Philadelphia Pelvic Mesh Trial

Transvaginal-Mesh1Record $57.1m awarded by Jury in Philadelphia Pelvic Mesh Trial

An award of $50 million in compensatory damages, and $7.1 million in punitive damages has been awarded against Johnson & Johnson’s subsidiary company, Ethicon, after it was held that it’s transvaginal mesh implant product was defective in a Philadelphia Pelvic Mesh Trial in America.

The award in Ebaugh v Ethicon is just one of several multi million dollar verdicts since the first of such pelvic mesh cases came through the Philadelphia Courts in late 2015. Ms. Ebaugh was awarded more than twice the second-largest award made in Philadelphia’s Mass Mesh Tort Program to date, which was a $20 million dollar verdict handed down in May 2017.

Vaginal mesh repair is a common gynaecological procedure, commonly used to treat symptoms of incontinence and/or prolapse. Transvaginal Mesh in the form of a permanent or semi permanent artificial support is used in vaginal repairs to support weak tissues in this area. Common complications arising out of the use of Transvaginal Mesh include the following;

  • Infection – which may require removal of the mesh.
  • Rejection – Loosening of the whole mesh, the mesh may partially or completely protrude through the vaginal skin causing discharge or pain to your partner during sex. This may need another operation to divide the mesh that is protruding out or to remove the entire mesh if there is infection present.
  • Mesh protrusion or erosion – Part of the mesh wears through a gap that develops in the vaginal skin so that it pokes out. This will usually require surgery to trim the loose portion and to close the gap in the skin.

Ms. Ebaugh had a TVT-Secur Sling (TVT-S) inserted in 2007 to relieve symptoms of incontinence following the birth of her five children. In 2007, she had to undergo corrective surgery, due to mid-urethral erosion and the TVT-S was replaced with another mesh, TVT (transvaginal tape). In 2011, she underwent another corrective surgery due to additional complications, and a further corrective surgery was carried out in 2012. In 2016, she was required to undergo mesh removal.

Ms. Ebaugh’s trial commenced on the 31st July 2017 wherein she alleged both negligence and product liability. She further contented that the company failed to warn patients and physicians of the associated risks inherent in the products, and withheld information about the likely complications from the medical community.

TVT-S mesh was pulled from the Australian market in 2006 by Ethicon, however remained on the US market until mid 2012. TVT mesh remains on the market today.

Throughout the trial, evidence was produced to show that the particular TVT-S Mesh, manufactured and produced by Ethicon, had not in fact been tested before marketing due to budget constraints at the time. Instead, five weeks of “randomized-control testing” was carried out on 31 women. The results of this trial were never published, however the jury heard that within five weeks, the product had failed amongst 30% of the women. Nevertheless, the product was released onto the market. It was further stated by counsel for the plaintiff, that in the case of TVT meshes, trial results were paid for and the underlying data was never verified prior to the product being release onto the market. Counsel for the plaintiff the defendant’s company emails to illustrate that “there were many attempts made to manipulate the literature…and they continued to sell them knowing this information…they made the case almost indefensible”.

The trial ran for one month, with the jury deliberating for two days before ultimately finding for the plaintiff.

A spokesperson for Ethicon indicated that the company intends to appeal the decision-

We believe the evidence showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems,”.

Johnson &Johnson have recently made efforts to have several cases thrown out based on the US Supreme Court decision in Bristol-Myers Squibb v. Superior Court of California wherein it was held that “out-of-state plaintiffs” can’t sue companies in states where the defendants aren’t considered to be “at home,” or haven’t conducted business directly linked to the claimed injury. However, this ruling is unlikely to have any standing in the Ebaugh case in circumstances where Ms. Ebaugh is a Pennsylvanian resident.

Ebaugh remains symptomatic today, suffering from a deformed urethra, covered in scar tissue near the opening and middle. She has almost no bladder control and has been diagnosed with Intrinsic Sphincter Deficiency, which is caused by anti-incontinence surgery and results in uncontrolled spasms of the bladder, amongst other symptoms.

RELEVANT ARTICLES:

http://colemanlegalpartners.ie/transvaginal-mesh-errors/

https://www.meshmedicaldevicenewsdesk.com/inside-ebaugh-v-ethicon-pelvic-mesh-trial/

http://www.law.com/sites/almstaff/2017/09/07/jury-hits-jj-with-record-57-1m-verdict-in-pelvic-mesh-case/