Healthcare and Pharmaceutical/Medical Devices Crises, Investigations and Enforcement
Corporations or individuals who face civil or criminal healthcare, pharmaceutical or medical device crises, investigations and enforcement turn to Arnold & Porter for our unparalleled depth of experience. With former agency counsel and more than a dozen former federal prosecutors who have experience dealing with healthcare specific issues for pharmaceutical and medical device manufacturers, hospitals, skilled nursing providers, physicians, as well as healthcare executives, we stand ready to focus on mitigating immediate risks. For some of the most complex and challenging issues across the life sciences and healthcare sectors, we have established a record of developing comprehensive and effective strategies to counsel and defend clients through all stages of internal investigations, recalls, inspections, audits, civil, criminal and congressional investigations, and trials.
Our team's credentials consist of a former head of criminal healthcare fraud for the U.S. Department of Justice, former head of civil healthcare fraud enforcement for the Eastern District of Pennsylvania, two former heads of the Major Crimes Unit for the Southern District of New York, the former Assistant Solicitor General responsible for healthcare issues for the US government, and an array of accomplished former Assistant United States Attorneys and FDA litigation counsel. Our litigators are complemented by a team of sophisticated regulatory attorneys who focus on FDA, HHS-OIG, and CMS matters. This collaboration delivers sophisticated and integrated legal counseling and a comprehensive commitment to achieving a successful outcome. Our focus remains addressing our client's needs, always conscious that the ultimate goal is to avoid indictment, civil liability, exclusion, and adverse publicity.
We also routinely work with clients to develop proactive crises plans and procedures, and help them avoid future crises by conducting continuous improvement reviews to identify important gaps in controls relative to regulatory and compliance risks.
Pharmaceutical and Medical Device Industry Matters
- Represented leading pharmaceutical manufacturers in off-label promotion investigations and qui tams by the U.S. Department of Justice and U.S. Attorney's offices in Massachusetts, Pennsylvania, Illinois, Tennessee, Florida, and New Jersey.
- Served as lead counsel in civil, criminal and congressional investigations into adulteration of heparin active pharmaceutical ingredient in the Chinese supply chain, which resulted in recalls of heparin-based products throughout the United States.
- Routinely assist clients in managing recalls of drug and medical device products, including numerous recalls involving products presenting significant human health risks and intense government and media scrutiny.
- In the course of parallel criminal, civil, and administrative investigations involving a pharmaceutical product, we publicly filed First Amendment and statutory challenges to FDA's intended use regulations in federal court in Washington, D.C.
- Represented a major diagnostic manufacturer in five simultaneous inspections at its manufacturing facilities in the U.S. and Europe.
- Represented a medical device manufacturer in a major FDA enforcement challenge to the marketing of its new version of a product incorporating a wireless technology, ultimately resulting in the FDA dropping the enforcement challenge and issuing a guidance permitting continued marketing of the product.
- Defended a manufacturer of diagnostic and medical imaging systems in an ongoing government investigation of the company's product discounts.
- Conducted FCPA and Bribery Act internal investigations for a global biopharmaceutical company into issues surrounding the distribution of drugs and payments to physicians in several countries.
- Defended a biopharmaceutical company in state and federal litigation and governmental investigations by the FBI, HHS-OIG, and multiple US Attorney's Offices, involving alleged promotional violations and Medicare and Medicaid fraud.
- Represented senior pharmaceutical executives in FCPA investigations being conducted by the Fraud Section of the Criminal Division of the U.S. Department of Justice.
- Conducted in-depth FCPA internal investigations for pharmaceutical and medical device manufacturers.
Healthcare Industry Matters
- Represented a national healthcare consulting service in connection with the civil investigations of the company's emergency department operations in numerousqui tams centralized through multi-district litigation.
- Represented numerous companies in a state Medicaid investigations led by state Attorneys General in over 25 states.
- Represented physician practices in high-profile criminal and civil investigations, including qui tam litigation, in the Southern District of Florida, Central District of California, District of Maryland, and Eastern District of Virginia.
- Filed statutory injunction challenging HHS Secretary's authority to suspend federal Medicare payments.
- Counseled hospitals, large multi-specialty physician practices, smaller physician groups, individual physicians, multi-state physician practices, and medical societies and professional associations on federal anti-kickback and self-referral (Stark) laws, state fraud and abuse laws, and patient confidentiality.
- Conducted internal audits and defend companies in investigations and litigation regarding allegations of fraud and abuse laws.