She was calm, personable and very knowledgeable. Dr. Anne Weber appeared on the stand this morning in Day Four of the Butke v. Ethicon (Johnson & Johnson) defective product trial. The family claims the Prolift system pelvic mesh implant in Joan Budke led to her deaths sixteen months later from massive infections caused and encouraged by the polypropylene mesh.
The case is being heard in the Camden Co. near Lake of the Ozarks, Mo. where she was a resident. It was brought by her husband Donald and the three adult Budke children. Two daughters were in the courtroom.
Dr. Weber brings enormous credibility to these proceedings. She did a residency in obstetrics and gynecology and was an advanced surgical resident at the Cleveland Clinic. Dr. Weber was one of the originators of the specialty of urogynecology, working and training others at the Cleveland Clinic. There students, residents and fellows trained in the specialty that would become urogynecology after a four year residency in Ob/gyn.
Eventually at the National Institute of Health she would direct funding and studies in the specialty field of women’s health – pelvic floor disorders which included prolapse and incontinence. She helped form the Pelvic Floor Disorders Network as program director. That became a collection of eight institutions around the country doing data analysis.
Dr. Weber didn’t stop there.
“I realized the research training I had to that point was not sufficient so I attended the University of Michigan at the School of Public Health to receive a masters degree in clinical research design and statistical analysis.” What is that? Basically, it’s clinical research designed to determine how you set up and perform studies so you can answer the question you set out to answer. First you set up a question you want to identify, pick the patient population, determine what kind of questions will you ask, analyze and condense and summarize into a report to ideally answer the question you started out with.
She has published abut 100 peer reviewed articles on the topic of pelvic floor disorders.
Predicting a defense question in advance, plaintiffs’ attorney Adam Slater asked her how many hours Dr. Weber had spent on this case. Many hours had brought her about $88,000 in compensation.
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Remember the ACOG Practice Bulletin? Earlier we reported on the use of the word “experimental” in describing mesh to do pelvic surgery.
It was Dr. Weber who authored that bulletin with the focus of protecting women and letting the end user doctors understand mesh repair was not a firmly accepted practice yet. She started talking about one of the reviewers noticing the word “experimental”… objection said the defense team, one of perhaps two dozen objections we would hear this day.
We know from past testimony that was Dr. Vincent Lucente (see last week’s testimony) who eventually had the word ‘experimental’ removed from the bulletin that doctors would read. That would encourage more use by doctors who would have fewer concerns about liability, and give the green light to insurance coverage.
But the objection meant that Adam Slater, the attorney for the Butke family, couldn’t continue.
$88,000 Consulting Fee
Knowing the other side would ask, Slater established that Anne Weber has been paid about $88,000 for the 240 hours she has put in to researching and reading to prepare her expert testimony for this case. Those questions are always asked of both side’s expert witnesses.
Slater asked her what was an available treatment to treat a mild case of incontinence.
Various options, said Dr. Weber – first, you could do nothing; then you could use a pessary; do a suture repair (Colporrhaphy) or a biologic or synthetic graft augmented repair. Lastly, you could use a mesh kit like the Prolift.
All of those traditional repairs would be reasonable considering her condition, said Dr. Weber, besides the Prolift was intended for a stage 3 or 4 prolapse, while Ms. Budke had stage one or two. Yes, prolapse might reoccur with a traditional repair, but one has to consider how the woman is feeling, in other words, her quality of life. And more often than not, an older patient with mild prolapse frequently did not see it return. Reoccurrence more often happened among younger patients.
Meanwhile, documents shown to the jury indicated industry-generated data showed a high rate of failure using a traditional repair, therefore the reason for pushing the Prolift.
Dr. Weber said, “In my opinion it was unnecessary.”
During one of the many objections this day, your editor was asked by defense attorney Bettina Strauss of St. Louis, “Is there no power on that side?” indicating I shouldn’t be sitting so close to the defense side, near the screen and on their half of the courtroom but also near the only power strip. She asked with a smile, but I don’t think she was kidding.
Go to the Videotape
The plaintiffs then showed an Ethicon-created animation of a prolapse procedure as well as an actual videotape of surgery. The defense objects again which ends in a sidebar. The jury leaves the courtroom.
The screen shows the roping of the arms in the animation as the cannula leaves the body. Judge Hass almost always granted a defense objection.
Slater argued, “The video shows roping in real life we are being severely prejudiced and we should have the right to put it in front of the jury. They don’t want the jury to see what they sold.”
After stipulated that Dr. Weber had never seen this procedure in person and had never performed a Prolift surgery, they continued. Dr. Weber is very professorial and comfortable explaining to the 15-person jury who seem engaged.
She shows the space where the Prolift mesh is going to be implanted between the front of the vagina (anterior) and the bladder.
About the Prolift implant she said, “The involvement of the hip and the groin would never be involved in a typical repair. In the Prolift, a whole new area is involved that has nothing to do with the prolapse.”
While a company animation showed the mesh arms laying flat, in real life they curled through the cannula, said Dr. Weber, making impossibly small the pore size of the arms in the process.
The Gynemesh PS study
Ethicon had sponsored a study to see what happens when Gynemesh PS is implanted abdominally or through the vagina. It was conducted to encourage doctors to be mesh users. In preparation for her expert testimony, Dr. Weber took the time to revisit the study protocol, study collection forms, raw data and information that had been transcribed from a medical chart.
Her results showed a drastic difference from what Ethicon reported to a scientific committee.
*1 year mesh exposure, same as erosion – Ethicon reported 9.4%
Actual – 15.4% erosion
“That’s a very high rate,” said Dr. Weber.
1 year prolapse recurrence rate 24% Actual – 33.8%
1 yr vaginal surgery prolapse recurrence rate (not reported) Actual -27.3%
Not only that, but doctor consultants working for Ethicon – Dr. Lucente, Dr. Miles Murphy and Dr. Dennis Miller, reported different results at different medical societies, said Dr. Weber.
At the same time the plaintiff side showed a document of another mesh being studied with favorable results.
Of the UltraPro (UP) the LIGHTning Human Cadaver Wet Lab participants said:
*Preferred Ultrapro over Gynemesh PS
*Better handling of UP with Prolift instruments
*Feels very soft in place
*No crumpling of the arms
Ethicon knew there was a better mesh. The document is dated September 6, 2006, 17 months before Ms. Budke received her implant.
Referring to the French inventors of the Prolift TVM group, Dr. Weber said they were not comfortable with having the Prolift used in widespread clinical practice. They felt the erosion rate was too high. “They felt it needed to be under 5% and they were not even close to that.”
Ethicon relied on the expertise of Charlotte Owens, a medical doctor just four years out of her residency.
Slater- Was it Owens who signed off on Prolift?
Objection – no foundation.
Slater – Have all of the witnesses in the case expressed whether the medical affairs director had to sign off?
Jones objects again jumping up from a half standing position.
Sustained, said Judge Hass, again.
Slater tries again – Do you have an opinion whether Ethicon should have been selling Gynemesh?
Another sidebar marked around 20 this day. Still the jury was attentive.
Slater tries again.
“Do you have an opinion whether medical affairs knew?
“Ethicon was knowledgeable medical affairs was about the complications. Yes. Is that the basis deposition testimony and internal documents from the company? Yes.
What happened to Joan Budke?
What happened to Joan Budke followed her mesh implant? A series of events, said Dr. Weber.
First, she experienced mesh contraction and mesh eroded through the vaginal wall. The vaginal implant naturally picks up bacteria and eventually the infection formed an abscess. The mass was so large it blocked off her ureters, the tubes that run from the kidney to the bladder. With the blockage, she developed acute kidney failure.
In the chronic phase, the white blood cells are fighting the foreign body, there is ongoing cell death and tissue damage. Dr. Weber described a “cascade of events ” – infections, erosions, extrusions, mesh shrinkage, vaginal granulation tissue, sinus formation abscess, fistulas or osteomyelitis (an infection in a bone).
“It’s my opinion she suffered all of these complications,” Dr. Anne Weber.
Ms. Budke lost more than 30 pounds. A foley catheter at one point was implanted to help her urinate. A fistula had developed between her bladder and vagina causing urine to escape that route. Her body began wasting away as she was bed bound. One month before her death in August 2009, doctors considered permanently removing her bladder because it was too destroyed to repair, but Ms. was determined to be too weak to withstand the surgery.
Dr. Weber told the jurors the downhill spiral cannot be reversed unless the mesh is removed, but with a Prolift mesh kit and its many arms, it’s nearly impossible to do so. The mesh was intended to become integrated with the tissue making removal difficult if not possible to remove.
“That’s a design defect.”
At this point the family appears to be crying. The two daughters have their heads down. At least one juror appeared to be tearing up.
“The Prolift was so defectively designed and so unsafe it should never have been on the market” said Dr. Anne Weber.
Defective design is the key to this product liability case as is a failure to warn doctors.
Dr. Simpson, the implanting physician, is also facing medical malpractice in this trial. She will return to the stand Wednesday. #