Category: Health

usalawyerstoday.com

usalawyerstoday.com

In product liability litigation, product sellers often rely on the so-called state-of-the-art defense.  By raising this defense, the seller – usually the product manufacturer – argues  that the risks or hazards of the product complained of in the current litigation were not known to it at the time the product was designed, marketed, and sold to the user or consumer.  As with everything in the law, arguments abound as to how to define the state of the art.  For example, manufacturers have argued that the state of the art should be defined as the industry standard at the time.  This was essentially the argument made by asbestos insulation products manufacturers in the seminal case of Borel v. Fibreboard  Paper Products Corp., 493 F.2d 1076 (5th Cir. 1973).  The court had a very different view, however.   Reflecting concerns that using the industry standard to define the state of the art at any point in time would encourage entire industries to be lax in conducting research on the hazards of their products and/or disseminating information about known hazards to the public, the court held the manufacturers to the standards of experts in the industry.  The court defined this as follows:

The manufacturer’s status as an expert means that at a minimum he must keep abreast of scientific knowledge, discoveries, and advances and is presumed to know what is imparted thereby.  But even more importantly, the manufacturer has a duty to test and inspect his product.  The extent of research and experiment must be commensurate with the dangers involved.

Id. at 1089-90.

Plaintiffs, on the other hand, prefer to define the state of the art to reflect technology on the cutting edge of scientific knowledge at the relevant time.  This concept would limit use of the state-of-the-art defense to a much smaller group of cases and result in broad liability for product sellers.  This view completely ignores whether making the product safer was feasible at the time or whether the utility of the product was greater than the possibility of any dangers it might create.  At the extreme, sellers could be absolutely liable for any and all injuries from their products.  Thus, in Beshada v. Johns-Manville Products Corp., 447 A.2d 539 (N.J. 1982) – another asbestos failure-to-warn case – the court refused to recognize the state-of-the-art defense on policy grounds because the manufacturers were in a better position to bear the losses associated with their products, and spread those costs, than the injured victims.

But the prevailing view allows product sellers to rely on state of the art as a defense to claims for defective products.  The Third Restatement of Torts:  Products Liability (1998) refers to “the foreseeable risks of harm” as a basis of liability for defective design and failure to warn of the hazards of a product.  But what is foreseeable?  All lawyers know the answer to that question is unclear and very fact specific.

Which brings us to the risks of nanotechnology.  What should we demand of sellers of nanotechnology and the products making use of the technologies?   Should the burdens of research into the risks be greater or less because the technology is developing?  Whether or not regulation occurs, personal injury litigation will arise at some point.  It seems inevitable, given the course of other consumer and workplace products.

One thing is clear:  It will not suffice for defendants to argue that they were not aware of the potential hazards of their products if they did not conduct research into the health and safety impacts and apprise themselves of all other available and pertinent research results.  If concerns arise from initial research (as they have in some studies of nanoparticles), their obligation is to conduct further research and to use the information in product design decisions or to provide sufficient warnings.  The words of the Court of Appeals in Borel resonate here:  “But even more importantly, the manufacturer has a duty to test and inspect his product.  The extent of research and experiment must be commensurate with the dangers involved.”

www.h20technologies.com

www.h20technologies.com

We are seeing an explosion of interest in and information about nanotechnology, its uses and its risks.  The law has yet to develop in this field.  I am pleased to start the conversation in this blog on the legal issues that are beginning to emerge about nanotechnology.  My entries will focus on efforts to determine what risks the new technologies may pose to consumers and the population in general.  My expertise in the area of toxic tort law is uniquely suited to examining the emerging health concerns from the viewpoint of anticipated litigation.  My co-blogger, Eric Laury, Widener Law ’11, will focus on the legal issues involving the development and use of the technologies, including intellectual property matters.  This blog is not intended to be a news source, though it will provide some links to stories in the news that bear upon our commentary.  Rather, we intend to analyze and question the developments as they emerge, and to place them in a legal context that will be useful for attorneys, regulators, and other legal observers.  We hope that our observations will begin the discussion and debate over the legal ramifications of nanotechnology.

Every week, numerous developments are reported in the media, but I will give my attention here to just one of them.  On March 25, 2010, the President’s Council of Advisors on Science and Technology (P-CAST) issued its report on the Third Assessment of the National Nanotechnology Initiative.  Among many other things, P-CAST calls for “clear principles” for identifying the environmental, health, and safety risks of nanotechnology.  To implement this, the report recommends further development of the existing cross-agency strategic plan to link research activities and information sharing and suggests that “member agencies increase coordinated efforts to overcome barriers to effective, sustainable, and responsible commercialization of nanotechnology.”

This is vague, suitably so for the first steps toward regulation.  One might question, however, the laissez-faire approach that it supports.  To start the discussion on examining the risks of nanotechnology, it is worthwhile to consider how the Government might regulate the products of these technologies.  What would regulation of the health and environmental impacts of nanotechnology look like?  One possibility is the current P-CAST proposal – interagency exchange of information with an individual directing interagency coordination efforts.  Another model would be the creation of an umbrella agency to manage nanotechnology, including the health, environmental, and safety risks of products using the technology.  This concept would take all nanotechnology-related matters away from other agencies – which, presumably, have at least some experience with handling new technologies – and place them within the authority of the new agency.  Another model might be creating a Department of Science and Technology along the lines of the Department of Homeland Security, though determining which agencies – or which parts of which agencies – would fall within the authority of a new Department would be problematic.  Finally, we could leave well enough alone and let existing agencies regulate individual uses of nanotechnology as they arise.  Under this incremental approach, for example, the FDA could regulate medical uses of nanotechnology on a use-by-use basis.

We need to think now about regulating nanotechnology and about what structure that regulation should take.  The history of toxic tort litigation is strewn with products that were allowed on the market with little or no health and safety regulation.  The result was massive health risks, seemingly endless litigation, and studies done too long after the fact.  Just consider the course of asbestos litigation.

www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-nano-report.pdf

http://www.techwall.org

http://www.techwall.org

As technology in the bioscientific realm advances, there is an emerging body of law pertaining to patents on biological material, which focuses squarely on the hotly contested areas of personalized medicine and nanotechnology.  Personalized medicine is the practice of creating therapies for the specific genetic profiles of patients and their diseased cells.  Examples of the nanotechnology involved include cancer treatment, bio sensors, bio markers, bio imaging, and drug delivery systems.  The controversies are beginning to form and the potential for litigation is building.  Are these inventions worthy of patent protection?  What happens to these particles after they perform the specific task they were designed to carry out?  Is it a health issue, environmental issue, both?  These are the types of inquiries I am interested in exploring.  By no means do I purport to have expertise in ANY of the myriad fields I plan to touch on, but I am curious, though, and look forward to initiating a robust dialogue with those who are experts or those who are passionate about the direction of the law in these areas.

With that being said, I would like to begin with a broad and general overview of the current patentability issues.  The first hurdle in the patent process is actually having something that is patentable subject matter.  The nexus of the debate is 35 U.S.C. § 101 which provides:  “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof, subject to the conditions and requirements of this title.”  The statute is inherently ambiguous and has enjoyed broad interpretation, when applied by the courts, to determine if something is actually patentable subject matter.  See, e.g., Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (statutory subject matter “include[s] anything under the sun that is made by man.”).  However, the statute does not afford limitless possibilities and probabilities to the inventors of the world.

There are three specific categories that are off limits to the powers afforded by obtaining a patent:  the laws of nature, physical phenomena, and abstract ideas.  Diamond v. Diehr, 450 U.S. 175, 185 (1981).   The primary reasoning for unpatentability was articulated in Gottschalk v. Benson, 409 U.S. 63, 67 (1972), whereby the Court reasoned that, although these three categories could be discovered, they ultimately “are the basic tools of scientific and technological work.”  The rationale is simple, if these basic building blocks of nature were allowed the protective rights of a patent, specifically the right to exclude others from practicing the inventions or discoveries, the world of research would be drastically encumbered and hindered.  These excluded categories, the basic building blocks, are utilized by scientists, inventors, and theorists to create patentable subject matter.

While the discovery of any of the three excluded categories does not qualify for patentability, the application of them that leads to a new and useful process, machine, manufacture, or composition of matter, may very well lead to a patent, including those that have helped to fuel the explosion of scientific research in biotechnology.  Diehr, 450 U.S. at 187.  Those developments have spawned the creation of personalized medicine.  Science is moving forward and is forcing the law to keep pace.

The paradigm to determine the patentability of nanotechnology related to biological material might be altered in the near future due to the Supreme Court hearing the case of In re Bilski (the discussion of this case and the implications of the opinion has the potential to occupy many future posts).  The Court heard oral arguments on In re Bilski on November 9, 2009, and the forthcoming opinion in that matter will have an impact on the patentability of processes, including those that have helped to fuel the explosion of scientific research in biotechnology.  As a result, the development of personalized medicine hangs in the balance.

In addition to the legal, scientific, and ethical debates, there are the personal policy concerns.  A few worth mentioning are those relating to autonomy, freedom to make decisions about resolving/preventing health issues, the right to feel safe about the treatments we receive, and the list goes on.  The point I am trying to make is that we are on the precipice of a new era with the interaction of nanotechnology, personalized medicine, and the law, and we stand to gain more than we could ever have imagined or we stand to lose more than we ever bargained for.

Personalized Medicine Coalition,

www.personalizedmedicinecoalition.org/communications/TheCaseforPersonalizedMedicine _5_5_09.pdf