If any of our loyal readers are looking for some CLE before the end of the year, Reed Smith is offering a virtual (live webcast) Life Sciences Litigation CLE Day on November 16, running from 10 a.m. to 4:30 p.m. ET. Bexis and Steve McConnell will be among your Reed Smith presenters. Here is a link to the registration page for details on jurisdictions in which credit will be offered.
Since it can be particularly challenging to find Ethics credits, we note that the day will end with an Ethics CLE. Our colleagues David Cohen and Mildred Segura will present “You Be the Judge: Ethics Edition,” a fun (we hope), interactive game that will test your knowledge of legal ethics rules surrounding e-discovery. David and Mildred will present relevant facts from several recent cases. For each case, participants will be presented with key e-discovery ethical questions faced by the judge and will need to decide how the judge ruled – or should have ruled.
The day will kick off with “Forewarned is Forearmed: Product Risk Assessments, Early Case Assessments, and Other Protective Measures,” a session presented by our colleagues Elizabeth Brandon, Melissa Geist, and Janet Kwuon. Product risk assessments, early case assessments, and other mitigation strategies are important tools for life sciences companies seeking ways to identify costly liabilities and reduce risk before potential problems become front page news. Elizabeth, Melissa, and Janet will provide an overview of these tools and their goals and focuses, discuss when the tools can most advantageously be implemented, share case studies and associated learnings derived from actual assessments, and provide best practices companies can implement going forward to mitigate product liability risk.
Next up is Bexis, who, along with our colleague Jenn Eppensteiner, will present “Preemption in Perspective: A Balanced Review of Preemption Issues Affecting Drugs, Medical Devices, and Vaccines as 2023 Draws to a Close.” Preemption remains the most powerful defense in prescription medical product liability litigation. This year’s presentation explains significant preemption-related developments over the last 12 months, both favorable and unfavorable. Learn an important preemption decision for our FDA-regulated sandbox that did not involve any of these products (and now has dodged a potential Supreme Court bullet). Our emphasis is practical – how preemption can win cases in litigation – but the presentation will also discuss the Supreme Court’s evolving preemption framework.
Steve McConnell, along with our colleagues Shana Russo and Alexandra Hussey, will then discuss “Current Developments in OTC Product Liability Litigation.” Plaintiffs’ counsel seem to be increasingly setting their sights on the OTC segment of the pharmaceutical industry, where the Learned Intermediary Doctrine does not serve as a barrier, where vast use of OTC products expands the range of potential plaintiffs, and where litigation can target well-known prescription drug parent companies. Related consumer fraud/economic loss claims also regularly abound. This session will provide an overview of recent developments and interesting decisions in this sector, examine the unique challenges of defending these sorts of claims, and highlight some successful defense strategies.
Next up, our colleagues Cori Annapolen Goldberg, Mildred Segura, and Sung Park will present on “Challenges in Digital Health and AI: Current Regulatory and Product Liability Landscape and Preparing for What’s Ahead.” Companies operating in the digital health, artificial intelligence, and machine learning space have quickly appreciated that the sophistication and technology involved in their products is light years ahead of the laws and regulations intended to govern them. This disparity is evident in how these products are regulated by the FDA, how these companies commercialize their products and offerings, and how their products can be used in the provision of health care services. This discussion will provide an overview of the current regulatory framework in place, including recent updates from FDA, as well as the current product liability legal landscape, including what we think is ahead for this segment of the industry, which is expected to experience continued explosive growth in the next decade.
And then our colleagues Joe Mahady, Heather Ritch Rocks, and Sarah Johansen will present on “Product Liability Expansion: New Plaintiff Theories and Effective Defenses.” This session will cover attempts to expand warnings and design defect claims; expanded negligence claims and involved, expansive discovery from third-party suppliers; an overview of plaintiffs’ counsel’s use of public nuisance claims; and the potential new “duty to innovate” under consideration in the California courts.
Again, you can find the registration page here.
CLE Information: The “You Be the Judge” session is presumptively approved for 1.0 CLE ethics credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Applications for CLE credit are being filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed.
All other webinars are presumptively approved for 1.0 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit are being filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed.
Please allow 4-6 weeks for CLE processing.