TALC

THURSDAY, June 13, 2024 -- Johnson & Johnson will pay $700 million to settle claims from 42 states and the District of Columbia that the company continued to market its talcum powder products even as evidence tied them to a heightened risk for cancer. J&J did not admit to any wrongdoing in settling with the states, which were led by Florida, Texas and North Carolina. “We have reached a landmark settlement with Johnson & Johnson ensuring that the company will abide by the law and take effective steps to protect consumers from potentially hazardous ingredients,” Texas Attorney General Ken Paxton said in a statement released Tuesday. “I’m proud to lead this coalition of 43 attorneys general to stand up for consumers’ health and truth in marketing.” As part of the settlement, which still needs judicial approval, the company has stopped making, promoting and selling all of its products that contain talcum powder. That includes Johnson's Baby Powder and Johnson & Johnson's Shower to Shower. J&J will make four settlement payments, starting at the end of July, according to the settlement. “This is a major advancement for consumer product safety, as Johnson & Johnson has stopped the manufacturing and marketing of products containing talc powder -- which may be linked to serious health issues, including cancer,” Florida Attorney General Ashley Moody said in a statement . "Companies cannot deceive people about the safety of the products they are selling,” North Carolina Attorney General Josh Stein said in a statement . “People need to have accurate information so they can buy the right products for their health.” J&J stopped selling talcum-based baby powder globally last year, switching to corn starch as the main ingredient. The company still faces tens of thousands of talc lawsuits, and a class action lawsuit accuses company of hiding the dangers of talcum powder from shareholders, Reuters reported. As of March 31, more than 61,000 were still suing J&J over talcum powder products. Most are women with ovarian cancer, while a smaller number had mesothelioma, a type of cancer linked to asbestos exposure, Reuters reported. On May 1, J&J proposed a $6.48 billion settlement to resolve most of the litigation through a third bankruptcy filing. It has set aside an $11 billion reserve to cover all talc liabilities, Reuters reported. “The company continues to pursue several paths to achieve a comprehensive and final resolution of the talc litigation,” Erik Haas , J&J's worldwide vice president of litigation, said in a statement . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Johnson & Johnson pulled its talc-based baby powder from the U.S. market in 2021, replacing it with a cornstarch version. The more than 53,000 women in the U.S. who have filed injury lawsuits against Johnson & Johnson have added ammunition for their claims as new research indicates there is an association between long-term use of talcum-based powders and an increased risk of developing ovarian cancer.   The findings from the National Institutes of Health (NIH) are timely, because most of the outstanding cases against J&J have been consolidated in a class-action suit in New Jersey scheduled to go to trial in December of this year. Also making them timely is the March ruling of a federal court in New Jersey that determined J&J could contest scientific evidence of a link between talcum powder and ovarian cancer. In making his decision, Judge Michael Shipp cited recent updates to the Federal Rule of Evidence 702, which gives judges more power to discredit flawed testimony in so-called Daubert hearings that rely on expert opinions. The new research, which was published last week in the Journal of Clinical Oncology, is based on data from the Sister Study, which included more than 50,000 participants in the U.S. between the ages of 35 and 74 who enrolled between 2003 and 2009. The study participants were then surveyed between 2017 and 2019. The study supports “a positive association between genital talc use and ovarian cancer,” the NIH researchers wrote. The team concluded that women who applied talcum powder to their genitals and did so over a long period of time were more prone to developing ovarian cancer. Those who used talcum powder for 20 years or more had roughly double the risk. “That’s a powerful finding, particularly in a study where prior data didn’t show an increased risk,” Leigh O’Dell, a lawyer from Beasley Allen who co-chairs the plaintiff steering committee, said in an interview. As it has for more than a decade in contesting the claims, J&J maintains that it should not be held liable. “This study does not change the overwhelming evidence that talcum powder does not cause ovarian cancer, and we remain confident these claims will be dismissed following Daubert review,” Erik Haas, J&J’s legal chief, said in a statement. In addition, Haas argues the study “explicitly states that the results do not establish causality and do not implicate any specific cancer-inducing agent.”  “In analyzing the actual data, the study concludes that there is an ‘inverse or weakly positive associations between both types of intimate care products and all cancers of interest,’” Haas added in the statement. “Only when speculative assumptions are layered over the actual data does the study infer a positive association.” For their part, lawyers for the plaintiffs believe the NIH findings bolster their case to include expert testimony in upcoming trials. “The results are completely consistent with what the plaintiffs’ experts have been saying for two years—and they are compelling,” O’Dell said. In drilling down into the available data, the researchers gained a more complete view of the participants’ lifetime use of talcum power. Researchers estimated that 56% of participants applied the product to their genitals. In a letter to New Jersey federal Judge John Porto on Tuesday, J&J criticized the methodology used to produce the new findings, writing that "results are not derived from the actual data. Instead, it is premised entirely on 'corrections' that lack a generally accepted methodology, and a series of assumptions leading to imputations that drive its results.". After twice failing to resolve the talc cases by creating a subsidiary to house them and then declare it bankrupt, J&J tried another tactic earlier this month as it announced its intention to “reorganize” the subsidiary, LTL Management. The plan comes with a $6.475 billion settlement offer to be paid to talc litigants over the next 25 years. The figure was less than the $8.9 billion settlement J&J offered with its second bankruptcy effort last year. J&J says the current settlement offer is a “far better recovery than the claimants stand to recover at trial.” The company backs up this claim by citing its 95% victory rate in ovarian cancer cases that have gone to trial over the last six years. But the losses have been costly, such as a 2018 case in Missouri in which $4.69 billion was awarded to 22 women. The payment was later adjusted by an appeals court to $2.11 billion. On Friday of last week, J&J filed a complaint against Beasley Allen accusing the law firm of providing “false information” to clients in an “anti-vote” campaign designed to influence their voting on the settlement offer, which will happen over the next three months. “It’s certainly not in good faith what they’re doing,” O’Dell said.    J&J has sold baby powder for more than a century, and its concerns with the product extend to at least half that time. In 1971, J&J funded a study where it injected asbestos into prisoners in Pennsylvania to compare their skin reactions to those using talc. J&J apologized for the study in 2022 while adding such tests on prisoners were “widely accepted” at the time. In 2019, after the FDA found trace amounts of asbestos in the talc-based product, J&J recalled 33,000 bottles out of “an abundance of caution.” With sales declining and settlements and litigation piling up, J&J took it off the market in the U.S. in 2021 and around the rest of the world by 2023, replacing it with a cornstarch version. Seven months ago, J&J rejected a $19 billion settlement plan supported by the coalition of law firms representing the plaintiffs. It was the first indication from the plaintiffs of what they would accept to resolve the cases. As for the oncoming Daubert review, the best-case scenario for J&J would be a ruling similar to a 2022 verdict that freed Sanofi, GSK and Boehringer Ingelheim of more than 50,000 lawsuits in a federal multidistrict case against their heartburn drug Zantac. That ruling in Florida overturned previous scientific findings.  Motions in the Daubert review are scheduled to be filed by July 23, with any filings opposing those motions due a month later.