Opinion ID: 755789
Heading Depth: 3
Heading Rank: 1

Heading: Independent Testing or Validation

Text: 14 The first factor identified by the Daubert Court as a key question in determining whether a technique can be considered reliable scientific knowledge is whether it has been tested and independently validated or replicated. Relating to the present case, Dr. Anderson's findings in a series of tests on carpet samples caused considerable public concern and spurred numerous attempts by the public and private sector to examine and replicate her results. (See Potential Health Risks from Carpets and Carpeting Material: Hearing Before the House Subcommittee on Environment, Energy, and Natural Resources, 103d Cong. lst Sess. 1 (1993), attached to B. Richard Dudek Affidavit as Exhibit 2, pp. 1-2.) 15 Of these attempts to evaluate the scientific reliability of the Anderson test, defendants place primary reliance on a study by the Environmental Protection Agency's (EPA) Office of Research and Development (ORD). (ORD Carpet Study, Toxicology Report: Evaluation of Off-Gassed Carpet Sample Atmospheres, August 6, 1993, at p. I, attached to Dudek Affidavit as Exhibit 1.) The ORD study was a cooperative effort between Anderson Labs and the EPA to conduct simultaneous but separate tests on carpet samples previously identified by Anderson Labs as toxic. Based on these tests, the EPA and Anderson Labs prepared separate reports, which reached radically different findings and conclusions. (Id. at pp. iii-iv.) 16 The EPA drew the following conclusions from its findings: 17 The bottom line from our studies ... is that despite our best efforts, which were considerable ... we have not been able to independently replicate the severe toxicity described by Anderson Laboratories. In fact, we were not able to produce any convincing signs of even mild toxicity attributable to carpet in our tests. Our present conclusion is that there must be an essential difference between the conditions of our experiments and those of Anderson Laboratories, which, despite our efforts, we have not been able to identify. 18 Id. at pp. ii-iii. In addition to the EPA study, defendants rely on the studies of two private corporations, Monsanto Company and Dow Chemical Company, that also were unable to replicate Dr. Anderson's findings of toxicity and neurotoxicity in mice exposed to carpet samples. (Dudek Affidavit at Para. 7; William T. Stott Affidavit at Para. 7.) 19 In response, plaintiffs argue that the protocol of the experiments conducted by EPA and the private companies varied in significant respects from tests conducted by Anderson Labs. (Rosalyn C. Anderson Deposition, Vol. 2, pp. 23-24.) For example, one significant objection Dr. Anderson lodged against EPA's protocol was that, rather than using ambient air to conduct its experiment, EPA used a clean air source and added water to it before it entered the carpet chamber. (Id. at p. 23.) In response, defendants submitted an affidavit of one of the EPA researchers stating that using a clean air source and controlling the humidity amounts, rather than using unfiltered ambient air as Anderson Labs did, was necessary to achieve a standard, controlled set of conditions. (Jeffrey S. Tepper, Affidavit at Para. 6.) In his affidavit, Dr. Tepper also stated that the EPA's protocol was endorsed by a neutral group of peer reviewers prior to commencement of the ORD carpet study. (Id.; see also Dudek Affidavit, Exhibit 1, p. PR-11.) 20 Other than the difference in air sources, Dr. Anderson cites two other examples of problems with EPA's protocol she personally observed. First, Dr. Anderson asserts that she observed instances in which the air flow system was not connected to the animal exposure chamber. Second, Dr. Anderson claims that the animals were not positioned properly in the exposure chamber. (Anderson Deposition, Vol. 1, p. 139.) Unfortunately, however, Dr. Anderson's statements do not indicate at what date she made these observations or whether these problems were remedied prior to the EPA's tests resulting in the ORD carpet study. (Id.) 21 In addition to pointing out differences in the protocols of the experiments relied upon by defendants, plaintiffs proffer two instances which they allege show that Dr. Anderson's results were independently replicated. First, plaintiffs assert that in January 1993 part of EPA's team of scientists visited Anderson Labs and observed some of the same results reported in Dr. Anderson's findings. (Anderson Deposition, Vol. 1, p. 139; Dudek Affidavit, Exhibit 1, ORD Carpet Study at p. ii.) However, one of the EPA scientists asserts that this study did not constitute replication of Dr. Anderson's findings, as that term in understood in the scientific community, because the term implies the ability to achieve the same results consistently and completely independently using the same test methodology in any laboratory. (Tepper Affidavit at Par. 10.) Because this test occurred at Anderson Labs and used their equipment, Dr. Tepper asserts it did not constitute independent replication. (Id.) 22 The second piece of evidence plaintiffs cite to support the reliability of the Anderson test is the results reached by Yves Alarie, Ph.D., Professor at the Graduate School of Public Health at the University at Pittsburgh. (See Anderson Deposition, Vol. 2, p. 23; Toxicological Investigations of Carpet Z attached to Dudek Affidavit as Exhibits 3 and 4.) Dr. Alarie's studies were able to partially replicate Dr. Anderson's results. For example, at the temperature used to evaluate plaintiffs' carpet sample, 98 degrees Fahrenheit, Dr. Alarie was able to replicate some of Dr. Anderson's results using her apparatus but was not able to do so with his own apparatus. (Dudek Affidavit, Exhibit 3 at p. 2, Exhibit 4 at pp. 17-18.) Using his own apparatus, Dr. Alarie was able to replicate Dr. Anderson's finding on sensory and pulmonary irritation and her finding for neurotoxicity for carpet Z when the sample carpet was heated to 158 degrees Fahrenheit, 60 degrees higher than the temperature used to evaluate plaintiffs' sample carpet. (Dudek Affidavit, Exhibit 3, pp. 12, 16.) 23 Defendants respond by noting that Dr. Alarie was not able to replicate the Anderson test using his own apparatus at the temperature at which the carpet sample from plaintiffs' home was tested. Further, defendants note that Dr. Alarie is Dr. Anderson's former mentor and was the original inventor of the technique employed in the Anderson test. Thus, defendants argue that Dr. Alarie's study also did not constitute an independent replication. 24 In summary, the only evidence that Dr. Anderson's findings have been replicated under the same conditions as used in evaluating plaintiffs' carpet sample was the EPA and Dr. Alarie's use of Dr. Anderson's own apparatus on two occasions. No organization, public or private, has been able to independently obtain consistent findings using the techniques employed by Anderson Labs with their own equipment. Thus, plaintiffs have presented no evidence that the Anderson test methodology has been independently replicated, as that term is used in the scientific community.