Kos Pharmaceuticals Pays $41M For Kickbacks, Off-Label Promotion Of Cholesterol Drugs

 BATON ROUGE, La. - (Mealey's) The Kos Pharmaceuticals subsidiary of Abbott Laboratories Inc. on Dec. 7 entered into a deferred prosecution agreement and agreed to pay a total of $41 million in criminal penalties and False Claims Act settlement for paying kickbacks to two Louisiana physicians to prescribe two cholesterol-lowering drugs and marketing one drug for off-label use (United States of America v. Kos Pharmaceuticals, Inc., No. 10-158, M.D. La.; United States of America, ex rel. Nanci Johnson, et al. v. Kos Pharmaceuticals, No. 04-277, E.D. Wis.).

 On Dec. 7, the federal government simultaneously filed a criminal information and deferred prosecution against Kos Pharmaceuticals Inc. in the U.S. District Court for the Middle District of Louisiana.  In 2004, Nanci Johnson, Theresa Lakebrink and Ruth Westover filed a False Claims Act complaint on behalf of the federal government against Kos in the U.S. District Court for the Eastern District of Wisconsin.

According to the deferred prosecution agreement, between 2002 and 2006, three Kos executives identified only as Executives A, B and C agreed to pay $100,000 to sponsor continuing education classes conducted by two cardiothoracic surgeons, identified as Physicians A and B, in exchange for the doctors prescribing Niaspan and Advicor, both anti-cholesterol drugs made by Kos.  In addition, the government said Kos paid one doctor to have a doctor's employee review 202 patient charts to identify patients who were candidates for the drugs.  

Kos was also given the names of doctors who attended the classes so they could be called on by Kos sales representatives.

The government said Executive C wrote to colleagues that prescriptions from the two doctors were being written "cause we gave them money."  Between 2002 and 2006, the government said Physician A wrote 4,130 prescriptions for Kos drugs, including Advicor. 

In a Dec. 7 press release, the government said Kos will pay $38 million to settle False Claims Act allegations that Kos paid kickbacks to get its drugs prescribed.  The government said Kos also promoted Advicor for off-label use as first-line therapy for cholesterol problems.

The federal government will get $33,705,310 of the civil settlement, and state Medicare programs will get $4,454,432.  The qui tam relators will receive $6.4 million from the federal portion as their statutory share of the recovery.

Under the deferred prosecution agreement, Kos agrees to pay a monetary penalty of $3,360,000.

[Editor's Note:  Full coverage will be in the Dec. 16 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the criminal information and deferred prosecution agreement are available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844.  Criminal information. Document #28-101216-010F.  Deferred prosecution agreement. Document #28-101216-011P.  For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]

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For more information, call Editor Tom Moylan at 215-988-7739, or e-mail him at tom.moylan@lexisnexis.com.