Mesh Medical Device News Desk, October 9, 2019~ At one time, mesh trials were being conducted on a regular basis. While they were supposed to indicate the relative value of each case, that never happened and instead, mesh makers have decided to settled with as little as they can offer.
A new round of product liability trials are planned while the mesh litigation continues into its eighth year!
It has been awhile since we have seen any pelvic mesh trials.
The last one was in June of this year Linda Dunfee, who had been implanted with a Prolift mesh, faced off against Ethicon in the Philadelphia Court of Common Pleas. Ultimately the jury awarded her $500,000. J&J appealed.
Dunfee was represented by the litigation team at Kline & Specter in Philadelphia.
The same lawyers have the next trials ahead.
On The Horizon
November 18, 2019, Kila Baldwin will represent Charleyne Kerchner in her product liability case against Coloplast. The case will be heard in the U.S. District Court for the Eastern District of Pennsylvania, which includes Philadelphia.
Coloplast, based in Denmark, makes medical products for continence and wound and skin care. It also makes four different types of mesh to treat pelvic organ prolapse. It was one of seven mesh makers consolidated in multidistrict litigation in West Virginia with No. 2387.
At one time, Coloplast had 2,717 product liability cases in the federal MDL.
Last June, Mesh News Desk reported Coloplast was exploring a sale. It had recently lost its last application to market pelvic organ prolapse (POP) mesh after the Food and Drug Administration would not approve its last mesh it had on the market, Restorelle DirectFix.
Restorelle is still on the Coloplast website to be used only in abdominal POP placement (sacrocolpopexy), but Axis and Suspend biologic grafts made from cadavers, no longer are sold. Coloplast still sells the Supris Retropublic sling. At one time, Coloplast sold Novasilk for POP, Suspend, Exair for POP and Axis.
Coloplast is facing another trial in February in the Western District of Pennsylvania.
The case of Debra Schrecengost, [Case No. 3:17-cv-00220], is before Judge Kim R. Gibson. The Coloplast mesh in question is the Aris mesh. Kline & Specter represent the plaintiff. Plaintiffs object to the use of surgeon and urologist Dr. Manish Patel here.
Aris mesh, a mid-urethral polypropylene sling, is still sold by Coloplast. It uses the transobturator approach.
Mesh implanted, Annette Sutphin, who filed her case in January, 2014, is scheduled to have her TVT-O (obturator approach TVT sling) case against Johnson & Johnson’s Ethicon division, heard by a Charleston, West Virginia jury December 3, 2019. She is represented by Kline Specter of Philadelphia.
Her case is 2:14-cv-01379. Any case could settle before trial.
Mazie Slater of New Jersey had planned a September 16th trial against CR. Bard over its Align TOT (TVT- Obturator), but Gasper v. C.R. Bard Inc settled before trial. Trial had been set before Judge Rachelle Harz, in New Jersey Superior Court, Bergen Co. BER L-3159-15.
In pre-trial motions, Judge Harz had ordered that the Material Safety Data Sheet (MSDS) could be used in trial. Referring to polypropylene, the material used in most mesh devices, it shows:
“Do not use material in medical applications in the human body. Do not use the material in medical applications involving brief or temporary application in the human body or contact with internal body fluids or tissue.”
Judge Harz also disallowed the defendant to explain to the jury that the polypropylene mesh implants were cleared for market under the FDA 510(k) or say that it complied with any FDA regulations. In the past mesh makers had secured some relief in having jurors believe that the FDA approved mesh, implying some degree of assurances for safety, which the 510(k) does not!
See the Judge’s order in the case here.
Adam Slater plans two trials naming the Bard Avaulta and Bard Align TOT before Judge Harz in January in New Jersey.
Asmussen and Cruz involve both Align and Avaulta meshes. (Case No. Asmussen, 017894-14,2 Cruz 017504-14,3)
Last January, plaintiffs sought multi-plaintiff consolidated trials rather than single plaintiff trials. That move was opposed by C.R. Bard but eventually granted. See the order here.
MND, Coloplast: Sixth MDl to Represent Women Injured by Transvaginal Mesh, August 30, 2012
MND, April 16, 2019, FDA Orders Mesh Makers to Stop Selling Prolapse Pelvic Mesh
MND, April 17, 2019, Pelvic Mesh Remains on the Market Despite FDA Decision
MND, March 4, 2014, Coloplast Reported to Offer $16 million to Settle Transvaginal Mesh Lawsuits
Coloplast Annual Report 2017/2018