Janssen Must Produce "Reanalysis" Records In Risperdal Trial

legalintelligencer
Max Mitchell, The Legal Intelligencer

November 13, 2015   

The Philadelphia judge overseeing an ongoing Risperdal-related trial has ordered Janssen Pharmaceuticals to turn over by Sunday any documents it may have pertaining to the reanalysis of a key medical report in the litigation, or face possible sanctions.

Philadelphia Court of Common Pleas Judge Kenneth Powell ordered the drug maker to produce all evidence, documents, reports, emails and other nonprivileged information related to a “reanalysis of data” by noon Nov. 15. The order added that, if the deadline is not met, the “custodian” of the items will need to appear Nov. 16 to show why the order was not complied with. Failure to appear will result in sanctions, the order said.

Although the order did not specify what the “reanalysis” pertains to, Thomas R. Kline, who is representing the plaintiff in the ongoing Stange v. Janssen case, said it is related to a 2003 medical article published in the Journal of Clinical Psychiatry, referred to in the litigation as the Findling article, which has become a major point of contention in the litigation.

The plaintiffs have argued in court documents and proceedings that some results linking gynecomastia—a condition causing excessive breast tissue in young males—to the drug were omitted from the report to conceal the risks and manipulate the marketplace.

Kline said attorneys were recently notified that a reanalysis had been done indicating that none of the omitted data showed a more significant link between Risperdal and gynecomastia, and about 3,000 documents were turned over in the litigation.

Kline said the order should result in about 12,000 additional pages of documents being filed, and said he expects the documents to show Janssen recently communicated with the authors of the articles.

“We now have an order requiring defendants to turn over all documents relating to the back-and-forth between Janssen and the authors of the article who sent this so-called reanalysis to the journal,” Kline said.

In an emailed statement, Janssen spokeswoman Robyn Frenze said, “We are in the process of complying with the court’s order and we look forward to continuing to present our case to the jury.”

Max Mitchell can be contacted at 215-557-2354 or mmitchell@alm.com. Follow him on Twitter @MMitchellTLI.

Thank You Mr Mitchell and Legal Intellingencer.


Hope they get better documents from Janssen than Congressman Issa got from Obama's AG.