton , 883 F.2d 923, 933 (11th Cir. 1989).
If the record presents factual issues, the Court must not decide them; it must deny the motion and proceed to trial. Envntl. Def. Fund v. Marsh , 651 F.2d 983, 991 (5th Cir. 1981). Summary judgment may be inappropriate even where the parties agree on the basic facts, but disagree about the inferences that should be drawn from these facts. Lighting Fixture & Elec. Supply Co. v. Cont'l Ins. Co. , 420 F.2d 1211, 1213 (5th Cir. 1969). If reasonable minds might differ on the inferences arising from undisputed facts, then the Court should deny summary judgment. Impossible Elec. Techs., Inc. v. Wackenhut Protective Sys., Inc. , 669 F.2d 1026, 1031 (5th Cir. 1982) ; see also Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ("[T]he dispute about a material fact is ‘genuine’ ... if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.").
Moreover, the party opposing a motion for summary judgment need not respond to it with evidence unless and until the movant has properly supported the motion with sufficient evidence. Adickes , 398 U.S. at 160, 90 S.Ct. 1598. The moving party must demonstrate that the facts underlying the relevant legal questions raised by the pleadings or are not otherwise in dispute, or else summary judgment will be denied notwithstanding that the non-moving party has introduced no evidence whatsoever. Brunswick Corp. v. Vineberg , 370 F.2d 605, 611-12 (5th Cir. 1967). The Court must resolve all ambiguities and draw all justifiable inferences in favor of the non-moving party. Liberty Lobby, Inc. , 477 U.S. at 255, 106 S.Ct. 2505.
IV. ANALYSIS
A. Expert Proof of Causation
Defendants first assert broadly that all of Plaintiffs' claims should be dismissed because they do not have admissible expert testimony to sustain their claims. Mot. at 5–7. However, their initial argument is actually that Plaintiffs lack expert evidence of causation. Under Florida law, a plaintiff suing on a products liability claim must prove, through expert testimony, that a product defect existed and that such defect caused injury. See, e.g. , Eghnayem v. Bos. Sci. Corp. , No. 1:14-cv-024061, 2016 WL 4051311, at *6 (S.D. Fla. Mar. 17, 2016) ("Federal courts applying Florida law have held that expert testimony is necessary to prove a product is defective.").
In this diversity case, the Court is "Erie-bound...to apply the tort law of Florida." Eghnayem v. Bos. Sci. Corp. , 873 F.3d 1304, 1319 (11th Cir. 2017) (citing Erie R. Co. v. Tompkins , 304 U.S. 64, 78, 58 S.Ct. 817, 82 L.Ed. 1188 (1938) ).
To prevail on this argument, Defendants would have needed to convince this Court to exclude the expert testimony of both of Defendants' case-specific causation experts, Drs. Margolis and Iakovlev. However, as the Court has already ruled, see D.E. 235, Plaintiffs will be permitted to present expert opinion testimony of Drs. Margolis and Iakovlev that the Artisyn Mesh was defective because it contains polypropylene, which degrades in vivo and causes injury. As a result, this argument fails. Cf. Eghnayem , 2016 WL 4051311, at *6–7.
B. Evidence of a Manufacturing Defect
To prove a manufacturing defect claim under Florida law, a plaintiff must prove that 1) the product was defective, 2) the defect existed at the time the product left the defendant-manufacturer's control, and 3) the defect proximately caused the plaintiff's injuries. See, e.g. , Wolicki-Gables v. Arrow Int'l, Inc. , 641 F. Supp. 2d 1270, 1285 (M.D. Fla. 2009) (citing Colville v. Pharmacia & Upjohn Co. , 565 F. Supp. 2d 1314, 1320 (N.D. Fla. 2008) ); see also Colville , 565 F. Supp. 2d at 1320 ("In order to prevail in a products liability action brought under a theory of either strict liability or negligence, a plaintiff must demonstrate that the injuries complained of were caused by a defective product whose defect existed at the time of injury and at the time in which the product left the manufacturer's control.").
"Manufacturing defects are generally limited to situations where something goes wrong in the manufacturing process and can be distinguished from other types of product liability claims such as design defects and inadequate warning defects." Benitez v. Synthes, Inc. , 199 F. Supp. 2d 1339, 1344 (M.D. Fla. 2002) (citing Cassisi v. Maytag Co. , 396 So. 2d 1140, 1145 (Fla. 1st DCA 1981) ). In Harduvel v. General Dynamics Corp. , Justice Powell, Associate Justice of the United States Supreme Court, retired, sitting by designation, articulated the distinction between manufacturing and design defect claims:
This distinction between "aberrational" defects and defects occurring throughout an entire line of products is frequently used in tort law to separate defects of manufacture from those of design.... Stated another way the distinction is between an unintended configuration, and an intended configuration that may produce unintended and unwanted results.
878 F.2d 1311, 1317 (11th Cir. 1989) (internal citation omitted). Thus, to prevail on their manufacturing defect claims, Plaintiffs must establish an unintended configuration or other manufacturing defect of the Artisyn Mesh implanted in Mrs. Salinero that existed at the time the mesh left Ethicon's manufacturing plant. See Beauregard v. Continental Tire N. Am., Inc. , 435 F. App'x 877, 879 (11th Cir. 2011). Defendants argue Plaintiffs have not done so.
Plaintiffs make no effort to respond to this argument in their response to the Motion. See D.E. 163. The Motion is therefore due to be granted on this ground by default. See S.D. Fla. L.R. 7.1(c). Even on the merits, Plaintiffs have presented no proof of an unintended manufacturing defect in Mrs. Salinero's Artisyn Mesh. They have established a prima facie design defect claim, in that they argue that Defendants intended to manufacture Artisyn Mesh with the allegedly unsafe polypropylene component. But they have not established any "aberration" in Mrs. Salinero's implanted mesh that differs from any other Artisyn Mesh. Indeed, Dr. Iakovlev, Plaintiffs' pathology expert, testified that he did not "see evidence of that specific unit was manufactured differently to a degree that would be detectible pathologically." D.E. 93-3 at 144:24–145:6. Accordingly, Defendants are entitled to summary judgment on all of Defendants' manufacturing defect claims.
C. Failure to Warn Claims
"Under Florida law, to succeed on a failure to warn claim a plaintiff must show (1) that the product warning was inadequate; (2) that the inadequacy proximately caused her injury; and (3) that she in fact suffered an injury from using the product." Eghnayem v. Bos. Sci. Corp. , 873 F.3d 1304, 1321 (11th Cir. 2017) (citing Hoffmann-La Roche Inc. v. Mason , 27 So. 3d 75, 77 (Fla. 1st DCA 2009) ). As to the causation element, in cases involving medical devices, "a plaintiff must show that her treating physician would not have used the product had adequate warnings been provided." Id. (citing Felix v. Hoffmann-LaRoche, Inc. , 540 So. 2d 102, 105 (Fla. 1989) ). Defendants argue that Plaintiffs' failure to warn claims fail as a matter of law under the "learned intermediary" doctrine because Dr. Sepulveda's testimony shows that the causal chain is broken. See Mot. at 8–14. Plaintiffs counter that the "learned intermediary" doctrine should not apply because Dr. Sepulveda is not an "objective" practitioner due to his financial entanglement with Defendants, and in any event, there are triable issues of fact as to the extent of Dr. Sepulveda's knowledge, the adequacy of the IFU warnings, and whether Dr. Sepulveda actually would have prescribed Artisyn Mesh if he had received adequate warnings. See D.E. 163 at 4–14. Defendants respond that Florida does not recognize a "financial interest" exception to the learned intermediary doctrine and, moreover, Plaintiffs failed to identify any genuine dispute of fact with respect to any causal link between the IFU's contents and Dr. Sepulveda's treatment decisions. See D.E. 177 at 1–8.
1. Credibility Challenges on Summary Judgment
As a preliminary matter, Plaintiffs challenge Defendants' failure-to-warn arguments to the extent they rely exclusively on Dr. Sepulveda's testimony, as Dr. Sepulveda is "biased" by his status as "Defendants' long-time paid expert witness, consultant, corporate committee member, and Ethicon sales force lecturer, who happens to also have been Mrs. Salinero's treating physician in this case." D.E. 163 at 1. The Court acknowledges that properly-lodged credibility challenges—that is, challenges based on supporting evidence and not mere speculation of bias—may give rise to a genuine dispute of fact. "The party seeking summary judgment bears the burden of demonstrating the absence of a genuine dispute as to any material fact." Christiansen v. Wright Med. Tech. Inc. (In re Wright Med. Tech. Inc., Conserve Hip Implant Prods. Liab. Litig.) , 127 F. Supp. 3d 1306, 1348 (N.D. Ga. 2015) (citing Herzog v. Castle Rock Entm't , 193 F.3d 1241, 1246 (11th Cir. 1999) ). "A dispute is genuine ‘if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.’ " Graham v. State Farm Mut. Ins. Co. , 193 F.3d 1274, 1282 (11th Cir. 1999) (quoting Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ). "[C]redibility determinations, the weighing of evidence, and the drawing of inferences from the facts are the function of the jury, and therefore the evidence of the non-movants is to be believed and all justifiable inferences are to be drawn in [their] favor." Id. But "[u]nreliable conjecture" and "speculative inference" are not "evidence" sufficient to survive summary judgment. Josendis v. Wall to Wall Residence Repairs, Inc. , 662 F.3d 1292, 1318 (11th Cir. 2011). Thus, Plaintiffs may be able to create a genuine issue of fact if they can present evidence to that would allow a reasonable juror to infer that Dr. Sepulveda's testimony regarding his choice of Artisyn Mesh to treat Mrs. Salinero's prolapse is biased or otherwise not credible.
2. The Learned Intermediary Doctrine
"The learned intermediary rule" under Florida law "is a corollary to the rule that a manufacturer of prescription drugs or products discharges its duty to warn by providing the physician with information about risks associated with those products." Christopher v. Cutter Labs. , 53 F.3d 1184, 1192 (11th Cir. 1995) (citing Felix v. Hoffmann-LaRoche, Inc. , 540 So. 2d 102, 104 (Fla. 1989) ). Where the learned intermediary doctrine applies, "the duty to warn is directed to physicians rather than patients...." Eghnayem , 873 F.3d at 1321 (11th Cir. 2017) (quoting Mason , 27 So. 3d at 77 ). "This is so because the prescribing physician acts as an intermediary between the manufacturer and the consumer, weighing the potential benefits of a device against the dangers in deciding whether to recommend it to meet the patient's needs." Id. (citing Felix , 540 So. 2d at 104 ).
However, "the ‘learned intermediary doctrine’ is not a complete defense" to all failure-to-warn claims. Aubin v. Union Carbide Corp. , 177 So. 3d 489, 514 (Fla. 2015). In Aubin , the Florida Supreme Court addressed whether the learned intermediary defense was "applicable in this type of asbestos case"—that is, where a bulk asbestos supplier argues that its duty to warn was discharged by warning the intermediary manufacturer of the risks associated with the final asbestos-containing products (there, joint compounds and texture sprays). See id. at 494–97. The Court concluded that the fact that an asbestos supplier conveyed warnings to an intermediary manufacturer does not per se relieve the supplier of liability; the touchstone is the adequacy of the supplier's warnings to the intermediary manufacturer and the reasonableness of the supplier's reliance on the manufacturer to convey those warnings to the end user. See id. at 514–16. As the Court explained:
The Second and Third Restatements both recognize that a manufacturer may be able to rely on an intermediary to relay warnings to the end user, but the critical inquiry is whether the manufacturer was reasonable in relying on the intermediary to fully warn the end user and whether the manufacturer fully warned the intermediary of the dangers in its product. The Second Restatement sets forth a list of non-exclusive factors: "Here, as in every case which involves the determination of the precautions which must be taken to satisfy the requirements of reasonable care, the magnitude of the risk involved must be compared with the burden which would be imposed by requiring them (see § 291), and the magnitude of the risk is determined not only by the chance that some harm may result but also the serious or trivial character of the harm which is likely to result." Restatement (Second) of Torts § 388 cmt. n (1965). The Third Restatement likewise states, "The standard is one of reasonableness in the circumstances. Among the factors to be considered are the gravity of the risks posed by the product, the likelihood that the intermediary will convey the information to the ultimate user, and the feasibility and effectiveness of giving a warning directly to the user." See Restatement (Third) of Torts: Prod. Liab. § 2, cmt. i (1998).
Id. at 515. So, for example, "a manufacturer may not be able to reasonably rely on an intermediary to provide warnings if the manufacturer knows that the necessary warnings would render the product less valuable and provide an incentive to the intermediary to withhold the necessary information from the consumer." Id.
"The reasonableness of a manufacturer's reliance on an intermediary to convey the warnings to the end user is also impacted by the dangerousness of the product. In general, the greater the harm that the end user would be subjected to if proper warnings are not given, the less reasonable a manufacturer will be in relying on an intermediary to ensure that the warnings are fully and adequately communicated to the end user." Id. at 515–16. Whether a manufacturer of a highly dangerous product acted reasonably in relying on an intermediary to adequately convey warnings to the end user generally is a jury question. See id. at 516. 3. Application of the Learned Intermediary Doctrine to Physicians Who Are Paid by Drug or Medical Device Manufacturers
Aubin 's caution that the "learned intermediary" rule is "not a complete defense" in certain cases has not been applied to medical device cases in Florida. However, some jurisdictions have recognized other "exceptions" to the learned intermediary doctrine. Defendants state that Plaintiffs' proposed "financial interest" exception "has never been recognized in Florida." D.E. 177 at 1. This appears to be true, but the Court has not located any Florida Supreme Court or intermediate appellate decisions expressly rejecting the exception, either. "In the absence of controlling state precedent," this Court "must discern how the Florida Supreme Court would rule if presented with the issue." Fritz v. Standard Sec. Life Ins. Co. , 676 F.2d 1356, 1358 (11th Cir. 1982) ; see also Beale v. Biomet, Inc. , 492 F. Supp. 2d 1360, 1363, 1375–77 (S.D. Fla. 2007) (Gold, J.) (concluding that the Florida Supreme Court likely would not recognize a "direct-to-consumer marketing" exception to the learned intermediary doctrine). Accordingly, the Court looks not only to Florida law, but to other jurisdictions that have considered a "financial interest" exception to their learned intermediary doctrines.
a. Cases where payment created a genuine dispute of fact
At least two federal courts in the Fifth Circuit—one applying Texas law and the other applying Missouri law—have concluded that summary judgment may be denied where the evidence shows financial incentives for the plaintiff's treating physician in respect of allegedly defective medical devices. In In re DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation , the Court addressed summary judgment motions filed against the bellwether plaintiffs suing DePuy Orthopaedics, Inc. ("DePuy") over the Pinnacle Device, a hip replacement device made with sockets lined with metal, ceramic, or polyethylene. See No. 3:12-cv-1672-K, 2016 WL 6268090, at *1 (N.D. Tex. Jan. 5, 2016). DePuy moved for summary judgment on, inter alia , Plaintiffs' claims sounding in failure to warn, arguing that "Plaintiffs cannot meet their burden to demonstrate that their surgeons relied on DePuy's statements in using the Pinnacle Ultamet or that a different representation or warning would have prevented their surgeons from using the Pinnacle Ultamet." Id. at *4. Specifically, DePuy relied on Texas's learned intermediary doctrine, which, like Florida's, provides that the manufacturer's duty to warn runs to the treating physician, not the patient. See id. However, the Court noted that, in viewing the summary judgment evidence in the light most favorable to Plaintiffs, the implanting physician (Dr. Heinrich) for two of the Plaintiffs had "agreed not to sell, evaluate, or promote non-DePuy products and to cooperate fully with DePuy in the handling of the claim or defense of any product liability litigation" and had at one time "participated in a ‘kickback scheme’ with DePuy. Id. at *6. Dr. Heinrich also "currently serve[d] as an expert for" DePuy. Id. Likewise, the implanting physician (Dr. Goletz) for another Plaintiff "ha[d] received from DePuy thousands of dollars in Honorariums, reimbursements, royalties, and payments for speaking engagements and promotional speaking events, and ha[d] been identified by Defendants as a ‘Key DePuy Surgeon.’ " Id. The court concluded: "Because of the relationship between DePuy and Drs. Goletz and Heinrich, a fact question exists regarding the legitimacy and objectiveness of Drs. Goletz and Heinrich that precludes application of the learned intermediary doctrine as a basis for summary judgment." Id. In so concluding, the Court stated that "the learned intermediary doctrine does not apply when a manufacturer compensates a physician or incentivizes him or her to use its product." Id. (citing Murthy v. Abbott Labs. , 847 F. Supp. 2d 958, 971–73 (S.D. Tex. 2012) ).
Similarly, in In re Vioxx Products Liability Litigation , Defendant Merck Sharp & Dohme Corp. ("Merck") moved for summary judgment against a plaintiff who had chosen not to opt in to the Vioxx drug MDL's master settlement agreement. See No. 06-9757, 2015 WL 1909859, at *1 (E.D. La. Apr. 21, 2015). The plaintiff claimed that her first physician, Dr. Hartman, prescribed Vioxx for her when she requested it after seeing advertisements for it. Id. Later, the plaintiff saw a new physician, Dr. Katz, who testified that it was appropriate for the plaintiff to start taking Vioxx daily and prescribed it for her independently of the prior prescription by Dr. Hartman. Id. The plaintiff disputed the position that Dr. Katz used independent judgment in prescribing her Vioxx and challenged his judgment as a "paid speaker and investigator for Merck." See id. at *2, *7. Therefore, she argued, Merck could not rely on the learned intermediary doctrine as to Dr. Katz. See id. at *7–9. The court, applying Missouri law ( id. at *3 ), concluded that the plaintiff had "raise[d] a genuine question of Dr. Katz's credibility, and a reasonable juror could question his testimony that he would prescribe Vioxx to [the plaintiff] with a black box warning. Further fact investigation into these alleged biases could ultimately thwart application of the learned intermediary doctrine and thus bolsters support for denial of summary judgment." Id. at *9.
b. Cases where payment did not create a genuine dispute of fact
Defendants argue that DePuy is wrongly decided and point to a litany of other cases where courts granted summary judgment on the grounds of the learned intermediary defense, despite the alleged bias of a learned intermediary who had been compensated by the defendant. See D.E. 177 at 1–5. These cases include Talley v. Danek Medical Inc. , 179 F.3d 154 (4th Cir. 1999) (applying Virginia law) and In re Trasylol Products Liability Litigation , No. 08-cv-80386, 2011 WL 2117257 (S.D. Fla. May 23, 2011) (Middlebrooks, J.) (applying Alabama law), as well as: Calisi v. Abbott Laboratories , No. 11-10671-DJC, 2013 WL 5462274, at *3–4 (D. Mass. Feb. 25, 2013) (applying Massachusetts law) ; DiBartolo v. Abbott Laboratories , 914 F. Supp. 2d 601, 616 (S.D.N.Y. 2012) (applying New York law) ; In re Zyprexa Products Liability Litigation , No. 06-CV-3457, 2010 WL 348276, at *11 (E.D.N.Y. Jan. 22, 2010) (applying Illinois law) ; and Miller v. Pfizer Inc. , 196 F. Supp. 2d 1095, 1129 n.108 (D. Kan. 2002) (applying Kansas law), aff'd , 356 F.3d 1326 (10th Cir. 2004), among others.
Plaintiffs did not cite the Eastern District of Louisiana's Vioxx opinion in their response, and Defendants did not address it in their reply; nevertheless, the Court infers that Defendants would also argue Vioxx was wrongly decided.
In Talley , plaintiff Janet Talley sued Danek Medical, Inc. ("Danek")—the manufacturer of a Dyna-Lok Device, an internal fixation device used for spinal fusion—where the device's orthopedic screws became loose after being implanted in the plaintiff. See 179 F.3d at 155–57. Danek moved for summary judgment based on Virginia's learned intermediary doctrine, and the plaintiff argued that the learned intermediary doctrine should not apply because the implanting physician (Dr. Mathews) "was not independent of Danek in view of his financial connection with Danek as a consultant." Id. at 163. The Fourth Circuit framed the inquiry in this way: "[I]f Dr. Mathews were an employee of Danek or so closely related to Danek that he could not exercise independent professional judgment, a question could legitimately be raised as to whether he was an intermediary. The resolution of that complex question would depend on the nature of the relationship between the manufacturer and the physician and the extent to which the physician was in fact afforded independence in making medical judgments." Id. at 163–64. Applying that framework to the facts of the case, the Fourth Circuit held that
there is no evidence that the consulting relationship between Dr. Mathews and Danek interfered with Dr. Mathews' independent medical judgment in treating Talley. On the contrary, the evidence suggests otherwise. The record shows that Dr. Mathews was not committed automatically to the installation of the Dyna-Lok Device. In fact, during his first operation on Talley's back, he attempted a fusion without implanting any internal fixation device. Moreover, the evidence shows that Dr. Mathews' selection of the kind of device to implant in a particular case was determined by the circumstances of the individual case. Dr. Mathews did not always choose to implant the Dyna–Lok Device. Rather, depending on a patient's physical circumstances, he sometimes installed similar devices made by competing manufacturers. Finally, Dr. Mathews' consulting relationship with Danek involved devices other than internal fixation devices.
Id. at 164.
Likewise, in In re Trasylol Products Liability Litigation , the estate of Rosella Mae Deal ("Mrs. Deal") argued that defendant Bayer Corporation ("Bayer") failed to warn of the dangers associated with Trasylol, a medication administered during Mrs. Deal's double-vessel coronary artery bypass graft surgery. 2011 WL 2117257, at *1, *4. The estate argued that Alabama's learned intermediary doctrine should not apply to Bayer because the prescribing surgeon, Dr. Lochridge, had entered into a paid consulting agreement with Bayer. See id. at *4. Judge Middlebrooks rejected this argument:
Dr. Lochridge has undisputed experience as a cardiothoracic surgeon and with prescribing Trasylol. The fact that he entered into a paid consulting agreement with Bayer does not, in and of itself, render his decision to prescribe Trasylol for Mrs. Deal biased and not based on his independent medical judgment. Dr. Lochridge's testimony and the agreement itself indicate that its purpose was for Dr. Lochridge to attend one cardiac meeting. Dr. Lochridge testified that Trasylol and other drugs were discussed at the meeting. Furthermore, the evidence does not indicate that Dr. Lochridge's decision to prescribe Trasylol was automatic; on the contrary, he testified that considered the particular circumstances of Mrs. Deal's case, including that she was going to undergo a surgery with a significant risk of blood loss. The evidence Plaintiff cites does not support Plaintiff's claims. The learned intermediary doctrine applies.
Id.
Defendants argue that these cases take the right approach because "[i]f Plaintiffs' argument is accepted, the end result would be an unmanageable system whereby every physician who consults with, speaks at meetings for, trains physicians for or works as an expert witness for a pharmaceutical company would have to keep records of all patients to whom that company's products are prescribed in order for the company to warn each of those patients directly." D.E. 177 at 4 n.3. "This not only creates an unsustainable burden on physicians, but also removes the physician with whom the patient has a relationship from the warning equation." Id.
c. Prediction of how the Florida Supreme Court would rule
The Court declines to adopt a bright-line rule that Florida's learned intermediary doctrine always applies to bar failure-to-warn claims in cases involving prescription medical devices. Such a rule would be inconsistent with the Restatement tests—which turn on reasonableness, an inherently fact-based inquiry—cited with approval by the Florida Supreme Court in Aubin . At the same time, the Court recognizes that Aubin has not, so far, been extended to the medical device context.
The Court predicts that the Florida Supreme Court would side with the weight of authority cited by Defendants in subsection b, above. These cases do not stand for the proposition that these states' learned intermediary doctrines always apply in suits against manufacturers of drugs or medical devices. Rather, the cases suggest that the learned intermediary doctrine may not apply if the manufacturer knew or reasonably should have known that the intermediary-physician would not be exercising his independent medical judgment, such that the manufacturer could not rely on the intermediary-physician to duly consider the provided warnings when prescribing treatment. See Talley , 179 F.3d at 164 ; Trasylol Prods. Liab. Litig. , 2011 WL 2117257, at *4. Compare with Aubin , 177 So. 3d at 515 (stating that "a manufacturer may not be able to reasonably rely on an intermediary to provide warnings if the manufacturer knows that the necessary warnings would render the product less valuable and provide an incentive to the intermediary to withhold the necessary information from the consumer"). But more than proof of some financial relationship between the physician and the manufacturer is required to show that the physician was not, or reasonably might not, exercise independent medical judgment. See Talley , 179 F.3d at 164 ; Trasylol Prods. Liab. Litig. , 2011 WL 2117257, at *4.
See also DiBartolo v. Abbott Labs. , 914 F. Supp. 2d 601, 616 n.6 (S.D.N.Y. 2012) (in analyzing New York's "informed intermediary doctrine" (IID), noting that "plaintiff has not demonstrated that an exception to IID would be justified even if one assumes that physicians compensated by Abbott would be more likely to prescribe Humira than to prescribe a competitor drug. Such physicians would not be absolved of their duty to prescribe drugs to patients only when medically appropriate. It is not clear, moreover, that manufacturer-compensated physicians would in fact neglect their professional duties to an extent that would undermine IID."); Miller v. Pfizer Inc. , 196 F. Supp. 2d 1095, 1129 n.108 (D. Kan. 2002) ("In so holding, the Court does not disregard the possible bias in Dr. Geenens' testimony arising from his business relationship with Pfizer, i.e. the fact that at or near the time he prescribed Zoloft for Matthew, Dr. Geenens was a paid consultant for Pfizer. Rather, the Court holds that no reasonable jury would discredit his testimony—which is not refuted by any direct of circumstantial evidence—on that ground alone. Plaintiffs' attack on Dr. Geenens' credibility does not create a genuine issue of material fact."); Burton v. Am. Home Prods. Corp. (In re Norplant Contraceptive Prods. Liab. Litig.) , 955 F. Supp. 700, 706 (E.D. Tex. 1997) ("[I]f any physician allowed himself to become a mere conduit for Wyeth's materials, then it is the physician who is responsible. By the same token, Wyeth cannot remove a physician from the decision making process, only the physician can do that by avoiding his responsibility to make an individualized balancing of the risks and benefits associated with a drug and to advise the patient of possible adverse reactions.").
This conclusion is reconcilable, at least in part, with DePuy Orthopaedics . For example, one of the surgeons in that case (Dr. Heinrich) had agreed not to sell, evaluate, or promote non-DePuy products and had participated in a "kickback" scheme with DePuy, see 2016 WL 6268090, at *6 ; this Court finds that such evidence would be proof of non-objectivity—or to use Talley 's language, proof of being "so closely related" to the manufacturer "that he could not exercise independent professional judgment," 179 F.3d at 163 —to defeat summary judgment on the learned intermediary doctrine. The Court disagrees, however, with DePuy Orthopaedics to the extent it suggests that the mere fact of Dr. Heinrich's having served as an expert witness for DePuy, or the mere fact of Dr. Goletz's having received "thousands of dollars in Honorariums, reimbursements, royalties, and payments for speaking engagements and promotional speaking events" and having been identified as a "Key DePuy Surgeon," created a genuine dispute that those surgeons acted or reasonably could have been expected to act in a non-objective manner when choosing a course of treatment for the plaintiffs in that case.
4. Application of the Learned Intermediary Doctrine in This Case
Here, Plaintiffs offer no evidence to suggest that Defendants knew or reasonably should have known that Dr. Sepulveda would not be exercising his independent medical judgment when he decided to implant Artisyn Mesh in Mrs. Salinero. Plaintiffs cannot prevent the application of the learned intermediary doctrine here simply by pointing to Dr. Sepulveda's history as an expert witness and consultant for Defendants. Dr. Sepulveda's role as an expert witness and consultant was broad; it included providing training on laparoscopic surgery and surgery associated with transvaginal mesh, as well as general review of standards for various slings and meshes for prolapse. See supra Section I.D. Indeed, nothing in Dr. Sepulveda's deposition ties his role as a consultant or expert witness to the Artisyn Mesh product specifically. Plaintiffs have not presented any evidence to suggest it was a foregone conclusion that Dr. Sepulveda would prescribe Artisyn Mesh to treat Mrs. Salinero's POP.
If Defendants had some sort of actual or constructive notice of non-objectivity on the part of Dr. Sepulveda (like Dr. Heinrich's "kickback" scheme with DePuy in DePuy Orthopaedics ), the outcome might be different. But here, there is no evidence beyond Plaintiffs' conjecture and speculation to cast doubt on Dr. Sepulveda's testimony that he believed that he was fully apprised of the risks of implanting Artisyn Mesh—including the risk of fistula formation, —and still would have chosen to implant it in Mrs. Salinero anyway. See generally Sepulveda Dep. at 44:21–53:15, 59:3–61:10, 102:14–103:25, 209:20–210:25. As Dr. Sepulveda testified, his decision to use Artisyn Mesh in Mrs. Salinero's surgery had nothing to do with any consulting or expert witness work he had done for Defendants. Id. at 43:5–8, 105:24–106:1. Rather, he testified that he "ha[d] enough evidence to use polypropylene, and [he was] going to use the largest pore, ... monofilament and the one that provides the best support with the best data behind it," which he determined to be Artisyn Mesh. See id. at 43:11–14. Plaintiffs have not controverted this testimony with evidence that could call into question Defendants' reliance on the learned intermediary defense.
The effect of applying the learned intermediary defense here is that Plaintiffs' failure to warn claims necessarily fail, because Defendants' duty to warn, if any, ran to Dr. Sepulveda and not to Mrs. Salinero. This result is buttressed by Dr. Sepulveda's undisputed testimony that (1) in assessing the risks of implanting Artisyn Mesh in Mrs. Salinero, he relied primarily not on the IFU but rather on what he knew "about polypropylene from before" from training, journals, textbooks and review, and his experience, and (2) he believed the IFU information to be appropriate and adequate in terms of apprising him of the potential risks, such that a revised IFU would not have changed his decision to treat Mrs. Salinero's POP with Artisyn Mesh. See Sepulveda Dep. at 49:14–50:2, 50:20–51:8, 52:13–25, 210:22–25. This testimony shows a break in the causal chain between Defendants' IFU warnings to Dr. Sepulveda and Dr. Sepulveda's treatment decision. Cf. Hoffmann-La Roche Inc. v. Mason , 27 So. 3d 75, 76–77 (Fla. 1st DCA 2009) (motion for directed verdict in drug manufacturer's favor was warranted where prescribing physician testified that even if the warning label had contained all of the information suggested by plaintiff's expert, he still would have prescribed the drug; "Thus, any inadequacies in [the drug's] warning label could not have been the proximate cause" of plaintiff's injuries).
In the alternative, the Court holds that there is no genuine dispute that the 2012 IFU was adequate to inform Dr. Sepulveda of the associated risks. " ‘While in many instances the adequacy of warnings ... is a question of fact,’ the Florida Supreme Court has held that ‘it can become a question of law where the warning is accurate, clear, and unambiguous.’ " Eghnayem v. Bos. Sci. Corp. , 873 F.3d 1304, 1321 (11th Cir. 2017) (quoting Felix v. Hoffmann-LaRoche, Inc. , 540 So. 2d 102, 104 (Fla. 1989) ). " ‘[T]he adequacy or inadequacy of the warning to inform a physician must, except in the more obvious situations, be proved by expert testimony.’ " Id. (alteration in original) (quoting Upjohn Co. v. MacMurdo , 562 So. 2d 680, 683 (Fla. 1990) ). Here, as the Court has already ruled, see D.E. 235, none of Plaintiffs' proffered experts are qualified to opine on the alleged inadequacy of the 2012 IFU. Thus, at trial, Plaintiffs would be unable to carry their burden to prove that the IFU was inadequate. Defendants are entitled to judgment as a matter of law on all the failure to warn claims.
D. False Information Negligently Supplied for the Guidance of Others Claim
Count V of Plaintiffs' Complaint is titled "False Information Negligently Supplied for the Guidance of Others." Under Florida law, such a claim requires proof "that the defendant ‘supplie[d] false information for the guidance of others in their business transactions’ and that the plaintiff suffered ‘pecuniary loss’ caused by justifiable reliance upon the false information. In pursuing such a claim, however, the plaintiff must plead and establish that she is one of a limited group of persons for whose benefit and guidance the defendant intended to supply this type of information and that the defendant intended the information to influence her transaction or a substantially similar transaction." Morgan v. W.R. Grace & Co.—Conn. , 779 So. 2d 503, 506 (Fla. 2d DCA 2000).
The Court agrees with Defendants that Count V is merely a re-packaged failure to warn claim, which fails for the reasons explained above. See, e.g. , Beale v. Biomet, Inc. , 492 F. Supp. 2d 1360, 1363, 1373 (S.D. Fla. 2007) (Gold, J.) ("While Plaintiffs have provided various names for their claims against Biomet, the claims are all ultimately based upon Biomet's alleged failure to warn of the risks of the device. Because Florida has adopted the learned intermediary doctrine, I conclude that it would follow the reasoning above and hold that the doctrine bars the Plaintiffs' claims in this case."); Burton v. Am. Home Prods. Corp. (In re Norplant Contraceptive Prods. Liab. Litig.) , 955 F. Supp. 700, 709 (E.D. Tex. 1997) ("The gravamen of all of Plaintiffs' causes of action, including misrepresentation and violation of the DTPA, is that Wyeth failed to adequately warn of or disclose the severity of Norplant's side effects. Therefore, the learned intermediary doctrine applies to all of Plaintiffs' causes of action. Additionally, whether the failure to warn is couched as an affirmative misrepresentation or a misrepresentation by concealment, the allegation collapses into a charge that the drug manufacturer failed to warn. If the doctrine could be avoided by casting what is essentially a failure to warn claim under a different cause of action such as violation of the DTPA or a claim for misrepresentation, then the doctrine would be rendered meaningless. Therefore, this summary judgment motion, based upon application of the learned intermediary doctrine, is dispositive of all of Plaintiffs' claims."). Moreover, Plaintiffs fail to address the argument that Count V is no different than their negligent failure to warn claim, and thus the Motion is due to be granted by default on this ground. See S.D. Fla. L.R. 7.1(c).
See also Cruz v. Mylan, Inc. , No. 8:09-CV-1106-T17-EAJ, 2010 WL 598688, at *3 (M.D. Fla. Feb. 17, 2010) (noting that because "the pharmaceutical company's duty to warn stops at the physician or prescriber and does not directly make statements to the ultimate purchaser," and "the ultimate consumer...cannot prove reliance on a misrepresentation of fact about which she has no knowledge," the learned intermediary doctrine bars a misrepresentation claim where there is no evidence of any direct advertising from the pharmaceutical company to the consumer).
E. Negligent Infliction of Emotional Distress Claim
Under Florida law, "the elements required to allege a cause of action for negligent infliction of emotional distress [are]: (1) the plaintiff must suffer a physical injury; (2) the plaintiff's physical injury must be caused by the psychological trauma; (3) the plaintiff must be involved in some way in the event causing the negligent injury to another; and (4) the plaintiff must have a close personal relationship to the directly injured person." Zell v. Meek , 665 So. 2d 1048, 1054 (Fla. 1995). Defendants argue that Plaintiffs have not established and cannot establish the elements of this cause of action.
Again, Plaintiffs make no effort to respond to this argument in their response to the Motion. See D.E. 163. The Motion is therefore due to be granted on this ground by default. See S.D. Fla. L.R. 7.1(c). Moreover, Defendants are correct in their position. Mrs. Salinero's negligent infliction of emotional distress claim fails on the second prong. Mrs. Salinero may have suffered various physical injuries (such as her fistula ), but her physical injuries allegedly were caused by defective Artisyn Mesh, not by psychological trauma. Efren Salinero's claim fails on the first and second prongs; Plaintiffs have not directed this Court to any evidence, nor has the Court found any in the record, showing that Efren Salinero suffered any psychological trauma, let alone any resultant physical injury. Accordingly, Defendants are entitled to summary judgment as to Count VI.
The Court does not have "an obligation to parse a summary judgment record to search out facts or evidence not brought to the court's attention." Atlanta Gas Light Co. v. UGI Utilities, Inc. , 463 F.3d 1201, 1209 (11th Cir. 2006) ; see also Chavez v. Sec'y Fla. Dep't of Corr. , 647 F.3d 1057, 1061 (11th Cir. 2011) (explaining that judges "are not like pigs, hunting for truffles buried in briefs...") (quoting United States v. Dunkel , 927 F.2d 955, 956 (7th Cir.1991) ).
V. CONCLUSION
For the reasons discussed supra , Defendants' Motion, D.E. 92, is GRANTED IN PART AND DENIED IN PART as to the liability arguments, and the Court RESERVES RULING on the punitive damages argument. Defendants are entitled to judgment as a matter of law on Counts II, III, V, and VI of Plaintiffs' Complaint (D.E. 20), as well as those portions of Counts I and VII pertaining to an alleged manufacturing defect and/or the alleged failure to warn. The Court shall enter a separate partial final judgment accordingly.
DONE AND ORDERED in Chambers at Miami, Florida, this 9th day of September, 2019.