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.
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.
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.
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.
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).
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