FDA and Vaping: The FDA's Enforcement Powers and Its Effect on Private Litigation

MCLE Credits: 2.0
Ethics Credits Included: 0.0

Tuesday, April 21, 12:00 p.m. - 2:00 p.m. ET (IN THE PROCESS OF BEING RESCHEDULED)
  • Live Webcast
  • Live Telephone
  • Live on Site at Virginia CLE (Attendance in Charlottesville no longer available, but webcast and telephone options
    still are available as originally scheduled)
Learn more about Virginia CLE webcast format
Learn more about Virginia CLE telephone format
Tuesday, May 12, 12:00 p.m. - 2:00 p.m. ET (IN THE PROCESS OF BEING RESCHEDULED)
  • Webcast with Live Q&A
  • Telephone with Live Q&A
MCLE Credit: 2.0 (Ethics: 0.0)
Live-Interactive Credit: 2.0 (all dates, all formats) Live Interactive MCLE Credit Symbol
Registration Fee: $159

Information

Why Attend?

  • Understand the powers of the FDA to regulate the vaping industry
  • Examine the regulatory scheme in place, and that proposed to replace it
  • Learn about private litigation efforts, and how FDA actions may affect them

In response to coronavirus (COVID-19) concerns, this program (both the April 21 and May 12 dates) is in the process of being rescheduled. Registration currently is not available.

Nicotine is highly addictive. Electronic nicotine delivery systems (ENDS), commonly known as vapes or vape pens, were promoted as the healthier alternative to inhaling tobacco smoke, with all the known risks of the latter. Yet it appears that vaping has its own health risks, and the Food and Drug Administration is moving to mitigate those risks.

This program will explore the FDA’s enforcement actions as a case study for how its actions can have a profound effect not only on the regulated industry, but also how private litigation against that same industry can be affected.

Among the topics to be discussed:

  • Overview of the FDA’s legal framework for exercising authority over ENDS
  • Examination of the FDA’s stated priorities for regulation
  • Discussion of the enforcement actions taken to date
  • Analysis of ongoing and likely litigation against manufacturers, and how the FDA’s action may play a role
 

Discounts available for Virginia CLE webcast-telephone-live seminars Follow link to learn about the Virginia CLE Online Bundle with savings up to 45% Follow link to learn about coupons for lawyers in First Year in Virginia practice Follow link to learn about discount for New Virginia Lawyers (first 3 years) Follow link to learn about Government Employee discount Follow link to learn about Legal Aid discount

Follow link to learn about coupons for lawyers in First Year in Virginia practice Follow link to learn about coupons for lawyers in First Year in Virginia practice Follow link to learn about Government Employee discount Follow link to learn about Legal Aid discount

Registration Deadlines:
Webcast: 10 minutes prior to seminar. If you register for a webcast the day of the seminar, your e-mail receipt will include a link to launch the seminar and download the materials.
Telephone: Online registration ends at 11:59 p.m. the day preceding the seminar
Call (800) 979-8253 to register up to one hour prior to the seminar
Live on Site: Online registration ends at 11:59 p.m. the day preceding the seminar
Walk-in registration is permitted on a space-available basis

Cancellation Policy: Cancellation/transfer requests will be honored until 5:00 p.m. the day preceding the seminar. You will, however, be charged $40 if you cancel or transfer your registration to a different seminar after the link to the materials has been e-mailed by Virginia CLE.

Full refunds or transfers are available up to two days after a webcast in the unlikely event that you experience technical difficulties.

MCLE Credit Caveat: The MCLE Board measures credits by the time you spend in attendance. If you enter a seminar late or leave it early, or both, you must reflect those adjustments accurately in the credits you report on your credit reporting form. A code will be given at the end of the seminar, which must be written on your MCLE form.


Can't Attend?
E-mail distance_ed@vacle.org to be notified when/if this program is made available as an online or USB seminar.
E-mail publications@vacle.org to be notified when/if this program's seminar materials are made available for sale.

Schedule

COURSE SCHEDULE (April 21) (Eastern Time) (IN THE PROCESS OF BEING RESCHEDULED)

12:00 FDA and Vaping: The FDA's Enforcement Powers and Its Effect on Private Litigation
2:00 Adjourn
  • Sign-in for live seminar attendees in Charlottesville begins at 11:30 a.m.
  • Q&A will be handled via chat room for Webcast attendees.
  • Q&A will be handled via e-mail for telephone seminar attendees.

COURSE SCHEDULE (May 12) (Eastern Time) (IN THE PROCESS OF BEING RESCHEDULED)

12:00 FDA and Vaping: The FDA's Enforcement Powers and Its Effect on Private Litigation
2:00 Adjourn
  • Q&A will be handled via chat room for Webcast attendees.
  • Q&A will be handled via e-mail for telephone seminar attendees.

Faculty

ABOUT THE SPEAKERS

Brian J. Donato, Hyman, Phelps & McNamara, PC / Washington, DC

Brian J. Donato began his career at Hyman, Phelps & McNamara, PC, providing information about various legal issues related to the Federal Food Drug and Cosmetic Act and FDA’s regulations and similar laws and regulations of the State of California.  Before joining Hyman, Phelps & McNamara in 1991, Mr. Donato practiced law in firms he founded in Virginia and in Florida. From 1976 to 1980, he served as General District Court Judge for Albemarle County, Virginia. He was Chief Judge for all of the General District Courts in the Sixteenth Judicial District of Virginia in 1978 and 1979. He served as Lecturer at the University of Virginia School of Law from 1978 through 1988. Since 1982, he has been a faculty member at the National Trial Advocacy College at the University of Virginia School of Law.

Robert A. Dormer, Hyman, Phelps & McNamara, PC / Washington, DC

Robert A. Dormer is one of three founding members of Hyman, Phelps & McNamara, PC. He has been an integral part of the firm’s growth and expansion in all areas of FDA law. He advises clients on a wide range of issues throughout the product lifecycle including development and approval, compliance, and enforcement.  From 1976 to 1979, Mr. Dormer served in the FDA’s Office of Chief Counsel. He was an Associate Chief Counsel for Enforcement and Associate Chief Counsel for Radiological Health. Mr. Dormer was responsible for counseling what was then known as the Bureau of Radiological Health, which is now part of the FDA’s Center for Devices and Radiological Health. He also represented the FDA in civil and criminal litigation throughout the country. Prior to joining the FDA, he served as an attorney for the White House Special Action Office on Drug Abuse Prevention. Mr. Dormer regularly counsels pharmaceutical clients on Hatch-Waxman patent and exclusivity issues, orphan drugs, and biosimilar regulation and policy. He also has extensive expertise with post-marketing issues such as advertising and promotion, and good manufacturing practices for drugs and medical devices. Mr. Dormer is the author of three book chapters on food and drug law as well as numerous published articles. He regularly speaks on food and drug law at legal and regulatory conferences and provides expert testimony.

Anne K. Walsh, Hyman, Phelps & McNamara, PC / Washington, DC

With more than 21 years of experience in private practice and government, Anne Walsh helps pharmaceutical and medical device companies comply with, and defend against, FDA regulation.  She regularly counsels clients on managing FDA inspections, and responding to seizure and injunction actions, warning letters, and recalls.  She has specific expertise in matters involving health care fraud, off-label promotion, and manufacturing practices, and has investigated and negotiated dozens of matters that have implicated False Claims Act liability and exclusion by the HHS Office of Inspector General. Ms. Walsh frequently applies this compliance and enforcement expertise to aid clients needing FDA perspective in M&A transactions.  She leads teams of attorneys to conduct a comprehensive FDA-related diligence, and advise clients on making determinations concerning the deal and its valuation. Her litigation experience is comprehensive and diverse, from defending product liability claims in state court, bringing suit under the Lanham Act, prosecuting individuals and corporations in federal court, and suing FDA for violating the Administrative Procedure Act. Prior to joining Hyman, Phelps & McNamara, Ms. Walsh served as Associate Chief Counsel with FDA’s Office of Chief Counsel, and received several awards for her work from FDA, DOJ, HHS Office of Inspector General, FDA’s Office of Criminal Investigations, and U.S. Attorney’s Offices throughout the country.

Locations, Dates and Fees

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