*Just In* Wave 7 Ethicon Trial Postponed Until Next Year

Mesh Medical Device News Desk, August 13, 2018 ~ It was set to start tomorrow, but the mass trial of more than 100 plaintiffs has been reset as thousands of cases are purged from the Ethicon docket.

WAVE 7 UPDATE

Image: Wave, WikiCommons

You’ve heard the term - a “Wave” of cases - that were set to begin Tuesday, August 14, 2018 where multiple plaintiffs, more than 100 at one time, all women from West Virginia who had suffered from TVT mesh implants, were to have their case against Ethicon ( J&J) heard in one mass trial.

The Wave is off as the court goes through a purging of cases in an attempt to have it dissolved.

Last May, it was announced that the Wave would be heard before Judge Joseph Goodwin. At the time he was overseeing more than 100,000 pelvic mesh cases before him representing seven mesh makers consolidated in one multidistrict litigation (MDL).

Judge Joseph Goodwin

Since then, Ethicon asked, and Judge Goodwin agreed to clear the docket of non--revision TVT meshes, of women who have not had any surgical removals of Ethicon meshes from the TVT family (tension-free vaginal tape) family. That includes TVT Retropubic, or Abdominal, TVT Obturator, TVT Abbrevo, TVT Exact.

Four devices which are no longer marketed are also included such as Prolift, Prolift +M, Prosima and TVT-Secur. The TVT family also includes Gynemesh PS and Prolene, the proprietary name of Ethicon (J&J’s) polypropylene mesh.

See MND on what Ethicon was granted here.

Judge Goodwin has been busy removing those cases from the So. District of WV docket as law firms announce they have reached settlement with Ethicon on behalf of their clients.

Between dismissals and settlements, the 100 woman caseload of Wave 7 is now whittled down to one.

Dr. David Afram, MD, YouTube

Sutphin v. Ethicon is scheduled to be heard April 22, 2019, before Judge Goodwin in Charleston, WV.

SUTPHIN V ETHICON

The West Virginia plaintiff was implanted with a TVT February 24, 2009 at Logan Regional Hospital in Logan, West Virginia by Dr. David Afram, MD, who now practices in Virginia.

The attorney on the complaint is Lee Balefsky and Michelle Tiger from Kline & Specter, while Kila Baldwin has tried many cases for the Philadelphia-based law firm.

JNJ WANTS 510(K) IN, PEGGY PENCE OUT - RECENT FILINGS IN SUTPHIN CASE

Filed this month in the Sutphin (2:14-cv-01379) case, Defendant Ethicon has objected to Plaintiff wanting to exclude the FDA 510(k) evidence.

Plaintiff says the defendants now attempt to introduce additional arguments that the 510(k) clearance of mesh means it is, “FDA cleared, safe and effective,” and without risk.

Kila Baldwin, the attorney for Sutphin, says the defendant has “cherry picked” from FDA language, “from case law and FDA determinations, made blanket assumptions, and have fully ignored the conclusions made both by the Courts and the FDA.”

The FDA’s 510(k) clearance to sell is not the same as a premarket approval or PMA which drugs must undergo.

Even the U.S. Supreme Court has acknowledged” “The 510(k) notification process is by no means comparable to the premarket approval process; in contract to the 1200 hours necessary to complete a premarket approval review, the 510(k) review is completed in an average of only 20 hours.”

Kila Baldwin, Kline Specter

To introduce the regulatory language by the FDA could be considered an attempt to go down the rabbit hole of FDA regulatory jargon, sure to take up time before a jury and serve to confuse and obfuscate exploration of the defective nature of the polypropylene mesh implant, used to treat incontinence.

Defendant corporations have tried, unsuccessfully in the past, to introduce the 510(k) issue.

Baldwin writes, “To ask this Court to now provide jury instructions implicitly stating that the FDA has determined that the TVT-O is safe and effective and/or that Defendants acted with “due care” because it is a Class II device, without mentioning the FDA’s litany of concern over the Device’s safety and efficacy is misleading and preposterous. “

Filed last March 5, 2018 was a defendant’s motion to exclude Peggy Pence, Ph.D from the Wave 7 trials.

As many readers are aware, Dr. Pence has testified about the FDA regulatory process, and is considered an expert in how drugs and devices are brought to market, development, regulatory affairs and labeling standards. Judge Goodwin said the expert opinions expressed early on in this MDL are identical to those offered today.

Dr. Peggy Pence, Courtesy CVN

The court attached similar rulings from a 2016 Memorandum Opinion and Order ECF 2075 on Peggy Pence:

Denied - Ethicons’ challenge of Dr. Pence and her 40 years of accumulated knowledge about the adequacy of the IFU, Instructions for use.

Denied- The use of Dr. Pence to testify about premarket testing of medical devices.

“Accordingly, the court will refrain from engaging the extremely inefficient practice of continuously reexamining the qualifications, reliability, and relevance of dozens of experts and their numerous opinions.” Challenges to experts, known as Daubert challenges, not previously addressed to the court are reserved for trial, says Judge Goodwin writing August 7, 2018. ###