Johnson & Johnson, one of the nation’s oldest and one of the world’s largest companies, has recently settled a massive series of lawsuits involving allegations that Johnson & Johnson, through two of its subsidiaries, engaged in marketing drugs for unapproved uses and giving kickbacks to physicians and nursing homes. Johnson & Johnson will pay a total of $2.2 billion in damages and fines and damages in both civil and criminal cases. Criminal fines amount to $485 million, and $1.72 billion will be allocated to civil settlements with both the federal government and several states. The global settlement is one of the largest health care fraud settlements in the history of the United States.
Allegations against Janssen Pharmaceuticals, one of Johnson & Johnson’s subsidiaries, regarding Risperdal spanned a course of conduct over the years 1999 through 2005. Johnson & Johnson, through its subsidiary, promoted the use of Risperal to treat specific individuals and conditions for which the drug had not been FDA-approved. During the time period, Risperdal was approved for use only to treat schizophrenia. However, Risperdal was improperly promoted for use treating behavioral problems in elderly dementia patients, including anxiety, agitation, and depression. Its use with this population was promoted, despite Johnson & Johnson’s awareness that Risperdal posed increased health risks to elderly patients, including stroke. It was also improperly promoted for use treating children suffering from conduct disorders, as well as in treating children with attention deficit hyperactivity disorder. This, too, was despite Johnson & Johnson’s awareness that Risperdal posed an increased health risk to children, including risk of increased hormone levels. Finally, Risperdal was improperly promoted for use in treating conduct disorders in individuals with development disabilities. Allegations involving Risperdal also included that Johnson & Johnson, through Janssen, violated the federal Anti-Kickback statutes by making illegal payments to health care providers and long-term care pharmacy providers for promoting the aforesaid uses of Risperdal.
With regard to Invega, a drug approved only for treatment of schizophrenia and schizoaffective disorder, allegations included that Johnson & Johnson, and Janssen Pharmaceuticals, marketed it for off-label uses from 2006 through 2009.
The allegations also include that the company paid kickbacks to Omnicare, Inc., the largest pharmacy in the United States. It specializes in dispensing drugs to nursing home patients. The kickbacks were designed to induce Omnicare and its consultants to encourage the use of Risperdal by nursing home patients.
Other allegations include that Johnson & Johnson, through another of its subsidiaries—Scios, Inc.—cause false and fraudulent submission of claims to federal health care programs related to the drug Natrecor. Natrecor is used to treat severe heart failure. Johnson & Johnson, through Scios, Inc., marketed the drug for use with patients with less than severe heart failure, which use was not scientifically supported.
The civil settlement includes damages for violations of the federal False Claims Act related to Risperdal, Invega, and Natrecor. Johnson & Johnson, through Janssen Pharmaceuticals, will pay $1.391 billion to resolve the False Claims Act allegations related to Risperdal and Invega and $184 million to resolve the False Claim Act allegations related to Natrecor. The company will also pay $149 million to resolve the kickback allegations related to Omnicare, Inc.
The massive settlement includes damages for whistleblower in three states. Whistleblowers in Pennsylvania will receive $112 million. Whistleblowers in California will receive $28 million. And, whistleblowers in Massachusetts will receive nearly $28 million.
As part of the settlement, Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals, has also agreed to plead guilty to two counts of introducing a misbranded drug, Risperdal, into commerce, which is a violation of the Food and Drug Act.
Barrett Law PLLC has a long history of representing individuals in whistleblower cases. We have been advising clients as to their rights and helping them through all variety of whistleblowing matters for 75 years. Barrett Law PLLC will be there to help you, too. Contact us today at (800) 707-9577 to schedule an initial consultation.