January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
A number of Ethicon, a Johnson & Johnson company, employees testified this week in the on-going transvaginal mesh trial, as well as, its expert urologist. Here are some highlights from their testimony:
Sean O’Bryan, Director of Regulatory Affairs
- No clinical data on Prolift transvaginal mesh was needed to determine its safety and efficacy.
- The design process for Prolift transvaginal mesh did not raise any new safety concerns.
Dr. Charlotte Owens, Medical Director
- Knew that some patients would have severe scar formation as a result of Prolift transvaginal mesh.
- The Prolift IFU, instructions for use, did not mention the risks of dsypareunia (pain with intercourse) or chronic pain form contraction.
- Ethicon’s education and training program was superior and physicians relied on it instead of the IFUs.
Dr. Elizabeth Kavaler, Ethicon’s Expert Urologist
- Plaintiff suffers from pelvic floor dysfunction, which is common following all types of surgeries to repair the pelvic floor.
- Plaintiff’s pain and condition started before the Prolift transvaginal mesh was implanted.
- Plaintiff’s pain after the Prolift surgery was not in the area where the mesh was implanted and is normal pain experience with this type of surgery.
- Plaintiff should not have had surgeries to remove the Prolift transvaginal mesh.
- The unnecessary removal surgeries are the cause of Plaintiff’s pain not the Prolift transvaginal mesh.
- The mesh exposure was a result of Plaintiff’s surgeries and not the Prolift transvaginal mesh.
- Prolift transvaginal mesh is not the cause of Plaintiff’s pain or urine retention.
- Has been an Ethicon consultant since 2005.
- Admitted she lied in her deposition about an article she had submitted to a journal that had in fact been rejected.
- Admitted if Plaintiff would not have had the Prolift transvaginal mesh implant she would not have had all of the other surgeries.
- Noted that when she examined Plaintiff she did not examine the Plaintiff to confirm that the Plaintiff suffered from pelvic floor dysfunction, despite her opinion that is the root cause of all of Plaintiff’s pain.
Closing arguments are planned for February 14, 2013. To be continued…