NEW YORK - Pharmaceutical giant Johnson & Johnson said Tuesday it would stop selling talc-based baby powder in the United States and Canada, where sales had already been hit by changing consumer habits and fears the product causes cancer.
The company has long denied claims that the talc powder it uses contains cancer-causing asbestos, but has nonetheless been taken to court several thousands of times over the allegations.
In a statement, Johnson & Johnson said it remained "steadfastly confident" in the product's safety and would "vigorously" defend against the lawsuits, noting that all guilty verdicts passed against the company have been overturned.
"As part of a portfolio assessment related to COVID-19, in March, Johnson & Johnson Consumer Health stopped shipping hundreds of items in the US and Canada to prioritize high-demand products and to allow for appropriate social distancing in manufacturing and distribution facilities," the statement said.
It then decided to discontinue around 100 products in the 2 countries, including the talc-based powder.
"Demand for talc-based Johnson's Baby Powder in North America has been declining due in large part to changes in consumer habits and fueled by misinformation around the safety of the product and a constant barrage of litigation advertising," the company said.
Existing stocks of the powder will be sold in the US and Canada until they run out, the company said, and the product will remain for sale in countries where there is "significantly higher consumer demand."
Agence France-Presse
Johnson & Johnson said Tuesday that it did not find asbestos in multiple tests of a bottle of baby powder that the Food and Drug Administration said contained trace amounts of the carcinogen.
The company had recalled 33,000 bottles of the product earlier this month after the regulator said it discovered evidence of chrysotile asbestos in a bottle bought from an online retailer. Johnson & Johnson said 15 new tests of that very bottle came up clean.
Another 48 tests of samples from the recalled lot, conducted by two third-party labs, reached the same conclusion, the company said. Johnson & Johnson is facing lawsuits from more than 15,000 plaintiffs who claim that the company’s baby powder and other talc-based products caused their cancer.
“We stand by the safety of our product,” the company said in a statement. Johnson & Johnson’s shares rose in after-hours trading Tuesday afternoon.
The company said it contacted the two labs after the recall to expedite tests of the baby powder in question. Three samples did initially test positive for asbestos, the company said in Tuesday’s statement, but after an investigation by the lab, the contamination was found to be coming from a portable air conditioner in the room.
“This finding underscores the importance of investigating any positive test result,” the company said, adding that “even when careful safeguards are followed, asbestos contamination may be introduced during sample division, storage, preparation and analysis.”
For decades, Johnson & Johnson has cast doubt on multiple findings of asbestos in its talc products, blaming poorly executed tests, unqualified scientists, similar-looking minerals and other factors. The company said that it “routinely” uses “a rigorous testing standard” to check its talc.
2019 The New York Times Company
source: news.abs-cbn.com
Johnson & Johnson said on Friday it is recalling around 33,000 bottles of baby powder in the United States after US health regulators found trace amounts of asbestos in samples taken from a bottle purchased online.
J&J shares fell more than 6 percent to close at $127.70.
The move marks the first time the company has recalled its iconic baby powder for possible asbestos contamination, and the first time US regulators have announced a finding of asbestos in the product. Asbestos is a known carcinogen that has been linked to deadly mesothelioma.
The recall is the latest blow to the more than 130-year-old US healthcare conglomerate that is facing thousands of lawsuits over a variety of products, including baby powder, opioids, medical devices and the antipsychotic Risperdal.
A jury last week ordered the company to pay $8 billion to a plaintiff in a case claiming J&J downplayed the risks of Risperdal. That award is not expected to stand, the company and legal experts have said.
J&J faces more than 15,000 lawsuits from consumers claiming its talc products, including Johnson's Baby Powder, caused their cancer.
On a conference call with reporters on Friday, Dr. Susan Nicholson, head of Women’s Health in the company's medical safety organization, called the asbestos finding "extremely unusual," adding that it was "inconsistent with our testing to date."
The voluntary recall announced on Friday is limited to one lot of Johnson's Baby Powder produced and shipped in the United States in 2018, the company said.
J&J in a news release said that testing by the US Food and Drug Administration as recently as a month ago found no asbestos in their talc.
The FDA said in a statement that the latest sampling took place during its testing for asbestos in talc-containing cosmetics that it began reporting this year. A second Johnson’s Baby Powder sample from a different lot tested negative for asbestos, the agency said.
The FDA said it stands by the quality of its testing and results and recommended consumers stop using the product if it comes from the affected lot.
J&J said on the conference call that it received a report from the FDA on Oct. 17 alerting the company about the asbestos finding. It said it has started an investigation and is reviewing manufacturing records and collecting data on the distribution of the lot to determine where the product was shipped.
J&J added that it is working with the FDA to determine the integrity of the tested sample as well as the validity of test results.
THOROUGH INVESTIGATION NEEDED
The type of asbestos discovered by FDA testing has not been found in the mine where the company sources its talc, J&J's Nicholson said. She described it as an environmental contaminant most commonly found in building materials and industrial applications.
J&J said it was too early to confirm whether cross-contamination of the sample had caused a false positive, whether the sample was taken from a bottle with an intact seal or whether it was prepared in a controlled environment. It added that it could not confirm whether the tested product was authentic or counterfeit.
"It is so critical that we perform a thorough investigation of the sample to determine the source of contamination," Nicholson said.
Since 2003, talc in Johnson's 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 much of the talc litigation. Imerys and J&J said the Chinese talc is safe.
J&J has known for decades that asbestos lurked in its talc, Reuters reported last year. Internal company records, trial testimony and other evidence show 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. 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, Reuters found.
J&J has repeatedly said that its talc products are safe, and that decades of studies have shown them to be asbestos-free and that they do not cause cancer.
The FDA test indicated the presence of no greater than 0.00002 percent of chrysotile asbestos in the tested sample, J&J said.
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.
Thousands of the lawsuits against J&J have been consolidated before a New Jersey federal judge, who is currently weighing company motions to disqualify plaintiffs’ expert witnesses, including the head of an asbestos testing lab who has testified in earlier trials that he found the contaminant in J&J powders.
Leigh O’Dell, one of the lead plaintiff attorneys, on Friday said the recall "vindicates the position we’ve been taking for months.”
Wells Fargo analyst Larry Biegelsen said in a research note that the recall could encourage additional lawsuits and prompt the company to pursue a broader settlement.
Jefferies healthcare strategist Jared Holz said J&J has already lost close to $10 billion in market value due to the talc issue over the past year.
He said further downside to J&J stock is likely to be limited because legal concerns over talc are well known and have already taken a toll on the share price. "This is one single bottle within one lot with barely a trace here," he said.
J&J said in February that it had received subpoenas from the US Justice Department and the Securities and Exchange Commission for documents related to the asbestos contamination allegations. A Bloomberg report, which Reuters has confirmed, said those inquiries include a criminal grand jury investigation into how forthright J&J has been in its statements about the safety of its powders.
While talc products make up less than 1 percent of J&J sales expected by analysts to reach $82 billion in 2019, the New Jersey-based healthcare-products maker considers its Baby Powder to be an essential facet of a carefully tended image as a caring company.
source: news.abs-cbn.com
NEW YORK/LOS ANGELES -- Johnson & Johnson Inc's statement was unequivocal.
"The FDA has tested Johnson's talc since the '70s. Every single time it did not contain asbestos," the company said in a Dec. 19 tweet. It followed by several days the publication of a Reuters investigation that found the healthcare conglomerate knew for decades that the carcinogen lurked in its Baby Powder and other cosmetic talc products.
The tweet, posted under the handle @JNJNews, didn't mention that the US Food and Drug Administration (FDA) found traces of asbestos in the company's Shower to Shower talc in 1973, as revealed in agency documents reviewed by Reuters. And it is only one of dozens of tweets conveying a similar message about talc safety since the Reuters article appeared Dec. 14.
The Reuters article prompted a stock selloff that erased about $40 billion from J&J's market value in one day and created a public relations crisis as the blue-chip healthcare conglomerate faced widespread questions about the possible health effects of one of its most iconic products.
To reassure investors and consumers, J&J has tweeted, posted on Facebook, run a series of full-page newspaper ads across the United States, published a lengthy rebuttal to the Reuters investigation on its website and announced a $5 billion stock buyback. Chairman and Chief Executive Officer Alex Gorsky has appeared in a company video and on CNBC's "Mad Money" to reinforce the company's position.
That position has been unwavering. J&J insists that its Baby Powder is safe and has been asbestos-free at least since regular testing began in the 1970s. The message doubles down on the stance the company has taken to defend against lawsuits in which about 11,700 plaintiffs allege that the J&J talc they used in past decades caused their cancer. The company is pursuing this strategy despite the evidence that talc in its raw and finished powders sometimes tested positive for the carcinogen from the 1970s into the early 2000s — test results that the company didn’t disclose to regulators or consumers.
In response to a Reuters request for comment, the company said it was committed to defending the talc litigation, "and that same, long-term view is reflected in our ongoing communications that consistently point to the strong scientific evidence that our talc is and always has been safe."
As for the 1973 Shower to Shower test, J&J noted that the result didn't "reflect FDA's final determination about this sample" in a 1976 table summarizing the agency's early 1970s cosmetic talc testing. However, in that 1976 table, which Reuters examined, the FDA did not indicate any result, positive or negative, for the type of asbestos found in the Shower to Shower sample in 1973.
Given the mass of litigation it faces, J&J has little choice but to zealously dispute findings that its products sometimes contained traces of asbestos, said Eric Dezenhall, a crisis-management consultant in Washington, DC. "If your position in court is that the claims being made are false…you can't just shrug your shoulders," he said.
Soon after the Reuters article appeared, J&J executives consulted crisis-management experts, according to people familiar with the matter. Among the company's reasons for deciding to maintain its stance on absolute talc purity, these people said, was a conviction that a company known for putting health and safety first had the facts on its side, a litigation track record that included victories and mistrials, and the expectation that adverse verdicts will be overturned on appeal.
THROUGH LAWYERS
Many of J&J's subsequent messages have mirrored the company's written responses to questions and findings Reuters presented to the company during its investigation: They deny that the company kept information from regulators and point to the many studies finding that talc is safe and doesn't cause cancer.
Those earlier responses were composed by J&J's outside litigators, led by Peter Bicks at Orrick, Herrington & Sutcliffe, and conveyed to Reuters by lawyers at a crisis-management firm co-founded by Lanny Davis, a lawyer who represented US President Bill Clinton in the 1990s and Michael Cohen, President Donald Trump’s former attorney who has pleaded guilty to multiple criminal charges.
Gorsky, in his appearance on "Mad Money," invoked J&J's now legendary response to the Tylenol crisis as evidence that the company can be trusted to address any safety problems linked to its products. In 1982, J&J moved decisively to pull all Tylenol from store shelves after 7 people died from taking cyanide-laced pills.
"I can't believe the company that took that dramatic of an action would allow a product that they felt in any way could be harmful to stay on the market," Gorsky told "Mad Money" host Jim Cramer. "We unequivocally believe that our talc, our Baby Powder, does not contain asbestos."
Citing the Tylenol recall provides "some reputational buffer," said Stephen A. Greyser, the Harvard Business School professor who wrote the first study of the company's handling of that crisis. "But it is not a total protection" because it won't shield the company from a loss of trust if consumers or investors conclude the company hasn't been fully forthcoming in this case, he said. J&J needs to guard against "reputational contagion," the risk that a loss of confidence in Baby Powder could bleed over into how consumers, shareholders and others view the company more broadly, Greyser added.
The key difference between the two crises is that poisoned Tylenol presented a threat to consumers at the time, while the documented asbestos contamination of J&J talc that Reuters investigated spanned from 1971 to the early 2000s. J&J says that if it believed that Baby Powder today presented safety risks, it wouldn't hesitate to remove it from store shelves, given that the product accounts for less than 0.5 percent of annual revenue.
The company joined its talc supplier, Imerys Talc America, a unit of Paris-based Imerys SA, in requesting that a trial scheduled for January in St. Louis be delayed for, among other things, what they called "negative national and local news coverage" resulting from the Reuters investigation that would inevitably taint prospective jurors.
The judge denied the motion. The same judge recently upheld a $4.69 billion jury award in a separate ovarian cancer case, which J&J says it expects to be overturned on appeal. The judge said J&J's promotion of a product that the evidence showed was contaminated with a known carcinogen was "particularly reprehensible."
In an emailed statement, Imerys Talc America said it "is committed to the quality and safety of its products," and that rigorous research "overwhelmingly confirms that talc is safe, and no agency has asserted that talc causes cancer."
UNDERMINED BY EVIDENCE
Some of J&J's messages in its recent campaign omit key details regarding findings on talc and, in certain instances, are undermined by other evidence, according to a Reuters review of the company's statements.
The Dec. 19 tweet claiming that the FDA’s own tests never found asbestos in J&J talc, for example, ignores an agency scientist's 1973 finding that a Shower to Shower sample contained asbestos fibers, according to a copy of an FDA report titled "Asbestos and Other Contaminants in Talc" and a deposition of a former J&J head toxicologist. The FDA did not respond to questions for this article, citing a partial government shutdown.
On CNBC, Gorsky said: "We also not only used the best testing methodologies that were available, but we continued to improve them through the years."
J&J's testing methods do exceed the industry standard. But even so, as a geologist and frequent J&J expert witness acknowledged in court this year, only a tiny fraction of the company's talc sold over the past 40 years has been tested using what is widely recognized as the best method to detect asbestos fibers, known as transmission electron microscopy.
Plaintiffs' lawyers are already homing in on inconsistencies between J&J's statements and other evidence regarding its talc, and they are planning to depose Gorsky in coming weeks.
"There is no flexibility in what they're saying," said Leigh O'Dell, one of the lead lawyers representing plaintiffs in thousands of lawsuits against J&J consolidated in a New Jersey federal court. "Taking these statements on behalf of the company and pointing out to juries and judges the misrepresentations contained in those statements — I think you're going to see that in every case going forward, whether it's an ovarian cancer case or a mesothelioma case."
One of J&J's recent tweets criticized plaintiffs' lawyers: "Far from a new theory or insight, plaintiffs' lawyers have resurrected a disproven argument about asbestos in our talc that dates to the 1970s."
The Reuters investigation found that tests by J&J's own contract labs and others periodically found small amounts of asbestos in talc from mines that supplied the mineral for Baby Powder as recently as the early 2000s.
Some J&J tweets and newspaper ads have adopted a question-and-answer format. "What about the allegation you withheld safety information?" the company said in a full-page ad in USA Today the day after Christmas.
"It is false,” the company said. “All safety concerns are taken seriously, and we share all relevant information with regulators."
Some Twitter users have responded to J&J's tweets with praise and support. Others have referenced their relatives' longtime use of J&J talc products and subsequent deaths from ovarian cancer. "We're very sorry to hear this," J&J responded to several Twitter users, expressing a desire to speak with them and offering a phone number to call.
In response to another recent tweet in which J&J said its talc doesn't contain asbestos, one Twitter user asked: "Did it USED to?"
"No," J&J responded. "For decades, J&J's baby powder has repeatedly been tested for asbestos and found not to contain asbestos."
source: news.abs-cbn.com
A Missouri jury on Thursday ordered Johnson & Johnson to pay a record $4.69 billion to 22 women who alleged the company's talc-based products, including its baby powder, contain asbestos and caused them to develop ovarian cancer.
The verdict is the largest J&J has faced to date over allegations that its talc-based products cause cancer. J&J is battling some 9,000 talc cases.
Thursday's massive verdict, handed down in the Circuit Court of the City of St. Louis, was comprised of $550 million in compensatory damages and $4.14 billion in punitive damages, according to an online broadcast of the trial by Courtroom View Network.
J&J shares fell $1.31, or 1 percent, to $126.45 in after-hours trading following the punitive damages award. They had risen $1.52 during regular trading.
The jury's decision followed more than 5 weeks of testimony by nearly a dozen experts on both sides.
The women and their families said decades-long use of Baby Powder and other cosmetic talc products caused their diseases. They allege the company knew its talc was contaminated with asbestos since at least the 1970s but failed to warn consumers about the risks.
J&J denies both that its talc products cause cancer and that they ever contained asbestos. It says decades of studies show its talc to be safe.
"Johnson & Johnson is deeply disappointed in the verdict, which was the product of a fundamentally unfair process," the company said in a statement. The company said it remained confident that its products do not contain asbestos or cause cancer.
"Every verdict against Johnson & Johnson in this court that has gone through the appeals process has been reversed and the multiple errors present in this trial were worse than those in the prior trials which have been reversed," J&J added, saying that it would pursue all available appellate remedies.
Mark Lanier, the lawyer for the women, in a statement following the verdict called on J&J to pull its talc products from the market "before causing further anguish, harm, and death from a terrible disease."
"If J&J insists on continuing to sell talc, they should mark it with a serious warning," Lanier said.
The majority of the lawsuits that J&J faces involve claims that talc itself caused ovarian cancer, but a smaller number of cases allege that contaminated talc caused mesothelioma, a tissue cancer closely linked to asbestos exposure.
The cases that went to trial in St. Louis effectively combine those claims by alleging asbsestos-contaminated talc caused ovarian cancer.
Previous talc trials have produced verdicts as large as $417 million. But that 2017 verdict by a California jury, as well as other verdicts in Missouri, was overturned on appeal, and challenges to at least another five verdicts are pending.
The US Food and Drug Administration commissioned a study of various talc samples from 2009 to 2010, including of J&J's Baby Powder. No asbestos was found in any of the talc samples, the agency said.
But Lanier during the trial told jurors that the agency and other laboratories and J&J have used flawed testing methods that did not allow for the proper detection of asbestos fibers.
Talc, the world's softest rock, is a mineral closely linked to asbestos and the 2 substances can appear in close proximity in the earth.
Plaintiffs claim the 2 can become intermingled in the mining process, making it impossible to remove the carcinogenic substance. J&J denies those allegations, saying rigorous testing and purification processes ensure its talc is clean.
source: news.abs-cbn.com
A California jury on Thursday ruled in favor of Johnson & Johnson in a lawsuit by a woman who said she developed the cancer mesothelioma after being exposed to asbestos in the company's talc-based products including J&J's Baby Powder.
The Los Angeles Superior Court jury's verdict came in the first trial centering on claims that J&J's talc products contained asbestos. J&J is separately battling thousands of cases claiming those products can also cause ovarian cancer.
The verdict came in a lawsuit by Tina Herford, who said she developed mesothelioma after using J&J talcum powder products that her lawyers claimed contained asbestos.
Reuters watched the verdict through an online broadcast by Courtroom View Network. The jury also found in favor of talc supplier Imerys Talc.
J&J in a statement welcomed the verdict. J&J said it believed that setbacks dealt to individuals pursuing ovarian cancer cases had "forced plaintiff attorneys to pivot to yet another baseless theory."
"Johnson's Baby Powder has been around since 1894 and it does not contain asbestos or cause mesothelioma or ovarian cancer," J&J said.
Chris Panatier, Herford's lawyer, in an email cautioned against reading too much into a single verdict.
"It is a matter of time before juries begin holding them to account," he said.
The verdict came as a federal jury, separately, ordered J&J to pay $247 million to six patients who said they were injured by defective Pinnacle hip implants.
Mesothelioma is a deadly form of cancer closely associated with exposure to asbestos. It affects the delicate tissue that lines body cavities, most often around the lungs, but also in the abdomen and elsewhere.
Herford's lawyers contended that internal J&J documents showed the New Jersey-based company for decades was aware of the presence of asbestos in the talc that was used in its products but kept selling them anyway.
J&J faces lawsuits by around 5,500 plaintiffs nationally asserting talc-related claims, largely based on claims it failed to warn women about the risk of developing ovarian cancer from the products.
In 5 trials in Missouri involving ovarian cancer lawsuits, juries found J&J liable 4 times and awarded the plaintiffs $307 million. In California, a jury awarded a now-deceased woman $417 million.
But in October, J&J scored major victories when a Missouri appellate court threw out the first verdict there for $72 million and a California judge tossed the $417 million verdict.
The case is Herford et al v. AT&T Corp et al, Los Angeles Superior Court, No. BC646315.
source: news.abs-cbn.com
