Taylor v. Mentor Worldwide LLC

• Decision Date: 08 October 2019
• Docket Number: No. 16-17245,No. 16-17147,16-17147
• Citation: 940 F.3d 582
• Parties: Teresa TAYLOR, Plaintiff – Appellee, v. MENTOR WORLDWIDE LLC, Mentor Corporation, Defendants – Appellants. In re: Mentor Corp. ObTape Transobturator Sling Products Liability Litigation. Teresa Taylor, Plaintiff – Appellant, v. Mentor Worldwide LLC, Mentor Corporation, Defendants – Appellees.
• Court: U.S. Court of Appeals — Eleventh Circuit

940 F.3d 582

Teresa TAYLOR, Plaintiff – Appellee,

v.MENTOR WORLDWIDE LLC, Mentor Corporation, Defendants – Appellants.

In re: Mentor Corp. ObTape Transobturator Sling Products Liability Litigation.

Teresa Taylor, Plaintiff – Appellant,

v.Mentor Worldwide LLC, Mentor Corporation, Defendants – Appellees.

No. 16-17147

No. 16-17245

United States Court of Appeals, Eleventh Circuit.

October 8, 2019

Edward Blizzard, Katherine Cornell, Holly W. Gibson, Blizzard & Nabers, LLP, Houston, TX, Austin Gower, Charles A. Gower, PC, Columbus, GA, Chad Lennon, Frank M. Lowrey, IV, Bondurant Mixson & Elmore, LLP, Atlanta, GA, for Plaintiff-Appellee in 16-17147, Plaintiff-Appellant in 16-17245.

John Q. Lewis, Dustin Bradley Rawlin, Benjamin Creighton Sasse, Tucker Ellis, LLP, Cleveland, OH, Allyson Newton Ho, Gibson Dunn & Crutcher, LLP, Dallas, TX, Michael E. Kenneally, Morgan Lewis & Bockius, LLP, Washington, DC, for Defendants-Appellants in 16-17147, Defendants-Appellees in 16-17245.

Before TJOFLAT and JULIE CARNES, Circuit Judges, and KAPLAN,^* District Judge.

KAPLAN, District Judge:

Teresa Taylor here sues Mentor Worldwide LLC ("Mentor") and Mentor Corporation¹ for compensatory and punitive damages for injuries she suffered as a result of the surgical implantation of a polypropylene mesh sling manufactured by Mentor to treat her stress urinary incontinence

. The jury found Mentor liable to Taylor for failure to warn both before and after implantation, defective design, and negligence. It awarded $400,000 in compensatory and $4 million in punitive damages. Mentor moved for judgment as a matter of law or, in the alternative, for a new trial or to reduce the punitive damages award. The district court upheld the jury’s verdict with respect to liability and compensatory damages, but concluded that the punitive damages award exceeded Florida’s statutory cap and consequently reduced the punitive damages award to $2 million.

Mentor now appeals. It contends that it is entitled to judgment as a matter of law because the district court erred in (1) receiving certain expert testimony on the issue of specific causation and (2) applying an incorrect causation standard to Taylor’s failure to warn claims. Mentor argues, in the alternative, that it is entitled to a new trial on the basis of various evidentiary rulings by the district court or to an amended judgment eliminating or further reducing the punitive damages award. Taylor cross appeals, arguing that the district court erred in reducing the punitive damages awarded by the jury. We find no error in the judgment and therefore affirm.

I. BACKGROUND

This is one of more than 800 cases that were consolidated by the Judicial Panel on Multidistrict Litigation into the multidistrict proceeding known as In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation , No. 4:08-MD-2004 (CDL). The cases arise from claims of medical complications allegedly associated with a polypropylene mesh sling manufactured by Mentor called ObTape. One such case, brought by Taylor, who was surgically implanted with ObTape in 2004 to treat stress urinary incontinence

, was selected to go to trial as a bellwether.

Taylor claimed defective design, negligence, and failure to warn both before and after implantation of the ObTape. She contended that her ObTape implant caused her to suffer from a thinning of her urethral wall and from chronic bladder inflammation (also called cystitis

). At trial, she endeavored to prove that her injuries resulted from two design defects in the ObTape, namely, a small pore size, which allegedly did not allow adequate tissue ingrowth, and an alleged propensity to degrade and shed polypropylene particles in the body. She relied at trial on several expert witnesses to establish both general causation – that is, that ObTape was capable of causing the types of injuries from which she suffered – and specific causation – that is, that the ObTape implanted in her in fact caused her injuries.

We begin with an overview of the evidence offered and objections made at trial to the extent such evidence and objections are relevant on appeal.

A. General Causation

1. Porosity of ObTape

Several witnesses testified, in their respective expert opinions, that ObTape’s small pore size did not allow adequate tissue ingrowth, which in turn led to inflammation, erosion, and infection.

One such witness was Dr. William Hyman, a professor emeritus of biomedical engineering at Texas A&M University. Dr. Hyman testified that large pores are better than small pores in a mesh sling implant such as ObTape. He explained that the goal is for the tissue to grow into the implant and to "stabilize it and hold it in place" in order to prevent the implant from "moving relative to the tissue." According to Dr. Hyman, if an implant has "big holes and relatively little material," the "[t]issue can grow through the holes, find other tissue on the other side, and anchor it all in place, and that helps control erosion."² He testified also about the ObTape sling in particular and opined that it had a "uniquely bad" design in part because it had a small pore size as well as smaller numbers of pores. In other words, according to Dr. Hyman, the small pore size of ObTape prevented adequate tissue ingrowth, which then permitted the ObTape to move around the implant area and cause erosion.³

Dr. Andrew Siegel, a urologist, testified along similar lines, saying that, in his experience with his patients, ObTape "didn’t develop the typical tissue ingrowth and incorporation that [he] had come to expect with some of the previous generation sling materials" and that the implant’s pores were not big enough to allow adequate tissue ingrowth.

2. Tendency to Degrade

Dr. Ahmed El-Ghannam, a professor of biomaterials at the University of North Carolina, testified on the degradation theory.

He said that he had conducted a series of scientific experiments on ObTape, including an electron microscope examination of the product after immersing it in a physiological solution, a Fourier Transform Infrared Spectroscopy

, a gas chromatography /mass spectrometry analysis of a physiological solution after the ObTape had been immersed in it, a differential scanning calorimetry, and an x-ray diffraction analysis. Each analysis, he said, confirmed that ObTape, although intended to be an inert, permanent material, had a propensity to degrade and shed polypropylene particles in the body. He testified that this degradation and shedding of particles sparked a reaction by the body’s immune system, causing the body continuously to release hydrogen peroxide – a strongly acidic fluid – in order to destroy the implant. The response by the body’s immune system caused tissue inflammation, erosion of tissue and, in some cases, infection. If the ObTape were inert, he testified, it still would stimulate the body’s immune system, but because of the size of the sling, the body would form a fibrous capsule around the implant to encase it which, in turn, would cause the immune system to stop attacking the foreign object.

Dr. El-Ghannam testified further that it was not a matter of whether degradation would occur, but when . He opined that any patient implanted with ObTape would suffer the effects of degradation because, after an initial incubation period during which the rate of degradation would be slow, the rate of degradation would increase dramatically, necessitating the removal of the ObTape.

B. Specific Causation

On the question of specific causation, Taylor proffered Dr. William Porter, a urogynecologist, as an expert witness to show that ObTape in fact caused the chronic inflammation

and pain she claimed to have suffered. In order to explain the significance of Dr. Porter’s testimony at trial, it is useful first to explain the opinions given in both his expert report and deposition.

Taylor disclosed Dr. Porter as a causation expert and provided an expert report prior to trial as required by Rule 26. In his Rule 26 report, Dr. Porter opined "to a reasonable degree of medical and scientific probability that [Taylor’s] injuries were caused by complications attributable to the Mentor ObTape product at issue in this case." In support of that opinion, he noted that medical literature indicated the ObTape had a higher incidence of erosion than did other such slings. Moreover, that same literature revealed that ObTape had a smaller pore size than did competing products, which increased the likelihood of infection. Dr. Porter noted that complications generally associated with implantation of ObTape included, among other things, "chronic inflammation

of tissue" and "erosion of mesh into tissues." The resulting injuries included vaginal and pelvic pain, inflammation, and bladder problems.

In summary, the report indicated that Dr. Porter had concluded, based on his physical examination of Taylor and a review of her medical records, that she suffered pain and chronic inflammation

that was primarily attributable to ObTape’s small pore size and to a "tightening/contraction" process that resulted from ObTape’s faulty design. Dr. Porter reached his conclusion that ObTape was the culprit largely through a process of elimination. He considered other possible causes for Taylor’s maladies but, upon examining her, was largely "able to rule out these other potential causes (except Arias Sling)" because Taylor’s symptoms started after placement of the ObTape. He therefore concluded "within a reasonable degree of medical certainty, that the most likely cause of her ... chronic inflammation

is the ObTape."

In his deposition, Dr. Porter expressed less confidence in the opinions described above. In response to questions by defense counsel, he conceded that none of Taylor’s medical records showed an erosion of her ObTape. He conceded also that there could be causes other than ObTape for Taylor’s chronic bladder inflammation. Indeed, at one point in his deposition, Dr. Porter stated that he could not say "to...