Johnson & Johnson (J&J) and its subsidiaries have agreed to pay over $2.2 billion in criminal and civil fines arising out of false marketing claims. The company allegedly promoted off-label uses for various drugs, and provided kickbacks to doctors and pharmacists for prescribing those drugs. The drugs at issue in this suit include Risperdal, Invega (forms of antipsychotic medications), and Natrecor (heart failure medication).
According to the Department of Justice, J&J marketed these drugs for uses not approved by the Food and Drug Administration (FDA). In the process of doing so, it not only endangered the public’s health, but robbed the government of millions of dollars in Medicaid funding. “The alleged conduct is shameful and it is unacceptable. It displayed a reckless indifference to the safety of the American people and it constituted a clear abuse of the public trust,” U.S. Attorney General Eric Holder proclaimed during his press conference.
What is the Problem with Marketing a Product for an Off-label Use?
Under the Federal Food, Drug and Cosmetic Act (FDCA), pharmaceutical companies must prove to the FDA that the specific use of a drug is safe and effective. The FDA then ensures that the label included with the drug provides accurate information about that specific use–or “indication”– and its risks and benefits. If a drug is marketed for a use not approved by the FDA, it is considered misbranded because the manufacturer has not provided evidence that it is safe and effective for that use. These rules help to prevent the modern equivalent of a company promoting snake oil.
Risperdal was approved by the FDA to treat patients with schizophrenia. However, J&J subsidiary Janssen Pharmaceuticals Inc. (Janssen) participated misbranding Risperdal to elderly, non-schizophrenic, dementia patients to treat anxiety, depression, and confusion. In the process of doing so, Janssen downplayed the serious risks of Risperdal for elderly patients, including the increased risk of stroke. It also downplayed the approved use of Risperdal as an anti-psychotic medication. Despite FDA warnings to Janssen that marketing Risperdal as a safe and effective drug for elderly patients would be misleading, Janssen targeted nursing homes and geriatricians. Janssen also promoted the off-label use of Risperdal to children and patients with mental disabilities, including ADHD, OCD, and autism.
J&J and its subsidiaries also allegedly encouraged doctors and pharmacists to increase prescriptions for these drugs. In return they would receive kickbacks. Kickbacks may come in the form of speaker fees, data-purchase agreements, grants, market share rebate payments, or educational funding. The settlement agreement addresses allegations that between 1999 and 2004, J&J targeted Omnicare Inc., the nation’s largest long-term care pharmacy, by paying tens of millions of dollars in kickbacks to promote Risperdal, among other J&J drugs. Omnicare would deliver drugs to nursing home patients and then submit reimbursement claims to state Medicaid programs.
Under the Magnifying Glass: J&J’s Corporate Integrity Agreement
J&J not only has agreed to pay criminal and civil fines, but it has entered into a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General. The agreement forces this pharmaceutical powerhouse to make some serious changes in its business practices and “increases individual accountability for board members, sales representatives, company executives and management.” Some of these changes include:
- changing its executive compensation program to allow the recovery of bonuses and/or incentives from executives who participate in significant misconduct;
- allowing the company to recover monies from executives who have left the company; and
- requiring J&J’s pharmaceutical companies to provide clarity as to their research practices, publication policies and payments to physicians.
Lopez McHugh is currently involved in Tylenol liver failure and transvaginal mesh lawsuits against Johnson & Johnson, and evaluates new scientific information about pharmaceuticals on an ongoing basis. If you or a loved one has suffered significant injury from a pharmaceutical or medical device, contact Lopez McHugh. We are here to discuss your options, with no obligation.