Pharma Fraud

April 27, 2016

Pharmaceutical giants Wyeth and Pfizer, Inc. agreed to pay $784.6 million to resolve allegations that Wyeth violated the False Claims Act by reporting to the government false prices on two of its proton pump inhibitor (PPI) drugs, Protonix Oral and Protonix IV.  Under the state Medicaid programs, drug companies must provide Medicaid rebates based on the best prices they offer other customers.  According to the government, Wyeth hid from Medicaid bundled discounts it provided to thousands of hospitals across the country on Protonix Oral and Protonix IV.  By failing to report these bundled discounts, Wyeth allegedly avoided paying hundreds of millions of dollars in rebates.  The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Lauren Kieff, a former hospital sales representative for AstraZeneca and William St. John LaCorte, a physician practicing in New Orleans.  They will collectively receive a whistleblower award of roughly $98 million from the proceeds of the federal and state settlements.  Whistleblower Insider

April 27, 2016

Michigan and 34 other states reached an agreement in principle to settle allegations against Wyeth, a subsidiary of Pfizer, Inc. The settlement will resolve allegations that Wyeth knowingly underpaid rebates owed under the Medicaid Drug Rebate Program for the sales, Protonix Oral and Protonix IV between 2001 and 2006. Both are drugs that are used to treat conditions such as acid reflux. Under the settlement Wyeth agreed to pay $784.6 million to the United States and the States. Over $371 million of this amount will go to the Medicaid Program. The settlement stems from two whistleblower lawsuits which were filed in the United States District Court for the District of Massachusetts. The United States, 35 states (including Michigan) and the District of Columbia intervened in the lawsuits. NY, NJ, MI, WA

March 31, 2016

The FTC filed a complaint in federal district court alleging that Endo Pharmaceuticals Inc. and several other drug companies violated antitrust laws by using pay-for-delay settlements to block consumers’ access to lower-cost generic versions of Opana ER and Lidoderm. Following more than a decade of FTC challenges to pay-for-delay settlements, the enforcement action is the first FTC case challenging an agreement not to market an authorized generic – often called a “no-AG commitment” – as a form of reverse payment. FTC

March 29, 2016

New York announced the guilty pleas of licensed pharmacist Glenn Schabel, 55, of Melville, and his company, Glenn Schabel, Inc. in connection with a nation-wide scheme to sell diverted HIV medication to unsuspecting New Yorkers. Schabel pled guilty to Criminal Diversion of Prescription Medications and Prescriptions in the First Degree, and Commercial Bribe Receiving in the First Degree. Schabel will be sentenced to up to two and one-third to seven years state prison and forfeit $5,456,267 to the New York State Medicaid Program. Glenn Schabel Inc., pled guilty to Money Laundering in the First Degree. In April 2012, MFCU investigators arrested Schabel and three other individuals and charged ten companies, for using a network of bogus prescription medication wholesalers in Alabama, Mississippi, North Carolina, and California to launder money and to sell over $274 million in diverted prescription medications. NY

March 23, 2016

Detroit-area doctor Laran Lerner was sentenced to 45 months in prison and to pay $2.8 million in restitution for his role in a $5.7 million Medicare fraud scheme in which he prescribed medically unnecessary controlled substances and billed for office visits and diagnostic testing that never took place.  DOJ

March 3, 2016

New York announced an agreement with Endo Health Solutions Inc. and Endo Pharmaceuticals Inc. (“Endo”), which make and sell the long-acting opioid, Opana ER. The agreement requires Endo to cease all misrepresentations regarding the properties of Opana ER, to describe accurately the risk of addiction to Opana ER, and to summarize studies regarding Opana ER on its website. Endo must also create a program that will prevent its sales staff from promoting this powerful narcotic painkiller to health care providers who may be involved in the abuse and illegal diversion of opioids. Endo, an Irish company with U.S. headquarters in Pennsylvania, makes a variety of prescription drugs. Endo’s opioid drug Opana ER has been widely abused in New York State. NY

February 19, 2016

Adventist Health System Sunbelt Healthcare Corporation agreed to pay $2.09 million to resolve allegations that patients were administered portions of single-dose vials of chemotherapy drugs that were left over from administrations to prior patients.  The settlement also resolves allegations that some platinum based drugs were administered inappropriately and that certain infusion services were upcoded.  The allegations originated in a whistleblower lawsuit filed by former Adventist employee Heather Huddleston under the qui tam provisions of the False Claims Act.  She will receive a whistleblower award of $376,452 from the proceeds of the government's recovery.  DOJ (MDFL)

February 11, 2016

Compounding pharmacies WELLHealth and Topical Specialists and four physicians, Manish Bansal, Mehul Parekh, Marisol Arcila, and Syed Asad, agreed to pay approximately $10 million to resolve allegations they violated the False Claims Act by submitting false claims to TRICARE, the military’s healthcare program.  According to the government, the physicians wrote hundreds of prescriptions for pain and scar creams never used by patients and billed to the government at a cost which yielded up to 90% in profits.  Bansal is a cardiologist at Baptist Hospital; Arcila is a pain management physician at Premier Spine & Pain Center; Asad is a neurologist at Universal Neurological Care; Parekh is a general practice physician at Baptist Hospital.  DOJ (M.D.Fla)

January 5, 2016

Nashville Pharmacy Services, LLC, and its majority owner Kevin Hartman, agreed to pay up to $7.8 million to settle charges they violated the False Claims Act by overbilling Medicare and TennCare for pharmacy services.  Specifically, the government claimed the Nashville-based pharmacy that specializes in dispensing HIV and AIDS-related medications automatically refilled medications without a request from the beneficiary or their physician; improperly waived TennCare and Medicare co-payments without an individualized assessment of ability to pay; improperly used pharmaceutical manufacturers’ co-payment cards to pay the co-payments of Medicare beneficiaries; billed for medications dispensed after the deaths of certain beneficiaries; and billed for medications that lacked a valid prescription.  The allegations originated in a whistleblower lawsuit filed by Marsha McCullough, a former Nashville Pharmacy order entry technician, under the qui tamprovisions of the False Claims Act.  She will receive a whistleblower award of 18 percent of the government’s recovery which could amount to $1.4 million.  Whistleblower Insider