APA Litigation

Sometimes, litigation is inevitable. Either it is the last and best option to challenge an incorrect FDA decision, or it is a competitor’s last and best option. In either case, a company may decide it makes sense to bring an APA lawsuit against FDA or intervene in a competitor’s APA lawsuit to help defend FDA’s decision.

Lawsuits can be tricky. FDA invariably seeks to have APA lawsuits dismissed based upon technicalities: failure to exhaust administrative remedies; lack of “ripeness”; no “final agency action”; or no standing. Thus, the actions a company takes before filing a lawsuit often are just as important, if not more so, as the strategies employed during the lawsuit itself.

FDA Litigation Expertise

Scott Lassman has extensive experience – and an impressive record of success – litigating APA cases against FDA. He has obtained preliminary and permanent injunctive relief for clients in a broad range of cases, including patent certification requirements, exclusivity, 505(b)(2) applications, product jurisdiction, product approval, enforcement discretion, and user fees. He also has helped clients intervene in lawsuits brought by competitors to successfully defend FDA decisions on issues such as pediatric exclusivity, 180-day exclusivity, and Freedom of Information Act (FOIA) requests. Scott has served both as first chair, successfully arguing motions for preliminary injunction and summary judgment, and as the designated FDA expert on litigation teams (including litigation teams with other law firms).

Many of Scott’s cases break new ground and become recognized precedent. For example, the Bracco Diagnostics case, a product jurisdiction case in which Scott represented the named plaintiff, is regularly cited for the proposition that federal agencies must treat similarly situated parties in a similar manner. Scott believes creativity, strategic thinking and determination are key ingredients to successful litigation against, or in support of, FDA.

You are invited to contact Lassman Law+Policy for more information on the firm's counsel and advocacy in APA litigation involving the FDA.

Scott Lassman

Scott M. Lassman's Profile Image
Scott Lassman has nearly 30 years’ experience in FDA law and policy, both as an in-house attorney and in private practice. He provides strategic advice and advocacy to small, mid-size and large pharmaceutical, biotechnology and medical device companies, as well as the trade associations that represent them and the investors who fund them. His practice covers all aspects of FDA regulatory law, with a special focus on exclusivity, biosimilars, product approval and policy matters...

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