KEMY Represents Whistleblower in $2.3 Billion Settlement

Dr. Stefan Kruszewski, M.D., came to KEMY with grave concerns about off label marketing of Geodon, an anti-psychotic, targeting children. Geodon is approved to treat only patients ages 18-65 diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder. The Harrisburg psychiatrist had noticed that Geodon was being systematically marketed for unapproved uses and to children. KEMY attorneys Brian Kenney and Tavy Deming agreed to work to correct the problem.

Today, as part of a record settlement involving Geodon and other drugs, Pfizer agreed to plead guilty to criminal conduct and to pay more than $2 billion in criminal and civil fines, penalties, and damages. To read KEMY's press release, click here.

Geodon is FDA-approved to treat only patients ages 18-65 diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder. According to KEMY’s lead partner, Brian Kenney, “Pfizer targeted pediatrics and adolescents to expand off-label use and maintained on its payroll an army of more than 250 child psychiatrists nationwide.” Kenney continued, "The purpose and intent of paying so many child psychiatrists is clear – to gain a foothold within the fastest growing market for antipsychotics – children. The practice of expansive off-label use is dangerous, particularly in children because the drug has not been evaluated for its safety for the unique physiological make up of children."

KEMY’s whistleblower complaint led to a national investigation into Geodon. The federal investigation into Pfizer’s Geodon marketing practices was conducted by the U.S. Attorney’s Office for the Eastern District of Pennsylvania under the direction of U.S. Attorney Michael Levy, Assistant U.S. Attorney Marilyn May and Assistant U.S. Attorney Charlene Keller Fullmer. Massachusetts Assistant Attorney General Bob Patten led the investigation on behalf of the states and the National Association of Medicaid Fraud Control Units (“NAMFCU”).

According to Kenney, Pfizer’s switching campaign “endangered patients by ignoring or materially understating Geodon’s serious, and even life threatening, side effects.”

Sadly, industry watchers say that large settlements are seen by the drug companies as merely a cost of doing business. Off label marketing of anti-psychotics, anti depressants, anti convulsants, and stimulants to children continues to reap big financial rewards for pharmaceutical companies, despite the safety risks. Children today are being highly medicated with drugs that have only been tested on adults. These drugs have serious side effects and can harm children. If you know of off label marketing targeting children, call KEMY today.