Defense gets OK to look at Digitek batch records

CHARLESTON -– Lawyers alleging that sloppy practices at an Actavis Totowa drug factory led to adulteration of heart medicine Digitek have gained 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, N.J.

"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 about 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 June 9, Fred Thompson of Motley Rice in Mount Pleasant, S.C., urged Stanley to allow the subpoena.

"Plaintiffs are shocked to discover the extent of commingling between product lines within the plant," Thompson wrote. "There is no way to separate out the Digitek product line from that of any of the other 105 product lines manufactured contemporaneously at the Little Falls plant."

Plaintiffs then moved for expansion of discovery to include all products at Little Falls.

Defense lawyer Richard Dean of Cleveland responded on June 22 that, "Though plaintiffs claim to be shocked that some equipment can be cleaned, disassembled, and adjusted to manufacture more than one product, this fact is unremarkable."

Dean wrote, "There are not dedicated teams to manufacture separate products. That is not a common practice in the industry, and indeed defies logic and common sense."

He wrote that plaintiffs didn't allege injury from any of the other products.

He estimated it would cost $30 million to produce the documents.

"To date, defendants have spent approximately $4,500,000 gathering and producing documents in this litigation," he wrote.

Thompson answered on June 26 that, "Defendants are in error in their claim that this litigation is limited solely to the Digitek manufacturing process."

He wrote that a pattern of poor manufacturing practices and inept quality assurance and control at Little Falls was relevant to the litigation.

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.