Ethicon 12/15

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

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1. Ethicon Says Bulk Demand For Mesh Records Is 'Burdensome'

   Dec 15, 2015 | Law360

   By Sindhu Sundar
   
   
   Johnson & Johnson's Ethicon Inc. on Friday fought a demand by patients in multidistrict litigation over its pelvic repair systems products for records detailing the design and production of various batches of those mesh products, arguing that it would be "inordinately burdensome."

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Ethicon Says Bulk Demand For Mesh Records Is 'Burdensome'

   Dec 15, 2015 | Law360

   By Sindhu Sundar

   Johnson & Johnson's Ethicon Inc. on Friday fought a demand by patients in multidistrict litigation over its pelvic repair systems products for records detailing the design and production of various batches of those mesh products, arguing that it would be "inordinately burdensome."
   
   In a filing in West Virginia federal court, where the MDL is consolidated, Ethicon said that although it could comply with U.S. Food and Drug Administration requirements to submit such so-called document history records in four days' notice, it "would be extremely time-consuming and expensive" to do so for hundreds of documents in the litigation.
   
   The patients, who allege injuries stemming from the products, had sought the records, calling them a key piece of evidence that would help them establish whether Ethicon handled complaints about the devices in accordance with industry standards, and whether the complaints linked to the products could have been caused by problems in the design or manufacturing process for the devices. The device history records show that a batch of devices were made according to a design "recipe" outlined in a master record, according to the plaintiffs' filing.
   
   Ethicon argued Friday that the plaintiffs could obtain such information from other documents it has already submitted, including medical device reports and adverse event reports, that could indicate potential manufacturing issues.
   
   "Indeed, plaintiffs’ experts have previously relied on exactly those types of documents in forming their opinions," Ethicon said in its filing. "Defendants have also made clear that they would provide device history records for any lots or batches with respect to which other documents suggest there was a problem during the manufacturing process."
   
   The patients sought the records in so-called wave 2 and 3 cases, groups of cases in the MDL separated out for trial purposes, according to the MDL docket. They had argued that the documents are crucial especially because they bear the burden of proof, and indicated that they would be relying on such records to cross-examine defendants on their manufacturing and design defect claims, according to their filing.
   
   They had also argued that they had already negotiated with Ethicon that the device history records should be part of the defendants' fact sheet submission, as part of plaintiffs' individual discovery of the defendants, according to their filing. Ethicon said Friday that although they had originally agreed to that request, they had believed at the time that it would apply to "a much smaller number of cases."
   
   "Sometimes, changed circumstances call for changed procedures," Ethicon said. "This is such a case."
   
   There are roughly 23,000 suits against Ethicon and J&J in the MDL, according to court records.
   
   The plaintiffs are represented by Bryan F. Aylstock and Renee Baggett of Aylstock Witkin Kreis and Overholtz PLC, and others.
   
   Ethicon is represented by David B. Thomas of Thomas Combs & Spann PLLC.
   
   The case is In re: Ethicon, Inc.. Pelvic Repair System Products Liability Litigation, case number 2:12-MD-02327, in the U.S. District Court for the Southern District of West Virginia.
   

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