Mesh News Desk, (MND) March 1, 2017~ The March 13th pelvic mesh trial of Sullivan v. Boston Scientific will not be heard because it has settled. There is no word on the specifics of that settlement. It is the first of many cases poised to go to trial in the Philadelphia Court of Common Pleas.
Sullivan v. Boston Scientific, Inc. et al (Case ID 130700971) named as its defendant Boston Scientific (BSC) from Natick, Mass and Secant Medical Inc. of Perkasie, PA and Prodesco Inc also of Perkasie, PA.
The Kline Specter firm represented Ms. Sullivan.
The case had received a Trial Date Certain from Judge Arnold New of March 13th.
Now MND has learned Sullivan has settled. Specifics are not available but yesterday, February 28, Susan Donnelly Murphy petitioned the court to be brought into the Sullivan case.
“She has a successful record of resolving lawsuits via trial, mediation, arbitration & dispositive motions,” says a write up on her Murphy & Riley law firm of Mass.
In her 30-page complaint, Sullivan received the Uphold vaginal support system to treat pelvic organ prolapse and stress urinary incontinence. Secant Medical and/or Boston Scientific designed, tested, inspected, wove, cut, treated, packaged, manufactured and marketed the mesh made from polypropylene. Secant sold the mesh components of BSC products.
On November 22, 2010 Sullivan was implanted with one or more of BSC mesh products and or Secant’s mesh components, by Dr. Stephen A. Metz at Mercy Medical Center in Springfield, Mass. He is board certified in obstetrics and gynecology.
He performed a bilateral sacrospinous ligament colposuspension, posterior colporrhalphy with repair of the perineal body, and a cystoscopy.
Uphold is made of Marlex polypropylene, a double-armed mesh placed using a Capio device. Its design is based on the Pinnacle mesh, with the difference being the shape of the mesh. There were no trials pre-market to determine whether the new design was safe and effective.
Uphold was placed on the market through the FDA’s 510(k) clearance for marketing on August 22, 2008. It has been replaced by Uphold Lite.
On July 14, 2011, Dr. Metz excised the exposed mesh from the vaginal wall and placed an AMS Monarc mid-urethral sling in Ms. Sullivan.
“As a result of having the Pelvic Mesh Products and/or the Mesh Components implanted in her, Plaintiff has sustained permanent injury, undergone corrective surgery, and has experienced, and will continue to experience, significant mental and physical pain and suffering, financial or economic loss, including, but not limited to, obligations for medical services and expenses.”
“Injuries include, but are not limited to, mesh erosion, exposure, contraction, infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain and/or recurrent urinary incontinence.”
The Complaint goes on to say the Defendants market their Pelvic Mesh Products to the medical community through carefully planned, multifaceted marketing campaigns and strategies. Direct to consumer advertising, aggressive marketing to health care providers at medical conferences, hospitals and private offices. BSC has failed to report high failure injury, complication rates, failure to perform as intended, re-operations and severe irreversible injuries.
BSC has “consistently under reported and withheld information about the propensity of their Pelvic Mesh Products and/or Mesh components manufactured by the Secant medical Defendants.
They know their disclosures to the FDA were and are incomplete and misleading and that their mesh components are causing numerous patients severe injuries and complications Boston Scientific consistently suppresses this information and failed to share with the FDA, health care providers and the patients. BSC provides insufficient and misleading training and information to physicians to increase its use. “As a result, the Defendant Boston Scientific actively and intentionally misled and continues to mislead the public….”
There were safer alternative designs and products as well as suitable alternative procedures and instruments for implantation and treatment of POP.
The Defendants failed to properly and adequately warn the Plaintiff or her physician. They were negligent in the manufacture, warning, sale and training of doctors to implant the mesh. Common law fraud means the Defendant falsely and fraudulently represented their medical device as safe and effective with a “callous, reckless, willful, and depraved indifference to the health, safety, and welfare of Plaintiff.”
Negligent infliction of emotional distress, Breach of Express Warranty- safe and fit for use by consumers. Breach of implied warranty, violation of consumer protection laws by making false deceptive representations and advertising, violating statutes that were enacted to protect consumers. Gross negligence is malice fraud, grossly negligent disregard for the rights of others.
The complaint is signed by Thomas R. Kline, Lee Balefsky and Michelle Tiger as well as attorneys from Aylstock Witkin Kreis and Overholtz of Pensacola.
A call into Boston Scientific’s media office about whether or not BSC has conducted its clinical testing of its pelvic mesh products as ordered by the FDA, January 2012, was not answered by publishing time. It will be added if there is a response.
A Mass. appeals court decided last September that the Albright case against Boston Scientific should receive a new trial because of information omitted by the Massachusetts trial court judge. See MND coverage here.
A RICO case was filed last June in federal court in Charleston, WV alleging Boston Scientific purchased counterfeit Marlex to make its pelvic mesh from a Chinese counterfeiter. See MND coverage here.
A North Carolina jury found for Boston Scientific and its Uphold mesh in the trial of Carlson v. Boston Scientific, October, 2015. See MND coverage here.