On January 05, 2023 a
Exhibit,Appendix
was filed
involving a dispute between
Dan Albasry
As Trustee Of The Estate Of Newal Al Saad,
Firas Mohammad,
and
Barretts Minerals Inc.,
Beacon Cmp Corp.,
Brenntag Specialties Llc,
Charles B. Chrystal Company Inc.;,
Colgate Palmolive Co.;,
Conopco Inc.,
Glaxosmithkline Consumer Healthcare Holdings,
Glaxosmithkline Llc,
Gsk Consumer Health Inc.,
Lornamead Inc.,
Pfizer Inc.,
Port Jervis Laboratories Inc.,
The Procter & Gamble Co.,
Whittaker, Clark & Daniels Inc.,
Yardley Of London Inc.,
Yardley Of London Ltd.,,
for Torts - Asbestos
in the District Court of New York County.
Preview
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023
EXHIBIT 42
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023
Meeting with Dra. Selikoff, Langer and Rohl at Mt. Sinai,
Monday, -March 15, 1976
On Monday, March 15, 1976, a meeting was held with Drs. Selikoff,
Langer and Rohl, in which the Johnson & Johnson representatives were
Mr. D. D. Johnston, Dr. D. R. Petterson, and Dr. G. fIildick-Smith.
The objective of the meeting was to review with the Mt. Sinai rep -
resentatives Johnson & Johnson's concern for the adverse publicity that
they had initiated on cosmetic talc which reported the presence of asbe stos
in talc, that Johnson & Johnson talc had a high nickel content, and that
this talc might be carcinogenic because of the nickel (see attached
WASHINGTON POST report of March 8, 1976).
Mr • . Johnston initially reviewed with them the content of a letter he
had written to Mr. G. Wald, President of NBC News, dated March 15, 1976
(see attached), which extolled the benefit of. talc and indicated the signifi-
~ant shortcomings in the data reported by the Mt. Sinai group to Marian
Burros of the WASillNGTON POST. The points of concern to Johnson &
Johnson of the POST article were:
1. Product samples assayed for asbestos by Mt. Sinai were
purchased over three years ago.
z. The analysis of these sam.p1es in which 9 of 19 were reported
to contain asbestos was in contrast to analysis of sam.e saIIl-
pIes by Dr. Pooley in which he found 5 of 19 contained EXHIBIT dS:
asbestos.
WIT: Wd.tJ,u;1.v.!
DATE: L/-tq -rJ
c. Campbell, ADA CAA CSA #13921
Protected Document--subject to protective order JNJ 000030487
1of7
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023
- 2 -
3. It was pointed out that the Food and Drug Administration
last year bad studied 76 powders purchased in 1975 and
that none of them showed asbestos.
4. The only contaminated baby powder brand (ZBT) had
less than 10/0 of the market and was, therefore, unim-
portant.
5. Numerous clinical studies and animal studies have
shown that talc per se was not a hazard under normal
cosmetic usage. The reference to ·1.I scarring" in the
lung in animals was reported in a study conducted to
identify whether talc was a carcinogen in rats. In the
study a dose in excess of 1, 000 times the normal human
usage exposure was used. Lung scarring was slight and
observed at the highest dose. It was pointed out that
Johnson & Johnson has done a similar study in hamsters
in which the dose was 185 tim.es the norm.al human expo.
sure level and no abnormalities were found.
6. The "possibly dangerous nickel cont~nt" attributed to
. JOHNSON'S Baby Powder was untenable as the nickel is
bound in the lattice of the talc particles and not available
for biological action. The amount of nickel in the powder
used by consumers in relation to the OSHA standards for
nickel represented 1/37,000 of the OSHA standard.
Protected Document-- subject to Prot ective order JNJ 000030488
2of7 Pltf_JNJ _OOOO8lDOO3 0488
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NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023
- 3 -
7. The FDA has encouraged the znanufacturers through their
trade associations to adopt pure talc sources and, as a
matter of fact, znanufacturers have xnoved to new talc
source!! for their products since the tales were studied
by the Mt. Sinai group.
Johnson & Johnson's concern was not only to make sure that the public was
accurately informed but avoid frightening lUothers unneces sadly who
were used to using a valuable Bafe product in infant care. It was pointed
out in plain language to the Mt. Sinai group that appropriate correction
of their statements should be rn.ade to the news media and the public, and
that this should be rn.ade available by noon of the next day. The Mt. Sinai
group were initially distressed that no one had given them credit for
stiInulating the companies' move to new talc sources in light oI their
previous reporting of asbestos in cosm.etic tales. The Sinai group also
indicated that they did not. agree that 1000/0 of all baby products were free
of asbestos. The JohnsoJ{ kJohnson'repl'esentatives pointed out that the
available data indicated that this was so for the leading products. At this
point Mr. Johnston leIt the II1eeting. Dr. Selikoff then requested confirII1a-
tion that all baby powders were free of asbesto·s and was told of the FDA
findings ;,and the fact that the CTFA had done an in-depth study of talc
products. Langer pointed out that babies are powdered 4 to 5 times a day
during their infancy and that people lived to 70 years. He was concerned
Protected Document--subject to Protective order JNJ 000030489
3 of 7 Pltf_J NJ_006DfDIBJ03 0489
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NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023
- 4 -
about the possibility of talc being a carcinogen. Selikoff indicated that
if all talc were free of asbestos he would be happy to say so in the news
media. It was pointed out that Johnson & Johnson talcs represent 70 to
800/0 of the market for both adult and infant tales.
The Mt. Sinai group pointed out that in their opinion asbestos was
in a fair number of tatcs which contained tremolite, anthophyllite and
chrysotile. They indicated that they had identified a few chrysotile
fibers in Johnson II. Johnson's talc, but they didn't think it was an issue
and didn't publicly announce the fact. They thought the chrysotile level
was too low to be of significance (they didn't indicate whether the inci-
dence of fibers was higher than that for background incidence of such
fibers). They then expressed the concern that all tales should be free
of asbestos. Johnson II. Johnson stated it could not speak for the industry,
but Mt. Sinai intim.ated that it was Johnson & Johnson's responsibility to
the public to check all samples. They indicated that the FDA had informed
Mt. Sinai that in 1976 there was no evidence of asbestos in the talcs they
studied. Mt. Sinai stated that the FDA had made errors before. Mt.
Sinai mentioned they regretted bringing up the nickel issue and suggested
that the FDA look at all talcs containing nickel. They felt that talc without
asbestos was a very good product and thought Mt. Sinai had done a good
job in the health field by alerting people to problems. They repeated that
the Johnson II. Johnson talc had no asbestos and that 19 of the U. S. tales
had a level of 0.1% asbesto~. They maintained that in 1973 they haq. bought
Protected Document--subject to Protective order JNJ 000030490
4of7 Pltf_J NJ_OOOOHJOOO3 0490
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023
- 5 -
the talcs that they studied with the limited funds then available. It was
their .belief that if there was no asbestos in talc, that was marvelous,
but it was up the the FDA to be sure that talc was free of asbestos and
that all talc should be free of asbestos.
The results of the Chris Wagner study were discussed, and it
was pointed out that it showed no cancer, although the Mt. Sinai people
had indicated that there were cancers that might be important. It was
pointed out that there were no malignant lesions reported in the animal
studies by Wagner . Lung "scarring" was reported by Wagner and the
Mt. Sinai group indicated concern about it. Selikoff indicated tmre were
some uncertainties relating to the Wagner study and that there was no
inforxnation in relation to toxicity (of nickel in talc .
Selikoff was questioned about the safety of talc containing nickel,
but;. as he indicated, he was not an expert. He suggested that we contact
Dr. Sunderman of the University of COllI.1ecticut, and that he would abide
by Sunderman's findings and cOlT.l.ITI.ents. If Sunderman said there was no
~ancer related to nickel-containing talc, he, Selikoff, would say so.
Selikoff said he was delighted to know that cosmetic tales were
free of asbestos but, in his opinion, this needs confirxnation. On the
nickel question, he indicated that some nickel compounds 'do cause cancer
and some don't., and that Dr. Sunderman should be reviewed on this
Protected Document- - subject to protective order JNJ 000030491
50f7 Pltf_J NJ_OOOOtmJOO3 0491
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023
- 6-
subject. In addition, he thought that talc workers' lungs should be
examined to see if there were changes in relation to long-term
exposure. Dr. Selikoff indicated that he would go on the media to
say that nickel is safe if Dr. Sunderman says that.
Dr. Selikoif regretted that Johnson & Johnson had not shared
with his group the data available on the safety of talc, but it was
pointed out that he had attended a meeting in Brighton at which Dr.
Wehner presented the Battelle study and Dr. Rubino presented his
data on the Italian mine study relating to the deaths of miners. In
addition, it wa5 pointed out that Dr. Rohl had attended the m.eeting
in Edinburgh where Dr . Wagner's paper was presented and Dr. Hildick-
Smith presented the paper on epidemiological studies in talc miners.
It was suggested that he. in fact, was familiar with these works and
had a copy of the abstract of Dr. Wagner's paper presented in Edinburgh.
Dr. Selikoff expressed an interest in participating in a round - robin study
of talc if and when it took place and it was indicated that he would be in-
eluded in any such study.
Tuesday. March 16, 1976
Dr. Langer called Dr. Hildick-Smith in the morning of Tuesday,
March 16, 1976, but was unable to reach him. The final conversation
Protected Document--subject to Protective order JNJ 000030492
6 of 7 Pitt JNJ_OOOOfOOOO30492
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023
- 7 -
wa.s held with Dr. Langer in the afternoon of Tuesday, March 16, a.nd
he made the following points:
1. The Mt. Sinai group did not believe that talc free
of asbestos was har·m ful.
Z. Talc containing nickel or other mineral contaminants
was not carcinogenic.
3/31/76
protected Document--subject to Protective order JNJ 000030493
7of7 Pltf_JNJ_OOMIDQD030493
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023
NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023
Preview
FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023 EXHIBIT 42 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023 Meeting with Dra. Selikoff, Langer and Rohl at Mt. Sinai, Monday, -March 15, 1976 On Monday, March 15, 1976, a meeting was held with Drs. Selikoff, Langer and Rohl, in which the Johnson & Johnson representatives were Mr. D. D. Johnston, Dr. D. R. Petterson, and Dr. G. fIildick-Smith. The objective of the meeting was to review with the Mt. Sinai rep - resentatives Johnson & Johnson's concern for the adverse publicity that they had initiated on cosmetic talc which reported the presence of asbe stos in talc, that Johnson & Johnson talc had a high nickel content, and that this talc might be carcinogenic because of the nickel (see attached WASHINGTON POST report of March 8, 1976). Mr • . Johnston initially reviewed with them the content of a letter he had written to Mr. G. Wald, President of NBC News, dated March 15, 1976 (see attached), which extolled the benefit of. talc and indicated the signifi- ~ant shortcomings in the data reported by the Mt. Sinai group to Marian Burros of the WASillNGTON POST. The points of concern to Johnson & Johnson of the POST article were: 1. Product samples assayed for asbestos by Mt. Sinai were purchased over three years ago. z. The analysis of these sam.p1es in which 9 of 19 were reported to contain asbestos was in contrast to analysis of sam.e saIIl- pIes by Dr. Pooley in which he found 5 of 19 contained EXHIBIT dS: asbestos. WIT: Wd.tJ,u;1.v.! DATE: L/-tq -rJ c. Campbell, ADA CAA CSA #13921 Protected Document--subject to protective order JNJ 000030487 1of7 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023 - 2 - 3. It was pointed out that the Food and Drug Administration last year bad studied 76 powders purchased in 1975 and that none of them showed asbestos. 4. The only contaminated baby powder brand (ZBT) had less than 10/0 of the market and was, therefore, unim- portant. 5. Numerous clinical studies and animal studies have shown that talc per se was not a hazard under normal cosmetic usage. The reference to ·1.I scarring" in the lung in animals was reported in a study conducted to identify whether talc was a carcinogen in rats. In the study a dose in excess of 1, 000 times the normal human usage exposure was used. Lung scarring was slight and observed at the highest dose. It was pointed out that Johnson & Johnson has done a similar study in hamsters in which the dose was 185 tim.es the norm.al human expo. sure level and no abnormalities were found. 6. The "possibly dangerous nickel cont~nt" attributed to . JOHNSON'S Baby Powder was untenable as the nickel is bound in the lattice of the talc particles and not available for biological action. The amount of nickel in the powder used by consumers in relation to the OSHA standards for nickel represented 1/37,000 of the OSHA standard. Protected Document-- subject to Prot ective order JNJ 000030488 2of7 Pltf_JNJ _OOOO8lDOO3 0488 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023 - 3 - 7. The FDA has encouraged the znanufacturers through their trade associations to adopt pure talc sources and, as a matter of fact, znanufacturers have xnoved to new talc source!! for their products since the tales were studied by the Mt. Sinai group. Johnson & Johnson's concern was not only to make sure that the public was accurately informed but avoid frightening lUothers unneces sadly who were used to using a valuable Bafe product in infant care. It was pointed out in plain language to the Mt. Sinai group that appropriate correction of their statements should be rn.ade to the news media and the public, and that this should be rn.ade available by noon of the next day. The Mt. Sinai group were initially distressed that no one had given them credit for stiInulating the companies' move to new talc sources in light oI their previous reporting of asbestos in cosm.etic tales. The Sinai group also indicated that they did not. agree that 1000/0 of all baby products were free of asbestos. The JohnsoJ{ kJohnson'repl'esentatives pointed out that the available data indicated that this was so for the leading products. At this point Mr. Johnston leIt the II1eeting. Dr. Selikoff then requested confirII1a- tion that all baby powders were free of asbesto·s and was told of the FDA findings ;,and the fact that the CTFA had done an in-depth study of talc products. Langer pointed out that babies are powdered 4 to 5 times a day during their infancy and that people lived to 70 years. He was concerned Protected Document--subject to Protective order JNJ 000030489 3 of 7 Pltf_J NJ_006DfDIBJ03 0489 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023 - 4 - about the possibility of talc being a carcinogen. Selikoff indicated that if all talc were free of asbestos he would be happy to say so in the news media. It was pointed out that Johnson & Johnson talcs represent 70 to 800/0 of the market for both adult and infant tales. The Mt. Sinai group pointed out that in their opinion asbestos was in a fair number of tatcs which contained tremolite, anthophyllite and chrysotile. They indicated that they had identified a few chrysotile fibers in Johnson II. Johnson's talc, but they didn't think it was an issue and didn't publicly announce the fact. They thought the chrysotile level was too low to be of significance (they didn't indicate whether the inci- dence of fibers was higher than that for background incidence of such fibers). They then expressed the concern that all tales should be free of asbestos. Johnson II. Johnson stated it could not speak for the industry, but Mt. Sinai intim.ated that it was Johnson & Johnson's responsibility to the public to check all samples. They indicated that the FDA had informed Mt. Sinai that in 1976 there was no evidence of asbestos in the talcs they studied. Mt. Sinai stated that the FDA had made errors before. Mt. Sinai mentioned they regretted bringing up the nickel issue and suggested that the FDA look at all talcs containing nickel. They felt that talc without asbestos was a very good product and thought Mt. Sinai had done a good job in the health field by alerting people to problems. They repeated that the Johnson II. Johnson talc had no asbestos and that 19 of the U. S. tales had a level of 0.1% asbesto~. They maintained that in 1973 they haq. bought Protected Document--subject to Protective order JNJ 000030490 4of7 Pltf_J NJ_OOOOHJOOO3 0490 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023 - 5 - the talcs that they studied with the limited funds then available. It was their .belief that if there was no asbestos in talc, that was marvelous, but it was up the the FDA to be sure that talc was free of asbestos and that all talc should be free of asbestos. The results of the Chris Wagner study were discussed, and it was pointed out that it showed no cancer, although the Mt. Sinai people had indicated that there were cancers that might be important. It was pointed out that there were no malignant lesions reported in the animal studies by Wagner . Lung "scarring" was reported by Wagner and the Mt. Sinai group indicated concern about it. Selikoff indicated tmre were some uncertainties relating to the Wagner study and that there was no inforxnation in relation to toxicity (of nickel in talc . Selikoff was questioned about the safety of talc containing nickel, but;. as he indicated, he was not an expert. He suggested that we contact Dr. Sunderman of the University of COllI.1ecticut, and that he would abide by Sunderman's findings and cOlT.l.ITI.ents. If Sunderman said there was no ~ancer related to nickel-containing talc, he, Selikoff, would say so. Selikoff said he was delighted to know that cosmetic tales were free of asbestos but, in his opinion, this needs confirxnation. On the nickel question, he indicated that some nickel compounds 'do cause cancer and some don't., and that Dr. Sunderman should be reviewed on this Protected Document- - subject to protective order JNJ 000030491 50f7 Pltf_J NJ_OOOOtmJOO3 0491 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023 - 6- subject. In addition, he thought that talc workers' lungs should be examined to see if there were changes in relation to long-term exposure. Dr. Selikoff indicated that he would go on the media to say that nickel is safe if Dr. Sunderman says that. Dr. Selikoif regretted that Johnson & Johnson had not shared with his group the data available on the safety of talc, but it was pointed out that he had attended a meeting in Brighton at which Dr. Wehner presented the Battelle study and Dr. Rubino presented his data on the Italian mine study relating to the deaths of miners. In addition, it wa5 pointed out that Dr. Rohl had attended the m.eeting in Edinburgh where Dr . Wagner's paper was presented and Dr. Hildick- Smith presented the paper on epidemiological studies in talc miners. It was suggested that he. in fact, was familiar with these works and had a copy of the abstract of Dr. Wagner's paper presented in Edinburgh. Dr. Selikoff expressed an interest in participating in a round - robin study of talc if and when it took place and it was indicated that he would be in- eluded in any such study. Tuesday. March 16, 1976 Dr. Langer called Dr. Hildick-Smith in the morning of Tuesday, March 16, 1976, but was unable to reach him. The final conversation Protected Document--subject to Protective order JNJ 000030492 6 of 7 Pitt JNJ_OOOOfOOOO30492 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023 - 7 - wa.s held with Dr. Langer in the afternoon of Tuesday, March 16, a.nd he made the following points: 1. The Mt. Sinai group did not believe that talc free of asbestos was har·m ful. Z. Talc containing nickel or other mineral contaminants was not carcinogenic. 3/31/76 protected Document--subject to Protective order JNJ 000030493 7of7 Pltf_JNJ_OOMIDQD030493 FILED: NEW YORK COUNTY CLERK 07/10/2023 10:29 PM INDEX NO. 190002/2023 NYSCEF DOC. NO. 127 RECEIVED NYSCEF: 07/10/2023