Products Litigation and Counseling

Companies regulated by the Food and Drug Administration (FDA) know that expertise and practical advice are critical to the bottom line. Goodwin’s experienced FDA practice, a key component of the firm’s Technology & Life Sciences team, provides strategic counseling and skillful advocacy to companies subject to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and related federal and state laws. 

Succeeding in the life sciences industry is as much about strategy and execution as it is about research and development. And with the breakneck pace of technology disrupting industries around the world, Goodwin’s depth of experience not only in the life sciences space, but also in collaboration with our technology, healthcare and private equity lawyers, makes our team exceptionally suited to address whatever the future brings. We partner with clients to embrace the promise and potential of innovation to make a profound and lasting impact.

Lawyers in our life sciences practice are deeply experienced in corporate governance, financing and M&A transactions, collaborations and licensing, regulatory matters, and intellectual property law. We understand the challenges of securing funding, safeguarding intellectual property, establishing partnerships, bringing new products to market, opening up new revenue streams, and protecting existing product lines. As part of our interdisciplinary approach, we collaborate with attorneys in our patent litigation, products litigation, privacy and cybersecurity, employment and tax practices to protect client interests and to advocate on their behalf.

With a full service team of highly experienced lawyers resident in key life sciences hubs, our team helps clients find the strategic paths that foster growth and minimize risk across all phases of the corporate life cycle. Motivated by the knowledge that the work that we do with you is improving people’s lives, we serve as an extension of your team so you can focus on your core business.

Over the past 25 years, Proposition 65 litigation has become a real threat to businesses providing goods and services in California. The potential costs faced by corporate defendants are high – massive civil penalties, mandatory warnings on their products and damage to a company’s brand. Many law firms can process Proposition 65 cases; very few can try them and win. Goodwin has quickly become preeminent among those few firms.

Pharmaceutical companies need experienced counsel to protect their regulatory interests. Goodwin’s FDA Litigation practice provides counsel, representation and strategic advice that covers all aspects of our clients’ interactions with the Food and Drug Administration. Our lawyers regularly advise clients on regulatory issues, engage with the FDA and other federal and state agencies through Citizen Petitions, comments, meetings and other petitioning, and represent drug manufacturers in Administrative Procedure Act challenges.