John R. Manthei > Latham & Watkins LLP > Houston, United States > Lawyer Profile

Latham & Watkins LLP
811 MAIN STREET, SUITE 3700
HOUSTON, TX 77002
TEXAS
United States

Position

John Manthei, Global Chair of the Healthcare & Life Sciences Practice, focuses his practice on regulatory matters involving the US Food and Drug Administration (FDA) for the medical device, pharmaceutical, and biotechnology industries.

John’s practice includes assisting clients with all aspects of the FDA-regulated product life cycle, including, among others:

    • Pre-market development
    • FDA product submissions
    • Development of market exclusivity strategies
    • Drafting and negotiation of both US and international clinical trial agreements
    • FDA and Federal Trade Commission (FTC) regulation of marketing and promotion of products
    • Quality System Regulation and Good Manufacturing Practice requirements (including assisting in third-party audits and drafting SOPs)
    • FDA inspections
    • Product market withdrawals and recalls
    • FDA and DEA export and import requirements
    • Civil and criminal compliance and enforcement

John has also been involved extensively in Administrative Procedure Act litigation, including successfully challenging the Agency in Catalyst Pharmaceuticals v. FDA, Eagle Pharmaceuticals v. FDA, Pacira Pharmaceuticals v. FDA, Endo/Par Pharmaceuticals v. FDA, Genus Medical Technologies v. FDA, Sottera/NJOY v. FDA, Commonwealth v. FDA, and Fontem v. FDA, as well as successfully intervening to defend FDA actions on behalf of clients in Jazz Pharmaceuticals v. FDATeva v. FDAWeyth Pharmaceuticals v. FDA, and Athenex v. FDA.

In addition, John regularly advises investment banks, and private equity funds in life sciences company investments and corporate transactions.

Lawyer Rankings

United States > Healthcare > Life sciences

(Hall of Fame)

John Manthei – Latham & Watkins LLP

Latham & Watkins LLP’s client base ranges from globally recognized life sciences businesses to biopharma and biotech start-ups. The busy practice is active across a range of life sciences industry sectors, from pharmaceuticals and biotechnology to cosmeceuticals and food tech. The team’s key areas of activity include complex corporate transactions such as M&A, with experts including Julie Scallen. Also on the transactional side, Shayne Kennedy focuses on capital markets along with Matthew Bush and Nathan Ajiashvili, while Cheston Larson advises on financing. Through its development of licensing structures and facilitation of commercial transactions, the team has been active in the funding of drug development and commercialization. The firm also handles litigation matters such as IP disputes, counting on experts such as Arlene Chow, as well as regulatory and legislative strategies; Ben Haas is a key figure in the latter. Among the practice’s key figures are also John Manthei and Elizabeth M. Richards, both experts in FDA regulatory matters, and Terra Reynolds, in white-collar defense and investigations. In 2024, litigation and regulatory specialists Jennifer L. Bragg and William McConagha joined the practice from Skadden, Arps, Slate, Meagher & Flom LLP, and in April 2025, Kate Hillier  joined from Cooley LLP.

United States > Healthcare > Health insurers

The interdisciplinary team at Latham & Watkins LLP flexes its muscles across regulatory, transactional, and contentious healthcare law matters, notably representing some of the country’s most prominent health insurance carriers in high-stakes litigation. The group is led by a DC trio of John Manthei, Ben Haas, and Jason Caron, and Chicago-based partner Terra Reynolds. The department has experience handling M&A and large-scale transactions in the healthcare space, managing lawsuits regarding Medicare Advantage regulation, and supporting clients facing government agency investigations and disputes, in addition to a range of other matters. Former General Counsel of the United States Department of Health and Human Services Daniel Meron contributes deep regulatory and investigatory expertise to the practice, and David Tolley assists insurers facing government investigations as well as representing them in court.

United States > Healthcare > Service providers

Primarily based in Washington DC, the practice at Latham & Watkins LLP stands out for its strength in healthcare private equity transactions, healthcare system bankruptcies, and 340B program issues. John Manthei, Ben Haas, Jason Caron, and Terra Reynolds jointly lead the practice. Caron often advises health systems and private investors on affiliations, public mergers, and joint ventures, and California’s Heather Deixler is well-known for her deep knowledge of genetic and de-identified data and its use in compliance with HIPAA and HITECH. In Chicago, Reynolds is noted for handling white-collar crime issues within the healthcare sector. Joseph Hudzik is a key contact for healthcare fraud and abuse compliance work. David Tolley works out of the Boston office, and regularly represents insurers, hospital systems, and pharmacy benefit managers in FCA and AKS investigations and disputes.