Johnson & Johnson To Pay More Than $1.6 Billion To Resolve Healthcare Fraud Allegations

Monday, November 04, 2013

Tennessee will receive more than $12 million as part of a multistate and federal agreement resolving allegations pharmaceutical manufacturer Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., used deceptive marketing tactics. Specifically, the parties will pay $1.6 billion to resolve civil and criminal allegations of unlawful marketing practices to promote the sales of their atypical antipsychotic drugs, Risperdal and Invega. 

J&J and Janssen will pay in excess of $1.2 billion to the states and the federal government to resolve four qui tam, or whistleblower, lawsuits filed in the U.S. District Court for the Eastern District of Pennsylvania under the provisions of the federal False Claims Act and similar state False Claims statutes. In addition, Janssen Pharmaceuticals, Inc. will plead guilty in federal court to a criminal misdemeanor charge of misbranding Risperdal in violation of the Food, Drug, and Cosmetic Act.  As part of the criminal plea, Janssen has agreed to pay an additional $400 million in criminal fines and forfeitures.

“We applaud the cooperative work of the states and federal government to stop drug companies from illegally marketing potentially dangerous drugs to the public,” Tennessee Attorney General Bob Cooper said.  “The public needs to be able to trust those responsible for their health and well-being, and that includes drug manufacturers and those who prescribe medications.” 

J & J and Janssen allegedly promoted, marketed and introduced Risperdal and Invega into interstate commerce for uses not approved by the Food and Drug Administration and for uses that were not medically indicated.  Once the FDA approves a drug as safe and effective, a manufacturer cannot market or promote a drug for an “off-label” or other use not identified in the FDA-approved product label.  The states contend that during the period Jan. 1, 1999 through Dec. 31, 2005, the companies promoted Risperdal for off-label uses and made false and misleading statements about the safety and efficacy of Risperdal.

The states additionally allege J&J and Janssen paid illegal kickbacks to health care professionals and long-term care pharmacy providers to induce them to promote or prescribe Risperdal to children, adolescents and the elderly when there was no FDA approval for Risperdal use in these patient populations. The states further contend that from Jan. 1, 2007 through Dec. 31, 2009, the companies promoted Invega for off-label uses and made false and misleading statements about the safety and efficacy of Invega.  The manufacturers’ alleged unlawful conduct caused false and/or fraudulent claims to be submitted to or caused purchases by government funded health care programs, including the state Medicaid programs. 

As part of the global resolution, the companies will enter into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services, Office of the Inspector General, which will monitor the company’s future marketing practices.

A team from the National Association of Medicaid Fraud Control Units worked with the federal government on the investigation and conducted the settlement negotiations with the pharmaceutical manufacturers on behalf of the states.  Team members included representatives from the Offices of the Attorneys General for the states of New York, Massachusetts, Ohio and California.

Bradley County EMS Reviews And Drills For Infectious Diseases

With the growing concerns of infectious disease, Bradley County EMS is being proactive and reviewing their infectious disease protocols. Current policies and procedures are being reviewed and updated. Personal protection equipment has been updated as well to provide the best protection to the EMS responders. Emergency responders are exposed to a variety of contaminates on ... (click for more)

Morning Pointe Of Hixson Celebrates 5th Anniversary

Morning Pointe of Hixson Assisted Living and Alzheimer's Memory Care is turning five. Officials said, "Come celebrate. Experience a day in the life of a Morning Pointe resident. Enjoy food, special activities and entertainment. Plus autograph the newly-released Hixson Family Genealogy Book. "   There will be a Kindermusik demo, mini art and baking classes along ... (click for more)

Additions And Improvements At Camp Jordan Arena Coming Soon

Additions and improvements are coming to Camp Jordan Arena in the near future. At the Thursday night meeting of the East Ridge city council, approval was given for buying new playground equipment. It will come from Gametime, a locally-based company. The VP of Marketing lives in East Ridge and made a proposal to set up the playground at Camp Jordan so his company could use it for ... (click for more)

Teenager Killed In ATV Accident Thursday Night

Damon Lee Jones, 15, was killed Thursday night in an ATV accident in Walker County. It was reported he was riding with a 17-year old, when they tried to enter a church parking lot, but ran into a cable barrier. The accident happened on Dunwoody Road in LaFayette. The other rider, identified as Timothy J. Wallin, was not injured.   (click for more)

Tom Dugan Was A Good Man

Tom was my boss for most of my 36 years at Carta.  At the ceremony where I was awarded my 30-year service award, Tom said, "Don disagrees with 85% of my decisions, but I wish I had 80 more employees just like him." This kind of indicates our relationship. When I asked him to help with my plans for a reunion for the group of Veterans that I served with in Vietnam, he quickly ... (click for more)

Roy Exum: A Veterinarian’s Horse Sense

I suspect you’ve heard by now that a doctor in New York City, who volunteers with “Doctors Without Borders,” just got back from the African nation of Guinea on October 17 – last Friday – and on Thursday tested positive for the deadly Ebola virus. Luckily, he came in actual contact with only a few people but he reportedly rode a subway, took a taxi, went on a three-mile run and ... (click for more)