Main Conference Wednesday, November 30, 2011
8:00 Registration Begins and Continental Breakfast8:30 Conference Co-Chairs’ Opening Remarks
Alan Maxwell
Partner,
Weinberg Wheeler Hudgins Gunn & Dial LLC (Atlanta, GA)
Leo Knowles
Senior Vice President & Chief Counsel
ConAgra Foods Inc. (Omaha, NE)
8:45 Assessing the Food Safety Modernization Act’s Impact on Your Litigation Paper Trail: Knowing What to Document, When and How
Nicholas M. White
General Counsel,
JBS USA Holdings, Inc. (Greeley, CO)
John Batz
Director, Quality & Food Safety
Malt-O-Meal Company (Lakeville, MN)
Sarah L. Brew
Partner,
Faegre & Benson LLP (Minneapolis, MN)
- Understanding FDA’s new authority to inspect records – what is discoverable by the FDA?
- knowing how far up and down the manufacturing, distribution and supply chain the record production obligation extends
- identifying what types and how many records can be requested and accessed by FDA
- how to litigation-proof your documents
- Registration of food facilities – preparing for the impact that a suspension of registration may have – follow-on civil litigation, increased government scrutiny
- hazard analysis and risk-based preventive controls recordkeeping – how to collect data and document testing results, instances of non-conformance, your written plan and reanalysis
- Understanding additional recordkeeping requirements for facilities that deal with high-risk foods
- Evaluating new requirements addressing surveillance
- knowing what type and the quantity of food-borne illness −data that will be collected, reported, stored and analyzed
- how long will the data be maintained and will it be publicly −accessible?
- The food recall search engine – what type and quantify of data can be posted?
- RFR – what type of information should your company be reporting?
- Accreditation of third-party auditors – understanding audit report submission requirements and associated records requirements
9:45 Dissecting Causation & the Science Behind the Claim: How to Effectively Defend Your Case
William E. Keene, PhD, MPH
Senior Epidemiologist, Acute & Communicable Disease Prevention
Oregon Public Health Division (Portland, OR)
Jeffrey Conner
Vice President, Associate General Counsel and Assistant Secretary
Dole Food Company, Inc. (Westlake Village, CA)
C. Harold (Hal) King
Senior Manager, Food and Product Safety,
Chick-fil-A (Atlanta, GA)
James Neale
Partner,
McGuire Woods LLP (Charlottesville, VA)
- Understanding how food-borne illnesses are transmitted and which types of salmonella and e.coli are found in which types of foods
- Distinguishing how various types of diseases are investigated – incubation periods, preservation of evidence, conclusive vs. inconclusive symptoms
- Contrasting the pros and cons of current methods for testing food adulterants, contaminants and pathogens and distinguishing each
- Obtaining the necessary information from federal, state and local health officials to discern what the source of the contamination
- How to overcome mistaken allegations or conclusions that your client or product is associated with during an outbreak – understanding “false negatives” and the impact they have on litigation
- Evaluating the effect of antibiotics on culture results
- Examining alternates to cultures – titre testing, common exposure claims, health department inspections
- Developing a defense for culture confirmed vs. no culture confirmed cases
- Knowing how liability is assessed from the plaintiff’s perspective
11:00 Morning Coffee Break
11:15 Preserving Your Corporate Brand and Controlling the Message During an Outbreak: Effective Crisis Communications Strategies for Mainstream and Social Media
Dean Panos
Partner,
Jenner & Block LLP (Chicago, IL)
- Acknowledging the importance of the initial consumer response as the fi rst step in minimizing risk and preventing additional litigation
- Developing a unified communication strategy to address publicity issues that arise when a case if filed as the direct result of government action
- Synchronizing messages conveyed by the company across media outlets, corporate communications and by outside counsel
- Tackling the increasing use of social media, networking sites and blogs that are often utilized to “get the word out” during a food-borne illness outbreak
- Coordinating a rebuttal response to address plaintiff exploitation of an isolated incident
- Preparing for collateral damage and other contingent liabilities associated with high-profi le food contamination litigation
- How to respond to shareholder inquiries and customer complaints arising out of a food-borne illness event
11:45 Focus on Criminal Prosecution of Corporate Individuals within the Food Industry Preparing for Increased Government Enforcement and Understanding How Government Builds a Criminal Case under the Park Doctrine
Nate Sabel
Associate Chief Counsel for Enforcement
U.S. Food and Drug Administration (Silver Spring, MD)
Gerald Wilhelm
Assistant U.S. Attorney,
US Attorney’s Office (Minnesota, MN)
Thomas J. Bondurant, Jr.
Partner,
Gentry Locke Rakes & Moore LLP (Roanoke, VA)
- Understanding the liability exposure created by FDA inspection documents that can open the door to criminal prosecution under the Park Doctrine
- Reviewing the FDA’s guidance on “Special Procedures and Considerations for Park Doctrine Prosecutions”
- Defining key terms under the Park Doctrine
- “responsible corporate officers” who does/does not fall into this category
- standard of care and the power to prevent or correct – no knowledge or intent required“
- prohibited acts” under 21 U.S.C. § 333(a)(1)
- demonstrating “extraordinary care”
- Distinguishing felony prosecutions also available for violations under 18 USC
- Making the case for a “305 hearing” should your company face criminal prosecution under a violation of the FDCA
- Overview of available fines and penalties – update on the status of new guidelines for health care offenses including violations of the FDCA
- Update on the status of the Food Safety Accountability Act of 2001 (S.216)
- Compliance and regulatory best practices to minimize corporate individual’s exposure to criminal prosecution
- Review of recent investigations against executives in the food industry
12:45 Networking Luncheon for Attendees & Speakers
2:00 Effective Recall Management: Understanding Government Expectations and How to Prevent Recall Mistakes that Lead to Litigation
Arthur P. Liang, MD, MPH
Director, Food Safety Office
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control (Atlanta, GA)
Lisa Volk
Director, Recall Management Staff, Office of Field Inspections
Food Safety Inspection Service, USDA (Washington, DC)
Paul E. Benson
Partner,
Michael Best & Friedrich LLP (Milwaukee, WI)
- Lessons learned from recent major recalls – Shell Eggs, Hydrolyzed Vegetable Protein Product (HVP)s, Pistachios and Peanuts
- Tips on how to effectively remove products from the market place
- Putting together the optimal crisis response team
- Working with state and federal government to streamline the recall process
- Communication – what and how to communicate with various parties
- personalizing the recall message for the consumer,government, employees
- knowing what the facts are before communication begins
- Maintaining proper documentation during a recall in anticipation of litigation
- Establishing effective remedial measures post-recall
3:15 Settlement Strategies: How to Effectively Assess the Value of the Claim and Negotiate a Long Term Resolution
Leo Knowles
Senior Vice President & Chief Counsel
ConAgra Foods Inc. (Omaha, NE)
Alan Maxwell
Partner
Weinberg Wheeler Hudgins Gunn & Dial LLC (Atlanta, GA)
- Negotiating a final resolution to a food-borne illness claim – best practices for engaging in the valuation discussion – when to begin the process and what to reveal
- How to assess the weak and strong points of the claim to negotiate the best financial resolution for your client
- How to accurately classify a food-borne illness as short term vs. long term
- Delineating the financial liability of various parties involved – manufacturer, distributor, supplier
- How to develop a negotiation strategy for a food-borne illness claim when working backwards from your bottom line
- Addressing and accounting for the impact of delayed consequences and future medical expenses of food-borne illnesses when formulating a compensation package
4:00 Afternoon Refreshment Break
4:15 Insurance Claims, Exclusions and Limitations: 5 Things You Need to Know About Your Coverage for Food-Borne Illness Incidents
Wendy Webb Williams
Associate General Counsel – Business Operations
U.S. Foodservice, Inc. (Chicago, IL)
Jonathan Cohen
Partner,
Gilbert LLP (Washington, DC)
- Understanding the terms of your coverage when faced with a food-borne illness or contamination vent
- Addressing recall coverage
- what are the policy triggers?
- what does the policy pay for/ not pay for?
- scope of limits, retained limits and deductions – what are they?
- working with the insurance carrier and other parties in the context of a recall – how to effectively work with the insurer’s recall team
- Managing the risk exposure created by the extended supply chains – how to address indemnity agreements/provisions
- What to do when an insolvent supplier, underinsured or financially at risk insurer is involved
- Going forward - how to prepare for future food-borne illness events
5:00 A View from the Plaintiff’s Side: Forecasting the Future of International Food-Borne Illness Claims and What It Could Mean for Your Company
William Marler
Managing Partner,
Marler Clark L.L.P. P.S.
Renowned food-borne illness attorney, Bill Marler, will provide an in-depth analysis of the recent Germany E. coli outbreak and what impact he sees this international incident having on the future of food-borne illness claims, here in the U.S. Take note as Bill provides insights into
- Corporate operations/procedures that typically open the door for a food-borne illness claim
- Points of exposure for U.S. companies created by international food contamination events
- What specific sectors within the food industry are most susceptible to food-borne illness claims who’s next on the plaintiff’s bar list
5:30 Conference Concludes Cocktail Reception
Conference Details