NEWS

ポールヘイスティングス、米国FDAエンフォースメント及び調査専門弁護士2名を迎えFDA規制プラクティスを開設

August 05, 2020

Washington, D.C. — Paul Hastings LLP, a leading global law firm, announced today the launch of the firm’s FDA Regulatory practice, with the addition of highly regarded Food and Drug Administration (FDA) enforcement and investigations lawyers Nathan Sheers and Peter Lindsay. Sheers and Lindsay have joined the firm as partners in the Investigations and White Collar Defense practice, based in the Washington, D.C. office.

The launch of the firm’s FDA Regulatory practice is the second strategic expansion of the firm’s leading Life Sciences practice in the last two months, following the recent addition of veteran life sciences consultant BJ D’Avella and the establishment of the firm’s Life Sciences Consulting Group to create a one-stop shop for Life Sciences companies’ legal, compliance, and execution needs.

“Our life sciences clients face a complex compliance environment, and they want experienced counsel to help them navigate investigations and other regulatory scrutiny,” said Seth Zachary, Chair of Paul Hastings. “The addition of outstanding FDA enforcement lawyers like Nathan and Peter further strengthens the compliance, investigations, and government defense capabilities we offer our clients.”

“Paul Hastings’ tremendous growth story was very attractive to us,” said Sheers. “We are excited by the many opportunities we see at Paul Hastings to expand our practice and collaborate with our new colleagues.”

“We are especially impressed with how the firm has built up its Investigations and White Collar Defense practice over the past several years, and developed such depth when it comes to serving the full array of life sciences clients’ needs,” said Lindsay.

Sheers concentrates his practice on complex civil, criminal and administrative regulatory matters. He has conducted many sensitive internal corporate investigations involving allegations of fraud and abuse against various healthcare and pharmaceutical entities and has defended clients in related civil and criminal proceedings, including grand jury inquiries, whistleblower suits and employment matters. His practice also includes internal investigations and preparations for FDA inspections, the implementation of Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR), and adverse event and medical device reporting. He has represented clients before various federal district courts, Courts of Appeals and the U.S. Supreme Court, and has presented oral argument at both the trial and appellate levels.

Lindsay focuses his practice on food and drug law. He advises clients on a variety of FDA regulatory and enforcement issues, such as issues related to manufacturing (cGMPs/QSR) requirements and post-approval promotional practices. He has also been involved in government investigations and internal reviews of healthcare companies involving issues related to alleged violations of the Federal Food, Drug and Cosmetic Act, the federal Anti-Kickback Statute, the federal False Claims Act and other fraud and abuse provisions. In addition to enforcement-related matters, Lindsay has advised companies on public policy matters involving FDA regulated products and reimbursement issues associated with products covered under federal healthcare programs.  Like Sheers, Lindsay has a global regulatory practice.

The addition of Sheers and Lindsay continues Paul Hastings’ strong lateral growth across its global platform. Over the past 18 months, the firm has welcomed more than two dozen partners, including Investigations and White Collar Defense partners Tom Best, Matt Herrington and Jonathan Drimmer in Washington, D.C. and Shaun Wu in Hong Kong; Entertainment and Media Litigation partners Bo Pearl and Steven Marenberg in Century City; Employment Law partner Jeff Webb in Los Angeles; Privacy and Cybersecurity partner Aaron Charfoos in Chicago; and Antitrust and Competition partner Camille Paulhac and Investigations and White Collar Defense managing director Nicola Bonucci in Paris.

Paul Hastings’ interdisciplinary Life Sciences and Healthcare practice helps clients protect and enhance their value. The practice has partnered with more than half of the top 50 life sciences companies by market capitalization on high-stakes litigation, multi-faceted government compliance, investigations and enforcement issues, and complex cross-border transactions.

At Paul Hastings, our purpose is clear — to help our clients and people navigate new paths to growth. With a strong presence throughout Asia, Europe, Latin America, and the U.S., Paul Hastings is recognized as one of the world’s most innovative global law firms.