While he was helping to guide the purchases, the press release stated, "he was also paid more than $12,000 by drug companies for appearances, speeches and presentations, as well as service on a drug company advisory board."
In October 2006, a state official in Texas, Dr Steven Shon, was fired after the state's attorney general found that Janssen had improperly influenced him to place Risperdal on the state formulary, while he was receiving money from Janssen.
According to Lilly's August 6, 2007 second quarter SEC filing, the California Attorney General's Office has subpoenaed documents related to Lilly's "efforts to obtain and maintain Zyprexa's status on the formulary, the marketing and promotion of Zyprexa, and the remuneration of health care providers."
Lilly's off-label marketing of Zyprexa has come under scrutiny in the past several years, in large part, because lawmakers and law enforcement agencies became suspicious about the skyrocketing costs of a drug approved to treat such limited conditions being prescribed to so many patients in public health care programs.
According to Lilly's SEC report, Medicaid fraud lawsuits filed against Lilly thus far include the states of Alaska, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, and West Virginia. Arkansas is the latest state to file a lawsuit.
The Medicaid fraud allegations include that Lilly illegally marketed Zyprexa for off-label uses while concealing the serious health risks associated with the drug, and most specifically high blood sugar levels, extreme weight gain and diabetes.
The lawsuits seek to recover not only the money paid to purchase Zyprexa for patients on Medicaid but also for the medical care of persons injured by the drug. Mississippi alleges that about 10% of the Medicaid patients who took Zyprexa in that state have developed diabetes which will require life-long care.
Montana's lawsuit alleges that Lilly gave kickbacks to doctors, promoted Zyprexa as a sedative in nursing homes, and created a 280-person sales force to promote the drug exclusively for off-label uses, specifically in long-term care facilities.
The West Virginia complaint alleges that Lilly promoted Zyprexa for off-label conditions including anxiety, sleep disruption, mood swings, attention deficit and dementia and "benefited from its misrepresentations and fraudulent conduct by gaining sales of Zyprexa at the expense of other, safe, effective drugs."
In private litigation, since June 2005 Lilly has entered into settlements with approximately 30,200 claimants in the US for about $1.2 billion and there were still about 350 lawsuits covering about 540 claims pending in the US at the time of the August 2007 filing.
However, off-label prescribing has obviously not ceased because in 2006, Zyprexa sales were $4.3 billion and for the second quarter and first half of 2007, US sales of Zyprexa increased 4% and 5%, respectively, and international sales increased 14% during both periods, according to Lilly's SEC filing.
Additional lawsuits are now being filed on behalf of suicide attempt survivors and the family members of suicide victims who died while taking Zyprexa. They allege that Lilly knew about the increased risk of suicide associated with the drug but failed to warn the public while it widely promoted the Zyprexa for off-label uses.
An August 2002 analysis of clinical trial data on drugs approved by the FDA between 1985 and 2000, by Dr Arif Khan of the Northwest Clinical Research Center in Bellevue Washington, found the rate of completed suicides in the antipsychotic trials to be 752 per 100,000, an astronomical number considering that the suicide rate is only 11 per 100,000 for persons in the general population.
Families seeking legal advice regarding Zyprexa related suicide can contact the Baum, Hedlund, Aristei & Goldman Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/
Evelyn Pringle evelyn-pringle@sbcglobal.net
(Written as part of the Pharmaceutical Industry Litigation Monthly Round-Up, Sponsored by Baum Hedlund's Pharmaceutical Antidepressant Litigation Department)
Lilly's incentive not to readily disclose deadly side affects (up to ten times diabetes risk over non users) is they had billions coming in from state medicaid scripts?
