A federal judge in Minnesota granted summary judgment to Coloplast in a lawsuit over the company’s transvaginal mesh.
Angela Dawn Cantrell received the Restorelle L mesh implant as part of surgery to correct vaginal prolapse in January 2018. Cantrell continued to experience pain and pelvic floor dysfunction after the surgery and underwent additional surgeries.
In 2020, Cantrell sued, advancing 11 claims against Coloplast, which moved for summary judgment and to exclude the opinions and testimony of Cantrell’s six expert witnesses. Cantrell opposed the motions but only contests the motion for summary judgment as to three of the 11 claims: negligent design, design defect and failure to warn.
Coloplast argued that the negligent design claim fails because of a lack of admissible specific causation evidence. The court excluded testimony of Cantrell’s two specific causation experts, meaning she can’t succeed on the claim as a matter of law. The court granted Coloplast summary judgment on that claim.
The company then argued that the design defect claim failed because, again, Cantrell did not provide admissible specific causation evidence. California law requires a plaintiff advancing product liability claims to prove that a defect in the product caused injury. The court found there was no admissible testimony supporting the claim that Restorelle L caused the injury, again granting Coloplast summary judgment.
Finally, Coloplast again contested that Cantrell had not supplied admissible specific causation evidence surrounding the failure to warn from the company. Due to the exclusion of testimonies from Cantrell’s experts, the court again granted Coloplast summary judgment.
Even if the testimonies hadn’t been excluded, the claim would have failed, the court ruled, as “a plaintiff asserting causes of action based on a failure to warn must prove not only that no warning was provided or the warning was inadequate, but also that the inadequacy or absence of the warning caused the plaintiff’s injury.”
Deposition testimony from Dr. Larry Bown, the surgeon who implanted Cantrell’s Restorelle L, stated that he did not recall reading the instructions for use for the Restorelle L. Because he did not review the instructions for use, Coloplast provided evidence that a different warning would not have changed the outcome and Cantrell provided no evidence to the contrary.
“Even if the court had not excluded the specific-causation testimony of [Cantrell’s experts], Coloplast would nonetheless be entitled to summary judgment as to Cantrell’s failure-to-warn claim,” the judgment reads.
The decision was handed down yesterday by U.S. District Judge Wilhelmina M. Wright.
Pelvic mesh has arguably proven to be one of medtech’s greatest failures in recent decades. The mesh products were meant to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs. In 2019, the FDA ordered Boston Scientific and Coloplast — the remaining companies selling the devices — to halt pelvic mesh distribution. At that point, there were already thousands of lawsuits and millions of dollars worth of settlements as women reported pain, excessive bleeding and loss of sexual function.
In 2020, the FDA released results of a study of 54,194 women in New York State that revealed that women treated with mesh had an 8.8% risk of reintervention 5 years after surgery, compared with 6.3% in the same size group of women treated differently for the same condition. Researchers concluded in the study of women implanted with transvaginal mesh to treat pelvic organ prolapse (POP) that the FDA should have banned the product sooner than it did.
Earlier this year, a California appeals court agreed that Johnson & Johnson must pay the state $302 million over misleading marketing around the risks of pelvic mesh products. The court reduced the size of the civil penalties against J&J’s Ethicon subsidiary by $42 million. The reasoning was that Ethicon couldn’t be fined over oral communications because there was no evidence of what its employees actually said in one-on-one communications with doctors.