Federal courthouse, Charleston, WV

Federal courthouse, Charleston, WV

MND, August 20, 2015 ~ There have been some new developments in Ethicon transvaginal mesh litigation.  The first news is that the upcoming trial of Edwards v. Ethicon (2:12-cv-09972) will not commence August 24 but is rescheduled for January 11, 2016.

Tonya Edwards, 43, a Georgia resident, was implanted with a TVT-O by Dr. Harold Wittcoff. She is represented by Mark R. Mueller, an Austin, Texas attorney.   According to a Judicial Order (Doc #222) filed August 12, the Pretrial and Final Settlement Conference is moved from August 17, 2015 to December 22, 2015, pushing the trial back to Monday, January 11, 2016.

BACKGROUND- What’s Ahead with this Trial

Christy Jones, from Linda Gross trial Feb 2013

Christy Jones, from Linda Gross trial Feb 2013

Johnson & Johnson defense attorneys Christy Jones and David Thomas (document #74) wanted to exclude the expert opinion of Dr. John T. Steege. He would testify the TVT0-O was defective and caused her present day pain.  Ms. Edwards had delivered three children vaginally and experienced stress urinary incontinence (SUI) before being implanted with pelvic mesh as a treatment.

The mesh explanted from Edwards was not properly preserved by Dr. Vladimir Iakovlev, argues Defense. For their part Defense used Dr. Elizabeth Kavaler, previously seen in the Linda Gross trial, to issue an expert report as well as Dr. Stanley Zaslau.

Defense planned to raise the usual defenses, Edwards was obese, had experienced hip and back pain prior to her mesh implant and had a small rectocele and cystocele as well as urethral hypermobility all prior to her implant.  Treatments such as injections had not treated her SUI.  She had had about 60 occasions to consult with various medical providers and did not report pelvic pain until more than six years after her implant, says the Defense. It was only after seeing a television ad for pelvic mesh litigation that she filed her case.

Eventually she sought treatment with Niall Galloway, MD with complaints of repeated urinary tract infections and pelvic pain.

Judge Joseph Goodwin

Judge Joseph Goodwin

JO HUSKEY TRIAL -VERDICT WILL STAND 

Pending before Judge Goodwin was Defendant Ethicon, Inc.’s (Johnson & Johnson) Motion for Judgment, or a directed verdict in its favor in the Huskey v. Ethicon trial, which Judge Goodwin denied. (See Husky #441 Motion for Judgment, August 19 2015).

Had he granted the motion the jury award of $3.27 million and conclusion that the TVT-O is defective would have been set aside.

The Huskey case (2:12-cv-05201) was the first bellwether jury trial for Ethicon before Judge Goodwin in this Multidistrict Litigation.  At the present time the MDL contains over 26,000 cases filed against the subsidiary of J&J.  Jo and her husband Allen Huskey, filed the action after she was implanted with the TVT-O (Obturator) used to treat incontinence.  Her implanting physician was Dr. Gretchen Byrkit and the date was February 23, 2011.  The mesh eroded and caused her pain. Another physician, Dr. Sohail Siddique attempted a mesh removal on November 18, 2011. He removed about one-third of the mesh from what he described as a “chronically infected space.” An athlete, Ms. Huskey now has limited ability to participate in physical activity and still experiences SUI, pain in her bladder, dyspareunia and joint pain.

Judge Goodwin could have granted the judgment as a matter of law, essentially setting aside the jury verdict.  He did not.

On September 5, 2014, a West Virginia jury decided the TVT-O was defectively designed and awarded Ms. Huskey $3.27 million.  Judge Goodwin wrote “While courts should not simply rubber stamp a jury’s verdict, judgment as a matter of law is a remedy to be applied sparingly and only in the most extraordinary circumstances.” 

Because this case is decided under Illinois law, her home state, in order to find a design defect decision, the jury found the design made the product unreasonably dangerous and it injured the Plaintiff.  Illinois Civil Jury Instructions say,

“When I use the expression ‘unreasonably dangerous,’ I mean that the risk of danger inherent in the design outweighs the benefits of the design when the product is put to a use that is reasonably foreseeable considering the nature and function of the product.” See Ill. Pattern Civ. Jury Instructions § 400.06A.3

Ethicon says no reasonable juror could conclude the TVT-O is unreasonably dangerous, but Judge Goodwin recounts the evidence in the case in a very compelling manner. It’s worth a read.

“From this evidence, a reasonable jury could conclude that the high risks of the TVT-O are not justified by the benefits, and as a result, the TVT-O cannot, as a matter of law, qualify as an unavoidably unsafe product. Ethicon, having failed to meet its burden, cannot save itself from the jury’s verdict on design defect by appealing to comment k’s exemption.”

On design defect the Plaintiffs presented evidence that the polypropylene mesh material had a tendency to erode, that laser-cut mesh was defective and that the placement in the obturator space of heavyweight mesh.  Judge Goodwin says,

“I FIND that the plaintiffs demonstrated sufficient circumstantial evidence to support proximate causation for at least one of these defects such that a reasonable jury could find in their favor on the design defect claim.”

The IFU (instructions for use) were inadequate a jury could reasonably conclude and Dr. Byrkrit (the implanting physician)  said to the jurors she would not use a TVT-O in an athletic woman, said Judge Goodwin, allowing those jury decisions to stand.  Judge Goodwin also allowed to stand the negligent design and negligent failure to warn claim.

Ethicon has not made the required showing to warrant a new trial, Judge Goodwin writes.

200 CASES READIED FOR TRIAL

In a pretrial order, Judge Joseph Goodwin orders TWO HUNDRED Ethicon cases to start the pretrial process.

The oldest cases filed before Judge Joseph Goodwin in the Ethicon MDL will now become Wave 1 cases. Judge Goodwin has just outlined a schedule to bring these cases to court. The discovery process, expert depositions must be completed by March 28, 2016 and the cases should be trial-ready.

Because there are so many Plaintiffs, the Defense is limited to ten Interrogatories (questions Plaintiffs must answer) and there will be a limit of 10 requests for admission per Plaintiff.  There will be a limit of no more than five experts per case. Both sides will meet by January 11, 2016 and decide the venue which other federal court the case may be tried or in the Southern District of West Virginia.

This is the corrected Docket Order.

http://www.wvsd.uscourts.gov/MDL/ethicon/pdfs/PTO_193.pdf

#

LEARN MORE

MND, July 24, 2014 ~ Huskey case survives Summary Judgment
https://www.meshmedicaldevicenewsdesk.com/huskey-v-ethicon-case-survives-summary-judgment

 

MND, September 5, 2014- Jury Decides for Huskey $3.27 Million in Pelvic Mesh Trial
https://www.meshmedicaldevicenewsdesk.com/awesome-jury-decides-for-huskey-3-27-million

 

Huskey #441 Motion for Judgment, August 19 2015