Digitek Batch Records to be Reviewed by Defense Teams

On July 27, 2009, The West Virginia Record reported that plaintiffs lawyers claiming that careless practices at an Actavis Totowa drug factory led to adulteration of heart medicine Digitek were granted permission to find out if sloppy practices spoiled other pills at the factory.

U.S. Magistrate Judge Mary Stanley ruled on July 1 that plaintiffs could examine the record of each batch of drugs that preceded a batch of Digitek from the same equipment. “Plaintiffs have shown good cause for a modest expansion of the scope of discovery,” Stanley wrote.

She didn’t grant the order they sought, which would have opened all production records for 106 different medicines at the Actavis Totowa factory in Little Falls, New Jersey.

“Plaintiffs’ contention that an incident involving one product would be similar or even identical to an incident involving Digitek is too speculative to justify the enormous and expensive expansion of discovery they seek,” she wrote.

Stanley presides over discovery in approximately 400 cases before U.S. District Judge Joseph Goodwin. The U.S. Judicial Panel on Multi District Litigation consolidated cases from around the nation last year and assigned them to Goodwin.

Plaintiffs seek to recover from Actavis Totowa, Mylan Pharmaceuticals, and affiliates of both.

On May 4, plaintiffs issued a subpoena on Gibraltar Laboratories for documents relating to production of Digitek and other medicines at Little Falls.

Stanley stayed the subpoena on June 4.

On July 1, Stanley ordered Gibraltar to produce documents, allowing Actavis and Mylan to review and redact the documents.

In a separate order, she granted discovery on batches that preceded Digitek batches.

“That is, if the 50 cubic foot blender was used to blend a product other than Digitek, (product A), and the blender was next used to blend Digitek or one of its precursors, then the scope of discovery will include the batch record for product A,” she wrote. “If records indicate that a blender was used for product A and was immediately thereafter used for Digitek, a fair assumption can be drawn that the blender was not cleaned between uses.”

A plaintiff should be able to trace backwards the lot number of a prescription and determine the likelihood that it contained only the ingredients it was supposed to contain, in the specified amounts, she wrote.