In these three product liability actions,^[FN1] Plaintiffs claim they contracted mesothelioma from asbestos exposure through their historic use of Cashmere Bouquet dusting powder, a talc powder product Defendant, Colgate-Palmolive Company ("C-P" or "Defendant") manufactured and sold ("talc powder" or "product"). Unlike many products formulated with asbestos material for use in an occupational setting, this talc powder, sold for personal consumer use, was never formulated to be used as an asbestos-containing product.

On November 11, 2011, Defendant filed an in limine motion to preclude Plaintiffs' proffered testing experts, Drs. James R. Millette ("Dr. Millette") and Ronald Gordon from giving testimony based on bulk sampling studies they respectively conducted on certain product exemplars in which they purportedly detected asbestos contamination ^[FN2] or, alternatively, for a Frye hearing. C-P essentially contended that Dr. Millette's 2009 bulk sampling studies did not comport with a generally accepted scientific methodology, thus, his proffered expert testimony would lack any scientific basis to satisfy a critical element in proving general/specific causation in each case.^[FN3]

In particular, Defendant pointed out that in Dr. Millette's seven reports, this expert claimed to have used the US Environmental Protection Agency's Test Method: Method for the Determination of Asbestos in Bulk Building Materials (July 1993)("EPA method") and acknowledged finding no asbestos in any of the seven samples using polarized light microscopy ("PLM"). When Dr. Millette resorted to transmission electron microscopy ("TEM"), this expert reported trace numbers of alleged asbestiform fibers in four of the samples. In rendering these findings, C-P contended Millette ran afoul of certain established criteria to confirm the presence of asbestos in bulk materials including talc. Defendants further argued that these criteria adopted in the scientific community, as evidenced in peer-reviewed articles as well as pursuant to the EPA method, mandate both a minimum fiber population requirement (i.e., at least five fibers [*2]in the sample count) and a fiber size having a mean aspect ratio (the ratio of length to width of a particle) of 20:1 for fibers longer than 5 microns. More pointedly, Defendant charged Dr. Millette with ignoring the fiber population requirement endorsed in his own peer reviewed article, A Standard TEM Procedure for Identification and Quantitation of Asbestiform Minerals in Talc, Microscope (1990) 38 at p. 463 ("The detection of five or more asbestiform minerals of one variety in an analysis constitutes a quantifiable level of detection.")(Frye Exhibit 9). In opposition, Plaintiffs found flaws in the talc testing reports of Dr. Richard Lee, Defendant's expert and generally viewed the dueling expert viewpoints as to the tested samples ^[FN4] to be a disputed issue of material fact for a jury to resolve.

On July 24, 2012, after hearing extensive argument on C-P's testing expert preclusion motion, this court granted Defendant's motion to the extent of directing a Frye hearing to determine the admissibility of Dr. Millette's product contamination opinion. Because this potential ruling could be outcome-determinative, this court stayed all further motion practice including C-P's then ready-to-be-filed motions for summary judgment.

Thereafter, Plaintiffs filed a motion to renew and for reconsideration of this court's July 24, 2012 order granting a Frye hearing. In its April 4, 2013 bench decision, this court denied Plaintiffs' motion and the Frye hearing was then held on July 31, August 1, and November 7, 2013.

During the direct and cross-examination of Dr. Millette over a two day period, here is what Defendant and this court learned from his sworn testimony:

•Dr. Millette utilized the criteria set forth in the EPA method when microscopically analyzing the samples using PLM and after applying the bundle morphology criteria, reported an inconclusive finding regarding a fiber in one sample (Frye Exhibit 17) which this court discounted (Frye Hearing Tr. 346:11-16), resulting in negative PLM findings for asbestiform fibers in the seven exemplars;

•When this expert witness microscopically analyzed these samples using TEM, he acknowledged for the very first time that he applied the criteria adopted by ASTM International ^[FN5] for air sampling tests designated D6281: Standard Test Method for Airborne Asbestos Concentration in Ambient and Indoor Atmospheres as Determined by Transmission Electron Microscopy Direct [*3]Transfer (TEM)^[FN6] ("D6281" as Frye Exhibit H) but with certain modifications for bulk sample testing of talc;

•To date, there is no generally accepted method for confirming the presence of asbestos in talc through TEM testing (see Frye Hearing Tr. 19:21-22 and 184:19-25), and D6281 is not the generally accepted method for confirming the presence of asbestos contamination in talc;

•For counting asbestos fibers, D6281 presumes the existence of asbestos in the air samples being tested as did Dr. Millette in his modified application of same to his fiber count(s) of the talc samples (Frye Hearing Tr. 307:3-11);

•For purposes of identification, D6281 cannot differentiate between individual asbestos fibers and non-asbestiform cleavage fragments (see also, §1.1.2 in the Scope section of D6281, supra, and §1.1 in the Scope section of the ISO Method, supra ["The method cannot discriminate between individual fibres of the asbestos and non-asbestos analogues of the same amphibole material . . ."]), and there is no generally accepted method in the scientific community to differentiate an asbestos amphibole from a non-asbestos amphibole on the basis of a single fiber (Frye Hearing Tr. 175:13-24);

•In performing a TEM analysis on the talc samples to report alleged trace asbestos contamination in three out of the seven exemplars (i.e., one fiber in one sample, three fibers in a second one and a set of two different fiber types in a third sample), Dr. Millette adopted the D6281 use of probability fiber distribution table using the Poisson process (see Table A6.1 of Frye Exhibit H, at p. 29)^[FN7] in lieu of the historic, albeit statistically significant five-fiber population criterion; and [*4]in this vein, never found 5 or even 4 alleged asbestiform fibers of the same amphibole mineral in any of the talc powder samples (Frye Hearing Tr. 286:19-26);

•Dr. Millette also chose not to apply the EPA method's asbestos fiber identification criteria (i.e., a dimensional aspect ratio of 20:1 to positively identify an asbestiform fiber as opposed to a non-asbestiform cleavage fragment), and conceded not performing a more in-depth SAED (selected area electron diffraction) study to accurately classify any trace fiber as an amphibole mineral particle as opposed to a talc particle (Frye Hearing Tr. 285:21-25 through 286:1-18; see also, Table A4.2 in the D6281 at p. 24); and

•Illustratively, as noted in Frye Exhibit 13, in Sample No. UO654, where Dr. Millette found one presumed asbestiform fiber, this expert witness extrapolated this finding to calculate a total concentration of 286 million asbestos fibers in an ounce of talc powder (Frye Hearing Tr. 307:3-14).

At the close of Plaintiffs' case, this court preliminarily concluded that Plaintiffs made a prima facie showing that their testing expert's opinion purports to comply with the analytical methodology accepted in the scientific community for bulk sample testing but reserved its decision on C-P's Frye motion to preclude to await the testimony of Dr. Richard Lee, Defendant's testing expert ("Dr. Lee").

On November 7, 2013, after a full day of questioning by the parties' attorneys, this court gleaned the following from Dr. Lee's testimony:

•Outside of Dr. Millette's testimony during the Frye hearing, there is no peer-reviewed publication by any other member of the scientific community that supports the notion that Plaintiffs' testing expert's modified application of D6281 for bulk sample testing can reliably detect asbestiform fiber contaminants in talc, nor is there a generally accepted method for confirming the presence of asbestos in talc through TEM testing (Frye Hearing Tr. 388:4-8 and 19-23);

•In the late 1960's, the CTFA (Cosmetic, Toiletry and Fragrance Association) developed a scientifically accepted/FDA approved protocol, USP-32 ^[FN8] with PLM, [*5]for testing pharmaceutical grade talc for asbestos contamination which utilizes the same bundle morphology/fiber dimension criteria as the EPA method (Frye Hearing Tr. 390:3 through 394:5);

•Dr. Lee opines that the fiber dimension criterion in the EPA method for bulk sample testing expressly noted in Dr. Millette's scholarly, peer-reviewed article(s), book chapter, etc. (i.e., to recognize an asbestiform fiber population in the tested sample, the fibers longer than 5 microns should generally have a mean aspect ratio of 20:1 to 100:1 or higher) is relevant and essential for fiber analysis and, contrary to Plaintiffs' testing expert's opinion, the scientific community has not jettisoned this significant asbestos identification "marker" with any of the varied tools used in microscopy studies (Frye Hearing Tr. 395:1 through 396:25);

•Illustratively, before a testing analyst starts counting fibers in a talc sample, it is not only necessary to scientifically establish via SAED whether the fiber is a true amphibole, among other factors, because the platy structure of talc particles can lead to false positives even with TEM high resolution ^[FN9] (Frye Hearing Tr. 410:4 through 415:18), but it is also equally necessary to correctly classify the amphibole as a true asbestiform fiber via D6281's requisite quantitative zone axis electron diffraction study (see Table A4.2 in the D6281 at p. 24);

•Dr. Millette intentionally eliminated this rigorous scientific method when Plaintiffs' testing expert used D6281, as modified, for bulk sample testing of the product (Frye Hearing Tr. 416:14 through 423:3) because he erroneously presumed the existence of asbestiform fiber(s) in the three product samples (Frye Hearing Tr. 429:10 through 432:14); and

•By eliminating what is currently a scientifically reliable and statistically significant fiber population criterion (a criterion Plaintiffs' testing expert wholly endorsed in his scholarly writings published prior to his testimony at the Frye hearing) and adopting a claimed consensus standard (a new testing analysis based on the Poisson distribution table) purportedly allowing for one fiber in a tested sample to be deemed statistically significant to show asbestos contamination, Plaintiffs' testing expert wrongly deviated from the quantitation analysis deemed reliable in the scientific community (in other words, it is the consensus of the scientific community that a reported 4 or less fiber count in a tested sample is below the [*6]detection limit ^[FN10] and must be deemed insignificant statistically)(Frye Hearing Tr. 446:17 through 454:6).

At the close of Dr. Lee's testimony the parties' attorneys respectively made closing statements in support of, and in opposition to, C-P's Frye motion to preclude Plaintiffs' testing expert's opinion, and this court reconsidered its preliminary bench decision issued on August 1, 2013 and orally granted C-P's motion on the record. A review of this court's questions to witnesses and counsel as well as extensive colloquy on the Frye hearing record allows for inferred factual findings supporting the bench decision granting C-P's motion. Nonetheless, as a matter of caution to ensure a proper record for purposes of a potential appeal, this court issues this written decision setting forth the essential findings of fact as the basis for its ruling as required by CPLR § 4213 (b). See also, For the People Theatres of NY Inc. v City of New York, 84 AD3d 48, 60 (1st Dept 2011).

In state and federal courts as well as here in New York, asbestos litigation is a mature litigation, and in this context, it is essentially unquestioned that asbestos exposure causes mesothelioma. Moreover, when an injured plaintiff's exposure to an asbestos-containing product is undisputed, if there are disputed issues of material fact as to the friable nature of the asbestos materials, components or parts and/or the level and extent of exposure, a resolution of those disputed issues will never warrant a Frye hearing. This is so because there is typically "no novel scientific technique or application of science . . . at issue . . ." Matter of New York City Asbestos Litig. (Weigman v A.C. & S, Inc.), 24 AD3d 375 (1st Dept 2005); see also Berger v Amchem Prods., 13 Misc 3d 335, 344-347 (Sup Ct NY Co, 2006, Freedman, J)(not novel science for an expert to proffer medical causation testimony linking plaintiff's product exposure to his/her mesothelioma).

However, C-P steadfastly maintains that this personal consumer product was manufactured and distributed as a safe asbestos-free product and takes strong exception to Plaintiffs' claim that its talc powder was the competent producing cause of their terminal cancer. For Plaintiffs' medical causation experts to have the factual foundation to support their anticipated opinions linking the product to Plaintiffs' mesothelioma, Plaintiffs must establish with scientific certainty that the talc powder these Plaintiffs used decades ago was sufficiently contaminated with hazardous asbestiform fibers. Thus, Plaintiffs' testing expert became a critical player to successfully advance their product liability claims.

The reliability of a novel scientific testing methodology can never be solely grounded on the stellar reputation of Dr. Millette no matter how impressively credentialed he is as a material scientist. That he is the chair of an ATSM International [*7]subcommittee that develops internationally accepted, consensus testing methodologies, while impressive, is similarly of no moment in this Frye review of his modification of the D6281 methodology for the bulk sample testing of talc. This court must keep in mind that "[w]hile foundation concerns itself with the adequacy of the specific procedures used to generate the particular evidence to be admitted, the test pursuant to Frye v United States (293 F 1013) poses the more elemental question of whether the accepted techniques, when properly performed, generate results accepted as reliable within the scientific community generally." People v Wesley, 83 NY2d 417, 422 (1994). Of singular importance, the acceptability and reliability of a testing methodology emphasize counting scientists' votes, rather than on verifying the soundness of a scientific conclusion. Parker v Mobil Oil Corp., 7 NY3d 434, 447 (2006) (quotation marks and citation omitted).

Here is what we now know. When Dr. Millette completed his bulk sample testing of the product exemplars in 2009, his CPLR § 3101(d) reports and subsequent deposition testimony expressly reference only the EPA method limiting its bundle morphology criteria to PLM analysis and eliminating the five-fiber population criterion in his TEM analysis of the talc powder sample, without more.^[FN11] What is most unusual is that until Dr. Millette testified at the Frye hearing in July-August 2013, no one (viz., not even Defendant, its counsel, Dr. Lee, C-P's testing expert, this court or, for that matter, any member of the relevant scientific community) had any meaningful clue that Dr. Millette actually used the 1998 D6281, as he unilaterally modified in 2009 for TEM analysis of bulk samples, to scientifically conclude the product samples allegedly contained trace asbestos contaminants.^[FN12]

Except for his testimony in this litigation, Dr. Millette has never published any literature, peer reviewed or otherwise, distancing himself from the very scientifically reliable criteria he historically ascribed to in the quantitation of hazardous asbestos [*8]fibers using the varied testing modalities.^[FN13] As to asbestos identification, Dr. Millette presumed the existence of asbestiform fibers in the samples he tested under TEM without applying the EPA method's bundle morphology criteria. Yet, a mere two years before his Frye hearing testimony, Plaintiffs' testing expert continued to publicly acknowledge the continued relevance and importance of using these criteria to identify asbestiform fibers with scientific certainty. In this expert witness-authored Chapter 2 of Dodson, R, Asbestos: Risk Assessment, Epidemiology and Health Effects, Boca Raton, 2nd Ed, (2011) § 2.16 Cleavage Fragments at p.41 (see text excerpt as Frye Exhibit I), the following authoritative identification criteria for asbestiform fibers was noted without limiting it to a particular type of microscopic analysis:

The distinction of how to tell an asbestos fiber from a cleavage fragment is currently being debated in the scientific community. A population of fibers as observed in a bulk sample having the asbestiform habit is generally recognized by several characteristics. These include mean A[spect]R[atios] in the range from 20:1-100:1 or higher for fibers longer than 5 �m. Asbestos is characterized by very thin febrils, usually less than 0.5 �m in width and two or more of the following:

• Parallel fibers occurring in bundles

• Fiber bundles displaying splayed ends

• Matter masses of individual fibers

• Fibers showing curvature

It is more difficult to classify individual fibers as to asbestiform or cleavage fragments because individual fibers do not exhibit all the characteristics of a population . . . (bracketed matter added).

Query: Where are the scientists' votes for Dr. Millette's modification of D6281 for bulk sample testing and its resultant analytical methodology, without the need for a statistically significant fiber population criterion, without the need for the application of [*9]the bundle morphology criteria to accurately distinguish between an asbestiform fiber and a non-asbestiform cleavage fragment and without the need for the more exacting SAED - zone axis diffraction study the D6281 otherwise requires for proper classification of an asbestiform amphibole? Where are the scientists' votes for a modified analytical methodology that presumes the existence of asbestiform contaminants in a talc powder sold for personal consumer use that was never formulated as an asbestos containing product? And where are the scientists' votes to demonstrate that Dr. Millette's modified analytical methodology for bulk sample testing if done in any accredited laboratory will achieve the same uniform results accepted as scientifically reliable?

After a thorough Frye review of Plaintiffs' testing expert's informed opinion grounded on his novel modification of D6281 (a consensus testing protocol adopted by thousands of members of ASTM International as an otherwise scientifically acceptable methodology for air sample testing with admitted limitations for asbestiform fiber identification),^[FN14] and his fiber analysis as to identification and quantitation reflecting his intentional disregard of criteria otherwise accepted as reliable in this expert witness's own scholarly writings as well as in the scientific community, this court respectfully concludes there is only the vote of Dr. Millette or, as Defendant's counsel noted in his closing arguments at the conclusion of the Frye hearing, a sample testing opinion grounded on a consensus of one.

This is not, as Plaintiffs insist, a question of weight as to the opinions of dueling expert witnesses to be resolved by a jury, but rather a question of admissibility involving a scientific opinion this court is constrained to conclude does not pass muster under Frye. Accordingly, C-P's motion is granted to preclude Dr. Millette from offering any opinion in these product liability cases that any talc powder sample he tested contains any hazardous asbestiform contaminant. An order will be signed and entered consistent with this ruling.

This constitutes this court's Decision and Order. Courtesy copies of same have been provided to counsel for the parties.

DATED: New York, New York

November 26, 2013

___________________________

HON. MARTIN SHULMAN, J.S.C.