Showing posts with label Depakote. Show all posts
Showing posts with label Depakote. Show all posts

Wednesday, October 19, 2016

Nation's Largest Nursing Home Pharmacy to Pay Over $28 Million to Settle Kickback Allegations

Omnicare and Depakote. Who's a thunk it?

US DOJ

The nation’s largest nursing home pharmacy, Omnicare Inc., has agreed to pay $28.125 million to resolve allegations that it solicited and received kickbacks from pharmaceutical manufacturer Abbott Laboratories in exchange for promoting the prescription drug, Depakote, for nursing home patients.  CVS Health Corporation, which is headquartered in Rhode Island, acquired Ohio-based Omnicare in 2015, approximately six years after Omnicare ended the conduct that gave rise to the settlement.
“Every day, elderly nursing home residents suffering from dementia rely on the independent judgment of our nation’s healthcare professionals for their personal care and their medical treatment,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Department of Justice’s Civil Division.  “Kickbacks to entities making drug recommendations compromise their independence and undermine their role in protecting nursing home residents from the use of unnecessary drugs.”
Nursing homes rely on consultant pharmacists, such as those employed by Omnicare, to review their residents’ medical charts at least monthly and make recommendations to their physicians about what drugs should be prescribed for those residents.  The settlement announced today resolves allegations that Omnicare solicited and received kickbacks from Abbott in exchange for recommending that physicians prescribe Depakote, an anti-epileptic drug manufactured by Abbott, to elderly nursing home residents.
According to the government’s complaint, Omnicare disguised the kickbacks it received from Abbott in a variety of ways.  Abbott allegedly made payments to Omnicare described as “grants” and “educational funding,” even though their true purpose was to induce Omnicare to recommend Depakote.  For example, Omnicare allegedly solicited substantial contributions from Abbott and other pharmaceutical manufacturers to its “Re*View” program.  Although Omnicare claimed that Re*View was a “health management” and “educational” program, the complaint alleges that it was simply a means by which Omnicare solicited kickbacks from pharmaceutical manufacturers in exchange for increasing the utilization of their drugs on elderly nursing home residents.  In internal documents, Omnicare allegedly referred to Re*View as its “one extra script per patient” program.  The complaint also alleges that Omnicare entered into agreements with Abbott by which Omnicare was entitled to increasing levels of rebates from Abbott based on the number of nursing home residents serviced and the amount of Depakote prescribed per resident.  Finally, the complaint alleges that Abbott funded Omnicare management meetings on Amelia Island, Florida, offered tickets to sporting events to Omnicare management and made other payments to local Omnicare pharmacies.
In May 2012, the United States, numerous states and Abbott entered into a $1.5 billion global civil and criminal resolution that, among other things, resolved Abbott’s liability under the False Claims Act for alleged kickbacks to nursing home pharmacies, including Omnicare and PharMerica Corp.  In October 2015, PharMerica agreed to pay $9.25 million to the United States and numerous states to resolve civil liability under the False Claims Act for the alleged kickbacks from Abbott.  The settlement announced today resolves Omnicare’s role in that alleged kickback scheme.
“This settlement ensures that some of the most vulnerable amongst us, those suffering from dementia, are provided with the level of care they deserve,” said U.S. Attorney John P. Fishwick Jr. for the Western District of Virginia.  “Families and loved ones who make the difficult decision to place those they care about into a nursing home must do so with the confidence that medical decisions are being made with the interests of the patient in mind, not big drug companies.”
Approximately $20.3 million of the settlement will go to the United States, while $7.8 million has been allocated to cover Medicaid program claims by states that elect to participate in the settlement.  The Medicaid program is jointly funded by the federal and state governments.
“It is disturbing that any health care corporation would pay kickbacks that corrupt the professional medical decision making process in order to pad their profits,” said Special Agent in Charge Nicholas DiGiulio of the Department of Health and Human Services Office of Inspector General (HHS OIG).  “These practices are unacceptable and will not be tolerated.”
The settlement with Omnicare announced today, together with the prior settlements with Abbott and PharMerica, resolves allegations in two lawsuits filed in federal court in the Western District of Virginia by Richard Spetter and Meredith McCoyd, former Abbott employees.  The lawsuits were filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private individuals to sue on behalf of the government for false claims and to share in any recovery.  The act also allows the government to intervene and take over the action, as it did in part in this case in May 2014.  The United States filed a complaint-in-intervention against Omnicare in December 2014.  As part of today’s resolution, McCoyd will receive $3 million from the federal share of the settlement amount.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $31.6 billion through False Claims Act cases, with more than $19.2 billion of that amount recovered in cases involving fraud against federal health care programs.”
This matter was jointly handled by the Civil Division’s Commercial Litigation Branch, the U.S. Attorney’s Office for the Western District of Virginia, HHS-OIG, the Office of the Attorney General for the Commonwealth of Virginia and the National Association of Medicaid Fraud Control Units.
The cases are captioned United States ex rel. Spetter v. Abbott Labs., et al., Case No. 10-cv-00006 (W.D. Va.) and United States ex rel. McCoyd v. Abbott Labs., et al., Case No. 07-cv-00081 (W.D. Va.).  The claims resolved by the settlement are allegations only, and there has been no determination of liability.
16-1203
Updated October 17, 2016


Tuesday, May 8, 2012

Depakote Earns Abbot Labs $1.5 Billion Fine

The United States Dept of Justice has;

Documents and Resources From The May 7th, 2012 Abbot Laboratories Press Conference

For Abbot Labs Statement:

And if you'd prefer it on One page rather than reading through All of the above:
See Bloomberg for:
By Jef Feeley and Margaret Cronin Fisk - May 8, 2012 12:01 AM ET
"Abbott Laboratories (ABT) said it reached an agreement to pay $1.6 billion to settle federal and state claims resulting from an investigation into its epilepsy medication Depakote, the second-largest drug-marketing settlement in U.S. history.



The company will pay $800 million to resolve civil allegations split among federal and state governments, $700 million for a criminal penalty, the Justice Department said in a statement. Abbott marketed the drug, approved for epilepsy, bipolar mania and migraine prevention, for unapproved uses including dementia, the U.S. said.
The settlement results from a four-year-old investigation into Abbott sales practices that began in 1998, the Abbott Park, Illinois-based company said yesterday in a statement. Abbott said it is also paying $100 million to the states to resolve consumer protection matters.
“Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies,” Acting Associate Attorney General Tony West said in the Justice Department statement. “As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price.”
Continue reading Bloomberg coverage here.
If you want to see Some of What the FDA knew as far back as Dec 2006 about Depakote:
For the FDA Leaflet on Depakote:
And if you look up Depakote at:
Valproic AcidReported By
Adverse ReactionCasesMDCNOTPHLWNR
Suicidal Ideations51922117017
Attempted Suicides861218189049
Completed Suicides1574223161100
Deaths Not From Suicide3421114299161208
Homicidal Ideations2101000
Homicides1100000
Hypomania/Mania792522186028
Heart Disease19952344574107
Movement Disorders662184181165412249
Birth Defects43711851105419251
Premature Births3412290219
Prenatal/Neonatal Deaths1153415284349


"Those who put Profits ahead of Patients will pay a hefty price."
Top 20 Adverse Drug Reactions reported for Valproic Acid and its Brand Names
Adverse ReactionCases
Convulsion639
Drug Exposure During Pregnancy411
Drug Interaction350
Somnolence295
Confusional State250
Drug Ineffective246
Tremor246
Weight Increased222
Hyperammonaemia217
Alopecia216
Thrombocytopenia215
Ammonia Increased199
Vomiting196
Abnormal Behaviour194
Foetal Anticonvulsant Syndrome171
Pyrexia165
Nausea163
Developmental Delay161
Completed Suicide157
Fall150



If You had $1.5 Billion, would you consider it a 'Hefty Price' to buy back your DEAD family member?