Nanotechnology - a term encompassing nanoscale science, engineering, and technology - offers extraordinary economic and societal benefits. The unique chemical, optical and biological characteristics of these materials are expected to lead to revolutionary advances in many fields.
At the same time, new concerns have emerged regarding the environmental, health, and safety (EHS ) impact of nanoscale materials. Potential EHS problems have led to new legislation and regulation and could inspire a wave of environmental and tort litigation.
In this program, a panel of experts addresses how companies can minimize legal risk while harnessing the promise of nanotechnology. Topics covered include:
- Current legislation
- The emerging regulatory landscape
- Technical underpinnings of EHS risk in nanomaterials
- Required disclosure of the presence of nanomaterials
- Minimizing potential liability when putting nanomaterials into commerce
- Litigation arenas
- Litigation issues
It will conclude with a question and answer period enabling you to raise your individual concerns with the panel.
Agenda
I. Legislative
A. Nanotechnology legislation in Congress
- Impact on the National Nanotechnology Initiative
- Impact on environmental, health, and safety research and potential regulation in the 111th Congress
- Hurdles to clear in reauthorizing the National Nanotechnology Initiative
II. The Emerging Regulatory Landscape
A. Identification of the technical and policy underpinnings fostering the strong interest in EHS considerations for nanomaterials.
B. The requirements to disclose the presence of nanomaterials in products and to investigate the EHS risks associated with a nanomaterial that a company places in commerce, including:
- the diminishing utility associated with data on, and experience with, materials that are larger than the nanoscale
- the U.S. agencies primarily responsible for human health research related to nanotechnologies
- the programs underway to investigate and/or help fund nanotechnology EHS research
C. What steps companies can take to minimize their exposure associated with placing nanomaterials in commerce
III. Litigation
A. Potential Litigation Arenas
- Product Liability Litigation/Mass Torts
- Occupational Safety/Work Place Exposure
- Environmental
- Consumer Fraud
- Insurance Coverage
B. Potential Litigation Issues
- Liability: What was "known or scientifically knowable"
- Causation: Can/should "standard" criteria apply (e.g., Bradford-Hill criteria, Koch's postulates, Naranjo algorithm)?
- Damages: Medical Monitoring
IV. Q&A
Speakers:
Daniel Herling
Daniel Herling, a partner with Keller and Heckman LLP, focuses his trial practice on product liability, with an emphasis on pharmaceuticals and medical devices; CA Proposition 65; and commercial litigation. Mr. Herling represents clients in both state and federal courts throughout California and the United States. He acts as counsel for international pharmaceutical, medical device, and dietary supplement industry companies. In addition, he counsels clients on California Green Chemistry Initiative and regulatory matters and has advised in the selection and supervision of local counsel and lead trial attorneys.
Kathleen Patterson
Kathleen Patterson is a partner in the San Francisco office of Orrick, Herrington & Sutcliffe, LLP. She focuses her practice on the defense of pharmaceutical, medical device, and biologic product manufacturers in complex product liability litigation. Ms. Patterson also advises and defends companies in regard to California's toxic exposure labeling law, Proposition 65. In addition, Ms. Patterson's practice involves counseling companies regarding Consumer Product Safety Act compliance, product labeling, and other litigation-preemptive strategies. Ms. Patterson is an experienced and accomplished trial lawyer, having successfully tried to verdict cases in various state and federal courts. She has substantial experience in multi-jurisdiction litigation, including class actions, multi-district litigation, and coordinated proceedings in state courts. She has served as national, regional, and state counsel in nationwide litigation on behalf of a variety of clients.
Martha Marrapese
Martha Marrapese, a partner at Keller and Heckman LLP, focuses on emerging technologies in the industrial chemicals, antimicrobial pesticides, and food packaging sectors. Ms. Marrapese facilitates the registration of new technologies in the global economy and has an expertise in the Toxic Substances Control Act and its counterparts in Canada, the European Union, and China. She offers counsel on right-to-know laws, such as Proposition 65, and assists companies with product defense and obligations arising out of the testing of chemicals in commerce. Ms. Marrapese serves as a U.S. delegate to the TC-229 150 Committee on Nanotechnologies and chairs the WG1, Nomenclature and Terminology, for the U.S. Technical Advisory Group to TC-229.
Paul Stimers
Paul Stimers, an associate at K&L Gates, focuses his lobbying efforts on matters related to nanotechnology, information technology policy, and defense, and advises a wide range of companies and industry associations in pursuing legislation and representing their interests before Congress and federal agencies. Mr. Stimers represents the NanoBusiness Alliance, the nanotechnology industry association, in developing and advocating for policies that will expand the nation's nanotechnology infrastructure. He coordinates the Alliance's annual Policy Tour, which brings dozens of nanotechnology leaders to the capital for meetings with senior government officials. He also works with several of the world's leading nanotechnology companies to secure federal funding for research and development projects. Mr. Stimers additionally works with software companies and industry associations to ensure data and network security without restricting technological development and has significant knowledge of and experience in defense and homeland security issues.
