Friday, April 28 was not a good day for Johnson & Johnson and its Ethicon division. The most recent suit over the giant corporation’s TVT-Secur transvaginal mesh concluded and the jury found in favor of plaintiff, Margaret “Peggy” Engleman. The eight-woman, four-man jury awarded Ms. Engleman $20 million, the third multimillion-dollar verdict against J&J in the last 15 months.
Ms. Engleman’s pelvic mesh case was the third to be tried in Philadelphia and, so far, the largest punitive damages award in that particular court. Of the $20M, $17.5M was for punitives, with the remaining $2.5M being compensatory damages for mesh-related complications. The other two cases heard in that court, Patricia Hammons and Sharon Carlino, concluded with jury awards of $12.5M and $13.5M respectively. Between the two earlier cases, the punitive damages awards totaled $17M, bringing the total of punitive damages alone to a stunning $35.4M for all three cases. Ms. Hammons’ case was heard in December 2015 and Ms. Carlino’s in February 2016. A third case was scheduled to be heard in February 2016, but it was settled before trial.
Transvaginal pelvic mesh is used to treat conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). J&J’s TVT-Secur, also referred to as TVT-S, was the company’s attempt to improve upon its mesh products. The TVT-Secur is shorter than traditional meshes used for incontinence treatment. It features Velcro-like fleece tips and arrow-shaped introducers.
The TVT-S is made of heavy, small-pore polypropylene, a plastic, and functions as a sling holding the urethra in cases of stress urinary incontinence. The TVT-S has two “arms” that anchor it. The “arms” reach up into the patients’ buttocks.
Dr. Bruce Rosenzweig, urogynecologist at Chicago’s Rush University and expert witness for the plaintiffs in several mesh cases, testified at Ms. Engleman’s trial. His testimony provided a look into what can happen when polypropylene mesh is implanted in the human body. It can:
- Degrade, fray and lose particles;
- Cause immune responses, such as chronic foreign body reactions;
- Cause fibrotic bridging (formation of bands of fibrous tissue);
- Contract/shrink (while remaining attached to tissue);
- Lose pore size under tension.
If you’re wondering how such a product ever made it to market, you’re in for an even worse bit of news. The TVT-Secur hit the market in 2006 after receiving the FDA’s 510(k) clearance. According to the FDA, this level of clearance, named after a section of the Food, Drug and Cosmetic Act, essentially requires that device manufacturers “submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.”
“FDA recognizes that clinical evaluation may be involved in the validation of the design of a modified device.” [Emphasis added.] The TVT-Secur was not subject to real clinical trials involving living humans. According to testimony, the device was tested on sheep (living and dead), cadavers, and 31 women. This “testing” lasted all of five weeks and the TVT-Secur was rushed to the marketplace.
J&J voluntarily pulled the TVT-S from the market in mid-2012, citing financial reasons. Three other meshes (the Prosima Pelvic Floor Repair System, the Prolift Pelvic Floor Repair System, and the Prolift MTM Pelvic Floor Repair System) were removed at the same time, according to MeshNewsDesk.
As a rather frightening aside, when searching for an image of the TVT-Secur, the author discovered that MedSurplusOnline, a Brooklyn, New York-based medical device and supply site, still offers the TVT-Secur for sale. The devices come four to a box for $900.00.
Ms. Engleman’s Case
Ms. Engleman, a resident of Cinnaminson, Pennsylvania, was implanted with the TVT-Secur in 2007 as treatment for stress urinary incontinence. One month post-op, her condition returned; two months post-op, her doctor found the mesh had already begun to erode. The device eroded into her vagina causing her pain and discomfort. She underwent three separate removal surgeries, all under anesthesia. To this day, pieces of the TVT-Secur still remain in Ms. Engleman’s body causing her chronic pain and pelvic floor spasms. She still deals with her original condition on top of the aftermath of the mesh device.
Ms. Engleman’s claim alleged not only that the TVT-S was “defective in design, warnings and instructions,” but that J&J knew of the erosion risk prior to the product’s release and failed to inform the public. Once again, it’s the industry standard of “Profits over Patients.”
Of course, J&J/Ethicon denied her allegations, stating that she provided no evidence of the company’s failure “to warn of risks not within the common knowledge of pelvic floor surgeons.” In a pretrial memorandum, J&J said, “Under New Jersey law, a manufacturer has no duty to warn of risks that are within the common knowledge of physicians.” How convenient for the corporation’s bottom line.
However, Ms. Engleman’s legal team was having none of that argument, or any other proffered by J&J’s lawyers. Ms. Engleman’s team was comprised of Christopher Gomez (Kline Specter), Ben Anderson (Anderson Law), and Bryan Aylstock (Aylstock, Witkin, Kreiz and Overholtz).
(Corrected to reflect that Dr. Flynn’s cross-examination was conducted by Mr. Gomez.) In a scene reminiscent of the best “Aha!” moment in a courtroom drama, Mr. Gomez’ cross-examination of former J&J consultant, Dr. Brian Flynn produced an unexpected reaction. Mr. Gomez believes this reaction may have been the turning point for the jury.
Mr. Gomez referenced an article published by the European Association of Urology in October 2012. The article, co-authored by Dr. François Haab, another former J&J consultant, stated very clearly that the TVT-Secur was not only an ineffective device, but was actually a dangerous device. The article said that the TVT-Secur had an almost 70% failure rate, with 40% of study participants reporting serious adverse events. The study’s “objective was to provide data on the efficacy and safety of TVT SECUR after 5 [years] of follow-up.”
The article ends on an ominous note, if you’re part of J&J’s legal team. “In our experience, the TVT SECUR device definitely did not stand the test of time, with a 31% success rate after 4.5-[years] of follow-up, and it should not be considered a valuable option for SUI [stress urinary incontinence] management unless supplementary data are provided regarding its long-term outcome.”
According to Mr. Anderson, this was the first time Dr. Flynn learned of the study’s existence. Mr. Anderson told MeshNewsDesk that “Flynn appeared shocked.” MeshNewsDesk reported the following interaction during Mr. Flynn’s cross-examination:
“Gomez: ‘The report said the TVT-Secur cannot be recommended for a first-line treatment. Did they (J&J) share this with you?’
Gomez: ‘Was it important?’
This was not the only dramatic impact that J&J’s behavior – or, lack thereof – had on the jury. Mr. Anderson took advantage of the fact that J&J, located a mere 100 miles from the courthouse, didn’t send a single company representative to take the stand in defense of the TVT-Secur. Mr. Anderson pointed to an empty chair during closing arguments to drive home the point.
He told MeshNewsDesk, “When the jury saw the amount of information on serious health risks to women that existed before it was ever launched, they decided there was clear and convincing evidence that Ethicon and Johnson & Johnson maliciously and with wanton disregard for women put this device on the market, that they put profits before people and they deserved to be punished.”
Finding for Ms. Engleman that the TVT-S design was defective and that J&J /Ethicon failed to warn the public of the serious risks involved with the product, the jury punished the corporate giant in the only way such defendants can understand: it hit them in the checkbook.
Roughly 200 pelvic mesh cases are still pending in the same court that heard Ms. Engleman’s case. Hundreds more are pending in Bergen, New Jersey. The defendants in these cases are primarily J&J and Boston Scientific. In federal court in Charleston, West Virginia, 102,000 cases have been consolidated in a multidistrict litigation (MDL). There are six defendants in the MDL, two of which are J&J and Boston Scientific.
J&J/Ethicon’s legal team was comprised of Jim Campbell, Rita Maimbourg, and Burt Snell (Butler Snow).
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