$2.5 Million Judgment for Defective Mesh Implant Stands

The Eleventh Circuit Court of Appeals affirmed a $2.5 million judgment in favor of the plaintiff, Virginia Redding, in a lawsuit against Coloplast Corporation. This case centered on allegations that Coloplast provided a defective pelvic mesh implant, a medical device used to treat pelvic organ prolapse, a condition where the pelvic organs, such as the bladder, uterus, or rectum, drop from their normal position due to weakened muscles and tissues.

A critical legal issue hinged on the statute of limitations, with the argument that the lawsuit was filed beyond the legally permissible timeframe. The court's decision revolved around whether the plaintiff initiated the legal action within this prescribed timeframe.

The court rejected Coloplast's statute of limitations defense. The plaintiff's initial 2009 symptoms, the court found, weren't sufficiently distinct from typical post-operative complications to suggest a product defect. Only the plaintiff's worsened symptoms in 2014 reasonably suggested a potential mesh defect, falling within Florida's four-year statute of limitations.

In 2009, Ms. Redding received two vaginal mesh devices, both manufactured by Coloplast Corp. The first device, the Supris mid-urethral sling, is a supportive mesh strip positioned beneath the urethra to aid in urinary control. The second, the Novasilk pelvic organ prolapse mesh, is a more extensive mesh designed to provide support to the pelvic organs.

Redding claimed that her doctor did not inform her of any defects or safety concerns regarding the surgical mesh implanted in her body. Medical records in the months following the surgery documented a “tiny erosion” (a small area of tissue breakdown) near the surgical site approximately one millimeter in width.

The tiny erosion remained stable in size, did not interfere with any structures, and was not causing any problems. Consequently, her doctor chose not to intervene, suggesting that such minor erosions could potentially heal spontaneously.

An expert witness concurred with the approach of Redding’s doctor. He confirmed that the erosion did not increase in size and classified it as a “postsurgical complication” that went on to resolve on its own.

However, Ms. Redding went on to experience severe complications over the years, including intense pain, recurring infections, and bleeding. As a result, she underwent two explant procedures, and surgeries intended to remove the mesh devices. These complications arose because the mesh products had degraded and worn through the surrounding tissue and migrated into nearby anatomical structures.

Despite these efforts, the complete removal of the mesh devices was unachievable due to tissue integration, a process where the mesh becomes embedded into the surrounding tissue. Consequently, Ms. Redding was left with permanent remnants of the mesh devices.

In a lawsuit filed in Florida, Redding accused Coloplast of gross negligence, liability, and unjust enrichment, among other charges. She claimed that the pelvic mesh she received was faulty, leading to various health issues.

The case went to a jury trial in 2022, where the jury found in favor of Redding. They determined that the mesh from Coloplast was indeed defective and was the cause of her injuries. As a result, Redding was awarded $2.5 million. The jury also ruled that the complaint was not time-barred.

Coloplast challenged the ruling, asserting that the statute of limitations began in late 2009. They argued that Redding's lawsuit, filed in September 2014, was beyond the permissible timeframe and should be considered expired. Coloplast’s argument was based on Redding’s testimony that she was aware of the mesh erosion in December 2009.

However, the Eleventh Circuit disagreed with Coloplast’s argument. They stated that the jury had the discretion to believe all, some, or none of Redding’s testimony. The jury found it reasonable to disregard Redding’s claim of knowing “something was wrong” in December 2009. Thus, the original verdict stood.

The United States District Court for the Middle District of Florida had already reviewed the case and denied Coloplast's motion for summary judgment, which argued that Redding’s claim was filed too late.

Drawing parallels to Eghnayem v. Boston Scientific Corporation, the district court found the cases "strikingly similar" and concluded that Redding’s symptoms were not distinct enough from typical post-surgery symptoms to alert her to the issue. Thus, they ruled the lawsuit was not time-barred.

The panel for the Eleventh Circuit was comprised of U.S. Circuit Judges Robert Luck, Gerald B. Tjoflat, and Elizabeth L. Branch.

In the lawsuit, Redding was represented by attorneys Brandon D. Henry, Adam S. Davis, and Karen L.E. Fritts from the law firm Wagstaff & Cartmell LLP. On the other hand, Coloplast was represented by Joseph H. Lang Jr. and David J. Walz of Carlton Fields PA, along with Val Leppert of King & Spalding LLP.

The case, officially known as Redding v. Coloplast Corp. (Case No. 22-13218), was heard in the U.S. Court of Appeals for the Eleventh Circuit.