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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.
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.
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.)
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.
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.”
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
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
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
