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Jim is a member of the Life Sciences Health Industry Group, practicing in the area of product liability litigation.  For more than 35 years, Jim has focused on the representation of manufacturers of prescription medicines and medical devices. His practice has involved representing and counseling manufacturers of prescription products involving a variety of issues.  These have included recalls of prescription products, marketing and promotion of these products, first amendment issues in marketing these products, off-label issues, preemption, product liability issues and the reuse of single use medical devices.

Based upon this experience, Jim co-authored a book with his partner Areta Kupchyk titled Recalls of Prescription Products: A Proactive Primer which details planning for and implementing the recall process for all regulated products. He served on a task force seeking to develop a national policy for the development of and liability protection for vaccines.

He has served as regional counsel for an international medical device company in a product liability action and was the multi-district litigation liaison counsel in the Gammagard® MDL litigation.

Jim's practice has given rise to a number of landmark decisions involving prescription products, medicines, devices and vaccines, including:

• Kelly Morson v. The Superior Court, 90 Cal. App. 4th 775, 109 Cal. Rptr. 2d 343, holding that the consumer expectations test could not be applied to claims in which users of medial devices such as natural rubber latex gloves alleged that the regulated device contained chemical substances that were of a toxic nature, and that exposure to the device had caused users' harm;
• Boaz, et al. v. Boyle & Company, Inc., et al., 40 Cal. App. 4th 700 (1995). The California Court of Appeal affirmed the dismissal of personal injury claims brought against pharmaceutical manufacturers on grounds of forum non conveniens, even though the non-resident plaintiffs could not recover under any legal theory in their resident states;
• Brown v. Superior Court, 44 Cal. 3d 1049 (1988), refusing to apply strict liability to measure a manufacturer’s liability for injuries because of the public’s interest in the development, availability and reasonable price of prescription drugs;
• Jolly v. Eli Lilly and Company, 44 Cal. 3d 1103 (1988), defining the issue of when the statute of limitations begins to run for an injury arising from the use of a pharmaceutical;
• Sheffield v. Abbott Laboratories, 144 Cal. App. 3d 583 (1983), refusing to extend the Sindell market share theory of liability to the Salk polio vaccine;
• Sindell v. Abbott Laboratories, 26 Cal. 3d 588 (1980), creating the market share theory of liability;
• McCreery v. Eli Lilly and Company, 87 Cal. App. 3d 77 (1978). The California Court of Appeal held that the plaintiff could not maintain a strict liability action against a pharmaceutical manufacturer where she was unable to identify the specific manufacturer of the product.

Jim is listed in The Product Liability Expert Guide, the inaugural issue of Who's Who Legal – Product Liability Lawyers 2010 and the 3rd Edition of The Guide to the World's Leading Product Liability Lawyers. For the sixth consecutive year, he also has been listed in The International Who's Who of Business Lawyers 2010 and Northern California Super Lawyers 2010. In 2006, Jim was the recipient of the Hero Award from the AIDS Legal Referral Panel for having donated 'extraordinary amounts of time and expertise to protect the legal rights of Bay Area residents living with HIV and AIDS.'

In 2010, Jim was named a finalist for Reed Smith's Sean Halpin Award for his representation of a recreational pilot whose HIV status was wrongfully disclosed by the government in a post-September 11 initiative called Operation Safe Pilot. The Sean Halpin Award was established by the firm to honor Sean Halpin, an outstanding young partner in its Philadelphia office who died in 2004.  A recipient is selected annually by the Reed Smith Pro Bono Committee from nominees who have made significant pro bono or other community service contributions during the previous year. In 2008, Jim was also a finalist for the award as a co-team leader of a group of attorneys who represented California's public school children with diabetes in litigation to ensure that they received care for their condition while in school.  Due to his tireless efforts in this matter, Jim was recognized by the California Lawyer "Angel Awards" in 2007 as one of the state's outstanding Pro Bono attorneys.  In 2006, Jim was named as the winner of the Sean Halpin award for his outstanding Pro Bono accomplishments.  Jim was also named "Attorney of the Year" by the San Francisco AIDS Legal Referral Panel in 2006.

Publications

• Co-author, FDLI Monograph Series, Volume 1, Number 4, International Prescription Product Recalls: A Practical Guide (2010)
• Co-author, "Five Year Review of Class I Medical Device Recalls: 2004-2008," FDLI's Food and Drug Law Journal, Volume 64, Number 4 (Winter 2009)
• Contributor, 2009 Supplement to the ABA Health Law Section's Pharmaceutical Law: Regulation of Research, Development and Marketing
• Co-author, "A Review of State Law Modifying the Collateral Source Rule: Seeking Greater Fairness in Economic Damages Awards," IADC's Defense Counsel Journal, January 2009.
• Co-author, "Appeals Court Ruling Heightens Anticipation On State Drug Suit Preemption," Washington Legal Foundation, July 11, 2008.
• Contributor, 2008 Supplement to the ABA Health Law Section's Pharmaceutical Law: Regulation of Research, Development and Marketing
• Co-Author, "The Selection of a Transferee Court for MDL," with Monique Hunt McWilliams and Delaney Anderson, DRI's For The Defense, November 2007.
• Co-author, “Liability for Failure to Recall: Most Courts Refuse to Recognize,” with Jason Maxwell, DRI's Rx For the Defense, Summer 2007.
• Co-author, "Recall of Prescription Products: A Proactive Primer," Food and Drug Law Institute, 2nd Edition (2007).
• "Courts Give Mixed Reviews To Preemption Policy In 2006 FDA Labeling Rule," Washington Legal Foundation, January 2007.
• “Liability and Evidentiary Issues Involving Prescription Product Recalls,” IADC’s Defense Counsel Journal, January 2007.
• “Hoarding Away Science: Towards a More Transparent View of Health and Online Registries for Independent Postmarket Drug Research,” Food and Drug Law Journal, 2005.
• “UCC Does not Apply to Structured Settlement of Tort Claim,” FDLI Update, January/February 2006.
• “Product Liability Protection for Stem Cell Research and Therapies – A Proposal,” The Health Lawyer, The ABA Health Law Section, October 2005, reprinted in Australian Product Liability Reporter, November/December 2005 and January 2006.
• “California’s Improper Reach on Prescription Product Marketing – A Disincentive to Develop Life-Saving Therapies,” FDLI Update, March/April 2005.
• “Tax on Dissemination of Drug Information Tramples First Amendment,” San Francisco Daily Journal, February 21, 2005.
• “Congress Should Encourage, Not Impede, Development of Vaccines,” Forum Column, San Francisco Daily Journal, October 22, 2004.
• “Stem Cell Research Ballot Initiative Tried,” San Mateo County Medical Association, April 2004.
• “Discovery of Pathology Evidence, a Primer,” For the Defense, December 2003.
• “Case Alert - Cryolife v. Superior Court,” FDLI Update, November/December 2003.
• "Project Bio Shield: A New Opportunity for Prescription Product Manufacturers," FDLI Update, May/June 2003.
• “Dot.Com Medicine” – Labeling in an Internet Age,” with Howard L. Dorfman, Food and Drug Law Journal, Vol. 56, No. 2 (2001).
• "Reuser Friendly – A Review of the Regulation of and Product Liability Regarding the Reuse of Single Use Medical Devices," August 6, 2001, with Ginger F. Heyman, Tort & Insurance Law Journal (2001).
• Contributing Author to ABA “Fifty State Survey of FDCA-Related Tort Causes of Action – A Report of the Pharmaceuticals and Biologicals Subcommittee – Products Liability Committee,” (2001).
• “The Judicial Coordination of Drug and Device Litigation: A Review and Critique,” Food and Drug Law Journal, Volume 54, No. 3 (1999).
• “Surfing the Net in Shallow Waters: Product Liability Concerns and Advertising on the Internet,” with Marilyn A. Moberg and Howard L. Dorfman, Food and Drug Law Journal, Summer 1998.
• “Warning: Increased Patient Involvement May Be Hazardous to the Health of the Learned Intermediary Rule,” with Mary F. Panetta, Drug and Medical Device Litigation: Defense Perspectives, DRI, 1998.
• “Erosion of the Learned Intermediary Rule,” with Pamela Rupright, Pharmaceutical Executive, Commentary, October 1997.
• “Market Share in its Second Decade: The Sindell Emperor Has No Clothes,” For the Defense, June 1994.
• “Daubert’s Lamppost: A Guide to the Admissibility of Scientific Evidence,” The Journal of Pharmacy & Law, Volume 2, No. 2 (1994).
• “Like A Lamppost Without A Light: Numbers In Today’s Courtroom,” Scientific Evidence Review, November 1992, Volume 1.
• “Special Report - AIDS Infects Not Only Victims, But Care-Givers and the Courts,” San Jose Business Journal, August 26, 1991.
• “The Sky’s the Limit: A California Court Lifts the Lid on Money Judgments in AIDS Transfusion Cases,” Infectious Disease News, July, 1991; republished in Daily Journal, July 25, 1991 and Orthopedics Today, August, 1991.
• “Strategic Device Hidden in Voir Dire Statute,” California Law Business, March 11, 1991.
• “Drug Experience Reports,” Defending Drug and Medical Device Cases, DRI, 1989.
• “Discovery of Pathology Evidence,” Defending Drug and Medical Device Cases, DRI, 1989.

Speeches / Presentations

• Speaker, CBI's 6th Annual Product Complaints Conference, June 23-25, 2010
• Speaker, "International Drug and Device Recalls: Proactive Planning for FDA, WHO, EMA and Health Canada," FDANews Webinar, March 24, 2010.
• Speaker, "The Impact of Litigation on Nanotechnology and How to Minimize the Risk,” The 5th International Congress of Nano-Bio Clean Tech 2008, San Francisco, CA, October 28, 2008.
• Moderator and Speaker, “How to Avoid the 10 Most Common Mistakes of an FDA Inspection,” GTCbio's 4th Annual Modern Drug Discovery and Development Summit: Regulation & Policy in Drug Development, San Diego, CA, October 15-17, 2008.
• Speaker, CBI’s 4th Annual Bio/Pharmaceutical and Medical Device Product Recalls Summit, Vienna, VA, September 25-26, 2008.
• Session Leader/Speaker, “Marketing Prescription Products,” RAPS Annual Conference & Exhibition, Boston, MA, September 16, 2008.
• Speaker, "Medical Device Recalls: Strategies and Best Practices to Know Before a Recall Occurs," Thompson Medical Publishing Audioconference, May 13, 2008.
• Speaker, "Developing a Recall Strategy: Dos and Don'ts," FDANews Audioconference, February 26, 2008.
• Speaker, “Confidentiality and HIV,” CLE seminar sponsored by AIDS Legal Referral Panel and the Alameda County Association Volunteer Legal Services Corporation in Oakland, CA, October 23, 2007.
• Speaker, "Pro Bono and Public Service Work - 'Why Do It?'," ABA TIPS Leadership Academy Seminar, San Francisco, CA, August 10, 2007.
• Speaker, "Proactive Planning for Recalls," FDANews Audioconference, November 6, 2006.
• Speaker, "Controlling the Risks of Off-Label Promotion Over the Internet," Pharmaceutical Education Associates 5th Annual Off-Label Usage Conference, Philadelphia, PA, September 20-21, 2006.
• Speaker, "Anticipating and Preparing for a Prescription Product Recall," CBI's Annual Recall Summit, Indianapolis, IN, September 18-19, 2006.
• Speaker, “Developing a Framework for Deciphering Where Lawful Scientific Exchange Ends and Illegal Off-Label Promotion Begins,” ACI's Off-Label Communications Program, Chicago, IL, September 13-14, 2006.
• Speaker, “The Master Class on Building a Powerhouse Compliance Program,” ACI's Off-Label Communications Program, Chicago, IL, September 13-14, 2006.
• Workshop Speaker, "Anticipating and Preparing for an FDA inspection," Institute of Validation Technology's FDA Inspections Conference, San Francisco, CA, June 2006.
• Speaker, “Off-Label Issues," Regulatory Affairs Professionals' Advertising, Promotion and Labeling Conference, Denver, CO, May 2, 2006.
• Speaker, “Controlling the Risks of Off-Label Promotion Over the Internet,” ACI’s Pharmaceutical & Medical Device Counsel’s Guide to Off-Label Communications Conference, April 2006.
• Speaker, “Product Liability Protection for Stem Cell Research & Therapies – A Proposal”, GTCbio 2nd International Conference on Stem Cell Research and Development, San Francisco, CA, March 3, 2006.
• Speaker, “Product Liability Perils to the Development of Vaccines - Lessons Learned and a Proposal for Reform" at "Vaccines - All Things Considered" sponsored by GTCbio, Alexandria, VA, November 3, 2005.
• Speaker, "Protecting Your Vaccine Before Launch - A Risk Assessment Plan," Institute of Validation Technology, Baltimore, MD, October 18-21, 2005.
• Speaker, "Anticipating and Preparing for a Prescription Product Recall," CBI's Annual Recall Summit, Arlington, VA, September 29-30, 2005
• Speaker, “Implementing the Stem Cell Initiative: The Future Is In California”, San Mateo, CA, March 9, 2005.
• Chair and Speaker, “Products Liability for FDA-Regulated Products,” Washington, DC, January 26-27, 2005.
• Speaker, "Taking and Defending Effective Depositions in California," Lorman Education Services, Oakland, CA, January 20, 2005.
• Speaker, “Are You “Recall Ready”? The In-House Counsel Guide to Pharmaceutical or Medical Device Recall", ACI Drug and Medical Device Litigation Conference, New York, NY, December 12, 2004.
• Speaker, "Immunization of Vaccine Manufacturers from Product Liability - a Critical Component of a Vaccine Supply" at "Vaccines - All Things Considered" two-day GTCbio seminar, San Francisco, CA, December 3, 2004.
• Chair and Moderator, "Preemption and Other Liability Relief for Pharmaceutical Companies," FDLI Annual Conference: Science, Regulation, Business and the Law: "Transforming Challenges into Opportunities," Washington, DC, April 14-16, 2004.
• Speaker, "Taking and Defending Effective Depositions in California," Lorman Education Services, Oakland, CA, January 23, 2004.
• Speaker, “Dot.Com Device – Product Liability and Regulatory Issues”, ACI's Reducing Legal Risks in the Sales and Marketing of Medical Devices Conference, Chicago, IL, November 18, 2003.
• Speaker, “Be Prepared for New Litigation Targets – Pharmaceutical Products, Carcinogens and More,” DRI Teleconference, September 30, 2003.
• Program Co-Chair/Speaker, “Bioterrorism: Threats and Responses for the Drug, Medical Device and Biologics Industries,” FDLI, Washington, DC, September 29, 2003.
• Chair/Speaker, "Product Liability Issues and Tort Reform" FDLI 46th Annual Conference, April 2003.
• Chair/Speaker, "Medical Device Development Lifecycle from Concept to Market: Strategies to Maximize Success," Drug Information Association, San Francisco, CA, February 23-26, 2003.
• Session Leader/Speaker, "The First Amendment and FDA Regulation," RAPS 2002 Conference and Exhibition, Washington, DC, October 7, 2002.
• Speaker, "Product Liability Issues," Biotechnology Law Institute, San Mateo, CA, May 21, 2002.
• Moderator and Speaker, ABA Medicine and Law Committee Program "Regulating Single Use Medical Devices: Legal & Regulatory Dilemmas, " Chicago, IL, August 4, 2001.
• Moderator and Speaker, "Dot.Com Medicine - The Benefits and The Risks", FDLI Annual Conference, Washington, DC, April 16, 2001.
• Co-Chair and Speaker, "The Reuse of Single Use Medical Devices," FDLI 43rd Annual Conference, Washington, DC, December 1999.
• Faculty, “Origins and Organizational Structure of FDA and an Overview of Medical Device Regulation,” FDLI, Burlingame, CA, September 23-24, 1999.
• Faculty, “Turncoat Witness: How to Exclude, Neutralize and Cross-Examine Them,” IADC Annual Meeting, Whistler, British Columbia, July 1999.
• Co-Chair and Speaker, “The Plague of Clinical Trials – And a Teaspoon of Medicine for the Cure,” FDLI 42nd Annual Conference, Washington, DC, December 1998.
• Faculty, “Understanding the Legal Aspects of Product Recalls,” FDLI, Costa Mesa, CA, April 1998.
• Faculty, “Recent Developments Impacting Warnings Liability for Advertising and Promotion for Prescription Drug and Medical Device Manufacturers,” FDLI 41st Annual Conference, Washington, DC, December 1997.
• Faculty, “Introduction to Drug Law and Regulation,” FDLI, San Francisco, CA, October 1997.
• Faculty, “Introduction to Drug Law and Regulation: Understanding How FDA Regulates the Drug Industry,” FDLI, Costa Mesa, CA, October 21-22, 1996.
• Speaker, “The Legalities of Promoting & Advertising Pharmaceuticals,” Washington, DC, May 16-17, 1996.
• Speaker, “A Good Offense is the Best Defense: Pharmaceutical Torts of the 90’s and How Not to Become Another Dow Corning.”
• Chair and Speaker, “Overcoming Legal Quandaries in Advertising & Promoting Biologics & Pharmaceuticals,” Rockville, MD, December 7-8, 1995.
• Speaker, “A Broadside at Manufacturers’ Warning Obligations: The Impact of Proposed Restatement of Torts and OBRA.”

Experience

Legal Education

Undergraduate Education

Professional Admissions / Qualifications

• California

Court Admissions

• State Supreme Court - California
• U.S. District Court - Northern District of California
• U.S. District Court - Central District of California
• U.S. District Court - Eastern District of California

Professional Affiliations

• Chair, Board of Directors of the Food and Drug Law Institute
• ADVAMED
• Drug Information Association
• American Health Lawyers Association
• International Association of Defense Counsel
• Northern California Association of Defense Counsel
• Alameda County Bar Association, representative to the Conference of Delegates of California Bar Associations 2009, member of the Board for Volunteer Legal Services Corporation
• Defense Research Institute
• American Academy of Hospital Attorneys
• International Society for Stem Cell Research