Attorney Daily - Your source for the most important legal news

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.

On May 12, 2009, the FDA said some Caraco-brand Digoxin 0.25 milligram tablets distributed prior to March 31 were recalled due to a safety hazard. The FDA said A S Medication Solutions LLC announced the tablets, which have an expiration date of August 2011, might differ in size and therefore could have more or less of the active ingredient.

The tablets were manufactured by Caraco Pharmaceutical Laboratories Ltd.

Digoxin is used to treat heart failure and abnormal heart rhythms, the FDA said, and the existence of a higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure.

Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and slow heart rate. Death can also result from excessive digoxin intake. A lower than labeled dose might pose a risk of heart failure and abnormal heart rhythms, the federal agency said.

Consumers with the products that have NDC No. 54569-5758-0 and are scored, round biconvex tablets imprinted with the number “441″ are advised to return the medication to the place of purchase.

In April 2008, Digitek digoxin pills manufacturerd by Actavis Totowa LLC were recalled after an unknown number of tablets were suspected of being double-sized and possibly carrying too much of the active ingredient. Approximately a dozen reports of patient deaths and injuries were linked to the double-dose Digitek digoxin pills.

A lawsuit on behalf of 97 individuals was filed against Actavis and Mylan Pharmaceuticals in St. Clair County Circuit Court. The plaintiffs’ claim that the prescription drug Digitek, they took for their heart problems contained twice the approved level of its active ingredient.

Digitek, which is generally prescribed to treat various heart conditions, including atrial fibrillation, atrial flutter and congestive heart failure, was recalled in April 2008, according to the complaint filed April 24 in St. Clair County Circuit Court.

The suit claims that little information has been released about the recalled Digitek, which reportedly contained twice the approved level of an active ingredient that can cause digitalis toxicity. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia, according to a warning the FDA issued about the drug.

Before placing Digitek on the market, Actavis and Mylan should have implemented adequate safeguards and tests to ensure the accuracy of the drug’s strength, the plaintiffs say.

The plaintiffs’ say they have already experienced or face an increased risk of developing severe injuries and dangerous side effects from the drug. They are asking Actavis and Mylan to pay for medical monitoring to determine whether they are prone to death and serious health complications, and are seeking damages in the neighborhood $7 million.

In addition to the St. Clair County lawsuit, Mylan is facing multiple lawsuits in Jefferson County District Court in Texas in which plaintiffs are complaining of the same overdose problems with the drug Digitek.