LOS ANGELES (Reuters) – Darlene Coker knew she was dying. She just wanted to know why.
She knew that her cancer, mesothelioma, appeared on the delicate membrane that enveloped her lungs and other organs. She knew it was as rare as mortal, a signature of asbestos exposure. And she knew that it afflicted mainly men who inhaled asbestos dust in mines and industries, such as shipbuilding, who used the carcinogen before their risks were understood.
Coker, 52, raised two daughters and ran a massage school in Lumberton, a small town in eastern Texas. How had she been exposed to asbestos? "She wanted answers," said her daughter Cady Evans.
Fighting for every breath and disabling pain, Coker hired Herschel Hobson, a personal injury lawyer. He came across a suspect: Johnson's baby powder that Coker used on his young children and sprayed on himself all his life. Hobson knew that talc and asbestos often occurred together in the earth, and that the extracted talc could be contaminated with the carcinogen. Coker sued Johnson & Johnson, claiming that "poisonous talc" in the company's beloved product was his killer.
Reuters Crystal Deckard examines an old photograph of her mother, Darlene Coker, as she recalls the life of her mother in California on August 15, 2018.
Crystal Deckard examines an old photograph of her mother, Darlene Coker, as she recalls the life of her mother in California on August 15, 2018.
J & J denied the allegation. Baby powder was asbestos-free, he said. As the case progressed, J & J was able to avoid delivering the results of the talc and other internal company records that Hobson had requested to file the case against Baby Powder.
Coker had no choice but to give up his action, Hobson said. "When you are the author, you have the burden of proof," he said. "We do not have that."
That was in 1999. Two decades later, the material that Coker and his lawyer sought is emerging, as J & J was forced to share thousands of pages of corporate memos, internal reports and other confidential documents with lawyers for some of the 11,700 claimants who now claim that the company's talc caused its cancers – including thousands of women with ovarian cancer.
A Reuters survey of many of these documents, as well as testimonials and testimony, shows that at least from 1971 to the early 2000s, raw talc and finished powders have sometimes tested positive for small amounts of asbestos, and company executives, my managers, scientists, doctors and lawyers worried about the problem and how to solve it, even though they did not disclose it to regulators or the public.
Reuters Darlene Coker is shown with her thoracic surgeon David Sugarbaker in this undated brochure family photograph.
Darlene Coker is shown with her thoracic surgeon David Sugarbaker in this undated brochure family photograph.
The documents also describe successful efforts to influence US regulators' plans to limit asbestos in cosmetic talc products and scientific research on the effects of talc on health.
A small part of the documents was produced in the trial and quoted in media reports. Many were protected from public opinion by court orders that allowed J & J to deliver thousands of documents designated as confidential. Much of its content is reported here for the first time.
HIGHLY ENHANCED & # 39;
The first mentions of the J & J contaminated talc that Reuters found came from the 1957 and 1958 reports from a consulting laboratory. They describe contaminants in talc from the Italian J & J supplier as fibrous and acicular tremolite, or as a needle. This is one of six minerals that, in their naturally occurring fibrous form, are classified as asbestos.
At various times, from then to the early 2000s, reports from J & J scientists, from outside laboratories and from J & J suppliers produced similar findings. The reports identify contaminants in talc and finished powder products such as asbestos or describe them in terms typically applied to asbestos such as "fiber form" and "rods".
In 1976, while the US Food and Drug Administration was evaluating the limits of asbestos on talc products, J & J assured the regulator that no asbestos was "detected in any sample" of talc produced between December 1972 and October 1973. Do not tell the agency that at least three tests conducted by three different laboratories, from 1972 to 1975, found asbestos in their talc – in one case at levels reported as "quite high."
Reuters The first page of a report examining a sample of Johnson & # 39; s Baby Powder of 1978, filed in court as an exposé of the plaintiff in a case against Johnson & Johnson, is portrayed in this undated leaflet photo.
The first page of a report examining a sample of Johnson & # 39; s Baby Powder of 1978, filed in court as an exposé of the plaintiff in a case against Johnson & Johnson, is portrayed in this undated leaflet photo.
Most of J & J's revised internal asbestos testing reports do not find asbestos. However, while J & J's testing methods have improved over time, they have always had limitations that allow contaminant traces to be undetected – and only a small fraction of the company's talc is tested.
The World Health Organization and other authorities do not recognize any safe level of exposure to asbestos. Although most people exposed never develop cancer, for some, even small amounts of asbestos are enough to trigger the disease years later. How small was not established. Many complainants claim that the amounts they inhaled when sprinkled with contaminated talcum powder were sufficient.
Evidence of what J & J knew came to light after people suspected talc caused their cancers hired lawyers experienced in decades of deluge of litigation involving workers exposed to asbestos. Some of the lawyers knew from these previous cases that talc producers tested asbestos and began demanding J & J testing documentation.
Reuters A combination of photographs of leaflets used in a report analyzing a sample of Johnson's Baby Powder of 1978, filed in court as an exposé of the plaintiff in a lawsuit against Johnson & Johnson.
A combination of photographs of leaflets used in a report analyzing a sample of Johnson's Baby Powder of 1978, filed in court as an exposé of the plaintiff in a lawsuit against Johnson & Johnson.
What J & J produced in response to these demands enabled the plaintiffs' lawyers to refine their arguments: the culprit was not necessarily talc itself, but also asbestos in the talc. This claim, backed by decades of solid science showing that asbestos causes mesothelioma and is associated with ovarian cancer and other cancers, has had mixed success in court.
In two cases earlier this year – in New Jersey and California – jurors gave large sums to plaintiffs who, like Coker, blamed J & J's asbestos-contaminated talc products for mesothelioma.
A third verdict in St. Louis was a watershed, expanding J & J's potential liability: the 22 plaintiffs were the first to succeed with the claim that asbestos-contaminated talc and the powder to Shower, a long-time brand sold by the company in 2012, caused ovarian cancer, which is much more common than mesothelioma. The jury awarded $ 4.69 billion in damages. Most cases of talc have been brought by women with ovarian cancer who claim to regularly use J & J talc products like antiperspirant and perineal deodorant.
At the same time, at least three juries rejected claims that baby powder was contaminated with asbestos or caused mesothelioma of the complainants. Others have failed to reach verdicts, resulting in judgments.
J & J said it will appeal the recent verdicts against it. He maintained in public statements that his talc is safe, as demonstrated years ago by the best available tests, and that the information he has been asked to disclose in recent litigation shows the care the company takes to ensure that its products are free from asbestos. He blamed his losses on jury confusion, "junk" science, unfair court rules and overly dedicated lawyers looking for a new group of asbestos plaintiffs.
"The plaintiffs' lawyers for personal financial gain are distorting historical documents and intentionally creating confusion in court and in the media," Ernie Knewitz, J & J's vice president of global media relations, wrote in an e- mail to the findings of Reuters. "This is a calculated attempt to divert attention from the fact that thousands of independent tests prove that our talc does not contain asbestos or cause cancer. Any suggestion that Johnson & Johnson knew about or concealed information about the safety of talc is false. "
J & J declined to comment further on this article. For more than two months, he declined repeated requests for an interview with J & J executives. On December 8, the company offered to make a specialist available. He had not done it Thursday night.
The company forwarded all questions to its external litigation lawyer, Peter Bicks. In replies sent via email, Bicks rejected Reuters's findings as "false and misleading." "The scientific consensus is that talc used in talc-based body powders does not cause cancer, regardless of what's in that talc," Bicks wrote. "This is true even if – and this is not the case – Johnson and Johnson's cosmetic talc already contained minimal and undetectable amounts of asbestos." He dismissed the tests cited in this article as "discrepant" results.
Reuters A Johnson & Johnson building is exhibited in Irvine, California, on January 24, 2017.
A Johnson & Johnson building is exhibited in Irvine, California, on January 24, 2017.
In court, J & J's lawyers told jurors that company records showing that asbestos was detected in their talc concerned talc for industrial use. Other records, they argued, referred to non-asbestos forms of the same minerals that their experts say are harmless. J & J also argued that some tests collected "background" asbestos – lost fibers that could have contaminated samples after floating in a mill or laboratory from a worn vehicle clutch or insulation.
The company has made some of the same arguments about laboratory tests conducted by plaintiffs recruited by plaintiffs. One such laboratory found asbestos in Shower to Shower talc from the 1990s, according to a court report of August 11, 2017. Another laboratory found asbestos in more than half of several samples of powdered talc from decades past – in bottles of plaintiffs' cabinets and purchased on eBay, and even in a 1978 bottle at the J & J corporate museum. The concentrations were large enough that users "were more likely to be exposed," the lab report concluded. presented by the authors in several cases this year.
Matthew Sanchez, a consultant geologist with RJ Lee Group Inc and a frequent expert at J & J, rejected these findings in testimony at the St. Louis trial: "I did not find asbestos in any of the current or modern ones, which I consider to be modern, Talc products from Johnson & Johnson, "Sanchez told the jury.
Sanchez did not return the calls for comment. RJ Lee said he does not comment on the work he does for clients.
Since 2003, baby powdered talc sold in the United States comes from China through Imerys Talc America, a unit of Paris-based Imerys SA and a co-defendant in most of the talc litigation. Imerys and J & J said that Chinese talc is safe. An Imerys spokeswoman said the company's tests "consistently do not show asbestos. Safe use of Talco has been confirmed by several regulatory and scientific bodies."
When people really understand what's going on, I think this increases J & J's exposure a thousand times.Mark Lanier
J & J, based in New Brunswick, New Jersey, has dominated the powdered talc market for more than 100 years, its sales exceeded that of all competitors, according to data from Euromonitor International. And while talc products contributed $ 420 million to J & J's $ 76.5 billion revenue last year, Baby Powder is considered an essential facet of the health care product's carefully "sacred cow", as it put an internal e-mail of 2003. this.
"When people really understand what's going on, I think this increases J & J's exposure a thousand times," said Mark Lanier, one of the women's advocates in the St. Louis case.
Growing controversy over J & J's talc has not shaken investors. The stock price has risen about 6 percent so far this year. Talc cases account for less than 10% of all pending personal injury lawsuits against J & J, based on the company's quarterly report on August 2, in which the company said it believed it had "strong grounds to appeal" .
J & J president and CEO Alex Gorsky has vowed to keep fighting, telling analysts in July: "We remain confident that our products do not contain asbestos."
Gorsky's comment, echoed in numerous statements by J & J, misses a crucial point. Asbestos, like many environmental carcinogens, has a long latency period. The diagnosis usually comes years after the initial exposure – 20 years or more for mesothelioma. J & J talc products today can be safe, but the talc in question in thousands of processes has been sold and used in the last 60 years.
& # 39; SAFETY FIRST & # 39;
In 1886, Robert Wood Johnson enlisted his younger siblings in an eponymous startup built around the "Safety First" motto. Johnson's baby powder grew from a line of medicated patches, sticky rubber strips laden with mustard and other home remedies. When clients complained of skin irritation, the brothers sent packets of talcum powder.
Soon, the mothers began to apply the talc in the diaper skin of babies' diapers. The Johnsons scored. They added a fragrance that would become one of the most recognizable in the world, sifted the talc into tin boxes and, in 1893, began to sell it as Johnson's baby powder.
In the late 1950s, J & J discovered that the talc of its main source of mines for the American market in the Italian Alps contained tremolite. This is one of six minerals – along with chrysotile, actinolite, amosite, anthophyllite and crocidolite – that occur in nature as crystalline fibers known as asbestos, a recognized carcinogen. Some of them, including tremolite, also occur as common non-asbestiform rocks. Both forms occur frequently together and in talc deposits.
J & J's concern at the time was that the contaminants made the company's abrasive powder. He sent tons of his Italian talc to a private laboratory in Columbus, Ohio to find ways to improve the appearance, feel and purity of the powder by removing as much grain as possible. In a couple of reports from 1957 and 1958, the laboratory said the talc contained "less than 1% to about 3% of contaminants", described as fibrous and acicular tremolite.
Most of these and other J & J records cited in this article are dead. Sanchez, RJ Lee's geologist whose company agreed to give him as a witness up to 100 J & J talc tests, testified that the tremolite found decades ago in the company's talc, from Italy and later Vermont, was not tremolite asbestos. Instead, he said, they were "cleavage fragments" of non-asbestiform tremolitis.
J & J's original records do not always make this distinction. In terms of health risk, regulators since the early 1970s have treated the same small fiber particles in both forms.
The US Environmental Protection Agency, for example, "makes no distinction between fibers and cleavage fragments (comparable)," agency officials wrote in response to a report by RJ Lee on an unrelated subject in 2006, the year before hiring of Sanchez. The Occupational Safety and Health Administration (OSHA), while removing the non-fibrous forms of the minerals from its definition of asbestos in 1992, nevertheless recommends that fiber-like fragments indistinguishable from asbestos be counted in its exposure tests .
And as the product safety director of the J & J talc supplier admitted in a 2008 email to colleagues: "(I) a deposit contains non-asbestiform 'tremolite', there is also asbestiform tremolite naturally gift".
& # 39; The lungs of babies & # 39;
In 1964, J & J's subsidiary Windsor Minerals Inc bought a set of talc mines in Vermont, with names such as Argonaut, Rainbow, Frostbite and Black Bear. In 1966, it was exploding and destroying the white rocks of the Green Mountain state. J & J used ground powder in their cosmetic powders and sold a less refined grade for coating companies, floors and tires for use in manufacturing.
Ten years after the tremolite appeared on Italian talc, it also appeared on Vermont talcum powder. In 1967, J & J found traces of tremolite and other mineral that can occur as asbestos, according to a table attached to a memorandum dated November 1, 1967, from William Ashton, J & J for decades.
J & J continued to look for sources of clean talc. But in a memo dated April 9, 1969 to a company physician, Ashton said it was "normal" to find tremolite in many US talc deposits. He suggested that J & J rethink his approach. "Historically, in our company, Tremolite has been bad," Ashton wrote. "How bad is Tremolite medical, and how much of it can safely be in a talc base that we can develop?"
As lung disease, including cancer, appeared to be increasing, "it seems prudent to limit any possible content of Tremolita … to an absolute minimum," came the response of another medical doctor days later.
The doctor told Ashton that J & J was receiving safety questions from pediatricians. Even Robert Wood Johnson II, son of the founder and then CEO retired, expressed "concern about the possibility of adverse effects on the lungs of babies or mothers," he wrote.
"We respond," the doctor wrote, "that we do not consider the use of our powders as a risk." Such guarantees would be impossible, he added, "if we include Tremolite in more than inevitable traits."
The memo is J & J's first paper reviewed by Reuters that discusses tremolitis as more than a nagging nuisance. The doctor asked Ashton to consult the company's lawyers because "it is not inconceivable that we could get involved in litigation."
NEVER & 100% CLEAN & # 39;
In the early 1970s, asbestos was widely recognized as the leading cause of mesothelioma among workers involved in production and the industries that used it in their products.
Regulation was in the air. In 1972, President Richard Nixon's newly established OSHA issued its first rule, setting limits for workplace exposure to asbestos dust.
Until then, a team at Mount Sinai Medical Center, led by prominent asbestos researcher Irving Selikoff, had begun to consider talcum powder as a possible solution to a puzzle: Why Pulmonary Tissue Tests were Removed from New Yorkers who have never worked with asbestos? to find signs of the mineral? As talc deposits are often mixed with asbestos, scientists reason that talcum powder may have played a role.
They shared their preliminary findings with New York City environmental protection chief Jerome Kretchmer. On June 29, 1971, Kretchmer briefed the Nixon government and convened a press conference to announce that two unidentified brands of cosmetic talc appeared to contain asbestos.
The FDA has opened an investigation. J & J issued a statement: "Our fifty years of research knowledge in this area indicates that there is no asbestos contained in the powder manufactured by Johnson & Johnson."
Reuters Dr. Arthur Langer poses for a portrait at his home in Williamsburg, Virginia, on November 13, 2018.
Dr. Arthur Langer poses for a portrait at his home in Williamsburg, Virginia, on November 13, 2018.
Later that year, another researcher at Mount Sinai, the mineralogist Arthur Langer, told J & J in a letter that the team found a "relatively small" amount of asbestos chrysotile powder of talcum powder.
Langer, Selikoff and Kretchmer ended up on a J & J list of "antagonistic personalities" in a memorandum dated November 29, 1972, which described Selikoff as the leader of a "talc attack."
"I think I was antagonistic," Langer told Reuters. Even so, in a subsequent J & J post test in 1976, he found no asbestos – a result that Mount Sinai announced.
Langer said he told lawyers at J & J that they visited him last year that he kept all of his discoveries. J & J did not call him as a witness.
Selikoff died in 1992. Kretchmer said he recently read that a jury found that Baby Powder was contaminated with asbestos. "I said to myself," Why did it take so long? "He said.
In July 1971, meanwhile, J & J sent a delegation of scientists to Washington to talk to FDA officials investigating asbestos powder talc. According to an FDA account at the meeting, J & J shared "evidence that talc contains less than 1%, if any, of asbestos."
Later that month, Wilson Nashed, a J & J scientist who visited the FDA, said in a memo to the company's public relations department that J & J talc contained traces of "fibrous minerals (tremolite / actinolite) .
& Quot; Uncontroversial Asbestos & quot;
While the FDA continued to investigate asbestos in talc, J & J sent powder samples to be tested in private laboratories and universities. Although a private laboratory in Chicago found traces of tremolite, it declared the amount "insignificant" and samples "substantially free of asbestiform material." J & J reported that upon receiving a letter of introduction to the FDA, the "results clearly show" that the samples tested "do not contain chrysotile asbestos". J & J's lawyer told Reuters the tremolite found in the samples was not asbestos.
But J & J's submission to the FDA omitted the finding of chrysotile from Professor Thomas E. Hutchinson of the University of Minnesota in a Shower to Shower sample, as he described in a lab note.
The FDA's own tests did not find asbestos in J & J's 1f970s powder samples. These tests, however, did not use the most sensitive detection methods. An initial test, for example, was unable to detect chrysotile fibers, as one FDA official acknowledged at a J & J meeting on August 11, 1972 with the agency: "I understand that some samples will be approved even containing fiber, but we are willing to live with it. "
In 1973, Tom Shelley, director of J & J's Central Research Laboratories in New Jersey, was investigating the patent acquisition of a process that a British mineralogist and a J & J consultant were developing to separate the tallow from tremolite.
We will want to carefully consider the … asbestos patents on talc. It may well be that we want to keep the whole thing confidential rather than allowing it to be published in patent form and thus let the whole world know.Tom Shelley
"It is quite possible that eventually tremolite will be banned in all talcum," Shelley wrote on February 20, 1973, to a British colleague. Therefore, he added, "the process can be a valuable property for us."
In late March, Shelley acknowledged the sensitivity of the plan in a memo sent to a J & J lawyer in New Jersey: "We will want to carefully consider … asbestos-related patents on talc. confidential rather than allowing it to be published in patent form and thus let the whole world know. "
J & J did not get the patents.
While Shelley was examining the patents, J & J research director DeWitt Petterson visited the company's mining operation in Vermont. "Occasionally, sub-trace amounts of tremolite or actinolite are identifiable," he wrote in an April 1973 report on the visit. "And these can be classified as asbestos fiber."
J & J should "protect our gunpowder franchise," eliminating as many tiny fibers that can be inhaled into the airborne talcum powder as possible, Petterson wrote. He warned, however, that "no end product will ever be produced, which will be totally free of breathable particles". Introducing a corn powder version of powdered milk, he noted, "is obviously another answer."
Bicks told Reuters that J & J believes that the tremolite and Petterson actinolite cited are not asbestos.
Corn starch emerged again in a March 5, 1974 report in which Ashton, J & J's talc supply chief, recommended that the company research this alternative "for defensive reasons" because "the boost against concentrated mainly on biological problems the inhalation of talc and related mineral particles. "
"WE CAN HAVE PROBLEMS"
A few months after Petterson's recognition that talc purity was a dream, the FDA has proposed a rule that talc used in drugs contains no more than 0.1% asbestos. While the agency's cosmetics division was considering similar powdered talc powder, it asked companies to suggest testing methods.
At the time, the J & J Children's Powder franchise consumed 20,000 tons of Vermont talc per year. J & J pressured the FDA to approve an X-ray scanning technique that a company scientist said in an April 1973 memo entitled "an automatic 1% tolerance to asbestos." That would mean that talc with up to 10 times the FDA's proposed limit for asbestos in medicines could be approved.
The same scientist confided in a note dated October 23, 1973 to a colleague who, depending on which test the FDA adopted to detect asbestos in cosmetic talc, "we may have problems."
The best way to detect asbestos in talc was to concentrate the sample and then examine it through microscopes, the Research Institute of the Colorado School of Mines reported to J & J in a report dated December 27, 1973. In a memo , a J & J laboratory supervisor said that the concentration technique that the company's own researchers had used to identify "tremolite" asbestos in Vermont talc had a limitation: "It may be too sensitive."
In his email to Reuters, J & J's lawyer said that the laboratory supervisor's concern was that the test would result in "false positives" showing asbestos where there were none.
It has been estimated that even if talc is pure asbestos, exposure levels of a baby during a normal spray are well below accepted tolerance limits.J & J meeting minutes
J & J also launched a survey to find out how much dust a baby was exposed during a diaper change and how much asbestos could be in that dust and remain within the new OSHA workplace exposure limits. Their researchers tied an air sampling device to a doll to make measurements while in powder, according to J & J memoranda and the minutes of February 19, 1974, the Association of Personal Hygiene and Fragrances (CTFA), a industry group.
"It was estimated that, even if the talc was pure asbestos, the exposure levels of a baby during a normal spray are well below the tolerance limits," says the minute.
In a letter dated September 6, 1974, J & J told the FDA that "a substantial safety factor can be expected" with talc containing 1% asbestos, "methods capable of determining less than 1% asbestos in talc are not required to ensure the safety of cosmetic talc ".
Not everyone at the FDA thought that basing a detection method on such a calculation was a good idea. One official called her a "fool," adding, according to a J & J account at a February 1975 meeting: "No mother would lay her baby with 1% of a known carcinogen regardless of the large safety factor ".
PRESS FOR SELF-REGULATION
Unable to persuade the FDA that up to 1% of asbestos contamination was tolerable, J & J began promoting self-policing as an alternative to regulation. The centerpiece of this approach was a March 15, 1976 letter packet from J & J and other manufacturers that CTFA gave the agency to show they had been able to eliminate asbestos from cosmetic talc.
"The attached letters demonstrate the industry's responsibility to monitor its talc," the cover letter read. "We are certain that the summary will give you assurances regarding the freedom of asbestos contamination for materials of talc cosmetic products."
In its letter, J & J said that talc samples produced between December 1972 and October 1973 were tested for asbestos, and none were detected "in any sample."
J & J did not tell the FDA about a test done in 1974 by a professor at Dartmouth College in New Hampshire who discovered asbestos in J & J's "fiber-like" actinolite talc, as he said. Neither company reported to the FDA about a 1975 report from its longtime laboratory that found particles identified as "asbestos fibers" in five of the 17 talc samples from the main source of the baby powder powder. "Alguns deles parecem bastante altos", escreveu o laboratório privado em sua carta de apresentação.
Estamos certos de que o resumo lhe dará garantias quanto à ausência de contaminação por amianto para materiais de produtos de talco cosméticos.Letra J & J
Bicks, advogado da J & J, disse que os resultados do laboratório contratado eram irrelevantes porque o talco era destinado ao uso industrial. Ele disse que a companhia agora acredita que o actinolito que o professor de Dartmouth descobriu "não era asbestiforme", baseado em sua interpretação de uma foto no relatório original do laboratório.
Apenas dois meses após o professor de Dartmouth ter relatado suas descobertas, o Gerente de Pesquisa e Desenvolvimento da Windsor Minerals Vernon Zeitz escreveu que o crisotila, "antofilita fibrosa" e outros tipos de amianto foram "encontrados em associação com o corpo de minério de Hammondsville". Talco em pó para bebês há mais de duas décadas.
O relatório de Zeitz de maio de 1974 sobre os esforços para minimizar o amianto no talco de Vermont "estimulou fortemente" a adoção de formas de proteção "contra o que atualmente é considerado um material com risco à saúde e potencialmente presente em todos os talco em uso no momento. "
Bicks disse que Zeitz não estava relatando os resultados reais dos testes.
No ano seguinte, Zeitz relatou que com base em testes semanais de amostras de talco durante seis meses, "pode-se afirmar com mais de 99,9% de certeza que os minérios e materiais produzidos nos minérios de Windsor Mineral estão livres de amianto ou asbestiforme minerais."
«DESAPARECIMENTO POR OMISSÃO»
O uso seletivo que a J & J faz dos resultados dos testes, decididos em uma decisão do juiz de Nova Jersey neste ano, de afirmar o primeiro veredicto contra a empresa em um caso que afirmava que o amianto nos produtos da J & J causava câncer. "Fornecer ao FDA resultados favoráveis sem amianto e sem fornecer resultados desfavoráveis, que mostram amianto, é uma forma de falsidade ideológica por omissão", disse a juíza da Corte Superior de Middlesex, Ana Viscomi, em sua decisão de junho.
"J & J respeitosamente discorda dos comentários do juiz", disse Bicks. "A J & J não reteve nenhum teste relevante da FDA."
A FDA se recusou a comentar a decisão.
Na falta de consenso sobre os métodos de teste, o FDA adiou a ação para limitar o amianto no talco. Anos depois, estabeleceu limites para o amianto no talco usado em drogas. Ele nunca limitou o amianto no talco cosmético ou estabeleceu um método preferido para detectá-lo.
Em vez disso, em 1976, um comitê do CTFA presidido por um executivo da J & J elaborou diretrizes voluntárias, estabelecendo uma forma de varredura de raios X com um limite de detecção de 0,5 por cento como o teste primário, o método preferido pela J & J. O método não foi projetado para detectar o tipo mais comumente usado de amianto, o crisotila. O grupo disse que a microscopia eletrônica mais sensível é impraticável.
O CTFA, que agora faz negócios como o Conselho de Produtos de Cuidados Pessoais, se recusou a comentar.
A varredura de raios X é o método primário que a J & J utiliza há décadas. A empresa também exige periodicamente as verificações mais sensíveis com microscópios eletrônicos. O advogado da J & J disse que os testes da empresa excedem o padrão da associação comercial, e eles o fazem. Ele também disse que hoje, os exames de raios-X da J & J podem detectar minerais suspeitos em níveis tão baixos quanto 0,1 por cento de uma amostra.
Mas a empresa nunca adotou a recomendação de 1973 do laboratório do Colorado de que as amostras fossem concentradas antes do exame em um microscópio. E as amostras de talco que foram submetidas ao teste de microscopia eletrônica mais sensível foram uma pequena fração do que foi vendido. For those and other reasons, J&J couldn't guarantee its Baby Powder was asbestos-free when plaintiffs used it, according to experts, including some who testified for plaintiffs.
As early as 1976, Ashton, J&J's longtime talc overseer, recognized as much in a memo to colleagues. He wrote that talc in general, if subjected to the most sensitive testing method, using concentrated samples, "will be hard pressed in supporting purity claims." He described this sort of testing as both "sophisticated" and "disturbing."
'FREE OF HAZARD'
By 1977, J&J appeared to have tamped down concerns about the safety of talc. An internal August report on J&J's "Defense of Talc Safety" campaign noted that independent authorities had deemed cosmetic talc products to be "free of hazard." It attributed "this growing opinion" to the dissemination to scientific and medical communities in the United States and Britain of "favorable data from the various J&J sponsored studies."
In 1984, FDA cosmetics chief and former J&J employee Heinz Eiermann reiterated that view. He told the New York Times that the agency's investigation a decade earlier had prompted the industry to ensure that talc was asbestos-free. "So in subsequent analyses," he told the paper, "we really could not identify asbestos or only on very rare occasions."
Two years later, the FDA rejected a citizen request that cosmetic talc carry an asbestos warning label, saying that even if there were trace contamination, the use of talc powder during two years of normal diapering would not increase the risk of cancer.
In 1980, J&J began offering a cornstarch version of Baby Powder – to expand its customer base to people who prefer cornstarch, the company says.
All talcum products used in homes have been asbestos-free since the 1970s.American Cancer Society website
The persistence of the industry's view that cosmetic talc is asbestos-free is why no studies have been conducted on the incidence of mesothelioma among users of the products. It's also partly why regulations that protect people in mines, mills, factories and schools from asbestos-laden talc don't apply to babies and others exposed to cosmetic talc – even though Baby Powder talc has at times come from the same mines as talc sold for industrial use. J&J says cosmetic talc is more thoroughly processed and thus purer than industrial talc.
Until recently, the American Cancer Society (ACS) accepted the industry's position, saying on its website: "All talcum products used in homes have been asbestos-free since the 1970s."
After receiving inquiries from Reuters, the ACS in early December revised its website to remove the assurance that cosmetic talcs are free of asbestos. Now, it says, quoting the industry's standards, that all cosmetic talc products in the United States "should be free from detectable amounts of asbestos."
The revised ACS web page also notes that the World Health Organization's International Agency for Research on Cancer classifies talc that contains asbestos as "carcinogenic to humans."
Despite the success of J&J's efforts to promote the safety of its talc, the company's test lab found asbestos fibers in samples taken from the Vermont operation in 1984, 1985 and 1986. Bicks said: "The samples that we know of during this time period that contained a fiber or two of asbestos were not cosmetic talc samples."
Then, in 1992, three years after J&J sold its Vermont mines, the new owner, Cyprus Minerals, said in an internal report on "important environmental issues" in its talc reserves that there was "past tremolite" in the Hammondsville deposit. Hammondsville was the primary source of Baby Powder talc from 1966 until its shutdown in 1990.
Bicks rejected the Cyprus report as hearsay, saying there is no original documentation to confirm it. Hammondsville mine records, according to a 1993 J&J memo, "were destroyed by the mine management staff just prior to the J&J divestiture."
Bicks said the destroyed documents did not include talc testing records.
In 2002 and 2003, Vermont mine operators found chrysotile asbestos fibers on several occasions in talc produced for Baby Powder sold in Canada. In each case, a single fiber was recorded – a finding deemed "BDL" – below detection limit. Bicks described the finding as "background asbestos" that did not come from any talc source.
In 2009, the FDA, responding to growing public concern about talc, commissioned tests on 34 samples, including a bottle of J&J Baby Powder and samples of Imerys talc from China. No asbestos was detected.
FDA Commissioner Scott Gottlieb said the agency continues to receive a lot of questions about talc cosmetics. "I recognize the concern," he told Reuters. He said the agency's policing of cosmetics in general – fewer than 30 people regulating a "vast" industry – was "a place where we think we can be doing more."
Gottlieb said the FDA planned to host a public forum in early 2019 to "look at how we would develop standards for evaluating any potential risk." An agency spokeswoman said that would include examining "scientific test methods for assessment of asbestos."
Before law school, Herschel Hobson worked at a rubber plant. There, his job included ensuring that asbestos in talc the workers were exposed to didn't exceed OSHA limits.
That's why he zeroed in on Johnson's Baby Powder after he took on Darlene Coker as a client in 1997. The lawsuit Coker and her husband, Roy, filed that year against J&J in Jefferson County District Court in Beaumont, Texas, is the earliest Reuters found alleging Baby Powder caused cancer.
Hobson asked J&J for any research it had into the health of its mine workers; talc production records from the mid-1940s through the 1980s; depositions from managers of three labs that tested talc for J&J; and any documents related to testing for fibrous or asbestiform materials.
J&J objected. Hobson's "fishing expedition" would not turn up any relevant evidence, it asserted in a May 6, 1998, motion. In fact, among the thousands of documents Hobson's request could have turned up was a letter J&J lawyers had received only weeks earlier from a Rutgers University geologist confirming that she had found asbestos in the company's Baby Powder, identified in her 1991 published study as tremolite "asbestos" needles.
Hobson agreed to postpone his discovery demands until he got the pathology report on Coker's lung tissue. Before it came in, J&J asked the judge to dismiss the case, arguing that Coker had "no evidence" Baby Powder caused mesothelioma.
Reuters Darlene Coker is shown with her husband Roy in this undated handout family photograph.
Darlene Coker is shown with her husband Roy in this undated handout family photograph.
Ten days later, the pathology report landed: Coker's lung tissue contained tens of thousands of "long fibers" of four different types of asbestos. The findings were "consistent with exposure to talc containing chrysotile and tremolite contamination," the report concluded.
"The asbestos fibers found raise a new issue of fact," Hobson told the judge in a request for more time to file an opposition to J&J's dismissal motion. The judge gave him more time but turned down his request to resume discovery.
Without evidence from J&J and no hope of ever getting any, Hobson advised Coker to drop the suit.
Hobson is still practicing law in Nederland, Texas. When Reuters told him about the evidence that had emerged in recent litigation, he said: "They knew what the problems were, and they hid it." J&J's records would have made a "100% difference" in Coker's case.
Had the information about asbestos in J&J's talc come out earlier, he said, "maybe there would have been 20 years less exposure" for other people.
Reuters Cady Evans and her sister Crystal Deckard are pictured in California on Aug. 15, 2018.
Cady Evans and her sister Crystal Deckard are pictured in California on Aug. 15, 2018.
Bicks, the J&J lawyer, said Coker dropped her case because "the discovery established that J&J talc had nothing to do with Plaintiff's disease, and that asbestos exposure from a commercial or occupational setting was the likely cause."
Coker never learned why she had mesothelioma. She did beat the odds, though. Most patients die within a year of diagnosis. Coker held on long enough to see her two grandchildren. She died in 2009, 12 years after her diagnosis, at age 63.
Coker's daughter Crystal Deckard was 5 when her sister, Cady, was born in 1971. Deckard remembers seeing the white bottle of Johnson's Baby Powder on the changing table where her mother diapered her new sister.
"When Mom was given this death sentence, she was the same age as I am right now," Deckard said. "I have it in the back of my mind all the time. Could it happen to us? Me? My sister?"