List of off-label promotion pharmaceutical settlements
The following are settlements reached with US authorities against
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
In 1996, whistleblower
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.[4] 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.[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". 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.[5] 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.[4]
Schering-Plough: Off-label promotion of Intron A and Temodar, August 2006
InterMune: Off-label promotion of Actimmune, October 2006
In 2007,
Cell Therapeutics: Off-label promotion of Trisenox, April 2007
In a
Medicis Pharmaceutical: Off-label promotion of Loprox, May 2007
This settlement of $9.8 million resolved allegations that
Orphan Medical and Jazz Pharmaceuticals: Off-label promotion of Xyrem, July 2007
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.[13]
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,
Cephalon: Off-label promotion of Actiq, Gabitril and Provigil, September 2008
Eli Lilly: Off-label promotion of Zyprexa, January 2009
After four whistleblowers initially filed suits under the False Claims Act, prompting a government investigation,
Pfizer: Off-label promotion of Bextra, Geodon, Zyvox and Lyrica, September 2009
In what was the largest
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,
AstraZeneca: Off-label promotion of Seroquel, April 2010
A
Ortho-McNeil-Janssen: Off-label promotion of Topamax, May 2010
Two subsidiaries of
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 Claims Act alleging off-label promotion of the cystic fibrosis drug Tobi between 2001 and 2006.[26]
Allergan: Off-label promotion of Botox, September 2010
Novartis: Off-label promotion of Trileptal, September 2010
Forest Laboratories: Off-label promotion of Levothroid, Celexa and Lexapro, September 2010
Élan: Off-label promotion of Zonegran, December 2010
Irish pharmaceutical company
Kos Pharmaceuticals: Off-label promotion of Advicor and Niaspan, December 2010
Kos Pharmaceuticals, a subsidiary of
UCB: Off-label promotion of Keppra, June 2011
The U.S. subsidiary of
Novo Nordisk: Off-label promotion of NovoSeven, June 2011
Pfizer: Off-label promotion of Detrol, October 2011
As was the case in the 2004
Abbott Laboratories: Off-label promotion of Depakote, May 2012
GlaxoSmithKline: Off-label promotion of Paxil, Wellbutrin, Advair, Lamictal and Zofran, July 2012
Amgen: Off-label promotion of Aranesp, Enbrel and Neulasta, December 2012
Par Pharmaceutical: Off-label promotion of Megace ES, March 2013
Wyeth Pharmaceuticals: Off-label promotion of Rapamune, July 2013
Johnson & Johnson: Off-label promotion of Risperdal, Invega and Natrecor, November 2013
CareFusion: Off-label promotion of ChloraPrep, January 2014
Endo Pharmaceuticals: Off-label promotion of Lidoderm, February 2014
Insys Therapeutics: Off-label promotion of Opioid drug Subsys, August 2015
In August 2015,
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.[48] 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.[48]
Biocompatibles Inc.: Off-label promotion of LC Bead, November 2016
On November 7, 2016, medical device company
Bristol-Myers Squibb Company: Off-label promotion of Abilify, December 2016
On December 9, 2016, pharmaceutical company
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.[51] 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.[51] 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,
Aegerion Pharmaceuticals: Off-label promotion of Juxtapid, September 2017
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.
Boehringer Ingelheim Pharmaceuticals Inc.: off-label promotion of Aggrenox, Atrovent, Combivent, and Micardis, December 2017
In December 2017,
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