Biography

Pharmaceutical, biologic and medical device manufacturers 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, who utilize her ability to handle complex product liability litigation in state and federal court, at both the trial and appellate levels.  

In addition to her trial work, Kelly counsels clients on FDA regulatory compliance, including post-approval issues such as labeling changes, adverse event reporting, good manufacturing requirements and promotional activities. She also provides crisis management counseling on product recalls, government investigations and similar issues.

She recently helped generic drug manufacturer Perrigo Pharmaceuticals Company (Perrigo) avoid several multi-million dollar claims by convincing the Northern District of California that plaintiffs' state-law claims against the generic drug manufacturer were preempted under the federal FDCA.  The court's ruling has broad implications, because it is one of only two in the country to explicitly recognize the preemptive effect of federal FDA’s labeling requirements with respect to generic drug manufacturers, who are required to provide the exact labeling information used by the brand-name drug manufacturer — no less, but also no more.

In the past few years, Kelly 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. 

Kelly has authored more than 20 articles on legal topics relating to the defense of pharmaceutical and medical device companies in product liability litigation.  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, and preemption.

Affiliations, Activities and Accomplishments

Kelly is admitted to practice in California and Ohio.  She is a member and participant in the Defense Research Institute, California Bar Association and San Francisco Bar Association.  She was recently appointed to the State Bar's Committee on Appellate Courts.

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. 

In her spare time, she is finishing a Master's thesis on the use of biomarkers to detect and treat ovarian cancer.  She plans to obtain her Master's Degree in Environmental Health from Wright State University later this year.

Recent Presentations

• “Drug and Device Off-Label Promotion:  Avoid Becoming a Cautionary Tale,” Pilgrim Software Webinar, June 2010.
• “Social Networking:  Flash in the Pan or Here to Stay?”  Alameda County Bar Association, Feb. 2010.
• “A Prescription for Managing the Risk of Off-Label Activities,” Medmarc Insurance Company Webinar, Oct. 2009.
• “Strategies for Managing Liability & Risks Associated with Outsourcing Overseas,” Pilgrim Software Webinar, Feb. 2009.
• “Brand Companies at Risk for Products Manufactured by Generic Firms: California’s Conte v. Wyeth Decision,” FDANews’ RxTrials Institute, Webinar, Jan. 2009.
• “Managing Product Liability Risks Associate with Worker E-Mail and Blog Misuse,” People-on-the-Go, Webinar, 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. 

Recent Publications

• “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, (pending publication in an upcoming client alert).
• “Federal Court Rejects Brand-Name Drug Liability for Generic-Caused Injury,” Washington Legal Foundation's Counsel's Advisory (July 2009).
• “Preemption: Deliberations Continue,” Sedgwick's Issue Tracker (May 2009).
• “Oklahoma Court Rejects Conte and Concludes Innovators Not  Liable for Injuries Arising from Use of  Generic Competitors' Products,” in Sedgwick’s Drug & Medical Device Alert (Mar. 2009).
• “Preserving the Record for Appeal: Protecting Your Clients’ Interests as Well as Your Own,” Sedgwick University, San Francisco, CA (March 2009).
• “Risks Associated with Outsourcing in Less Regulated Markets,” White Paper for Medmarc Insurance Company, (January 2009).
• "California Court Finds Wyeth Liable for Injuries Arising from Use of Generic Drug,” in Sedgwick’s Drug & Medical Device Alert (November 2008).
• “Responsive Pleadings and Petitioner’s Reply,” in 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 (August 2008).

Education

Ms. Savage Day obtained her undergraduate degree from Ohio State University, where she graduated cum laude in the field of history.  She obtained her J.D., with honors, from Ohio Northern University, where she served as an associate editor for law review and as a member of a national moot court team.

In her spare time, she is finishing a Master's thesis on the use of biomarkers to detect and treat ovarian cancer.  She plans to obtain her Master's Degree in Environmental Health from Wright State University later this year.