With decades of national healthcare litigation experience as former federal prosecutors and defense lawyers, we understand the intricacies of your business and the high stakes that you face from government enforcement actions. We’ve won trial acquittals in high-profile federal healthcare prosecutions and quietly resolved “bet the company” government investigations without adverse publicity for our satisfied clients. Often, we are entrusted to successfully navigate clients through complex, parallel healthcare proceedings in criminal and civil actions.

MNR Recent Cases:

• Bascom Palmer: Representation of one of the nation’s leading ocular oncologists and retinal surgeons in the world, in a DOJ investigation regarding cutting-edge medical treatments performed at the University of Miami’s nationally-renowned Bascom Palmer Eye Institute. MNR was successful in convincing the government to not charge our client. A related qui tam suit brought by a rival physician also was dismissed.

• U.S. v. Clinton/Numed:Representation of the chief operating officer of Numed, one of the largest compounding pharmacy management service companies in the U.S. 16 individuals were charged with orchestrating a $175 million dollar insurance fraud and every defendant pled guilty.  Based on the applicable sentencing guidelines, Clinton was facing decades in prison.  Instead, based on some creative variance arguments, MNR obtained a sentence of only five years – which represented a massive sentence reduction and ten years less than the CEO received.

• U.S. v. Esformes: Successfully convinced the government to not charge a senior employee in U.S. v. Esformes, described by the DOJ as the largest heathcare fraud case charged by the department. The allegations concerned more than $1 billion dollars of Medicare reimbursements to a network of assisted living facilities.

• Ongoing representation of the CEO of a large manufacturer of medical supplies in a criminal misbranding investigation conducted by the DOJ/FDA.

• Successfully convinced the DOJ to not bring any charges against a large national retail pharmacy related to allegations of misbranding and drug diversion.

• Successful internal investigation for a large for-profit health insurance corporation related to allegations that several managers engaged in a self-dealing scheme. The investigation resulted in the termination of several managers.

• Ongoing representation of 20 former sales representatives of a large multinational pharmaceutical company being criminally investigated by the DOJ for its sales and marketing practices.

• U.S. v. Cowan: MNR was able to obtain an almost 75% sentence reduction for a senior executive of a mental health center in a multimillion-dollar Medicare fraud case.

• U.S. v. Mackenzie: Successfully obtained an acquittal on all counts after a four-month federal trial for a senior sales executive  of a major pharmaceutical company accused of violating the AKS  through the use of educational grants and charitable donations to hospitals.

• Successfully convinced the DOJ not to charge the Chief Medical Officer of a national hospital corporation in connection with an investigation into alleged violations of the AKS and Stark Law. The investigation centered around practices and policies concerning Emergency Room admissions and treatment.

• Successfully convinced the DOJ to bring no charges against the owners of a large diagnostic laboratory related to allegations of third-party payments in violation of the AKS and Stark Law.

Marcus Neiman Rashbaum & Pineiro, LLP is one of the nation’s leading law firms in defending government investigations and criminal and civil actions relating to medical device and pharmaceutical practices, including the defense of manufacturers, suppliers, distributors, and marketers.

MNR Recent Cases:

• U.S. v. Clinton/Numed: Representation of the chief operating officer of Numed, one of the largest compounding pharmacy management service companies in the U.S. 16 individuals were charged with orchestrating a $175 million dollar insurance fraud and every defendant pled guilty.  Based on the applicable sentencing guidelines, Clinton was facing decades in prison.  Instead, based on some creative variance arguments, MNR obtained a sentence of only five years – which represented a massive sentence reduction and ten years less than the CEO received.

• U.S. v. Scott Balotin: Balotin and others were indicted in October 2019 in the Northern District of Florida relating to a multimillion-dollar alleged fraud related to the marketing and selling of compound pain medications.  The case is set for trial in 2021.

• Ongoing representation of the CEO of a large manufacturer of medical supplies in a criminal misbranding investigation conducted by the DOJ/FDA. The investigation concerns product safety and related recall issues.

• Successfully convinced the DOJ to not bring any charges against a large national retail pharmacy concerning allegations of misbranding and drug diversion.

• Ongoing representation in a DOJ criminal investigation of a group of sales representatives over sales and marketing practices related to an opioid-based pain medication.

• Ongoing representation of an officer of a medical device company in parallel civil and criminal DOJ investigation into allegations of inadequate reporting of adverse events to FDA regulators.

• Successfully convinced the DOJ to not charge the owner of a specialty pharmacy, who was identified as a “target” prior to our engagement.  The allegations concerned the payment of alleged kickbacks to sales and marketing representatives.

• U.S. v. Mackenzie: Successfully obtained an acquittal on all counts after a four-month federal trial for a senior sales executive  of a major pharmaceutical company accused of violating the AKS  through the use of educational grants and charitable donations to hospitals.

• Internal investigation for a professional sports franchise related to compliance with federal and state pharmaceutical and narcotics laws.

Our former government experience informs our firm’s approach in navigating clients through the many obstacles associated with healthcare enforcement actions, including Civil Investigative Demands or “CIDs”; program exclusion, revocation, or suspension actions; professional licensing and disciplinary proceedings; program integrity audits, on-site inspections, and reviews; prepayment reviews and overpayment disputes and appeals. We understand both your business and regulators’ priorities and employ that insight to achieve practical solutions for our clients that protect their core business concerns.

MNR Recent Cases:

• Successfully convinced the DOJ/HHS to bring no charges against a specialty pharmacy as part of a civil enforcement investigation initiated by a whistleblower lawsuit. The investigation concerned allegations of dispensing medically unnecessary medications.

• Successfully convinced the DOJ to bring no charges against  a senior executive of a large medical rehabilitation center as part of a parallel DOJ/HHS investigation into allegations of billing fraud.

• Successfully convinced HHS not to bring charges against owners of medical clinic related to allegations of improper storage and dissemination of HIPAA-protected patient information.

• Ongoing representation of an officer of a medical device company in parallel civil and criminal DOJ investigation into allegations of inadequate reporting of adverse events to FDA regulators.

• Representation of the CEO of a national manufacturer of health care products in a criminal FDA investigation and a parallel civil False Claims Act investigation into company’s awareness of product defects that posed potential safety risks to patients.

• Successfully convinced the DOJ to bring no charges against the owners of a large diagnostic laboratory related to allegations of third-party payments in violation of the AKS and Stark Law.

Our firm is well versed in the intricacies of whistleblower and false claims act investigations and litigation. We have the varied skill set required to devise comprehensive defense strategies across parallel civil and criminal enforcement actions which are a regular feature of qui tam defense work. We appreciate the serious collateral consequences that these matters can cause for our clients and craft approaches intended to minimize business disruption and reputational damage. We also litigate aggressively when necessary and have successfully dismissed unfounded qui tam lawsuits on behalf of thankful clients.

On occasion, as part of our plaintiff’s litigation practice, we will represent a small number of qui tam relators and whistleblowers in federal and state actions that we have thoroughly investigated pre-complaint to assess likely government interest. Contrary to popular belief, most whistleblower claims do not result in positive results for plaintiffs, with the government declining to join the large majority of filed complaints. These cases to be successful take years of persistence and proactive lawyering. For these reasons, we take a thoughtful and measured evaluative approach to potential cases which we believe to be in our clients’ long-term interests. And for the cases we do file, we actively work with the government to maximize the chances of the government joining your case and of a successful outcome.

MNR Recent Cases:

• Successfully convinced the DOJ to bring no civil or criminal charges against a senior executive of a large chain of skilled nursing facilities as part of a parallel DOJ/HHS investigation into allegations of upcoding and overbilling of Medicare.

• U.S. ex rel. Rosenfeld/Bascom Palmer: Representation of one of the nation’s leading ocular oncologists and retinal surgeons in a federal FCA case brought by a rival physician related to cutting-edge eye treatments performed at the University of Miami’s nationally-renowned Bascom Palmer Eye Institute. The case was dismissed.

• Carrel v. AIDS Healthcare Foundation: Representation of AIDS Healthcare Foundation (AHF) the largest non-profit provider of HIV and AIDS-related health care services, in defending a whistleblower qui tam action brought by ex-employees alleging violations of the federal anti-kickback statute in excess of $100 million.  MNR obtained an outright dismissal of the case at summary judgment, which was later affirmed by the U.S. Court of Appeals for the Eleventh Circuit.

• Successfully convinced the DOJ/HHS to bring no charges against a specialty pharmacy as part of a civil enforcement investigation initiated by a whistleblower lawsuit. The investigation concerned allegations of dispensing medically unnecessary medications.

• Successfully convinced the DOJ to bring no civil or criminal charges against a senior executive of a large medical rehabilitation center as part of a parallel DOJ/HHS investigation into allegations of billing fraud.

• Successful FCA recovery for relators related to national manufacturers and suppliers of durable medical equipment.