Day six of Husky v. Ethicon had the defense putting forth its best case.
After Dr. Thames, the polypropylene expert, was dismissed from the morning session it was time for the taped deposition of Dr. Aaron Kirkemo, MD, a urologist and assistant Medical Director for Ethicon, a division of Johnson & Johnson. Dr. Kirkemo had a urology practice with about 60 percent female patients until he was recruited by J&J to join the ranks of the healthcare giant where he worked from August of 2008 to July 2012.
Dr. Kirkemo is now the Medical Director at Urology and Women's Health for Boston Scientific, see his LinkedIn here.
Ulf Ulmsten, founder of TVT
The first perk came as an all-expense paid trip to Sweden to visit with Dr. Ulf Ulmsten the inventor of the TVT (transvaginal tape) who eventually sold his patent to J&J for $25 million, as has been revealed in the Lewis trial, the first trial naming J&J in this court. Kirkemo learned the TVT method directly from Dr. Ulmsten which he described as an "epiphany" moment.
Dr Ulmsted had figured out that putting a sling in the middle of the urethra (mid-urethral) was more effective than at the neck of the bladder. He innovated the TVT which was launched in 1997 in Europe and in 1998 in the U.S.
The TVT-O, the type implanted in plaintiff Jo Husky, was invented in France and brought to the U.S. in 2002.
Under direct examination on videotape it was established that Dr. Kirkemo had been a favorite spokesmen and consultant to a number of medical device companies where he received honorariums to speak, including - AdvaMed, Sheraton Laboratories, AMS (American Medical Systems), Beecham, Merck, Eli Lilly, Glaxo, Pharmacia, Upjohn - Yes, he said to all.
Dr. Kirkemo was even an early adaptor of the ProteGen, a Boston Scientific mesh sling that was taken off the market in 1999 for being defective. As stated in the FDA's enforcement report of March 17, 1999, "Use of ProteGen in the treatment of female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended." See background story here.
Ethicon had failed to warn about dyspareunia (painful sex) or pelvic pain in its instruction for use (IFU), one element of a defective product claim. Dr. Kirkemo was asked why not warn about dyspareunia to surgeons, the end users?
"I don't think I've ever seen a patient have dyspareunia from a retropublic sling," he testified under oath.
Later he added "dyapareunia is part of all surgical procedures."
He was asked if he remembered a meeting with Dr. Meng Chen. Dr. Chen was an Ethicon employee responsible for the daily reports coming in from women who felt they were injured by the defective products. Painful sex and chronic pain, chronic infections were among the many complaints coming into her New Jersey office. Dr. Chen asked for a meeting of her superiors to suggest expanding the IFU to include the real-life complaints she was hearing.
Dr. Kirkemo said he didn't recall the conversation or the meeting.
The plaintiff presented documents that Dr. Kirkemo was on record as hating the TVT-O. Under questioning he blamed that on the difficulty of the operation and the fact that women had to be in an extremely flexed position to have the device implanted.
"Patients with arthritis did not like it they woke up with hip pain," he said.
MESH DOES NOT ERODE
The plaintiffs contend that polypropylene mesh erodes in the human body as well as shrinks and contracts, leaving the patient in chronic pain. Does mesh erode? It does not, said the doctor and when facing evidence presented from Professor Klosterhalfen, who had worked for Ethicon trying to develop a better mesh. Dr. Klosterhalfen was an Ethicon consultant who was introduced during the Lewis case.
Dr. Bernd Kloserhalfen
From the Lewis case: The TVT mesh is the worst, said Dr. Klosterhalfen as he referred to images that showed enlarged microscopic images of cracking and degrading mesh. As the mesh degrades in the body small particles of polypropylene have been found in a woman’s vagina causing irritation and infection as the body tries to rid itself of the foreign invader. Nerves coming into contact with this mesh mess create the chronic pain seen in many women suffering transvaginal mesh complications.
Klosterhalfen is on record as saying mesh erodes. One can see that in microscopic photos of cracked surfaces of polypropylene mesh. But Dr. Kirkemo disagreed with Klosterhalfen.
Q: Did Professor Klosterhalfen get it wrong?
"He misinterpreted it" said Kirkemo. "He didn’t prove it with the next step." The doctor said the erosion was actually protein serums that had coated the mesh and accounted for the image of the dried up mud.
Did Dr. Kirkemo ever reach the conclusion that the mesh was defective, he was asked.
"I mostly found it was the physicians' fault," he said in explanation of the adverse events.
For his part, Dr. Kirkemo said he'd only seen two mesh exposures in patients. He had excised portion of the mesh.
"Is it difficult?
“No, its like any other place.
Aren't there nerves in the vagina? For example, per square inch when compared to my leg, are there more or less in the vagina?
"I can't tell you that."
Within any medical device company, innovation is the key.
A product change means the marketing department can sell the latest and greatest innovation. Ethicon had other meshes in the production line that were never launched. The Scion was one innovation.
Documents presented to Dr. Kirkemo showed he was a big fan of the Scion. It was "beautifully designed" he wrote and would solve the problems of the leg and nerve pain caused by the TVT-O where large needles pass through the obturator muscle potentially damaging nerves and muscles and causing permanent pain.
"You write, positioning can produce both orthopedic and neurologic injury and bone and nerve injuries you describe? “Yes. If done incorrectly, you can still have leg pain, groin pain, hip pain… you can have pain."
Then came the Abbrevo, which in documents he called a "game changer." Why? It contained less mesh, 32 percent less mesh and the traditional thought, "less mesh is less mess," Kirkemo agreed less mesh was a benefit that would produce less foreign body response.
Interestingly, the IFU for the Abbrevo mesh, which was eventually marketed, shows how to position a patient on the table, something Dr. Kirkemo admitted is missing from today's TVT-O instructions for use. "It incorporates updates I thought were important," he said referring to Abrevo IFU.
BENEFITS EXCEED RISK
Dr. Kirkemo insisted in testimony that the adverse event section of the TVT-O IFU contained a comprehensive list of adverse events or complications.
How frequently does leg pain occur with TVTO? - “One to two percent."
Fortunately, those are very "rare" he added. As it says in the IFU, chronic groin pain can be managed with mild analgesics. "It says after the operation you’re going to have sore thighs.”
Q: "Do you believe benefits of TVT-O outweigh the risks?
A: "Yes I do there are tremendous amt of physicians in love with TVT-O and in their hands they have success with low morbidity. If you have something working well for you you stick with it."
IFU for TVT-O, here
IFU for Abbrevo, IFU here
Doctors Divide- Mesh News Desk, here - The growing dissent within the medical community about mesh-injuries.
Mesh News Desk, What Jurors Never Saw in Lewis v. Ethicon, March 2014, here
Background on Ulf Ulmsten, here.
Mesh News Desk - Ethicon Defends Questionable TVT Tape Science, Feb.11, 2014 here. (includes background on Dr. Klosterhalfen)