Michelle Arevalo v. Coloplast Corp

CourtCourt of Appeals for the Eleventh Circuit
DecidedNovember 8, 2022
Docket21-11768
StatusUnpublished

This text of Michelle Arevalo v. Coloplast Corp (Michelle Arevalo v. Coloplast Corp) is published on Counsel Stack Legal Research, covering Court of Appeals for the Eleventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Michelle Arevalo v. Coloplast Corp, (11th Cir. 2022).

Opinion

USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 1 of 23

[DO NOT PUBLISH] In the United States Court of Appeals For the Eleventh Circuit

____________________

No. 21-11768 ____________________

MICHELLE AREVALO, Plaintiff-Appellant, versus MENTOR WORLDWIDE LLC, et al.,

Defendant,

COLOPLAST CORP,

Defendant-Appellee. USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 2 of 23

2 Opinion of the Court 21-11768

Appeal from the United States District Court for the Northern District of Florida D.C. Docket No. 3:19-cv-03577-TKW-MJF ____________________

Before LUCK, BRASHER, and ED CARNES, Circuit Judges. PER CURIAM: In 2010 Michelle Arevalo was surgically implanted with two of Coloplast Corp.’s pelvic mesh products: the Aris Transobturator Sling System and the Exair Prolapse Repair System. She suffered pain and complications after the surgeries and sued Coloplast un- der theories of strict liability and negligence. The district court granted Coloplast’s Daubert motion to ex- clude as unreliable the specific causation opinion of Dr. Bruce Rosenzweig, Arevalo’s retained specific causation expert. It later struck her belated disclosure of Dr. John Miklos as a non-retained specific causation expert. The court then granted Coloplast sum- mary judgment because Arevalo did not have admissible expert tes- timony on specific causation. This is Arevalo’s appeal. USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 3 of 23

21-11768 Opinion of the Court 3

I. BACKGROUND Arevalo’s pelvic area issues began in childhood when she started having bladder and urinary tract infections (UTIs). 1 Later she developed pelvic pain, heavy and painful periods, and pain dur- ing intercourse. Her three pregnancies each resulted in vaginal de- liveries, some with complications. During her first delivery in 1994, she suffered a torn sphincter and had an episiotomy. Her second and third deliveries (1997 and 2001) were both precipi- tous (unusually fast). In 1995 she had a loop electrosurgical exci- sion procedure (LEEP) to remove abnormal tissue from her cervix, and in 2002 she had her tubes tied. In 2010 Arevalo sought treatment from gynecologist Dr. Glenn Bankert for her heavy and painful periods, pain during inter- course, and occasional urine leakage. Dr. Bankert diagnosed her with menorrhagia (heavy or prolonged periods), dysmenorrhea (painful periods), pelvic pain, and stress urinary incontinence. He also gave her a pelvic exam and found that she had an enlarged uterus, a second-degree uterine prolapse, and a first-degree cysto- cele. 2 In September 2010 he performed a total vaginal hysterec- tomy to remove Arevalo’s uterus and cervix. At the same time, he

1 At this stage “we are required to view the evidence and all factual inferences therefrom in the light most favorable to [Arevalo], and resolve all reasonable doubts about the facts in [her] favor.” Feliciano v. City of Miami Beach, 707 F.3d 1244, 1247 (11th Cir. 2013) (quotation marks omitted). 2 A uterine prolapse occurs when the uterus drops down into the vaginal canal. A cystocele occurs when the bladder drops down into the vaginal canal. USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 4 of 23

4 Opinion of the Court 21-11768

implanted her with Coloplast’s Aris mesh to treat her stress urinary incontinence. Less than two months later Dr. Bankert diagnosed Arevalo with significant pelvic organ prolapse. Her first-degree cystocele had progressed to second-degree, meaning that her bladder had fallen about halfway down her vaginal canal. She also had a sec- ond- to third-degree rectocele. 3 That December Dr. Bankert per- formed a second pelvic reconstructive surgery, this time to repair her prolapsing organs. To strengthen her front and back vaginal walls, he implanted them with Coloplast’s Exair mesh. He thought both surgeries were successful. Three and a half years later, Arevalo saw gynecologist Dr. Marjorie Kahn for help with persisting pelvic area issues. Arevalo complained of incomplete bladder emptying, vaginal bulging, uri- nary frequency, occasional urine leakage, UTIs, uncomfortable uri- nation, fecal incontinence, and pain during intercourse. During Dr. Kahn’s pelvic exam of Arevalo, she could feel the Exair mesh in Arevalo’s front vaginal wall. When Dr. Kahn touched the mesh, Arevalo felt tenderness. Dr. Kahn ultimately diagnosed Arevalo with a litany of conditions, including organ prolapse, scar pain, and mesh implant complications. For treatment she recommended physical therapy and trigger point injections in the tender areas to break up any scar tissue. Arevalo reported some improvement af- ter the injections but still felt pain during intercourse. Believing it

3 A rectocele occurs when the rectum protrudes through the back vaginal wall. USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 5 of 23

21-11768 Opinion of the Court 5

would help relieve the pain and tenderness, Dr. Kahn proposed re- moving some of the mesh. In February 2014 Dr. Kahn performed a graft removal sur- gery during which she removed most of the Exair mesh from Are- valo’s front vaginal wall. 4 She also repaired and strengthened Are- valo’s front vaginal wall and repaired her sphincter. Dr. Kahn noted that Arevalo’s vaginal tissue was more pliable after surgery, which she hoped would lessen the pain. But Arevalo continues to have pelvic pain, pain during intercourse, and stress urinary incon- tinence. II. PROCEDURAL HISTORY In February 2013 Arevalo filed a short form complaint against Coloplast and other entities in a multidistrict litigation pro- ceeding in the Southern District of West Virginia. In re: Coloplast Corp., Pelvic Support Sys. Prods. Liab. Litig., No. 2:12-md-2387 (S.D. W. Va. 2012). Her short form complaint adopted sixteen counts from the MDL master complaint, but she ultimately pur- sued only the following claims: negligent design and failure to warn, strict liability design defect, strict liability failure to warn, and gross negligence. She also sought punitive damages. In September 2019 Arevalo’s case was transferred to the Northern District of Florida, and the transfer order stated that the

4 Dr.Kahn testified that she never felt or located the Exair mesh in Arevalo’s back vaginal wall. USCA11 Case: 21-11768 Date Filed: 11/08/2022 Page: 6 of 23

6 Opinion of the Court 21-11768

case was ready to be set for trial. At the time of transfer, Coloplast had two outstanding motions. One was a motion for partial sum- mary judgment on Arevalo’s uncontested claims. 5 The other was a Daubert motion to exclude or limit opinions offered by Dr. Bruce Rosenzweig, one of Arevalo’s general causation experts and her only retained specific causation expert. The parties had also filed other Daubert motions in the MDL action that had been denied without prejudice, giving them the option to refile those motions in the transfer court. Upon transfer, the parties told the district court that they intended to renew these motions, and Coloplast asked for the chance to re-brief them under our circuit’s law. Are- valo opposed any re-briefing. The district court held a case management conference, con- cluded that the case was not ready for trial, and allowed the parties to re-brief their Daubert motions. Arevalo re-filed four Daubert motions and Coloplast re-filed five. One of Coloplast’s re-briefed motions sought to exclude or limit Dr. Rosenzweig’s opinions. Coloplast argued that Dr. Rosenzweig’s specific causation opinion was unreliable because his differential diagnosis methodology —

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