Fourth Circuit Excludes FDA Evidence in Transvaginal Mesh Products Liability Case

In the Southern District of West Virginia, Johnson & Johnson and its subsidiary, Ethicon, Inc., were sued for defective design and failure to warn for their transvaginal mesh TVT-O, in addition to a loss of consortium claim.

This specific case, Huskey v. Ethicon, Inc., involved the product Tension-Free Vaginal Tape-Obturator (“TVT-O”), which was implanted in the Plaintiff for her stress urinary incontinence.  After the Plaintiff’s surgery, she allegedly developed mesh erosion, pain, and dyspareunia.  The Plaintiff’s doctor discovered that the mesh on her right side had eroded.  A second surgery was performed, but was also unsuccessful.  The Plaintiff eventually underwent a third surgery with a different doctor, but the mesh could not be completely removed, causing the Plaintiff recurrent pain.

The FDA approved this type of transvaginal mesh in 2003 for use in surgeries related to pelvic organ prolapse and stress urinary incontinence. It is a mid-urethral sling that uses a heavyweight laser-cut mesh and polyproplene.  Various issues and complications were reported after surgeries using transvaginal meshes.

The Plaintiff sued Ethicon, Inc. and Johnson & Johnson (“Ethicon, Inc.”) as part of the multidistrict litigation, In Re Ethicon Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2327.  The Plaintiff and her husband, as Illinois residents, brought the product liability claims under Illinois law.  Following an unsuccessful motion for summary judgment by Ethicon, Inc., five claims went to trial: punitive damages, strict liability, negligent design defect,  negligent failure to warn, and loss of consortium.

At the conclusion of Plaintiff’s evidence, Defendants orally moved for judgment as a matter of law under Federal Rule of Civil Procedure 50(a). The district court granted Defendants’ motion as to Plaintiff’s punitive damages claim, but deferred ruling on the rest of the motion.  Defendants renewed this motion at the conclusion of the trial, but the judge deferred a ruling and submitted the issues to the jury.  The jury returned a verdict for the Plaintiff on all five claims for a total award of $3,070,000.00 for design defect and failure to warn and an additional $200,000.00 to Plaintiff’s husband for his loss of consortium claim.  Following the jury verdict, Defendants again renewed their motion for judgment as a matter of law, or alternatively, a motion for a new trial under Federal Rule of Civil Procedure 59(a)(1)(A).

The decision to deny Defendant’s motion for a judgment as a matter of law and motion for a new trial was appealed to the Fourth Circuit. In support of  its motion for judgment as a matter of law, Defendants argued that the Plaintiffs failed to prove a specific design defect in the TVT-O as compared to a general complication from the product’s implantation, and that the jury should have been instructed on comment k of the Restatement (Second) of Torts § 402(A) regarding unavoidably dangerous products.  Since the jury returned a general verdict on all of the product liability claims, the Fourth Circuit could only reverse the lower court’s decision if it found that the Plaintiffs failed to prove both the defective design and the failure to warn claims.

Applying Illinois law, the Fourth Circuit affirmed both of the district court’s decisions in denying the Defendants’ motion for judgment as a matter of law. The Plaintiff presented expert testimony that the TVT-O’s heavyweight polypropylene mesh could have been made safer with a lightweight mesh because the human body would be less likely to  reject the mesh as a foreign body or cause inflammation, and posed less potential for scar plating.  The Fourth Circuit found that this expert testimony was sufficient for a reasonable jury to conclude that the mesh was defectively designed.

The important takeaway for product manufacturers facing claims within the Fourth Circuit, as the number of transvaginal mesh lawsuits continues to grow, is the Fourth Circuit’s denial of the Defendants’ motion for a new trial under established Fourth Circuit law. A motion for a new trial under Federal Rule of Civil Procedure 59(a)(1)(A) will only be granted if the verdict is “contrary to the clear weight of evidence, rests upon false evidence, or will cause a miscarriage of justice.”  (citing Minter v. Wells Fargo Bank, N.A., 762 F.3d 339, 346 (4th Cir. 2014)).  So the Court’s evaluation of the proffered evidence within that controlling standard is instructive.

One of the reasons the Defendants argued for a new trial was that the district court had “excluded multiple pieces of evidence involving the FDA. . . evidence of the TVT-O’s compliance with the FDA’s Section 510(k) evaluation process, evidence that a 2011 FDA Advisory Committee deemed mesh slings, including the TVT-O, safe and effective, a 2013 published guidance, which reported the Advisory Committee’s conclusions; and the regulatory history of the Prolene suture, an Ethicon product that contains the same polypropylene as the TVT-O’s mesh.” In excluding that evidence, the district court used the Federal Rule of Evidence 403 balancing test, which excludes evidence, even if relevant, if its “probative value is substantially outweighed by a danger of unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.”

Regarding the first portion of excluded evidence, the TVT-O’s compliance with the FDA’s Section 510(k) evaluation process, the district court found that the risk of confusing the jury outweighed any probative value from that evidence, citing to Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S. Ct. 2240 (1996) and Cisson v. C.R. Bard, Inc. (In re C.R. Bard, Inc.), 810 F.3d 913 (4th Cir. 2016). The 510(k) evaluation process determines if a potential new product is “substantially equivalent” to an already existing product.  If the FDA finds that there is a substantially similar device already in existence, the proposed device does not need to undergo further regulatory analysis.  The district court determined that the risk of confusing the jury by igniting a battle between experts regarding the FDA 510(k) evaluation process, did not outweigh the “limited probative value” of the proposed evidence.

The district court also excluded evidence of a 2011 Obstetrics and Gynecology Devices Advisory Committee Executive Summary on first generation minimally invasive slings. These conclusions were later repeated in a published guidance by the FDA in 2013.  The district court excluded both pieces of evidence based on the risk of the jury misunderstanding the FDA Advisory Committee’s actual conclusions, since the FDA was commenting on studies done by others.  The district court did allow the Defendants to admit evidence of the studies themselves, but not any evidence of the FDA’s view of the studies.

Lastly, the district court excluded evidence of the regulatory history of the Prolene suture, which has the same polypropylene used in the TVT-O mesh. Defendants attempted to admit evidence that the FDA had approved the Prolene suture and its use in over 30 New Drug Applications and that “the FDA approved language indicating that Prolene [in the suture] is not subject to degradation via tissue enzymes.” The district court excluded the evidence because “evidence regarding the FDA process that the Prolene suture underwent . . . says little about the safety and effectiveness of the final project, the TVT-O.”  The jury had to make its decision based on the design of the entire device, not just one component of it, and “the jury might draw too strong a conclusion from the fact that the evidence of Prolene’s safety comes from the FDA.”

Common to all of the district court’s evidentiary determinations was an underlying need to protect the jury from the apparent weight of the FDA. The district court seemed to make its rulings based on a feeling that the jury could or would not properly question evidence coming from the FDA.  However, under an abuse of discretion standard, the Fourth Circuit affirmed all of the decisions to exclude such evidence and affirmed the jury verdict in an opinion issued on January 26, 2017.