{"id":2015,"date":"2013-10-09T00:17:41","date_gmt":"2013-10-09T00:17:41","guid":{"rendered":"http:\/\/ncjolt.org\/?p=2015"},"modified":"2020-06-04T20:53:59","modified_gmt":"2020-06-04T20:53:59","slug":"replacing-lab-rats-with-lawyers-the-courts-evidentiary-role-in-ending-animal-testing","status":"publish","type":"post","link":"https:\/\/journals.law.unc.edu\/ncjolt\/blogs\/replacing-lab-rats-with-lawyers-the-courts-evidentiary-role-in-ending-animal-testing\/","title":{"rendered":"Replacing Lab Rats with Lawyers: The Courts\u2019 Evidentiary Role in Ending Animal Testing"},"content":{"rendered":"

Tuesday, October 8, 2013, by Llogan Walters
\nIn the past, even in the most ancient years of scientific research, toxicology and effectiveness testing for substances and procedures to be used on humans was conducted using animals as research subjects<\/a>.\u00a0 But it is often suggested that the institution is more trouble than it is worth<\/a>. \u00a0One arguably obvious problem with the animal testing model is that it does not fit its final intended beneficiaries\u2014humans.\u00a0 More simply put, that the problem with animal testing of human products is that animals are not human.
\nThe use of animals as research subjects is a practice that was used as early as ancient Greece; the practice is nearly 2,500 years old<\/a>.\u00a0 Lately, however, the practice has begun to come under fire from activists and scientists alike.\u00a0 The result has been a sharp increase in the amount of regulation<\/a> of animals used in scientific and medical research in recent decades.\u00a0 However, \u00a0\u201cmethods of testing that do not use animals are being and continue to be developed which are faster, less expensive, and more accurate than traditional animal experiments[.]\u201d<\/p>\n

\u201c\u2018It has been shown that the technology is such today that animal testing is outdated,\u2019 Moran said. \u2018I do think that animal testing will one day be a dim memory.\u2019 . . . Notably, many chemical companies have said they support alternatives to animal testing and some have already switched to such methods<\/a>.\u201d<\/p>\n

\n

[S]imply put, that the problem with animal testing of human products is that animals are not human.<\/p>\n<\/blockquote>\n

One popular example of these methods is explant tissue culturing.\u00a0 An explant culture may involve specific types of cells or multiple cells types which may be obtained from humans<\/a>.\u00a0 Established cultures can be used for observational or experimental purposes, including scientific and medical testing. \u00a0Normal tissues have also been manipulated to develop disease<\/a>.
\nRegulations are not nearly as strict for cultured tissue research subjects as they are for animal subjects<\/a>.\u00a0 These lighter requirements may act as incentives to use alternatives such as explant culture for many facilities. An additional incentive to use explant culturing is the scientific concern of accuracy, which is higher in explant tests than in animal tests<\/a>.\u00a0 The goal is noble, the concern valid, and the regulations well-placed to put pressure on researchers to do away with a flawed system; at times, the courts have made contributions of their own.
\nDecided in 1993 by the Supreme Court of the United States, Daubert v. Merrell Dow Pharmaceuticals, Inc.<\/i><\/a> established the current standard governing when experts are allowed to give testimony based on opinions that they have developed through their research.\u00a0 The Court created what is sometimes referred to as the two-prong Daubert<\/i> test,\u00a0 charging courts with determining whether expert witnesses possessed \u201cscientific knowledge\u201d that would \u201cassist the trier of fact to understand or determine a fact in issue.\u201d
\nThe Supreme Court of North Carolina, however, expressly rejected Daubert<\/i> \u00a0In Howerton v. Arai Helmet, Ltd.<\/i><\/a>\u00a0 Instead this court currently applies its own standard\u2014laid out in State v. Goode<\/i><\/a> and known, appropriately, as the Goode analysis. \u00a0The court supported its \u00a0original reasoning by stating that the standard formed in Daubert<\/i> was actually far more austere than it should be.
\nHines v. Wyeth<\/i><\/a> <\/i>and Bourne<\/i> v. E.I. Dupont de Nemours & Co<\/i><\/a>. <\/i>are two cases in the Fourth Circuit in which the plaintiffs brought suit against companies due to alleged adverse effects from chemical exposure. \u00a0In Hines<\/i>, plaintiff Leah Royce Hines was diagnosed with breast cancer after being prescribed hormone replacement therapy drugs.\u00a0 Hines brought several products liability claims against Wyeth LLC and Upjohn, the manufacturers of the three drugs which she had been prescribed.\u00a0 Two expert witnesses, Doctors Tilley and Austin, were to testify in the case; each believed that Provera (or medroxyprogesterone acetate (MPA)) was unsafe for women needing hormone replacement therapy.\u00a0 The court granted the defendants\u2019 motion to exclude the doctors\u2019 testimony due to their research methods.
\nDr. Tilley based his testimony in large part upon a 2006 study performed using Wood monkeys as test subjects.\u00a0 The results indicated that the monkeys given the MPA drug were more highly predisposed toward the development of breast cancer.\u00a0 The court, using the Daubert<\/i> standard, refused to apply the results of the Wood monkey experiment to humans because of the lack of any verified data that MPA drugs had a significant carcinogenic effect on humans.\u00a0 The court explicitly stated that \u201canimal studies cannot be reliably extrapolated to humans.\u201d
\nIn Bourne<\/i>, the plaintiff sued the manufacturer of a chemical fungicide known as benomyl, stating that exposure to the chemical during pregnancy had caused her child to be born with severe birth defects.\u00a0 The Bourne<\/i> court, also applying the Daubert<\/i> standard, excluded the testimony of expert witnesses who conducted in vivo<\/i> and in vitro <\/i>tests for the effects of benomyl on rats, which the court found insufficient to justify expert witness testimony that the chemical had caused plaintiff\u2019s birth defects.
\nIn both cases, plaintiffs\u2019 experts based their testimony upon results obtained from animal subjects. \u00a0The courts in both cases relied on the two-prong Daubert<\/i> test. \u00a0And in both cases, the courts ruled that findings based upon animal tests failed.
\nNorth Carolina courts, unlike others in the Fourth Circuit, currently bind themselves to a precedent which places its focus on the amount of evidence that a court admits to trial, rather than the relevance thereof\u2014a standard of quantity rather than quality.\u00a0 Not only does the relevance of testimony protect plaintiffs\u2019 interests but stricter standards may, just as increased regulations on animal research<\/a> have, incentivize the use of more modern technologies.\u00a0 If researchers are pushed to utilize methods that are more accurate to humans, such as explant culture, it would have a positive lasting in the sense that public concerns regarding animal testing as flawed and often inaccurate would be alleviated.
\nAnimal research is a long-lived practice, however it is not the only method of conducting scientific research meant for the benefit<\/a> of humans.\u00a0 At the same time, explant culturing and the collection of human tissues therefor have remained largely unregulated, and explant culture continues to surge forward in its applicability to humans and public health and welfare.\u00a0 At current, there is an opportunity for efficiency to intersect with justice; will simply being more comfortable with its older standard lead North Carolina to miss it?
\n <\/p>\n","protected":false},"excerpt":{"rendered":"

Tuesday, October 8, 2013, by Llogan Walters In the past, even in the most ancient years of scientific research, toxicology and effectiveness testing for substances and procedures to be used on humans was conducted using animals as research subjects.\u00a0 But it is often suggested that the institution is more trouble than it is worth. \u00a0One …<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[51],"tags":[],"_links":{"self":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts\/2015"}],"collection":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/comments?post=2015"}],"version-history":[{"count":1,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts\/2015\/revisions"}],"predecessor-version":[{"id":7566,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/posts\/2015\/revisions\/7566"}],"wp:attachment":[{"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/media?parent=2015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/categories?post=2015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/journals.law.unc.edu\/ncjolt\/wp-json\/wp\/v2\/tags?post=2015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}