On Tuesday, March 25, Dr. M testified for the plaintiff, Ms. Batiste, on the sixth day of the trial of Batiste vs. Johnson & Johnson. Ms. Batiste continues to experience pain and dyspareunia which she attributes to her Ethicon sling. Her case is being heard in the 95th Judicial District Court of Judge Ken Molberg, George L. Allen, Sr. Courts Building, 600 Commerce Street, 6th Floor New Tower, Dallas, TX 75202.
Questions by Ms. Batiste’s attorney Rich Freese verified Dr. M’s qualifications as an expert in this litigation, thus: obstetrician/gynecologist, board certified in pelvic reconstructive surgery, also known as urogynecology; licensed to practice medicine in California, Wisconsin and Colorado; medical privileges at eight hospitals in the San Francisco bay area; serves on a Robotic Steering Committee; serves on several other medical committees; acting chair of the Quality Assurance Committee at Peninsula Hospital; holds three teaching positions; has published in peer review journals and non-peer reviewed journals; written textbooks. For the Batiste case he reviewed the medical records; read several depositions related to the case; reviewed opening statements and slides from defense; read “numerous, numerous documents, internal documents of Ethicon’s.”
Dr. M said he is being paid $350 an hour to review records, $500 an hour for deposition testimony; $2,000 per day for trial testimony, and had devoted roughly 60 hours to prepare for the Batiste case at hand.
Dr. M testified that his practice is solely pelvic reconstructive surgery. He treats patients for urinary incontinence, pelvic organ prolapse and complications of other pelvic surgeries. He said he has done”an ordinate amount of work on mesh and sling complications.”
Under further questioning from Mr. Freese, Dr. M said he has implanted “approximately 1,500 slings in my career over the last 25 years or so.” The slings he has implanted have all been implanted from organic materials, using cadaver or animal (such as pig) tissue which can dissolve in the body, unlike plastic mesh such as that which Ms. Batiste said injured her.
Dr. M said he now spends 20 to 30 percent of his time removing, or trying to remove, plastic mesh or plastic slings from women’s bodies. Of some 10 surgeries he does a week, 2-3 involve plastic mesh removal. “I’ve taken out about 300 sling and mesh systems, mostly slings.”
Dr. M said patients come to him from all over the country. “The majority of the patients that I see are referred in by other surgeons. They do a surgery, something goes bad, and they send them to me.”
Asked by Mr. Freese what kind of complications he sees in his medical practice every week relating to synthetic mesh slings, Dr. M answered:
“The complications that I see on a regular basis – and I did one last Wednesday before getting on an airplane to come over here – are erosions of the – and this is all Polypropylene, by the way. These are all plastic Polypropylene slings [the same material as Ms. Batiste’s] . Complications: Erosions, infections, obstructions, contraction, damage to adjacent organs, inflammation, scarring, loss of function, pain, loss of leg function, dyspareunia, painful intercourse. What am I missing?”
Prompted by further questioning from Mr. Freese, Dr. M said he sees groin pain, pelvic pain, vaginal pain, urethral pain, leg pain, pain with intercourse or dyspareunia, which he said he sees regularly with removal of the plastic slings. He also said he sees contraction and shrinkage (which are synonymous) with the mesh. He said the plastic contracts and chokes off adjacent organs.
Dr. M under further questioning said he treats all manner of women, young and old, some with many health problems and some whose only health problem is the plastic mesh inside them.
Mr. Freese asked Dr. M if he had ever seen anything from Ethicon explaining to surgeons how to properly remove the plastic mesh. Dr. M said Ethicon has presented “no instructions for removal of mesh or slings in the form of seminars” nor has the company presented any in written material.
Mr. Freese referenced the deposition of one of Ethicon’s physician’s, Thomas Barbolt, who was asked if one could determine the cytotoxicity potential or effect associated with explanted mesh, and Dr. Barbolt said, “No,” and “I don’t think so.” Asked to explain why not, Dr. Barbolt said, “because explanted meshes are like a plane crash. . . it’s a small disaster.”
Dr. M was asked if he agreed with Dr. Barbolt’s assessment and he said, “I agree with him that it is like a plane crash when you have to take these things out. the mesh is all over the place. It’s – there are particles broken off from it. There is roping and degradation of the material. There is scarring and distortion of the material.”
“I can assure you that the mesh when it comes out looks nothing like this pristine mesh going in. It is, I would agree with him, like a plane crash or a train crash. It’s a mess.”
Dr. M explained under further questioning that surgeons put the mesh in blindly, that they cannot see it and have no way to adjust the tension; there is no way for them to feel the tension, the pull of the mesh, upon implantation.
Dr. M also detailed several options for female pelvic floor surgery that do not involve the use of plastic mesh, and he testified that Ethicon’s attorneys in opening statement in this trial misrepresented the possible complications of those non-plastic options on several counts..
Dr. M testified: “Chronic pelvic pain is described [by defense in opening statement] as a complication of a Burch colposuspension. That is not correct. That is a misrepresentatin of the fact. That is untrue. I have performed over 4,000 Burch procedures, mostly laparoscopic. That simply is not true. Dyspareunia, pain with intercourse, long-term, not, doesn’t happen, rare, exceedingly rare.” He also testified that autologous facial slings (organic) rarely result in long-term pelvic pain. He said he has performed some 1,500 operations installing facial slings and it is “exceedingly rare” that they result in long-term pelvic pain. The reason, he said, is that because an organic – made of pig skin, cadaver skin, cadaver fascia or the patient’s own fascia – eventually dissolves, while plastic “just ain’t going away.”
“When this goes bad, not only does it cause erosions, infections, contractions and so forth and so on, but then it has to come out. And so that is going to require one, two, three, sometimes four I’ve seen – I’ve had to take patients back four times to try to get this stuff out. So the need for multiple subsequent surgeries to extract or extirpate the mesh fragments (is) very common.”
Under further questioning, Dr. M testified, “There is no way the entire mesh can be removed by anyone. It will fray. Particles will break off. Even if you’ve got the majority of the body of the mesh out, this frays, and particles break off as it’s deployed and as it’s removed, and you’ll never get all those particles out.”
“They are serious, permanent complications. (They) are irreversible. . . They are absolutely life-altering. They’re serious, chronic, permanent, profound, irreversible. They change women’s lives. I see patients like Ms. Batiste every day in my practice. . . She and they will never be able to be without pain, without voiding dysfunction, without dysfunction of the leg. (Ms. Batiste has a pronounced limp and uses a cane.) It’s permanent. It’s life-altering, and it’s with her for life, ain’t coming out.”
Mr. Freese through questioning then had Dr. M explain an Ethicon study of TVT vs. TVT-O in which 25 percent of the O group was experiencing groin pain. The researchers suspended the study. One researcher wrote that it seemed “unethical” to continue giving women the TVT-O product.
Dr. M and Mr. Freese then reviewed an email in which Ethicon’s World Medical Affairs Director Dr. Martin Weisberg is notified, in 2001, that TVT mesh has design problems, fully 10 years before Ms. Batiste was implanted with the same mesh (in 2011); but Dr. Weisberg simply says he doesn’t know what’s going on and is not certain that a Dr. Wang’s complaints about the TVT, about the injuries he is reporting, have any “clinical significance.”
Dr. M then testified that in his review of the case, he did not see Ethicon taking up these concerns with relevant studies, that all the company had for safety assurance was Dr. Weisberg’s saying he believed it was “unlikely” that the reported design problems were issues Ethicon needed to address. Other emails concerning reports of mesh fraying – with a subject line titled: “mesh fraying for TVT devices” – came across Dr. Weisberg’s desk two years later. Dr. Weisberg also chose to take no apparent action to follow up on them with safety studies.
Mr. Freese’s next line of questioning concerned an email string from 2006 in which Ethicon engineer Gene Kammerer sounded the difference between machine cut mesh (the type put in Ms. Batiste five years later) and laser cut laser cut mesh. The engineer points out the superiority of laser cut mesh, that it frays and ropes less and doesn’t leave the rough edges machine cut mesh does. Mr. Freese produced Ethicon’s own pictures from this time period which showed the rough edges and fraying of the machine cut mesh that Ethicon has noted internally since at least 2001.
Dr. M testified that as the machine cut mesh is pulled, it ropes and frays, loses particles, leaves a rough edge and causes pain. “And what is the cause of that pain” asked Mr. Freese.
“The roughness and large bead size of the edge quality. The edge is – as we discussed, as it’s pulled apart, the edge frays, and it starts to tear into tissue. . . The fraying causes prickly things to go into the tissue and hurt.”
Further questioning revealed that in 2003 a Professor Hausler, who was implanting TVT mesh in Germany, suggested to Ethicon’s Dr. Axel Arnaut that erosions of the mesh were more common than reported and that the solution might be to put a smooth edge on the mesh. Ethicon already had the solution with the laser cut mesh, but the company nevertheless continued to implant the machine cut mesh. Dr. Arnaut promises Prof. Hausler that he will forward his email to Ethicon engineers; but he never does. Arnaut does, however, write to another colleague that “we would want to be very careful with any modification of our tape (the TVT) since a change in the mesh would obsolete all the long-term clinical results we have about the procedure.”
Mr. Freese then asked Dr. M what that meant. Why didn’t Ethicon then cease producing the machine cut mesh in favor of the superior laser cut mesh?
Defense objected, was overruled, and Dr. M explained, “If they change the mesh design, they can’t continue to claim that they have long-term data on the sling. . . If they made a change, even something simple like a laser cut to it, (then) they’d have to start over from square one. (They) lose their old data, and that hurts them from a marketing advantage – prospective.”
Question: (by Mr. Freese) [Mr. M], is it ever appropriate for a medical device manufacturer to not market a safer product simply to protect the legacy of its lng-term clinical data?
Objection: (by Mr. Gage): Objection, beyond the scope of the witness’s expertise.
The Court: Overruled.
Answer: (by Dr. M): Of course not. If a manufacturer identifies a design defect in the device that they’re telling us physicians (on) the front line to put in, to install and implant into patients, if they find a design defect, they need to stop it. They need to change. They need to stop making that thing. They need to make improvements. That’s what research and development is all about, make a product, find a problem, improve on it, keep on improving until you get a product that’s hopefully some day perfect.
Secret Highly Confidential
Mr. Freese then took Dr. M through a 2006 email from Ethicon engineer Gene Kammerer in which he tells other Ethicon staffers that six of their leading surgeons in France are all telling Ethicon they are finding problems with the TVT, specifically with particle loss, edge abrasiveness, distortion after pulling and softness. Mr. Freese asked Dr. M if any of these ever showed up in the product’s IFU. Dr. M said none of this had ever been disclosed by Ethicon. These documents, Mr. Freese showed through questioning, were marked by Ethicon as “secret highly confidential.”
Mr. Freese then questioned Dr. M through a series of internal Ethicon emails which showed the company was getting emails from other surgeons reporting particle loss from the machine cut mesh and erosion of the plastic mesh causing pain during intercourse.
The next line of questioning took Dr. M through Ethicon’s own studies that showed a significantly greater incidence of groin pain with the TVT-O compared with the TVT. The two products are made of the same plastic, but the TVT-O is inserted differently, passing closely to the obturator nerve, possibly damaging it and leading to the greater incidence of lasting groin pain.
The next questions concerned the IFU – Instructions for Use – of the TVT-O device. Dr. M testified that the IFU excluded known complications and hazards, or else downplayed the significance of those complications and hazards.
Informed Consent Impossible with Inadequate IFU
Dr. M said, “When a manufacturer downplays the risk to the physician, the surgeon, it basically gives the surgeon a false sense of security. It gives me a false sense of security (and) as a result, I can’t adequately consent my patient. (If) I don’t know them (the problems), I can’t tell them to her. (Then) she’s not able to make a proper decision as to whether or not she wants this device in her or not.”
The next line of questioning brought out several things, that dyspareunia was not included in the IFU or the warnings, and neither were chronic and permanent groin pain, nor chronic and permanent pelvic pain – all of which Ms. Batiste now suffers.
“The IFU is wholly inadequate,” testified Dr. M. “The IFU fails to describe all reasonably associated risks, reasonably associated serious hazards associated with the device that the company knew about for years prior to Mrs. Batiste’s implantation surgery.”
The IFU, said Dr. M, also failed to warn of chronic and permanent urethral pain and motor function loss or impairment.
The next questions walked Dr. M through an article written by, among others, Dr. Mickey Karram, a key opinion leader for Ethicon. Mr. Freese read a quote from the article about plastic mesh complications. He read, “This raises the potential concern that physicians who perform mesh procedures may not be aware of the complications their patients experience and that these providers may be responsible for future mesh-related complications with no awareness of the existing magnitude of the issue.“
Dr. M testified, “I agree wholeheartedly with that.”
Dr. M also said he saw in his practice what Dr. Karram and others concluded: “We can only observe that when they (complications) do occur, the nature of the complication is usualy severe and often requires surgical intervention.”
Through questioning, Dr. M said, “I agree with them (the authors) completely. This is what I see in my practice.”
To be continued. . .