July 10, 2013~ Saying it was the first time in his 20 years on the bench he had declared a mistrial, federal Judge Joseph R. Goodwin ended the first federal trial involving one of six transvaginal mesh manufacturers, C.R. Bard, after just two days of testimony.
More than 25,000 cases have been consolidated in the Charleston, West Virginia federal courtroom. This was the first case to go to trial.
The problem was contained in a statement made by Dr. Lennox Hoyte, who took the stand this morning.
Days ago, Judge Goodwin ruled that any mention of the Food and Drug Administration (FDA) and 510(k), the fast-track approval process that allows mesh on the market, should be excluded from trial.
Dr. Hoyte opened that door by a statement he made just before the lunch break.
A Harvard educated professor of female pelvic medicine at the University of South Florida in Tampa, Dr. Hoyte had nothing good to say about the Bard Avaulta Plus posterior mesh that had been implanted in plaintiff Donna Cisson, 55, in 2009.
Dr. Hoyte said he now removes mesh at least twice a week and has explanted about 400 meshes made by various manufacturers which is implanted in women to shore up pelvic organs. How many were Bard Avaulta, he was asked. About one-quarter, or 100 mesh removals, he answered.
Mesh Problems Continue
Women continue to have complaints with the Avaulta long after the mesh is removed because the arms are firmly implanted in the levator ani muscles, which provide support for the pelvic floor and aids in urination and defecation, Dr. Hoyte said. The mesh will shrink and cause the muscles to spasm and the bare mesh arms serve as a saw cutting the pelvic floor muscles, he said, causing a woman’s ongoing pain, long after the center portion of the mesh is removed. Dr. Hoyte testified he felt it was too dangerous to retrieve the mesh arms used to anchor the mesh in place because how deeply they are placed.
“The Avaulta Plus posterior is the Avaulta Solo with porcine collagen. The thought is it would decrease the risk of erosion. That’s not how it turned out,” he told the 8 jurors of 5 women and three men.
Clean Contaminated Field
Another complication with transvaginal mesh (TVM) is its passage through the highly acidic vaginal area where incisions are cut and steel tools are used to pull the plastic mesh into the pelvic region.
“Passage of the TVM through the vagina creates the set-up for erosion and failure,” he told the jury. “The vagina is a clean contaminated field that can never be sterilized. If infection is introduced during the passage, there will be erosion of the mesh.”
Almost professorial, Dr. Hoyte stood before the jurors and illustrated a 3-D version of mesh like the one that had been implanted in Donna Cisson. Although he had never examined Ms. Cisson, he had reviewed the medical records of her two doctors, Dr. Bryan Raybon, who took the stand yesterday (see back story here), and Dr. John Miklos, her implant and explant surgeons. Both were competent, Dr. Hoyte testified; it was the mesh itself that caused her ongoing pain.
“The blind passage of trocars through the area with important blood vessels and muscles, the side-to-side attachment, puncture of the levator ani area and mesh shrinkage affects normal sexual functioning and pain,” he said.
During an examination by attorney Paul Ferrell, a plaintiff attorney from Huntington, West Virginia, Hoyte was asked if the instructions for use (IFU) or warning label that accompanied the product were accurate. Bard has contended that Ms. Cisson and her doctor both understood complications. (Editor note*- back and forth added below from my notes for further clarity).
Ferrell: “The instruction read, “Potential adverse reports, are those associated with any permanently implanted materials.”
Hoyte: “No because the vagina is not a sterile environment, it’s a clean contaminated, you can’t keep it clean like hernia mesh.”
Ferrell: “When did you think it was a bad idea?”
Hoyte: “When I was informed by the Bard company representative.”
Ferrell: “What made you think it was a bad idea?”
Hoyte: “Blind trocar- based passage through a clean contaminated environment prone to infection with side-to-side anchoring that can shrink. I take a lot out, nobody is implanting it anymore. No one sells it anymore.”
Ferrell: “To your knowledge, is anyone in the U.S. still implanting mesh with arms?”
Hoyte: “No [objection- overruled] It’s not for sale in the U.S. It was withdrawn.”
Ferrell continued to ask why polypropylene mesh does not have the same complications as polypropylene sutures. Dr. Hoyte explained the sheer volume in the Avaulta mesh overwhelms the amount of mesh you might find in a suture. [Editors add* – It has been said by doctors “the more mesh, the more mess.”]
Ferrell asked the doctor if he believes the Avaulta Plus Posterior is reasonably safe for its intended use?
“The answer is no!” the doctor said quite emphatically.
Defense attorney Lori Cohen objected. The jury was ushered out of the room.
Cohen told the courtroom that she had, upon the judge’s instructions, removed from her opening statement anything about the FDA and the 510(k) approval process that allowed mesh on the market with no safety and efficacy studies. That also meant there would be no mention of the post approval 522 studies ordered by the FDA to follow women for three years to gauge mesh complications.
Two years ago, after the FDA discovered that mesh complications had increased five-fold with no explanation, it ordered 33 mesh manufacturers to go back and conduct three years of monitoring the health of women who had been implanted. The FDA has the authority to issue post-approval monitoring of a medical device under a 522 order.
By June 2012, C.R. Bard, as well as Ethicon, a division of Johnson & Johnson, had voluntarily removed their mesh kits from the market, allegedly for financial reasons. The move, however, also relieved them of having to conduct the post-approval monitoring studies ordered by the FDA. See the back story here and here.
Cohen told the judge she would have trouble telling the jury why Bard had removed its Avaulta line of meshes from the market without going into the FDA’s order.
“It is intertwined. It raised the whole 510(k) issue. Because it’s been opened, that’s grounds for a mistrial,” she told the judge.
“I’ll think about it,” Judge Goodwin said dismissing everyone for lunch.
By 2 pm the jury was not back and neither was the judge. Shortly afterword, Judge Goodwin returned and said about the utterance, “I don’ think its a bell that can be unrung,” and that the spontaneous statement would not withstand an appeal in the 4th Circuit Court.
“Ive never declared a mistrial in my 20 years on the bench, but it would be very difficult for a jury to ignore it and a discussion of the FDA would confuse the jury. I’m declaring a mistrial.”
The Donna Cisson v. C.R. Bard case was rescheduled to start July 29.
Plaintiff attorney Henry Garrard gave a bear hug to Donna and her husband, Dan. “Its gonna be okay, it’s gonna be okay,” he assured them.
Lori Cohen told MDND, “I’m disappointed what the plaintiff’s witness blurted out and forced us to move for a mistrial. I look forward to the next trial.” #