How do executives, researchers, manufacturers, marketers and pubic relations counselors deal with risks that aren't known now and might not be known for years?
That's the core issue which could impede the growth in nanotechnology. In their March 5, 2009 article in TOXICS LAW REPORTER [TLR], Jones Day partner Charles H. Moellenberg Jr. and Of Counsel Robin L. Juni advise: Ask the right questions - and all of them. The article titled "A Practical Guide to Reduce Product Liability Risk for Nanotechnology" might be thought of as the sequel to Ronald C. Wernette's January 15, 2009 TLR discussion - "The Dawn of the Age of Nanotorts" - of the many potential tort theories in the wings for nanoproducts. Moellenberg and Juni forge ahead with pragmatic counsel for risk managers and liability attorneys.
What is assumed is that, yes, nanomaterials are theorized to have health risks. And those fall into just about every category of liability claims, from defective design to negligence in marketing. At the time the products are put on the market those risks could be unknowns. But it's still possible to proceed in legally prudent manner. Moellenberg and Juni pose 12 types of questions that must be asked related to processes and procedures. Remember, this is a new scientific frontier. The best offense is to apply the best existing science to prevent or reduce potential risks. That's exactly what will be on jurors's minds.
- Research, Development, Testing. Much of this represents best practices in product research such as was the feasibility of alternative designs considered, what health and safety measures were planned for and implemented, and types of testing. There are also common sense issues about paying attention to e-trails.
- Compliance with Regulations and Industry Guidelines. An exhaustive and ongoing search must be made about what information, research, injury reports, litigation, regulations exist. Can regulations and standards be drafted to limit liability.
- Manufacturing and Quality Control. Obviously, new manufacturing processes will have to be engineered, tested out and continually monitored. To be determined are expected failure or defect rate. Are there procedures to ensure impeccable record-keeping.
- Adequate Warnings and Instructions. This is a tough nut to comply with because so many of the risks are unknowns. Therefore, it's necessary to spell these uncertainties out in warnings and directions for use. It helps to bring in third-party experts and compare one's own warnings/instructions with those made explicit by the competition, regulatory standards, and the literature.
- Advertising, Marketing and Promotion of Product. Because the product is new, it will require educating the consumer about uses and limitations. That education has to be done within the framework of regulations, facts and what can be supported by testing, scientific literature, and expert advice.
- Express Warranties. The challenge here is that data supporting express warranties of performance will likely come from research and development tests. Yet, field performance might deviate from that for unexpected reasons. Those could be due to divergent uses or misuses. Attention has to be paid to the alignment of the express warranties to proven product performance and characteristics. What are the procedures for review of legal and safety issues as well as collecting, monitoring, and analyzing express warranty claims.
- Implied Warranties. Are the limitations of implied warranties, damages and remedies drafted as broadly as permitted by law. And do these reflect the unknows.
- Packaging, Distribution and Transport. Ask if special handling instructions and new hazard symbols are needed. Has the entire process being reviewed for risk factors and these reviews documented. Are procedures in place to learn from field experience.
- Maintenance and Repair. Special training and procedures will be required for inspection as well as use, maintenance, repair, and replacement. Have precautions be established in the event of untrained personnel deal with the product. The expected product life has to be determined.
- Disposal of Product. The product attributes of persistence and ability to migrate through minute spaces can present unique issues for safe disposal. The legal, environmental, health and safety implications and regulations have to be factored in.
- Control and Retention of Documents. Are the usual precautions taken, ranging from careful wording of communications to factual and comprehensive description of risk.
- Crisis Management. Obviously, a crisis plan has to be completed and cover every what-if scenario and all the constituencies which have to informed, in what order, when, and how. Those include the insurance carriers, media, government representatives, and consumers. What procedures will be there for product recall and/or a major public health problem.
The authors can be contacted: