TVT graphic www.kup.at
Mesh News Desk, January 26, 2016 ~ The plaintiffs are Sharon and Charles Carlino of New Jersey and they are finally having their day in a Philadelphia, Pennsylvania court over her transvaginal mesh implant made by Johnson & Johnson. The case is A. Carlino v. Ethicon, Philadelphia Court of Common Pleas, Case No. 1306-03470 before Judge Kenneth J. Powell Jr.
This is the first trial of the TVT (transvaginal tape) since Lewis v. Ethicon which was dismissed by Judge Goodwin in WV federal court following a directed verdict motion by J&J. Unlike Lewis, this time a Failure to Warn the doctor will be allowed.
The case pits the couple against giant healthcare company J&J and its Ethicon division, maker of the transvaginal mesh implanted in Ms. Carlino. This is the second pelvic mesh trial in the Philadelphia court and one of 40,000 mesh cases filed against Ethicon, which is facing more defective product lawsuits filed in state and federal court than another other mesh maker.
In this court alone there are 180 cases pending for trial.
Mesh News Desk will not be in the courtroom, however, The Legal Intelligencer filed a story Monday, Jan. 25. See it here.
On August 18, 2005 Ms. Carlino was implanted with a Gynecare TVT to correct incontinence, by Dr. Andrew Blechman. By November 26, 2007 she had corrective surgery to revise and/or remove the J&J product. By December 2010, she had another revision surgery. All three surgeries were performed by Dr. Blechman.
TVT (transvaginal tape) is a polypropylene knitted mesh placed to support the urethra and bladder.
Secant Medical of Perkasie, PA is also a defendant in this case in that they manufactured and sold the mesh components to J&J.
As a result she has sustained injuries including, “mesh erosion, mesh exposure, mesh contraction, infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain and recurrent urinary incontinence,” which have led to corrective surgeries, mental and physical pain and financial losses, says her Complaint (Carlino complaint).
Laura Hensley Smith, attny for Ethicon
The Legal Intelligencer reports the TVT was the "worldwide gold standard" used in treating stress-related incontinence, according for the attorney representing Ethicon Laura Hensley Smith during opening statements Monday.
When the TVT was the first sling created by J&J to address incontinence, "It was revolutionary," said Smith.
Shanin Specter said the TVT was defective in its design and was developed by Dr. Ulf Ulmsten who had a financial incentive to develop test results to J&J.
Eventually Dr. Ulmsten would sell his patented device to the company for millions, according to testimony in previous trials. TVT (transvaginal tape) was first sold in Europe in 1997 and in the U.S. in 1998.
Dr. Ulf Ulmsten, inventor of TVT
Ms. Carlino first felt something sharp in her vagina and her doctor found part of the mesh had eroded. She had a second removal surgery after feel a sharp pain again. Her pain did not subside. Specter said the remaining pelvic mesh could not be removed safely.
The issue of small pelvic mesh pore size and and non-laser cut edges will also be brought into this trial as it has in other litigation. Small pores, under 3 mm, encourage bridging fibrosis and scar plate formation which shrinks the mesh. The TVT has sharp exposed edges not smoother edges which results when the polypropylene mesh material is cut with a laser.
Specter added that Ms. Carlino's doctor was not informed of the defective and dangerous nature of the mesh. Dr. Blechman is an obstetrician-gynecologist. Ethicon attorney Smith said he was well trained in implanting the pelvic mesh and that she received the standard of care. Her problems are not related to the mes, the attorney said.
The mesh had to be removed because Ms. Carlino's vaginal wall had thinned, she argued, reports The Legal Intelligencer.
The Carlinos are represented by Shanin Specter, Thomas Kline, Lee Balefsky and Michelle Tiger of Kline Specter O.C. of Philadelphia and Rich Freese of Freese & Goss, Dallas. Laura Hensley Smith is with Eldredge & Clark of Little Rock, Arkansas.
Plaintiffs' attorney allege defective manufacture and design of the TVT and a failure to warn her physician or the plaintiff, “the defendants intentionally, recklessly, and maliciously misrepresented the safety, risks and benefits of the pelvic mesh products and or the mesh components understating the risks and exaggerating the benefits in order to advance their own financial interests, with wanton and willful disregard for the rights and health of the plaintiff." Also alleged is negligence (a duty to care), common law fraud, negligent representation, negligent infliction of emotional distress, breach of express/ implied warranty (was safe to use by consumers), violation of consumer protection law, violating PA state consumer protection statutes, gross negligence, loss of consortium. Asking for punitive damages as well as compensatory damages. The Carlino case was filed June 26, 2013.
Judge Powell has limited each side to six days of testimony.
Kline Specter is the same law firm that just secured a $12.5 million jury award in the Patricia Hammons pelvic mesh case against Ethicon held in the Philadelphia court last month.
It took jurors less than one day to add the punitive portion of $7 million to the $5 million in compensatory damages.
See the Mesh News Desk story here. #
Ulf Ulmsten, MND Huskey trial coverage, September 2014
MND, When Ethicon Knew TVT had Problems, Lewis Case, Feb. 2014