Upcoming Pennsylvania Pelvic Mesh Trials Has J&J Motioning to Exclude Experts

Jane Akre
January 14, 2016
Philadelphia Court of Common Pleas
Philadelphia Court of Common Pleas

MND, January 14, 2016 ~ A review of documents in two upcoming pelvic mesh trials, scheduled for this month and next, show defendant Ethicon, a subsidiary of Johnson & Johnson, filing motions to gut the Plaintiffs' case.

Carlino v. Ethicon, ~ January 25, 2016, Philadelphia.  Case No. 1306-03470, Philadelphia Court of Common Pleas.

On or about August 18, 2005, Ms. Carlino was implanted with one or more of meshes and Gynecare TVT by her doctor, Andrew Blechman of Neptune Township, NJ.  She had two corrective surgeries to revise and/or remove the mesh in November 2007 and again in December 2010, both with Dr. Blechman.

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.

Plaintiffs plan to introduce evidence of J&J spoliation or document destruction which J&J argues will highly prejudice the case. See  Mesh News Desk background story here.

TVT mesh breaks apart, Wisbech Standard, UK
TVT mesh breaks apart, Wisbech Standard, UK, Jaye Lee

Defendant notes "the fact that some Ethicon employees made inadvertent mistakes with respect to document retention is not a basis to taint the upcoming trial with plaintiffs’ spoliation allegations. This trial should be about whether the TVT product at issue is defective; whether it carried appropriate warnings; and whether it caused the specific injuries alleged by Ms. Carlino. Injecting spoliation evidence into the plaintiffs’ presentation to the jury would overshadow the trial, confuse the jurors and distract them from making those critical determinations. “

Claims include - Negligence, fraud, failure to warn, defective manufacturing and design, negligent misrepresentation, breach of warranty, violation of consumer protection law and gross negligent disregard for others. Also loss of consortium.

TVT Secur, Megamed Services
TVT Secur, Megamed Services

McGee v. Ethicon, ~ Philadelphia, Kline & Specter, TVT Secur, February 22, 2016, Case No. 1306-03483

Ms. McGee was implanted with an Ethicon (Johnson & Johnson) TVT-S (Secur)  in Mason City, Iowa by Dr. Charles Debrah on September 6, 2007.  She underwent corrective surgery March 7,  2008 also by Dr. Debrah and another corrective surgery July 21, 2008.

Dr. Klinge

Ethicon has filed motions to exclude experts - Dr. Uwe Klinge, is a biomedical researcher from Germany. At his Institute of Pathology at the Hospital of Duren are 485 pelvic mesh explants and  22 explanted TVT and TVT O samples, all made of J&J's Prolene mesh. He will testify about the changes the mesh underwent in the body.

Peggy Pence, PdD and team at Symbion Research Intl.
Peggy Pence, PdD and team at Symbion Research Intl.

Experts Include

J&J also wants excluded from the case Dr. Peggy Pence, who has previously testified in pelvic mesh litigation as an expert on FDA regulation, and Dr. Bruce Rosenzweig as an expert on the body's reaction to mesh.

Another filing suggests federal preemption may apply in that the Prolene mesh, which makes up hernia mesh and is the same mesh used in pelvic mesh repair, was approved by the FDA as a Class III medical device, therefore subject to federal preemption protections. See an explanation under Riegel v. Medtronic here.

Only in 1990 was it reclassified as Class II allowing it to be marketed under the FDA's 510(k).

Solyx Sis System
Solyx Sis System

Sherrer ~ Editor's Note* The plaintiffs' case in Sherrer in Kansas City, Missouri has concluded. The case began on December 2, 2015 and  was interrupted in mid- December for the holiday season. The trial resumed January 4.  MND  will bring updates as we are able. The case number is 1216-CV27879, Sherrer v Boston Scientific and C.R. Bard and Truman Medical Center.   Here is a background story on the trial.

The trial was interesting because Sherrer was implanted with two meshes, however a reader's comment allegedly upset one member of the defense team who appealed to the judge to omit cameras in the court.  MND lost its access to the courtroom camera at that point, which was allowed to stay.

Ms. Sherrer was reportedly only mildly incontinent when she was implanted with the Solyx (Boston Scientific) in October, 2010. The Solyx has tips that anchor into the pelvic region and its edges are detanged, meaning they are not raw but looped.  She was also implanted with the Align S (Bard) when the Solyx failed that surgery occurred January 3, 2011. Eventually she had a mesh removal by Dr. Shlomo Raz at UCLA.

Dr. Raz and Suzanne M.
Dr. Raz and Suzanne M.

Trials Also Ahead:

Way v. C.R. Bard, February 22, 2016, Volusia County Florida

Mullins v. Ethicon, April 11, 2016, Charleston WV, (Case No. 2:12-cv-02952.)   This case consolidates 37 plaintiffs who have similar actions in one trial naming Ethicon/ Johnson & Johnson.  They all have a TVT (transvaginal tape) implant and were implanted by different surgeons in West Virginia. Those are the common issues of law and fact that allow them to be consolidated into one trial.

Figueroa v. Boston Scientific, May 16, 2016, Dallas, Texas.

Edwards v. Ethicon, June 3, 2016, Charleston, WV


Philadelphia Court of commons list of upcoming trials


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