J&J Mishandled Transvaginal Mesh Litigation Files - Let the Jurors Decide

Jane Akre
February 7, 2014
Renee Selman from LinkedIn

Renee Selman from LinkedIn

An update now on the missing Johnson & Johnson (J&J) files that were requested by lawyers for the injured in upcoming transvaginal mesh litigation, only to find they went missing or were intentionally destroyed.

A judge has West Virginia judge has ruled the healthcare giant did improperly destroy or lose thousands of files, emails, documents and videotapes. J&J could have been sanctioned as a message to the company and the five other mesh makers facing litigation in that court not to destroy potential evidence.

But in the ruling this week, Cheryl Eifert, a U.S. Magistrate judge from Charleston, West Virginia, recommended to allow that evidence before jurors so plaintiffs can argue it puts them at a disadvantage.

The ruling comes on the eve of a February 10th first federal trial for Johnson & Johnson over its Prolift transvaginal mesh.

The company has 15,129 cases pending before Judge Joseph Goodwin, overseeing the federal litigation in that federal court among the 50,000 cases filed. Court here.

Mesh Medical Device News Desk (MND) on December 8, 2013 reported on What Was Lost in the Purge of Documents here.

Company officials regularly rotated through their high-profile positions and just as regularly had their computer hard drives purged after they left their position. That included the Worldwide President for Women’s Health & Urology at Ethicon from 2005-2010, Renee Selman and Charlotte Owens, Global Medical Director for Gynecare from September 2003 to August 2005.

Charlotte Owens, Gynecare

Charlotte Owens, formerly with Gynecare

Plaintiffs say there were 22 current or former Ethicon employees who produced few if any documents for discovery.

The company in an email told Bloomberg News here, While Ethicon produced millions of pages of documents in the MDL, it did inadvertently fail to preserve some documents, many of which were available elsewhere” referring to files turned over in litigation.

Why no Sanctions?

According to plaintiffs’ attorneys, there had been an order in place over the last decade to preserve the documents, according to the filing, but the documents, records, personal notes, databases, e-mails and videotapes were destroyed regardless.

Ultimately the reason Ethicon lost and destroyed thousands of documents is not the key issue, the filing says. “Whether it was willful or negligent, Ethicon is culpable under the law”~ Plaintiffs' lawyers in Document #952, Plaintiffs’ Motion for a Finding of Spoliation and for Sanctions.

The legal term “spoliation,” refers to the destruction or alteration of evidence or a failure to preserve property to be used as evidence in pending or foreseeable litigation.

In the Tuesday ruling, Judge Eifert found “Ethicon did destroy or otherwise lost documents that should have been preserved in anticipation of this litigation. However, the court further finds that Ethicon’s loss of evidence was negligent, not willful or deliberate, and Plaintiffs have failed to establish a resulting prejudice sufficient to support the severe sanctions of default judgment, striking of defenses, and the offering of an adverse instruction in every case.”

The court found the Plaintiffs are entitled to financial compensation for the additional time spent identifying the missing files and preparing for depositions of key employees in the absence of information by Ethicon. The plaintiffs should be allowed to, on a case-by-case basis, introduce evidence of spoliation at trial when appropriate and seek “adverse instruction in specific cases.”


The first transvaginal tape (TVT) lawsuit was filed against J&J in March 2003 and at that point Ethicon’s attorneys issued a “Document preservation notice” specific to this Oregon case. They were supposed to preserve documents pertaining to TVT either in print or on the computer and keep them in a safe place.

At the filing of the second TVT case, Keeton v. Gynecare Worldwide in April 2006 a notice covered the same types of document preservation.

In April 2007, a third document preservation notice was issued concerning TVT documents in a California case which was voluntarily dismissed. The Keeton case was dismissed by summary judgment.

After that a steady stream of cases began coming in – in 2008 there were five cases - the same year that the FDA issued its first public health notification concerning synthetic transvaginal mesh.

After 60 cases were pending in New Jersey in February 2010, Ethicon’s in-house counsel issued a “Consolidated Hold Notice for Pelvic Mesh/Gynecare Product Liability Litigation” for the TVT and Prolift product lines as well as those involved in the ongoing litigation such as the TVT Obturator and the TVT Secur.

The court was not persuaded by Plaintiffs’ argument that 2003 was the date the company should have been put on notice to preserve evidence relevant to today’s MDL especially since the case was dismissed in January 2004. Personnel within the company knew the case was resolved, even though the formal notice for document preservation remained in place.

“Nothing before this court suggests that Ethicon had any reason in 2003 to anticipate additional litigation relating to its transvaginal mesh products," says the Eifert ruling.


Sanctions require bad faith, gross negligence, willfulness or ordinary negligence or lack of due care. Plaintiffs argued that wiping of Renee Selman’s hard drive was bad faith while Ethicon’s failure to implement an effective retention policy was grossly negligent.

Plaintiffs established the spoliation of evidence but at the same time they argued its difficult to know what evidence was destroyed or lost therefore difficult to the extent of the prejudice.

Since Ethicon employees “intentionally and in bad faith deleted numerous e-mails after the litigation had been instituted and hold orders were issued”, the court ruled the Plaintiffs were still able to present their case and the prejudice did not rise to the level necessary to enter a default judgment or strike defenses.

“Plaintiffs have not demonstrated prejudice so substantial that their cases are irreparably damaged. Therefore, extreme sanctions like default judgment and striking of defenses are not justified”~ Eifert

The court denied Plaintiffs’ request for those forms of relief because the plaintiffs did not identify the weakness in their cases because critical evidence was lost or destroyed or identify any evidence that was relevant to the pending litigation. Because of that, the court denied plaintiffs’ motion for an order offering an adverse inference instruction in every case but “recommends that the Presiding District Judge allow Plaintiffs the opportunity to introduce evidence regarding Ethicon’s loss of relevant documents on a case-by-case basis, and, when appropriate, to tender an adverse inference instruction.”


Because of the difficulty and cost involved by Plaintiff attorneys in piecing together information and determining which documents were missing, plaintiffs request for monetary sanctions and reasonable costs was granted.

Learn More:

Pretrial Order #100 Plaintiffs’ Motion for a Finding of Spoilation and for Sanctions MDL No. 2327, 44 pages


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