Ms. Budke, age 77, died in August 2009. The official cause of death was a pulmonary mass, with a secondary cause - pelvic mesh infection.
Her daughters, and husband Donald, are sitting in the Camden Co. courtroom. Joan and Donald lived in nearby Osage Beach, Missouri. Gynecologist and implanting physician, Dr. Becky Simpson is being sued by the family for medical malpractice. And the family is suing Ethicon, a division of Johnson & Johnson over its pelvic mesh, the Prolift System, claiming it's defective.
The third day of the Budke v. Ethicon trial showed how the late woman suffered before she died from numerous infections.
The plaintiffs in this product liability/ medical malpractice trial blame the implantation of Prolift, large polypropylene mesh used to treat incontinence, as the start of a series of infections that could not be controlled. Ms. Budke also had a transvaginal sling mesh, the TVT-Secur, put in at the same time to treat incontinence.
This case puts Dr. Simpson between a rock and a hard place - Does she blame the company for not informing her about problems it knew existed with the Prolift? Does she still defend her use of the Prolift? If so, did she make a mistake?
So far in these trials, the plaintiffs have argued that mesh makers failed to inform doctors and they are not at fault. This is one of the few cases that blames the physician too.
As we’ve seen in this trial, a French team of doctors, the TVM group, had been working on innovating the Prolift for years, complete with its stainless steel implanting hooks and pre-cut mesh.
But Dr. Simpson had never been told that a June 27, 2006 final study report for the French TVM team found a failure rate of Prolift in excess of 20%.
Simpson also didn’t realize the Prolift was recommended for stage 3 or 4 prolapse. Ms. Budke had stage one or two.
Dr. Simpson didn’t know that behind the scenes, the French doctors wanted to replace the Prolift polypropylene mesh with one that was slightly absorbable and had wider pores, the UltraPro. It allowed for easier integration with the body and less formation of scar plate and foreign body reaction which causes mesh to contract and encapsulate nerves.
Slater was friendly and light in his questioning of Simpson. He offered her a water.
Slater – “Fair to say you are not aware when you are being trained, the doctors who created the Prolift were all over the medical director because they wanted a new mesh and other changes to the Prolift as soon as possible, is that fair?”
Simpson – “That’s fair."
Slater –“Would you want to know more about this if you knew?”
Simpson – “Absolutely.”
Dr. Simpson’s Trainer - The $1.7 Million Dollar Preceptor
Dr. Simpson was trained on implanting the Prolift in October 2006 by Dr. Vincent Lucente, a long-time preceptor or trainer for Ethicon.
In this day three of trial, Slater pointed out to the jury how Dr. Lucente collected $1,709,000 in compensation for his work for the company over a dozen years for training and recruiting other doctors to use the Prolift and other Ethicon products, a role known as a "preceptor."
Dr. Simpson was not told that Dr. Lucente was favoring a new mesh made by Ethicon, the UltraPro, that would eventually replace the Prolift Gynemesh PS, in the latest generation of Prolift, Prolift +M. Slater showed Dr. Simpson inside company documents quoting doctor’s reactions to the UltraPro, including Dr. Lucente was quoted as saying, “This one and throw the rest out, this feels like a piece of vaginal wall.”
A glossy brochure given to doctors said the Prolift mesh did not potentiate infection (increase the power, effect or likelihood), but medical literature at the time cited by Ethicon told a different story. A literature citation in the Ethicon brochure said, “The ideal synthetic mesh material for pelvic surgery, one that induced minimal foreign body reaction has yet to be developed,” wrote Dr. Cheryl Iglesia.
Dr. Simpson, a busy gynecologist, like most doctors, relied on the promises of a company and didn’t read all of the literature.
Slater – “If you knew all the things you now learned about the Prolift that you didn’t know April 2008, is it fair to say you would not have used a Prolift on Ms. Budke?”
Simpson – “If I had the same information…..if it was taught in that training class, no.”
Dr. Simpson looked sad when she described Joan Budke. Budke was 76 at the time of her implant, she volunteered at the hospital, always had a smile. She was kind. Her daughter looks like her. Dr. Simpson called her "a nice patient."
Dr. Simpson put in an anterior Prolift System April 28, 2008 to treat a cytocele or prolapsed bladder that caused her to have urine leakage. At the same time, she also put in a TVT, transvaginal tape, a smaller piece of mesh under the bladder. Raising the bladder and the urethra that empties the bladder at the same time just made sense.
Soon after the implants, Dr. Simpson found mesh had exposed in the vagina. The incision line cut in the vagina had never fully closed over. Dr. Simpson prescribed vaginal cream. Otherwise, Joan Budke felt good and called the doctor's office to see if she could resume exercising.
Joan continued to have occasional spotting and by January 2009, she went back to Dr. Simpson – she just didn’t feel well. She was voiding every 45 minutes at night. She wasn’t sleeping. She had a tender low mid-abdomen. Dr. Simpson ordered an ultrasound.
The ultrasound revealed a bright, white area – probably mesh the doctor documented. “Anatomically it was in the same location I knew I had placed the mesh and the density of the mesh doesn’t translate the sound waves the rest of the tissue does,” said Simpson on the stand.
The ultrasound did not show the cause of the post-menopausal spotting. Ms. Budke was treated for a bladder infection. Her ovaries were hard to find. The fear was she might have cancer.
January 20, 2009, still unable to urinate, Ms. Budke went to the emergency room. On January 21, she received a foley catheter to allow her to urinate and get some rest. A CT scan revealed a collection of air in the lower part of the uterus, an indication of an abscess or infection. Her bladder was very swollen and puffy and the opening to the ureters was very small. An inflammatory mass was impinging on the ureters, the tubes that run from the kidney to the bladder. A fellow surgeon was unable to put in a stent to open up the blockage.
Dr. Simpson's diagnosis – vaginitis with secondary, probably infected subvaginal mesh.
Slater – “You thought the mesh had become infected?”
Simpson – “Correct.”
Dr. Simpson removed the mesh in the top part of the vaginal wall, essentially the center of the Prolift System, leaving behind its many arms anchored into the pelvis. Removal of the Prolift is one of the most difficult procedures. Most expert mesh removal doctors in the U.S. will not even try.
Necrotic or dead tissue was removed. A second trip to the hospital had her on IV antibiotics and pain medicine. She was discharged home but presented with a right flank kidney region pain. A Versijet was used to clean out the area, like a dental water pic, said Dr. Simpson. Because pressure on the kidneys for any time is dangerous, Ms. Budke was transferred to Missouri Baptist Hospital. She was released in February 2009. After that time, Ms. Budke sought treatment in three cities and five hospitals from dozens of other doctors.
Slater – “Shortly after that you stopped using the Prolift correct?”
Simpson – “I don’t know the time frame. I went from Prolift to a different generation.” (Note- Dr. Simpson said she started using the next generation of Prolift, Prolift M+ made with UltraPro, a larger pore partially absorbable mesh.)
Slater – “You didn’t use the Prolift anymore?”
David Ball an attorney for Ethicon objected.
Judge Hass sustained the objection. Dr. Simpson didn’t have to answer.
Joan Budke’s health went downhill and she eventually died August 5, 2009, sixteen months after her implant.
Under cross examination, attorney David Ball had to undo the damage done by the Slater questioning. Even though it is late in the afternoon, the jury appears awake and attentive.
Mr. Ball established that Dr. Simpson has performed about 100 Prolift surgeries and 100 TVT (transvaginal tape) surgeries to correct incontinence.She was a board certified gynecologist.
He suggested the surgeries kept the bladder where it was supposed to be for eight months, a rather confusing question considering the outcome. “As far as you were concerned it was a good result," asked Mr. Ball.
Dr. Simpson answered yes.
Mr. Ball asked, “You don’t base medical decision on emails and internal company documents do you?”
No, said Dr. Simpson.
You don’t know if Mr. Slater cherry picked emails he presented to you do you? No, said Dr. Simpson.
You don’t know if he took them out of context do you? No, she said.
Mr. Ball asked in a leading manner, “And so you can’t as you are sitting here today, based on what he said, you can’t reach a final professional medical judgment whether it was accurate and in context and the whole story. You cannot reach a conclusion as to whether you would have done something differently or not, true?”
True, agreed Dr. Simpson.
Monday a number of lawyers will be absent from the courtroom. The must depose the doctor who signed off on the Budke death certificate to make it official.
It reportedly says the cause of her death was a pulmonary mass with a secondary pelvic mesh infection. Even though it is in writing and official, the defense wants it authenticated with testimony on videotape. No doubt the plaintiffs will deliver just that. #