Pharma Fraud

December 23, 2015

A $2.5 million settlement with long term care pharmacy Pharmerica, which services hundreds of nursing homes across the nation, completes the final leg of litigation involving the illegal promotion of Aranesp, an anemia drug manufactured by Amgen, Inc.  Including the 2013 settlement with Amgen ($24.9 million) and the 2014 settlement with Omnicare ($4.19 million), this settlement brings the government’s total recovery in this matter to just over $31.5 million.  The allegations were originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act. DOJ (DSC)

December 16, 2015

Qualitest Pharmaceuticals, the company’s corporate shell, Vintage Pharmaceuticals, its parent Endo Pharmaceuticals, and seven of their affiliates, agreed to pay $39 million to 48 states and the federal government to settle charges they violated federal and state False Claims Acts by selling understrength chewable fluoride tablets.  As part of the settlement, Qualitest admitted the drug labeling for its chewable fluoride tablets represented fluoride amounts in line with guidelines of the American Dental Association and the American Academy of Pediatrics when in reality it used less than half of these represented amounts.  The allegations were first raised in a whistleblower lawsuit brought Dr. Stephan Porter under the qui tam provisions of the False Claims Act.  He will receive a whistleblower award of roughly $4.71 million from the proceeds of the government’s recovery.  Whistleblower Insider, NY, NH

November 25, 2015

The US settled for more than $30 million allegations against several Florida compound pharmacies and their owners for violating the False Claims Act by fraudulently billing TRICARE, the military’s healthcare program.  The settling defendants and their respective settlements include: MedMatch Pharmacy (agreeing to pay more than $4.7 million to resolve concerns that it paid kickbacks to marketers, that it filled prescriptions it knew or should have known were not legitimate, and that it sent prescriptions to states in which it did not have a valid license); OHM Pharmacy (agreeing to pay $4.1 million to resolve allegations of filling prescriptions from a doctor who was writing them outside the ordinary course of practice); WELL Health Pharmacy and its owner (agreeing to pay more than $3 million, as well as 50% of its net profits for five years, for filling prescriptions written by referral sources that had a financial interest in the prescriptions); Topical Specialists (agreeing to pay more than $2.2 million for submitting prescriptions that were tainted by so-called “research fees,” which was an elaborate guise for paying physicians to write prescriptions); Durbin Pharmacy (agreeing to pay $2.1 million, plus 50% of its net profits for five years, for submitting prescriptions that were tainted by kickbacks); and North Beaches Pharmacy (agreeing to pay $10,000, plus 50% of its net profits for five years, for filling compound prescriptions that the government contends were tainted by illegal kickbacks).  DOJ (MDFL)

November 20, 2015

Novartis Pharmaceuticals Corp. agreed to pay $390 million to resolve charges it gave kickbacks to specialty pharmacies in return for recommending two of its drugs, Exjade and Myfortic.  The settlement follows the January 2014 and April 2015 settlements of specialty pharmacies Bioscrip, Inc. and Accredo Health Group under which the pharmacies agreed to pay a total of $75 million to resolve False Claims Act charges based on the same allegations.  That brings to $465 million the total government recovery from this alleged kickback scheme.  The allegations leading to the settlement were first brought to the attention of federal law enforcement by David Kester, who filed a whistleblower lawsuit under the qui tam provisions of the False Claims Act.  He will receive a yet-to-be disclosed whistleblower award from the government’s recovery.  Whistleblower Insider

November 13, 2015

Tamara Esponda, owner of Miami-area pharmacy Biomax Pharmacy Inc., was sentenced to 42 months in prison and to pay roughly $1.6 million in restitution for her role in the submission of more than $1.5 million in fraudulent claims to Medicare Part D.  According to admissions made in connection with Esponda’s guilty plea, Biomax Pharmacy submitted fraudulent claims to Medicare for prescription drugs that were not prescribed by physicians, not medically necessary and not provided to Medicare beneficiaries.  Esponda further admitted that in perpetrating this fraud she and her accomplices used the beneficiaries’ and doctors’ Medicare identification numbers without their consent.  DOJ

November 4, 2015

AstraZeneca LP and Cephalon, Inc. agreed to pay $54 million to settle government charges they violated federal and state False Claims Acts by overcharging state Medicaid programs for their pharmaceutical products.  AstraZeneca will pay $46.5 million and Cephalon, the wholly-owned subsidiary of Teva Pharmaceutical Industries. Ltd., will pay $7.5 million.  According to the government, the two pharmaceutical companies underpaid drug rebates owed the states under the Medicaid Drug Rebate Program, which requires drug makers to periodically return to the government a portion of their Medicaid proceeds.  The allegations first arose in a whistleblower lawsuit filed by Virginia pharmacist and attorney Ronald Streck under the quit tam provisions of the Federal False Claims Act, New York False Claims Act and other state false claims statutes.  Mr. Streck will receive a yet-to-be-disclosed whistleblower award from a portion of the government’s recoveries.  Whistleblower Insider

October 29, 2015

Warner Chilcott US Sales LLC, a subsidiary of pharmaceutical manufacturer Warner Chilcott PLC, agreed to plead guilty to a felony charge of health care fraud as part of a global settlement in which Warner Chilcott agreed to pay $125 million to resolve its criminal and civil liability arising from illegally marketing the drugs Actonel, Asacol, Atelvia, Doryx, Enablex, Estrace and Loestrin in violation of the False Claims Act and Anti-Kickback Statute.  Specifically, the government charged that between 2009 and 2013, Warner Chilcott paid physicians to induce them to prescribe Warner Chilcott drugs.  The government also alleged that Warner Chilcott employees submitted false or misleading prior authorization requests and other coverage requests to federal health care programs for the osteoporosis medications Atelvia and Actonel.  The government further claimed that Warner Chilcott employees were instructed by members of the company’s management team to make unsubstantiated superiority claims when marketing the drug Actonel.  The allegations first arose in a whistleblower lawsuit by two former Warner Chilcott sales representatives filed under the qui tam provisions of the False Claims Act.  The whistleblowers will receive a whistleblower award of approximately $22.9 million from the federal share of the civil recovery.  Whistleblower Insider

October 8, 2015

Evelio Fernandez Penaranda, owner of Miami-based Naranja Pharmacy Inc., was sentenced to 46 months in prison and to pay $1,876,241 in restitution for his role in the submission of more than $1.8 million in fraudulent claims to Medicare.  According to his guilty plea, Naranja Pharmacy submitted fraudulent claims to Medicare for prescription drugs not prescribed by physicians, not medically necessary and not provided to Medicare beneficiaries. DOJ

October 7, 2015

Kentucky-based nursing home pharmacy PharMerica Corp. agreed to pay $9.25 million to resolve allegations it violated the False Claims Act by soliciting and receiving kickbacks from pharmaceutical manufacturer Abbott Laboratories in exchange for promoting the anti-epileptic prescription drug Depakote for nursing home patients.  The settlement is part of the continuing fallout of the $1.5 billion settlement Abbott entered into with the government in May 2012 to resolve Abbott’s liability under the False Claims Act for alleged kickbacks to nursing home pharmacies, including PharMerica.  The settlement partially resolves allegations raised in two whistleblower lawsuits brought by former Abbott employees Richard Spetter and Meredith McCoyd under the qui tam provisions of the False Claims Act.  Ms. McCoyd will receive a whistleblower award of $1 million from the federal share of the settlement amount. Whistleblower Insider

September 3, 2015

Genzyme Corporation, a wholly-owned biotechnology subsidiary of French pharmaceutical company Sanofi, agreed to resolve criminal charges it violated the Food, Drug and Cosmetic Act with regard to the unlawful distribution of the surgical device Seprafilm.  As part of the agreement, Genzyme agreed to admit to the facts underlying the charges and pay a monetary penalty of $32,587,439.  Whistleblower Insider