Biography

Fortune 500 clients rely on Kelly Savage Day for her industry knowledge, aggressive advocacy, and practical advice. She has served as national, regional and state counsel for a variety of clients in the computer, automotive, pharmaceutical, biologic and medical device industries, who utilize her ability to handle complex commercial litigation in state and federal court, at both the trial and appellate levels.  

In addition to her trial work, Kelly counsels clients in heavily regulated industries on regulatory compliance issues, including labeling changes, adverse event monitoring and reporting, current good manufacturing practices and promotional activities. She also provides crisis management counseling on product recalls, government investigations and similar issues.

Over the past decade, Kelly has been the primary architect of winning arguments to help define the scope of the duty to warn of product hazards in the automotive and pharmaceutical industries.  In 2011, she helped generic drug manufacturer Perrigo Pharmaceuticals Company avoid several multi-million dollar claims by convincing the United States Supreme Court to vacate the Ninth Circuit’s decision that plaintiffs' state-law claims against the generic drug manufacturer were not preempted under the federal FDCA.  The court's ruling has broad implications, because it is the first to explicitly recognize the preemptive effect of federal FDA’s labeling requirements with respect to generic OTC drug manufacturers.

In the past few years, Kelly also saved an international pharmaceutical company from hundreds of thousands of dollars in attorney's fees by persuading a trial court to dismiss a class-action complaint filed by plaintiffs claiming the brand-name company's warnings on prescription and OTC products violated California's Proposition 65 and the UCL.  She also rescued a small local business from bankruptcy by persuading the California Court of Appeals to vacate a $1.7 million judgment in a high-profile employment case featured on both The Oprah Winfrey Show and Today Show.  In both instances, she worked closely with clients to control legal expenses and prevent wasteful and unnecessary activity. 

In addition, Kelly’s various articles on preemption, product liability, crisis management and appellate strategy have been cited in The Wall Street Journal, Corporate Counsel, Forbes and numerous blogs.  As a leading authority in the field, she is often interviewed by and quoted in the national media. She has appeared in Forbes, The Wall Street Journal and numerous trade publications as an expert on generic drugs, product liability issues, recalls, social media and preemption.

Affiliations, Activities and Accomplishments

Kelly is an AV-rated, 2011 Northern California Super Lawyer® Rising Star admitted to practice in California, Ohio and the U.S. Supreme Court. She is one of California’s Women in the Law Seminar Marketing Representatives for the Defense Research Institute, and she has been appointed to the California Bar Association’s Committee on Appellate Courts as well.  Additionally, she is a member of the American Bar and San Francisco Bar Associations. 

Kelly is a former state appellate and federal district court law clerk.  She is a contributing editor to one of the preeminent California appellate practice guides and frequently offers presentations on the defense of pharmaceutical, biologic and medical device product liability litigation.  Kelly was recently selected as one of a handful of 2012 Residence Writers for Ms. JD.

Representative Presentations

 “The FDA and Social Media:  Going Digital,”  FX Conferences, Oct. 2011.
 “Product Liability Recalls on the Rise: Legal Strategies - Preparing for Recalls, Defending Litigation and Leveraging Case Developments,” Strafford Publications, Sept. 2011.
 “Navigating the Life Science Claims Minefield” Wells Fargo Insurance Services Life Science Practice Seminar,
 June 2011.
 “The FDA and Social Media,” FX Conferences, Mar. 2011.
 “Being ‘Recall Ready’: Taking Proactive Steps for Crisis Avoidance,” American Conference Institute’s Summit on Drug and Device Product Recalls, Mar. 2011.
 “Preserving the Record for Appeal: The Importance of Jury Charge,” Sedgwick University, Dec. 2010.
 “Managing Life Science Risks and Opportunities from Social Media,” Berkley Life Science Policy Seminar, Nov. 2010.
 “Drug and Device Off-Label Promotion:  Avoid Becoming a Cautionary Tale,” Pilgrim Software Seminar, June 2010.
  “A Prescription for Managing the Risk of Off-Label Activities,” Medmarc Insurance Company Seminar, Oct. 2009.
 “Strategies for Managing Liability & Risks Associated with Outsourcing Overseas,” Pilgrim Software Seminar, Feb. 2009.
  “Brand Companies at Risk for Products Manufactured by Generic Firms: California’s Conte v. Wyeth Decision,” FDANews’ RxTrials Institute Seminar, Jan. 2009.
 “Managing Product Liability Risks Associate with Worker E-Mail and Blog Misuse,” People-on-the-Go, Seminar, Dec. 2008.
 “Managing the Risk of Worker E-Mail and Blog Misuse,” Northern California Human Resources Association, Oakland, California, Sept. 2008.
 “Preempting Product Liability Claims Against Generic Drug Manufacturers,” Medmarc Insurance Company, Chantilly, Virginia, July 11, 2008.
 “Wits and Writs, Rights and Wrongs,” The Bar Association of San Francisco, Appellate Section, Jan. 29, 2007.

Representative Publications

 “So Much for Summer Lovin’:  Citizen Group Asks FDA to Change Regulations for Generic Drug Manufacturers So that they are Liable for Failures to Warn,”  Sedgwick’s Generic Drug Law Update (Oct. 2011).
 “From the Experts:  Brave New (Post-Mensing) World, Corporate Counsel (Aug. 2011).
 “Supreme Court Sides with Vaccine Manufacturers; State-Law Design Defect Claims Preempted,” Sedgwick’s Pharmaceutical Law Update (Mar. 2011).
 “Justice Kagan and the Future of Generic Drug Preemption:  U.S. Supreme Court Will Decide Fate of Preemption Defense for Generic Companies This Term,” Sedgwick’s Generic Drug Law Update (Feb. 2011).
 “Supreme Court Prepares to Hear Pivotal Generic Drug Preemption Cases,” FDA Week (Dec. 2010).
 "Preemption of State-Law Tort Claims: Change of Heart in Federal Agencies?" The Legal Pulse (Oct. 2010).
 “Continuing Viability of Preemption Defense for Generic Drug Manufacturers Remains Unclear,” Sedgwick’s Generic Drug Law Update (July 2010).
  “More Musings on Mensing—Will Conte Rear Its Ugly Head if Claims Against Generic Drug Companies Are Preempted,” The Wall Street Journal (May 2010).
 “Generic Drugs and Preemption in the Wake of Wyeth v. Levine,” WLF Legal Backgrounder (May 2010).
 “Managing Risks Associated with Off-Label Promotion of Pharmaceuticals,” IADC Committee Newsletter (Apr. 2010).
 Guest Contributor, Drug and Device Law blog.
 Contributor, Sedgwick’s Appellate Strategist blog.
 "A Prescription for Managing the Risks of Off-Label Activities," white paper for Medmarc Insurance Company, (Oct. 2009).
 “Federal Court Rejects Brand-Name Drug Liability for Generic-Caused Injury,” Washington Legal Foundation's Counsel's Advisory (July 2009).
 “Preemption: Deliberations Continue,” Sedgwick Issue Tracker (May 2009).
 “Oklahoma Court Rejects Conte and Concludes Innovators Not Liable for Injuries Arising from Use of Generic Competitors' Products,” Sedgwick’s Drug & Medical Device Alert (Mar. 2009).
 “Risks Associated with Outsourcing in Less Regulated Markets,” White Paper for Medmarc Insurance Company, (Jan. 2009).
 “California Court Finds Wyeth Liable for Injuries Arising from Use of Generic Drug,” Sedgwick’s Drug & Medical Device Alert (Nov. 2008).
 “Responsive Pleadings and Petitioner’s Reply,”  California Civil Writ Practice 185 (Continuing Education of the Bar, 4th ed. 2008).
 “Has California Provided a New-End Run around Preemption,” 18 Washington Legal Foundation 8 (May  2008).
 Co-author, “Extraterritoriality and Punitive Damages:  Setting Limits on California’s Ability to Punish Defendants for Out-of-State Conduct,” The Recorder (Aug. 2008).