Salinero v. Johnson

Decision Date10 September 2019
Docket NumberCase No.: 1:18-cv-23643-UU
Citation400 F.Supp.3d 1334
CourtU.S. District Court — Southern District of Florida
Parties 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.



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.


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;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, 9.2 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.

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[3 ]...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.

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); fistula4 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 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...

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