Brad Welsh

Associate

Clients turn to Brad as a trusted advisor. Brad advises and represents clients in regulated industries, with a predominant focus on life sciences and healthcare. His practices consist of product liability litigation defense and commercial contracting and commercial operating advice. As a litigator, Brad has successfully defended complex mass tort claims. As a commercial advisor, he leverages his in-depth knowledge of the life sciences industry to lead complex commercial contracting initiatives.  Brad provides practical advice to small and mid-size companies aimed at achieving business objectives while minimizing legal risk and ensuring compliance with a variety of complex legal and regulatory obligations including but not limited to the Food, Drug, and Cosmetic Act; federal and state false claims acts; federal and state anti-kickback statutes; Foreign Corrupt Practices Act; Stark Law; Open Payments provision of the PPACA; state drug price transparency reporting requirements and the Lanham Act.

Prior to joining Kendall Law, Brad served as in-house counsel at a small pharmaceutical company where he helped to successfully commercialize the company’s first U.S. product. Working for an emerging company afforded Brad the ability to be involved in all aspects of commercial operations.  Brad has first-hand experience solving the complex legal, regulatory, and compliance problems faced by emerging companies. 

Brad graduated, cum laude, from Temple University Beasley School of Law in 2013. While in law school, Brad acted as a Research Editor for the Temple Journal of Science, Technology, and Environmental Law.  He also served as a judicial intern for the Honorable Timothy J. Savage of the Eastern District of Pennsylvania. He is admitted to practice law in the Commonwealth of Pennsylvania and the State of New Jersey. Prior to his legal career, Brad obtained a graduate degree in Forensic Science and prior to that, he obtained his Bachelor of Science degree in Chemistry and worked as a chemist at a leading chemical manufacturer. 

NOTABLE REPRESENTATIONS:

Litigation

• Representation of an international pharmaceutical company in nationwide product liability claims related to MRI contrast dyes.
  • Successfully excluded all of Plaintiff’s general causation expert testimony resulting in complete summary judgement for our client and resulting in the voluntary dismissal of almost all additional cases nationwide. Davis v. McKesson Corp., No. CV-18-1157-PHX-DGC, 2019 WL 3532179 (D. Ariz. Aug. 2, 2019).
  • Successfully opposed Plaintiff’s petition to create Multi-District Litigation (MDL). In re Linear Gadolinium-Based Contrast Agents Prod. Liab. Litig., 341 F.Supp.3d 1381 (U.S. Jud. Pan. Mult. Lit. 2018).

Commercial Contracting

• Manufacturing and Development
  • Representation of manufacturers and contract manufacturers (“CMOs”) in the drafting and negotiation of complex supply and manufacturing agreements.
  • Representation of contract development organizations (“CDOs”) in the negotiation and execution of product development agreements.
  • Advising manufacturers in the execution of clinical trial agreements and investigator-initiated study agreements (“IIS”).
• Distribution and Reimbursement
  • Representation of manufacturers in the negotiation of exclusive third-party logistics provider (“3PL”) agreements.
  • Advising manufacturers in the negotiation of wholesale distribution/service agreements, including against the Big Three wholesalers.
  • Representation of manufacturers in the negotiation of product rebate and reimbursement agreements with Pharmaceutical Benefit Managers (“PBMs”), Group Purchasing Organizations (“GPOs”) and other purchasing entities.
• Mergers and Acquisitions
  • Performing due diligence regarding commercial contracting strategies as part of asset purchase agreements.

Life Sciences Specific Business Operations / Regulatory Compliance

• Advising clients on State Level Drug Price Increase Transparency Reporting Obligations and assisting clients with the compilation and submission of necessary transparency reports.
• Representation of a pharmaceutical manufacturer undergoing a Department of Veterans Affairs (“VA”) Office of Inspector General (“OIG”) audit related to drug price reporting practices.
• Assisting clients with the development of responses to FDA Untitled Letters, Warning Letters, and Letters of Inquiry, including those from the Office of Prescription Drug Promotion (“OPDP”).
• Serving as the legal subject matter expert on various client promotional review committees (‘PRC”) or product review teams (“PRT”).
• Counseling pharmaceutical manufacturers on regulatory pathways related to pharmaceutical label changes and potential product liability impact related thereto.
• Counseling clients, based on specific business operations, of the applicability of state-specific pharmaceutical and medical device manufacturer and distributor licensure and permit requirements.
• Designing and conducting compliance investigations.
• Developing processes and procedures designed to allow small start-up life sciences companies to comply with various nuanced regulatory frameworks, including the Open Payments reporting requirements of the Patient Protection and Affordable Care Act and analogous state-specific requirements; various state-specific healthcare gift bans; and the Prescription Drug Marketing Act (“PDMA”) with respect to the provision of drug samples.

Publications

• Jamie Kendall, Brad Welsh & Paul DeVastey, FDA Preemption and Albrecht’s Progeny, 76 Food and Drug L.J. 579 (2022).