Fern P. O'Brian

Practices

• Product Liability Litigation
• Business Litigation
• Life Sciences

Professional Experience

Fern is a partner in the firm's Product Liability Litigation, Business Litigation, International, and Life Sciences practice groups and the Washington, D.C. office chair of the Diversity and Inclusion Initiative. She focuses her practice on health effects litigation and regulatory matters involving product liability and toxic tort. She has litigated numerous cases involving medical and pharmaceutical products, consumer products, environmental exposures to heavy metals, chemicals, and tobacco, among others.

Fern also represents emerging technology companies and research organizations, including those developing and commercializing nanotechnology-enabled products. She represented Wyeth in "fen-phen" diet drug litigation. She served as national counsel for a major bloodbank in US AIDS and hepatitis C cases.

Fern regularly counsels clients on liability prevention, regulatory matters, and liability-related transactional issues, including due diligence. She also represents companies in the homeland security and biodefense areas; recently she advised a private research and university consortium in pursuing a bid for a national bioterror research laboratory.

Fern is a frequent author and speaker on product liability and mass tort issues such as class actions, admissibility of expert evidence, and product liability prevention. Prior to private practice, she served as a law clerk to former Circuit Judge Kenneth W. Starr of the US Court of Appeals for the District of Columbia Circuit.

Fern is admitted to practice in the District of Columbia, the Commonwealth of Virginia, the United States District Court for the District of Columbia, United States District Court for the Eastern District of Virginia, United States District Court for the Western District of Virginia, United States District Court for the District of Maryland, United States Court of Appeals for the District of Columbia Circuit, District of Columbia Court of Appeals, and the United States Court of Appeals for the Fourth Circuit.

Education

• Georgetown University Law Center, J.D., 1983
• University of North Carolina at Chapel Hill, B.A., 1978

• Represented a consortium of private research and university institutions in site selection proceeding for a national bioterror research laboratory
• Advised major government contractor on product liability risks associated with security screening products used in military and civilian installations
• Represented major children's furniture manufacturer on Consumer Protection Safety Commission (CPSC) recall and related product liability litigation
• Advise consumer product manufacturers on business and regulatory impacts of legislative proposals
• Advise medical device company on clinical trial and related regulatory issues
• Defense of Wyeth in its diet drug litigation
• National counsel for a major blood bank in successful defense of AIDS, hepatitis C, and other transfusion transmitted disease cases
• Lead counsel in defense of FORTUNE 100 energy company in toxic tort suit involving exposure to lead, arsenic, and cadmium
• Successful defense of global telecommunications device manufacturer in suits alleging personal injury
• Advised on regulatory and product liability issues in numerous transactions, including US$5 billion acquisition of a pharmaceutical company, a US$1 billion licensing transaction, numerous medical device companies, and consumer product companies
• Advised on CPSC recalls and related regulatory proceedings for major outdoor furniture manufacturer
• Advised major food, medical device, luxury goods, and beverages manufacturers on product liability prevention issues

• "Green Products Update: California Proposes New Green Chemistry Regulations" · Thompson Hine Product Liability Alert, November 17, 2011
• "Sweeping Overhaul of FDA Regulation of Food Industry Promises New Challenges" · HCLL News, January 2011
• "An Overview of Evolving U.S. and International Nanotechnology Regulation" · Chapter in Cambridge University Press The Nanotechnology Challenge, 2011
• "Settlement Issues under the Class Action Fairness Act" · Chapter in Settlement Agreements in Commercial Disputes: Negotiating Drafting and Enforcement, R. Rosen, Ed., 2011
• "The Class Action Fairness Act of 2005: Where Have We Been and Where Do We Go From Here?" · Class Action Litigation Report, February 2007
• "Medical Technology Multinationals and the US - Navigating the Regulatory Framework" · Practical Law Company's Cross-Border Life Sciences Handbook, 2006/07
• "Trial and Error: The Rise of Litigation in Clinical Trials" · Pharmaceutical Visions, Autumn 2000

• Moderator: "The Politics of Food," FDLI Food Week; February 5, 2013
• FDA Regulatory Update, 2nd Annual "Cancer Immunotherapy: A Long-Awaited Reality" Conference, New York, NY, October 6, 2011
• "Regulating Tiny Technology: Preparing for Big Impacts on Innovation and Commercialization", 10th Annual NanoBusiness/Nanomanufacturing Summit 2011 , Boston, MA, September 25, 2011
• "Product Liability Recalls on the Rise: Legal Strategies - Preparing for Recalls, Defending Litigation and Leveraging Case Developments", Strafford Webinar, September 13, 2011
• "Nanotechnology and the Cosmetics Industry: Navigating the Regulatory Maze", Personal Care Products Council Legal and Regulatory Meeting - San Francisco, May 18, 2011
• Presentation: "Minimizing Potential Products Liability Risks from Drug and Device Recalls" at the American Conference Institute's Summit on Drug & Device Product Recalls, Philadelphia, PA, March 22, 2011
• "NanoEngineered Products: EH&S Risk Prevention in an Evolving Regulatory Environment", NanoBusiness Alliance Meeting - Chicago, IL, September 28, 2010
• Chair, Searle Civil Justice Institute Board of Overseers Meeting, Washington, DC, October 28, 2010
• Webinar: Chinese Product Recalls, ACI, February 23, 2010
• "Terrorism, Crime & Business Symposium", St. Mary's University School of Law, Center for Terrorism Law, Houston, Texas, April 30-May 1, 2009
• Panel Moderator: "Green Buildings and Advanced Technology Infrastructure", Fourth Annual Axiom Capital Management Livingston Nanotechnology Conference, Marriott Financial Center, New York, NY, December 8, 2008
• "CAFA & Consequences: Measuring the Impact of the Class Action Fairness Act of 2005", 12th Annual National Institute on Class Actions, November 7, 2008
• "1st Annual Conference on Nanotechnology Law, Regulation and Policy", The Food and Drug Law Institute, Washington, DC, February 28-29, 2008
• "Developing Homeland Security Technologies: Understanding and Reducing Associated Product Liability Risk (SAFETY Act and Beyond)", Hilton Washington, DC/North Gaithersburg, February 26, 2008
• "CAFA Removal Trends", Strafford Teleconference, February 19, 2008
• Presentation: "Deal Maker or Deal Breaker: Best Practices in Regulatory, IP, and Product Liability Due Diligence", AdvaMed 2007, Washington, DC, October 1, 2007
• Presentation: "Daubert v. Frye in the States: Does the Standard Make a Difference?", American Enterprise Institute/Brookings Institute Joint Center for Regulatory Studies, June 2007
• Presentation: "Nanotechnology", CTFA Legal and Regulatory Meeting, April 2007
• Presentation: "Product Liability for Off-Label Promotion of Medical Devices", CBI Medical Device and Diagnostics Marketing Compliance Congress, April 2005
• Panel: "Analyzing Risks, Anticipating Threats and Avoiding Disputes", Drug & Medical Device Litigation Conference, March 1-2, 2005

• Euromoney/LMG Life Sciences, Life Sciences Star, 2012
• NanoBusiness Commercialization Association's Most Influential Nanotechnology Leaders, 2011
• Recommended in the PLC Life Sciences Multi-Jurisdictional Guide, 2011
• Recommended in the PLC Cross-border Life Sciences Handbook
• Recommended in the Guide to the World's Leading Product Liability Lawyers, 2010
• Recommended in The Legal Media Group's Guide to the World's Leading Product Liability Lawyers; 2009
• Recommended in PLC Which lawyer? Yearbook 2009 for Life sciences: Product Liability