Transvaginal Mesh Lawsuit Tossed on Appeal

Richmond, VAA transvaginal mesh lawsuit against mesh manufacturer Boston Scientific has been dismissed by an appellate panel, agreeing with a lower court’s ruling that plaintiff Martha Carlson could not adequately prove that Boston Scientific Corp. (Boston Scientific) failed to warn about the potential risks associated with their TVM product. The Fourth Circuit also concluded that Carlson did not adequately prove that she and her doctor didn’t know about the potential risks.

The mesh lawsuit, according to court records, has travelled a varied pathway since first launched directly into multidistrict litigation for transvaginal mesh complications before US District Judge Joseph R. Goodwin at federal court in West Virginia.

Initially, defendant Boston Scientific petitioned the Court to set aside Carlson’s failure to warn claim, which was granted by the Court.

But Carlson’s transvaginal mesh side effects lawsuit wasn’t dead, as the Court allowed claims of design defect and breach of warranty to move forward. Carlson’s case was then transferred to North Carolina and consolidated with a case being litigated by another plaintiff alleging similar claims.

That case, brought by plaintiff Romona Winebarger, eventually settled. That left Carlson’s case as somewhat of an orphan.

One month after the Winebarger mesh lawsuit settled, a federal jury in October 2015 found for Boston Scientific on Carlson’s claims for breach of warranty and design defect, finding that Carlson had failed to prove her claims. Carlson had previously asked the court to revisit the previous order made by the MDL court in West Virginia to set aside the plaintiff’s claim for failure to warn – but that motion was defeated.

Carlson appealed both the MDL court’s partial summary judgement award to Boston Scientific, together with the denial of her motion to the trial court to reconsider the MDL’s partial summary judgement order.

But she lost her appeal. “[Carlson] cited zero evidence establishing that either she or Dr. [Michael] Kennelly so much as read the allegedly inadequate warning in the [directions for use],” the panel said. “The portions of Dr. Kennelly’s testimony to which [Carlson] cited attempted to establish the inadequacy of the warnings in the [directions for use], but importantly, those portions did not indicate that if the [directions for use] included an adequate warning, Dr. Kennelly would have read it.”

US Circuit Judge Stephanie D. Thacker, who penned the unanimous decision for the Fourth Circuit, also dismissed the plaintiff’s argument that the MDL court abused its discretion in awarding a partial summary judgement to the defendant – in spite of the availability and presentation of additional excerpts from Dr. Kennelly’s deposition.

“The entirety of Dr. Kennelly’s deposition testimony was available well before summary judgment briefing and the additional portions of testimony [Carlson] provided to the district court for ‘reconsideration’ thus did not amount to the type of evidence constituting grounds for a valid motion for reconsideration,” the opinion said.

Transvaginal mesh is a treatment for Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP), a condition that often affects women in their middle years. Women who have borne children are particularly susceptible. Pelvic muscles weaken, and organs begin to sag and press against the uterus over time. TVM slings to support the abdomen and abdominal organs were originally fashioned from the patient’s own tissue and were sewn into place by way of invasive surgical procedures.

In later years, transvaginal mesh was developed and deployed as a sling through laparoscopy. The updated procedure results in reduced blood loss, faster healing times and reduced strain on hospitals and the health care industry.

However, TVM mesh has proven anything but helpful for scores of women, who allege transvaginal mesh complications including, but not limited to mesh which pierces and becomes entwined with internal organs. There have been cases where mesh has protruded through the vaginal wall – resulting in pain, suffering, mobility issues, infection, and loss of coital capacity with a partner.

Many a transvaginal mesh side effect lawsuit has come to the fore. In some cases, TVM mesh has become so involved with internal organs and other abdominal tissue, that it’s impossible to remove – sentencing the plaintiff to a lifetime of pain.

Plaintiff Martha Carlson received her TVM mesh in July, 2010 and soon began suffering from transvaginal mesh complications including, but not limited to pain, recurrent pelvic organ and bladder prolapse, incontinence, and urinary and bowel problems.

It is not known if Carlson will appeal her transvaginal mesh lawsuit to a higher court.

The transvaginal mesh side effects lawsuit is Martha Carlson v. Boston Scientific Corp., Case No. 15-2440, in the US Court of Appeals for the Fourth Circuit.