Mesh Trials on the Horizon
Mesh Medical Device News Desk, November 1, 2017 ~ Despite what appears to be a lull in litigation concerning pelvic and hernia mesh, a number of cases are set to go before a jury in the coming months. New Jersey, Philadelphia, Charleston, WV and Los Angeles all have transvaginal mesh defective product cases consolidated and waiting for trial.
You all realize these trials are public and it is acceptable to sit and learn from both sides. Trials are very enlightening, especially since many of you are already familiar with the issues.
Mesh News Desk will attempt to keep up-to-date on the dockets. Your updates are very welcome as well!
The New Jersey law firm of Mazie Slater Katz & Freeman, will bring the defective product trial of Elizabeth Alice and Tadeusz Hrymoc v Ethicon, Monday, November 27.
Ms. Hrymoc was implanted with two meshes made by Ethicon, the medical device division of Johnson & Johnson (J&J).
The two polypropylene meshes are Prolift, used to treat pelvic organ prolapse (POP), and TVT (tension-free vaginal tape), used to treat stress urinary incontinence (SUI). Both have been found defectively designed in previous jury actions.
Opening statements will be heard in Bergen County (Bergen Co Docket No BER-L-13696-14 MCL), before Judge Rachelle Harz. Jury selection will begin before that date. The case was filed September 24, 2009. See Pre-Trial scheduling here.
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 Co.~ November 6, 2017 / Patricia Blockus et al vs Ethicon Women’s Health and Urology. * Late Breaking ** This trial has been moved to January 8, 2018, with jury selection set for January 4.
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 and a PelviSoft Acellular Collagen BioMesh made by Bard. See Bard brochure here.
Ms. Blockus was implanted with Prolift March 19, 2007, and the PelviSoft 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.
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.
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.
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.
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.
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.
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. ###