Prolift, sold on eBay

Prolift, sold on eBay

The first federal trial accusing healthcare giant Johnson & Johnson (J&J)  of making defective transvaginal mesh will begin with jury selection Monday morning, February 10, in a Charleston, West Virginia courtroom. This is the first of 15,000 cases naming Ethicon, a division of J&J, consolidated before Judge Joseph R. Goodwin.

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph R. Goodwin, Charleston, WV

Because there are 50,000 cases against six manufacturers consolidated in multidistrict litigation, Judge Goodwin has allowed four cases to be heard against each of the manufacturers. These bellwether trials, as they are known, are intended to get a reading on how jurors will respond to the presentations of each side. Too many losses and a defendant may decide to offer a settlement or continue fighting each case as Johnson & Johnson has vowed to do.

Plaintiff Carolyn Lewis was implanted with the Ethicon Gynecare TVT (tension free tape) transvaginal mesh to treat stress urinary incontinence in 2009. Her attorneys will president evidence that the mesh is defective in its design and in its manufacture. Punitive damages may also be awarded by the jurors.  Last February, a jury in state court in Atlantic City, New Jersey, awarded mesh-injured plaintiff Linda Gross $11.1 million dollars including $7.76 million in punitive damages for the damages caused by her Ethicon Prolift mesh. See background story here.

Lewis, like the other 15,000 plaintiffs claim they suffer from mesh erosion, mesh movement throughout the body, mesh contraction, infections, inflammation, painful scar tissue growth, organ perforation, chronic nerve damage and pelvic floor damage and an inability to have intercourse.

Transvaginal mesh is made of petroleum-based polypropylene and this may be the first time a complaint has listed autoimmune issues among the host of complications.

“Despite claims that polypropylene is inert, the scientific evidence shows that this material as implanted in the relevant female plaintiff set forth below is biologically incompatible with human tissue and promotes a negative immune response in a large subset of the population implanted with the Pelvic Mesh Products. This negative response promotes inflammation of the pelvic tissue and can contribute to the formation of severe adverse reactions to the mesh. When mesh is inserted in the female body according to the manufacturers’ instructions, it creates a non-anatomic condition in the pelvis leading to chronic pain and functional disabilities.” (Carolyn Lewis Doc #1 Complaint 2:12-cv-04301)

Thomas Cartmell, Wagstaff Cartmell

Thomas Cartmell, Wagstaff Cartmell

 

Christy Jones, attorney Butler Snow

Christy Jones, attorney Butler Snow

Attorney Christy Jones will represent Ethicon in the federal case. The Butler Snow attorney also represented Ethicon in the Linda Gross state trial in New Jersey.

Thomas Cartmell of Wagstaff Cartmell represents Ms. Lewis along with Renee Baggett of Aylstock, Witkin, Kreis & Overholtz who authored many of the motions in this case.

Renee Baggett, attorney Aylstock Witkin

Renee Baggett, attorney Aylstock Witkin

Failure to Warn
A product can be defective in its instruction to the end user, that is the physician or medical personnel who will use the device.  In the Gross case, the failure to warn her physician was presented to jurors, but in the Lewis case, Judge Goodwin has ruled there will be no failure to warn element of this product liability claim because her implanting physician said she had not read the product insert (Instructions for Use of IFU) since 2002.

510(k)

In the first federal case against C.R. Bard, Judge Goodwin ruled that jurors could not hear about the FDA’s 510(k) approval shortcut which allows manufacturers to notify the agency it plans to sell  a product that is the “substantial equivalent” of one already on the market. Companies can then bypass any clinical trials to assure safety and efficacy. During the Gross case it was revealed that the Prolift was never tested on humans before it was approved for market.

Lost and Mishandled Documents
Last week U.S. Magistrate Judge Cheryl Eifert  ruled that Ethicon lost or destroyed documents that should have been preserved for litigation. She ruled that jurors should hear documents were destroyed on a case-by-case basis. Judge Goodwin will likely address that issue on Monday.

Ethicon is the second mesh manufacturer to face jurors in this courtroom. Last summer, jurors took 12 days to award C.R. Bard mesh-injured plaintiff Donna Cisson $2 million including $1.75 million in punitive damages. The second bellwether case settled, the third was dismissed by the Plaintiff and the fourth will not be heard until May 2014.

Charleston attorney Harry Bell of Bell Law tells the Sunday Gazette-Mail (here) that this is the largest multidistrict litigation ever filed based purely on the number of cases.
The defendant is Ethicon, a wholly-owned subsidiary of J&J located in Somerville, N.J., Ethicon Women’s Health and Urology, a division of Ethicon; Gynecare, a division of Ethicon.  The case is MDL No. 2327. #