Dr. Joseph Piacentile

Joseph Piacentile M.D.Joseph Piacentile, M.D., who goes simply by “Dr. Joe,” is the Founder and CEO of Whistleblowers Against Fraud (“WAF”). Dr. Joe has dedicated 27 years of his professional career to seeking justice against those who commit fraud against the U.S. government. Dr. Joe has assisted the U.S. government in recovering more than $8 billion.

Dr. Joe is very upfront about his own history, which led him to this career path with WAF. In the mid-1980s, Dr. Joe was a partner in a national durable medical equip- ment company. In charge of a sales force of 160 em- ployees, Dr. Joe grew sales from $1 million to $20 mil- lion in a mere three years. This early success did not end well, as Dr. Joe and his partners pled guilty to one count each of Medicare and tax fraud, for “falsifying Medicare forms,” which had been submitted in 1985. Dr. Joe’s background and personal experience with the le- gal system has proven invaluable in his career as a case consultant with pharma and medical fraud.

A licensed physician, with a degree from Georgetown University Medical School, Dr. Joe is an expert in a broad array of healthcare and pharmaceutical issues. While healthcare fraud was the focus of his early cases, Dr. Joe has developed an extensive arsenal of expertise across many industries. In addition, he was granted a US Patent in April 2014 for Point-of-Prescription (PoP) intelligent messaging.

The PoP system is designed to disrupt the way pharmaceutical companies message their products. The system allows pharmaceutical companies, and other healthcare stakeholders, to message physicians and providers based on real-time, patient-specific data. This means that FDA-approved messages can be embedded in the prescription process. This system affords tremendous efficien- cies for the pharmaceutical sales process, real-time metrics, feedback, and total transparency for the government regulators, such as the FDA and the Department of Justice. The licensable patent allows for two-way communication between the medical science officers and the physicians.

This PoP system is a well-received solution for multiple problems currently faced by the Pharmaceutical industry, including the ability to off-label message, sample tracking, inventory controls, and real time sales metrics based on patient/provider-specific data. The system integrates with all cur- rent EMR platforms in much the same way that PayPal has monetized on a bid-for-placement model, similar to Google.

Whistleblowers Against Fraud Successes

While most of WAF’s cases remain under seal, here are some of the most recent settlements in which Dr. Joe has been involved:

  • JOHNSON & JOHNSON PAID $2.2 BILLION TO RESOLVE OFF-LABEL MARKETING AND KICKBACK ALLEGATIONS

J&J agreed to pay more than $2.2 billion to resolve allegations it promoted Risperdal, Invega and Natecor for off-label uses. The company promoted Risperdal for use in children and individuals with mental illness, while knowing that the drug posed health risks to children.

  • ABBOTT LABS PAID $1.5 BILLION TO RESOLVE DEPAKOTE INVESTIGATIONS

Abbott plead guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was FDA-approved.

  • MEDCO PAID $155 MILLION TO SETTLE FALSE CLAIMS ACT

Cases Settled allegations that the company submitted false claims to the government, solicited and accepted kickbacks from pharmaceutical manufacturers to favor their drugs and paid kickbacks to health plans to ob- tain business.

  • CEPHALON PAID $425 MILLION FOR OFF-LABEL MARKETING VIOLATIONS

Settled allegations with the U.S. government related to the illegal off-label marketing of three of its drugs – Actiq, Gabitril and Provigil. Bristol-Myers Squibb Paid $515 Million for Illegal Drug Marketing and Pricing Settled allegations with the U.S. government to resolve a broad array of allegations involving the company’s drug marketing and pricing practices.

  • FOREST LABORATORIES PAID $170 MILLION FOR OFF-LABEL DRUG MARKETING

Settled a Department of Justice investigation into its marketing and promotion of two antidepressants, Celexa and Lexapro.

  • MCKESSON PAID $340 MILLION TO RESOLVE FALSE CLAIMS ALLEGATIONS

Settled claims that it violated the False Claims Act by reporting inflated pricing information for a large number of prescription drugs, causing Medicaid to overpay for those drugs.

  • AMGEN PAID $612 MILLION IN A CIVIL SETTLEMENT OF MISBRANDING CLAIMS

Amgen, the world’s largest biotechnology company, pleaded guilty to a misdemeanor charge of mis- branding its anemia drug Aranesp and agreed to settle a group of whistle-blower suits alleging the company also engaged in illegal sales practices regarding other drugs. The company agreed to pay $150 million in criminal penalties and $612 million in civil settlements.

  • AMGEN PAID $612 MILLION IN A CIVIL SETTLEMENT OF MISBRANDING CLAIMS

Amgen, the world’s largest biotechnology company, pleaded guilty to a misdemeanor charge of mis- branding its anemia drug Aranesp and agreed to settle a group of whistle-blower suits alleging the company also engaged in illegal sales practices regarding other drugs. The company agreed to pay $150 million in criminal penalties and $612 million in civil settlements.

  • PHARMERICA 2015 ​

Pharmerica paid $9.25 Million to resolve its role in receiving kickbacks from Abbott Labs. 

  • OMNICARE 2016

Omnicare paid $28 Million to resolve its role in receiving kickbacks from Abbott Labs.

  • WARNER CHILCOTT 2015

$120 Million settlement for the Federal and State False Claims Act violations. In addition, there was a California Insurance Fraud Statute (a kickback statute) for an additional $50 Million with a 50% relator share of $25 Million, for the illegal marketing of Actonel, Atlevia, Doryx and Loestrin. The former president of the company was subsequently indicted for conspiracy to pay kickbacks to physicians.

  • VASCULAR SOLUTIONS, INC. 2014

An off-label medical device case with a civil settlement of $520,000, for the marketing of a Varicose Vein product, Vari-Lase, with a subsequent criminal indictment of the CEO.

  • DYNASPLINT SYSTEMS, INC. 2015

A $10 Million settlement for the illegal marketing of medical splints to Medicare beneficiaries in skilled nursing facilities.

  • BRISTOL-MYERS SQUIBB

BMS pays more than $515 million to resolve allegations of illegal drug marketing and pricing.

  • OTSUKA

Otsuka pays more than $4 million to resolve off-label marketing allegations involving Abilify.