Document Lgd36xBba117ar6LgoxyZaY1Q

FILE NAME: Johnson & Johnson (JAJ) DATE: 2025 Feb 3 DOC#: JAJ211 DOCUMENT DESCRIPTION: Proof of Evidence: BC Authentication of his correspondence and notes exchanged with Johnson & Johnson, FDA, 1971-1975 Statement o f Barry Castleman On behalf of: the Claimant Dated the: Statement No: 1 Exhibits: 18 In the proposed matter Various -and- Prospective Claimants JOHNSON & JOHNSON JOHNSON & JOHNSON MANAGEMENT LTD Prospective Defendants PR OOF OF EVIDENCE OF BARRY CASTLEMAN 1. My name is Barry Castleman. 2. My address is 4406 Oxford St., Garrett Park, Maryland 20896, U.S.A. 3. I am an Environmental Consultant. My education consists of a Bachelors Degree in Chemical Engineering obtained from Johns Hopkins University in 1968. In 1972 I obtained a Masters Degree in Environmental Engineering, which was mainly in areas related to air pollution control, from Johns Hopkins University. In 1985 I obtained a Doctor of Science Degree in Health Policy from Johns Hopkins School of Hygiene and Public Health. 1 4. My professional experience goes back over 40 years in the area of asbestos and other occupational and environmental health problems. My field is occupational and environmental health policy, which is a branch of Public Health, mainly oriented towards the recognition of risk factors and the prevention of disease from industrial activities. 5. I am a lay witness in this case. I have authored a book and numerous public health reports on asbestos. My statement in this case is not as an expert but relates to an exchange of letters I had with Johnson & Johnson (amongst others) in the 1970s. 6. This statement has been prepared following a Teams meeting with a Solicitor. The Solicitor took notes and typed up my statement before sending it to me to be approved and signed. 7. This statement has been prepared from my own knowledge. It has been prepared with reference to direct memory of the events. I have also had the opportunity to review the letters I exchanged with Johnson & Johnson in the 1970s. 8. Where any information in this statement is not a matter of my personal direct knowledge but drawn as a source of information or belief I have clearly stated the same. 2 Background 9. My interest in talc started because I used talcum powder myself. I was completing my thesis on asbestos as a chemical engineer and was being trained as an air pollution specialist. I started reading about health effects and came across asbestos. I was amazed at how dangerous it was. I read through journal articles and came across the talc issue. 10. I joined the Baltimore County Health Department at the start of 1972. I assumed that by virtue of my role, I could write letters to Members of Congress about public health matters I understood. My thesis and interest at this time was asbestos and so I wrote to companies including J & J about the risks and dangers arising from the use of asbestos. William Henderson 11. I read the 1971 paper by William Henderson who worked at the Tenovus Lab in Cardiff. He found talc in the tumour tissue of ovarian cancer patients. I was so fascinated by his research that I wrote to him and we corresponded over a number of years. 12. An example of one of the letters I exchanged with William Henderson is my letter from him dated 4 March 1975 referred to and marked `Exhibit BC1'. 13. My correspondence with Henderson started prior to 1975. I have looked through my old files but have been unable to locate any other letters that may 3 be of relevance to this case. I believe my correspondence with William Henderson ended in around the mid to late 1970s. 14. I found William Henderson's research fascinating but also very concerning. We knew that asbestos was a carcinogen. It made me think that if the talc is chemically similar to asbestos, then the talc itself could also be a carcinogen. Talc was being dusted on prime cancer sites and inhaled. The presence of talc in the tumours that Henderson reported and the way in which talc was being used made me think that if this was a carcinogen, there will be problems. Johnson & Johnson (J & J) 15. I have re-read the letters I exchanged with J & J. I can authenticate all the letters and documents exhibited to this statement. 16. Looking at the letters now, it looks like I had a large interest in talc but in reality, I didn't have much time for talc, the asbestos industry was taking up most of my time, and that was my primary focus. 17. I first wrote to J&J as an innocent graduate student trying to collect information and expand my knowledge. 18. A copy of a letter is attached, referred to as Exhibit BC2. This is a letter I wrote to J & J on the 25 July 1971 in which I ask, "what would be involved (cost, plant, process changes) in removing the asbestos fibre from talc, in which (I believe) it naturally occurs?" I also queried, "do all talcum powders 4 contain asbestos, and, among those which do, what is the range of tremolite content?" I went on to state that, "any information you can provide will be greatly appreciated, in making a fair appraisal of this "problem" ". My awareness of asbestos in talc had all come from my own reading of the published literature as a student. 19. I have, in recent years, become aware of an internal J & J memo in which my letter of 25 July 1971 is discussed. The memo is dated 28 July 1971 and is attached and referred to as Exhibit BC3. The memo states my inquiry, "appears to require a more scientific response than we have been using in handling consumer correspondence". 20. I received a response to my 25 July 1971 letter dated 2 August 1971, a copy of which is attached and referred to as Exhibit BC4. It states, "we have no asbestos in our baby powder...the `5 to 25' percent quoted by the newspapers is not based on carefully documented scientific evidence". 21. At the time, I was unaware that the FDA was holding a symposium on 3 August 1971 in respect of asbestos and talc, and J & J did not mention this to me in their letter. In attendance were several J & J representatives, including the author of the 2 August 1971 letter, Thomas H Shelley. A copy of the memo of the symposium is attached and referred to as Exhibit BC5. 5 22. I received further correspondence from J & J dated 7 March 1972, a copy of the letter is attached and referred to as Exhibit BC6 and indicated that careful analysis by independent experts had shown J & J talc to be free of asbestos. 23. On 3 August 1972, I wrote to Dr Shelley at J & J directly, a copy of this letter is attached and referred to as Exhibit BC7. I was interested to know whether talc per se can enhance the likelihood of cancer development in individuals who are occupationally exposed. I explained that Kleinfeld's study of talc miners had "revealed a 4 fold excess of lung cancer"; however, the tremolite and anthophyllite (asbestos) content of the dust was about 30% and so it was unclear whether the cancers had been caused by the asbestos or talc. I asked Dr Shelley to help me locate a study group either from his company records or from union records to enable me to conduct research. I was eager to determine whether talc itself could cause lung and ovarian cancers, given reports of talc particles in ovarian tumour tissue. 24. I was never provided with any records by Dr Shelley or anyone else at J & J to enable me to research the point. I did receive a substantive reply from Gavin Hildick-Smith dated 19 September 1972, copy attached and referred to as Exhibit BC8, which maintained that talc was not a carcinogen. 25. When I received replies from J & J assuring me there was no asbestos within their talc, I believed and trusted this information. I could not imagine that they had received reports from outside laboratories stating that there was asbestos in the talc they were using or in their talcum powder product. 6 26. J & J were known to have a good reputation at the time and were a trusted corporation in the eyes of the public. Society was more innocent about the things that big business did, and the concept of corporate crime was barely developed at all. Corporations in the early 1970s had a high level of trust and public confidence compared to now. And I was at a very early stage in my career learning about how corporations deal with toxic hazards of their products. 27. Even though J & J assured me that there was no asbestos, I was still concerned that the talc itself could be carcinogenic. 28. As time went by, I became more sceptical of what J&J told me in response to my inquiries. However, it wasn't until the Reuters article came out in 2018 that I realised J & J had deceived me in their early letters assuring me that there was no asbestos in their talc. 29. My correspondence with J&J stopped in around 1975 or so. I recall receiving a call from someone at J&J and made a note of it. A copy of my note is enclosed and referred to as Exhibit BC9. Here, I recorded that Dr Bruce Semple rang me to discuss talc studies I had requested. Dr Semple told me that Henderson had been scientifically discredited and was `gone'. I believe it was around this time that my communications with J & J ended. I ended up doing other things instead. It wasn't a conscious decision, I was just busy elsewhere. 7 FDA 30. I also wrote to the FDA regarding my concerns in respect of talc as a carcinogen and asbestos within talc. 31. My letter to the FDA dated 22 March 1972 is attached and referred to as Exhibit BC10 and was written when I worked at the Baltimore County Bureau of Environmental Services. I asked, "what the FDA is doing to research the suspected carcinogenicity of talcs (with and without tremolite asbestos)". I raised my concerns regarding talc being a potential carcinogen and how, "the most disturbing use of talc I know of is in the recently marketed feminine hygiene sprays". I also expressed concern about cosmetic powders with "strikingly high fibrous content." 32. The FDA replied in a letter dated 6 April 1972, a copy of which is attached and referred to as Exhibit BC11. This stated the FDA were aware of the `asbestos problem' and they were to all intents and purposes investigating the issue. 33. I replied to the FDA's letter on 13 April 1972 raising my concerns in respect of talc products that did not contain asbestos, saying that talc was a suspected carcinogen. I also referenced how the National Institute for Occupational Safety and Health had recommended that asbestos containing materials used industrially bear a hazard label. A copy of this 13 April 1972 letter is attached and referred to as Exhibit BC12. 8 34. My correspondence with the FDA continued. I attach and refer to as Exhibit BC13 a letter in which they reply to my letter of 25 April 1972. I no longer have my letter dated 25 April 1972. The response from the FDA explains how limited FDA's authority was in regulating cosmetic products: "the FDA must prove a cosmetic is hazardous before it can act against it." 35. My letters to the FDA and Senator Charles Mathia Jr, led the Senator to write to me on 15 June 1972 enclosing a letter from the Department of Health, Education and Welfare. A copy of that letter and enclosure is attached and referred to as Exhibit BC14. 36. Whilst at the Centre for Science in the Public Interest I again wrote to the FDA. In a letter dated 4 June 1973, copy attached and referred to as Exhibit BC15, I again raised my concerns that talc was carcinogenic and referred to studies that supported the hypothesis that talc played a role in malignancies developing. I wrote that "most talc deposits and talc products contain traces to large fractions of tremolite asbestos." I reiterated my concerns regarding talc in cosmetics. Unfortunately, the FDA was almost useless in taking action and, to this day, have taken for little action to prevent the public health risks of talc products. Center for Science in the Public Interest 9 37. In an effort to stimulate research into the risks of talc and asbestoscontaminated talc, my letter writing extended to contacting the Center for Science in the Public Interest. I wrote to them on the 10 May 1972, copy attached and referred to as Exhibit BC16. In that letter I raised my concerns regarding non-occupational exposure to talc and how it could carry an excess risk of developing cancer. Their reply, dated 15 May 1972, is attached and referred to as Exhibit BC17. In it, Albert Fritsch on behalf of the Center for Science in the Public Interest (CSPI) states, "you are right in suspecting that the talcs are bad". This was my introduction to the non-governmental environmental and consumer protection groups in Washington, with whom I would go on to work for many years. I became a fulltime employee at CSPI in late 1973. 1973 Senate Committee Hearing 38. I was invited and testified at a Senate committee hearing in February of 1973 in respect of the Toxic Substances Control Act of 1973. In a report I co authored and presented to the US Senate committee hearing, I mentioned that J&J had sold cornstarch powder before introducing talcum powder in the 1890s and recommended that people switch from talc to cornstarch. 39. Attached and referred to as Exhibit BC18 is a full copy of the committee hearing. 40. My testimony starts at the bottom of p. 114. A report I wrote with Dr. Fritsch 10 al the Center for Science in the Public Interest, "Asbestos and You", was published as an appendix in the committee hearing record. The report begins on page 157. On page 170, we discuss talc, calling for immediate investigation o f talc powders. On page 173, we recommended switching from talc to cornstarch in order to reduce the public health risk. 1, Barry Castleman, believe that the facts stated in this Witness Statement are true. I understand that proceedings for contempt of court may be brought against anyone who makes, or causes to be made, a false statement in a document verified by a statement of truth without an honest belief in its truth: