Mesh Trials on the Horizon

Adam Slater, Mazie, Slater

Mesh Medical Device News Desk, January 7, 2018~ 2018 promises to see a revival of transvaginal mesh product liability trials around the country. A number of cases are set to go before a jury in the coming months in New Jersey, Philadelphia and even Charleston, WV, where the multidistrict litigation is centered with more than 104,000 cases filed.

Mesh News Desk will attempt to keep you up-to-date on the trials, however if anyone wants to attend and send updates to MND, it would be much appreciated.

In Charleston, WV expect May 15, 2018 as the trial date for the Wave 7 Ethicon cases and in June, Wave 6 of the Bard cases will be set for trial.

NEW JERSEY

Prolift, MedTech Marketing

The New Jersey law firm of Mazie Slater Katz & Freeman, will bring the defective product trial of Mary and Thomas McGinniss v. Bard to trial in Bergen Co. New Jersey on Monday, March 19. Docket No. L-017543-14.

There are 154 product liability cases naming C.R. Bard in this venue. See the state cases consolidated in New Jersey here.

There are 9,093 cases in the same court naming Ethicon (Johnson & Johnson). See the list here.

Opening statements will be heard in Bergen County before Judge Rachelle Harz.

Lori Cohen, attorney for C.R. Bard

Defendant C.R. Bard has added attorneys Lori Cohen (Greenberg Traurig), Marcella Duca, Melissa Gist and Marilyn Moberg (Reed Smith) to its team. Cohen lost the first MDL case against Bard (Cisson) in August 2013 in the Charleston, WV court to attorney Henry Garrard.

New Jersey cases only allow you to receive the docket here. You must request by mail to receive documents if you are not an attorney.

Philadelphia Court of Common Pleas

PHILADELPHIA

Philadelphia Court of Common Pleas, Philadelphia Co.~ Patricia Blockus et al vs Ethicon Women’s Health and Urology, was reset from November to January 8, 2018.

Blockus is from Hunlock Creek, Pennsylvania, where she lives with her husband, Eugene. The defendant corporations are Ethicon, American Medical Systems, Boston Scientific and CR Bard Inc. as well as Sofradim Production SAS, Tissue Science Laboratories Limited, Secant Medical and Prodesco, Inc. The trial was moved from June 19, 2017 and the Case No. is 1307-00707 before Judge Arnold New.

See the case list here.

She was implanted with a Prolift pelvic organ prolapse (POP) mesh March 19, 2007, and a PelviSoft Acellular Collagen BioMesh made by Bard here, July 28, 2008, both at Gesinger Medical Center in Danville, PA to treat pelvic organ prolapse. The implant surgeon is Barbara Plucknett, MD. Ms. Blockus underwent one explant surgery, July 28, 2008 by Dr. Mitesh Parekh, MD.

Bard claims its PelviSoft is highly effective for posterior vaginal wall defects and is “ideal for use in repairing rectocele and cystocele prolapse.” It was developed after Pelvicol, another biomesh, made by C.R. Bard in Covington, Georgia. The promotional material does not say where the “natural” mesh is derived but further research finds it is made from porcine (pig) dermis or skin.

*Note* - See this Porcine dermis study, randomized control trial, with 12 month followup. Using a cure definition as anatomic with no pelvic organ prolapse at Stage 2 or greater. 57 patients. Published in Obstetrics and Gynecology January 2013 by Patrick Culligan MD, Division of Urogynecology Atlantic Health System, Morristown, NJ. See Clinical Trials here.

The complaint states negligence, manufacturing defect, failure to warn, defective product, design defect and common law fraud, the first among 16 claims. The Blockus family asks for punitive damages.

Peggy Pence, PdD and team at Symbion Research Intl.

BLOCKUS MOTIONS FILED

On May 5, 2017, Johnson & Johnson/ Ethicon filed motions to preclude the testimony of expert Peggy Pence, Ph.D., Uwe Klinge, M.D., Ph.D and Daniel Elliott, M.D..

This was done under Pennsylvania Rule of Evidence 702, known as the Frye Motion. (Frye v. United States, 293). Ethicon had filed almost identical Frye motions to preclude testimony in the Hammons case against Ethicon.

With Peggy Pence, for example, Pence is a regulatory expert with more than 40 years experience in the regulation of medical devices. Dr. Pence has testified that the Prolift was misbranded when brought to market because the manufacturer made false and misleading statements.

Dr. Uwe Klinge, mesh expert for Plaintiff

Prolift actually was marketed by Ethicon beginning in March 2005, prior to having any FDA clearance at all. It was only when Prolift M+ was submitted for FDA clearance did the FDA even know the existence of Prolift. Then, and only then, did the FDA issue it clearance to market, three years after it was already being sold!

Dr. Uwe Klinge is a biomaterials scientist who collects explanted hernia mesh and examines its properties. Ethicon wants to prevent him from testifying about Ethicon’s purported knowledge and state of mind, about degradation of mesh and particle loss.

Ethicon wants to exclude the testimony of Dr. Daniel Elliott, who will say that Prolift is defective and that Ethicon had a duty as a medical device manufacturer to make a safe and effective product.

Dr. Rosenzweig, from his promotional materials

The Ethicon motion aims to exclude Bruce Rozenszweig, MD as an expert witness. There is a defense motion in limine to eliminate the Chevron MSDS and any discussion of Johnson & Johnson shredding of documents pertaining to its transvaginal mesh production. See MND story here.

There is a defense motion to eliminate discussions heard in the Ethicon/Budke wrongful death trial and the Linda Gross Prolift trial in New Jersey from 2013.

A Motion for Summary judgment filed by Ethicon October 6, cites that Ms. Blockus allegedly filed outside of her statute of limitation. Ms. Blockus should have been aware of her mesh injury July 2008 and October 2010 and/or should have been aware of the 2008 and 2011 FDA Public Health Notices.

See Blockus Def Ethicon Motion for Summary Judgement, Oct, 2017

Ms. Blockus said she was not aware her injuries might be linked to mesh until she saw television commercials after which she filed her lawsuit.

The defendant says “a plaintiff cannot just sit back and wait to see a lawyer television advertisement before filing suit when there is similar, if not more detailed, information from a government source regarding a potential causal connection between a product and certain symptoms that has been accessible and available to the public for 5 years.”

Between March 2007 and November 2011 she says she experienced ongoing pain and urinary symptoms, four mesh erosions and underwent four surgical procedures to correct the erosions. She also had an additional prolapse device implanted.

Philadelphia Court of Common Pleas

ALSO IN PHILADELPHIA

Also listed for trial in the Philadelphia court is Hespe v Boston Scientific, Trial date certain - January 22, 2018. Case No. 130700947

Deimler vs. Ethicon Women's Health and Urology, Trial date certain - May 14, 2018, Case No. 13070136

There are 131 records found waiting for trial in this pelvic mesh mass tort in Philadelphia. ###