761:. 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.
449:. 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.
183:(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.
271:. 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.
776:. 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.
120:
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.
866:
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.
738:. 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.
227:, 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.
791:. 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.
473:, 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.
365:
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.
820:
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.
900:
allegations that
Aegerion, promoted Juxtapid for off-label uses not approved by the FDA, made false and misleading statements to medical practitioners regarding the drug, violated risk-management regulations designed to ensure safe use, and broke anti-kickback laws with charity donations. In addition to civil
819:
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
119:
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
646:
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
836:
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
347:
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
886:
to
Medicare and state Medicaid programs. In addition to listing off-label promotion under the covered conduct, the settlement agreement separately covered alleged "false and misleading" statements Celgene made about the drugs, including by concealing or minimizing adverse events. In its July 2017
718:
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
86:
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
865:
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
626:
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
364:
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
899:
On
September 22, 2017, Aegerion Pharmaceuticals agreed to pay $ 28.2 million to resolve allegations that it violated federal marketing rules in promoting its cholesterol medication Juxtapid, resulting in the violation of the Federal False Claims Act and state analogues. The settlement resolved
338:
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.
91:
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
693:
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
670:, 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
837:
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.
614:. 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.
266:
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
559:, 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.
713:
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
322:, 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
1869:
519:. 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.
591:, 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
250:
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
530:
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
151:(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
504:, 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.
425:. 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.
484:
Vaccines & Diagnostics and Novartis Pharmaceuticals Corporation agreed to pay $ 72.5 million to settle claims brought under the False Claims Act alleging off-label promotion of the cystic fibrosis drug
579:. 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.
374:
88:
2157:
853:. 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.
571:, 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
83:
678:, 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.
1895:
702:
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.
2295:
1873:
401:, 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
2068:"Endo Pharmaceuticals and Endo Health Solutions to Pay $ 192.7 Million to Resolve Criminal and Civil Liability Relating to Marketing of Prescription Drug Lidoderm for Unapproved Uses"
163:. 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.
279:
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,
878:
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 its drugs
1030:
807:
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.
385:
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
2144:"Medical Device Maker Biocompatibles Pleads Guilty to Misbranding and Agrees to Pay $ 36 Million to Resolve Criminal Liability and False Claims Act Allegations"
2281:
2193:
2161:
2126:
921:
1540:
849:
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
674:, an anti-epileptic medication, for off-label, non-covered psychiatric uses, neuropathic pain and pain management. Further, GSK promoted certain forms of
343:, meanwhile, received FDA approval as a treatment for partial seizures, but the manufacturer allegedly marketed the drug for anxiety, insomnia, and pain.
2314:
2143:
242:, 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
409:(Medicare and Medicaid do not reimburse for off-label drug prescriptions). Six whistleblowers shared a $ 102 million reward under the False Claims Act.
1899:
913:
1127:
551:
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
445:
to make a massive $ 520 million settlement to resolve all civil and criminal liability with respect to illegal promotion of the anti-psychotic drug
2258:
515:
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
421:
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
539:, an antidepressant approved to treat adult depression. According to the government, Forest marketed Celexa for use in children and adolescents.
1958:"Amgen Inc. Pleads Guilty to Federal Charge in Brooklyn, NY.; Pays $ 762 Million to Resolve Criminal Liability and False Claims Act Allegations"
887:
Form 10-Q, Celgene disclosed that it resolved the matter in full for $ 315 million, including fees and expenses. The case was brought under the
689:
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
642:
agreed to pay $ 800 million to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug
2282:"Drug Maker Aegerion Agrees to Plead Guilty; Will Pay More Than $ 35 Million to Resolve Criminal Charges and Civil False Claims Allegations"
2178:
595:. UCB was alleged to have promoted the drug for the treatment of migraine headaches, a use for which Keppra had not received FDA approval.
27:
1980:"Par Pharmaceutical Pleads Guilty and Agrees to Pay $ 45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing"
1438:
1075:
1009:
904:
liability, Aegerion also agreed to a guilty plea involving the same conduct and to pay a criminal fine and forfeiture of $ 7.2 million.
382:
2046:"CareFusion to Pay the Government $ 40.1 Million to Resolve Allegations That Include More Than $ 11 Million in Kickbacks to One Doctor"
469:, agreed to pay more than $ 81 million to settle all civil and criminal liability as a result of the companies’ illegal marketing of
2194:"Celgene Agrees to Pay $ 280 Million to Resolve Fraud Allegations Related to Promotion of Cancer Drugs For Uses Not Approved by FDA"
1848:"U.S. Subsidiary of Belgian Pharmaceutical Manufacturer Pleads Guilty to Off-Label Promotion; Company to Pay More Than $ 34 Million"
116:
2215:
803:
reached a $ 1.1 million settlement with the Oregon Department of Justice, resolving allegations that it promoted its opioid drug
1730:
417:
After a government investigation precipitated by a whistleblower suit filed by Debra Parks under the False Claims Act in 2006,
247:
1756:"Drug Maker Forest Pleads Guilty; To Pay More Than $ 313 Million to Resolve Criminal Charges and False Claims Act Allegations"
2339:
730:, which was acquired by Pfizer in 2009, agreed to pay $ 257.4 million to resolve claims involving off-label promotion of the
2103:
908:
Boehringer Ingelheim Pharmaceuticals Inc.: off-label promotion of Aggrenox, Atrovent, Combivent, and Micardis, December 2017
1638:"Novartis Vaccines & Diagnostics to Pay More Than $ 72 Million to Resolve False Claims Act Allegations Concerning TOBI"
1006:"Warner-Lambert to Pay $ 430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion"
1587:"Two Johnson & Johnson Subsidiaries to Pay Over $ 81 Million to Resolve Allegations of Off-Label Promotion of Topamax"
606:, a Danish drug manufacturer, agreed to a $ 25 million settlement to resolve allegations of illegal promotion of the drug
180:
1390:
208:
148:
31:
1708:"Novartis Pharmaceuticals Corp. to Pay More Than $ 420 Million to Resolve Off-label Promotion and Kickback Allegations"
211:, but the manufacturer promoted Trisenox as effective treatment for other cancers for which the drug was not approved.
2349:
2002:"Wyeth Pharmaceuticals Agrees to Pay $ 490.9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses"
1191:"Biopharmaceutical Firm Intermune to Pay U.S. Over $ 36 Million for Illegal Promotion and Marketing of Drug Actimmune"
658:(GSK) agreed to pay $ 1.043 billion relating to false claims arising from off-label promotion. GSK promoted the drugs
462:
2233:
2127:"Johnson & Johnson Subsidiary Acclarent Inc. Pays Government $ 18 Million to Settle False Claims Act Allegations"
143:. Allegations of off-label promotion, however, centered on the off-label promotion of several cancer drugs. The drug
1922:"Abbott Labs to Pay $ 1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote"
1518:"Alpharma to Pay $ 42.5 Million to Resolve False Claims Act Allegations in Connection with Promotion of Drug Kadian"
1102:
2334:
2329:
1870:"Danish Pharmaceutical Novo Nordisk to Pay $ 25 Million To Resolve Allegations of Off-Label Promotion of Novoseven"
787:
agreed to pay $ 171.9 million to resolve civil liability under the False Claims Act for its off-label promotion of
535:, which at the time was an unapproved new drug. The settlement also resolved allegations of off-label marketing of
61:
1336:"Bristol-Myers Squibb to Pay More Than $ 515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing"
356:
After four whistleblowers initially filed suits under the False Claims Act, prompting a government investigation,
2344:
34:(FDA), and corporations that market drugs for off-label indications may be subject to civil liability under the
402:
1660:"Allergan Agrees to Plead Guilty and Pay $ 600 Million to Resolve Allegations of Off-Label Promotion of Botox"
1416:"Eli Lilly and Company Agrees to Pay $ 1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa"
917:
78:
55:
19:
1826:"Kos Pharmaceuticals to Pay More Than $ 41 Million to Resolve Kickback and Off-Label Promotion Allegations"
1804:"Pharmaceutical Companies to Pay $ 214.5 Million to Resolve Allegations of Off-label Promotion of Zonegran"
1134:
220:
69:
829:
1944:"GSK to Plead Guilty and Pay $ 3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data"
1308:
727:
357:
196:
1292:
846:
784:
746:
719:
agreement are allegations only, and there has been no determination of liability as to those claims.
466:
458:
280:
239:
816:
815:
On July 22, 2016, California-based medical device manufacturer and Johnson & Johnson subsidiary
291:
suits filed under the False Claims Act. Specifically, the company engaged in off-label promotion of
235:
30:, it is illegal for pharmaceutical companies to promote their products for uses not approved by the
2024:"Johnson & Johnson to Pay More Than $ 2.2 Billion to Resolve Criminal and Civil Investigations"
639:
568:
527:
2158:"AG Paxton: Texas and 42 States Reach $ 19.5 Million Settlement with Bristol-Myers Squibb Company"
1755:
1707:
1541:"The Alpharma Morphine Painkiller Probe Ain't Over: 'Unnamed Defendant' Still Twists in the Wind"
1053:
800:
710:
651:
GlaxoSmithKline: Off-label promotion of Paxil, Wellbutrin, Advair, Lamictal and Zofran, July 2012
246:, a drug approved by the FDA for narcolepsy and the street version of which is classified by the
132:
2089:
1957:
1825:
1803:
1659:
1495:
1335:
749:
agreed to pay $ 1.391 billion to resolve false claims resulting from its off-label promotion of
115:
patients experience rapid weight loss. However, around the same time, the advent of more robust
76:
for uses not approved by the FDA. Franklin and his attorney, Thomas M. Greene, filed a lawsuit,
2067:
2023:
862:
2045:
1682:
1415:
1190:
1079:
987:
731:
715:
330:
relators who filed suits collectively recovered $ 46,469,978 as their share. The FDA approved
304:
252:
172:
1216:
2108:
1979:
1943:
1896:"Detrol Settlement of $ 14.5 Million Adds to List of Off-Label Cases Under False Claims Act"
1586:
1564:
1517:
1463:
1296:
977:
969:
901:
888:
35:
2001:
1921:
1847:
1358:
742:
Johnson & Johnson: Off-label promotion of Risperdal, Invega and Natrecor, November 2013
1637:
1611:
1321:
1267:
1244:
1165:
1048:
655:
523:
Forest Laboratories: Off-label promotion of Levothroid, Celexa and Lexapro, September 2010
128:
1005:
1778:
275:
Bristol-Myers Squibb and Otsuka American: Off-label promotion of Abilify, September 2007
982:
957:
307:. The government alleged that Bristol promoted the drug for pediatric use and to treat
156:
1300:
1245:"Medicis Pharmaceutical to Pay U.S. $ 9.8 Million to Resolve False Claims Allegations"
1128:"Schering to Pay $ 435 Million for the Improper Marketing of Drugs and Medicaid Fraud"
199:
agreed to settle claims for $ 10.5 million that it illegally promoted the cancer drug
2323:
588:
300:
296:
23:
2179:"Shire PLC Subsidiaries to Pay $ 350 Million to Settle False Claims Act Allegations"
1565:"Pharmaceutical Giant AstraZeneca to Pay $ 520 Million for Off-label Drug Marketing"
2234:"UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q"
1391:"Pharmaceutical Company Cephalon to Pay $ 425 Million for Off-Label Drug Marketing"
603:
260:
1779:"Forest, Maker of Celexa, to Pay More Than $ 313 Million to Settle Marketing Case"
1496:"Justice Department Announces Largest Health Care Fraud Settlement in Its History"
72:, after learning of the company's marketing strategy to promote the epilepsy drug
50:
Parke-Davis, Warner-Lambert and Pfizer: Off-label promotion of Neurontin, May 2004
631:, a drug approved by the FDA to treat urinary incontinence, for off-label uses.
442:
231:
Orphan Medical and Jazz Pharmaceuticals: Off-label promotion of Xyrem, July 2007
160:
65:
2296:"NJ to Get $ 287K Share of Boehringer's $ 13.5M Off-Label Marketing Settlement"
369:
Pfizer: Off-label promotion of Bextra, Geodon, Zyvox and Lyrica, September 2009
773:
772:
agreed to pay $ 40.1 million to resolve allegations of off-label promotion of
769:
663:
611:
563:
Kos Pharmaceuticals: Off-label promotion of Advicor and Niaspan, December 2010
532:
486:
203:. Trisenox won approval by the FDA in 2000 to treat a relatively rare form of
140:
973:
315:
Cephalon: Off-label promotion of Actiq, Gabitril and Provigil, September 2008
103:, a Swiss biotechnology company, obtained approval from the FDA for the drug
933:
870:
Celgene Corporation: Off-label promotion of Revlimid and Thalomid, July 2017
750:
607:
516:
176:
73:
991:
841:
Bristol-Myers Squibb Company: Off-label promotion of Abilify, December 2016
795:
Insys Therapeutics: Off-label promotion of Opioid drug Subsys, August 2015
937:
929:
925:
895:
Aegerion Pharmaceuticals: Off-label promotion of Juxtapid, September 2017
883:
879:
788:
758:
735:
699:
682:
Amgen: Off-label promotion of Aranesp, Enbrel and Neulasta, December 2012
671:
643:
552:
512:
497:
481:
446:
418:
406:
344:
340:
335:
319:
308:
256:
204:
200:
179:, which goes by the generic name of Interferon-gamma, as a treatment for
152:
136:
124:
Schering-Plough: Off-label promotion of Intron A and Temodar, August 2006
112:
108:
104:
87:
going to Franklin for his participation in the lawsuit. It is one of the
857:
Shire PLC: Kickbacks and off-label promotion of Dermagraft, January 2017
1078:. United States: Department of Justice. 17 October 2005. Archived from
875:
850:
833:
690:
576:
572:
548:
470:
436:
361:
325:
292:
286:
195:
suit filed under the False Claims Act by whistleblower James Marchese,
192:
144:
1133:. United States: Department of Justice. 29 August 2006. Archived from
811:
Acclarent Inc.: Off-label promotion of Sinus Spacer Product, July 2016
360:
agreed to plead guilty and pay $ 1.415 billion for promoting its drug
2259:"Celgene to Pay $ 280 Million to Settle Fraud Suit Over Cancer Drugs"
2104:"One company symbolizes everything sickening about the opioid crisis"
804:
754:
695:
675:
667:
666:
for unapproved, non-covered uses. GSK also promoted its asthma drug,
628:
623:
592:
536:
422:
398:
390:
386:
378:
224:
100:
1872:. United States: Department of Justice. 10 June 2011. Archived from
1076:"Serono to Pay $ 704 Million for the Illegal Marketing of Aids Drug"
780:
Endo Pharmaceuticals: Off-label promotion of Lidoderm, February 2014
824:
Biocompatibles Inc.: Off-label promotion of LC Bead, November 2016
686:
659:
556:
501:
394:
331:
243:
18:
The following are settlements reached with US authorities against
723:
Wyeth Pharmaceuticals: Off-label promotion of Rapamune, July 2013
706:
Par Pharmaceutical: Off-label promotion of Megace ES, March 2013
46:
Descriptions of the lawsuits are listed in chronological order.
215:
Medicis Pharmaceutical: Off-label promotion of Loprox, May 2007
635:
Abbott Laboratories: Off-label promotion of Depakote, May 2012
453:
Ortho-McNeil-Janssen: Off-label promotion of Topamax, May 2010
187:
Cell Therapeutics: Off-label promotion of Trisenox, April 2007
958:"Whistleblower charges drug company with deceptive practices"
610:, approved by the FDA to treat certain bleeding disorders in
2216:"Recent Settlements Suggest Off-Label Cases Aren't Extinct"
2160:. Texas: Attorney General. December 8, 2016. Archived from
765:
CareFusion: Off-label promotion of ChloraPrep, January 2014
219:
This settlement of $ 9.8 million resolved allegations that
139:
program in connection with the pricing of its allergy drug
2284:. United States: Department of Justice. 22 September 2017.
508:
Novartis: Off-label promotion of Trileptal, September 2010
42:
Off-label promotion settlements under the False Claims Act
1758:. United States: Department of Justice. 15 September 2010
1710:. United States: Department of Justice. 30 September 2010
1490:
1488:
1486:
1484:
1385:
1383:
1381:
1379:
1338:. United States: Department of Justice. 28 September 2007
891:
by Beverly Brown, a former Celgene sales representative.
599:
Novo Nordisk: Off-label promotion of NovoSeven, June 2011
167:
InterMune: Off-label promotion of Actimmune, October 2006
2196:. Central District of California: U.S. Attorney's Office
2181:. United States: Department of Justice. 11 January 2017.
2146:. United States: Department of Justice. 7 November 2016.
2070:. United States: Department of Justice. 21 February 2014
1960:. United States: Department of Justice. 19 December 2012
1806:. United States: Department of Justice. 15 December 2010
1662:. United States: Department of Justice. 1 September 2010
1498:. United States: Department of Justice. 2 September 2009
916:
agreed to pay $ 13.5 million to settle claims by all 51
429:
AstraZeneca: Off-label promotion of Seroquel, April 2010
2138:
2136:
2026:. United States: Department of Justice. 4 November 2013
1828:. United States: Department of Justice. 7 December 2010
1418:. United States: Department of Justice. 15 January 2009
352:
Eli Lilly: Off-label promotion of Zyprexa, January 2009
2048:. United States: Department of Justice. 9 January 2014
924:) that it engaged in off-label promotion of its drugs
493:
Allergan: Off-label promotion of Botox, September 2010
2129:. United States: Department of Justice. 22 July 2016.
1589:. United States: Department of Justice. 29 April 2010
1567:. United States: Department of Justice. 27 April 2010
1520:. United States: Department of Justice. 16 March 2010
1268:"Maker of Narcolepsy Drug Pleads Guilty in U.S. Case"
1031:
List of largest civil only pharmaceutical settlements
96:
Serono: Off-label promotion of Serostim, October 2005
2004:. United States: Department of Justice. 30 July 2013
1982:. United States: Department of Justice. 5 March 2013
1946:. United States: Department of Justice. 2 July 2012.
1464:"Pfizer Pays $ 2.3 Billion to Settle Marketing Case"
1159:
1157:
1155:
543:Élan: Off-label promotion of Zonegran, December 2010
283:
paid out approximately $ 50 million to settle seven
1850:. United States: Department of Justice. 9 June 2011
1239:
1237:
618:
Pfizer: Off-label promotion of Detrol, October 2011
413:
Alpharma: Off-label promotion of Kadian, March 2010
89:
largest recoveries against a pharmaceutical company
2121:
2119:
1924:. United States: Department of Justice. 7 May 2012
1640:. United States: Department of Justice. 4 May 2010
1247:. United States: Department of Justice. 8 May 2007
1166:"Drug Maker Stops Work on Lung Disease Medicine"
477:Novartis: Off-label promotion of Tobi, May 2010
2276:
2274:
2272:
2173:
2171:
1898:. Greene LLP. 20 October 2011. Archived from
1731:"Novartis Pays $ 422.5 Million in Settlement"
1437:Gardiner Harris, Alex Berenson (2009-01-15).
1217:"Whistle-Blower Finds a Finger Pointing Back"
1210:
1208:
1193:. U.S. Department of Justice. 26 October 2006
1103:"Schering-Plough pleads guilty to conspiracy"
583:UCB: Off-label promotion of Keppra, June 2011
8:
1606:
1604:
1559:
1557:
1049:"Settlement in Marketing of a Drug for AIDS"
922:Attorney General of the District of Columbia
845:On December 9, 2016, pharmaceutical company
828:On November 7, 2016, medical device company
381:reached a $ 2.3 billion settlement with the
92:Parke-Davis case settled for $ 190 million.
64:left his position as a medical liaison with
647:claims in addition to off-label promotion.
434:
323:
284:
2315:List of largest pharmaceutical settlements
441:suit filed under the False Claims Act led
175:abandoned all efforts to develop the drug
1612:"Drug Makers to Pay Fine of $ 81 Million"
1042:
1040:
1038:
981:
914:Boehringer Ingelheim Pharmaceuticals Inc.
1293:"FDA Sanctions Off-Label Drug Promotion"
299:drug approved by the FDA to treat adult
82:, under the False Claims Act in federal
948:
1317:
1306:
1777:Singer, Natasha (15 September 2010).
1462:Harris, Gardiner (2 September 2009).
627:engaging in the illegal promotion of
567:Kos Pharmaceuticals, a subsidiary of
7:
1681:Singer, Natasha (1 September 2010).
311:, both of which are off-label uses.
155:, meanwhile, for use in superficial
28:Federal Food, Drug, and Cosmetic Act
1439:"Settlement Called Near on Zyprexa"
1359:"Side Effects May Include Lawsuits"
1101:Krasner, Jeffrey (30 August 2006).
1047:Lichtblau, Eric (18 October 2005).
1010:United States Department of Justice
1729:Wilson, Duff (30 September 2010).
14:
1618:. Associated Press. 29 April 2010
1301:10.1377/forefront.20160719.055881
2092:. Oregon: Department of Justice.
1683:"Maker of Botox Settles Inquiry"
1396:. justice.gov. 29 September 2008
1215:Meier, Barry (25 October 2007).
1164:Pollack, Andrew (6 March 2007).
135:to make false statements to the
1357:Wilson, Duff (3 October 2010).
1266:Berenson, Alex (14 July 2007).
248:Drug Enforcement Administration
131:pleaded guilty to one count of
68:, a pharmaceutical division of
38:as well as criminal penalties.
2257:Thomas, Katie (25 July 2017).
2192:Mrozek, Thom (July 24, 2017).
26:promotion of drugs. Under the
1:
547:Irish pharmaceutical company
377:in U.S. history at the time,
181:idiopathic pulmonary fibrosis
622:As was the case in the 2004
209:acute promyelocytic leukemia
149:Food and Drug Administration
147:, which was approved by the
32:Food and Drug Administration
1539:Edwards, Jim (2010-03-17).
920:(of the 50 states plus the
463:Ortho-McNeil Pharmaceutical
2366:
393:, an anti-psychotic drug;
53:
22:to resolve allegations of
956:Lenzer, J. (2003-03-22).
375:pharmaceutical settlement
974:10.1136/bmj.326.7390.620
373:In what was the largest
348:of energy, and fatigue.
269:United States v. Caronia
20:pharmaceutical companies
918:state attorneys general
587:The U.S. subsidiary of
489:between 2001 and 2006.
111:, a condition in which
79:Franklin v. Parke-Davis
60:In 1996, whistleblower
56:Franklin v. Parke-Davis
2300:New Jersey Law Journal
1316:Cite journal requires
500:, the manufacturer of
435:
324:
285:
221:Medicis Pharmaceutical
70:Warner-Lambert Company
2340:Medical controversies
747:Johnson & Johnson
459:Johnson & Johnson
397:, an antibiotic; and
383:Department of Justice
358:Eli Lilly and Company
2302:(December 21, 2017).
2090:"All Media Releases"
1902:on 15 September 2012
847:Bristol-Myers Squibb
785:Endo Pharmaceuticals
467:Ortho-McNeil-Janssen
457:Two subsidiaries of
281:Bristol-Myers Squibb
240:Jazz Pharmaceuticals
2294:Kristen Rasmussen,
830:Biocompatibles Inc.
640:Abbott Laboratories
569:Abbott Laboratories
528:Forest Laboratories
117:protease inhibitors
2350:Off-label drug use
2263:The New York Times
1876:on 13 January 2012
1783:The New York Times
1735:The New York Times
1687:The New York Times
1616:The New York Times
1468:The New York Times
1363:The New York Times
1272:The New York Times
1221:The New York Times
1170:The New York Times
1107:The New York Times
1082:on 2 November 2013
1054:The New York Times
912:In December 2017,
832:, a subsidiary of
801:Insys Therapeutics
711:Par Pharmaceutical
238:, a subsidiary of
2335:Lists of lawsuits
2330:Product liability
861:In January 2017,
732:immunosuppressant
716:megestrol acetate
305:bi-polar disorder
197:Cell Therapeutics
107:in 1996 to treat
2357:
2345:Drug advertising
2303:
2292:
2286:
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2154:
2148:
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2130:
2123:
2114:
2113:
2109:Business Insider
2100:
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1044:
1033:
1028:
1022:
1021:
1019:
1017:
1002:
996:
995:
985:
953:
902:False Claims Act
889:False Claims Act
799:In August 2015,
440:
329:
290:
36:False Claims Act
2365:
2364:
2360:
2359:
2358:
2356:
2355:
2354:
2320:
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2017:
2007:
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826:
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684:
656:GlaxoSmithKline
653:
637:
620:
601:
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545:
525:
510:
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479:
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371:
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129:Schering-Plough
126:
98:
58:
52:
44:
12:
11:
5:
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2317:
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2307:
2305:
2304:
2287:
2268:
2249:
2225:
2207:
2184:
2167:
2164:on 2017-07-30.
2149:
2132:
2115:
2095:
2081:
2059:
2037:
2015:
1993:
1971:
1949:
1935:
1913:
1887:
1861:
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1817:
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1721:
1699:
1673:
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1600:
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1509:
1480:
1454:
1443:New York Times
1429:
1407:
1375:
1349:
1327:
1318:|journal=
1284:
1258:
1233:
1204:
1182:
1151:
1140:on 31 May 2011
1119:
1093:
1067:
1034:
1023:
997:
947:
945:
942:
909:
906:
896:
893:
874:In July 2017,
871:
868:
858:
855:
842:
839:
825:
822:
817:Acclarent Inc.
812:
809:
796:
793:
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451:
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236:Orphan Medical
232:
229:
216:
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188:
185:
168:
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157:bladder cancer
125:
122:
97:
94:
84:district court
62:David Franklin
54:Main article:
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1012:. 13 May 2004
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968:(7390): 620.
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301:schizophrenia
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297:antipsychotic
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