Fraud and Abuse Litigation and Investigations

Representative engagements include:

  • representing a subsidiary of one of the world’s largest pharmaceutical and health care products companies in two False Claims Act cases involving allegations of unlawful marketing practices and violations of the Anti-Kickback statute. In the Central District of California, we successfully argued that all claims related to 12 products should be dismissed for lack of subject matter jurisdiction and, after extensive briefing on jurisdictional and procedural issues, anticipate a 9th Circuit ruling on Relator’s appeal in late 2019.  In the District of New Jersey, we are defending the client in a case involving two medicines used to treat HIV/AIDS and novel legal issues related to the interplay among the FDA drug approval process, the Medicare and Medicaid statutory frameworks, and the False Claims Act. We successfully moved to dismiss the parent company, and engaged in extensive fact discovery. Expert discovery is ongoing and trial is likely to occur in early 2020. 
  • currently representing a global pharmaceutical company to guide its compliance under a Corporate Monitorship pursuant to a Deferred Prosecution Agreement for violations of the FCPA, as well as conducting internal investigations involving operations in numerous affiliates worldwide.
  • represented an international pharmaceutical company in an industry-wide investigation by the U.S. Department of Justice, the U.S. Attorney’s Office for the District of Massachusetts and the Office of Inspector General of the U.S. Department of Health and Human Services of Independent Charity Patient Assistance Programs. Pepper defended the company and successfully resolved the matter.
  • represented multiple pharmaceutical companies and device companies in Attorney General litigation and investigations.  Pepper currently represents multiple companies with 50 state multi-state investigations, as well as individual investigations by activist state Attorneys General and those that hire private counsel.
  • represented a leading pharmaceutical manufacturer in criminal and civil investigations by a U.S. Attorney’s Office relating to the manufacturing quality of certain products and whether the company complied with current Good Manufacturing Practices (cGMPs), following highly publicized product recalls and national media attention.
  • obtained a declination of prosecution by a U.S. Attorney's office of a leading health insurance company following an investigation into its billing practices related to Medicare regulations.
  • represented the U.S. subsidiary of a Japanese pharmaceutical company in investigations by the DOJ and 50 states of alleged off-label promotion and kickback violations. Pepper represented this client in the parallel investigations and brought the matter to a successful conclusion. The settlement with DOJ and the 50 states involved a multimillion-dollar False Claims Act civil settlement. The DOJ declined to prosecute, and the OIG declined to require a CIA. We continue to represent this client in other investigations and related matters.
  • represent CEO of ACO in DOJ health care investigation
  • obtained declination of prosecution after two-year DOJ investigation of physician practice group
  • represented health care executive in DOJ investigation
  • represented hospital executives in multiple DOJ criminal civil investigations
  • represented a pharmaceutical company in a qui tam action alleging that it violated the federal False Claims Act and the Anti-Kickback Statute, and we represented the same company in a federal criminal investigation based on whistleblower allegations of false marketing practices and other alleged unlawful activity. Pepper persuaded the DOJ and the U.S. Attorney’s Office, Southern District of New York, to decline the matter.
  • represent a leading medical device manufacturer, guiding the company through a three-year federal monitorship and a CIA. This matter involves every aspect of the company’s business and involves daily counseling on sales and marketing practices related to AKS and the Foreign Corrupt Practices Act. We negotiated a global settlement with DOJ criminal prosecutors, as well as with civil prosecutors and Attorneys General in all 50 states in a qui tam case involving alleged AKS violations.
  • represented a medical device company in a FINRA and SEC inquiry into insider trading; no charges filed.
  • conducted internal investigations for hospitals and doctors of drug diversion activities and coordinated cooperation with police and prosecutors.
  • supervised an internal investigation for a pharmaceutical company on an international data security issue involving alleged infiltration of company data by Russian organized crime, and helped implement revisions to the company’s compliance program.
  • represented the largest pharmaceutical company in Asia, in a case filed in state court by the Mississippi Attorney General alleging a price-fixing conspiracy relating to the global sale of vitamins. This case was the last remaining civil case that was part of the largest antitrust matter ever prosecuted criminally by the US Department of Justice relating to the sale of bulk vitamins. We have represented the company in all phases of the civil litigation.
  • counsel pharmaceutical manufacturers regarding fraud and abuse issues, including those presented under sales and marketing arrangements, consulting agreements and arrangements with health care professionals.
  • represent major pharmaceutical companies and medical device companies facing government investigations or alleged violations of fraud and abuse laws.
  • conduct internal investigations for major pharmaceutical companies and other health care entities regarding the conduct of clinical trials, sales and marketing practices, pricing, good manufacturing practices and other issues.
  • represent a physician advisor company and several affiliates in a qui tam litigation alleging FCA violations arising out of claims for inpatient hospital admissions.
  • represent a PBM in qui tam litigation alleging multiple FCA violations arising out of claims submitted under the Medicare Part D Program.
  • represented a hospital in a qui tam action brought under the FCA for alleged submission of fraudulent claims for services to Medicaid where the government declined to intervene. The court granted partial summary judgment to the hospital, and the relator voluntarily dismissed the case.
  • represented a multi-state radiation oncology business with over 80 healthcare facilities and its principals in a qui tam action brought to recover over $12 million for alleged fraudulent billing to Medicare. The case was filed in the U.S. District Court for the District of Maryland and involved complex insurance coverage and settlement issues that were ultimately resolved by the United States Court of Appeals for the Fourth Circuit.
  • represented 20 Pennsylvania counties through the County Commissioners Association in defending an FCA case for alleged fraud involving approximately $3 billion in Medicaid funds. The case was brought in the U.S. District Court for the Western District of Pennsylvania. Discovery revealed that the information alleged by the relator was already within the public domain. Pepper moved for summary judgment on this ground, and the relator voluntarily dismissed the case.
  • advising hospitals, ASCs, specialty hospitals and outpatient diagnostic centers on regulatory compliance issues under federal and state fraud and abuse laws (including the federal Anti-Kickback Statute), anti-referral laws (including Stark), licensure and securities laws arising from physician and non-physician, including hospital, ownership of these centers and related real estate acquired through a private offering of partnership interests.
  • defended hospitals facing criminal, civil and regulatory investigations by multiple federal and state agencies.
  • represented health insurance providers and retail pharmacy chains facing government investigation under the FCA.

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