Multinational medical device, pharmaceutical, and health care products manufacturer Johnson & Johnson and its subsidiaries will pay more than $2.2 billion to settle allegations that they marketed three drugs – Risperdal, Invega, and Natrecor – for uses that were never approved, according to the Department of Justice (DOJ).
Johnson & Johnson and three of its subsidiaries agreed to resolve criminal and civil claims that they marketed three prescription drugs for uses that were not approved as “safe and effective.” Additionally, the companies paid kickbacks to physicians and pharmacies to prescribe and promote the drugs.
The settlement resolves multiple investigations regarding the antipsychotic drugs Risperdal and Invega and the congestive heart failure-treating drug Natrecor.
“These companies lined their pockets at the expense of American taxpayers, patients, and the private insurance industry,” Attorney General Eric Holder said at a press conference today.
The DOJ filed a criminal complaint against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, alleging that the companies promoted Risperdal and Invega to doctors and nursing homes as a way to control “behavioral disturbances” in dementia patients, children, and the mentally disabled. The companies downplayed the associated health risks, including the risk of stroke in elderly patients, and paid doctors to prescribe the drugs.
Janssen Pharmaceuticals will plead guilty to misbranding Risperdal, for which it will pay $400 million in criminal fines and forfeitures. Johnson & Johnson and Janssen Phamaceuticals will also pay more than $1.2 billion under the False Claims Act. Johnson & Johnson will pay an additional $149 million to resolve claims related to pharmacy kickbacks.
The DOJ also alleges that Johnson & Johnson and its subsidiary Scios Incorporated promoted the heart drug Natrecor for “off-label uses that caused patients to submit to costly infusions of the drug.” The companies agreed to pay $184 million, in addition to a criminal fine of $85 million that Scios agreed to pay in 2009 to resolve a separate matter regarding the misbranding of Natrecor.
“Put simply, this alleged conduct is shameful and it is unacceptable,” Mr. Holder said. “It displayed a reckless indifference to the safety of the American people. And it constituted a clear abuse of the public trust, showing a blatant disregard for systems and laws designed to protect public health.”
The settlement was a result of the efforts of the Health Care Fraud Prevention and Enforcement Action Team (HEAT).
Recently, Johnson & Johnson has been faced with a barrage of lawsuits regarding its subsidiary, DePuy Orthopaedics Inc.’s decision to continue to sell metal-on-metal hip implants that the company knew were defective. The company has also come under fire for their drug Tylenol – one of the most popular pain relievers in the US, which has caused liver damage even when taken at recommended doses.
“Johnson & Johnson’s misbranding of the drugs Risperdal, Invega, and Natrecor is yet another incident in which the company and its subsidiaries decided to market products despite the risks to patient safety,” said Megan McBride, a Tylenol Liver Damage attorney with the Levin, Papantonio law firm.