J&J Systematically Destroyed Evidence in Upcoming Mesh Trials, Pl Lawyers Call it ”Severe” Destruction of Evidence

Dec 8th, 2013 | By | Category: Legal News

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Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation
Joseph R. Goodwin, presiding
Date filed: 02/07/2012
Date of last filing: 12/03/2013

PART ONE     (Continues in Part 2)

According to a 30-page document filed in federal court in West Virginia December 2, officials at Johnson & Johnson (J&J) destroyed upward of hundreds of thousands of documents over a decade that would have been essential to upcoming federal litigation that puts Johnson & Johnson’s Ethicon division and its transvaginal mesh on trial.

Prolift mesh sold on ebay

Prolift, ebay July 2013

Ethicon makes the Prolift mesh kit as well as the TVT-O (Obturator) System. The first of four federal bellwether cases is set to begin February 10, 2014 in Charleston, West Virginia testing legal arguments presented by both sides before a jury.

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.”

The missing evidence is highly relevant to the plaintiffs’ claims, according to the filing, especially when you consider the sheer volume of information that was lost or destroyed.

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph R. Goodwin, Charleston, WV

Attorneys for the women have asked Judge Joseph R. Goodwin, who is presiding over 12,200 Ethicon defective product cases in Charleston, West Virginia, to impose “severe sanctions” including a default judgment in favor of the bellwether plaintiffs.

The concern is unless an example is made of this type of irresponsible corporate behavior others may decide to do the same thing.

Document #952, Plaintiffs’ Motion for a Finding of Spoliation and for Sanctions, asks for an even playing field.

(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.)

Plaintiffs Want to Even the Playing Field      

Attorneys representing the women ask the court to issue “severe sanctions against Ethicon based on its rampant spoliation.”

1) Plaintiffs ask the Court to “grant default judgments to Plaintiff Carolyn Lewis, as well as the plaintiffs in the first TVT-O bellwether trial and the first Prolift bellwether trial.

2) Declare the Court will issue a spoliation instruction to the jury at every Ethicon bellwether

3) Strike the Defendant’s learned intermediary defense for every trial as well as

4) Strike any statute-of-limitations defenses for every trial and

5) Charge Plaintiffs reasonable costs and attorney’s fees associated with this motion to the Defendant

The defendants should not benefit from the gaps they created, says the filing.

According to Matthew Johnson, a spokesman for Ethicon, the company has turned over millions of pages to plaintiffs’ lawyers through its “appropriate process” and he denied any relevant documents have been intentionally destroyed. He e-mailed to Bloomberg:

“We have never intentionally destroyed, withheld or failed to produce relevant documents,”   and that the plaintiffs weren’t “prejudiced by any isolated instances where documents may have inadvertently not been maintained.”

In the first state court case against J&J over mesh, the trial of plaintiff Linda Gross concluded last February in a New Jersey court with an $11.1 million judgment against the company, including $7.7 million in  punitive damages. Presumably some of the same documents would have been sought to prepare that litigation.

What Was Lost

Ethicon has admitted to losing or destroying the documents associated with key company officers in charge of the development of the TVT and TVT-O transvaginal meshes. Missing are documents from those in charge of the development of the Prolift and TVT-O transvaginal mesh – sales reps, regulatory experts who had regular contact with the FDA and those who took in complaints about early safety failures.

Several videos have been lost or destroyed produced by one of its expert witnesses as well as documents from the original manufacturer of the TVT product, Medscand Medical A.B. Ethicon destroyed 600 pounds of documents from Medscand, says the filing.

“Ethicon’s conduct demonstrates bad faith/knowing destruction, gross negligence, and ordinary negligence. As to some of the spoliation that occurred, one could easily infer bad faith.”

Attorneys for the plaintiffs must prove design defect, negligence, failure to warn, fraud, negligent misrepresentation, negligent infliction of emotional distress breach of express and implied warranties, violations of consumer protection laws and punitive damages.

With the judicial process disrupted, the trial court can use its power to control the judicial process “to determine an appropriate sanction” write the plaintiffs’ attorneys.

“Ethicon failed miserably to comply with its duty to preserve evidence.”

Renee Selman from LinkedIn

Renee Selman from LinkedIn

Among the losses are thousands of important documents for several key Ethicon officers who left the company including Renee Selman, former worldwide president for women’s health & urology at Ethicon from 2005 to 2010.

She admitted all documents on her company hard drive had been destroyed, according to the filing. She presided during a critical period when Ethicon interacted with the FDA on mesh development and safety issues including during the FDA’s Public Health Notification in 2008.

In the end, Ethicon only produced about 25 documents for Ms Selman and has admitted it destroyed all documents on her company computer hard drive, seven years after a litigation hold had been instituted.

“Given Ms. Selman’s role as a high-level decision-maker at Ethicon, her hard drive surely contained vital information about Ethicon’s policies, safety procedures, marketing strategies, and numerous other key issues. All of that information is gone. Ms. Selman testified that she was aware of the litigation hold, she believed that it applied to the entire [tension-free vaginal tape] family of products, she knew not to delete relevant documents, and she followed procedures closely, placing documents in properly designated folders. But Ethicon has only produced about 25 documents for Ms. Selman, a remarkably low number for someone who was head of the company for five years, and has admitted that it destroyed all documents that Ms. Selman has saved on her hard drive.”

What Was Lost? Continued in Part 2 Here

Learn More:

PTO # 100 Magistrate Cheryl Eifert on Document Destruction
Carolyn Lewis Doc PTO#100 Doc #1069 Eifert Ruling, Feb 4 2014

Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327
In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation

Joseph R. Goodwin, presiding

Bloomberg News on J&J, December 3, 2013 
http://www.businessweek.com/news/2013-12-03/j-and-j-lost-or-destroyed-vaginal-mesh-files-lawyers-contend-1

Plaintiffs’ Motion for a Finding of Spoliation and for Sanctions
in the Ethicon multidistrict litigation, MDL  12-MD-02327,
Doc #952 Pl Motion for a finding of Spoilation and for Sanctions

Plaintiffs’ Memorandum in Support of Their Motion for a Finding of Spoilage and for Sanctions
Doc #953 Pl Motion in Support of Motion for Spoilation and for Sanctions 30 pages

FDA’s Public Health Notification, 2008
http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm

 Mesh Medical Device News Desk, February 2013, Linda Gross Trial conclusion
http://meshmedicaldevicenewsdesk.com/latest-in-the-litigation-concerning-mesh-and-medical-devices/day-31-linda-gross-v-ethicon-its-over-11-1-million/

 

 

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11 Comments to “J&J Systematically Destroyed Evidence in Upcoming Mesh Trials, Pl Lawyers Call it ”Severe” Destruction of Evidence”

  1. Bejah Notrettu says:

    When I learned of this I became physically ill, even more than I am because of their “product” already…I can’t sleep, I feel like I am going to throw up constantly, I am deeply depressed and I fear that our judicial system wil also bend to the will of BIG CORPORATE AMERICA and that the judicial system will now also be under the boot of corporations. BUT these documents, these files, are not destroyed…this is a lit. For decades every organization in this nation has had redundant back up systems and off site back up. It is a lie. I have had enough. I want the Department of Justice to raid Ethicon and Johnson and Johnson NOW. I want their executives including Ms. Selman to be brought to testify under oath. If these things are not done America is dead. Only a fool would believe this story. Just how much does the shadow government think the American people are going to take. Our numbers are far greater than yours. We had a revolution once and we can do it again and will if this is not stopped NOW.

    • Bejah Notrettu says:

      I must apologize for my spelling and other errors…I was not feeling well and should have just gone to bed! Clearly, ranting and wailing is not going to help regardless of what the defendants do. I have not read Jane’s reporting on this completely yet but as a victim I wonder how this will effect me/us all, what we might hope the courts response is, how this wil effect the course o the MDL litigation, does it set any presceddent (Have they used this tactic effectively before), does it harm or strengthen out position as plantiffs? I hope to see a lively discusion about all of this. I must also thank Jane for her very professional reporting and ask her forgivensss for my failure to acknowledge it earlier. Sometimes I feel Jane is a lifeline, especially on those days when things are difficult.

      • Barbara says:

        I was glad to find this small support area. After suffering emotional/physical pain for so many years, I find myself homebound, jittery, anxious and fearful that my future visiting our 3 children and 5 grandchildren was a pipe dream. They visit as often as they can. I feel like a recluse. I am an RN and have spent 25 years helping others. Mainly Hospice pts.I thought I could volunteer part time but due to cramping, frequent and painful urination I rarely leave the house unless my husband goes with me. I was able to find a Doctor 250 miles from where I live to remove as much of the mesh as he could. He is a UroGyno surgeon. I have lost a job making $26-$30/hr and my husband who is 12 years my senior must continue to work. What is done, cant be undone. Some of the mesh “Had to be left in me” per my surgeon.Otherwise my vagina would be upside down.I just want this over and these people punished for deliberately harming thousands of us. They only tested on “Hamsters and rabbits”. It is beyond evil.How convenient all the evidence has disappeared.

        • Jane Akre says:

          Barbara~ I’m so sorry. So many mesh participants are RNs it really is amazing. Do you have your medical records, know what kind of mesh you have, and do you have insurance and access to a second opinion. There are some mesh removal docs who are having better success if it needs to come out. A partial removal makes it more difficult to “find” the mesh in that case. You seemed resigned to living with this, but there may be more that can be done. Write to me if you’d like to contact patient advocates for some advice. Thank you and again, I’m sorry. ~ja

  2. Aaron Leigh says:

    AMAZING WORK (as usual) Jane! Thank you for keeping us all up to date!

  3. Betty says:

    I should be shocked. I am not. Such a sad statement on today’s ethical standards from every level. I highly doubt this was an error made in good faith, as I’m sure will be claimed. Our rights have clearly been violated in so many ways. There is no real answer that will compensate us for the misery and suffering. I pray the courts listen and some form of justice will be had. We shall see. Thank you Jane for your fight for what is right. We need many more reporters who are ethical. Keep up the good work.

  4. Jodois Martinewitz says:

    I wouldn’t count on too much support from this judge. He’s the one that threw out the entire case against Actavis Totowa in September 2010, four months before they were to begin the bellwether trials for all of the people who died as a result of taking Digitek. “No sufficient evidence,” despite textbook cases of the patients who died, and multiple warnings from the FDA for shoddy quality control. (Annnnnd….just because the murder weapon can’t be found, doesn’t mean a murder didn’t occur?) Makes you wonder. Will be interesting to see what happens. Prayers and condolences to these patients and their families.

  5. Samantha Squires says:

    This is totally an act showing guilt on their part. They knew from the beginning that this was going to hurt people and they did not care. You only lie and get rid of things that prove your guilty of doing something wrong. I really hope that they are penalized to a greater degree because they did this.

  6. Shirley Dodson says:

    Why am I not shocked for one we/us the Plaintiffs are the ones suffering. Total removal of their product that was planted inside me cannot be done because of where it inserted yeah. If it was one of them who had to suffer due to a product for one that was not approved by the FDA then they would of been more sensitive to our pain and suffering. If you ever watched Erin Brockovich you will understand how these companies try to wiesel themselves from the products they produce that hurt so many people and try to push it under the rug just to earn a profit. Truly I don`t know what they think our uterus is worth but if it was their life at stake and had to deal with the pain we do they would admit that they screwed so many women out of a total Happy life of which they claimed we would get after having their product. We are taught in Law school to practice with ethics understanding of the laws helps us to achieve our goals but if we have health issues because of products that hasn’t been truly tested before introduced to pharmaceuticals and the medical professions then whats that tell us that our field of research telling us. Obviously this has been going on before 2005. I have had mine in from 2004. I still had leakages and I had pain during intercourse. Had mine removed in 2012 and still have complications. I feel like I have been put through the grinder. And yet they throw this up. What kind of Life do they think I truly have after the insertion of their product has totally messed me up for life of Happiness. Truly I sympathize with all the women who have gone through the pain and agony that I have endured. And pray the Judge looks at their negligence in these cases in favor of all the plaintiffs.

  7. […] February 2014, Judge Joseph R. Goodwin will preside over 12,200 defective transvaginal mesh product cases in Charleston, West Virginia.  It is anticipated that over 100,000 cases involving mesh-injured […]

  8. Richard M Howden(AMU) says:

    When the manufacturers can pay off the FDA with grants and perks, a Judge should be easy. Government officials can ignore subpenas, claim the 5th and still get paid, then a few tens of thousands of pertinent documented pages of evidence being destroyed is chump change. We have tens of thousands of submitted complaints, we have video evidence, we have whistle blower accounts and yet all it takes is one Judge to dismiss the evidence to shoot down the hope for so many victims. To ignore the systematic destruction of so many documents when so much hinges on them for evidence is horrific! My faith in our Government to protect us from bad Medical devices has been gone for many years. But to read what this Judge ignores and disallows makes me believe that there has to be a pay off. And to think that he is going to preside over more of these cases. Great.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.