CHICAGO (CN) - Albertson's-owned Osco pharmacies sell generic drugs that did not get FDA approval to treat ADHD like their brand-name "equivalent," Concerta, a father claims in court.
Alex Turetsky says his minor son J.T. was prescribed Concerta, an extended-release attention deficit hyperactivity disorder (ADHD) drug approved by the U.S. Food and Drug Administration in 2000.
Turetsky tried to fill J.T.'s Concerta prescription at an Osco Drug Store in Evanston, Ill., on April 24 of this year, according to a class action lawsuit the father filed on Friday in Federal Court. He sued American Drug Stores LLC dba Osco Drug, along with its subsidiaries, American Stores Co. LLC, New Albertson's Inc. and Albertson's LLC.
He "expected to receive either brand-name Concerta or a therapeutically-equivalent generic," the lawsuit states. "Plaintiff's expectations were objectively reasonable given the superior position of knowledge and expertise of the pharmacists."
But the Osco pharmacy sold Turetsky - for about $173 - generic tablets manufactured by nonparty Mallinckrodt Inc. in Ireland, which do not medically equate to Concerta, he claims.
"While there are three manufacturers that purport to manufacture generic Concerta, just one form of generic Concerta is currently approved by the U.S. Food and Drug Administration as being therapeutically equivalent," the complaint states. "In fact, the FDA has expressly found that the two other generic versions of Concerta are not therapeutically equivalent because their effectiveness wears off much more quickly and does not provide the consistent, long-lasting ADHD symptom control equivalent to Concerta."
The two subpar generics are manufactured by nonparties Mallinckrodt and Indiana-based Kremers Urban Pharmaceuticals Inc., or Kudco, according to the complaint.
"The FDA adverse event reporting system database received reports of patients describing insufficient therapeutic effect, with nearly 200 reports about the Mallinckrodt product and over 100 reports about the Kudco product," from May 2013 to June 2014, Turetsky claims.
While Concerta releases into the body over a period of 10 to 12 hours, the Mallinckrodt and Kudco drugs have a "diminished" release between seven to 12 hours, according to the lawsuit.
Even after the FDA found in late 2014 that those drugs did not live up to Concerta's standard, Osco "nonetheless continued to substitute and dispense the Mallinckrodt products and/or Kudco products in lieu of Concerta to plaintiffs and the class," Turetsky says.
The two generics still "hold approximately 30 percent of market share for generic Concerta, with Actavis holding the remaining 70 percent," as of May 2015, the complaint states.
Turetsky says Albertson's stores "hold their pharmacies and pharmacists out to the public as occupying a superior position of knowledge regarding prescription fulfillment." He alleges Osco's safety and trust is touted in advertisements.
Turetsky seeks to represent all Americans who were prescribed Concerta or generic versions and received and paid for generic Mallinckrodt or Kudco drugs from Osco or Albertson's between November 13, 2014, and the present.
His lawsuit alleges consumer fraud under state law, breach of implied warranties and unjust enrichment. It seeks actual, statutory, punitive or treble damages and a jury trial.
Turetsky is represented by Daniel Kurowski of Hagens Berman Sobol Shapiro in Chicago.
Melissa Hill, a Jewel-Osco spokeswoman, said the company is "reviewing the complaint," but declined to comment on pending litigation.
Albertson's did not immediately return an emailed request for comment.
Concerta is made by nonparty Janssen Pharmaceuticals Inc.
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