Legal Implications of Nanotechnology Developments from New England Nanotechnology Association Meeting

3/6/2014

Engineered nanoparticles are becoming increasingly prevalent and are now widely incorporated in consumer products including athletic equipment, sunscreens, cosmetics, and some printer toners. In addition to widespread use in consumer products, nanotechnology is driving many cutting-edge medical and drug delivery technologies, which promise great improvement in the treatment of cancer and other diseases. However, researchers acknowledge that "[t]here is mounting evidence that engineered nanoparticle exposure can lead to DNA damage that ultimately contributes to cytotoxicity and mutations that drive cancer." 1

As part of Governo Law Firm's efforts to stay up-to-date on developments in the nanotechnology field and counsel clients concerning regulatory compliance and good business practices, we recently attended the first 2014 meeting of the New England Nanotechnology Association (NENA) held at Harvard School of Public Health's Center for Nanotechnology and Nanotoxicology. The speakers reviewed recent regulatory and commercial developments impacting New England businesses involved with nanotechnology. The featured speaker was Dr. Joseph D. Brain, who is the Cecil K. and Philip Drinker Professor of Environmental Physiology at the School of Public Health. Dr. Brain is the principal author of the seminal study regarding the potential fibrogenecity of nanomaterials. 2

Because the physical properties (such as color and magneticity) and the chemical properties (such as the generation of free-radicals) of nanomaterials vary depending on the size, method of creation, and other properties of the substance, it is difficult to assess the potential toxicity of the vast array of different nanoparticle types. At the NENA meeting, Dr. Brain gave an overview of his current work to evaluate the safety of nanomaterials and to engineer safer nanomaterials. For example, researchers at the Center for Nanotechnology and Nanotoxicology recently have designed high throughput nanogenotoxicity assays which allow engineered nanoparticles to be tested on living lung tissue, prior to market or at an early stage in the product lifecycle. The Center also has developed improvements in the flame spray pyrolysis system used to generate many nanoparticles which provide for greater output control and options to coat the nanoparticles with a thin layer of an inert element to improve the safety of metallic nanoparticles used in medical applications and sunscreens.

The scientific efforts to identify and control the toxicity of nanoparticles have legal implications in both the regulatory and litigation arenas. We recently co-sponsored, designed and conducted a jury research study to evaluate jurors' attitudes about failure to warn claims involving nanoparticle-based sunscreens and clothing designed with nanotechnology. The study also assessed differing attitudes among Baby Boomers, Generation X and Generation Y to nanotechnology. Our research indicates that modern United States jurors are critical of any lack of notice or warning about a product containing potentially harmful ingredients, even if the potential harm is speculative. Our findings were published in For The Defense. For additional information about nanotechnology, our jury study, or the defense of litigation generally, please contact David Governo at dgoverno@governo.com or Sarah O'Leary at soleary@governo.com.

1 http://www.hsph.harvard.edu/nano/research/a-high-throughput-nanogenotoxicity-assay/

2 Brain JD, Curran MA, Donaghey T, Molina R. Responses of the lungs to nanomaterials depend on exposure, clearance, and material characteristics. Nanotoxicology. 2009; 3(1-4):173-9


<back