Nunez v. Coloplast Corp.

461 F.Supp.3d 1260

Maricel NUNEZ, Plaintiff,

v.COLOPLAST CORP., Defendant.

Case No. 19-cv-24000-SINGHAL/Louis

United States District Court, S.D. Florida.

Signed May 20, 2020

Adam Daniel Peavy, Pro Hac Vice, Kathryn Grace Hooten, Pro Hac Vice, Clayton A. Clark, Lauren Schultz, Lezzlie Elizabeth Hornsby, Scott A. Love, Pro Hac Vice, Shelley Van Natter Hutson, Pro Hac Vice, William Michael Moreland, Pro Hac Vice, Clark, Love & Hutson, PLLC, Houston, TX, Joseph Anthony Osborne, Osborne & Francis, Boca Raton, FL, for Plaintiff.

Amy E. Furness, Carlton Fields Jorden Burt, P.A., Miami, FL, Caycee Danielle Hampton, Edward Walter Gerecke, David J. Walz, Carlton Fields Jorden Burt, P.A., Tampa, FL, Valentin Leppert, Pro Hac Vice, King & Spalding LLP, Atlanta, GA, William E. Steimle, Pro Hac Vice, King & Spalding LLP, San Francisco, CA, Lana K. Varney, Pro Hac Vice, King & Spalding, Austin, TX, for Defendant.

ORDER ON DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

RAAG SINGHAL, UNITED STATES DISTRICT JUDGE

THIS CAUSE is before the Court on Defendant Coloplast Corp.'s Motion for Summary Judgment and Incorporated Memorandum of Law (DE [101] ). In addition to the following filings—Defendant Coloplast's Statement of Material Facts in Support of its Motion for Summary Judgment (DE [102] ), Plaintiff's Response in Opposition to Defendant Coloplast Corp.'s Motion for Summary Judgment (DE [118] ), Plaintiff's Response to Coloplast Corp.'s Statement of Material Facts in Support of its Motion for Summary Judgment (DE [119] ), and Defendant Coloplast Corp.'s Reply Memorandum of Law in Further Support of its Motion for Summary Judgment (DE [135] )—and record evidence, the Court had the benefit of looking to dozens of district court and circuit court opinions on nearly identical issues raised in the myriad related multidistrict-litigation actions ("MDLs") across the nation emanating from mesh-sling implants. Taking all of the foregoing into consideration and being fully advised in the premises, after careful consideration, this order follows.

I. LEGAL STANDARD ON A MOTION FOR SUMMARY JUDGMENT

Summary judgment is appropriate "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). "A district court must grant a motion for summary judgment only if 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 a judgment as a matter of law." Essex Ins. Co. v. Barrett Moving & Storage, Inc. , 885 F.3d 1292, 1299 (11th Cir. 2018). An issue is "genuine" if a reasonable trier of fact, viewing all of the record evidence, could rationally find in favor of the nonmoving party in light of his burden of proof. Harrison v. Culliver , 746 F.3d 1288, 1298 (11th Cir. 2014). And a fact is "material" if, "under the applicable substantive law, it might affect the outcome of the case." Hickson Corp. v. N. Crossarm Co. , 357 F.3d 1256, 1259–60 (11th Cir. 2004). "[W]here the material facts are undisputed and do not support a reasonable inference in favor of the non-movant, summary judgment may properly be granted as a matter of law."

DA Realty Holdings, LLC v. Tenn. Land Consultants , 631 F. App'x 817, 820 (11th Cir. 2015).

The moving party's burden on a motion for summary judgment "depend[s] on whether the legal issues ... are ones on which the movant or the non-movant would bear the burden of proof at trial." Fitzpatrick v. City of Atlanta , 2 F.3d 1112, 1115 (11th Cir. 1993). "[F]or issues on which the movant would bear the burden of proof at trial, ‘that party must show affirmatively the absence of a genuine issue of material fact: it must support its motion with credible evidence ... that would entitle it to a directed verdict if not controverted at trial.’ " Id. (emphasis in original) (quoting United States v. Four Parcels of Real Prop. in Greene & Tuscaloosa Ctys. In State of Ala. , 941 F.2d 1428, 1437 (11th Cir. 1991) ). "For issues, however, on which the non-movant would bear the burden of proof at trial, ‘the moving party is not required to support its motion with affidavits or other similar material negating the opponent's claim in order to discharge this initial responsibility.’ " Id. (emphasis in original) (quoting Four Parcels , 941 F.2d at 1437–38 ).

II. BACKGROUND ¹

This action began as an MDL and has since been transferred from the Southern District of West Virginia ("MDL Court"). According to Plaintiff, this action is one of more than 120,000 products liability cases consolidated into seven related pelvic mesh cases as a multidistrict litigation in 2010. Plaintiff brings claims against Coloplast, manufacturer of the Altis Single Incision Sling System ("Altis").

In 2009, Plaintiff elected to undergo pelvic floor reconstructive surgery to treat her symptoms of stress urinary incontinence. In 2013 and 2015, she had a second and third follow-up surgery. All three surgeries were performed by the same surgeon. In the first, she received a mesh sling manufactured by the company Ethicon; in the latter two, she received an Altis manufactured by Coloplast. Following complications from these surgeries, she brought claims for products liability, alleging that her Altis implants were defective and that Coloplast failed to warn of any risks associated with its Altis implants.²

III. DISCUSSION

Of Plaintiff's sixteen claims,³ Coloplast first moves for summary judgment on all sixteen, arguing Plaintiff has not proven specific causation. The Court will address this argument first, as it would be dispositive of all other arguments raised by Coloplast, if the Court agrees. The Court will then address Coloplast's arguments as to individual counts.

First, some housekeeping. Coloplast does not move for summary judgment on Count I (Negligence, as to Negligent Testing, Design, or Formulation)⁴ or Count V (Strict Liability—Design Defect). Those specific claims shall proceed to trial. As for the following counts, Plaintiff does not oppose summary judgment in Coloplast's favor or has agreed not to pursue them at trial:⁵ Count I (Negligence, as to Negligent Manufacturing); Count II (Strict Liability—Manufacturing Defect); Count IV (Strict Liability—Defective Product); Count XV (Unjust Enrichment); and Count XVII (Discovery Rule and Tolling). Thus, for these five counts, summary judgment is GRANTED as unopposed in favor of Coloplast. The remaining arguments and counts are addressed below.

A. Specific Causation (All Counts)

Coloplast contends specific causation must be proven by medical-expert testimony; and that summary judgment is required where a plaintiff fails to provide such expert testimony. However, the Court is not entirely convinced the rule is as rigid as Coloplast represents. The cases to which it cites seem to find that expert testimony was necessary there as a matter of fact, not necessarily as a per se matter of law. See Kilpatrick v. Breg, Inc. , 613 F.3d 1329, 1334 n.4 (11th Cir. 2010) ; McClain v. Metabolife Int'l, Inc. , 401 F.3d 1233, 1237 (11th Cir. 2005) ; Guinn v. AstraZeneca Pharm. LP , 598 F. Supp. 2d 1239, 1242 (M.D. Fla. 2009) ; Haller v. AstraZeneca Pharm. LP , 598 F. Supp. 2d 1271, 1275, 1303 n.190 (M.D. Fla. 2009) ; Drury v. Cardiac Pacemakers, Inc. , 2003 WL 23319650, at *4 (M.D. Fla. June 3, 2003) ; Marking v. Novartis Pharm., Corp. , 2002 WL 32255405, at *3 (S.D. Fla. Feb. 12, 2002).

Nevertheless, this argument fails also because it is premised solely on the Court excluding Plaintiff's expert Bruce Rosenzweig, M.D. Coloplast argues: "Because the testimony of Plaintiff's lone expert on specific causation is inadmissible, she lacks the expert testimony necessary to meet her burden of proving causation." Because the Court denied Coloplast's Daubert challenge to Dr. Rosenzweig, see Nunez v. Coloplast Corp. , 2020 WL 2315077, at *7–8 (S.D. Fla. May 11, 2020), this argument is unavailing. Coloplast's motion for summary judgment on all counts for Plaintiff's failure to prove specific causation is DENIED .

B. Failure-to-Warn Claims (Counts I and III)

Next, Coloplast moves for summary judgment on Count I (Negligent Failure to Warn) and Count III (Strict Liability Failure to Warn). The warnings that came with the Altis implants—the "instructions for use" ("IFU")—at the time of Plaintiff's surgeries provided the following:

Adverse Reactions

Potential adverse reactions are those associated with surgery using implantable mesh materials. As with all foreign bodies, the Altis sling is likely to exacerbate any existing infection. Transitory local irritation at the wound site and a foreign body response may occur. There is also the risk of complete failure of the procedure resulting in incontinence and continued mild to moderate incontinence due to incomplete support or overactive bladder.

Known risks of incontinence [related to] surgical procedures with synthetic slings include the following:

  •  Vaginal extrusion                           •  Scarring
  •  Erosion (e.g., vaginal urethral)            •  Transient or permanent urinary
  •  Dyspareunia (i.e., painful intercourse)        retention/obstruction
  •  Sling migration                             •  Urethral obstruction
  •  Infection                                   •  Voiding dysfunction
  •  Pain                                        •  Nerve injury
  •  Hematoma                                    •  Vascular injury
                                                •  Bladder, bowel, urethra, vessel and/or
                                                   nerve perforation

The IFU also provided results of a clinical study of the Altis implants, which included data on the frequency of a dozen adverse events. These included: mesh extrusion, pelvic/urogenital pain, urinary retention, urinary tract infection, de novo urgency, dyspareunia,...