Osco Drug is facing a federal class action lawsuit over the sale of generic prescription drugs used to treat ADHD, which they allegedly knew were inferior to the brand name drug for which they were substituting.
Chicago resident Alex Turetsky, parent of a minor identified as J.T., filed a complaint in federal court in Chicago this week against the companies doing business as Osco Drug. He alleges Osco pharmacists made substitutions for the drug Concerta — an extended release drug known as methylphenidate hydrochloride used to treat attention deficit hyperactivity disorder, or ADHD — with a generic drug that he alleged they knew to not be therapeutically equivalent to the name brand original.
Concerta is a once-daily drug expected to be effective for 12 hours. Although three manufacturers claim to produce equivalent generics, the complaint said “just one form of generic Concerta is currently approved by the U.S. Food and Drug Administration as being therapeutically equivalent.” The other two, the FDA found in November 2014, “are not therapeutically equivalent because their effectiveness wears off much more quickly and (do) not provide the consistent, long-lasting ADHD symptom control equivalent to Concerta.”
Turetksy said he attempted to fill a prescription for Concerta for his child in April at an Osco pharmacy in Evanston, but was instead given the allegedly lesser generic versions.
The generics that don’t measure up are products of Mallinckrodt Inc. and Kremers Urban Pharmaceuticals, known as Kudco. The third generic is a product of Concerta manufacturer Janssen Pharmaceuticals; it is marketed by Actavis under a licensing agreement. The complaint said the Mallinckrodt and Kudco drugs still constitute 30 percent of the market for generic Concerta. Turetsky’s complaint detailed the FDA progress for generic drug approval and cites the “Orange Book,” the common name for the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations listing, which is publicly available on the FDA website. The FDA has a separate Orange Book database it updates daily as new approvals warrant.
“The FDA began to receive reports of lack of effectiveness of the Mallinckrodt and Kudco Products shortly after the initial approvals of each product, in December 2012 and July 2013, respectively,” the complaint alleged. “Between May 2013 and June 2014, 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.”
Those incidents led to the FDA’s review of both generics, resulting in the November 2014 report finding neither to be therapeutically equivalent to Concerta. Specifically, Concerta and Actavis release in the body over 10 to 12 hours, which delivers the same effect as three immediate release doses. The two generics in question release at a slower rate during the seven- to 12-hour range, which “affects the consistent, longer-term control of ADHD symptoms.”
The complaint included three counts for violation of numerous state consumer fraud statutes, breach of implied warranties and unjust enrichment. Osco’s parent company, Albertson’s, operates more than 2,200 stores in 33 states and Washington, D.C.; the state statute complaint includes 26 states and the District of Columbia. If class status is granted, the warranty and unjust enrichments complaints could expand beyond Illinois to include implied warranty laws for any class member’s home state.
A jury trial is requested along with actual, statutory, punitive or treble damages, as well as legal fees.
Turetsky’s representation includes attorneys with the firm of Hagens Berman Sobol Shapiro, of Chicago and Seattle; and with the Freydin Law Offices, of Skokie.