Thanks to Courtroom View Network for access to the proceedings in Kern Co.
Coleen Perry of Bakersfield, California, and her husband Patrick, have sued Johnson & Johnson and its subsidiary, Ethicon Inc., claiming the company makes a defective product that led to her permanent injuries.
This is the first time Abbrevo has been the subject of product liability litigation. Judge Lorna Brumfield is presiding.
Abbrevo is made by Johnson & Johnson (J&J), the world’s largest medical device company, headquartered in New Brunswick, New Jersey. Ethicon, Inc. is a subsidiary of J&J. Abbrevo is considered a mini-sling used to treat incontinence.
It is shorter than a TVT-O or a TVT measuring 1.1 cm x 12 cm and is made of polypropylene mesh. It’s known as the “Mini TVT-O.”
It claims “84% less mesh is placed in adductor muscles and 38% less mesh overall.” It is placed through the obturator internus, obturator membrane and obturator externus.
Abbrevo passed through 510(k) clearance in July 2010. The TVT-O was named as the predicate device under its 510(k) approval (#K 100936).
Called one of the “TVT Family” of meshes, its lineage is less than pristine. Among the TVT family members are:
- TVT (Retropubic);
- TVT-Obturator System (found defective twice in legal proceedings – Huskey, Batiste);
- TVT-Secur (taken of the market in 2012);
- TVT-Exact ( still on the market)
- TVT-Abbrevo (still on the market)
What’s known is that there have never been any long-term studies with safety as an end point on Prolene mesh (polypropylene) used in the TVT family of meshes.
Some familiar faces are appearing at this Abbrevo trial in Bakersfield.
Tom Cartmell is the lead attorney for the Perrys. He will present witnesses including, Dr. Stephen Guelcher (Huskey case); Dr. Peggy Pence (Linda Gross, Enghayem, Carolyn Lewis, Batiste cases); Dr. Bruce Rosenzweig (Huskey case); and M. Tom Margolis MD.
For the defense, William Gage of Butler Snow is asking questions of witnesses.
The defense must show that the company did due diligence in bringing the Abbrevo polypropylene mesh to market and/or that it went beyond what was required by the Food and Drug Administration. They must also show that adequate warnings were contained in the IFU (instructions for use) for the doctor and in the patient brochure so the woman could have true informed consent.
Laser v. Machine Cut Mesh
The defense has told jurors there is no clinical difference between laser cut or machine (mechanically) cut mesh. The TVT Abbrevo uses laser cut mesh.
Attorney Kim Schmid told jurors on day one of trial that the Abbrevo is superior because it does not require any large abdominal incisions, any hospitalization, and is made of polypropylene so there is no foreign animal or human cadaver tissue foreign body reaction. It is less painful for the patient and all of this ends up with a shorter recovery period for women, she told jurors.
It is very effective, she said, because women are still dry after treatment.
On the stand in day two of Perry v. Ethicon, Dr. Peggy Pence appeared for the plaintiffs. An expert in regulatory requirements, Dr. Pence has appeared at many pelvic mesh trials as an expert. Always poised, she appears to hold her own even under difficult and sometimes aggressive questioning. Even in just asking if she can elaborate on her answer, she sends a subtle message to the jury she differs with the characterization by, in this case, defense attorney William Gage.
As is customary, Mr. Gage asks about her compensation rate to be in the courtroom and to prepare as an expert. At roughly $500 an hour and with about 200 hours in this case, she’s charged the client about $100,000. She is pleasant and polite in answering his questions.
Problems with Laser Cut
TVT-O started out as mechanically or machine cut mesh, said Dr. Pence, but in 2006, the company made it available in either laser or machine cut. The laser cut didn’t catch on. Scandinavian countries refused to use it. They wanted mechanically cut mesh. Why?
Pence pointed to a study that found laser cut mesh in the TVT Secur had seven times as many erosions when compared to TVT-O and all of those erosions required surgical repair. The TVT Secur was made with laser cut mesh.
In the patient brochure were there any warnings about laser cut mesh? No, she answered. Was there anything about it being more stiff or dangerous once placed in the patient? Again the answer was no. Additionally, developers within Ethicon had expressed concerns, among them, Dan Smith a lead engineer and Abbrevo inventor Dr. Jean de Leval.
Asking Dr. Pence about a study published in March 2011 on the TVT Secur (laser cut mesh) outcomes after 12 months on 1,000 women concluded the erosion rate was 2.4%, pointed out Mr. Gage. And besides, he added, there is no requirement by the Food and Drug Administration that a patient even be provided a patient brochure.
Dr. Hung Luu appeared on the stand in the afternoon.
See Patient Profile – Hope Pagano who developed Lupus three weeks after her Abbrevo implant.
Here is the 510(k) approval from the FDA dated received April 5, 2010 but with a stamped date of September 28, 2012.
Here is a MAUDE Adverse Event Report on the Gynecare TVTO Abbrevo Kit Continence System Mesh Sling Vaginal Tape. MAUDE represents adverse events called into the FDA.
Here is the FDA Summary of Safety and Effectiveness, July 1, 2010 – Gynecare TVT Abbrevo Continence System, the Gynecare TVT Obturator System was the predicate [which has been found to be defective]