Today was Day One for opening arguments in the trial of Diane Albright v. Boston Scientific being heard in Middlesex Co. Superior Court in Woburn, Massachusetts.
It appears to be the first product liability trial against Boston Scientific, maker of transvaginal mesh. The case is being heard before Judge Diane M. Kottmyer and could take up to one month.
New/ Revised* Attorneys for the Plaintiff are Motley Rice- Fidelma Fitzpatrick, Jonathan Orent and Fred Thompson. Also Edward Wallace (Wexler Wallace, Chicago) Erin Copelend (Fibich Leebron, Houston) Kimberly Dougherty (Janet, Jenner & Suggs, Boston).
For the Defendant are Susan Donnelly Murphy (Murphy & Riley, Boston) and Jon A. Strongman and Robert T. Adams (Shook, Hardy & Bacon, Kansas City, Mo.)
Boston Scientific of Marlborough, Massachusetts makes the Pinnacle Pelvic Floor Repair Kit to treat pelvic organ prolapse and the Obtryx Transobturator Mid-Urethral Sling used to correct stress urinary incontinence.
New Add* Diane Albright was implanted with a Pinnacle mesh to treat Stage 1-2 bladder prolapse by a Dr. Meyer in 2010. She did not suffer from incontinence.
*Add* The Plaintiff claims the mesh caused erosion, infection, chronic pain, among other complications, and that the polypropylene mesh implant is defective in its design, manufacture and construction and that the warnings were defective and that the Pinnacle did not conform to the warranty promise by Boston Scientific.
(*Additional information/analysis on the days proceedings are available by contacting Editor, Jane Akre at email@example.com)
Federal Court – Boston Scientific Multidistrict Litigation
There are currently 12,800 product liability cases filed against Boston Scientific federal court in Charleston, West Virginia, as well as in state courts around the country.
The first of the federal cases before Judge Joseph R. Goodwin was supposed to begin last March but was rescheduled. Judge Goodwin specified he only wanted to see cases before him of women between the ages of 40 to 60 who had up to three explants or reconstructive surgeries.
Boston Scientific has the third highest number of pelvic mesh product liability cases filed in the federal court behind Ethicon (Johnson & Johnson) and American Medical Systems (Endo).
Boston Scientific Recall
On May 10, 2011, Boston Scientific sent an “URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED” letter to all affected customers concerning its Class 2 recall for the Pinnacle Pelvic Floor Repair Kit because ‘the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”
See the FDA notice here.
Boston Scientific still sells Advantage Fit, Advantage, Lynx, Obtryx, Solyx, slings used to treat incontinence. The company is famous for making the first polypropylene mesh sling for incontinence, the ProteGen, which was removed from the market in 1999 over safety concerns. That did not stop it from being used as the “predicate” or equivalent device the Food and Drug Administration relies on as a basis for approval of new devices. See more here.
Boston Scientific in November 2012 (here) reported that California Attorney General, Kamala Harris, launched a probe of the sales of its transvaginal surgical mesh products.
Boston Scientific also reported a lawsuit unsealed in August alleges that its Valencia, Calif.-based neuromodulation business ran a scheme to defraud Medicare and promote off-label use of its Precision Plus spinal cord stimulation system.
The whistleblower lawsuit alleges violations of the False Claims Act “through submission of fraudulent bills for implanted device.”
Boston Scientific – Federal Product Liability Cases
Harris Martin reports (here) that July 1 federal Magistrate Judge Cheryl Eifert found Boston Scientific had good standing to require eight pelvic mesh plaintiffs in the federal case to submit to independent physical examinations. The doctors chosen by the company are duly qualified to perform the exams, ruled Eifert.
According to the July 1 ruling, the eight all had allegedly suffered injured from the Obtryx Transobturator Mid-Urethral Sling.
The first Boston Scientific cases involving 11 consolidated cases will be heard in federal court before Judge Goodwin beginning October 14, 2014. Judge Goodwin plans to remand 200 other cases to various District Courts around the country following a July 25 pretrial conference. See Pretrial Order #100.
Boston Scientific and the Plaintiffs began discovery on 200 defective product cases grouped into Wave 1 and Wave 2. They were selected 50 cases at a time beginning last January, with another 50 selected in May. Plaintiffs have until October to disclose experts and their reports that will be used in the trials. Expert discovery is set to close in January 2015.
Boston Scientific is also famous for offering it Cadaver Clinics, part of the Pelvic Floor Institute, where doctors from around the country are brought to Boston to train on mesh implantation using hemi pelvis cadavers. See more here.
Boston Scientific – Cadaver Clinic Pelvic Floor Institute
Drugwatch on the History of Boston Scientific
Research – ProteGen Mesh Predicate