An examination shows that from at least 1971 to the early 2000s, products sometimes tested positive for small amounts of asbestos.<\/b>
\nLOS ANGELES, Dec 14 (Reuters) — Darlene Coker knew she was dying. She just wanted to know why.
She knew that her cancer, mesothelioma, arose in the delicate membrane 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 mostly 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 massage school in Lumberton, a small town in eastern Texas. How had she been exposed to asbestos? \u201cShe wanted answers,\u201d 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\u2019s 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 \u201cpoisonous talc\u201d in the company\u2019s beloved product was her killer.
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, Hobson said. \u201cWhen you are the plaintiff, you have the burden of proof,\u201d he said. \u201cWe didn\u2019t have it.\u201d
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 company memos, internal reports and other confidential documents with lawyers for some of the 11,700 plaintiffs now claiming that the company\u2019s talc caused their cancers \u2014 including thousands of women with ovarian cancer.
A Reuters examination of many of those documents, as well as deposition and trial testimony, shows that from at least 1971 to the early 2000s, the company\u2019s 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\u2019 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. Many were shielded from public view by court orders that allowed J&J to turn over thousands of documents it designated as confidential. Much of their contents is reported here for the first time.
«RATHER HIGH»
The earliest mentions of tainted J&J talc that Reuters found come from 1957 and 1958 reports by a consulting lab. They describe contaminants in talc from J&J\u2019s Italian supplier as fibrous and \u201cacicular,\u201d or needle-like, tremolite. That\u2019s 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\u2019s 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 \u201cfiberform\u201d and \u201crods.\u201d
In 1976, as the U. S. Food and Drug Administration (FDA) was weighing limits on asbestos in cosmetic talc products, J&J assured the regulator that no asbestos was \u201cdetected in any sample\u201d of talc produced between December 1972 and October 1973. It didn\u2019t tell the agency that at least three tests by three different labs from 1972 to 1975 had found asbestos in its talc \u2013 in one case at levels reported as \u201crather high.\u201d
Most internal J&J asbestos test reports Reuters reviewed do not find asbestos. However, while J&J\u2019s testing methods improved over time, they have always had limitations that allow trace contaminants to go undetected \u2013 and only a tiny fraction of the company’s talc is tested.
The World Health Organization and other authorities recognize no safe level of exposure to asbestos. While 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\u2019t been established. Many plaintiffs allege that the amounts they inhaled when they dusted themselves with 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\u2019s testing documentation.
What J&J produced in response to those demands has allowed plaintiffs\u2019 lawyers to refine their argument: The culprit wasn\u2019t 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 \u2013 in New Jersey and California \u2013 juries awarded big sums to plaintiffs who, like Coker, blamed asbestos-tainted J&J talc products for their mesothelioma.
A third verdict, in St. Louis, was a watershed, broadening J&J\u2019s potential liability: The 22 plaintiffs were the first to succeed with a claim that asbestos-tainted Baby Powder and Shower to Shower talc, a longtime brand the company sold in 2012, caused ovarian cancer, which is much more common than mesothelioma. The jury 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\u2019 mesothelioma. Others have failed to reach verdicts, resulting in mistrials.
«JUNK» SCIENCE
J&J has said it will appeal the recent verdicts against it. It has maintained 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 company takes to ensure its products are asbestos-free. It has blamed its losses on juror confusion, \u201cjunk\u201d science, unfair court rules and overzealous lawyers looking for a fresh pool of asbestos plaintiffs.
«Plaintiffs\u2019 attorneys out for personal financial gain are distorting historical documents and intentionally creating confusion in the courtroom and in the media,\u201d Ernie Knewitz, J&J\u2019s vice president of global media relations, wrote in an emailed response to Reuters\u2019 findings. \u201cThis 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. Any suggestion that Johnson & Johnson knew or hid information about the safety of talc is false.\u201d
J&J declined to comment further for this article. For more than two months, it turned down repeated requests for an interview with J&J executives. On Dec. 8, the company offered to make an expert available. It had not done so as of Thursday evening.
The company referred all inquiries to its outside litigation counsel, Peter Bicks. In emailed responses, Bicks rejected Reuters\u2019 findings as \u201cfalse and misleading.\u201d \u201cThe scientific consensus is that the talc used in talc-based body powders does not cause cancer, regardless of what is in that talc,\u201d Bicks wrote. \u201cThis is true even if — and it does not — Johnson & Johnson’s cosmetic talc had ever contained minute, undetectable amounts of asbestos.\u201d He dismissed tests cited in this article as \u201coutlier\u201d results.
In court, J&J lawyers have told jurors that company 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 harmless. J&J has also argued that some tests picked up \u201cbackground\u201d asbestos \u2013 stray fibers that could have contaminated 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. Another lab found asbestos in more than half of multiple samples of Baby Powder from past decades \u2013 in bottles from plaintiffs’ cupboards and acquired from eBay, and even a 1978 bottle held in J&J\u2019s corporate museum. The concentrations were great enough that users \u201cwould have, more likely than not, been exposed,\u201d the plaintiffs\u2019 lab report presented in several cases this year concluded.
Matthew Sanchez, a geologist with consultants RJ Lee Group Inc and a frequent expert witness for J&J, dismissed those findings in testimony in the St. Louis trial: \u201cI have not found asbestos in any of the current or modern, what I consider modern, Johnson & Johnson talc products,\u201d 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 SA, a co-defendant in most of the talc litigation. Both companies said the Chinese talc is safe. An Imerys spokesman said the Paris-based company\u2019s tests \u201cconsistently show no asbestos. Talc\u2019s safe use has been confirmed by multiple regulatory and scientific bodies.\u201d
J&J, based in New Brunswick, New Jersey, has dominated the talc powder market for more than 100 years, its sales outpacing those of all competitors combined, according to Euromonitor International data. And while talc products contributed just $420 million to J&J\u2019s $76.5 billion in revenue last year, Baby Powder is considered an essential facet of the healthcare-products maker\u2019s carefully tended image as a caring company \u2013 a \u201csacred cow,\u201d as one 2003 internal email put it.
\u201cWhen people really understand what\u2019s going on, I think it increases J&J\u2019s exposure a thousand-fold,\u201d said Mark Lanier, one of the lawyers for the women in the St. Louis case.
The mounting controversy surrounding J&J talc hasn\u2019t shaken investors. The share price is up about 6 percent so far this year. Talc cases make up fewer than 10 percent of all personal injury lawsuits pending against J&J, based on the company\u2019s Aug. 2 quarterly report, in which the company said it believed it had \u201cstrong grounds on appeal.\u201d
J&J Chairman and Chief Executive Officer Alex Gorsky has pledged to fight on, telling analysts in July: \u201cWe remain confident that our products do not contain asbestos.\u201d
Gorsky\u2019s comment, echoed in countless J&J statements, misses a crucial point. Asbestos, like many environmental carcinogens, has a long latency period. Diagnosis usually comes years after initial exposure \u2013 20 years or longer for mesothelioma. J&J talc products today may be safe, but the talc at issue in thousands of lawsuits was sold and used over the past 60 years.
«SAFETY FIRST»
In 1886, Robert Wood Johnson enlisted his younger brothers in an eponymous startup built around the \u201cSafety First\u201d motto. Johnson\u2019s Baby Powder grew out of a line of medicated plasters, sticky rubber strips loaded with mustard and other home remedies. When customers complained of skin irritation, the brothers sent packets of talc.
Soon, mothers began applying the talc to infants\u2019 diaper-chafed skin. The Johnsons took note. 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 selling it as Johnson\u2019s Baby Powder.
In the late 1950s, J&J discovered that talc from its chief source mine for the U. S. market in the Italian Alps contained tremolite. That\u2019s one of six minerals \u2013 along with chrysotile, actinolite, amosite, anthophyllite and crocidolite \u2013 that occur in nature as crystalline fibers known as asbestos, a recognized carcinogen. Some of them, including tremolite, also occur as unremarkable \u201cnon-asbestiform\u201d rocks. Both forms often occur together and in talc deposits.
J&J\u2019s worry at the time was that contaminants made the company\u2019s 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 \u201cgrit\u201d as possible. In a pair of reports from 1957 and 1958, the lab said the talc contained \u201cfrom less than 1 percent to about 3 percent of contaminants,\u201d described as mostly fibrous and \u201cacicular\u201d 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 tremolite found decades ago in the company\u2019s talc, from Italy and later Vermont, was not tremolite asbestos at all. Rather, he has said, it was \u201ccleavage fragments\u201d from non-asbestiform tremolite.
J&J\u2019s original records don\u2019t always make that distinction. In terms of 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, \u201cmakes no distinction between fibers and (comparable) cleavage fragments,\u201d agency officials wrote in a response to an RJ Lee report on an unrelated matter 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\u2019s talc supplier acknowledged in a 2008 email to colleagues: \u201c(I)f a deposit contains \u2018non-asbestiform\u2019 tremolite, there is also asbestiform tremolite naturally present as well.\u201d
«THE LUNGS OF BABIES»
In 1964, J&J\u2019s Windsor 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 Mountain 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 tremolite turned up in the Italian talc, it showed up in Vermont talc, too. In 1967, J&J found traces of tremolite and another mineral that can occur as asbestos, according to a table attached to a Nov. 1,1967, memo by William Ashton, the executive in charge of J&J\u2019s talc supply for decades.
J&J continued to search for sources of clean talc. But in an April 9,1969, memo to a company doctor, Ashton said it was \u201cnormal\u201d to find tremolite in many U. S. talc deposits. He suggested J&J rethink its approach. \u201cHistorically, in our Company, Tremolite has been bad,\u201d Ashton wrote. \u201cHow bad is Tremolite medically, and how much of it can safely be in a talc base we might develop?\u201d
Since pulmonary disease, including cancer, appeared to be on the rise, \u201cit would seem to be prudent to limit any possible content of Tremolite\u2026 to an absolute minimum,\u201d came the reply from another physician executive days later.
The doctor told Ashton that J&J was receiving safety questions from pediatricians. Even Robert Wood Johnson II, the founder\u2019s son and then-retired CEO, had expressed \u201cconcern over the possibility of the adverse effects on the lungs of babies or mothers,\u201d he wrote.
\u201cWe have replied,\u201d the doctor wrote, that \u201cwe would not regard the usage of our powders as presenting any hazard.\u201d Such assurances would be impossible, he added, \u201cif we do include Tremolite in more than unavoidable trace amounts.\u201d
The memo is the earliest J&J document reviewed by Reuters that discusses tremolite as more than a scratchy nuisance. The doctor urged Ashton to consult with company lawyers because \u201cit is not inconceivable that we could become involved in litigation.\u201d
NEVER «100% CLEAN»
By the early 1970s, asbestos was widely recognized as the primary cause of mesothelioma among workers involved in producing it and in industries that used it in their products.
Regulation was in the air. In 1972, President Richard Nixon\u2019s newly created OSHA issued its first rule, setting limits on workplace exposure to asbestos dust.
By then, a team at Mount Sinai Medical Center led by pre-eminent asbestos researcher Irving Selikoff had started looking at talcum powders as a possible solution to a puzzle: Why were tests of lung tissue taken post mortem from New 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 preliminary findings with New York City\u2019s environmental protection chief, Jerome 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 statement: \u201cOur fifty years of research knowledge in this area indicates that there is no asbestos contained in the powder manufactured by Johnson & Johnson.\u201d
Later that year, another Mount Sinai researcher, mineralogist Arthur Langer, told J&J in a letter that the team had found a \u201crelatively small\u201d amount of chrysotile asbestos in Baby Powder.
Langer, Selikoff and Kretchmer ended up on a J&J list of \u201cantagonistic personalities\u201d in a Nov. 29,1972, memo, which described Selikoff as the leader of an \u201cattack on talc.\u201d
\u201cI suppose I was antagonistic,\u201d Langer told Reuters. Even so, in a subsequent test of J&J powders in 1976, he didn\u2019t find asbestos \u2013 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. Kretchmer said he recently read that a jury had concluded that Baby Powder was contaminated with asbestos. \u201cI said to myself, \u2018How come it took so long?\u2019 \u201d he said.
In July 1971, meanwhile, J&J sent a delegation of scientists to Washington to talk to the FDA officials looking into asbestos in talcum powders. According to an FDA account of the meeting, J&J shared \u201cevidence that their talc contains less than 1%, if any, asbestos.\u201d
Later that month, Wilson Nashed, one of the J&J scientists who visited the FDA, said in a memo to the company\u2019s public relations department that J&J\u2019s talc contained trace amounts of \u201cfibrous minerals (tremolite\/actinolite).\u201d
«INCONTROVERTIBLE ASBESTOS»
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 tremolite, it declared the amount \u201cinsignificant\u201d and the samples \u201csubstantially free of asbestiform material.\u201d J&J reported that finding to the FDA under a cover letter that said the \u201cresults clearly show\u201d the samples tested \u201ccontain no chrysotile asbestos.\u201d J&J\u2019s lawyer told Reuters the tremolite found in the samples was not asbestos.
But J&J\u2019s FDA submission left out University of Minnesota professor Thomas E. Hutchinson\u2019s finding of chrysotile in a Shower to Shower sample \u2013 \u201cincontrovertible asbestos,\u201d as he described it in a lab note.
The FDA\u2019s own examinations found no asbestos in J&J powder samples in the 1f970s. 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 of an Aug. 11,1972, meeting with the agency: \u201cI understand that some samples will be passed even though they contain such fibers, but we are willing to live with it.\u201d
By 1973, Tom Shelley, director of J&J\u2019s 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.
\u201cIt is quite possible that eventually tremolite will be prohibited in all talc,\u201d Shelley wrote on Feb. 20,1973, to a British colleague. Therefore, he added, the \u201cprocess may well be valuable property to us.\u201d
At the end of March, Shelley recognized the sensitivity of the plan in a memo sent to a J&J lawyer in New Jersey: \u201cWe will want to carefully consider the \u2026 patents re asbestos in talc. It\u2019s 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.\u201d
J&J did not obtain the patents.
While Shelley was looking into the patents, J&J research director DeWitt Petterson visited the company\u2019s Vermont mining operation. \u201cOccasionally, sub-trace quantities of tremolite or actinolite are identifiable,\u201d he wrote in an April 1973 report on the visit. \u201cAnd these might be classified as asbestos fiber.\u201d
J&J should \u201cprotect our powder franchise\u201d by eliminating as many tiny fibers that can be inhaled in airborn talc dust as possible, Petterson wrote. He warned, however, that \u201cno final product will ever be made which will be totally free from respirable particles.\u201d Introducing a cornstarch version of Baby Powder, he noted, \u201cis obviously another answer.\u201d
Bicks told Reuters that J&J believes that the tremolite and actinolite Petterson cited were not asbestos.
Cornstarch came up again in a March 5,1974, report in which Ashton, the J&J talc supply chief, recommended that the company research that alternative \u201cfor defensive reasons\u201d because \u201cthe thrust against talc has centered primarily on biological problems alleged to result from the inhalation of talc and related mineral particles.\u201d
«WE MAY HAVE PROBLEMS»
A few months after Petterson\u2019s 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. While the agency\u2019s cosmetics division was considering similar action on talcum powders, it asked companies to suggest testing methods.
At the time, J&J\u2019s Baby Powder franchise was consuming 20,000 tons of Vermont talc a year. J&J pressed the FDA to approve an X-ray scanning technique that a company scientist said in an April 1973 memo allowed for \u201can automatic 1% tolerance for asbestos.\u201d That would mean talc with up to 10 times the FDA\u2019s proposed limit 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, \u201cwe may have problems.\u201d
The best way to detect asbestos in talc was to concentrate the sample and then examine it through microscopes, the Colorado School of Mines Research Institute told J&J in a Dec. 27,1973, report. In a memo, a J&J lab supervisor said the concentration technique, which the company\u2019s own researchers had earlier used to identify a \u201ctremolite-type\u201d asbestos in Vermont talc, had one limitation: \u201cIt may be too sensitive.\u201d
In his email to Reuters, J&J\u2019s lawyer said the lab supervisor\u2019s concern was that the test would result in \u201cfalse positives,\u201d 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\u2019s new workplace exposure limits. Its researchers had strapped an air sampling device to a doll to take measurements while it was powdered, according to J&J memos and the minutes of a Feb. 19,1974, meeting of the Cosmetic Toiletry and Fragrance Association (CTFA), an industry group.
\u201cIt 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 limits,\u201d the minutes state.
In a Sept. 6,1974, letter, J&J told the FDA that since \u201ca substantial safety factor can be expected\u201d with talc that contains 1 percent asbestos, \u201cmethods capable of determining less than 1% asbestos in talc are not necessary to assure the safety of cosmetic talc.\u201d
Not everyone at the FDA thought that basing a detection method on such a calculation was a good idea. One official called it \u201cfoolish,\u201d adding, according to a J&J account of a February 1975 meeting: \u201cNo mother was going to powder her baby with 1% of a known carcinogen irregardless of the large safety factor.\u201d
PUSH FOR SELF-REGULATION
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 March 15,1976, package of 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.
\u201cThe attached letters demonstrate responsibility of industry in monitoring its talcs,\u201d the cover letter said. \u201cWe are certain that the summary will give you assurance as to the freedom from contamination by asbestos for materials of cosmetic talc products.\u201d
In its letter, J&J said samples of talc produced between December 1972 and October 1973 were tested for asbestos, and none was detected \u201cin any sample.\u201d
J&J didn\u2019t tell the FDA about a 1974 test by a professor at Dartmouth College in New Hampshire that turned up asbestos in talc from J&J \u2013 \u201cfiberform\u201d actinolite, as he put it. Nor did the company tell the FDA about a 1975 report from its longtime lab that found particles identified as \u201casbestos fibers\u201d in five of 17 samples of talc from the chief source mine for Baby Powder. \u201cSome of them seem rather high,\u201d the private lab wrote in its cover letter.
Bicks, the J&J lawyer, said the contract lab\u2019s results were irrelevant because the talc was intended for industrial use. He said the company now believes that the actinolite the Dartmouth professor found \u201cwas not asbestiform,\u201d based on its interpretation of a photo in the original lab report.
Just two months after the Dartmouth professor reported his findings, Windsor Minerals Research and Development Manager Vernon Zeitz wrote that chrysotile, \u201cfibrous anthophyllite\u201d and other types of asbestos had been \u201cfound in association with the Hammondsville ore body\u201d \u2013 the Vermont deposit that supplied Baby Powder talc for more than two decades.
Zeitz\u2019s May 1974 report on efforts to minimize asbestos in Vermont talc \u201cstrongly urged\u201d the adoption of ways to protect \u201cagainst what are currently considered to be materials presenting a severe health hazard and are potentially present in all talc ores in use at this time.\u201d
Bicks said that Zeitz was not reporting on actual test results.
The following year, Zeitz reported that based on weekly tests of talc samples over six months, \u201cit can be stated with a greater than 99.9% certainty that the ores and materials produced from the ores at all Windsor Mineral locations are free from asbestos or asbestiform minerals.\u201d
«MISREPRESENTATION BY OMISSION»
J&J\u2019s selective use of test results figured in a New Jersey judge\u2019s decision this year to affirm the first verdict against the company in a case claiming asbestos in J&J products caused cancer. \u201cProviding the FDA favorable results showing no asbestos and withholding or failing to provide unfavorable results, which show asbestos, is a form of a misrepresentation by omission,\u201d Middlesex County Superior Court Judge Ana Viscomi said in her June ruling.
\u201cJ&J respectfully disagrees with the Judge\u2019s comments,\u201d Bicks said. \u201cJ&J did not withhold any relevant testing from FDA.\u201d
The FDA declined to comment on the ruling.
Lacking consensus on testing methods, the FDA postponed action to limit asbestos in talc. Years later, it did set limits on asbestos in talc used in drugs. It has never limited asbestos in cosmetic talc or established a preferred method for detecting it.
Instead, in 1976, a CTFA committee chaired by a J&J executive drafted voluntary guidelines, establishing a form of X-ray scanning with a 0.5 percent detection limit as the primary test, the method J&J preferred. The method is not designed to detect the most commonly used type of asbestos, chrysotile, at all. The group said the more sensitive electron microscopy was impractical.
The CTFA, which now does business as the Personal Care Products Council, declined to comment.
X-ray scanning is the primary method J&J has used for decades. The company also periodically requires the more sensitive checks with electron microscopes. J&J\u2019s lawyer said the company\u2019s tests exceed the trade association standard, and they do. He also said that today, J&J\u2019s 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\u2019s 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\u2019t 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\u2019s 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, \u201cwill be hard pressed in supporting purity claims.\u201d He described this sort of testing as both \u201csophisticated\u201d and \u201cdisturbing.\u201d
«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\u2019s \u201cDefense of Talc Safety\u201d campaign noted that independent authorities had deemed cosmetic talc products to be \u201cfree of hazard.\u201d It attributed \u201cthis growing opinion\u201d to the dissemination to scientific and medical communities in the United States and Britain of \u201cfavorable data from the various J&J sponsored studies.\u201d
In 1984, FDA cosmetics chief and former J&J employee Heinz Eiermann reiterated that view. He told the New York Times that the agency\u2019s investigation a decade earlier had prompted the industry to ensure that talc was asbestos-free. \u201cSo in subsequent analyzes,\u201d he told the paper, \u201cwe really could not identify asbestos or only on very rare occasions.\u201d
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 \u2013 to expand its customer base to people who prefer cornstarch, the company says.
The persistence of the industry\u2019s 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\u2019s also partly why regulations that protect people in mines, mills, factories and schools from asbestos-laden talc don\u2019t apply to babies and others exposed to cosmetic talc \u2013 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\u2019s position, saying on its website: \u201cAll talcum products used in homes have been asbestos-free since the 1970s.\u201d
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\u2019s standards, that all cosmetic talc products in the United States \u201cshould be free from detectable amounts of asbestos.\u201d
The revised ACS web page also notes that the World Health Organization\u2019s International Agency for Research on Cancer classifies talc that contains asbestos as \u201ccarcinogenic to humans.\u201d
Despite the success of J&J\u2019s efforts to promote the safety of its talc, the company\u2019s test lab found asbestos fibers in samples taken from the Vermont operation in 1984,1985 and 1986. Bicks said: \u201cThe samples that we know of during this time period that contained a fiber or two of asbestos were not cosmetic talc samples.\u201d
Then, in 1992, three years after J&J sold its Vermont mines, the new owner, Cyprus Minerals, said in an internal report on \u201cimportant environmental issues\u201d in its talc reserves that there was \u201cpast tremolite\u201d 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, \u201cwere destroyed by the mine management staff just prior to the J&J divestiture.\u201d
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 \u2013 a finding deemed \u201cBDL\u201d \u2013 below detection limit. Bicks described the finding as \u201cbackground asbestos\u201d 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. \u201cI recognize the concern,\u201d he told Reuters. He said the agency\u2019s policing of cosmetics in general \u2013 fewer than 30 people regulating a \u201cvast\u201d industry \u2013 was \u201ca place where we think we can be doing more.\u201d
Gottlieb said the FDA planned to host a public forum in early 2019 to \u201clook at how we would develop standards for evaluating any potential risk.\u201d An agency spokeswoman said that would include examining \u201cscientific test methods for assessment of asbestos.\u201d
«FISHING EXPEDITION»
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\u2019t exceed OSHA limits.
That\u2019s why he zeroed in on Johnson\u2019s 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\u2019s \u201cfishing expedition\u201d would not turn up any relevant evidence, it asserted in a May 6,1998, motion. In fact, among the thousands of documents Hobson\u2019s 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\u2019s Baby Powder, identified in her 1991 published study as tremolite \u201casbestos\u201d needles.
Hobson agreed to postpone his discovery demands until he got the pathology report on Coker\u2019s lung tissue. Before it came in, J&J asked the judge to dismiss the case, arguing that Coker had \u201cno evidence\u201d Baby Powder caused mesothelioma.
Ten days later, the pathology report landed: Coker\u2019s lung tissue contained tens of thousands of \u201clong fibers\u201d of four different types of asbestos. The findings were \u201cconsistent with exposure to talc containing chrysotile and tremolite contamination,\u201d the report concluded.
\u201cThe asbestos fibers found raise a new issue of fact,\u201d Hobson told the judge in a request for more time to file an opposition to J&J\u2019s 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: \u201cThey knew what the problems were, and they hid it.\u201d J&J\u2019s records would have made a \u201c100% difference\u201d in Coker\u2019s case.
Had the information about asbestos in J&J\u2019s talc come out earlier, he said, \u201cmaybe there would have been 20 years less exposure\u201d for other people.
Bicks, the J&J lawyer, said Coker dropped her case because \u201cthe discovery established that J&J talc had nothing to do with Plaintiff\u2019s disease, and that asbestos exposure from a commercial or occupational setting was the likely cause.\u201d
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\u2019s daughter Crystal Deckard was 5 when her sister, Cady, was born in 1971. Deckard remembers seeing the white bottle of Johnson\u2019s Baby Powder on the changing table where her mother diapered her new sister.
\u201cWhen Mom was given this death sentence, she was the same age as I am right now,\u201d Deckard said. \u201cI have it in the back of my mind all the time. Could it happen to us? Me? My sister?\u201d
(Edited by Janet Roberts and John Blanton)<\/p>\n