Category: Litigation

Checks and Balances

Posted May.24, 2012 under Cosmetics, Courts, Environment, FDA, Food, Government Agencies, Health, Litigation, Regulation, Safety

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Sometimes the Government  just might work as it was intended.

In an earlier post, I reported on a lawsuit brought by a coalition of environmental and consumer safety groups requesting declaratory and injunctive relief under the Administrative Procedure Act to force the FDA to respond to a 2006 petition seeking action by the agency to assure the safety of members of the public exposed to nanomaterials, particularly nanoparticles in sunscreens.  On May 14, 2012, the coalition voluntarily dismissed its action, International Center for Technology Assessment v. Hamburg, a case that had been brought in federal court for the Northern District of California (No. 11-6592).

In other posts on this blog, I have reported on the draft guidances recently issued by the FDA on the safety of nanomaterials in food, food packaging, and cosmetics, as well as the upcoming International Cooperation on Cosmetics Regulation (ICCR), to be hosted by the FDA.  The coalition has withdrawn its lawsuit because the FDA has in fact finally responded to the earlier petition by issuing the draft guidances.  Although attorneys for the coalition have emphasized that the FDA’s response does not propose all the relief the coalition sought in its lawsuit, at the present time the FDA is showing interest in the safety of engineered nanomaterials in products within the agency’s jurisdiction.  The lawsuit had sought, among other things, regulation of these nanomaterials.  But the FDA guidance documents made recommendations for voluntary measures by industry, not new regulation.  This, of course, leaves open the possibility of a future lawsuit challenging the steps taken – or not taken – by the FDA in furtherance of the safety initiatives.

Our high school civics classes teach us that the tripartite structure of the federal Government is intended to allow the various parts of the Government to act as a check on the actions or inactions of the other parts.  In recent years, the judicial system has been much maligned.  In the matter of nanomaterials and the FDA, the threat of judicial intervention – being told by the courts what it should do – was likely one (and only one) motivation for the FDA to pursue a safety agenda for nanomaterials.  Instead of needlessly consuming resources at this stage, the coalition withdrew its lawsuit when the FDA moved forward on this subject.  So let’s give a hand all around for the Government working as it was intended.

The withdrawal of the coalition’s lawsuit was reported by

Pat Rizzuto, Coalition Withdraws Lawsuit Against FDA Following Agency’s Release of Guidance, 100 Daily Env’t Rep. (BNA) A-15 (May 24, 2012) (by subscription)

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Let the Lawsuits Begin

Posted Dec.28, 2011 under Cosmetics, Courts, Drugs, Environment, FDA, Food, Government Agencies, Health, Litigation, Regulation, Safety

prod liab imageIt had to happen sooner or later.  And it’s happening now.  A coalition of nonprofit consumer safety and environmental groups brought an action on December 21 in federal district court in California against the Food and Drug Administration (FDA).  The action seeks an order for declaratory and injunctive relief under the Administrative Procedure Act to require the FDA to respond to a petition filed with the FDA in 2006 which sought action by the agency to assure the safety of the public exposed to nanomaterials, particularly sunscreen products.  The requested relief is detailed on pages 3-4 of the petition.  The lawsuit is International Center for Technology Assessment v. Hamburg (N.D. Calif., CV 11-6592).

The coalition includes the International Center for Technology Assessment (ICTA) as lead plaintiff for Friends of the Earth, Greenpeace, Food and Water Watch, the Center for Environmental Health, the Action Group on Erosion, Technology and Concentration (ETC Group), the Institute for Agricultural and Trade Policy, and several other groups.

Among other things, the petition detailed the status of research on and knowledge of the risks of nanomaterials, both relating to consumer products and the environment.  This information included studies that have indicated some of the ways that engineered nanoparticles may harm living cells through new channels of exposure.  Moreover, in 2007, the FDA’s own Nanotechnology Task Force issued a report recommending that the FDA issue guidance to manufacturers using nanomaterials and take steps to improve scientific knowledge of nanotechnology.

In the weeks to come, we will be anticipating the response from the FDA, which may very well insist that it has undertaken the efforts sought by the petitioners.  There are several other legal strategies that the FDA could employ, including claiming the lack of legal authority to put into place some or all of the relief sought in the petition or the need for interagency coordination.

The greatest significance of this lawsuit is that it puts nanotechnology into the courts.  This may be the first time, but it certainly won’t be the last time.

The 80-page petition is available at

http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf

The 2007 Nanotechnology Task Force report is available at

http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForceReport2007/default.htm

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The Bigger Picture: Thinking About Technology, Nano and Otherwise

Posted Sep.25, 2011 under Environment, Evidence, Government Agencies, Litigation, Products Liability, Supreme Court, Toxic Torts
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usalawyerstoday.com

Wondering where we’ve been for the past month?

 My summer was spent thinking and writing about technology – all sorts of technology.  It got me thinking about how technology has changed our lives and how it is poised to change all aspects of the law.  Let me share with you my summer projects, which go well beyond nanotechnology issues.  I hope it will enable me to put the legal issues of nanotechnology in a broader context going forward.

 1.  Neuroscience and Tort Law.  I and my co-author (and co-blogger) Eric Laury embarked upon a project more than a year ago to examine how the so-called “new neuroscience” will impact tort law.  By “new neuroscience” we mean mostly functional neuroimaging (fMRI and SPECT), but also any other neuroscientific methods to examine the human brain, including brain wave technology.   Our approach to this extensive law review article was both doctrinal (i.e. how the new neuroscience will eventually change the rules of tort doctrine) and practical (i.e. the problems of incorporating it in tort litigation, particularly under the rules of evidence).  We spent a lot of time predicting the effect that the new neuroscience will eventually have in the courtroom.  Professor Stephen Morse at UPenn Law School has pointed out that much of what we currently know as legal doctrine is based upon “folk psychology” – that is, what we believe causes people to act the way they do.  The new neuroscience will eventually change the law by changing our understanding of human behavior.

 2.  Cell Phones.  I also found myself writing a piece on cell phones and product liability.  In particular, I looked at whether actions claiming the telecommunications industry should be marketing cell phones with headsets to protect against the hazards of radio frequency (“RF”) emissions should be allowed, or whether they are preempted by regulations granting the FCC the authority to set radiation standards for cell phones.  The question, it turns out, it much more complicated than one might think and involves several federal statutes and regulations, including the two major statutes governing the wireless networks in this country.  The Supreme Court will consider a petition for certiorari in Farina v. Nokia, 625 F.3d 97 (3d Cir. 2010), early in the new term.  Even if cert is not granted, this topic likely will continue to make waves in the courts.  My article appears on the BNA subscription service at 39 Prod. Safety & Liab. Rep. (BNA) 871 (Aug. 5, 2011) and 26 Toxics L. Rep. (BNA) 949 (Aug. 10, 2011).  It also appears in U.S. Law Week at 80 U.S.L.W. 321 (Sept. 13, 2011).

 3.  Nanotechnology and the Environment.   I also wrote a short article to be published in the “Insight” section of the upcoming Natural Resources & Environment journal, which is the journal of the ABA Environmental Law Section.  My goal was to alert attorneys to some of the regulatory initiatives either in the works or in the pipeline.  The piece focuses on TSCA, FIFRA, OSHA, and foreign initiatives (EU, Australia).  It was interesting to look at the impact of nanomaterials exclusively from the environmental (outdoors and indoors) perspective.

So while I may not have been spending a lot of time blogging about nanotechnology and the law, I was busy getting the bigger picture on technology.

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U.S. Supreme Court to Address an Issue Left Open in Bilski

Posted Jul.21, 2011 under Bionanotechnology, Litigation, Nanomedicine, Patents, Statutes, Supreme Court

supctIn 2010, the U.S. Supreme Court issued a closely-watched decision on patentable subject matter under § 101 of the Patent Act, Bilski v. Kappos, 130 S. Ct. 3218 (2010).  The Court has now granted cert in another case on patentable subject matter – Prometheus Laboratories, Inc. v. Mayo Collaborative Services, in which the Federal Circuit Court of Appeals held in 2010 that certain medical inventions met the requirements of patentable subject matter in § 101.  Prometheus was the sole and exclusive licensee of certain patents that claim methods for determining the optimal dosage of thiopurine drugs used to treat gastrointestinal and non-gastrointestinal autoimmune diseases.  When Prometheus sued Mayo for patent infringement, Mayo filed a motion for summary judgment of invalidity, arguing that the patents in question were invalid because they claimed subject matter unpatentable under the Patent Act, 35 U.S.C. § 101. Specifically, Mayo argued that the patents impermissibly claimed natural phenomena – i.e. the correlations between drug metabolite levels and efficacy and toxicity – and not patentable inventions.  In 2008, the district court granted Mayo’s motion for summary judgment of invalidity.

In 2009, the Federal Circuit reversed and upheld the patents under the “machine or transformation” test (the sole test at the time).  The U.S. Supreme Court then decided Bilski v. Kappos, which we discussed in this blog a year ago.  In Bilski, the Court rejected the “machine or transformation” test as the definitive test of patentability, relegating that test to one factor – “a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101.”  130 S. Ct. at 3227.  The Supreme Court then granted Mayo’s petition for certiorari in the Prometheus lawsuit, vacated the Federal Circuit’s 2009 decision, and remanded the case for further proceedings consistent with Bilski.  The Federal Circuit decided the case on briefs, without further oral argument, and held, in light of Bilski, that Prometheus had recited patentable subject matter under § 101.  628 F.3d 1347 (Fed. Cir. 2010).  Once again, the Supreme Court granted certiorari, and the Court will hear the case in the term that begins in October, 2011.

Although the Supreme Court has consistently construed § 101 broadly, the section does have limits.  The Federal Circuit described one limitation as follows:

The Supreme Court has . . . established that while a law of nature, natural phenomenon, or abstract idea cannot be patented, “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”

628 F.3d at 1354 (quoting Bilski, 130 S.Ct. at 3230) (emphasis added).  This is the core of the issue to be decided by the Supreme Court. 

As my co-blogger, Eric Laury, now J.D., stated in his earlier post about Bilski, “biotech and nanotech patents are not theoretically involved with . . . a machine nor do they transform matter.”  Bilski was good news for the bionanotech industry, but the case left loose ends.  Now it appears that the Supreme Court will take another step in the direction of defining patentable subject matter for the brave new world of modern inventions.  Nanotech firms, particularly those working in the area of biotechnology, should be closely watching the Supreme Court’s next move.

Mayo presented the following question in its cert petition:  “Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve ‘transformations’ of body chemistry.”

I suspect the fact that the Court granted cert a second time in Mayo v. Prometheus may not be a good sign for Prometheus.  It may mean that the Court had been expecting the Federal Circuit to reach the opposite result and wants to set the record straight.  On the other hand, the Court may further refine its definition of patentable subject matter under § 101 in a way that may achieve middle ground between innovation and patent protection.

The Federal Circuit’s 2010 decision may be accessed at

http://www.cafc.uscourts.gov/images/stories/opinions-orders/08-1403.pdf

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Supreme Court Rules in Favor of i4i Limited Partnership in Closely Watched Patent Case

Posted Jul.13, 2011 under Bionanotechnology, Litigation, Patents, Statutes, Supreme Court

supctEarlier I reported here on Microsoft Corp. v. i4i Limited Partnership, then subsequently on the oral argument before the U.S. Supreme Court.  The case arose from a patent infringement dispute relating to the method for editing computer documents, but generated wide-ranging interest in the business community, including developers of nanotechnology-based inventions, because of the broad legal issue addressed.  i4i sued Microsoft for patent infringement, and Microsoft defended on the ground that i4i’s patent was invalid.  The federal district court gave a jury instruction that the invalidity of a patent had to be proved by “clear and convincing” evidence.  Despite Microsoft’s arguments that it should be easier to prove invalidity of a patent (such as by applying a preponderance-of-the-evidence standard) in patent infringement litigation, the federal district court, Federal Circuit Court of Appeals, and the U.S. Supreme Court (in an 8-0 decision) all decided that the clear and convincing standard applied.

Justice Sotomayor, writing for the unanimous Court, 131 S. Ct. 2238 (2011), based the Court’s decision squarely on Section 282 of the Patent Act, 35 U.S.C. § 282, which provides a presumption of validity to patents, and on longstanding common-law doctrines.  The Court deferred to the judgment of Congress in the Patent Act, saying that “[w]here Congress has prescribed the governing standard of proof, its choice controls absent ‘countervailing constitutional constraints.”  (p. 2244)  No such constraints existed here.  Addressing Microsoft’s other argument – that a preponderance standard should apply where, as here, not all evidence in the case had been before the PTO during the patent examination process – the Court said that information could be a factor in the jury’s decision, but did not warrant a different standard of proof.  (p. 2250-51).

For nanotechnology firms with existing patents on inventions or in the R&D process, the Court’s decision is good news.  It provides a strong measure of certainty and economic stability to stakeholders investing in and promoting the patented technologies.  It also allows firms to bring patent infringement claims while maintaining some sense of security about their own patent’s validity.  Taken together with the 2010 Supreme Court case of Bilski v. Kappos, 129 S. Ct. 2735 (2010), which retained a broad definition for patentable subject matter, Microsoft v. i4i should provide nanotech patent holders with plenty of reason to be pleased.

 The decision is available at

http://www.supremecourt.gov/opinions/10pdf/10-290.pdf

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Justices Consider Many Options in Microsoft v. i4i Patent Case Oral Arguments

Posted May.10, 2011 under Litigation, Patents, Statutes, Supreme Court

supctOn April 18, 2011, the U.S. Supreme Court heard oral arguments in Microsoft v. i4i Limited Partnership, a patent case I previously addressed in this blog.  The central issue before the Court involved the standard of proof used to determine the validity of a patent in patent infringement litigation.  The court below had held that a party sued for patent infringement who raises invalidity of the patent as a defense must prove invalidity by clear and convincing evidence.  Microsoft, the petitioner, argued that because Section 282 of the Patent Act, 35 U.S.C. § 282 – which provides a presumption of validity for a patent – does not specify a heightened standard, the standard should be a preponderance of the evidence, thereby making it easier to challenge the validity of a patent.  i4i argued that the clear and convincing evidence standard, which has been followed for decades, should continue to apply.  Chief Justice Roberts has recused himself from the case because of investments he holds in Microsoft.

Early in the argument, Justice Kagan noted that the early cases addressing the subject contained broad language suggesting a heavy burden of persuasion.  Justice Ginsberg further noted the absence of any attempt by Congress to clarify the standard in the Act.  Absent statutory language to the contrary, Justice Kagan suggested simply following precedent and applying the clear and convincing evidence standard.

Justice Breyer acknowledged that the Supreme Court could make a change to the procedural way this issue is resolved.  He framed the problem as an economic one, a need to achieve balance between providing legal protection for inventions that warrant it and preventing undeserving inventions from taking advantage of the protections of patent law.  One approach to the central issue in the case, he suggested, would be to ask the Patent Office for reconsideration.  Another would be to let the jury apply the clear and convincing standard to the “brute facts,” then allow the judge to make the ultimate decision about validity.

Much of the questioning involved Microsoft’s argument that a clear and convincing standard is not appropriate in a case in which the PTO did not previously consider the  prior art evidence introduced by the defendant in the infringement litigation.  The justices considered whether accepting that argument would mean that two different standards should apply, depending on whether the evidence had been considered by the PTO.  i4i countered with several justifications for applying the clear and convincing standard across the board.  One point was the unfairness of a lower standard, which would make it easier for a single non-expert jury to invalidate a patent when so many parties (inventor, investors, licensees) relied upon the patent at the time it was issued.  Along this vein, another approach considered by the Court during the argument was to instruct the jury to apply the clear and convincing evidence standard, but include a further instruction that the jury could consider, in appropriate circumstances, that the PTO had not considered the prior art.

The variety of suggestions discussed in the oral arguments make prediction of the ultimate result difficult.  It is still possible that the Court will find a clear answer in the language of Section 282.  Firms with patents on nanotechnology applications could be disappointed to find that the Court rejects an across-the-board use of the clear and convincing evidence standard.  If that happens, infringers will have an advantage over original inventors, and more patents will be held invalid in court.  The effect could be significant, perhaps having a chilling effect on advances in science and on investment in original inventions.

The transcript of the oral argument may be found at

http://www.supremecourt.gov/oral_arguments/argument_transcripts/10-290.pdf

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Patent Case Before U.S. Supreme Court Will Impact Nanotech Firms

Posted Apr.09, 2011 under Litigation, Patents, Statutes, Supreme Court

supctOn April 18, 2011, the U.S. Supreme Court will hear oral arguments in Microsoft Corp. v. i4i Limited Partnership, in which i4i accused Microsoft of patent infringement.  i4i won a verdict in the 2009 case, but Microsoft has pursued the matter on appeal, claiming, among other things, that i4i’s patent was not valid.  The Supreme Court is now being asked to address the standard of proof required to establish whether a patent is invalid in patent litigation.

 Section 282 of the Patent Act, 35 U.S.C. § 282, provides that “[a] patent shall be presumed valid” and imposes the burden of proving the invalidity of a patent on the party claiming that the patent is invalid.  But the Act does not indicate the strength of that presumption.  In 1984, the Federal Circuit Court of Appeals, in American Hoist & Derrick Co. v. Sowa & Sons Inc., 725 F.2d 1350 (Fed. Cir. 1984), held that invalidity must be proved by clear and convincing evidence.  This means that sometimes invalid patents will benefit from the gloss of validity because the standard of proving invalidity is so high.  Although the U.S. Supreme Court has not yet addressed this issue, Microsoft has pointed to the Court’s language in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), in support of its challenge to the clear and convincing language.  In KSR, the Court stated that at least under the circumstances of that case “the rationale underlying the presumption . . . seems much diminished.”

 If the Supreme Court were to reject the clear and convincing standard and impose one based upon, for example, a preponderance of the evidence, alleged infringers would have an easier time challenging the validity of the holder’s patent.  All participants in patent litigation would feel the impact, including patent holders, challengers, and judges.

 How will the Microsoft v. i4i decision impact nanotech firms?

 Patents incorporating nanotechnology often involve newer innovations, with the patent holders seeking to establish a place in commerce.  If a party challenging the patent’s validity must prove invalidity by clear and convincing evidence, the holder of the patent may have an advantage in litigation. And this litigation advantage could translate into a commercial advantage.  By contrast, if the Supreme Court lowers the threshold for the presumption of validity, holders of newer and more innovative patents could lose their competitive edge.  The impact in the nanotechnology field would be felt most strongly by smaller, upstart firms.

 I will report again on this matter after the oral arguments on April 18.

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Thinking Again about Nanoparticles and Asbestos

Posted Mar.29, 2011 under Asbestos, Environment, EPA, Governmental Interaction, Health, Litigation, Nanotubes, Products Liability, Regulation, Research, Safety, Toxic Torts, Workplace

asbestos-fibreEarlier, I wrote about some potential similarities between asbestos personal injury litigation and the litigation that is certain to come over nanoparticles and human health.  I will be writing on and off about this topic going forward as well.  I can’t emphasize enough the urgency of avoiding another disaster like asbestos litigation, which has clogged the courts since the 1970s.

For example, engineered nanomaterials are being placed into building materials.  In the first instance, these materials are being designed and manufactured in the primary workplace environment, thus potentially exposing workers to hazards about which little or nothing is known.  Another set of workers, those using the building materials in the secondary workplace, run the risk of exposure to potentially harmful substances.

The history of asbestos shows that the early studies were conducted on asbestos textile factory workers, but that meaningful studies on workers out in the field who were installing the materials lagged far behind.  Then, when the studies began to raise danger signals, the industry ignored those signals until the specter of mass litigation and government regulation forced recognition.  By then it was too late.

Nanomaterials present some of the same workplace issues, particularly when used in building materials.  The hazards of the primary workplace may be different from those in the secondary workplace.  Studies must be conducted on both types of environments.

Further, there is a third concern, which also mirrors the asbestos experience.  At some point down the line (years or decades), the anticipated life of the materials will expire, just as asbestos insulation materials have done.  At that point, degeneration of the materials could put nanomaterials into the environment to a degree that could endanger the safety of persons in the vicinity.

In the case of nanomaterials, do we know any of this for certain?  No.  But at the present time we know almost nothing about any of these safety issues.  In December, the National Institute for Occupational Safety and Health (NIOSH) proposed a workplace exposure limit for carbon nanotubes and nanofibers.  This is a start; but without hard data, it is really only a guess.  And it is not necessarily consistent with limits for other substances.

While the industries creating and using nanomaterials will likely take seriously the lessons of asbestos, more should be done up front to ascertain the seriousness and scope of the hazards that the materials may present.  Now is the time.  If the hazards outrun the studies, the finish line will be litigation.

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Daubertizing Nanolitigation – Part 4

Posted Mar.22, 2011 under Chemicals, Cosmetics, Evidence, Health, Litigation, Pesticides, Products Liability, Research, Safety, Toxic Torts

nano 6In my previous post, I indicated that I would be moving on to discuss the relevancy arm of the Daubert admissibility test.  It turns out I have a few more thoughts about the reliability arm.

 What does it mean for admissibility purposes when the expert testimony sought to be introduced in litigation is based on an established methodology used in a new context?  This is likely to be an issue when parties seek to introduce studies of the health and safety effects of nanomaterials.    Does such a new subject of a study transform an established methodology into a new and untested methodology?  If so, the evidence would face a much more rigorous level of scrutiny.

 Researchers acknowledge that the state of research on the health and safety aspects of nanomaterials is in its infancy.  Some have noted that due to the costs of obtaining necessary quantities of nanomaterials for animal testing, that type of toxicological testing has given way to the use of more efficient in vitro laboratory tests.  While both animal testing and in vitro tests have been used to test toxicity for a very long time, their reliability in testing chemicals at the nanoscale has yet to be fully assessed.  This could lead to exclusion of the evidence under either the Frye or Daubert analysis, at least until such the use of the studies gains greater reliability.  In other words, courts could view this as a new and untested methodology.

 A related issue is the value of in vitro tests generally in litigation to show a connection between exposures and injuries.  Studies conducted in laboratory containers do not receive high marks from courts generally when introduced to demonstrate causation between an exposure and a person’s injuries.  Courts prefer both epidemiological studies – which determine statistical risks in human populations – and animal bioassays over in vitro studies.

 All of this adds up to some thorny questions that will have to be resolved.

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Daubertizing Nanolitigation – Part 3

Posted Mar.01, 2011 under Chemicals, Cosmetics, Environment, Evidence, Health, Litigation, Pesticides, Products Liability, Research, Safety, Toxic Torts

supctThis post continues the discussions in earlier posts about evidentiary standards for admissibility of health and safety studies on nanomaterials under both the Frye standard and the Daubert standard.  I will resume the reliability discussion here, this time focusing on the reliability standards applied in the federal courts and other Daubert jurisdictions.

Under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), reliability of expert scientific evidence is determined in relation to four factors.  These four “general observations” set forth in the Daubert decision were intended to provide guidance to the trial court making a decision about admissibility of expert scientific evidence.  All four need not be favorable to the party seeking admission of the evidence for the evidence to be ruled admissible.  The Supreme Court has said that when it comes to scientific studies, evidentiary reliability is the equivalent of scientific validity.  What makes a scientific study (and the expert testimony relying on it) valid?  The Supreme Court set forth these “general observations”:

 (1)  Whether the scientific theory or technique on which the evidence is based has been tested (presumably by the scientific method);

(2)  Whether the study has been published or has undergone another form of peer review;

(3)  The known or potential rate of scientific error associated with the methodology;

(4)  Whether the methodology has achieved general acceptance in its field.

Although these factors reduce the weight of general acceptance (the sole Frye criterion) in the admissibility analysis, the reality is that the Daubert test has raised the bar in litigation for plaintiffs seeking to have their scientific proof admitted.  These factors are often applied strictly.

Will scientific studies on the health and safety effects of nanomaterials be treated differently under the Daubert reliability analysis than under the Frye general acceptance test?  The primary difficulty under Daubert, as under Frye, is the newness of the studies.

Although the Supreme Court in Daubert said that the focus of the reliability analysis should be on the scientific methodology or technique – and not on the conclusions reached – the Court subsequently modified that statement.  In General Electric Co. v. Joiner, 522 U.S. 136 (1997), the Supreme Court said that “conclusions and methodology are not entirely separate from one another,” thus inviting the trial court to consider the conclusion and whether it constitutes the kind of novel theory that may not be admissible.

It may be true generally that newer methodologies may not have been sufficiently tested, peer reviewed, or accepted in the relevant scientific community, and that they could have a potentially high (or unknown) rate of error.  But one issue that will need to be sorted out in the era of nanostudies will be whether the methodologies for these studies consist of tried-and-true testing methods or, in contrast, will be viewed as novel because of their focus on materials at the nanoscale.  This distinction could make a critical difference in whether such studies will be admitted in litigation in a Daubert jurisdiction.  Tried-and-true carries more admissibility weight.

Perhaps one way to look at this issue – and one that is relevant to the emerging studies of nanomaterials – is the way that a federal district court analyzed the problem in Smith v. General Electric Co., 2004 WL 870832 (D. Mass. 2004).  When confronted with novel and admittedly “controversial” studies, the court concluded that the experts were “serious scientists with controversial views that are in many respects on the periphery of the mainstream, but views that are not so divorced from a scientific method of investigation that they can be dismissed as quackery or armchair conjecture.”  While the district court was likely correct in observing that Daubert did not require or perhaps even empower a court to “determine which of several competing scientific theories has the best provenance,” many would reject the flexible view of Daubert applied in Smith.

Reliability is only part of the admissibility analysis for scientific studies articulated by the Supreme Court in Daubert.  Relevance of the evidence is equally important, and my next post on the subject will look at the relevance of scientific evidence as it has been explained by the Supreme Court in Daubert and Joiner (mentioned above).

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