State Lawsuits - Atypical Antipsychotics
Abilify, Geodon, Risperdal, Seroquel, Zyprexa
The TMAP Drugs (Texas Medication Algorithm Project)
TMAP and TeenScreen (video here, petition here)
Endorsed by the New "Freedom" Commission on Mental Health
Lilly has received civil investigative demands or subpoenas from
the attorneys general of a number of states. Most of these requests are now part of a multistate investigative effort
being coordinated by an executive committee of attorneys general. Lilly says they are aware of 26 states participating
in this joint effort and they anticipate that additional states will join the investigation. These attorneys general are seeking
a broad range of Zyprexa documents, including documents relating to sales, marketing and promotional practices, and
remuneration of health care providers. SEC filing
State of Alaska v. Lilly
Civil action for the damages and penalties arising from the marketing and sale of the prescription drug Zyprexa Article Complaint Description of Claim
Settled, $15 Million, March 26, 2008
Arkansas is planning a lawsuit against Eli Lilly, Janssen Pharmaceutica and Astra Zeneca for ?improper and unlawful marketing? of anti-psychotic drugs. The drugs in question are Zyprexa, Risperdal and Seroquel. The Medicaid program of Arkansas has spent $200 million on those drugs over the last eight years and, under Arkansas? Medicaid fraud law, the state could collect three times that much. Article
Drug companies improperly marketed an anti-psychotic drug, Arkansas Attorney General Dustin McDaniel claimed Tuesday as he asked a state judge to force the firms to repay millions shelled out by the state's Medicaid program for unnecessary prescriptions. McDaniel filed a lawsuit in Pulaski County Circuit Court against Janssen Pharmaceutica Inc., Janssen LP and Johnson & Johnson Inc. (JNJ). In the filing, McDaniel said the companies "engaged in a direct, illegal, nationwide program of promotion of the use of Risperdal for non-medically necessary uses". Article
Arkansas Attorney General Dustin McDaniel filed suit Tuesday against drug manufacturer AstraZeneca claiming the company encouraged doctors to prescribe a dangerous drug to children and the elderly for uses beyond its federal approval, harming patients and costing the state millions of dollars.
The suit filed in Pulaski County Circuit Court claims London-based AstraZeneca PLC and four of its related companies in the U.S. and abroad misled doctors and the public to increase sales of the antipsychotic drug Seroquel, even though the company knew people taking it were at risk of injury, disease and sickness.
Johnson & Johnson's Janssen unit received a subpoena from the California
attorney general's office over sales and marketing of Risperdal. The subpoena asked for documents
on "sales and marketing and side effects" of the drug, as well as on "interactions with state officials" in Medicaid.
In September 2006, Lilly received a subpoena from the California Attorney General's
office seeking production of documents related to their efforts to obtain and maintain Zyprexa's status on California's formulary,
marketing and promotional practices with respect to Zyprexa, and remuneration of health care providers. SEC Filing
Eli Lilly & Co., AstraZeneca PLC and Bristol-Myers Squibb Co., revealed that they
received subpoenas from California's Attorney General's office to reveal information about their anti-psychotic prescription drugs.
The subpoena requests marketing practices and status on California's insurance list of "preferred drugs. (Zyprexa, Seroquel, Abilify)
A Pfizer spokesman confirmed that the company received a subpoena Sept. 8, 2006 from
the California attorney general's office concerning Geodon. The company is "cooperating fully," said the spokesman, who declined
to elaborate. Article
State of Connecticut v. Lilly
Connecticut is joining at least nine other states suing drug maker Eli Lilly and Co. over the antipsychotic drug Zyprexa.
Attorney General Richard Blumenthal says Connecticut's lawsuit seeks to recover more than $190 million that the state's medical assistance program spent on Zyprexa over more than a decade.
The lawsuit accuses Indianapolis-based Eli Lilly of running an illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including treating children.
Press Release Complaint
In June 2005, Lilly received a subpoena from the office of the Attorney General, Medicaid Fraud Control Unit, of the State of Florida, seeking production of documents relating to sales of Zyprexa and their marketing and promotional practices with respect to Zyprexa. SEC Filing
The State contends BMS knowingly and willfully offered and paid illegal remuneration in the form of consulting arrangement fees to physicians to induce them to prescribe
Abilify. The State contends that BMS's promotion of Abilify for pediatric use and to treat dementia-related psychosis violated the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C.
§§~ 331(a) & (d). Furthermore, the State contends that, during the relevant time period, these uses of Abilify were not medically accepted indications, as defined by 42 USC § 1396r-8(k)(6) (uses approved under the FDCA or included in or approved for inclusion in specified drug compendia), and that certain State Medicaid Programs did not cover Abilify dispensed for these uses. In addition, the State contends that, during this time period, BMS knowingly caused false and/or fraudulent claims to be submitted to its Medicaid program for Abilify for pediatric use and for dementia-related psychosis. Settlement
Idaho has joined a parade of states suing Eli Lilly over the pharmaceutical company's top-selling drug, an antipsychotic medicine called Zyprexa.
Idaho says Zyprexa is a costly drug that has been improperly marketed, sickening Idaho patients and taking a financial bite from the state's Medicaid health insurance program for low-income and disabled people. The Idaho lawsuit contends Eli Lilly illegally marketed Zyprexa for "off-label" uses not approved by the FDA. Article
The Illinois attorney general's office demanded that Eli Lilly hand over documents concerning the marketing of Zyprexa Article
State of Louisiana v. Janssen
A multimillion dollar civil lawsuit against
Janssen Pharmaceutical alleges unfair business practices and violations of consumer protection laws. The lawsuit seeks
damages for increased medical costs due to side effects suffered and for increased Medicaid expenses due to misleading
sales pitches. The suit was filed in connection with the production and marketing of the drug Risperdal.Article
State of Louisiana v. Eli Lilly, Brie Lablanc, Roger Parikh and Gerald Cahee, (Sales Reps for Lilly in Louisiana)
Upon information and belief, despite the fact that Zyprexa has not been tested or approved by the Food and Drug Administration (FDA) for pediatric use, Eli Lilly marketed Zyprexa, a potent anti-psychotic drug, for use with children. As a result thereof, many children residing in the State of Louisiana have suffered from Zyprexa related injuries and illnesses such as diabetes, pancreatitis and seizures. Article Complaint
Minnesota has joined a long line of states aiming to wrangle money from Eli Lilly and Co. with a lawsuit over the drugmaker's top seller, the anti-psychotic Zyprexa. The state attorney general's office filed a complaint in federal court last week echoing claims of other lawsuits that say Lilly downplayed the drug's side effects and marketed it for uses not approved by federal regulators. Article
State of Mississippi v. Lilly
Mississippi became the fifth state to sue the Indianapolis drug maker over its antipsychotic Zyprexa. Mississippi's attorney general, Jim Hood, charged that Lilly promoted Zyprexa for unapproved uses, including for children. The lawsuit by Hood seeks repayment from Lilly for more than $100 million that the state's Medicaid program for the poor has paid for the drug, plus reimbursement for diabetes-related injuries the drug caused some Medicaid users.
State of Montana v. Lilly
Eli Lilly & Co. was sued by the state of Montana
over claims the company fraudulently marketed its antipsychotic drug Zyprexa for unapproved uses and owes the
state for prescription costs and harm to patients. Lilly allegedly gave kickbacks to doctors and improperly promoted the drug to
nursing homes as a sedative, Montana Attorney General Mike McGrath said in a complaint filed March 7, 2007 in state court in Helena.
He claimed Lilly, the world's biggest maker of psychiatric drugs, bought off a ``disgruntled'' sales
director to keep him from disclosing its marketing practices. Article Complaint
State of Montana v. Janssen & AstraZeneca
Attorney General Mike McGrath has sued two national pharmaceutical companies and accused them of manufacturing certain prescription drugs that were ?in defective condition and unreasonably dangerous.?
McGrath filed the complaint in state district court in Helena Wednesday against Janssen Pharmaceutica Inc. and AstraZeneca Pharmaceuticals LP over their prescription drugs Risperdal and Seroquel, respectively. These medicines were intended to treat adult schizophrenia and short-term treatment of acute mania associated with bipolar disorder.
He charged that the two companies ?have engaged in false and misleading marketing, advertising and sales campaigns to promote these drugs for non-medically indicated uses.? McGrath said the companies ?successfully deceived physicians, citizen-users and others in the medical community? about the safety of these drugs compared to other antipsychotic drugs in order to carve out a greater market share.
This false promotion of these two atypical antipsychotic drugs have led to some Montanans who faced ?serious injuries, illnesses, diseases or death,? McGrath said.
He said the two companies illegally marketed and promoted Risperdal and Seroquel for uses not approved by the U.S. Food and Drug Administration, including treatment of dementia, sleep disorders, depression, attention deficit disorder, autism, depression, mood disorders and others. Article
State of New Mexico v. Lilly
Plaintiff seeks to recover the costs of Olanzapine (Zyprexa) induced diabetes and diabetes related illnesses to the State of New Mexico. Complaint
State of New Mexico v. Janssen
According to the lawsuit: Janssen got FDA approval to market Risperdal oral tablets for the treatment of schizophrenia in 1993 and for variations to treat bipolar disorder in 2003. But the drug has shown a propensity for its users to gain weight, have movement disorders and other health problems, including diabetes.
Since its launch, the maker has "engaged in widespread fraudulent statements and conduct, and pervasive false and misleading marketing, advertising and promotion." The maker failed to warn and misled physicians, consumers and the state regarding its adverse effects. Article
Ohio has not sued directly but has attached claims - for $7.5 million so far - to lawsuits involving 1,100 Ohio Medicaid beneficiaries. (Zyprexa) Article
Oregon Attorney General Hardy Myers is investigating whether Eli Lilly illegally promoted uses of Zyprexa that have not been approved by the U.S. Food and Drug Administration.
Commonwealth of Pennsylvania v. Lilly, AstraZeneca, Janssen
Eli Lilly & Co., AstraZeneca Pharmaceuticals and Johnson & Johnson were sued
by Pennsylvania over claims they fraudulently marketed antipsychotic drugs and
owe the state for prescription costs and harm to patients.
Lilly, based in Indianapolis, hid the risks and exaggerated the benefits of its
antipsychotic medication Zyprexa while persuading doctors to prescribe it for
unapproved uses, the state said. London-based AstraZeneca PLC's U.S. unit did
the same for its drug Seroquel and Johnson & Johnson's Janssen
Pharmaceutical unit for Risperdal, Pennsylvania claimed in a Feb. 26, 2007 complaint.
State of South Carolina v. Janssen
Johnson & Johnson, the world's largest maker of health care products, was sued by the state of South Carolina over claims the company's
Janssen LP unit fraudulently marketed the antipsychotic drug Risperdal. The companies promoted the drug for unapproved uses, contrary
to U.S. Food and Drug Administration regulations, and concealed the risk of diabetes and other side effects, the state said in its complaint.
State of South Carolina v. AstraZeneca
This is an action by Plaintiff seeking damages for personal injuries and damages suffered as a result of the defective and dangerous pharmaceutical
product Seroquel, which was manufactured, marketed, distributed and/or sold by Defendant AstraZeneca
State of South Carolina v. Eli Lilly
The State has discovered that Defendant has engaged in a protracted and willful course of corporate misconduct and misrepresentation... Defendant's
failure to provide an adequate warning of the risks of using Zyprexa has compromised the general health and welfare of South Carolina citizens
State of Texas and Allen Jones v. Janssen
The Texas attorney general says TMAP was just one part of an elaborate marketing
scheme to increase psychotropic drug sales.
The Texas state attorney general joined a whistleblower lawsuit this past December accusing the
pharmaceutical and consumer goods giant Johnson and Johnson inc. of exaggerating the
benefits and minimizing the known adverse effects associated with its second-generation
antipsychotic Risperdal (risperidone), marketed by subsidiary Janssen L.P. Article Complaint
State of Utah v. Lilly
Prior to selling its product Zyprexa, Lilly knew there was a risk of Zyprexa patients developing severe and harmful health conditions including, but not limited to, hyperglycemia (dangerously high blood sugar levels), acute weight gain, exacerbation of diabetes mellitus and pancreatitis. Furthermore, Lilly was aware of internal studies linking Zyprexa to these conditions, yet failed to warn the United States Food and Drug Administration, the State, physicians, and consumers?as a result of inappropriate marketing of Zyprexa for off-label uses, the State of Utah has paid millions of dollars for inappropriate and medically unnecessary doses of Zyprexa induced diabetes and diabetes related illnesses.
The state of Utah is asking for an award for Zyprexa-related damages of past, present, and future medical expenses for recipients of the Utah Medicaid program, the cost of all Zyprexa prescriptions paid by the State, triple damages as a civil penalty and an additional penalty of not more than $10,000 for each prescription that was not medically necessary.
Settled, $24 Million, November 11, 2009
Illinois attorney general Lisa Madigan has ratcheted up the pressure on pharmaceutical giant Eli Lilly. Lawyers at the consumer protection division of the Illinois attorney general's
office last week demanded that company officials hand over documents concerning the marketing of Zyprexa, Lilly's blockbuster mental health drug. Their counterparts in the Vermont AG's office have joined the action. Article
State of West Virginia v. Lilly
West Virginia Attorney General Darrell McGraw sued Eli Lilly in February, 2006 claiming that Zyprexa harmed West Virginia citizens. McGraw's suit claimed Zyprexa sales benefited Eli Lilly at the expense of West Virginia's Medicaid program. McGraw claimed the sales would not have occurred if Eli Lilly had disclosed its risk to medical providers. He wrote, "The money paid by the State would not have been paid to Eli Lilly except for its fraudulent conduct." He asked for three times the amount of the overpayments.
January 2004, the Office of the Inspector General for the U.S. Office of Personnel Management asked J&J for documents related to payments made to doctors in connection with sales, marketing and clinical trials for Risperdal. Article
November 3, 2005 Eli Lilly reported to the Securities and Exchange Commission that the U.S. attorney's office in Massachusetts subpoenaed the company, seeking documents on Lilly's business relationship with an unnamed long-term care pharmacy related to some of the company's drugs, including the antipsychotic drug Zyprexa.
November 2005 J&J's Janssen unit received a subpoena from the U.S. Attorney's Office in Philadelphia seeking information about marketing and adverse side effects of Risperdal, according to an October 2006 regulatory filing.Article
December 21, 2006 Bristol-Myers Squibb reported that it reached a tentative agreement to pay $499 million to settle a federal investigation into illegal sales and marketing activities from the late 1990s through 2005. The United States attorney's office in Boston, which first subpoenaed the records of Bristol-Myers in the matter in 2003, declined to confirm the announcement, saying it did not comment on such negotiations unless a final settlement has been signed. Jeff Macdonald, a company spokesman, confirmed previous reports that one product involved was the antipsychotic drug Abilify. Article
March 1, 2007 Congressman Henry A. Waxman, Chairman of the Committee on Oversight and Government, requested information relevant to Seroquel from AstraZeneca: "Allegations have been raised that AstraZeneca inappropriately marketed Seroquel". Subpoena
March 1, 2007 Congressman Henry A. Waxman, Chairman of the Committee on Oversight and Government, requested information relevant to Zyprexa from Eli Lilly: "Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa" Subpoena
March 12, 2007 Johnson & Johnson said that it had received subpoenas from U.S. attorneys in Philadelphia, Boston and San Francisco over allegations the company marketed schizophrenia drug Risperdal for unapproved uses.Article
NAMI's Role in the Scheme
Local 28 Sheet Metal Workers v. Lilly
Lilly also utilized a non-profit organization as a front to further its own purposes of increasing market share for atypical antipsychotics. Lilly?s funding and partnering with the National Alliance for the Mentally Ill (NAMI) in the late 1990s and early 2000s was designed to accomplish through a non-profit organization what it could not on its own: giving the appearance of independent analysis and a grassroots movement encouraging the use of atypical antipsychotics by state and private insurers. The scheme worked and Lilly certainly benefited from its significant donations to NAMI. Zyprexa was the leading antipsychotic in the world in 2000, capturing nearly 40% of the global antipsychotic market. A year later, Zyperexa was the sixth highest selling pharmaceutical product in the world, with $3.2 billion in sales.
UFCW Local 1776 v. Lilly
Lilly has been the largest contributor among pharmaceutical manufacturers to NAMI, giving the organization approximately $2.87 million between 1996 and 1999.
Lilly ?donations? to NAMI were not limited to money. In 1999, Mother Jones Magazine reported that Lilly executive Jerry Radke was ?on loan? to NAMI as an executive. Also in 1999, Bob Postlethwait, a Lilly executive (and TeenScreen advisor) who headed the group that produced and marketed Zyprexa assisted NAMI Indiana in securing government funding for an executive director.
Lilly also provided funding for a variety of brochures and programs produced by NAMI highlighting the use of atypical antipsychotics. One such Lilly-funded brochure ? ?Understanding Schizophrenia? ? produced by NAMI for patients and families of schizophrenics minimized the side effects of atypical antipsychotics such as Zyprexa. Another ? the 2001 ?Access to Effective Medications? brochure produced by NAMI National for legislators and paid for by Lilly ? lays out a blueprint for nationwide NAMI lobbying of state governments to reduce or remove any limitations to payments for atypical antipsychotics, again down-playing the side effects of such drugs.
Using money from Lilly and other pharmaceutical companies, NAMI ? both the various state-level association and the national organization ? has effectively lobbied state and federal governments to increase spending on atypical antipsychotic drugs and to reduce restrictions on access to those pharmaceuticals, thereby protecting pharmaceutical industry profits through the guise of independent, grassroots advocacy. For example, between 1998 and 2000, Lilly gave NAMI Washington State $91,000. During that time, NAMI Washington State, in an effort led by NAMI lobbyist Brad Boswell, lobbied the state legislature for $1 million specifically for atypical antipsychotic drugs. Brad Boswell was Lilly?s Washington state lobbyist just prior to his assignment with NAMI Washington State. NAMI also joined a suit initiated by the Pharmaceutical Research and Manufacturers of America (PhRMA) against the state of Michigan in order to increase physician access to higher cost pharmaceuticals ? including atypical antipsychotics ? under the state?s Medicaid program.
Class Action Complaint
Sergeants Benevolent Association Health and Welfare Fund v. Eli Lilly
The U.S. Department of Health and Human Services Office of the Inspector General issued a report in 2002 warning that cozy financial relationships between non-profit advocacy groups and pharmaceutical companies ? such as the one between NAMI and Lilly ? which result in the generation of revenue for the pharmaceutical companies could be considered illegal under the federal anti-kickback statute.