Day Four: Doctors and Patients in Boston Scientific Pinnacle Mesh Trial
Two of the four female plaintiffs who’ve filed defective product cases against mesh maker Boston Scientific (BSC) appeared on the stand in this fourth day in a Miami federal courtroom.
It will be up to the 9 person jury to decide, by the preponderance of the evidence, whether the Pinnacle Pelvic Floor Repair mesh kit, made by BSC, was defectively designed and whether the company failed to warn doctors through the product directions for use (DFU).
The women claim negligence, defective product, a failure to warn, a breach of express and implied warranty and fraudulent concealment. They are seeking punitive damages. The jury of five men and four women appeared to be alert for Thursday’s testimony.
Plaintiff AE appeared on the stand in the morning. Married and the mother of seven children she is an ultrasound technologist. In February of 2008 she had a Pinnacle Mesh kit repair done at Good Samaritan Hospital in West Palm, Florida by Dr. William Porter.
AE complained of vaginal loosening and she experienced prolapsing organs, a cystocele and rectocele, as a result. AE told the court she never had incontinence until after the Pinnacle was placed. What followed for her and her husband was dyspareunia (painful sex) which she says harmed her relationship. She experienced a heaviness in her bowel, pain and loss of sensation in her pelvis.
On one trip to visit her husband in Egypt, something she called a “tough trip,” she had a bout of incontinence on the plane. “It was embarrassing,” she said. In August 2012 she had a removal surgery which was followed by four to six weeks of a painful recovery.
The pain is gone but she still has a feeling of pressure and has lost sensation in her vaginal area.
On cross examination Molly Craig asked whether the doctors suggested having seven children might have contributed to poor vaginal tone. Yes, the witness answered.
Craig charged that in 2008 AE saw symptoms similar to her on the internet and concluded her problems were associated with mesh.
“May we approach” said plaintiffs’ counsel, Jim Perdue as that line of questioning stopped.
Dr. Vladimir Iakovlov
A lean looking scientist entered the courtroom around this time. One could surmise he was a scientist because he was carrying a bulky microscope.
On the stand, witness Dr. Vladimir Iakovlov introduced himself as the Director of Cytotechnology at St. Michael’s Hospital in Toronto. The anatomic pathologist looks at biomarkers and conducts pathological evaluations of explanted transvaginal mesh, among other materials.
Dr. Iakovlov looked at the medical records of AE and confirmed she had suffered mesh erosion in the anterior and posterior positions. Her mesh had been removed and was preserved.
Judge Goodwin asked the Russian-born scientist to speak slowly so the transcriber would not miss scientific jargon delivered with a heavy accent.
On a large demonstration board set up before the jury, oversized images of explanted mesh were displayed. Resembling a huge piece of fried chicken breast, Dr. Iakovlov explained the mesh had stiffened like a piece of plastic. The Pinnacle arms were rolled into a cord or rope-like structure and were no longer flat. One arm remained behind in her body. The second photo showed fragments of stiffened and hardened mesh removed in jagged irregular pieces. It was also devoid of any flat surfaces.
The jurors leaned in to more closely observe the pink stained images dotted with specs of blue and sparkling white lights, highlighted through polarization. The pathologist explained the foreign body response, incited by the presence of mesh, causes inflammation. What results is scar tissue that encapsulates the mesh as the body tries to distance itself from the invader. See a study he authored in 2013: Mesh is Not Inert.
Nerve entrapment is long associated with pain. Arteries can be obliterated next to the mesh. In this slide, mesh had migrated into the bladder and the bladder wall.
“In my opinion to a reasonable degree of medical certainty, mesh had degraded, scars encapsulated and caused erosion in AE,” he concluded.
To rebut the witness, the attorney for Boston Scientific asked Dr. Iakovlov whether his polarization technique was widespread and accepted? For example had the other pathologist, who looked at the mesh the day it was explanted in 2012, used such techniques?
“No he didn’t take sections” said the doctor explaining his slices of the mesh were like a salami slice. “If you have unusual findings, you take sections,” he said.
Attempting to raise questions about his credentials, the Russian-trained doctor said in his country one enters medical school right out of high school. He has been hired by plaintiff lawyers and has done five or six depositions.
Dr. Iakovlov also concludes hernia mesh reacts the same way pelvic mesh reacts.
The testimony of plaintiff JB took place in the afternoon. As a Cuban woman in her 60’s Juana came to Miami in 1992 and speaks Spanish. A translator had to convey every sentence to her slowing down the pace of testimony.
In her native country, JB had suture surgery to correct a prolapse and rectocele. She had no problems with it until many years later when she again she had prolapsing organs protruding through her vagina.
JB said she thought the Miami surgeon, also a Spanish speaker, would approach her repair the same way even though he explained it was a mesh.
In June 2010 she received a Pinnacle implant, the largest of all mesh kits, to hold back her prolapse. Another surgery followed in 2012 to address the pain and discomfort, inflammation, pain upon urination and a return of incontinence but that partial removal failed to resolve the stabbing pains, discomfort and pain in her leg and lower abdomen. She told the jury she is looking at another procedure as her symptoms remain.
“What can you no longer do you would like to do?” asked attorney Jim Perdue.
Some days are harder than others, she said. “I always have discomfort,” she said and added she can no longer play with her granddaughter. “My life is no longer the same. I can’t work much,” she said. Talk of her children and grandchildren brought forth the first tears the courtroom has seen from any of the four plaintiffs.
At that point, one of the jurors, a young Hispanic-appearing male in the back row, also appeared to be crying. His eyes were red and his head stayed on the monitor before him.
To show the other side, on cross-exam, Hildy Sastre of Shook Hardy asked JB if she felt pain and difficulty with urination before her Pinnacle implant. The Spanish translation made it difficult to pin down the plaintiff. With her surgery scheduled in Miami for June 2010, she had three months to discuss the risks of a pelvic mesh surgery with the surgeon, yet she hadn’t. She signed an informed consent in 2008 and that document was shown to the jury.
Sastre presented medical reports following surgery that showed JB had no complaints of pelvic pain. That left was confusion about medical records and whether they can always be trusted. Did your doctor use a computer Jim Perdue asked on re-direct.
Objection Judge, not in evidence, said the defense.
Judge Goodwin cleared up the confusion. “He (Perdue) is suggesting that doctors make mistakes.” Bring the doctors in here to refute the doctor records, said Judge Goodwin, trying to move things along.
Almost on cue, the two treating doctors for JB appeared to the jury via videotape. Dr. Gomez-Pedrazo the implanting physician said if he had known complications were “not rare” with the Pinnacle he would have changed his use of the product. Today he uses sacral suspension to treat prolapse. And explant physician, Dr Pando said JB had mesh erosion that creates chronic inflammation one symptom of which is pain.
“Is there anything in her past medical history that would cause pelvic pain and dyspareunia”
“No nothing other than the placement of mesh,” said Dr. Pando. He added that “I won’t be able to fix it. I don’t think a second surgery is going to help.” #