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Drug Maker to Settle Kickback, Off-Label Allegations for $41M

John Commins, for HealthLeaders Media, December 9, 2010

Kos Pharmaceuticals, a subsidiary of Abbott Laboratories, will pay more than $41 million to resolve criminal and civil False Claims Act violations related to illegal kickbacks and off-label marketing for the cholesterol drugs Advicor and Niaspan, the U.S. Justice Department announced.

Delaware-based Kos will pay more than $38 million to settle civil allegations under the False Claims Act. The civil settlement resolves allegations that Kos paid doctors, other medical professionals, physician groups, and MCOs illegal kickbacks in money, free travel, grants, honoraria, and other valuables and services, in violation of the Anti-Kickback Statute to get them to prescribe or recommend Niaspan and Advicor.

Wednesday?s announcement marks the second time in as many days that Abbott has been named in a multimillion dollar False Claims Act settlement related to Medicare/Medicaid fraud.
On Tuesday, federal prosecutors said Abbott and two other drug makers would pay a combined $421 million to settle whistleblower allegations that they inflated prices for drugs paid for by Medicare and Medicaid. Abbott agreed to pay $126.5 million to resolve the claims against it in two whistleblower cases challenging its pricing of intravenous dextrose solutions, sodium chloride solutions, sterile water, vancomycin, and the oral antibiotic drug erythromycin.

Abbott released a statement Wednesday saying "the actions occurred prior to Abbott's acquisition of Kos in 2006 and Abbott has not been accused of any wrongdoing."

In the Kos investigation, federal prosecutors claim the drug maker promoted the sale of Advicor as a first-line therapy for management of mixed dyslipidemias—a disruption of the lipids in the blood. The off-label use was not approved by the Food and Drug Administration, and it was not a medically-accepted indication for Medicare/Medicaid programs. The federal share of the civil settlement is $33.7 million and the state Medicaid share is $4.4 million.

"Pharmaceutical companies that pay kickbacks to medical professionals take from the taxpayers and undermine the integrity of choices that doctors make for their patients," said Tony West, assistant attorney general for the Civil Division of the Department of Justice. "We will work with our federal partners to ensure that important health care decisions are based on sound medicine, not illegal payments."

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1 comments on "Drug Maker to Settle Kickback, Off-Label Allegations for $41M"


Francesca Moore (1/1/2011 at 11:10 PM)
I am writing this letter with a very heavy heart with regards to the state-sanctioned torturous, medical abuse of my only child while in the care of the Florida Dept. of Children & Families, the doctors on DCF's payroll, and my daughter's "medical" foster parent. To better understand my baby's circumstances, one must know that she was born extremely premature at a very minute birth weight. At birth, my Miracle from God, weighed a mere one pound, eight ounce after only a 26 weeks gestation period. She was diagnosed with FTT Organic (Failure to Thrive), an eating disorder that required a surgically implanted feeding tube to be connected to her stomach so she can receive enough nutrients to survive. An employee at the Florida Dept. Children & Families Coalition targeted my only child for adoption and used her influence within the system to assure their adoption goal. The people charged with caring for my child in an "unbiased" and legal manner are the same people who illegally administered adult psychotropic medications without the knowledge or consent of the Family Court or myself. Upon being returned to my custody, my child's medical problems only seemed to get worse, as neither my baby's private pediatrician nor myself was were arware that a DCF sanctioned "resident" physicians had placed her on two Adult anti-depressive" drugs which were not studied or approved for use in children. After my parental rights were terminated and my child was successfully adopted, I fought to get the transcripts of my case, which verified my worse fears. Unbeknownst to me, "weight-loss", "appetite-loss", and "suicide" are some of the negative side-effects of the drugs "Celexa" and "Lexapro", which, to this day, have warnings on their boxes' that state: "Not for the use in Pediatric Patients under the age of 12". Its extremely disheartening that they would keep such important information hidden away from me or my doctors; placing her life in extreme danger in the process. These drugs were secretly provided to my baby at the age of three and half years old; a fact that I did not uncover until I was able to obtain my case transcripts, years after my child was taken from me and their adoption goal was completed. The drugs' side effects were only exacerbated when she was returned to my care and her body began to experience withdrawal symptoms from abrupt discontinuation of the drugs. Once I realized how ill she felt, I rushed her to the ER to alleviate her condition. The ER doctor stated: "she is the appropriate height and weight for a child or her age" and could not understand why she was very ill and had to be hospitalized. In spite of the ER doctor's letter, DCF removed my daughter from my custody within a month from stating: she was "failing to gain weight" at a suitable rate. She never would have been taken if she weren't illegally prescribed these "un-approved" drugs behind my back; completely preventing me offering a defense for myself in Court. As it turns out, I am not the only parent whose civil rights were trampled upon. In a recent case against DCF, an attorney in Orlando, Florida recovered $501 Million for other parents with eerily similar stories. This case only helped further my resolve and focus to expose the culture of corruption with this State Funded agency. Unbelievable, the company that manufactures, markets, and distributes the adult psychotropic drugs "Celexa" and "Lexapro", recently plead guilty to multiple criminal charges. My daughter, at the age of 3 ½, was prescribed the adult anti-depressants "Celexa" and "Lexapro", without the knowledge or consent of either: the Family Court, my council, or my child's private physician. DCF and their cohorts, clearly violated my civil rights and my ability to defend myself when they willingly disregarded FS 39.407 and Rule 8.355, as well as other laws on the books pertaining to the administration of psych meds to a child in the custody of DCF. Florida Statute 39.407(3)(e) clearly states: "before the department provides psychotropic medications to a child in its custody, the prescribing physician shall attempt to obtain express and informed consent, as defined in s. 394.455(9) and described in s. 394.459(3)(a), from the child's parent or legal guardian. Last year, the FDA finally approved the anti-depressant drug "Lexapro" for the treatment of acute depression in adolescents age 14-17yrs old. The reason that this is so shocking is because my daughter was placed on this and other "unapproved" drugs without my knowledge at the age of 3 ½. In September 2010, Forest Laboratories entered into a plea deal with the US Attorney's Office, entering in guilty pleas for "obstruction of justice", off-label marketing, and willfully violating the "False Claims Act". In plea deal, Forest Labs admits that false claims could be filed with government health care organizations like Medicaid by marketing the drugs "Celexa" and "Lexapro" to pediatric physicians without providing the proper studies on negative side effects in children. Per the plea, Forest also agreed to set-aside more than $313 million to settle pending "False Claims Act" lawsuits. My daughter was also on Medicaid due to the exorbitant medical costs associated with the numerous medical complications she's had since birth. As a mother I am extremely worried about the long-term health risks associated with "Lexapro" and "Celexa" while in such a delicate health state when she was a young child. Prior to this writing, I discovered yet another horrific story about these drugs and child. In this case, the suicide of an 11-year-old girl was attributed to the "Lexapro" drug therapy that she was receiving. As an American citizen, with no charges or allegations of abuse or neglect, period, it is my goal to try and tell my story so that parents can better understand the ways which greedy corporations and corrupt tax-funded state agencies, trample on their Civil Rights. My Civil Rights including: my Right to defend myself in court, my Right to informed consent with regards to the drugs my child was placed-on, as well as my right to "life, liberty, and the pursuit of happiness" are but a few of the inalienable Rights so blatantly denied to me and my only child based on my financial status. The safety and well being of my child have always been my priority in life. The same people charged with her safety, are the same people who illegally administered drugs to her and then withheld her medication history from her medical records and the Court I hope that this letter has provided a bit of insight into the nightmare that my fiancé and I have been fighting for years. The recent criminal guilty plea from the drug-maker, Forest Labs, combined with the two enormous civil cases against DCF clearly shows; everything we've been saying has been the truth! It's also interesting to note that in the Thursday edition of the St. Petersburg Times, the Pinellas County Clerk of the Court's office admitted to somehow loosing a number of child-custody cases with DCF. Florida State law requires the records from all child-custody cases with DCF be held for "75 years". My case just happens to be one of the cases mysteriously lost: a fact that I learned this past summer while attempting to find the records of my case. Now, the only way I can prove my story is the court transcripts and original copies of DCF records, which were provided to me after years of struggling for their release. Anything that you can do to help me spread-light on the misdeeds of the Juvenile Justice System and the safety issues involved with respect to children would be fantastic. Everything thing I have stated can be documented, please let me know if there is anyway you can help. God Bless! Sincerely, Francesca Moore DESTROYED MOTHER Cell: 727-422-0149 Email: franmoore7777@yahoo.com