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BakerHostetler Grows FDA Practice in Washington, D.C.



4/17/2013 10:37:26 AM

Washington, D.C., April 17, 2013 — BakerHostetler announced today that Lance L. Shea has joined the firm as a Partner in its Washington, D.C., office. Shea will serve as the national team leader of the firm’s Food and Drug Administration practice. Shea joins BakerHostetler from Fulbright & Jaworski L.L.P.

Shea brings decades of experience representing life science companies in complex regulatory and litigation matters. With leadership in advocacy of scientific information and evidence, he represents clients in the pharmaceutical, medical device and other industries regulated by agencies such as the FDA and EPA. In the regulatory space, Shea recently advised a drug company on assessment of safety signals for a prescription product, a food facility on preparation for a cGMP inspection, a medical device company on efficacy and safety positions based on epidemiology studies of competing products, and a drug company on comments to draft bioequivalence guidance. In his litigation practice he recently represented a drug company in a nationwide docket of products liability cases, as well as a drug/device company on breach of contract litigation.

“We are excited to welcome Lance as the new chair of our national FDA practice,” said Jeffrey H. Paravano, managing partner of BakerHostetler’s Washington D.C. office. “Lance represents the rare combination of an attorney who can strategically navigate regulatory compliance and litigation while maintaining a highly technical understanding of the science behind our clients’ products.”

Shea’s practice focuses on the development, interpretation and advocacy of efficacy, safety and regulatory science issues. He regularly appears in front of the FDA, EPA and other federal and state level regulatory agencies. Shea’s success in front of these boards comes from his ability to craft innovative and highly technical arguments based on the interpretation of scientific information. His litigation practice includes experience with lawsuits ranging in size from single-plaintiff cases to nationwide actions. He has also led the development and litigation of scientific evidence in nationwide pharmaceutical injury dockets.

“BakerHostetler represents the opportunity for me to bring a strong FDA element to the firm’s life science clients,” said Shea. “I look forward to growing our capabilities in the space and helping our clients successfully resolve their bet-the-company compliance matters.”

Shea is an Adjunct Professor at the University of Maryland Francis King Carey School of Law where he teaches litigation and regulatory scientific evidence. In 2012, Shea was named one of “Washington D.C. & Baltimore's Top Rated Lawyers," by LexisNexis Martindale-Hubbell. He is a frequent writer and speaker at FDA conferences, including the annual conference of the Food & Drug Law Institute. He is past chair of the Food & Drug Law Institute’s Monograph committee.

Shea holds a J.D. (magna cum laude) from the University of San Diego School of Law, and a M.S. in Health Science and B.S. (with distinction) from Arizona State University. While at San Diego School of Law, he was the Editor-in-Chief of the San Diego Law Review.

About BakerHostetler

BakerHostetler is among the nation's 100 largest law firms with more than 800 attorneys coast to coast, delivering the highest quality legal counsel on the most complex and critical issues facing clients today. The firm has offices in Chicago, Cincinnati, Cleveland, Columbus, Costa Mesa, Denver, Houston, Los Angeles, New York, Orlando and Washington, D.C. Its five primary practice groups are Business, Employment, Intellectual Property, Litigation and Tax. For more information, visit www.bakerlaw.com


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