Johnson & Johnson Subsidiaries - $81 Million, April 2010

In April of 2010, Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals, both subsidiaries of Johnson & Johnson, agreed to pay over $81 million to settle criminal and civil liability claims arising from the illegal promotion of the drug Topamax. The settlement arose from two qui tam cases which led to federal and state investigations into the companies’ illegal activities. The Justice Department’s Civil Division, the U.S. Attorney’s Office for the District of Massachusetts, the National Association of Medicaid Fraud Control Units, and various state Attorneys General handled these cases. The Practice: Illegal Promotion and Kickbacks In 2003 two qui tam lawsuits were filed alleging that Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals had illegally promoted the drug Topamax for uses unapproved by the FDA. Topamax is FDA approved as treatment for partial onset seizures for patients with epilepsy. Allegedly, Ortho-McNeil created a "Doctor-for-a-Day" program, in which it hired physicians to visit other health care providers and speak at meetings and dinners promoting the drug for off-label psychiatric uses and doses, despite serious risks to patients' health. The company also allegedly paid physicians to attend conferences where Topamax was promoted for off-label uses and paid them kickbacks as encouragement to prescribe the drug for unapproved uses. In 2010, Ortho-McNeil Pharmaceutical pled guilty to a misdemeanor and paid a $6.14 million fine for the misbranding of Topamax from 2001-2003, in violation of the Food, Drug and Cosmetic Act. In addition, Ortho-McNeil-Janssen Pharmaceuticals paid $73.37 million to resolve civil allegations that they violated the federal False Claims Act by illegally promoting Topamax for off-label uses and thereby caused claims to be submitted to government health programs for uses that were not medically accepted and therefore not covered by those programs. Ortho-McNeil-Janssen also agreed to enter into a five-year corporate integrity agreement with the U.S. Health and Human Services Department to detect and prevent similar conduct in the future.

The Whistleblowers

Dr. Gary Spivack filed a qui tam case against Ortho-McNeil in December of 2003 after he attended a "Psychiatrist Consultants' Conference" that the company sponsored. Attendees were paid $500 or more to attend meetings and listen to company presentations that promoted Topamax for off-label uses and doses. Dr. Spivack felt he had to act: "I found it outrageous that Ortho-McNeil would try to pay doctors to influence them to prescribe a drug for uses that clearly endangered patients' health. Doctors need impartial and accurate information to make decisions on the best treatment for their patients, but that's not what Ortho-McNeil provided."

Angela Maher and Anastasia Savka-Klovski are both former Ortho-McNeil sales representatives who filed a qui tam suit against the company in August of 2003 due to its improper marketing, promoting and selling of Topamax.

The three whistleblowers shared $9 million out of the federal government's share of the civil recovery.

Click here for a printable version of this page.