Archive

July 6, 2016

New Jersey-based Pharmaceutical Innovations Inc. pleaded guilty to criminal charges and resolved a civil lawsuit arising from the company’s distribution of ultrasound gel contaminated with bacteria.  In addition to placing the company on two years probation, the court ordered the company to pay a criminal fine of $50,000 and to forfeit an additional $50,000 – the approximate value of the adulterated gel.  DOJ

July 6, 2016

The U.S. District Court for the Southern District of Alabama entered a consent decree of permanent injunction against BEK Catering LLC (dba Floppers Foods LLC) to prevent the distribution of adulterated and misbranded seafood products.  DOJ

June 21, 2016

David Allen and William Timothy Rogers, former pharmacist-in-charge and former president of the now-defunct compounding pharmacy Advanced Specialty Pharmacy (doing business as Meds IV)were sentenced to 12 and 10 months in prison for their roles in the distribution of adulterated drugs.  DOJ

June 6, 2016

Genentech Inc. and OSI Pharmaceuticals LLC agreed to pay $67 million to resolve charges they violated federal and state False Claims Act by making misleading statements about the effectiveness of the cancer drug Tarceva.  According to the government, Genentech and OSI made misleading representations to physicians and other health care providers about the effectiveness of Tarceva when there was little evidence to show that Tarceva was effective to treat those patients unless they also (i) had never smoked or (ii) had a mutation in their epidermal growth factor receptor, which is a protein involved in the growth and spread of cancer cells.  The allegations originated in a whistleblower lawsuit filed by former Genentech employee Brian Shields under the qui tam provisions of the False Claims Act.  He will receive a whistleblower award of approximately $10 million out of the proceeds of the government’s recovery.  Whistleblower Insider GA, MA, OH

May 9, 2016

CA oncologist Dr. John F. Kiraly and his wife Rena Kiraly, who served as the doctor’s office administrator, have paid $300,000 to settle allegations that they violated the False Claims Act by improperly billing Medicare for certain chemotherapy drugs purchased from an unlicensed foreign pharmaceutical distributor.  Specifically, the Kiralys purchased chemotherapy drugs from Warwick Healthcare Solutions Inc., also known as Richards Pharma, a former United Kingdom-based drug distributer that distributed non-FDA approved drugs throughout the United States.  DOJ (EDCA)

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