Mesh Medical Device News Desk, May 10, 2017 ~ An appellate court on Tuesday affirmed a lower court decision in the pelvic mesh lawsuit of Martha Carlson.
It too rejected her failure to warn claim, citing she didn’t prove that Boston Scientific failed to provide an adequate warning about the potential risks of the Uphold mesh.
Martha Carlson lost her pelvic mesh lawsuit in October, 2015, before a Statesville, North Carolina jury. (No. Ramona Winebarger et al v. Boston Scientific 5:15-cv-00057-RLV-DCK)
In 2010, Ms. Carlson, 65, was implanted with the Uphold Vaginal Support System, a mesh to treat pelvic organ prolapse (POP), and began having complications such as recurrent pelvic organ prolapse, pain, incontinence, dyspareunia, urinary and bowel problems.
She alleged neither she or her doctor received adequate warnings.
Carlson’s case was initially filed in the MDL in Charleston, WV. before Judge Joseph Goodwin. Her attorney’s alleged a defective design, breach of warranty and a failure to warn.
In the early stages, lawyers for Boston Scientific were successful in throwing out her failure to warn claim in summary judgment. They alleged she did not present evidence that any inadequate warnings caused her injuries.
Here is a Mesh News Desk story on the Carlson trial.
On Tuesday, May 9, the Fourth Circuit Court of Appeals, based in Los Angeles, affirmed the lower court decision. Read it here.
FAILURE TO WARN
Carlson’s physician, Dr. Michael Kennelly, when deposed, said any warnings from Boston Scientific were inadequate. Ms. Carlson also testified if she had known that the mesh “Could result in life changing conditions, [she] would not have agreed to the procedure.”
Lawyers for Boston Scientific argued that Dr. Kennelly did not read or rely on the Directions for Use, which accompany the mesh, therefore did not rely on allegedly inadequate warnings.
That’s when the Goodwin court awarded summary judgment to BSC.
The case was then transferred to a Raleigh, North Carolina district court for trial on the claims of defective product. That court too would not consider a failure to warn claim even though plaintiffs’ counsel provided additional excerpts from the implanting doctor’s deposition that he did read the Directions for Use.
Under North Carolina law, under a failure to warn claim, the plaintiff must prove the defendant unreasonably failed to provide an adequate warning and that failure to warn was the proximate cause of her damages. Also, the product must pose a substantial risk of harm without an adequate warning when it is sold.
Plaintiffs’ counsel provided additional evidence of a failure to warn, but that was considered too little too late.
“Appellant woefully failed to meet her burden of production in opposition to summary judgment to establish a triable issue of fact as to the proximate cause,” wrote the Fourth Circuit.
According to her trial brief, the polypropylene used to make the Uphold is “impure, non-medical-grade” known as Marlex that “shrinks, hardens, bunches and degrades,” in the body. The weave is so small that bacteria is entrapped and so are nerves, resulting in pelvic pain.
After a partial removal attempt, Ms. Carlson says the mesh broke apart into small pieces.
Marlex resin is issued by Chevron Phillips. Its Material Safety Data Sheet says it is not to be used in implantable medical devices that come in contact with internal bodily fluids or tissues.
See the Martha Carlson Trial Brief.
Carlson lost on the remaining claim of a defective product at trial. She was represented by William Louis Hurlock of Mueller Law of of Austin, Texas. BSC was represented by Shook Hardy & Bacon.
Her lawyers immediately filed an appeal that went to the Fourth Circuit to try and reinstate the failure to warn claim and to approve the motion to reconsider. Ultimately that court affirmed the lower court’s decision, denying a motion to reconsider, despite Ms. Carlson’s citation to addition excerpts of her doctor’s deposition.