PA Gets Part of Largest Multi-State Settlement with Pharmaceutical Company

Pennsylvania Attorney General Linda Kelly announced Thursday that Pennsylvania has joined 36 other attorneys general in the largest multi-state consumer protection settlement to be reached with a pharmaceutical company.

Kelly said the record $187,047,439.00 settlement was reached with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson, over allegations that Janssen improperly marketed the atypical antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.

Risperdal is an atypical antipsychotic medication commonly used to treat mental illnesses including schizophrenia, bipolar disorder, and irritability associated with autism. The drug has a number of serious side effects including: hyperglycemia, diabetes, pancreatitis, a heightened risk of neurological problems, cardiovascular complications and weight gain.

According to the states, Janssen promoted Risperdal for off-label uses to both geriatric and pediatric populations and specifically targeted nursing home patients for Alzheimer’s disease, dementia, depression, and anxiety.  These uses were not FDA-approved nor shown to be safe and effective. Federal law prohibits pharmaceutical manufacturers from promoting their products for off-label uses.

After an extensive four year investigation, Janssen agrees to change how it promotes and markets atypical antipsychotics and to stop the false, misleading and deceptive promotion of the drugs.

Additionally, the following conditions also apply to Janssen for five-years:
 

  • Must disclose the risks in the FDA’s black boxed warnings for atypical antipsychotics in Janssen’s promotional materials;
  • Must present information about effectiveness and risk in a balanced manner in its promotional materials;
  • Shall not promote its atypical antipsychotics using selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses;
  • Require its scientifically trained personnel, rather than its sales marketing personnel, to develop the medical content or scientific communications to address requests for information from health care providers regarding Janssen’s atypical antipsychotics;
  • Must refrain from providing samples of its atypical antipsychotics to health care providers whose clinical practices are inconsistent with FDA-approved labeling of those atypical antipsychotics;
  • Must not use grants to promote its atypical antipsychotics nor condition medical education funding on Janssen’s approval of speakers or program content;
  • Must contractually require medical education providers to disclose Janssen’s financial support of their programs and any financial relationship with faculty and speakers; and
  • Must have policies in place to ensure that financial incentives are not given to marketing and sales personnel that encourage or reward off-label marketing.

Pennsylvania joined the following states and the District of Columbia in the settlement: Alabama, Arizona, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin, and Wyoming.