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Ethicon 27/1
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Boston Scientific Counterfeit Mesh Material Row Sent To FDA
Jan 26, 2016 | Law360
By Kat Greene
Boston Scientific Corp. won a bid Tuesday to scuttle a proposed West Virginia class action alleging the company started smuggling a cheap knockoff resin to use in its pelvic mesh while the accusations are considered by the U.S. Food and Drug Administration. -
Carlino v. Ethicon Transvaginal Mesh Trial Gets Started in Philadelphia
Jan 26, 2016 | Mesh Medical Device News Desk
By Jane akre
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.
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Boston Scientific Counterfeit Mesh Material Row Sent To FDA
Jan 26, 2016 | Law360
By Kat Greene
Boston Scientific Corp. won a bid Tuesday to scuttle a proposed West Virginia class action alleging the company started smuggling a cheap knockoff resin to use in its pelvic mesh while the accusations are considered by the U.S. Food and Drug Administration.
The agency will have to assess the issue of whether the device maker started using counterfeit parts that aren’t up to federal standards to make its surgical mesh after it lost its U.S. supplier of the synthetic resin used to make the product, which is implanted in the lower abdomen to support organs, U.S. District Judge Joseph R. Goodwin ruled Tuesday.
Teresa Stevens accused Boston Scientific earlier this month of resorting to substandard materials, buying the resin from a known counterfeiter and smuggling it out of China through secret shipments — as if it were a “drug deal,” according the complaint. But Judge Goodwin found that the FDA has authority to prevent or ameliorate the use of adulterated or misbranded devices in the market, according to Tuesday’s ruling.
“The FDA is in the best position to determine whether Boston Scientific’s mesh device is in compliance with the FDA’s own statutes, regulations and directives — particularly because the FDA was the very agency that cleared Boston Scientific’s mesh device in the first place,” Judge Goodwin wrote.
The judge determined that the FDA has primary jurisdiction over the issue, that is, that the court can refer the technical or factual issue to the administrative agency, according to the ruling.
Stevens, a 46-year-old grandmother, filed suit on behalf of women who say they experienced bleeding and other complications from the plastic mesh implants. They wanted the court to block Boston Scientific immediately from selling any medical devices containing the allegedly harmful material.
Stevens argued against shifting the case to the agency by contending that the suit doesn’t invoke the Food, Drug and Cosmetic Act, a federal law that imbues the FDA with the authority to monitor medical devices. Instead, she avoided any discussion of the FDA and safety issues, saying the alleged smuggling and sale of counterfeit products caused economic injury, according to filings in the case.
The judge refused to block the company’s sales, then agreed with Boston Scientific’s contention that the suit should be put on hold and referred to the FDA, court records show.
The suit is the latest among tens of thousands of lawsuits against the makers of vaginal mesh implants, including 15,000 against Boston Scientific, according to a statement last week by theMostyn Law Firm, which represents Stevens.
C.R. Bard Inc. faced the first jury trial in the seven multidistrict litigation suits over the use of transvaginal surgical mesh to treat pelvic organ prolapse and stress urinary incontinence. It was hit with a $2 million verdict in August 2013.
The MDL against Johnson & Johnson unit Ethicon Inc. includes more than 23,000 cases, claiming that its mishandling of transvaginal surgical mesh devices caused serious injuries to patients.
Earlier this month, federal regulators finalized measures to reclassify transvaginal mesh devices as high-risk devices that need a safety evaluation by the FDA before they can be sold.
“We’re pleased with the judge’s decision,” a spokeswoman for Boston Scientific said Tuesday.
Steve Mostyn, who represents Stevens, noted that he's still working to make some of the documents from his case available to the FDA, an action that Boston Scientific opposes.
Mostyn said he wasn't surprised by Tuesday's decision to move the case to the agency, but that he now wants the FDA to have the same documents he has as it conducts its review.
"We will continue to assist them [the FDA] in any way we can," Mostyn said.
Stevens is represented by J. Steve Mostyn and Amber Mostyn of the Mostyn Law Firm, and Harry F. Bell of the Bell Law Firm PLLC.
Boston Scientific is represented by Jack Arthur Wilson, Jeremy Cain Vest and William S. Ohlemeyer of Boies Schiller & Flexner LLP, and Michael Bonasso of Flaherty Sensabaugh Bonasso PLLC.
The case is Teresa L. Stevens v. Boston Scientific Corp. et al., case number 2:16-cv-00265, in the U.S. District Court for the Southern District of West Virginia. -
Carlino v. Ethicon Transvaginal Mesh Trial Gets Started in Philadelphia
Jan 26, 2016 | Mesh Medical Device News Desk
By Jane akre
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.
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.
BACKGROUND
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).
OPENING STATEMENTS
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. Ulm Umsted ** 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.
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, reportsThe 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. #
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