Mesh Medical Device News Desk, April 10, 2017 ~ It’s been 14 months since the last product liability trial naming a mesh manufacturer.
In this case, Ms. M. Engleman was implanted with two pelvic meshes made by Ethicon, the division of Johnson & Johnson.
Jury selection begins today.
An army of eight law firms has converged in this Philadelphia courtroom to hear the first defective product case against Johnson & Johnson pelvic mesh in 14 months.
The case, Engleman v. Gynecare ( No. 140305384) will be heard before The Honorable Arnold New in the Philadelphia Court of Common Pleas, the same court that delivered two overwhelming jury verdicts against J&J in December 2015 and again in February 2016.
Ms. Engleman was implanted with the TVT-Secur (TVT-S) and the TVT in 2007 and 2008, in two separate Philadelphia hospitals. Her implanting doctors are not named in the action, Dr. Gregory Bolton and Dr. Joseph Montella.
In mid 2012, Johnson & Johnson quietly removed four troublesome meshes from the market citing business reasons. TVT- Secur was among them. See the Mesh News Desk story here.
The plaintiff has filed 15 claims against Ethicon including defective design, failure to warn, negligence, breach of warranty and violation of consumer laws, among others. She is seeking punitive damages.
Also named as defendants are in the case are Johnson & Johnson, Ethicon Inc, Ethicon Women’s Health and Urology, a division of Ethicon Inc. Gynecare is a division of Ethicon. See the court docket here.
If previous cases heard in this court are an indication, punitive damages could be huge and drive the defendant one step closer to mass settlements, which it has so far rejected.
In the Carlino case, also heart in this Philadelphia court in February 2016, the jury awarded Sharon Carlino $13.5 million finding her TVT mesh was defective. The award includes $3.25 million in compensatory damages for her pain and suffering, $250,000 for loss of consortium to Mr. Carlino and $10 million in punitive damages.
See Mesh News Desk on the Carlino verdict here.
Patricia Hammons was awarded $12.5 million in December 2015 after jurors listened to her case against the J&J and its Prolift mesh to treat pelvic organ prolapse (POP). The award included $5.5 million in compensatory damages and $7 million in punitive damages. J&J has quietly removed Prolift from the market.
See Mesh News Desk on the Hammons trial here.
The defense team is led by Butler Snow firm of Ridgeland, Mississippi.
It has filed to limit the expert testimony of Dr. Uwe Klinge who has been an expert in other Ethicon cases. Dr. Klinge is a former hernia surgeon from Germany who has used Ethicon’s Prolene mesh in hernia repair. He has also collected explanted meshes that have failed.
Defense argues he has not treated stress urinary incontinence (SUI) and never used the TVT-Secur in his practice.
In suggesting an alternative design, Dr. Klinge says the PVDF mesh or larger-pore like Ultrapro would have been a safer treatment for SUI, however, defense argues the PVDF is not cleared for use in the U.S.
Dr. Klinge will testify, as he has in both the Gross case and the Huskey case, that Prolene will degrade, fray and lose particles but Ms. Engleman has not provided any evidence that occurred in her case, says the defense.
Plaintiff’s Motion in Limine No. 6 is written to exclude information about the FDA to the jury, including that the TVT-S was submitted to the FDA August 30, 2005 to be marketed under the 510(k) clearance, a short-cut fast-track way to get to market, and that the FDA never pursued an enforcement action against TVT-Secur.
Defense argues that under New Jersey law (the Plaintiff is from New Jersey), a device maker’s compliance with FDA regulations indicates Ethicon acted reasonably in designing TVT-Secur and warning about its risks. Defense wants this information before a jury.
Under New Jersey law, a product manufacturer is not liable for harm caused by a failure to warn if the product contains an adequate warning or instruction. Complying with FDA requirements presumes one has an adequate label.
Attorneys for the plaintiff are Ben Anderson, Bryan Aylstock, Lee Balefsky and Stark and Stark. Representing Ethicon are Butler Snow, Drinker Biddle & Reath, Tucker Ellis and Combs & Spann.
There are dozens of defective product cases naming mesh manufacturers filed in the Philadelphia Court of Common Pleas that are being readied for trial.
In multidistrict litigation in federal court in Charleston, WV, J&J is facing more than 38,000 cases with another 9,000 filed in a state MDL in New Jersey, more lawsuits than any other mesh maker. ###