Michelle Arevalo v. Coloplast Corp

Court of Appeals for the Eleventh Circuit·Decided November 8, 2022·No. 21-11768·Unpublished

Opinion

[DO NOT PUBLISH]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.

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 under theories of strict liability and negligence.

The district court granted Coloplast’s Daubert motion to exclude 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 summary judgment because Arevalo did not have admissible expert testimony on specific causation. This is Arevalo’s appeal.

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 during intercourse. Her three pregnancies each resulted in vaginal deliveries , 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 precipitous (unusually fast). In 1995 she had a loop electrosurgical excision 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 intercourse , 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 cystocele . 2 In September 2010 he performed a total vaginal hysterectomy 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.

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 second - to third-degree rectocele. 3 That December Dr. Bankert performed 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, urinary frequency, occasional urine leakage, UTIs, uncomfortable urination , 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 after the injections but still felt pain during intercourse. Believing it

3 A rectocele occurs when the rectum protrudes through the back vaginal wall.

21-11768 Opinion of the Court 5

would help relieve the pain and tenderness, Dr. Kahn proposed removing some of the mesh.

In February 2014 Dr. Kahn performed a graft removal surgery during which she removed most of the Exair mesh from Arevalo ’s front vaginal wall. 4 She also repaired and strengthened Arevalo ’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 incontinence .

II. PROCEDURAL HISTORY

In February 2013 Arevalo filed a short form complaint against Coloplast and other entities in a multidistrict litigation proceeding 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 pursued 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.

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 summary 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. Arevalo opposed any re-briefing.

The district court held a case management conference, concluded 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 —

5 Coloplast moved for partial summary judgment on Arevalo’s claims for negligent manufacturing, strict liability manufacturing defect, strict liability defective product, breach of express warranty, breach of implied warranty, constructive fraud, “discovery rule, tolling, and fraudulent concealment,” negligent infliction of emotional distress, violation of consumer protection laws, and unjust enrichment. Arevalo conceded that Coloplast was entitled to summary judgment on these claims, and the district court granted Coloplast’s motion .

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the scientific process of identifying and ruling out other possible causes of an injury — was deficient. The district court granted all nine Daubert motions in part. Relevant to this appeal, it excluded as unreliable Dr. Rosenzweig’s specific causation opinion.

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