Mesh News Desk is grateful to Joleen Chambers as our court watcher. She is sitting in the trial of Martha Salazar v. Boston Scientific. Here are her notes. She reports that on Wednesday, August 27, Plaintiff Martha Salazar (MS) was seated and was in obvious discomfort.
Salazar has filed a product liability lawsuit against Natick, Mass.-based Boston Scientific. DrugWatch has more on the background of the company here.
Judge (J.) Ken Molberg is overseeing this trial. The case is #DC 12 14349, Martha (Rodriguez) Salazar et al (Feliz Salazar, husband) v Jorge Lopez, MD et al (Boston Scientific) filed over the Obtryx® Transobturator Mid-Urethral Sling (MUS) System.
Plaintiff Opening Statement:
The plaintiff lives in a near northern suburb of Dallas and her husband of 20 years is a truck driver. For 20 years, the plaintiff has been involved in management of complexes for a company and according to her employer, was exemplary and was in line for promotion to an executive position. She is unable to fulfill her responsibilities and has lost her job.
The Obtryx was implanted January 17, 2011 (3.5 y ago) by Dr. Jorge Lopez in a procedure that took just 15 minutes to prevent SUI leakage, a common complaint of women who have borne children.
The plaintiff noticed the SUI symptoms only with active exercise or with a cough/sneeze.
Dr. Lopez was called on by Boston Scientific Corp.(BSC) sales rep. Neil Geismer (subpoenaed).
The doctor was told the surgery was minimally evasive. Minimal short-term side effects could be expected and that it was safe and effective.
BSC funded several trips (Houston, Seattle, Arlington) allowing Dr. Lopez to participate in training. The directions for use (DFU), also called the Instructions for Use (IFU) describes a polypropylene plastic) product that is intended as a permanent implant.
There is no warning about the permanency, irreversibility and severity of the side effects that this plaintiff is experiencing; permanent dyspareunia, pain, irreversible nerve damage to femoral and obturator nerve. Damage to adductor in right leg causes plaintiff to walk with limp. She just had 4th major surgery to remove mesh (last wed) under general anesthesia for hours. More dangerous and invasive surgeries are to follow.
The Plaintiff alleges:
– warnings were inadequate to warn of the nature and extent of possible irreversible, permanent, catastrophic injuries. groin and pelvic pain. Dyspareunia, nerve damage, chronic debilitating UTI,
– the product is defective
– the risks outweigh the benefits.
-BSC did not adequately test the product on humans. Transvaginal implantation is not a sterilized field Bacteria with plastic initiates degradation, erosion, biofilm, shrinkage up to 50%. The middle of the Obtryx mesh is heat treated to make it stronger with no testing. It becomes stiff and jagged edges form and effectively mechanically saw or dissect the urethra and other soft tissue.
-BSC ignored the MSDS issued by Phillips Sumika
-BSC withheld or concealed clinical trial information about these potential injuries
-the obturator approach is uniquely dangerous and needs more long term study
-BSC did not budget adequately for post-market surveillance and complaint investigation
Stay Tuned for more on this story!
The lawyers for the plaintiff are Freese and Goss, Dallas- Richard Capshaw, David Matthews (Matthews law) and Tim Goss, Sheila Bossier. Lawyers for the defendants are Shook, Hardy and Bacon – Mr. Robert Adams.