Hanson v. Colgate-Palmolive Co.

353 F.Supp.3d 1273

Douglas B. HANSON, Individually as the Surviving Spouse of Sharon M. Hanson, Deceased, and in His Capacity as the Duly Appointed Executor of the Estate of Sharon M. Hanson, Plaintiff,

v.COLGATE-PALMOLIVE COMPANY, Defendant.

CV 216-034

United States District Court, S.D. Georgia, Brunswick Division.

Signed September 24, 2018

ORDER

BRIAN K. EPPS, UNITED STATES MAGISTRATE JUDGE

Sharon Hanson suffered from pleural mesothelioma and ovarian cancer allegedly caused by exposure to asbestos in Defendant's Cashmere Bouquet Body Talc ("CB talc"). Before the Court is a series of motions to exclude testimony by scientific and medical experts. (Doc. nos. 51, 52, 56, 60, 67, 118, 120, 132, 133, 172.) After careful consideration of the briefs, evidence, and oral argument, the Court

(1) DENIES AS MOOT Plaintiff's motion to exclude evidence of Dr. Ronald Gordon's felonious past;

(2) EXCLUDES Plaintiff's expert Dr. Gordon's opinions CB talc is contaminated with asbestos and caused Mrs. Hanson's pleural mesothelioma ;(3) EXCLUDES the causation opinions of Plaintiff's experts Drs. Richard Kradin and Jacqueline Moline because of their reliance on Dr. Gordon's now excluded opinion CB talc is contaminated with asbestos;

(4) EXCLUDES Plaintiff's expert Dr. James Webber's opinions regarding alleged Cosmetic, Toiletry, and Fragrance Association ("CTFA") misconduct during its collaboration with EPA in development of the J4-1 test method;

(5) DENIES Defendant's motion to preclude admission into evidence of vintage CB talc containers;

(6) ALLOWS defense expert Dr. Matthew Sanchez's opinions regarding the absence of asbestos in CB talc and biological benignity of cleavage fragments;

(7) ALLOWS defense expert Dr. Brooke Mossman's opinions regarding threshold levels of asbestos exposure and biological benignity of cleavage fragments;

(8) DENIES Plaintiff's motion to exclude reference to six articles Dr. Mossman cited for the first time during her deposition and DENIES AS MOOT Plaintiff's motion to exclude statements by Dr. Mossman that are critical of Plaintiff's expert Dr. Arnold Brody; and

(9) ALLOWS defense expert Dr. Suresh Moolgavkar's opinion age was Mrs. Hanson's biggest risk factor for mesothelioma and CB talc was not a risk factor.

I. FACTUAL AND PROCEDURAL BACKGROUND

A. Amended Complaint Allegations

Seeking compensatory and punitive damages, the Amended Complaint asserts claims under Georgia law against Defendant Colgate-Palmolive Company, as manufacturer of CB talc, for negligence, product liability, breach of warranty, loss of consortium, and wrongful death. (Doc. no. 200, pp. 6-17.) The Amended Complaint alleges Mrs. Hanson's exposure to asbestos occurred through her and her mother's use of CB talc during the period of 1952 through 1974. (Id. at 4, 6-7.) Mrs. Hanson's mother used CB talc daily, and Mrs. Hanson's exposure occurred through contact with her mother, inhalation of suspended particles during application, and contact with surfaces upon which CB talc settled. (Id. at 7.)

Mrs. Hanson personally used CB talc daily from 1962 through 1970, and her exposure occurred through direct contact with her skin and inhalation of talc particles suspended in the air during application. (Id. ) Mrs. Hanson and her mother did not know CB talc contained asbestos and would not have used CB talc had they known. (Id. at 8-9.) Mrs. Hanson was diagnosed with ovarian cancer in the Fall of 2009 and with pleural mesothelioma in the Fall of 2014, which led to the realization in the Summer of 2015 that CB talc could cause ovarian cancer and pleural mesothelioma. (Id. at 5.) Mrs. Hanson died on April 21, 2018, at the age of sixty-six. (Doc. no. 148-55, pp. 7:25-8:1; doc. no. 195.)

B. Key Mineralogy Concepts

The Food and Drug Administration ("FDA") regulates talc powder as a cosmetic, defined as an "articl[e] intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance ...." 21 U.S.C. § 321(i) ; 21 C.F.R. § 73.1550. The Federal Food, Drug, and Cosmetic Act prohibits (1) adulteration of cosmetics in interstate commerce; (2) introduction, delivery, and receipt of adulterated cosmetics in interstate commerce; and (3) manufacture of adulterated cosmetics. 21 U.S.C. § 331.

Federal regulations promulgated by the Occupational Safety and Health Administration ("OSHA") and the Environmental Protection Agency ("EPA") define asbestos as the asbestiform variety of the following six naturally occurring minerals: chrysotile, amosite, crocidolite, anthophyllite, tremolite, and actinolite. 29 C.F.R. § 1910.1001 ; 40 C.F.R. § 763.163 ; Occupational Exposure to Asbestos, Tremolite, Anthophyllite, and Actinolite, 57 Fed. Reg. 24310-01, 24316 (June 8, 1992) ; James R. Millette, Asbestos Analysis Methods, in Asbestos: Risk Assessment, Epidemiology, and Health Effects, 42 (Ronald F. Dodson, et al., eds., 2d ed. 2011) [hereinafter "Millette 2011"]. Chrysotile belongs to the serpentine family of minerals, and the remaining five belong to the amphibole family of minerals. Occupational Exposure to Asbestos, Tremolite, Anthophyllite, and Actinolite, 57 Fed. Reg. at 24316 ; Millette 2011 at 42.

The shape or form a crystal takes during crystallization as determined by environmental and geological conditions is described as its "habit." Occupational Exposure to Asbestos, Tremolite, Anthophyllite, and Actinolite, 57 Fed. Reg. at 24316. The asbestiform crystallization habit is unusual because it requires unique temperature and pressure conditions inducing unidirectional and rapid crystal growth and formation of long thread-like fibers with aspect ratios of 20:1 to 100:1 and higher. Id.; Millette 2011 at 42. Asbestiform fibers bend like a wire under pressure, and they are polyfilamentous, meaning they grow in bundles. Occupational Exposure to Asbestos, Tremolite, Anthophyllite, and Actinolite, 57 Fed. Reg. at 24316. Asbestiform fibers have many commercial applications because of their stability in acids and alkalies, thermal and electrical insulating properties, and high tensile strength. Id. Asbestiform and nonasbestiform amphibole minerals have the same chemical composition and crystal structure, and the sole difference is caused by unique crystallization of the asbestiform habit. Id.; (Gordon Dep. 5/1/2017, doc. no. 147-23, pp. 42:18-43:8). Nonasbestiform prismatic crystals are the common crystal habits of amphiboles. Occupational Exposure to Asbestos, Tremolite, Anthophyllite, and Actinolite, 57 Fed. Reg. at 24316.

A mineral particle formed by breakage is called a cleavage fragment. Id.; (WHO IARC Monograph, doc. no. 63-1, p. 13; EPA Region IX Response, doc. no. 147-18, p. 14). While asbestiform fibers typically separate from their populations when crushed or milled, non-asbestiform minerals break into fragments along their plane of growth. Occupational Exposure to Asbestos, Tremolite, Anthophyllite, and Actinolite, 57 Fed. Reg. at 24316. Some commentators contend non-asbestiform cleavage fragments occur in similar dimensions as asbestiform cleavage fragments. Id. at 24317-19. Others contend this is not true except for infrequent occasions when a non-asbestiform cleavage fragment has an abnormally high aspect ratio or an asbestiform fibril has an abnormally low aspect ratio. Id. Plaintiff argues, citing EPA Region IX's Response to the November 2005 National Stone, Sand & Gravel Association Report, the distinction between asbestos fibers and cleavage fragments is artificial and meaningless for the purpose of evaluating health hazards. (Doc. no. 147, p. 7 (citing EPA Region IX Response, p. 14).)

C. Asbestos Detection Standards

The United States Pharmacopeia ("USP") method is FDA's standard test for detecting the presence of asbestos in talc. See 21 C.F.R. § 73.1550(b) ("Talc shall meet the specifications for talc in the United States Pharmacopeia XX (1980) ...."). To distinguish a fiber as asbestos rather than a cleavage fragment, talc, or an accessory mineral, an analyst uses optical microscopy to identify asbestos fibers with the following three characteristics:

1) a range of length to width ratios of 20:1 to 100:1, or higher, for fibers longer than 5 µm;

2) capable of splitting into very thin fibrils; and

3) two or more of the following characteristics:

(i) parallel fibers occurring in bundles;

(ii) fiber bundles displaying frayed ends;

(iii) fibers in the form of thin needles; or

(iv) matted masses of individual fibers and/or fibers showing curvature.

(USP Monograph, doc. no. 145-1, p. 6.)

The FDA Monograph Modernization Task Group is considering revisions to the USP Monograph to ensure "the tests for asbestos have adequate specificity" to detect the presence of asbestos in talc. (Doc. no. 72-2, p. 2.) The task is still underway, and the USP Monograph remains the industry standard for detection of asbestos in talc. (Doc. no. 185, p. 80.)

EPA applies a similar standard to analyze bulk building materials for asbestos in EPA R-93, entitled Method for the Determination of Asbestos in Bulk Building Materials , which defines an asbestos fiber as follows:

1) Mean aspect ratios ranging from 20:1 to 100:1 or higher for fibers longer than 5 µm. Aspect ratios should be determined for fibers, not bundles.

2) Very thin fibrils, usually less than 0.5 micrometers in width, and

3) Two or more of the following:

(i) Parallel fibers occurring in bundles,

(ii) Fiber bundles displaying splayed ends,

(iii) Matted masses of individual fibers, and/or

(iv) Fibers showing curvature.

(EPA R-93, doc. no. 143-4, p. 71.) EPA R-93 explains, "It is not unusual to observe occasional particles having aspect ratios of 10:1 or less, but it is unlikely that the asbestos component(s) would be dominated by particles (individual fibers) having aspect ratios of < 20:l for fibers longer than 5µm." ( Id. )

Other organizations and agencies have different length and aspect ratio standards,...