What was Lost in J&J Purge of Ethicon Transvaginal Mesh Documents?

Jane Akre
December 8, 2013
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PART  TWO    (Continued from Part I here)

Lawyers for thousands of women who have filed product liability lawsuits against Johnson & Johnson and its  Ethicon division say the company purged documents for a decade, documents that are crucial to proving their defective transvaginal mesh cases in federal court. Calling it a "systemic failure at all levels," the plaintiffs' lawyers want the judge to  "even the playing field" in upcoming litigation.

There are 12,200 defective product cases naming defendant Ethicon consolidated in federal court in Charleston, West Virginia before Judge Joseph R. Goodwin. Ethicon is one of six defendants facing nearly 40,000 cases alleging defective transvaginal mesh caused permanent injuries and disability.

In Document #953 Plaintiffs Memorandum in Support of Their Motion for a Finding of Spoilation and for Sanctions, the lawyers say that,

“As there is no question that Ethicon destroyed important evidence, the law requires a remedy. The proverbial slap on the hand is not enough, for it would only incentivize these and other Defendants to do the same.”

The first federal Ethicon trial is scheduled to be heard in the Charleston court on February 10. Plaintiffs' attorneys want a default judgment in the case and in the initial TVT-O and Prolift cases.

Ethicon faced its first and only product liability case in New Jersey state court last February where a jury awarded plaintiff Linda Gross, a South Dakota nurse, $11.1 million. That award is being appealed by  Johnson & Johnson.

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.”

What was Lost?

Renee Selman from LinkedIn
Renee Selman from LinkedIn

Renee Selman - Former Worldwide President for Women's Health & Urology at Ethicon from 2005 to 2010. According to the filing, all documents on her company’s hard drive had been destroyed.  She was president during a critical period when Ethicon interacted with the FDA on mesh development including during the FDA’s Public Health Notification in 2008 and would have knowledge how J&J dealt with injury reports coming in while issuing assurances of safety. In the end, Ethicon only produced about 25 documents for Selman and has admitted it destroyed all documents on her company computer hard drive.

According to the filing, “The complete destruction of the hard drive of the outgoing world-wide president, at a time when a litigation hold had been in place for years, is truly remarkable.”

Ramy Mahmoud – Chief Medical Officer and Worldwide President of Evidence-based Medicine, August 2007-July 2010.  He headed four departments and was involved in product complaints and post-market surveillance of POP and TVT. How did the company deal with complaints and warranty claims? Those are questions that could be asked to assess punitive damages. Ethicon has produced 27 documents from his files not tens of thousands that should be there.

Charlotte Owens – Global medical director, Gynecare, September 2003 to August 2005. Owens worked in product development, marketing and sales and provided information to the FDA. Owens help draft the instructions for use of the Prolift mesh and reviewed adverse events coming into the company. Ethicon has produced 6 documents from Owens while a company computer search shows there should be 14,000.

Sean O'Bryan from Linda Gross trial
Sean O'Bryan from Linda Gross trial, Courtroom View Network

Sean O’Bryan – Senior project manager Regulatory Affairs, November 2001 to April 2005. O’Bryan reported to the FDA about the safety of products being developed and was the regulatory lead on the TVT-Blue and TVT-O projects. He was involved in regulatory strategy and product development. He helped draft the instructions for use for the TVT-O. Ethicon produced 54 documents from O’Bryan while a company computer search shows 5,500.

Laura Angelini – VP of Global Strategic Marketing for Ethicon Surgical Care who worked on the TVT from 1997 to 2005 including marketing strategies and development. She started at the company in 1991. As the designee, she was to testify about the originator of the TVT product, Ulf Ulmsten, and how much he was paid. What information was hidden from the public to increase sales, lawyers ask. Her files were purged when she left the company briefly in 2005. Ethicon has no custodial files from 1997 to 2005.

Jennifer Paine – Worldwide Director of Regulatory Affairs June 2004-December 2009, among other positions. Paine worked on the TVT line for over a year. Ethicon produced 71 documents and no e-mails from her even though she had regular contact with the FDA and other agencies.

Price St. Hillaire – Sales and Marketing, Marketing Director 1999 through 2008. He directed Ethicon’s incontinence line so was involved with TVT. He says he was not aware of a litigation hold yet says he destroyed nothing leaving his files in his office when he left Ethicon. Ethicon has produced no files from Mr. St. Hillaire.

Cheryl Bogardus – Worldwide Marketing Director January 2001 through May 2007, among other positions. She says she left her electronic documents behind when she left Ethicon in 2007 and was not aware of a mandate to preserve documents. She says she would have sent or received about 100 e-mails per day. Ethicon has produced no documents for Bogardus.

Gregory Jones – Worldwide Director of Regulatory Affairs 1989-2003 including other positions. Jones kept FDA correspondence, regulatory documents, audit reports, 510k’s and says he was not aware of any effort to preserve those documents.  Ethicon produced 20 documents in Jones' custodial file.

Richard Isenberg, former Ethicon
Richard Isenberg, former Ethicon WW Dir.

Richard Isenberg, former Ethicon

Rick Isenberg – Worldwide Director of Medical Affairs, 1999-2002. His LinkedIn profile says he was in charge of designing and executing clinical trials, supporting research and development, medical evaluations, legal case review, safety surveillance, device design and development, among other responsibilities. Ethicon produced one page from his Human Resources file.

Patricia Hojnoski – Senior project manager and positions in regulatory affairs 2002-2009. She says she would have preserved copies. Ethicon produced 6 documents in her custodial file and apparently destroyed all other documents from her seven years employment.

Jill. Schiaparelli, former Ethicon
Jill Schiaparelli, former Ethicon Dir.

Jill Schiaparelli – Project director for strategic growth 2000-2007. She worked with the Ethicon expert witness, Dr. Todd Heniford who advocates a light mesh material and worked on the strategic growth of Ethicon products. Ethicon has no custodial file for her.

Ethicon has admitted to losing or destroying the documents associated with key company officers and has produced custodial files for fewer than half of the sales representatives.

Ethicon says it has “no database or other mechanism for tracking information provided by sales representatives to physicians or patients.”

Paul Courts- Sales representative. He is the sales rep scheduled to testify in the first bellwether trial. Ethicon has produced 35 documents from his custodial file despite the fact he has testified he had CDs and visual aids used as part of his job. He said he had no idea if they had been preserved.

Troy Mohler- Sales representative, May 2004 to May 2012.  Mohler says he talked to doctors and had a binder of physician call notes when left the company.  He had procedural videos related to TVT on his laptop. Ethicon produced 186 documents and no binder or videos.

Allison London Brown – Marketing Director for Women’s Health and Urology, 2004 to 2007. Employed at Ethicon since 1997.  Her jobs including worldwide strategy for the pelvic floor and incontinence markets and launching the first pelvic floor segment. Ethicon produced no custodial filed for Brown.

B. Todd Heniford, MD
B. Todd Heniford, MD, hernia doc

Videos - Created by expert witness for Ethicon, Dr. Todd Heniford, advocated using a lightweight large-pore mesh materials because “heavyweight meshes should not be used anywhere in the human body, and there is no excuse to continue to do so.”

TVT products are still made from the heavyweight “old old” mesh products used decades earlier in hernia applications says the filing.

Ethicon counsel says they “have not been able to locate any additional videos.”

Documents from Medscand – 600 pounds of documents from Medscand, the original manufacturer of the TVT product. Ethicon says research studies should have been preserved including studies by the late Ulf Ulmsten, called the “cornerstone of Ethicon’s marketing campaign related to the safety and efficacy of the TVT.”

Ethicon has produced one binder and says other documents were destroyed in a fire. Medscand is out of business. An e-mail estimates the documents lost weighed about 600 pounds despite the fact a document hold was in place.

Ethicon had a litigation document hold notification for all products covered in the MDL from May 22, 2003.

According to the filing, a report from Business Edge Solutions concluded Ethicon’s document retention program was failing and could not sustain “the current roster of development efforts and poses a significant compliance risk.”

In 2007, five years after a 2002 audit said there was a lack of a formal records management program, the company instituted a Corrective and Preventative Action (CAPA) because “Ethicon cannot appropriately provide all relevant documents in case of litigation or inspection.” #
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