claims act alleging off-label promotion of the cystic fibrosis drug tobi between 2001 and 2006. allergan: off-label promotion of botox, september 2010 allergan, the manufacturer of botox, agreed to a $600 million settlement to resolve all civil and criminal liability surrounding the promotion of botox for treatment of chronic migraines before fda review or approval of the drug for such use. novartis: off-label promotion of trileptal, september 2010 novartis made a settlement of $422.5 million, including a $185 million criminal fine and forfeiture for the off-label promotion of the anti-epilepsy drug trileptal. trileptal was approved by the fda to treat partial seizures, but was allegedly promoted to treat pain and some psychiatric conditions. the government also accused novartis of paying illegal kickbacks to healthcare providers. forest laboratories: off-label promotion of levothroid, celexa and lexapro, september 2010 forest laboratories made a settlement of more than $313 million to resolve all criminal and civil liability related to three different drugs. forest laboratories pleaded guilty to obstruction of justice and illegal distribution of levothroid, which at the time was an unapproved new drug. the settlement also resolved allegations of off-label marketing of celexa, an antidepressant approved to treat adult depression. according to the government, forest marketed celexa for use in children and adolescents. élan: off-label promotion of zonegran, december 2010 irish pharmaceutical company élan and its u.s. subsidiary agreed to pay $203 million to resolve allegations that the company engaged in off-label promotion of the anti-epilepsy drug zonegran. eisai, a japanese drug marketer that purchased the drug from élan, agreed to pay $11 million. the settlement resolved claims of illegal promotion under the food, drug, and cosmetic act as well as civil claims filed under the false claims act. kos pharmaceuticals: off-label promotion of advicor and niaspan, december 2010 kos pharmaceuticals, a subsidiary of abbott laboratories, agreed to a settlement of more than $41 million to dispose of all civil and criminal liability resulting from the company's off-label promotion and illegal payment of kickbacks in the marketing of advicor and niaspan. the department of justice entered into a deferred prosecution agreement with kos based on actions taken by the company to conduct internal investigations and its ongoing cooperation with the government. ucb: off-label promotion of keppra, june 2011 the u.s. subsidiary of ucb, a belgian pharmaceutical company, agreed to pay more than $34 million as part of a settlement agreement to resolve all criminal and civil liability arising from its alleged off-label promotion of the epilepsy drug keppra. ucb was alleged to have promoted the drug for the treatment of migraine headaches, a use for which keppra had not received fda approval. novo nordisk: off-label promotion of novoseven, june 2011 novo nordisk, a danish drug manufacturer, agreed to a $25 million settlement to resolve allegations of illegal promotion of the drug novoseven, approved by the fda to treat certain bleeding disorders in hemophiliacs. the government’s complaint alleged numerous off-label uses for which the company promoted the drug, including as a coagulatory agent for trauma patients, general surgery, cardiac surgery, liver surgery, liver transplants and intra-cerebral hemorrhage. pfizer: off-label promotion of detrol, october 2011 as was the case in the 2004 pfizer settlement over off-label promotion of neurontin, in 2011 pfizer agreed to a settlement as a result of a whistleblower complaint filed under the false claims act without intervention by the department of justice. the $14.5 million settlement arose from a complaint which alleged that pfizer was engaging in the illegal promotion of detrol, a drug approved by the fda to treat urinary incontinence, for off-label uses. abbott laboratories: off-label promotion of depakote, may 2012 abbott laboratories agreed to pay $800 million to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug depakote for uses not approved as safe and effective by the fda. the company misbranded depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was fda approved. this settlement figure represents resolution of other claims in addition to off-label promotion. glaxosmithkline: off-label promotion of paxil, wellbutrin, advair, lamictal and zofran, july 2012 glaxosmithkline (gsk) agreed to pay $1.043 billion relating to false claims arising from off-label promotion. gsk promoted the drugs paxil and wellbutrin for unapproved, non-covered uses. gsk also promoted its asthma drug, advair, for first-line therapy for mild asthma patients even though it was not approved or medically appropriate under these circumstances. gsk also promoted advair for chronic obstructive pulmonary disease with misleading claims as to the relevant treatment guidelines. gsk also promoted lamictal, an anti-epileptic medication, for off-label, non-covered psychiatric uses, neuropathic pain and pain management. further, gsk promoted certain forms of zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women. this settlement figure represents resolution of other claims in addition to off-label promotion. amgen: off-label promotion of aranesp, enbrel and neulasta, december 2012 amgen agreed to pay $612 million for the off-label promotion of three drugs it manufactured, enbrel and neulasta. amgen promoted the sale and use of aranesp for dosing regiments and indications which were (a) not approved by the fda, and (b) not medically accepted indications, including anemia caused by cancer, anemia caused by chronic disease, chronic anemia, and anemia caused by myelodysplastic syndrome. similarly, amgen promoted its drugs enbrel and neulasta for off-label indications that were not eligible for coverage by federal health care programs. this settlement figure represents resolution of other claims in addition to off-label promotion. par pharmaceutical: off-label promotion of megace es, march 2013 par pharmaceutical agreed to pay $22.5 million to the federal government and various states to resolve claims arising from its off-label marketing. par made unsubstantiated and misleading representations about the superiority of megace es over generic megestrol acetate for elderly patients to encourage providers to switch patients from generic megestrol acetate to megace es, despite having conducted no well-controlled studies to support a claim of greater efficacy for megace es. except as admitted in the plea agreement, the claims settled by the civil settlement agreement are allegations only, and there has been no determination of liability as to those claims. wyeth pharmaceuticals: off-label promotion of rapamune, july 2013 wyeth, which was acquired by pfizer in 2009, agreed to pay $257.4 million to resolve claims involving off-label promotion of the immunosuppressant drug rapamune. the government alleged that wyeth violated the false claims act, from 1998 through 2009, by promoting rapamune for unapproved uses, some of which were not medically accepted indications and, therefore, were not covered by medicare, medicaid and other federal health care programs. these unapproved uses included non-renal transplants, conversion use (switching a patient from another immunosuppressant to rapamune) and using rapamune in combination with other immunosuppressive agents not listed on the label. johnson & johnson: off-label promotion of risperdal, invega and natrecor, november 2013 johnson & johnson agreed to pay $1.391 billion to resolve false claims resulting from its off-label promotion of risperdal, invega and natrecor. risperdal was approved only to treat schizophrenia, yet janssen, a johnson and johnson (j&j) subsidiary, promoted risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion. similarly, although invega was approved only for the treatment of schizophrenia and schizoaffective disorder, from 2006 through 2009, j&j and janssen marketed the drug for off-label indications. finally, scios inc,. a subsidiary of j&j, launched an aggressive campaign to market natrecor for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the fda-approved label and not covered by federal health care programs. this settlement figure represents resolution of other claims in addition to off-label promotion. carefusion: off-label promotion of chloraprep, january 2014 carefusion agreed to pay $40.1 million to resolve allegations of off-label promotion of chloraprep. chloraprep had been approved by the fda for the preparation of a patient’s skin prior to surgery or injection. this settlement also resolves allegations that, during the period between september 2009 and august 2011, carefusion knowingly promoted the sale of chloraprep for uses that were not approved by the fda, some of which were not medically accepted indications, and made unsubstantiated representations about the appropriate uses of chloraprep. this settlement figure represents resolution of other claims in addition to off-label promotion. endo pharmaceuticals: off-label promotion of lidoderm, february 2014 endo pharmaceuticals agreed to pay $171.9 million to resolve civil liability under the false claims act for its off-label promotion of lidoderm. the government charged that, between 2002 and 2006, endo misbranded lidoderm and introduced it into interstate commerce in violation of the food, drug and cosmetic act (fdca). lidoderm's labeling lacked adequate directions for use in the treatment of non-phn related pain, including low back pain, diabetic neuropathy and carpal tunnel syndrome. these uses were intended by endo pharmaceuticals inc. but never approved by the fda. insys therapeutics: off-label promotion of opioid drug subsys, august 2015 in august 2015, insys therapeutics reached a $1.1 million settlement with the oregon department of justice, resolving allegations that it promoted its opioid drug subsys to treat off-label non-cancer uses that were not approved by the fda. insys has also paid new hampshire $2.9 million to settle allegations of aggressive marketing of subsys. acclarent inc.: off-label promotion of sinus spacer product, july 2016 on july 22, 2016, california-based medical device manufacturer and johnson & johnson subsidiary acclarent inc. agreed to pay $18 million to resolve allegations that it marketed and distributed its sinus spacer product for use as a drug delivery device without fda approval. the government alleged that it continued its off-label marketing even after the fda rejected the company's request to expand the approved uses, and even though the company added a warning to its label regarding the use of active drug substances in the device. on july 20, 2016, the company's former ceo and former vice president of sales also were convicted following a trial of ten misdemeanor counts of introducing adulterated and misbranded medical devices into interstate commerce. biocompatibles inc.: off-label promotion of lc bead, november 2016 on november 7, 2016, medical device company biocompatibles inc., a subsidiary of btg plc agreed to pay $25 million to resolve allegations that it violated the false claims act by causing false claims to be submitted to government health care programs. the company allegedly promoted lc bead, its embolization device—designed, to be inserted into blood vessels to block the flow of blood to tumors—for off-label use as a "drug-delivery" device, which was not an fda-approved use and was not supported by substantial clinical evidence. the company also agreed to pay an additional $11 million in criminal fines and forfeitures for a total of $36 million. bristol-myers squibb company: off-label promotion of abilify, december 2016 on december 9, 2016, pharmaceutical company bristol-myers squibb agreed to pay $19.5 million to settle claims with forty-three state attorneys general concerning the alleged off-label promotion of its schizophrenia drug abilify. the lawsuit alleged the company promoted the drug for use in pediatric populations and to treat dementia and alzheimer's in elderly patients, despite the fact that those were not fda-approved uses. shire plc: kickbacks and off-label promotion of dermagraft, january 2017 in january 2017, shire plc subsidiaries entered into a global resolution under the civil fca with federal and state governments for $350 million. the settlement largely focused on payment of alleged kickbacks to induce clinics and physicians to use or overuse its product dermagraft, a bioengineered human skin substitute approved by the fda for the treatment of diabetic foot ulcers. the settlement also resolved allegations that shire and its predecessor abh unlawfully marketed dermagraft for off-label uses not approved by the fda, made false statements to inflate the price of dermagraft, and caused improper coding, verification, or certification of dermagraft claims and related services. the allegations resolved by the settlement were brought in six lawsuits filed under the qui tam, or whistleblower, provisions of the false claims act. celgene corporation: off-label promotion of revlimid and thalomid, july 2017 in july 2017, celgene agreed to pay $280 million to government agencies to settle allegations that it caused the submission of false claims or fraudulent claims for non-reimbursable uses of