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Settlement Reached In Drug Labeling Lawsuit

Drug manufacturer settles drug labeling lawsuit with packaging firm over errors affecting cancer drug clinical trial.

Peregrine Pharmaceuticals and Clinical Supplies Management have settled a lawsuit filed over an alleged labeling mix-up that led to costly failure of a cancer drug clinical trial. Terms of the settlement, reached in U.S. District Court in central California, were not disclosed, but Peregrine Pharmaceuticals claimed in its drug labeling lawsuit that it would cost at least $20 million to fix problems caused by the mislabeling in the research trial between 2010 and 2012. Clinical Supplies Management, based in Fargo, ND, denied doing anything wrong and said Peregrine "consented to and approved the alleged acts" in the legal dispute. Messages seeking comment from CMS's lawyers were not returned Friday, and Peregrine's lawyer declined to comment on the settlement. Peregrine, based in Tustin, CA, hired CMS to package, label and distribute vials used in the trial of a drug called bavituximab. The trial was designed to be randomized and double-blind, meaning that Peregrine wouldn't know which of the 121 patients received the drug being tested or a placebo. CSM was to distribute 8,000 vials to three groups of patients. In distributing the vials, CMS erred by mixing up some vials sent to two of the groups, according to Peregrine's lawsuit. U.S. District Judge Jesus G. Bernal dismissed Peregrine's lawsuit at the request of both parties. The settlement came after Bernal issued a ruling granting CMS a partial summary judgment, a decision throwing out some of Peregrine's claims, but allowing breach of contract claims to go to a jury. A trial had been scheduled for February. Peregrine's lawsuit claimed it was the victim of fraud, negligence and concealment. "The damage resulting to Peregrine from the failure of its clinical trial is many times the amount paid to CSM for its services," Bernal wrote in his decision. He said the study cost more than $12 million. If the study had been successful, the judge wrote, Peregrine might have achieved "commercial success" and could have gotten the drug to market three or four years sooner. Before it found some vials had been mislabeled, Peregrine's stock soared after it reported encouraging early results for the drug, but its stock plunged after it disclosed the mixup, in 2012. Originally posted by Patrick Springer on Drug Labeling Lawsuit - Ball & Bonholtzer Trial Attorney - Los Angeles  

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