‘Johnson & Johnson talk pudrası ürünlerinde tarihi skandal’

Reuters haber ajansı, dünyanın en büyük kişisel bakım ve ilaç şirketlerinden birisi olan

Johnson & Johnson’ın ürettiği talk pudrasında asbest olduğunu bildiği yönünde bir haber yayımladı.

Reuters haber ajansının bildirdiğine göre, şirkete karşı açılan davalar sonucu Johnson & Johnson’ın açıklamak zorunda kaldığı 1971’den 2000’lerin başlarına kadar uzanan binlerce belgeyi incelediğini belirtti.

Şirket yazışmalarının açık ve gizli olanlarını içeren bu belgelerde, şirketin ürettiği pudralarda küçük miktarda da olsa asbest çıktığının yer aldığı ifade edildi.

Şirket yöneticilerinin, mühendislerin, doktorların ve avukatların bu sorunla başa çıkmaya çalıştığını, ancak bir yandan bunu yaparken diğer yandan Amerikalı denetleyici kurumlara bu yönde bir bilgi vermedikleri aktarıldı.

Reuters’ın Cuma günü yayımlanan bu haberi üzerine Johnson & Johnson hisseleri, yüzde 10 değer kaybetti.

Şirketin son 16 yıldır yaşadığı bu en büyük kayıp, piyasa değerinden 40 milyar doların silinmesine yol açtı.

Johnson & Johnson, Reuters’ın bu iddialarının yanlış olduğunu belirten bir açıklama yayımladı.

Şirket, talk pudrasının kansere yol açtığı gerekçesiyle çok sayıda dava ile yüz yüze.

Bu yıl içerisinde ABD’nin Missouri eyaletinde görülen davada jüri, Johnson & Johnson talk pudrasının kadınlarda yumurtalık kanserine yol açtığı hükmüne vardı ve şirketi önce 550 milyon dolar tazminat ödemeye mahkûm etti, ardından da 4,1 milyar dolarlık cezai tazminat kararı aldı.

Daha önce de ABD’de çeşitli mahkemeler, talk pudrasının yumurtalık kanserine yol açtığı gerekçesiyle Johnson & Johnson aleyhine 50 milyar doları aşan çok sayıda tazminat cezası verdi.

Johnson & Johnson knew for decades that asbestos lurked in its Baby Powder

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.

Filed 

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? “She wanted answers,” her daughter Cady Evans said.

Fighting for every breath and in crippling pain, Coker hired Herschel Hobso

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. “When you are the plaintiff, you have the burden of proof,” he said. “We 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 company 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 many 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. 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.

n, 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.

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.”

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’s Italian supplier as 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.”

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 “detected in any sample” of talc produced between December 1972 and October 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 high.”

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 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’t 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’s testing documentation.

What J&J produced in response to those demands has allowed plaintiffs’ lawyers to refine their argument: The culprit wasn’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 New Jersey and California – 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’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 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’ mesothelioma. Others have failed to reach verdicts, resulting in mistrials.

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, “junk” 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 media,” 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. Any suggestion that Johnson & Johnson knew or hid information 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 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’ findings as “false and misleading.” “The scientific consensus is that the talc used in talc-based body powders does not cause cancer, regardless of what is in that talc,” Bicks wrote. “This is true even if – and it does not – Johnson & Johnson’s cosmetic 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 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 “background” asbestos – 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 – 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.

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: “I have not found asbestos in any of 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 multiple regulatory and scientific bodies.”

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’s $76.5 billion in revenue last year, Baby Powder is considered an essential facet of the healthcare-products maker’s carefully tended image as a caring company – a “sacred cow,” as one 2003 internal email put it.

“When people really understand what’s going on, I think it increases J&J’s exposure a thousand-fold,” said Mark Lanier, one of the lawyers for the women in the St. Louis case.

The mounting controversy surrounding J&J talc hasn’t 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’s Aug. 2 quarterly report, in which the company said it believed it had “strong grounds on appeal.”

J&J Chairman and Chief Executive Officer Alex Gorsky has pledged to fight on, telling analysts in July: “We remain confident that our products do not contain asbestos.”

Gorsky’s 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 – 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.

That point is recognized in a 2013 markup of 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 (we cannot say “always”) asbestos free, as confirmed by regular testing since the 1970s.”

In 1886, Robert Wood 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. When 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 become 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 mine for the U.S. market in the Italian Alps contained tremolite. That’s one of six minerals – along with chrysotile, actinolite, amosite, anthophyllite and crocidolite – that occur in nature as crystalline fibers known as asbestos, a recognized carcinogen. Some of them, including tremolite, also occur as unremarkable “non-asbestiform” rocks. Both forms often occur together and in talc deposits.

J&J’s worry at the time was that contaminants made the company’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 of 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 tremolite found decades ago in the company’s talc, from Italy and later Vermont, was not tremolite asbestos at all. Rather, he has said, it was “cleavage fragments” from non-asbestiform tremolite.

J&J’s original records don’t 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, “makes no distinction between fibers and (comparable) cleavage fragments,” 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’s talc supplier acknowledged in a 2008 email to colleagues: “(I)f a deposit contains ‘non-asbestiform’ tremolite, there is also asbestiform tremolite naturally present as well.”

In 1964, J&J’s 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’s 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 “normal” to find tremolite in many 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 pulmonary disease, including cancer, appeared to be on the rise, “it would seem to be prudent to limit any possible content of Tremolite … to an absolute minimum,” 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’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.

“We have replied,” the doctor wrote, that “we would not regard the usage of our powders as presenting any hazard.” Such assurances would be impossible, he added, “if we do include Tremolite in more than unavoidable trace amounts.”

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 “it is not inconceivable that we could become involved in litigation.”

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’s 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’s 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: “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.

https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/

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