Tag Archives: laboratories

TN Getting $5M More from Abbot Laboratories

News release from Attorney General’s office:
Tennessee Attorney General Bob Cooper and Health Care Finance and Administration (HCFA) Deputy Commissioner Darin Gordon announced Tennessee will receive at least $5 million as part of a $1.5 billion settlement with a major pharmaceutical company. The announcement comes on the heels of a separate consumer protection agreement announced Monday with Abbott Laboratories of almost $2 million designated for Tennessee.
The agreement resolves allegations by Tennessee, several other states and the federal government that Abbott Laboratories illegally marketed Depakote. The states contend that from January 1998 through Dec. 31, 2008, Abbott promoted the sale and use of Depakote for uses that were not approved by the Food and Drug Administration as safe and effective. This alleged conduct resulted in false claims to Medicaid and other federal healthcare programs.
In addition, Abbott is alleged to have made false and misleading statements about the safety, efficacy, dosing and cost-effectiveness of Depakote for some unapproved uses; improperly marketed the product in nursing homes; and paid illegal remuneration to healthcare professionals and long term care pharmacy providers to induce them to promote and/or prescribe Depakote.
The $1.5 billion settlement is the second largest recovery from a pharmaceutical company in a single civil and criminal global resolution. Abbott Laboratories will pay the states and the federal government a total of $800 million in civil damages and penalties to compensate Medicaid, Medicare, and various federal healthcare programs for harm suffered as a result of its conduct. In addition to the civil settlement, Abbott Laboratories has pleaded guilty to a violation of the Food, Drug, and Cosmetic Act (FDCA) and agreed to pay a criminal fine and forfeiture of $700 million. Further as a condition of the settlement, Abbott Laboratories will enter into a corporate integrity agreement with the U.S. Department of Health and Human Services, Office of the Inspector General. By law, the whistleblowers will receive a portion of the proceeds.
“Our Office will continue work diligently with our state and federal partners to pursue any company that attempts to illegally divert funds designated for TennCare,” Attorney General Cooper said.
“The hard work from state and federal authorities to ensure taxpayer dollars are not misused is vital to the success of the TennCare program,” Deputy Commissioner Gordon said. “The continued investigation and prosecution of Medicaid fraud is a significant component in keeping TennCare’s trend well below national levels.”
This settlement is based on four whistleblower cases that were consolidated and are pending in the United States District Court for the Western District of Virginia in Abingdon, Virginia. The cases were filed under Federal and State false claims statutes. A state team appointed by the National Association of Medicaid Fraud Control Units participated in the investigation and conducted the settlement negotiations with Abbott on behalf of the participating states.

TN Shares in $50M Abbott Laborities Lawsuit Settlement

News release from Attorney General’s office:
Tennessee, along with 44 other states and the District of Columbia, has joined a $100 million multistate agreement with Abbott Laboratories over allegations of illegal off-label marketing of its Depakote drug, Attorney General Bob Cooper along with Commerce and Insurance’s (TDCI) Consumer Affairs Director Gary Cordell, announced today.
The agreement marks the largest consumer protection-based pharmaceutical agreement ever reached. Tennessee will receive $1.95 million and the Illinois-based Abbott will be restricted from marketing the drug for off-label uses not approved by the U.S. Food and Drug Administration.
“We are pleased to announce the resolution of this investigation into the off-label promotion of this drug,” Attorney General Cooper said. “We hope other companies will think twice before promoting drugs for uses that have not been approved.”
In a complaint filed today along with the agreement, the states alleged Abbott engaged in unfair and deceptive practices when it marketed Depakote for off-label uses. Depakote is approved for treatment of seizure disorders, mania associated with bipolar disorder and prophylaxis of migraines, but the attorneys general alleged Abbott marketed the drug for treating unapproved uses, including schizophrenia, agitated dementia and autism.
As a result of the states’ investigation, Abbott has agreed to significantly change how it markets Depakote and to cease promoting off-label uses.
Under the agreement, Abbott Laboratories is:
· Prohibited from making false or misleading claims about Depakote,
· Prohibited from promoting Depakote for off-label uses, and
· Required to ensure financial incentives on sales do not promote off-label uses of Depakote.
In addition, for a five-year period Abbott must:
Limit the creation and use of responses to requests by physicians for non-promotional information about off-label uses of Depakote,
Limit dissemination of reprints of clinical studies relating to off-label uses of Depakote,
Limit use of grants and CME,
Disclose payments to physicians, and
Register and disclose clinical trials.
The State’s Complaint and Agreed Final Judgment may be viewed by going online to
www.tn.gov/attorneygeneral and clicking on “Filings of Interest.”
Consumers may file complaints regarding prescription drug advertisements or any other deceptive conduct by going online to www.tn.gov/consumer or calling the TDCI Division of Consumer Affairs at (615) 741-4737 or toll-free in Tennessee at 1-800-342-8385.