[4] 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".
[4] 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.
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.
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.
[14] 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.
[16] Gabitril, meanwhile, received FDA approval as a treatment for partial seizures, but the manufacturer allegedly marketed the drug for anxiety, insomnia, and pain.
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.
[16] 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.
[17] 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.
[20] 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.
[22] 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.
[33] 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.
[34] 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.
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.
[37] 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.
Similarly, Amgen promoted its drugs Enbrel and Neulasta for off-label indications that were not eligible for coverage by federal health care programs.
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.
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.
[45] 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.
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.
[49] 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.
[50] 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.
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.
[56] The settlement resolved 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.
[56] In addition to civil False Claims Act liability, Aegerion also agreed to a guilty plea involving the same conduct and to pay a criminal fine and forfeiture of $7.2 million.