A Timeline of Asbestos and Talc
Beginning in the 1930s, medical and scientific literature emerged indicating talc was commonly,
if not invariably, contaminated with substances known or suspected of
being carcinogenic, such as asbestos, silica, quartz, nickel and arsenic.
Within the next several decades, an ever-growing body of medical and scientific
literature demonstrated that direct and secondary exposure to talc, including
asbestos-containing talc, was hazardous to exposed persons’ health
in that it could cause lung disease, cancer, and death.
Defendants and their affiliates, employees, agents and/or suppliers were
members of the National Safety Council.
In March of 1933, Waldemar C. Dreesen of the United States Public Health Service reported
to the National Safety Council the results of a study conducted among
tremolite, talc and slate workers. The study indicated that the talc was
a hydrous calcium magnesium silicate, being 45% talc and 45% tremolite,
and the National Safety Council stated “The results of the study
seemed to indicate a relationship between the amount of dust inhaled and
the effect of this dust on the lungs of the workers.” As early as
1934, the National SafetyCouncil was publishing information stating that
“a cause of severe pulmonary injury is asbestos,a silicate of magnesium.”
In the September 1935 issue of National Safety News, an article entitled “No Halfway Measures
in Dust Control” by Arthur S. Johnson reported lowered lung capacity
resulting from “asbestosis” and “similar conditions”
that developed “from exposure to excess of many mineral dusts relatively
low in free silica content.” The article further noted that claims
for disabilities from workers who alleged exposure to “clay, talc,
emery, and carborundum dusts” had “claims prosecuted successfully.”
The article concluded that “[i]n the absence of adequate diagnoses,
occupational histories and a more satisfactory method of adjudicating
claims than prosecution at common law, we must conclude that it is necessary
to find a practical method for controlling all mineral dusts.”
In 1936, the National Safety Council published an article entitled “Lesser
Known Facts About Occupational Diseases” stating that “exposure
to asbestos fibers, present in the weaving and grinding of dry asbestos
material offers another type of dust which may cause fatalities among
workers.” In 1958, The New York Department of Labor published Industrial
Code Rule No. 12 establishing regulations applying to all employees and
employers relating to dangerous air contaminants and listing both asbestos
and talc as such substances.
In 1968, a study presented at the American Industrial Hygiene Conference &
Exposition and published in the American Industrial Hygiene Association
Journal concluded that “[a]ll of the 22 talcum products analyzed have a…
fiber content… averaging 19%. The fibrous material was predominantly
talc but contained minor amounts of tremolite, anthophyllite, and chrysotile
as these are often present in fibrous talc mineral deposits… Unknown
significant amounts of such materials in products that may be used without
precautions may create an unsuspected problem.” L. J. Cralley, et al.,
Fibrous and Mineral Content of Cosmetic Talcum Products, 29 AM. IND. HYG. ASSOC. J. 350-354 (1968).
A 1976 follow-up study conducted by researchers at Mount Sinai Hospital in New York
concluded that “[t]he presence in these products of asbestiform
anthophyllite and tremolite, chrysotile, and quartz indicates the need
for a regulatory standard for cosmetic talc…We also recommend that
evaluation be made to determine the possible health hazards associated
with the use of these products.” Rohl A.N., et al.,
Consumer Talcums and Powders: Mineral and Chemical Characterization, 2 J. TOXICOL. ENVIRON. HEALTH 255-284 (1976). The Mount Sinai study results
were published by various newspapers, including the
New York Times and the
Washington Post.
In the early 1970s, the FDA began an inquiry into whether to regulate and require warnings
on consumer talcum powder products. Defendants and the CTFA, an exclusive
lobbying and advocacy group representing companies engaged in the cosmetic
products industry, repeatedly conspired and worked in concert to block
efforts to label and warn consumers regarding the dangers associated with
such cosmetic talcum powder products as Defendants’ products.
In 1971, the New York City of Environmental Protection Administration Air Resources
Board conducted a study of two “leading” brands of talcum
powder using transmission electron microscopy (“TEM”) and
X-ray diffraction analysis (“XRD”), and found them to contain
5-25% tremolite and anthophyllite asbestos fibers.
In August of 1971, a symposium to discuss the issue of asbestos content of talcum powders
assembled the FDA, members of the talc industry, government officials,
and doctors and scientists from Mount Sinai Hospital — then the
epicenter of the medical and scientific study of asbestos. Among other
statements, participants and attendees heard that: asbestos should be
banned in talcum powders; models should be set up to measure the levels
of asbestos exposure experienced by persons using talcum powder containing
asbestos at the lowest level of microscopic detection; and finding asbestos
in talc and talcum powder is extremely difficult, and the only truly reliable
way to determine the asbestos content of talc and talcum powder is through
TEM and electron diffraction. Defendants, citing costs as well as their
fear of the public learning talc was contaminated with asbestos, ignored
and completely rejected any measures to meaningfully test talc products
to make sure they were free from asbestos and other carcinogens.
After this 1971 symposium, Dr. Weissler of the FDA hired Dr. Seymour Z.
Lewin to test commercially available talcum powders for asbestos. Dr.
Lewin tested 195 samples and found asbestos of varying amounts in 43.
The results, however, were uncorroborated by two other laboratories, leading
the FDA to the conclusion that XRD, optical and electron microscopy, and
electron diffraction must be used to detect asbestos in talc and talcum powders.
Contemporaneously, evidence began to emerge from testing conducted by various
regulatory agencies revealing that asbestos was being found in food, beer,
and drugs, including intravenously injected medicines.
In 1972, and later in 1973, the FDA filed notices of proposed rulemaking requiring talc used in food,
food packing, and drugs to be asbestos-free. The talc in these products
were among the same grades of talc used by Defendants.
The talc industry’s response, including that of the Defendants, was
swift and well-coordinated through the CTFA, an exclusive lobbying and
advocacy group representing the cosmetics industry that conspired and
worked in concert with Defendants to purposely create a flawed, voluntary
testing and surveillance methodology for detecting asbestos in talc and
block efforts to label and warn consumers regarding the dangers associated
with the talc products, including Defendants’ products.
Regarding the FDA’s
proposed 1972 ruling-making, Dr. Schaffner, the FDA Director of Product Development and Cosmetics,
invited representatives of the talc industry to a meeting in August of
1972 to discuss the results of Dr. Lewin’s study and inform them
that the FDA was preparing to release a “Proposed Statement of Policy
On Asbestos in Cosmetics Containing Talc.” Dr. Schaffner explained
that he was duty-bound and must publicize the brand names of the talcum
powders that contained asbestos. The CTFA’s president, Dr. Merritt,
strongly objected to the FDA alerting the general public and publishing
the brand names of the talcum powders, as it would cause the manufacturers
“economic hardship.” Dr. Merritt also threatened to sue the
FDA to prevent the disclosure of the brand names. Unsurprisingly, the
FDA, Defendants, and the CTFA never revealed or publicized the brand names
of the talcum powders that contained asbestos, much to the detriment of
the Plaintiffs and the general public. On September 2, 1973, the Scientific
Advisory Committee of the CTFA decided to create the “CTFA Talc
Subcommittee” to study the optical microscopy method proposed by
the FDA. Subsequently,
on October 4, 1973, the first meeting of the CTFA Subcommittee of the Scientific Advisory
Committee on Asbestos in Talc (“SAC Subcommittee”), which
consisted of 14 members, was held at the Colgate-Palmolive Co.’s
Research Center, located in Piscataway, New Jersey. In attendance were
Dr. David Hammar, Dr. DeWitt Petterson, and Dr. Robert Rolle of Johnson
& Johnson, as well as Ray R. Krammer and Fred Roesch of Whittaker,
Clark & Daniels, Inc. (“WCD”).
Id. At this meeting, the members discussed their concern with asbestos in talc
and the optical microscopy method proposed by the FDA. The SAC Subcommittee
agreed to create a “Round Robin” test using six samples of
talc “deliberately spiked with chrysotile and tremolite” spearheaded
by Dr. Rolle of Johnson & Johnson.
Id. The six deliberately spiked talc samples were tested by multiple companies
and agencies, including Johnson & Johnson and WCD. Despite the deliberate
contamination, the final report showed that the spiked talc samples “passed”
the majority of the testing (i.e., “non-detect” for asbestos).
Based on the results of the October 1973 testing, rather than admit the
inadequacy of its testing methods, the CTFA recommended to the FDA that
there be a “postponement of the finalization of the proposed regulation
of talc.”
On December 10, 1973, the CTFA issued its “Report of CTFA Talc Subcommittee on Method
to Detect Chrysotile and Tremolite in Talc.” (12/10/1973 memo from
G.W. Sandland to the Members). In this report, the CTFA Talc Subcommittee
discussed the results of the “Round Robin” analysis that was
performed using the optical microscopy method proposed by the FDA. Chrysotile
was detected in all samples tested by Harold Stanley of Pfizer and Dr.
John A. Reffner of Avon. Additionally, chrysotile and tremolite were detected
in all samples tested by Richard E. Stevens of WCD. Therefore, the CTFA
determined the following: 1) optical microscopy could not always detect
chrysotile and tremolite asbestos, even in spiked samples; 2) XRD had
a sensitivity limit and was unable to distinguish between fibrous and
non-fibrous tremolite; 3) differential thermal analysis (“DTA”)
is not capable of detecting tremolite; and 4) transmission electron microscopy
(“TEM-SAED”) was the “best, most reliable method and
is probably capable of detecting chrysotile and tremolite (fibrous), both
at a level of 0.1%.”
Id. However, the CTFA then dismissed TEM-SAED as too expensive and impractical.
The CTFA Talc Subcommittee further concluded that “the method published
in the Federal Register does not provide a truly reliable means for the
detection of asbestos in talc. It results in both false-positive and false-negative
findings. It is also tedious and may consume as much as one half day per
sample.”
Two weeks later,
on December 26, 1973, the CTFA wrote to the FDA regarding the “Proposed Order Method
for Asbestos in Talc.” (12/26/1973 CTFA’s correspondence to
the FDA). In this correspondence, the CTFA criticized the FDA’s
proposed “optical icroscopic method” as unreliable and tedious,
and urged the FDA to defer finalizing the proposed method until the FDA
and the CTFA could develop a “truly reliable method.”
Id.
On June 21, 1974, the CTFA Task Force on Methodology for the Detection of Asbestos in Talc
(hereinafter “Task Force on Methodology”) was held at Johnson
& Johnson’s Research Center and led by Dr. Rolle of Johnson
& Johnson, who was designated as the Task Force Chairman.
In its response to the “Final Report of the CTFA Talc Subcommittee”
a memorandum, dated March 6, 1974, concluded, “It is quite obvious,
from the disparity of results obtained in the round-robin trial, that
the test, as presently designed, is not practical.” (3/6/1974 CTFA
correspondence).
From there, Defendants knew that there was no such thing as asbestos-free
talc— only talc in which asbestos could not be detected using the
prevailing, most economic analytical methodology, XRD, which at the time
could not accurately identify chrysotile asbestos in talc, nor could XRD
detect tremolite asbestos contamination levels below 2-5%.
Defendants never disclosed to the FDA that the overwhelming majority of
talcum powder manufacturers and sellers were not testing their products
for asbestos – and even if they were, they were doing so superficially,
for only four or so grams per 20 tons of pre-shipment, pre-processed talc.
Defendants hid from the FDA that they were not testing off-the-shelf talc
powder products, but rather old samples that were never from the end products
themselves. They hid from the FDA that they were limiting their testing
of talc to only one type of asbestos fiber to the exclusion of all other
fiber types that are commonly found in talc deposits. What is more, to
the extent Defendants found asbestos in their samples, these positive
results were not reported to the FDA. Instead, on their behalf, Defendants
sent letters to the FDA in March of 1976 fraudulently claiming that industry
testing had shown all talcum powder products to be completely free of asbestos.
In 1976, Defendants and the CTFA developed a method for testing talcum powders
products for the presence of asbestos known as the “J4-1 Method.”
(10/7/1976 CTFA Method J4-1). Their J4-1 Method, published on October
7, 1976, states that TEM-SAED “offers greater sensitivity, but is
not presented since it is unsuitable for normal quality control applications.”
The published method, rather, relies on XRD with “the level of detection
of amphibole by this method [being] 0.5% and above.” Defendants
met and corresponded with members of the CTFA and third parties to individually
and collectively advocate to the FDA for the use of the inadequate XRD
method – which would test only miniscule portions of the tons of
talc obtained from the mining sources to be used in the consumer products
– followed by fewer “periodic” tests by TEM. This voluntary
method was developed by Defendants and was advocated to the FDA by Defendants
in lieu of regulations requiring labeling and warnings on talcum powder
products, even though Defendants knew that the J4-1 Method allowed for
asbestos-containing talc to be described as “non-detect.”
In fact, the first “Round Robin” tests, which analyzed a “CTFA
Tremolite-Spiked Talc,” resulted in 6 of 7 participating laboratories
failing to detect the tremolite. In other words, 84% of the industry’s
laboratories failed to detect asbestos in a sample known to contain tremolite
asbestos while using the CTFA’s own J4-1 Method. There is no evidence
that Defendants ever shared this remarkable failure with the FDA or the public.
There are no records of the CTFA discussing the failures of its method
with the FDA. The use of TEM, recognized by the CTFA as offering “greater
sensitivity” for asbestos analysis, continued to increase over the
next decades as its advantages were applied to more matrices. In 1990,
Kremer and Millette published a TEM method for analysis of asbestos in
talc with a theoretical detection limit of about 0.00005%. Despite such
improvements in analytical techniques, the cosmetic talc industry continues,
four decades later, to use its antiquated and wholly inadequate J4-1 Method.
It relies on XRD, a method whose 0.5% detection limit could still allow
millions of fibers per gram to be present in the talc and that also ignores
chrysotile, a type of asbestos the industry has known to be a common contaminant
of talc. In fact, the two-tiered logic of the J4-1 Method was designed to
demonstrate the absence of asbestos in that an XRD negative requires no further scrutiny. If the method had
been designed to
detect the presence of asbestos, it would have required that a
negative XRD result be followed by demonstrably more sensitive and definitive microscopy.