Huskey v. Ethicon, Inc.

• Decision Date: 26 January 2017
• Docket Number: No. 15-2118,15-2118
• Citation: 848 F.3d 151
• Parties: Jo HUSKEY; Allen Huskey, Plaintiffs–Appellees, v. ETHICON, INC.; Johnson & Johnson, Defendants–Appellants.
• Court: U.S. Court of Appeals — Fourth Circuit

848 F.3d 151

Jo HUSKEY; Allen Huskey, Plaintiffs–Appellees,

v.ETHICON, INC.; Johnson & Johnson, Defendants–Appellants.

No. 15-2118

United States Court of Appeals, Fourth Circuit.

Argued: December 8, 2016

Decided: January 26, 2017

ARGUED: David B. Thomas, Thomas Combs & Spann, PLLC, Charleston, West Virginia, for Appellants. Edward Anthony Wallace, Wexler Wallace LLP, Chicago, Illinois; Fidelma Louise Fitzpatrick, Motley Rice LLC, Providence, Rhode Island, for Appellees. ON BRIEF: Charles C. Lifland, Los Angeles, California, Stephen D. Brody, David K. Roberts, O'Melveny & Myers LLP, Washington, D.C.; Philip J. Combs, Thomas Combs & Spann, PLLC, Charleston, West Virginia; Christy D. Jones, Butler Snow LLP, Ridgeland, Mississippi, for Appellants. Mark R. Miller, Wexler Wallace LLP, Chicago, Illinois; Jeffrey Kuntz, Adam Davis, Wagstaff & Cartmell LLP, Kansas City, Missouri, for Appellees.

Before MOTZ and DIAZ, Circuit Judges, and DAVIS, Senior Circuit Judge.

Affirmed by published opinion. Judge Motz wrote the opinion, in which Judge Diaz and Senior Judge Davis joined.

DIANA GRIBBON MOTZ, Circuit Judge:

After Jo Huskey experienced complications from the implantation of a transvaginal mesh medical device, she and her husband Allen Huskey filed this products liability action against Ethicon, Inc. and Johnson & Johnson (collectively "Ethicon"). Following a nine-day trial, the jury returned a general verdict for the Huskeys on their design defect, failure to warn, and loss of consortium claims. Ethicon now appeals the denial of its post-trial renewed motion for judgment as a matter of law or, in the alternative, for a new trial. The Huskeys offered sufficient evidence to sustain the jury's verdict and the district court committed no reversible error. Accordingly, we affirm.

I.

A.

In 2008, Mrs. Huskey began suffering symptoms of Stress Urinary Incontinence ("SUI"). In January 2011, after her condition had worsened, she discussed treatment options with her doctor, Dr. Gretchen Byrkit. By this time, Mrs. Huskey was regularly leaking urine while coughing, laughing, and sneezing, and she also experienced pain during intercourse. At Dr. Byrkit's suggestion, Mrs. Huskey agreed to have Dr. Byrkit surgically implant a medical device called the Tension–Free Vaginal Tape–Obturator ("TVT–O").

The TVT–O is a mid-urethral sling that uses a heavy-weight laser-cut mesh. Ethicon received clearance from the Food and Drug Administration ("FDA") to market the TVT–O in December 2003. Ethicon uses polypropylene for the TVT–O's mesh. The TVT–O was not the first mid-urethral sling Ethicon had manufactured; rather, it was a second-generation version of an earlier Ethicon device called the Gynecare TVT and is one of multiple slings that Ethicon has manufactured and sold.

On February 23, 2011, Dr. Byrkit performed Mrs. Huskey's implantation surgery. A few weeks later, Mrs. Huskey visited Dr. Byrkit's office for a post-operative check-up. At this visit, Dr. Byrkit examined Mrs. Huskey and found that some mesh on her right side had eroded. This eroded mesh caused Mrs. Huskey to experience pelvic pain.

On June 24, 2011, after various alternative treatments that Dr. Byrkit had recommended failed, Mrs. Huskey agreed to have a second surgical operation to cover the exposed mesh. Dr. Byrkit performed this operation on June 29, 2011. Unfortunately, this operation was not successful and did not relieve Mrs. Huskey's pain. Dr. Byrkit then referred Mrs. Huskey to Dr. Sohail Siddique, a urogynecologist, for further treatment.

On November 18, 2011, Dr. Siddique performed surgery to excise Mrs. Huskey's mesh. He found that she had an infection and that the mesh on Mrs. Huskey's right side had completely eroded. He could not remove all the mesh because some had retracted behind Mrs. Huskey's pubic bone.

To this day, the remaining mesh and scar tissue from her operations cause Mrs. Huskey to experience severe pain, particularly when engaging in physical activity and sexual intercourse. Additionally, her SUI symptoms have returned. For the rest of her life, she will require medication for pain management; no surgical intervention can permanently cure her.

B.

On September 6, 2012, the Huskeys filed the operative Short Form Complaint in the Southern District of West Virginia in the instant multidistrict litigation, In Re Ethicon Inc., Pelvic Repair Sys. Prods. Liab. Litig. , MDL No. 2327. The Huskeys, Illinois residents, brought all of their claims under Illinois law. After the district court granted Ethicon partial summary judgment, five claims remained for trial: strict liability and negligent design defect; strict liability and negligent failure to warn; and Mr. Huskey's loss of consortium. Beyond actual damages, Mrs. Huskey sought punitive damages for the substantive claims.

Trial began on August 22, 2014 and lasted nine days. The Huskeys presented their case, which consisted of testimony from thirteen witnesses and the introduction of numerous documents, over the first six trial days. At the conclusion of their case, Ethicon orally moved for judgment as a matter of law under Federal Rule of Civil Procedure 50(a). The court granted the motion as to Mrs. Huskey's claim for punitive damages but otherwise deferred ruling on the motion. Ethicon renewed its motion at the close of its case, and the court, again deferring a ruling, submitted the case to the jury.

The jury returned a unanimous general verdict for the Huskeys on all five claims. The jury awarded Mrs. Huskey $3.07 million in total damages, allocated between past expenses for medical care, previous pain and suffering, and future pain and suffering. The jury awarded Mr. Huskey an additional $200,000 for his loss of consortium.

After the jury returned its verdict, Ethicon again renewed its motion for judgment as a matter of law. In the alternative, Ethicon sought a new trial pursuant to Rule 59(a)(1)(A). The court issued a thorough written order denying the motion. Huskey v. Ethicon, Inc. , No. 2:12–cv–05201, 2015 WL 4944339 (S.D. W. Va. Aug. 19, 2015). Ethicon subsequently noted this timely appeal.

II.

A.

Ethicon initially contends that the district court erred in denying it judgment as a matter of law. We review de novo the denial of Ethicon's motion. Durham v. Jones , 737 F.3d 291, 298 (4th Cir. 2013). A court "may grant judgment as a matter of law only if, viewing the evidence in a light most favorable to the non-moving party and drawing every legitimate inference in that party's favor, ... the only conclusion a reasonable jury could have reached is one in favor of the moving party." Saunders v. Branch Banking & Tr. Co. of Va. , 526 F.3d 142, 147 (4th Cir. 2008). If, upon the conclusion of a party's case, "a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue," a court may grant a motion from the opposing party for judgment as a matter of law. Fed. R. Civ. P. 50(a). When the court defers ruling on such a motion, Rule 50(b) allows a party to renew it after the jury returns a verdict.

Ethicon moved for judgment as a matter of law on all five of the Huskeys' claims. As Ethicon's counsel conceded at oral argument, since the jury returned a general verdict, we can reverse the court's denial of Ethicon's motion only if the Huskeys failed, as a matter of law, to prove both their design defect and failure to warn claims. Given our resolution of the Huskeys' design defect claims, we need not discuss their failure to warn claims. Moreover, because their negligent design defect claim relies on the same facts and arguments as their strict liability design defect claim, we address those claims together. Similarly, because it is wholly derivative of Mrs. Huskey's claims, we do not separately consider Mr. Huskey's loss of consortium claim. See Blagg v. Ill. F.W.D. Truck & Equip. Co. , 143 Ill.2d 188, 157 Ill.Dec. 456, 572 N.E.2d 920, 926 (1991).

B.

To prevail on their design defect claims, the Huskeys had to demonstrate: 1) that a certain condition of the TVT–O resulted from Ethicon's design, 2) that this condition made the product unreasonably dangerous, 3) that the dangerous condition existed when Mrs. Huskey's TVT–O left Ethicon's control, and 4) that the dangerous condition in the TVT–O proximately caused harm to Mrs. Huskey. See Mikolajczyk v. Ford Motor Co. , 231 Ill.2d 516, 327 Ill.Dec. 1, 901 N.E.2d 329, 345 (2008). Ethicon makes two arguments in support of its contention that the court erred in denying it judgment as a matter of law: 1) that the Huskeys failed to prove a specific flaw in the TVT–O's design—as opposed to a general complication flowing from implantation, and 2) that comment k of the Restatement (Second) of Torts § 402A shields it from liability. We address these arguments in turn.

1.

The record belies Ethicon's assertion that the Huskeys failed to prove that a specific defect of the TVT–O's design caused harm to Mrs. Huskey. As the district court properly held, the Huskeys offered sufficient evidence for a reasonable jury to find that Ethicon's use of heavyweight polypropylene mesh in the TVT–O caused Mrs. Huskey's injuries.

First, Dr. Scott Guelcher, an associate professor of chemical engineering at Vanderbilt University and one of the Huskeys' expert witnesses, testified about the body's reaction to polypropylene and the consequences that ensue. He explained that "the body recognizes [the polypropylene mesh] as a foreign material, and ... will continue to attack it in this way until it's removed or destroyed or it's gone." And Dr. Guelcher testified, based on his research, that "it's best to minimize the amount of polypropylene that's present in the mesh," because "the more polypropylene surface that's present, the greater those changes would be, [and] the more hazardous they could be."

Next, Dr. Bruce Rosenzweig, a urogynecologist and another of the Huskeys' expert witnesses, bolstered Dr. Guelcher's testimony. Dr. Rosenzweig testified that Ethicon used a...