A.G. Schneiderman Announces $95 Million National Settlement With Pharma Company Over Fraudulent Practices
New York Will Receive $3.1 Million From Boehringer-Ingelheim Pharmaceuticals, Inc. To Resolve Off-Label And Kickback Charges
Schneiderman: Pharma Companies That Market Unapproved Drugs Will Be Held Accountable
NEW YORK – Attorney General Eric T. Schneiderman announced today that Boehringer-Ingelheim Pharmaceuticals, Inc. (BIPI) has agreed to pay $95 million to resolve charges that the company engaged in various illegal schemes related to the marketing of the drugs Aggrenox, Atrovent, Combivent and Micardis. The New York Medicaid Program will receive over $3.1 million in the national settlement with the Federal Government, 50 states and the District of Columbia. In addition, BIPI has entered into a Corporate Integrity Agreement with the Health and Human Resources’ Office of Inspector General to improve corporate practices moving forward.
New York and its state and federal government partners charged that BIPI engaged in a pattern of unlawfully marketing these drugs for uses not approved by the FDA; making false statement about the cost effectiveness for the drug Atrovent; and offering kickbacks to medical professionals.
“There are no excuses for deceptively marketing unapproved drugs, offering kickbacks to health care professionals and ripping off taxpayers by defrauding Medicaid and other programs,” said Attorney General Schneiderman. “With this settlement, we continue our message to Boehringer-Ingelheim and other big pharmaceutical companies: you are not above the law.”
This agreement, unsealed today, settles charges that BIPI engaged in the following activities:
- Marketed the drug Aggrenox® for off label uses in cases of myocardial infarction and peripheral vascular disease, and made false statements to the State Medicaid Program about the superiority of Aggrenox® in comparison with the drug Plavix, despite the lack of clinical evidence to make such a claim.
- Made misrepresentations concerning the cost of Atrovent® to the State’s Medicaid Program on which the State Medicaid program relied in making formulary and prior authorization decisions. BIPI represented to the State Medicaid program that Atrovent® was a more cost effective treatment than its competitors based on its approved dosing information, despite the fact that BIPI marketed the drug at doses in excess of its approved dosage.
- Marketed the drug Combivent® for use in treating Chronic Obstructive Pulmonary Disease, and promoted the sale and use of Combivent® at dosages that exceeded those covered by the State Medicaid Program.
- Marketed of the drug Micardis® for uses which was not approved by the FDA, including treatment of early diabetic kidney disease.
- Offered and provided services and other things of value to health care professionals to induce them to promote and prescribe Aggrenox ®, Atrovent®, Combivent® and Micardis®. These kickbacks included remuneration for participating in advisory boards, speakers’ training programs, speaker programs and consultant programs, in violation of the Federal Anti-Kickback Statute.
This settlement is based on a qui tam action brought by a private individual pursuant to state and federal false claims acts and filed in the U.S. District Court of Maryland.
A National Association of Medicaid Fraud Control Unit (NAMFCU) team participated in the investigation and analysis of the claims and conducted the settlement negotiations with BIPI on behalf of the settling states.
Jay Speers, Counsel for the Medicaid Fraud Control Unit, Stacey Millis, Supervising Special Auditor Investigator, and Kenneth Deis, Special Investigator handled the matter for the State of New York under the supervision of Deputy Attorney General Monica Hickey-Martin.