Product Safety Internal Investigations: Attorney-Client Privilege and Reporting Obligations for Potential Hazards

Meeting Reporting Requirements, Preserving Privilege During the Investigation, Lessons Learned From Recent Enforcement Actions

A live 90-minute CLE webinar with interactive Q&A


Wednesday, August 16, 2017
1:00pm-2:30pm EDT, 10:00am-11:30am PDT

Early Registration Discount Deadline, Friday, July 28, 2017


This CLE webinar will discuss internal investigations involving product safety issues. The program will discuss reporting requirements under the four main product safety agencies (CPSC, FDA, and NHTSA), how each agency approaches recalls and notification to consumers, and recent trends in agency enforcement and penalties. Finally, the program will discuss attorney-client privilege issues and best practices for preserving the privilege during the internal investigation.

Description

Manufacturers, distributors and retailers in the auto, food, drug, medical device, and consumer product industries have a duty to notify the appropriate federal agency when the company detects a potential defect or dangerous product. Substantial fines and penalties can result due to failure to give required notice.

Companies must understand which agency has jurisdiction over a particular product’s safety and the details of notice requirements. The timing of agency recalls, information manufacturers are required to submit, and recall notifications vary considerably among the agencies.

Counsel advising companies in internal investigations either prior to agency notification or after notification must be mindful of proceeding in a manner that preserves the attorney-client and work product privilege to the maximum extent possible.

Listen as our panel of product liability and regulatory attorneys advises counsel on internal investigations involving product safety issues. The panel will discuss reporting requirements of product safety agencies (CPSC, FDA, and NHTSA), the agencies’ varying approaches with respect to recalls and notification to consumers, and recent trends in agency enforcement and penalties. The panel will also analyze attorney-client privilege issues that arise during the internal investigation and best practices for preserving the privilege.

Outline

  1. Agency reporting obligations
    1. CPSC
    2. FDA
    3. NHTSA
  2. Enforcement mechanisms and penalties
  3. Agency approaches to recalls and notification to consumers
  4. Recent trends in agency enforcement and penalties
  5. Preserving the attorney-client privilege

Benefits

The panel will review these and other key issues:

  • What are the different agency notification requirements, timing of agency recalls, and information manufacturers are required to submit?
  • What are the latest trends in product safety agency enforcement actions and penalties?
  • What are best practices for counsel advising companies in internal product safety internal investigations to protect the attorney-client privilege during the investigation?

Faculty

Jeffrey A. Soble, Partner
Foley & Lardner, Chicago

Mr. Soble’s practice focuses on product liability, commercial disputes between businesses, class action defense, post-transaction disputes, construction losses, and general contract and tort law. He is experienced in supply chain management and contract enforcement, in particular with limited or sole-source suppliers and just-in-time suppliers. He has further experience in the litigation of insurance coverage claims. He is a member of the Firm's Business Litigation & Dispute Resolution Practice and former co-chair of the Automotive Industry Team. 

Christopher H. Grigorian, Partner
Foley & Lardner, Washington, D.C.

Mr. Grigorian's practice focuses on federal motor vehicle safety law, antitrust, trade regulation and related litigation. He represents motor vehicle manufacturers and major parts suppliers on National Highway Traffic Safety Administration issues, including recalls, defect investigations and related enforcement proceedings, compliance with Federal motor vehicle safety standards, rulemaking proceedings, FOIA and confidentiality matters, and other compliance issues under the National Traffic and Motor Vehicle Safety Act, TREAD Act and implementing regulations. He represents a wide range of industry-related companies and advises industry associations on motor vehicle safety issues and compliance issues.

Bartholomew F. Reuter, Partner
Foley & Lardner, Milwaukee

Mr. Reuter's practice focuses on insurance regulatory, coverage, and corporate transactional matters. He is a member of the Firm’s Insurance and Reinsurance Litigation Practice and the Insurance & Reinsurance Industry Team.

David L. Rosen, Partner
Foley & Lardner, Washington, D.C.

Mr. Rosen has extensive experience in health law, life sciences, and food and drug regulation, including a range of FDA regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. He is co-chair of the Firm’s Life Sciences Industry Team and is also a member of the Firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams. He was formerly employed by the FDA, progressing to various supervisory positions involving virtually all aspects related to the drug approval process, combination products, jurisdictional issues and related compliance activities.


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