Document 7OxLbMRkmODk4DXb7zg8waO2g

FILE NAME: Talc (TALC) DATE: 2018 Dec DOC#: TALC194 DOCUMENT DESCRIPTION: Reuters Investigation - J&J Knew for Decades that Asbestos Lurked in its Baby Powder Johnson & Johnson knew for decades that asbestos lurked in its Baby Powder ' A REUTERS INVESTIGATION REUTERS/Mike Wood Facing thousands of Lawsuits alleging that its talc caused cancer, J&J insists on the safety and purity of its iconic product. But internal documents examined by Reuters show that the company's powder was sometimes tainted with carcinogenic asbestos and that J&J kept that information from regulators and the public. By LISA GIRION in Los Angeles Filed Dec. 14, 2018, 2 p.m. GMT Darlene Coker knew she was dying. She just wanted to know why. She knew that her cancer, m esotheliom a, arose in the delicate m em brane surrounding her lungs and other organs. She knew it was as rare as it was deadly, a signature of exposure to asbestos. And she knew it afflicted m ostly men who inhaled asbestos dust in mines and industries such as shipbuilding that used the carcinogen before its risks were understood. Coker, 52 years old, had raised two daughters and was running a m assage school in Lumberton, a small town in eastern Texas. How had she been exposed to asbestos? "She wanted answers," her daughter Cady Evans said. Fighting for every breath and in crippling pain, Coker hired Herschel Hobson, a personal-injury lawyer. He homed in on a suspect: the Johnson's Baby Powder that Coker had used on her infant children and sprinkled on herself all her life. Hobson knew that talc and asbestos often occurred together in the earth, and that mined talc could be contaminated with the carcinogen. Coker sued Johnson & Johnson, alleging that "poisonous talc" in the company's beloved product was her killer. EARLY INDICATION: Cady Evans (left) and her sister, Crystal Deckard, surrounded by pictures of their mother, Darlene Coker, whose lawsuit against Johnson & Johnson 20 years ago was one of the first to allege that the company's Baby Powder caused cancer. REUTERS/Mike Blake J&J didn't tell the FDA that at least three tests by three different labs from 1972 to 1975 had found asbestos in its talc - in one case at levels reported as "rather high." J&J denied the claim. Baby Powder was asbestos-free, it said. As the case proceeded, J&J was able to avoid handing over talc test results and other internal company records Hobson had requested to make the case against Baby Powder. Coker had no choice but to drop her lawsuit, H obson said. "W hen you are the plaintiff, you have the burden o f proof," he said. "W e didn't have it." That was in 1999. Two decades later, the material Coker and her lawyer sought is emerging as J&J has been compelled to share thousands of pages of com pany memos, internal reports and other confidential documents with lawyers for some of the 11,700 plaintiffs now claiming that the company's talc caused their cancers -- including thousands of women with ovarian cancer. A Reuters examination of m any of those documents, as well as deposition and trial testimony, shows that from at least 1971 to the early 2000s, the company's raw talc and finished powders sometimes tested positive for small amounts of asbestos, and that company executives, mine managers, scientists, doctors and lawyers fretted over the problem and how to address it while failing to disclose it to regulators or the public. The documents also depict successful efforts to influence U.S. regulators' plans to limit asbestos in cosmetic talc products and scientific research on the health effects of talc. A small portion of the documents have been produced at trial and cited in media reports. M any were shielded from public view by court orders that allowed J&J to turn over thousands o f docum ents it designated as confidential. M uch of their contents is reported here for the first time. The earliest mentions of tainted J&J talc that Reuters found come from 1957 and 1958 reports by a consulting lab. They describe contam inants in talc from J& J's Italian supplier as RELATED coNTENT fibrous and "acicular," or needle-like, tremolite. That's one of the six minerals that in their naturally occurring fibrous form are classified as asbestos. At various times from then into the early 2000s, reports by scientists at J&J, outside labs and J&J's supplier yielded similar findings. The reports identify contaminants in talc and finished powder products as asbestos or describe them in terms typically applied to asbestos, such as "fiberform " and "rods." A guiding hand on talc safety research Read the documents cited in this article After damaging Reuters report, J&J doubles down on talc safety message In 1976, as the U.S. Food and Drug Adm inistration (FDA) was weighing limits on asbestos in cosmetic talc products, J&J assured the regulator that no asbestos was "detected in any sam ple" o f talc produced betw een D ecem ber 1972 and O ctober 1973. It didn't tell the agency that at least three tests by three different labs from 1972 to 1975 had found asbestos in its talc - in one case at levels reported as "rather h igh." Most internal J&J asbestos test reports Reuters reviewed do not find asbestos. However, while J&J's testing methods improved over time, they have always had limitations that allow trace contaminants to go undetected - and only a tiny fraction of the com pany's talc is tested. The W orld Health Organization and other authorities recognize no safe level of exposure to asbestos. W hile most people exposed never develop cancer, for some, even small amounts of asbestos are enough to trigger the disease years later. Just how small hasn't been established. M any plaintiffs allege that the am ounts they inhaled w hen they dusted them selves w ith tainted talcum powder were enough. The evidence of what J&J knew has surfaced after people who suspected that talc caused their cancers hired lawyers experienced in the decades-long deluge of litigation involving workers exposed to asbestos. Some of the lawyers knew from those earlier cases that talc producers tested for asbestos, and they began demanding J&J's testing documentation. 0:00 / 7:44 M A big verdict fuels a reporter's curiosity. REUTERS/Mike Wood W hat J&J produced in response to those dem ands has allow ed plaintiffs' law yers to refine their argum ent: The culprit w asn't necessarily talc itself, but also asbestos in the talc. That assertion, backed by decades of solid science showing that asbestos causes mesothelioma and is associated with ovarian and other cancers, has had mixed success in court. In two cases earlier this year - in N ew Jersey and California - juries awarded big sums to plaintiffs who, like Coker, blam ed asbestos-tainted J&J talc products for their mesothelioma. A third verdict, in St. Louis, was a watershed, broadening J&J's potential liability: The 22 plaintiffs were the first to succeed with a claim that asbestos-tainted Baby Powder and Shower to Shower talc, a longtim e brand the company sold in 2012, caused ovarian cancer, which is m uch more common than mesothelioma. The ju ry awarded them $4.69 billion in damages. Most of the talc cases have been brought by women with ovarian cancer who say they regularly used J&J talc products as a perineal antiperspirant and deodorant. At the same time, at least three juries have rejected claims that Baby Powder was tainted with asbestos or caused plaintiffs' mesothelioma. Others have failed to reach verdicts, resulting in mistrials. J&J has said it will appeal the recent verdicts against it. It has m aintained in public statements that its talc is safe, as shown for years by the best tests available, and that the information it has been required to divulge in recent litigation shows the care the com pany takes to ensure its products are asbestos-free. It has blam ed its losses on ju ro r confusion, "ju n k " science, unfair court rules and overzealous lawyers looking for a fresh pool of asbestos plaintiffs. "Plaintiffs' attorneys out for personal financial gain are distorting historical documents and intentionally creating confusion in the courtroom and in the m edia," Ernie Knewitz, J&J's vice president of global media relations, wrote in an emailed response to Reuters' findings. "This is all a calculated attempt to distract from the fact that thousands of independent tests prove our talc does not contain asbestos or cause cancer. A ny suggestion that Johnson & Johnson knew or hid inform ation about the safety of talc is false." J&J declined to comment further for this article. For more than two months, it turned down repeated requests for an interview w ith J&J executives. On Dec. 8, the com pany offered to m ake an expert available. It had not done so as o f Thursday evening. The com pany referred all inquiries to its outside litigation counsel, Peter Bicks. In emailed responses, Bicks rejected Reuters' findings as "false and m isleading." "The scientific consensus is that the talc used in talc-based body powders does not cause cancer, regardless o f w hat is in that talc," Bicks wrote. "This is true even if - and it does not - Johnson & Joh nson's cosm etic talc had ever contained minute, undetectable amounts of asbestos." He dismissed tests cited in this article as "outlier" results. In court, J&J lawyers have told jurors that com pany records showing that asbestos was detected in its talc referred to talc intended for industrial use. Other records, they have argued, referred to non-asbestos forms of the same minerals that their experts say are harm less. J&J has also argued that som e tests picked up "background" asbestos - stray fibers that could have contam inated samples after floating into a mill or lab from a vehicle clutch or fraying insulation. The company has made some of the same arguments about lab tests conducted by experts hired by plaintiffs. One of those labs found asbestos in Shower to Shower talc from the 1990s, according to an Aug. 11, 2017, court report. A nother lab found asbestos in more than half of multiple samples of Baby Powder from past decades - in bottles from plaintiffs' cupboards and acquired from eBay, and even a 1978 bottle held in J& J's corporate museum. The concentrations were great enough that users "would have, more likely than not, been exposed," the plaintiffs' lab report presented in several cases this year concluded. M atthew Sanchez, a geologist with consultants RJ Lee Group Inc and a frequent expert witness for J&J, dismissed those findings in testim ony in the St. Louis trial: "I have not found asbestos in any o f the current or modern, what I consider modern, Johnson & Johnson talc products," Sanchez told the jury. Sanchez did not return calls seeking comment. RJ Lee said it does not comment on the work it does for clients. Since 2003, talc in Baby Powder sold in the United States has come from China through supplier 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 the Chinese talc is safe. An Imerys spokesman said the company's tests "consistently show no asbestos. Talc's safe use has been confirmed by m ultiple regulatory and scientific bodies." J&J, based in N ew Brunswick, N ew Jersey, has dominated the talc powder market for more than 100 years, its sales outpacing those of all competitors combined, according to Eurom onitor International data. And while talc products contributed just $420 m illion to J&J's $76.5 billion in revenue last year, Baby Powder is considered an essential facet of the healthcare-products m aker's carefully tended im age as a caring com pany - a "sacred cow ," as one 2003 internal email put it. "W hen people really understand what's going on, I think it increases J&J's exposure a thousand-fold," said M ark Lanier, one of the lawyers for the wom en in the St. Louis case. The m ounting controversy surrounding J&J talc hasn't shaken investors. The share price is up about 6 percent so far this year. Talc cases m ake up few er than 10 percent o f all personal injury lawsuits pending against J&J, based on the com pany's Aug. 2 quarterly report, in which the com pany said it believed it had "strong grounds on appeal." J&J Chairm an and C hief Executive O fficer A lex G orsky has pledged to fight on, telling analysts in July: "W e rem ain confident that our products do not contain asbestos." Gorsky's comment, echoed in countless J&J statements, misses a crucial point. Asbestos, like m any environmental carcinogens, has a long latency period. Diagnosis usually comes years after initial exposure - 20 years or longer for mesothelioma. J&J talc products today m ay be safe, but the talc at issue in thousands of lawsuits was sold and used over the past 60 years. That point is recognized in a 2013 m arkup o f a statement for the "Safety & Care Commitment" page of J&J's website. The original version conveyed a blanket assurance of safety. The edited version was less definitive: "Our talc-based consumer products are have always been (w e cannot say "always") asbestos free, as confirmed by regular testing since the 1970s." 2013 NEEDLES IN A HAYSTACK: Bundles (top, center) and a single fiber (bottom) that a plaintiffs' lab found in a 1978 bottle of Baby Powder from J& J's corporate museum show the telltale needle-like shape of asbestos. Photo courtesy of Mark Lanier. JOHNSON'S* talc products are made using U.S. Pharm acopeial (USP) grade talc to ensure it meets the highest-quality, purity and compliance standards. Our talc-based consumer products arehovo a lways boon(we cannot say "always") asbestos free, as confirm ed by regular testing conducted since the 1970s. We also make JOHNSON'S Baby Powder that contains cornstarch. THEN AND NOW: A 2013 markup of a statement for J& J's website implicitly recognizes the possibility that the company's talc could have been tainted in earlier times. "Safety first" In 1886, Robert W ood Johnson enlisted his younger brothers in an eponymous startup built around the "Safety First" motto. Johnson's Baby Powder grew out of a line of medicated plasters, sticky rubber strips loaded with mustard and other home remedies. W hen customers complained of skin irritation, the brothers sent packets of talc. Soon, mothers began applying the talc to infants' diaper-chafed skin. The Johnsons took note. They added a fragrance that would becom e one of the most recognizable in the world, sifted the talc into tin boxes and, in 1893, began selling it as Johnson's Baby Powder. In the late 1950s, J&J discovered that talc from its chief source m ine for the U.S. market in the Italian Alps contained tremolite. That's one o f 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 unremarkable "non-asbestiform" rocks. Both forms often occur together and in talc deposits. J&J's worry at the tim e was that contaminants m ade the com pany's powder abrasive. It sent tons of its Italian talc to a private lab in Columbus, Ohio, to find ways to improve the appearance, feel and purity of the powder by removing as much "grit" as possible. In a pair o f reports from 1957 and 1958, the lab said the talc contained "from less than 1 percent to about 3 percent of contaminants," described as mostly fibrous and "acicular" tremolite. Most of the authors of these and other J&J records cited in this article are dead. Sanchez, the RJ Lee geologist whose firm has agreed to provide him as a witness in up to 100 J&J talc trials, has testified that trem olite found decades ago in the company's talc, from Italy and later Vermont, was not trem olite asbestos at all. Rather, he has said, it was "cleavage fragm ents" from nonasbestiform tremolite. J& J's original records don't always m ake that distinction. In term s o f health risk, regulators since the early 1970s have treated small fiber-shaped particles of both forms the same. The U.S. Environmental Protection Agency, for example, "m akes no distinction between fibers and (comparable) cleavage fragm ents," agency officials wrote in a response to an RJ Lee report on an unrelated m atter in 2006, the year before the firm hired Sanchez. The Occupational Safety and Health Administration (OSHA), though it dropped the non-fibrous forms of the minerals from its definition of asbestos in 1992, nonetheless recommends that fiber-shaped fragments indistinguishable from asbestos be counted in its exposure tests. And as the product safety director for J&J's talc supplier acknowledged in a 2008 email to colleagues: "(I)f a deposit contains `non-asbestiform ' tremolite, there is also asbestiform trem olite naturally present as w ell." "SACRED COW": Today, Baby Powder accounts for only a small portion of J& J's annual revenue, but is considered essential to the company's caring image. REUTERS/Mike Segar "The lungs of babies" In 1964, J&J's W indsor Minerals Inc subsidiary bought a cluster of talc mines in Vermont, with names like Argonaut, Rainbow, Frostbite and Black Bear. By 1966, it was blasting and bulldozing white rock out of the Green M ountain state. J&J used the milled powder in its cosmetic powders and sold a less-refined grade to roofing, flooring and tire companies for use in manufacturing. Ten years after trem olite turned up in the Italian talc, it showed up in Verm ont talc, too. In 1967, J&J found traces o f trem olite and another m ineral that can occur as asbestos, according to a table attached to a Nov. 1, 1967, m em o b y W illiam Ashton, the executive in charge of J&J's talc supply for decades. J&J continued to search for sources o f clean talc. But in an April 9, 1969, m em o to a com pany doctor, Ashton said it was "norm al" to find trem olite in m any U.S. talc deposits. He suggested J&J rethink its approach. "Historically, in our Company, Tremolite has been bad," Ashton wrote. "How bad is Tremolite medically, and how much of it can safely be in a talc base we might develop?" Since pulm onary disease, including cancer, appeared to be on the rise, "it would seem to be prudent to lim it any possible content o f Trem olite ... to an absolute m inim um ," cam e the reply from another physician executive days later. The doctor told Ashton that J&J was receiving safety questions from pediatricians. Even Robert W ood Johnson II, the founder's son and then-retired CEO, had expressed "concern over the possibility of the adverse effects on the lungs of babies or mothers," he wrote. "W e have replied," the doctor wrote, that "w e w ould not regard the usage o f our powders as presenting any hazard." Such assurances would be impossible, he added, "if we do include Tremolite in more than unavoidable trace am ounts." The memo is the earliest J&J document reviewed by Reuters that discusses trem olite as more than a scratchy nuisance. The doctor urged Ashton to consult with com pany lawyers because "it is not inconceivable that we could becom e involved in litigation." Never "100% clean" By the early 1970s, asbestos was w idely recognized as the prim ary cause of m esotheliom a am ong workers involved in producing it and in industries that used it in their products. Regulation was in the air. In 1972, President Richard N ixon's newly created O SH A issued its first rule, setting lim its on workplace exposure to asbestos dust. By then, a team at Mount Sinai Medical Center led by pre-em inent asbestos researcher Irving Selikoff had started looking at talcum powders as a possible solution to a puzzle: W hy were tests o f lung tissue taken post mortem from N ew Yorkers who never worked with asbestos finding signs of the mineral? Since talc deposits are often laced with asbestos, the scientists reasoned, perhaps talcum powders played a role. They shared their prelim inary findings with N ew York City's environmental protection chief, Jerom e Kretchmer. On June 29, 1971, Kretchmer informed the Nixon administration and called a press conference to announce that two unidentified brands of cosmetic talc appeared to contain asbestos. The FDA opened an inquiry. J&J issued a statem ent: "Our fifty years of research knowledge in this area indicates that there is no asbestos contained in the powder manufactured by Johnson & Johnson." Later that year, another Mount Sinai researcher, mineralogist Arthur Langer, told J&J in a letter that the team had found a "relatively small" amount of chrysotile asbestos in Baby Powder. ROCK STEADY: Dr Arthur Langer, who was part of a Mount Sinai team researching asbestos in talc in the 1970s, says he stands by his finding of small amounts of asbestos in Baby Powder. REUTERS/Julia Rendleman SPREADING THE WORD: Jerome Kretchmer was New York City's environmental protection chief when he announced that the Mount Sinai research team had found what appeared to be asbestos in two unidentified brands of cosmetic talc. REUTERS/Jeenah Moon 1972 REC tw eo \9TZ D fcCl ^cfuvron ^ofvmcn 'NnNNl^JOHNSON j0h n so n & JU Subject: Antagonistic Personalities In The T alc Story In The U .S .A . New Brunswick, N.J. November 29, 1972 NOTORIETY: Langer and Kretchmer ended up on an internal J&J list of "antagonistic personalities." Langer, Selikoff and Kretchmer ended up on a J&J list of "antagonistic personalities" in a Nov. 29, 1972, m emo, which described Selikoff as the leader of an "attack on talc." "I suppose I was antagonistic," Langer told Reuters. Even so, in a subsequent test o f J&J powders in 1976, he didn't find asbestos - a result that Mount Sinai announced. Langer said he told J&J lawyers who visited him last year that he stood by all of his findings. J&J has not called him as a witness. Selikoff died in 1992. Kretchm er said he recently read that a jury had concluded that Baby Powder was contaminated with asbestos. "I said to myself, `How com e it took so long?' " he said. In July 1971, meanwhile, J&J sent a delegation of scientists to W ashington to talk to the FDA officials looking into asbestos in talcum powders. According to an FDA account of the meeting, J&J shared "evidence that their talc contains less than 1%, if any, asbestos." Later that month, W ilson Nashed, one of the J&J scientists who visited the FDA, said in a memo to the company's public relations department that J&J's talc contained trace amounts of "fibrous minerals (tremolite/actinolite)." As the FDA continued to investigate asbestos in talc, J&J sent powder samples to be tested at private and university labs. Though a private lab in Chicago found trace amounts of TOP TESTER: Irving Selikoff, who led the Mount Sinai team that investigated asbestos and talc, was also listed among J& J's "antagonistic personalities." Photo courtesy of Arthur Langer tremolite, it declared the amount "insignificant" and the samples "substantially free of asbestiform material." J&J reported that finding to the FDA under a cover letter that said the "results clearly show" the samples tested "contain no chrysotile asbestos." J&J's lawyer told Reuters the trem olite found in the samples was not asbestos. But J&J's FDA submission left out University of M innesota professor Thomas E. Hutchinson's finding of chrysotile in a Shower to Shower sample - "incontrovertible asbestos," as he described it in a lab note. 1972 -fi> e s re o-f &s<kes~fds (U \d 0 *i . j ' <j* ilon/ttKAacc/ (Lftx \ y \ i r & r ~ l e (ks /-c. _. . yk xskUj __/SISTd. ^ j u ^ t s w trt... <L&i&re/ __ LSl<Us~ ~hv( t i Gcw (Lr&o%. NO DOUBT: In a lab note, a University of Minnesota professor recorded finding "incontrovertible asbestos" in a sample of J& J's Shower to Shower talc. The FDA's own examinations found no asbestos in J&J powder samples in the 1970s. Those tests, however, did not use the most sensitive detection methods. An early test, for example, was incapable of detecting chrysotile fibers, as an FDA official recognized in a J&J account o f an Aug. 11, 1972, m eeting w ith the agency: "I understand that som e sam ples w ill be passed even though they contain such fibers, but we are willing to live with it." By 1973, Tom Shelley, director of J&J's Central Research Laboratories in New Jersey, was looking into acquiring patents on a process that a British mineralogist and J&J consultant was developing to separate talc from tremolite. "It is quite possible that eventually tremolite will be prohibited in all talc," Shelley wrote on Feb. 20, 1973, to a British colleague. Therefore, he added, the "process may well be valuable property to us." At the end of March, Shelley recognized the sensitivity of the plan in a memo sent to a J&J lawyer in New Jersey: "W e will w ant to carefully consider the ... patents re asbestos in talc. It's quite possible that we may wish to keep the whole thing confidential rather than allow it to be published in patent form and thus let the whole world know." J&J did not obtain the patents. W hile Shelley was looking into the patents, J&J research director DeW itt Petterson visited the com pany's Verm ont mining operation. "Occasionally, sub-trace quantities of tremolite or actinolite are identifiable," he wrote in an April 1973 report on the visit. "A nd these m ight be classified as asbestos fiber." J&J should "protect our powder franchise" by elim inating as many tiny fibers that can be inhaled in airborn talc dust as possible, Petterson wrote. He warned, however, that "no final product will ever be made which will be totally free from respirable particles." Introducing a cornstarch version of Baby Powder, he noted, "is obviously another answer." it takes moreMthaamnaattaouwgehl ttomreeally get dry. IKtsillheabrrdewtowimasaoginncee, bauttinIylalritntiloenbaby. AsplrtienrkhleisJObaHthN,ShOisNm'SoUthaebr\ wPoouwldder twillhiotveeprohwisdleirttwleobuolddyh. eTlhpadtrpyuurpe the moisture his towel left behind. lfeoarvtainbgleIalallmovioern. cool and com pItremsusisotnh. aBveecianuasieleHaalramstoinngKimillc- iirew JOHN SstOilNl d'SriBesabhyimPsoewlfdoefrf. wItitghe t s him drier than just a towel. And JhOelHpNs ShOimN'sStaByacbryisPpoawnddecr.ooItl.keeps yliottulecbomabfyorotraabl2e1w0-hpeotuhnedr `yKoiull'erre;a liny JOH N SON S Baby Powder. It gets you drier than just your towel. - 1973 1972: Baseball Hall of Fame slugger Harmon Killebrew plugs Baby Powder. undertaken with a good chance of success in this area. It should be cautioned, however, that no final product will ever be made which will be totally free from respirable particles. We are talking about a significant reduction in fine particle count but not 100% clean-up. UNACHIEVABLE: J&J research director DeWitt Petterson warned the company that producing pure talc was impossible. Bicks told Reuters that J&J believes that the tremolite and actinolite Petterson cited were not asbestos. Cornstarch cam e up again in a M arch 5, 1974, report in w hich Ashton, the J& J talc supply chief, recom m ended that the com pany research that alternative "for defensive reasons" because "the thrust against talc has centered prim arily on biological problems alleged to result from the inhalation of talc and related mineral particles." "We may have problems" A few months after Petterson's recognition that talc purity was a pipe dream, the FDA proposed a rule that talc used in drugs contain no more than 0.1 percent asbestos. W hile the agency's cosmetics division was considering similar action on talcum powders, it asked companies to suggest testing methods. At the tim e, J& J's Baby Powder franchise was consum ing 20,000 tons o f Verm ont talc a year. J&J pressed the FDA to approve an X-ray scanning technique that a com pany scientist said in an April 1973 memo allowed for "an autom atic 1% tolerance for asbestos." That would mean talc with up to 10 tim es the FDA's proposed lim it for asbestos in drugs could pass muster. The same scientist confided in an Oct. 23, 1973, note to a colleague that, depending on what test the FDA adopted for detecting asbestos in cosmetic talc, "we m ay have problem s." The best w ay to detect asbestos in talc was to concentrate the sample and then examine it through microscopes, the Colorado School o f Mines Research Institute told J&J in a Dec. 27, 1973, report. In a m em o, a J&J lab supervisor said the concentration technique, which the com pany's own researchers had earlier used to identify a "trem olite-type" asbestos in Verm ont talc, had one limitation: "It m ay be too sensitive." "N o mother was going to powder her baby with 1% of a known carcinogen irregardless of the large safety factor." An FDA official commenting in 1975 on the talc testing method J&J backed In his email to Reuters, J&J's lawyer said the lab supervisor's concern was that the test would result in "false positives," showing asbestos where there was none. J&J also launched research to find out how much powder a baby was exposed to during a diapering and how much asbestos could be in that powder and remain within OSHA's new workplace exposure lim its. Its researchers had strapped an air sampling device to a doll to take m easurem ents while it was powdered, according to J&J m em os and the m inutes of a Feb. 19, 1974, m eeting of the Cosmetic Toiletry and Fragrance Association (CTFA), an industry group. "It was calculated that even if talc were pure asbestos the levels of exposure of a baby during a normal powdering are far below the accepted tolerance lim its," the minutes state. In a Sept. 6, 1974, letter, J&J told the FD A that since "a substantial safety factor can be expected" w ith talc that contains 1 percent asbestos, "m ethods capable of determ ining less than 1% asbestos in talc are not necessary to assure 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 it "foolish," adding, according to a J&J account o f a February 1975 m eeting: "N o m other w as going to pow der her baby w ith 1% o f a known carcinogen irregardless of the large safety factor." "Misrepresentation by omission" Having failed to persuade the FDA that up to 1 percent asbestos contamination was tolerable, J&J began promoting self-policing as an alternative to regulation. The centerpiece of this approach was a M arch 15, 1976, package o f letters from J&J and other manufacturers that the CTFA gave to the agency to show that they had succeeded at eliminating asbestos from cosmetic talc. "The attached letters demonstrate responsibility o f industry in monitoring its talcs," the cover letter said. "W e are certain that the summary will give you assurance as to the freedom from contamination by asbestos for materials of cosmetic talc products." In its letter, J&J said samples of talc produced between December 1972 and October 1973 were tested for asbestos, and none was detected "in any sample." J&J didn't tell the FD A about a 1974 test b y a professor at D artm outh College in N ew H am pshire that turned up asbestos in talc from J&J - "fiberform " actinolite, as he put it. N or did the com pany tell the FD A about a 1975 report from its longtim e lab that found particles identified as "asbestos fibers" in five of 17 samples of talc from the chief source mine for Baby Powder. "Some of them seem rather high," the private lab wrote in its cover letter. Bicks, the J&J lawyer, said the contract lab's results were irrelevant because the talc was intended for industrial use. He said the com pany now believes that the actinolite the D artm outh professor found "was not asbestiform ," based on its interpretation o f a photo in the original lab report. Just two months after the Dartmouth professor reported his findings, W indsor Minerals Research and Development Manager Vernon Zeitz wrote that chrysotile, "fibrous anthophyllite" and other types of asbestos had been "found in association with the Hammondsville ore body" - the Vermont deposit that supplied Baby Powder talc for more than two decades. Life son, life father. Like daughter. like i-iother. Lihemillions ofpeople, you chi tart your day wf aliiuc better with JOHNSON'S Baby Powder. There's nothing like giving yourself the fresh, clear,, dry feeling tafmwri*wwuvn sables havebeen getting fetyears r Andthere'sno age Until when Hcomes lo staying cool, corr/ortable and well-cared-for with JOHNSONS Baby Powder Gets everyone off to a good start. A_ y - baby powder Y Touch, more than oik. u what ababy beat understands. Every Inchofhim responds i your touch,, .cuddling,,.comforting .caringfor him. Johnson's putsspecial gentleness Inyour touch. With the pureitoLl and the softest powderinall theWorld. mvYon FOR EVERYONE: For decades, J&J has promoted its iconic Baby Powder as a safe, gentle product for babies and adults alike. Zeitz's M ay 1974 report on efforts to minimize asbestos in Verm ont talc "strongly urged" the adoption of ways to protect "against what are currently considered to be materials presenting a severe health hazard and are potentially present in all talc ores in use at this tim e." Bicks said that Zeitz was not reporting on actual test results. The following year, Zeitz reported that based on weekly tests o f talc samples over six months, "it can be stated with a greater than 99.9% certainty that the ores and materials produced from the ores at all W indsor M ineral locations are free from asbestos or asbestiform minerals." J& J's selective use of test results figured in a N ew Jersey judge's decision this year to affirm the first verdict against the com pany in a case claiming asbestos in J&J products caused cancer. "Providing the FDA favorable results showing no asbestos and withholding or failing to provide unfavorable results, which show asbestos, is a form o f a m isrepresentation by omission," Middlesex County Superior Court Judge Ana Viscomi said in her June ruling. "J&J respectfully disagrees w ith the Judge's com m ents," Bicks said. "J&J did not w ithhold any relevant testing from FD A." The FDA declined to comment on the ruling. Lacking consensus on testing methods, the FDA postponed action to lim it asbestos in talc. Years later, it did set limits on asbestos in talc used in drugs. It has never lim ited asbestos in cosm etic talc or established a preferred m ethod for detecting it. Instead, in 1976, a CTFA com m ittee chaired by a J&J executive drafted voluntary guidelines, establishing a form o f X-ray scanning with a 0.5 percent detection lim it as the prim ary test, the m ethod J&J preferred. The m ethod is not designed to detect the most com m only used type o f asbestos, chrysotile, at all. The group said the m ore sensitive electron m icroscopy was im p ractical. The CTFA, which now does business as the Personal Care Products Council, declined to comment. X-ray scanning is the prim ary method J&J has used for decades. The company also periodically requires the more sensitive checks with electron microscopes. J& J's lawyer said the com pany's tests exceed the trade association standard, and they do. He also said that today, J&J's X-ray scans can detect suspect minerals at levels as low as 0.1 percent of a sample. But the company never adopted the Colorado lab's 1973 recommendation that samples be concentrated before examination under a microscope. And the talc samples that were subjected to the most sensitive electron microscopy test were a tiny fraction of what was sold. For those and other reasons, J&J couldn't guarantee its Baby Pow der was asbestos-free when plaintiffs used it, according to experts, including some who testified for plaintiffs. As early as 1976, Ashton, J&J's longtim e talc overseer, recognized as much in a memo to colleagues. He wrote that talc in general, if subjected to the m ost sensitive testing m ethod, using concentrated sam ples, "w ill be hard pressed in supporting purity claim s." He described this sort of testing as both "sophisticated" and "disturbing." By 1977, J&J appeared to have tam ped 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 o f "favorable data from the various J&J sponsored studies." In 1984, FDA cosmetics chief and form er 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, "w e really could not identify asbestos or only on very rare occasions." Blair Brown for Johnson's Baby ... 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 c u s to m s ta s e to p e o p k w h o prefer com starcli, the company says. Actress Blair Brown touts Baby Bowder in this 1970s.era Tv ^ m ercial The persistence o f the industry's view that cosmetic talc is asbestos-free is w hy no studies have been conducted on the incidence of mesotheliom a among users of the products. It's also partly w hy regulations that protect people in m ines, m ills, 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 Am erican Cancer Society (ACS) accepted the industry's position, saying on its website: "A ll 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 W orld Health Organization's International Agency for Research on Cancer classifies talc that contains asbestos as "carcinogenic to humans." Despite the success o f J& J's efforts to prom ote the safety o f its talc, the com pany's test lab found asbestos fibers in sam ples taken from the Verm ont operation in 1984, 1985 and 1986. Bicks said: "The samples that we know o f during this tim e period that contained a fiber or two of asbestos were not cosmetic talc samples." Then, in 1992, three years after J&J sold its Verm ont mines, the new owner, Cyprus Minerals, said in an internal report on "im portant environmental issues" in its talc reserves that there was "past trem olite" in the Hammondsville deposit. Hammondsville was the prim ary 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 m em o, "were destroyed by the m ine m anagement staff just prior to the J&J divestiture." Bicks said the destroyed documents did not include talc testing records. 1993 (Note- The specifics of the mining operation at Hammondsville are uncertain, as most of the pre-Luzenac records were destroyed by the mine management staff just prior to the J & J divestiture and the Cyprus purchase. However, several former Hammondsville miners are still employed at the Ham mine, and they provided us with useful information as to the nature of the underground works.) MISSING: A J& J memo reveals that records of the Hammondsville mine, the main source of Baby Powder talc from 1966 until 1990, were destroyed by mine managers while J&J still owned the business. 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 com e 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 m ore." G ottlieb said the FD A planned to host a public forum in early 2019 to "look at how w e w ould develop standards for evaluating any potential risk." An agency spokeswoman said that would include examining "scientific test methods for assessment of asbestos." "Fishing expedition" Before law school, Herschel Hobson worked at a rubber plant. There, his job included ensuring that asbestos in talc the workers w ere exposed to didn't exceed O SH A lim its. 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 m ine workers; talc production records from the m id-i940s 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. H obson's "fishing expedition" would not turn up any relevant evidence, it asserted in a M ay 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 com pany's Baby Powder, identified in her 1991 published study as trem olite "asbestos" needles. Hobson agreed to postpone his discovery demands until he got the pathology report on Coker's lung tissue. Before it cam e in, J&J asked the judge to dismiss the case, arguing that Coker had "no evidence" Baby Powder caused mesothelioma. 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 tim e to file an opposition to J&J's dismissal motion. The judge gave him more time but turned down his request to resume discovery. W ithout 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. W hen Reuters told him about the evidence that had emerged in recent litigation, he said: "They knew what the problem s 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, "m aybe there would have been 20 years less exposure" for other people. NO SATISFACTION: Lacking the evidence she needed, Darlene Coker, here with one of her doctors, died without ever finding out what caused her mesothelioma. Cady Evans/Handout via REUTERS Bicks, the J&J lawyer, said Coker dropped her case because "the discovery established that J&J talc had nothing to do with Plaintiffs 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 m other diapered her new sister. "W hen M om was given this death sentence, she was the same age as I am right now," Deckard said. "I have it in the back of m y m ind all the time. Could it happen to us? Me? M y sister?" A guiding hand on talc safety research By LISA GIRION Johnson & Johnson developed a strategy in the 1970s to deal with a growing volum e of research showing that talc miners had elevated rates of lung disease and cancer: Promote the positive, challenge the negative. That approach was summ ed up by a J&J applied research director in a "strictly confidential" M arch 3, 1975, m emo to m anagers of the baby products division, which used the talc in J&J's signature Baby Powder. "Our current posture with respect to the sponsorship of talc safety studies has been to initiate studies only as dictated by confrontation," the memo said. "This philosophy, so far, has allowed us to neutralize or hold in check data already generated by investigators who question the safety of talc." 1973 Our current posture with respect to sponsorship of talc safety studies has been to initiate studies only as dictated by confrontation. This philosophy, so far, has allowed us to neutralize or hold in check data * - already generated by investigators who question the safety of talc. The principal advantage for this operating philosophy lies in the fact that wo minimize the risk of possible self-generation of scientific data which may be politically or scientifically embarrassing. ^ L . a. _ _ _ _ _ _ _ _ _ -3 A . U _ A. . . _ 4 Jl f > f A J& J executive laid out the company's policy of countering negative research about the health effects of talc in a memo to managers. Also, the memo said, "we m inimize the risk of possible self-generation of scientific data which m ay be politically or scientifically em barrassing." J&J's effort to protect its iconic Baby Powder franchise by shaping research was led by physician and scientist executives. An early 1970s study of 1,992 Italian talc miners shows how it worked: J&J com m issioned and paid for the study, told the researchers the results it wanted, and hired a ghostwriter to redraft the article that presented the findings in a journal. The effort entailed other attempts to influence research, including a U.S. government study o f the health of talc workers in Vermont. J&J's W indsor Minerals Inc subsidiary, one of several m ine operators involved in the study, developed a relationship with the U.S. National Institute of Occupational Safety and Health researchers to "even influence the conclusions" through suggestions of "subjective interpretations," according to a 1973 W indsor Minerals m em o. Peter Bicks, outside counsel for J&J, told Reuters in an email that for the Vermont study, company "representatives acted in an `educational and advisory capacity' to provide the researchers with a realistic study plan." A 1979 article in the Journal of Environmental Pathology and Toxicology detailing the findings of the study was not good news for talc. It reported a "significant increase" in "respiratory cancer mortality" among miners. A subsequent analysis of the underlying data published in 1988 determined that at least one of the workers died of mesothelioma, the cancer most closely associated with asbestos. The proposal to study the health of miners of the Italian talc used in Baby Powder for decades came from W illiam Ashton, J&J's longtim e talc supply chief. Ashton had obtained a summ ary of m iners' medical records compiled by an Italian physician, who also happened to control the country's talc exports. J&J should use those records "for m axim um benefit," A shton said in a M ay 8, 1973, letter to D r Gavin H ildick-Sm ith, J& J's director of medical affairs. "It seems to me that the Italian records give us the opportunity to fortify a position on talc safety." At the time, the U.S. Food and Drug Adm inistration was considering a lim it on asbestos in talcs. In an Oct. 18, 1973, m em o, Hildick-Smith advised J& J: "The risk/benefit ratio o f conducting an epidemiological study in these mines must be considered." By early 1974, the study was a go. Hildick-Smith sent m oney to the Italian talc exporter-physician to hire a team of researchers. H ildick-Sm ith told the lead researcher in a June 26, 1974, letter exactly w hat J&J wanted: data that "w ould show that the incidence of cancer in these subjects is no different from that of the Italian population or the rural control group." That is exactly what J&J got, Hildick-Smith told colleagues a few months later. At a meeting on Sept. 27, 1974, for a "Talc/powder Safety Studies Review," he reported the Italian study would dispel the "cancer concern associated with exposure to talc." The following spring, Hildick-Smith got a draft of the Italian study from the lead researcher. It needed work to meet the "form and style" requirements of the target journal, he told colleagues in a March 31, 1975, m em o. He added that he would send it to a scientific ghostw riter "w ho w ill hold it in confidence and rew rite it." The article that appeared in 1976 in the Journal of Occupational and Environmental M edicine reported results even better than J&J had bargained for. The study found fewer lung cancer deaths than expected, a result that the authors said supported "the thesis of no cancerogenic effect attributable to pure talc." REUTERS INVESTIGATES More Reuters investigations and long-form narratives It also found no mesothelioma, the signature cancer of asbestos exposure. There is no evidence J&J m anipulated or misused the data. Experts for plaintiffs have testified that the Italian study was too small to draw any conclusions about the incidence o f such a rare cancer. J&J's expert witnesses have concluded the opposite. Got a confidential news tip? Reuters Investigates offers several ways to securely contact our reporters Bicks noted that the Italian study has been updated three times - in 1979, 2003 and 2017 - "confirming the lack of association between exposure to asbestos-free talc, lung cancer and m esotheliom a." J&J got a lot o f m ileage out o f the study. It was cited in a review article titled "The Biology o f Talc," published Nov. 1, 1976, in the British Journal of Industrial Medicine. In addition to dozens of published studies, the review cited unpublished research, including one experiment that used a doll as a proxy for infants and that supported the com pany's position on the safety of talc. It didn't disclose that J&J had com m issioned the unpublished research. The author of the review article concluded that the "concern that has been expressed about the possible health hazard from consum er exposure to cosm etic talc is unw arranted ... There is no evidence that its norm al use poses a hazard to health." The author was Hildick-Smith, the J&J physician executive who had overseen the Italian study and played a key role in the com pany's talc safety research. The article did not disclose his J&J connection, identifying him only as a Rutgers University clinical assistant professor. Hildick-Smith died in 2006. Powder Keg By Lisa Girion Photo editing: Steve McKinley Video: Zachary Goelman, Jane Lee, Mike Wood and Krystian Orlinski Design: Troy Dunkley Edited by Janet Roberts and John Blanton f # in S f # Follow Reuters Investigates OTHER REUTERS INVESTIGATIONS The Loyalists Stealing Clouds How Venezuela overhauled its military to jumble the chain of command, make its troops more partisan and keep the armed forces loyal to President Nicols Maduro Reuters shows how Chinese hackers invaded myriad global companies, exposing entrenched weaknesses in Western cyber defenses. Hidden Injustice In case after case, U.S. judges sealed evidence about the risks - the result of a lethal secrecy that Reuters found shrouds many product-liability cases. False records, big fees Ambushed at Home |Reuters shows how a U.S. military landlord falsified maintenance logs, helping it win bonuses as families pleaded for repairs.