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Sep 29, 2016

We return to the Gavel & Pestle Podcast with Darshan Kulkarni, PharmD, MS, Esq. to discuss the sensitive topic of Whistleblowers in healthcare & pharmacy.

What is a Whistleblower?

A whistleblower is effectively an individual who has witnessed or been part of an unethical or illegal process, often against their will as a condition of employment, and decides to submit the incriminating evidence to the proper authorities. Whistleblowers begin the indictment process in cases that are criminal. Whistleblowers are not just restricted to the private sector, but the dynamics of retaliation from cases arising from the public sector can be different. Congress understands the precarious situations that whistleblowers are in and have established legislation for retributive protection.  

Cases in the private sector are covered by The Corporate and Criminal Fraud Accountability Act and are enforced by the U.S. Department of Labor. A subset of the Zarbanes-Oxley Act of 2002, the law allows whistleblowers to enjoin the government in any civil claim that the Attorney General will advance to prosecution.

The legislation essentially protects employees of publicly-traded companies from the employer and criminalizes retaliation.  In addition to employee protections, the law requires employers to establish a company policy and reasonable protocol to allow whistleblowers an opportunity to present situations occurring within the company that may have been overlooked in normal operations. Conditions of the legislation also require attorneys to become whistleblowers in the event of illegal activity.  

The Equal Employment Opportunity Act provides additional protection for cases involving discrimination and retaliation, effectively giving a discriminated individual more legal leverage. The legal protections of remedies in this legislation allow for protections in legal standing for the witness of a discriminating act as well as the victim if the employer retaliates against the informant.

Dr. Kulkarni is the Principal Attorney at the Kulkarni Law Firm. He provides regulatory and legal advice to pharmacies and other FDA regulated entities and their service providers.  He speaks and regularly advises on currently legal and compliance related matters including the physician payment sunshine act, clinicaltrials.gov, the False Claims Act, the Anti-Kickback Law and other developments of laws and regulations that affect the life sciences industry and compounding facilities.  He has worked as a pharmacist for more than 14 years in multiple capacities, including hospitals, retail pharmacies, managed care, and has even participated as a clinician in clinical trials.