The plaintiff, Jo Huskey, and her husband filed a product liability lawsuit against Ethicon Inc. and Johnson & Johnson. After a nine-day trial, the jury returned a general verdict in the amount of $3.27 million for the Huskeys on their design defect, failure to warn and loss of consortium claims. Ethicon appealed after the trial judge denied its post-trial renewed motion for judgment as a matter of law or in the alternative for a new trial.

The court of appeals found that the Huskeys offered sufficient evidence to sustain the jury’s verdict and the district court committed no reversible error.

In 2008, Jo Huskey began suffering symptoms of Stress Urinary Incontinence (SUI).  In January 2011, after her condition worsened, she discussed treatment options with her physician. By this time, Mrs. Huskey was regularly leaking urine while coughing, laughing and sneezing. She also experienced pain during intercourse. At the suggestion of her physician, Mrs. Huskey agreed to have the doctor 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 the summer of 2003. Ethicon uses polypropylene for the TVT-O’s mesh. The TVT-O was a second-generation version of an earlier Ethicon device called the Gynecare TVT as one of multiple slings that Ethicon has manufactured and sold over the years.

On Feb. 23, 2011, Dr. Byrkit, Mrs. Huskey’s surgeon, implanted the transvaginal mesh. When Mrs. Huskey returned for a postoperative checkup a few weeks later, Dr. Byrkit examined her and found that some mesh on her right side had eroded. This eroded mesh caused her to experience pelvic pain. A second operation to cover the exposed mesh was done on June 29, 2011, but this operation did not work either. Dr. Byrkit referred Mrs. Huskey to another physician, a urogynecologist, for further treatment.

When yet a third surgery was done by the urogynecologist on Nov. 18, 2011, he found that Mrs. Huskey had an infection and that the mesh on her right side had completely eroded. He said he could not remove all the mesh because some had retracted behind Mrs. Huskey’s pubic bone.

Including up to the present time, the remaining mesh and scar tissue from Mrs. Huskey’s operations cause her severe pain, particularly when engaging in physical activities and sexual intercourse. Additionally, her SUI symptoms have returned. For the rest of her life, Mrs. Huskey will require medication for pain management.  No surgical intervention can permanently cure her.

The Huskeys are Illinois residents and they brought all of their claims under Illinois law. After the district court granted Ethicon’s partial summary judgment, five claims remained for trial, including a negligent failure to warn and Mr. Huskey’s loss of consortium.  The initial lawsuit was filed on Sept. 6, 2012 in the Southern District of West Virginia in the multidistrict litigation.

On Aug. 22, 2014, the trial began and lasted nine days. The Huskeys presented their case, which consisted of testimony from 13 witnesses and the introduction of numerous documents over the first six days of trial. 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 the ruling submitted the case to the jury.

The jury returned a unanimous general verdict for the Huskeys on all five claims, which totaled $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 an additional $200,000 to Mr. Huskey for his loss of consortium.

After the jury returned its verdict, Ethicon again renewed its motion 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. Ethicon subsequently filed this appeal.

As Ethicon’s counsel conceded at oral argument, since the jury returned a general verdict, the appeals panel can reverse the court’s denial of Ethicon’s motion only if the Huskeys fail, as a matter of law, to prove both their design defect and failure to warn claims.  The court of appeals stated that given resolution of the Huskeys’ design defect claims, it needed not to discuss their failure to warn claims.  Moreover, because the Huskeys’ negligent design defect claim relies on the same fact and arguments as their strict liability design defect claim, the court addressed those claims together.  Similarly, the court stated that it was wholly derivative of Mrs. Huskey’s claims to not separate Mr. Huskey’s loss of consortium claim.

To prevail on their design defect case, 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 Mikolajcvyk v. Ford Motor Co., 901 N.E.2d 329, 345 (Ill. 2008).

The court held that the Huskeys offered sufficient evidence for a reasonable jury to find Ethicon’s use of heavyweight polypropylene mesh in the TVT-O caused Mrs. Huskey’s injuries.

One of the Huskey’s expert witnesses, a chemical engineer, 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.”

Another expert, a urogynecologist, bolstered the chemical engineer’s testimony. This doctor testified that Ethicon used a heavyweight mesh and “[t]he more mesh there is in the pelvis, the more of a foreign body response.”  The doctor explained that heavyweight mesh can lead to a foreign body response in an area near the inner thigh called the obturator space and that these foreign bodies can “irritate the nerve [that passes nearby] and lead to pain.”

Ethicon also argued that an exception to strict liability is found in comment k to ¶ 402(A) of the Restatement (Second) of Torts, on which Illinois courts rely; nevertheless shields it from liability.  Whether a product is unavoidably unsafe is a question of fact on which the defendant bears the burden of proof.  If a reasonable jury could find that the TVT-O did not meet common k’s parameters, Ethicon’s reliance on common k fails.

The court affirmed the judgment, concluding that the district court did not commit reversible error where plaintiffs offered sufficient evidence to sustain the jury’s general verdict for plaintiffs on their design defect, failure to warn and loss of consortium claims. In addition, the court of appeals stated that the district court judge did not err by excluding evidence of the FDA’s Section 510(k) evaluation process; excluding the FDA Advisory Committee evidence; and excluding evidence of the Proline Suture’s regulatory history.  The court also rejected the Ethicon arguments requesting a new trial. Accordingly, the U.S. Court of Appeals affirmed the judgment of the district court.

Huskey v. Ethicon, Inc., No. 15-2118 (U.S. Court of Appeals for the 4^th Circuit); Jan. 26, 2017.

Kreisman Law Offices has been handling transvaginal mesh design defect cases, pelvic mesh implant cases, Physiomesh lawsuits, pharmaceutical defect cases and medical device defect cases for individuals and families who have been harmed, injured or died as a result of the carelessness or negligence of a medical device maker for more than 40 years in and around Chicago, Cook County and its surrounding areas, including Glenview, Gurnee, Rosemont, Arlington Heights, Hoffman Estates, Orland Park, Bridgeview, Melrose Park, Elmhurst, Clarendon Hills, Winnetka, Joliet, Aurora, Bensenville, Romeoville, Chicago (West Town, South Loop, Jefferson Park, Jackson Park, Lawndale, Austin, Calumet Lake, East Side, Rogers Park, Andersonville), St. Charles and Geneva, Ill.

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