list of off-label promotion pharmaceutical settlements list of off-label promotion pharmaceutical settlements the following are settlements reached with us authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. under the federal food, drug, and cosmetic act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the food and drug administration (fda), and corporations that market drugs for off-label indications may be subject to civil liability under the false claims act as well as criminal penalties. off-label promotion settlements under the false claims act descriptions of the lawsuits are listed in chronological order. parke-davis, warner-lambert and pfizer: off-label promotion of neurontin, may 2004 main article: franklin v. parke-davis in 1996, whistleblower david franklin left his position as a medical liaison with parke-davis, a pharmaceutical division of warner-lambert company, after learning of the company's marketing strategy to promote the epilepsy drug neurontin for uses not approved by the fda. franklin and his attorney, thomas m. greene, filed a lawsuit, franklin v. parke-davis, under the false claims act in federal district court in boston. in the first off-label promotion case ever litigated in a whistleblower suit under the false claims act, the settlement was announced after eight years of litigation in may 2004. warner-lambert agreed to pay $430 million to resolve all civil and criminal liability, with $24.64 million going to franklin for his participation in the lawsuit. it is one of the largest recoveries against a pharmaceutical company in u.s. history. the total settlement remained the largest against a pharmaceutical company in a non-intervened false claims act case until a july 2017 settlement against celgene corporation exceeded it, as the civil settlement in that case was $280 million while the civil component of the parke-davis case settled for $190 million. serono: off-label promotion of serostim, october 2005 serono, a swiss biotechnology company, obtained approval from the fda for the drug serostim in 1996 to treat aids wasting, a condition in which aids patients experience rapid weight loss. however, around the same time, the advent of more robust protease inhibitors that could interact in aids cocktails to markedly slow the advancement of the syndrome led to a decline in symptoms of aids wasting and, consequently, demand for serostim. as a result, according to prosecutors, serono devised a marketing scheme by which the definition of aids wasting would be changed to measure a loss in "body cell mass". the company then created a computerized medical test designed to detect loss of body cell mass and thereby diagnose aids wasting even in patients who had not experienced any weight loss. serono ultimately agreed to pay $704 million to resolve all civil and criminal liability. five whistleblowers, all former employees of serono, initiated complaints under the false claims act, ultimately leading to the government's investigation. the whistleblowers shared in a $51 million reward from the settlement. schering-plough: off-label promotion of intron a and temodar, august 2006 schering-plough pleaded guilty to one count of conspiracy to make false statements to the medicaid program in connection with the pricing of its allergy drug claritin. allegations of off-label promotion, however, centered on the off-label promotion of several cancer drugs. the drug temodar, which was approved by the food and drug administration (fda) in 1999 for treatment of a specific type of brain tumor, was allegedly being promoted as a treatment for other types of brain cancer for which it had not been approved. schering-plough allegedly promoted intron a, meanwhile, for use in superficial bladder cancer and hepatitis c. the case arose from claims filed under the false claims act; the company was forced to pay a $180 million criminal fine and an additional $255 million to settle all civil claims. intermune: off-label promotion of actimmune, october 2006 in 2007, intermune abandoned all efforts to develop the drug actimmune, which goes by the generic name of interferon-gamma, as a treatment for idiopathic pulmonary fibrosis (ipf), a chronic lung condition, after experimental trials showed the drug was ineffective at treating the disease. the decision was announced after the company agreed to pay $36.9 million to resolve criminal charges and civil liability in connection with intermune's off-label promotion of the drug, which had only been approved by the fda to treat chronic granulomatous disease and severe malignant osteopetrosis, both extremely rare illnesses which would have generated sales of only $20 million a year. sales of the drug to treat ipf, however, soared as high as $141 million in the year 2003. intermune's yearly sales were entirely from actimmune. cell therapeutics: off-label promotion of trisenox, april 2007 in a qui tam suit filed under the false claims act by whistleblower james marchese, cell therapeutics agreed to settle claims for $10.5 million that it illegally promoted the cancer drug trisenox. trisenox won approval by the fda in 2000 to treat a relatively rare form of leukemia known as acute promyelocytic leukemia, but the manufacturer promoted trisenox as effective treatment for other cancers for which the drug was not approved. medicis pharmaceutical: off-label promotion of loprox, may 2007 this settlement of $9.8 million resolved allegations that medicis pharmaceutical promoted loprox, a topical skin preparation, for use on children under the age of 10 despite the fact that use in children under 10 had not been approved by the fda. according to the government and the whistleblower complaint filed by four former medicis sales representatives under the false claims act, pediatricians were urged to prescribe loprox as a treatment for diaper rash. the four relators shared a $1,078,000 reward for providing information in the lawsuit. orphan medical and jazz pharmaceuticals: off-label promotion of xyrem, july 2007 orphan medical, a subsidiary of jazz pharmaceuticals, pleaded guilty to felony misbranding under the fdca and agreed to pay $20 million to resolve all civil claims and criminal charges in connection with xyrem, a drug approved by the fda for narcolepsy and the street version of which is classified by the drug enforcement administration as a schedule i drug. although the drug's distribution as a narcolepsy medication is strictly regulated, the complaint filed under the false claims act alleged that the company promoted the drug as a treatment for depression, insomnia, and fibromyalgia. this case was later overturned as the drug was found to be effective for insomnia and fibromyalgia. in 2012, the second circuit court of appeals further expanded first amendment commercial speech protection in the realm of pharmaceutical marketing in united states v. caronia. the court overturned a pharmaceutical sales representative’s conviction arising from a recording of his promotion of off-label use of xyrem (sodium oxybate) to a group of doctors. xyrem was approved for the indication of excessive daytime sleepiness, but caronia promoted it for insomnia and fibromyalgia. the court held that convicting the sales representative for off-label marketing that was not untruthful or misleading violated his first amendment rights. in contrast, off-label promotion that is untruthful and misleading would be fraudulent, and thus not protected by the first amendment. bristol-myers squibb and otsuka american: off-label promotion of abilify, september 2007 in a settlement totaling $515 million to settle a host of civil charges and civil liabilities related to alleged illegal pricing and marketing practices for several of its drugs, bristol-myers squibb paid out approximately $50 million to settle seven qui tam suits filed under the false claims act. specifically, the company engaged in off-label promotion of abilify, an antipsychotic drug approved by the fda to treat adult schizophrenia and bi-polar disorder. the government alleged that bristol promoted the drug for pediatric use and to treat dementia, both of which are off-label uses. cephalon: off-label promotion of actiq, gabitril and provigil, september 2008 cephalon, a pennsylvania-based drug company, paid out $425 million, $50 million of which was paid to resolve a criminal indictment for violations of the fdca, and $375 million to dispose of claims brought under the false claims act. four qui tam relators who filed suits collectively recovered $46,469,978 as their share. the fda approved actiq, a fentanyl product manufactured as a lollipop, for use in cancer patients for whom morphine-based painkillers are no longer effective. according to the government, cephalon promoted actiq for use in non-cancer patients to treat such conditions as migraines, sickle-cell pain crises, and other injuries. gabitril, meanwhile, received fda approval as a treatment for partial seizures, but the manufacturer allegedly marketed the drug for anxiety, insomnia, and pain. provigil was initially approved to treat excessive daytime sleepiness resulting from narcolepsy, and later approved the drug for further label indications. cephalon allegedly promoted provigil for a five-year period as a non-stimulant drug for the treatment of sleepiness, tiredness, decreased activity, lack of energy, and fatigue. eli lilly: off-label promotion of zyprexa, january 2009 after four whistleblowers initially filed suits under the false claims act, prompting a government investigation, eli lilly and company agreed to plead guilty and pay $1.415 billion for promoting its drug zyprexa for uses not approved by the fda. specifically, the private whistleblower complaints and the government alleged that eli lilly engaged in a marketing scheme over a period of several years to promote the drug's use in children and the elderly, groups particularly vulnerable to the product's side effects. an antipsychotic drug initially approved in 2000 to treat manifestations of certain psychotic disorders, the government's indictment contended that eli lilly deliberately marketed the drug to treat agitation, aggression, hostility, dementia, alzheimer’s dementia, depression and generalized sleep disorder, none of which were uses approved by the fda. pfizer: off-label promotion of bextra, geodon, zyvox and lyrica, september 2009 in what was the largest pharmaceutical settlement in u.s. history at the time, pfizer reached a $2.3 billion settlement with the department of justice to resolve criminal charges and civil claims under the false claims act. the pharmaceutical giant was accused of off-label promotion of the anti-inflammatory drug bextra; geodon, an anti-psychotic drug; zyvox, an antibiotic; and lyrica, an anti-epileptic drug. the drugs were allegedly promoted for uses not approved by the fda, and therefore the company's marketing caused non-reimbursable prescriptions to be paid by medicare and medicaid (medicare and medicaid do not reimburse for off-label drug prescriptions). six whistleblowers shared a $102 million reward under the false claims act. alpharma: off-label promotion of kadian, march 2010 after a government investigation precipitated by a whistleblower suit filed by debra parks under the false claims act in 2006, alpharma agreed to a $42.5 million settlement to resolve all civil and criminal liability in connection with the company's alleged off-label marketing of kadian. according to the government, the company promoted kadian, a morphine-based drug, for uses unapproved by the fda. in addition, the company made misrepresentations about the safety and efficacy of the drug. astrazeneca: off-label promotion of seroquel, april 2010 a qui tam suit filed under the false claims act led astrazeneca to make a massive $520 million settlement to resolve all civil and criminal liability with respect to illegal promotion of the anti-psychotic drug seroquel. approved by the fda in 1997 to treat manifestations of psychotic disorders, in 2000 the fda subsequently approved seroquel for short-term treatment of schizophrenia, bipolar disorder, and bipolar depression. between january 2001 through december 2006, astrazeneca promoted seroquel to psychiatrists and other physicians for certain uses that were not approved by the fda, including aggression, alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness. federal health programs do not reimburse for prescriptions prescribed for indications not approved by the fda. ortho-mcneil-janssen: off-label promotion of topamax, may 2010 two subsidiaries of johnson & johnson, ortho-mcneil pharmaceutical and ortho-mcneil-janssen, agreed to pay more than $81 million to settle all civil and criminal liability as a result of the companies’ illegal marketing of topamax, an anti-epileptic drug. as part of the settlement, ortho-mcneil agreed to plead guilty to one count of a misdemeanor violation of the food, drug, and cosmetic act. the criminal fine amounted to $6.1 million, and the government recovered $75 million in damages under the false claims act. the whistleblowers who filed suit under the false claims act stood to recover, collectively, more than $9 million. novartis: off-label promotion of tobi, may 2010 novartis vaccines & diagnostics and novartis pharmaceuticals corporation agreed to pay $72.5 million to settle claims brought under the false