A bottle of Johnson and Johnson Baby Powder is seen in a photo illustration taken in New York, February 24, 2016. Image Credit: Reuters

As a kid accompanying my parents to first birthday parties and baby showers, I remember the ideal gift being just one – a set of baby products from talc and lotion to shampoo and soap from Johnson and Johnson. I grew up loving the scent of the products that were and are so commonly used on kids and adults alike.

No one would have ever thought then or now that the white, baby-scented powder, that parents lovingly douse their young ones with, could have a dangerous carcinogen.

What happened now?

On Friday, a sample from one batch were tested and found positive for asbestos – a known carcinogen. Another batch was tested, also at random, and showed negative for the same test.

J&J decided to act “out of an abundance of caution" and recalled the batch that tested positive, 33,000 bottles to be exact. Increased and prolonged exposure to asbestos has been proven to cause cancers in humans.

The move marks the first time the company has recalled its iconic baby powder for possible asbestos contamination, and the first time U.S. regulators have announced a finding of asbestos in the product.

The company also noted that the levels found were no greater than 0.00002 per cent, and that it cannot confirm whether cross-contamination occurred. The company also alleged that the product could be counterfeit though the US Food and Drug Administration said that there was no indication that the samples were counterfeit.

The recall is the latest blow to the more than 130-year-old U.S. healthcare conglomerate that is facing thousands of lawsuits over a variety of products, including baby powder, opioids, medical devices and the antipsychotic Risperdal.

Asbestos and cancer

Talc is a naturally occurring mineral mined by manufacturers like J&J and used in several cosmetic products. However, unlike asbestos – also a naturally occurring mineral, talc is not a carcinogen.

Johnson and Johnsons
Johnson and Johnsons Image Credit: Johnson and Johnsons

Increased and prolonged exposure to asbestos has been proven to cause cancers in humans.

A common cancer for those exposed to the mineral is the very rare form of deadly cancer called mesothelioma. Mostly found in mine workers who were exposed to asbestos for prolonged periods of time, the very first lawsuit against J&J came from a woman who had no reason to be exposed to the deadly mineral.

Darlene Coker, a 52-year old woman, was diagnosed with mesothelioma knew the cancer she had was from asbestos exposure. As a massage school manager in Texas, she had no reason to be exposed asbestos at all. A personal-injury lawyer honed in on the probable reason - the Johnson’s Baby Powder that Coker had used on her infant children and herself all her life. Coker, however, had to drop the case as the burden of proof was on her and she couldn’t prove that the powder was the reason for her cancer.

That was in 1999.

Two decades later, the material Coker and her lawyer sought to prove her claims 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.

They knew

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.

Plaintiffs in the talc cases have accused Johnson & Johnson of failing to warn customers of the risks of asbestos contamination, despite being aware of concerns for decades. A New York Times investigation last year found internal memos and reports made public during litigation that document executives' concerns about potential contamination that date back 50 years.

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% of chrysotile asbestos in the tested sample, J&J said, on Friday.

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 mesothelioma years later. A lot of lawsuits against the company involve women diagnosed with ovarian cancer.

While health risks increase with heavier and longer exposure to asbestos, the overall evidence suggests no level of asbestos exposure is safe, and disease has been found in people with only brief exposures, according to the National Cancer Institute.

Trouble worth billions

Analysts estimate the baby powder lawsuits could cost Johnson & Johnson $5 billion to $10 billion. The latest asbestos-related recall comes as the company, which reaches into the lives of millions of people through brands such as Tylenol, Band-Aid and Rogaine and reported nearly $82 billion in sales last year, is entangled in numerous legal battles over the safety of its products.

The company has settled some claims - and is still fighting others - involving its role in the nationwide opioid crisis. On Thursday, Johnson & Johnson agreed to pay $117 million in a settlement over deceptive marketing of transvaginal pelvic mesh implants, and a jury this month ordered it to pay $8 billion to a Maryland man who accused the company of downplaying the risks associated with the antipsychotic drug Risperdal. In total, the company faces more than 100,000 lawsuits over its products.

Baby powder can bring down reputation

More than 15,000 of those are from people who said baby powder and other talc-based products caused them to develop cancer. Some have mesothelioma, an aggressive cancer that is considered the signature disease of asbestos exposure, while others have ovarian cancer.

The decision to pull the baby powder, sourced from China and distributed last year, is a "whopper" for a company as dependent on consumer trust as Johnson & Johnson, said David Noll, a law professor at Rutgers University.

Baby powder represents a tiny fraction of Johnson & Johnson sales but an outsize threat to its reputation.

Johnson & Johnson's name is "so synonymous with their line of baby products," said Alla Valente, an analyst with Forrester. But recently, she said, the company has started a "damage control campaign" that casts it as bigger than its baby powder, focusing on its slate of other products.

"It's about trust: If a mother could trust a Johnson & Johnson product for their children, then that product must be safe," Valente said. "But now, the dam is finally breaking, where consumers are saying that enough is enough."

Johnson's baby powder on display at a supermarket Image Credit: File photo

Talc is a natural mineral, formed in underground deposits under the same geological conditions as asbestos. In mines, veins of asbestos can intermingle with talc, geologists said.

"I can't imagine an attorney for Johnson & Johnson standing up in front of a jury now and saying with a straight face that the product is safe," Noll said. He added that "if people come to associate the company's signature product with deadly diseases, there will be huge spillover effects for its ability to market other products."

Susan Nicholson, Johnson & Johnson's vice president of women's health, said during a short conference call with investors Friday that the FDA's report showed "an extremely unusual finding" that was "inconsistent with our testing to date."

In response, an agency spokeswoman, Gloria Sanchez-Contreras, said, "The FDA stands by the quality of its testing and results."

Shares of the company closed down more than 6 per cent Friday.

More trouble looms

Johnson & Johnson disclosed this year that it was being investigated by the Justice Department and the Securities and Exchange Commission over concerns about possible asbestos contamination of its talc-based products.

Johnson & Johnson is awaiting a major decision that could tilt the talc litigation in its favor. As part of pretrial proceedings for thousands of talc lawsuits consolidated in New Jersey, a federal judge is mulling whether to block testimony from expert witnesses hired by plaintiffs, a move that could cause many talc cases to be dismissed or dropped.

Regular testing for asbestos

The FDA does not require safety testing for personal care products and cosmetics before they are marketed and tests products only occasionally, usually after complaints by consumers or advocacy groups.

The agency considered - and soon abandoned - a plan to monitor talcum products for asbestos in the 1970s, when concern about asbestos in household products captured the public's attention. The FDA commissioned tests of Johnson & Johnson powders back then, and the company successfully challenged their validity.

This year, after consumer tests found asbestos in makeup kits for children sold at Claire's, the FDA followed up with its own tests. It detected the carcinogen in half of 20 products, including Claire's eye shadow and compact powder, JoJo Siwa makeup sold at Claire's, and bronzers, blush and other makeup made by Beauty Plus Global City Color Cosmetics and sold in retail outlets. The products were eventually recalled.

The agency plans to test 30 more products containing talcum powder, including those popular on social media and others marketed to children, Sanchez-Contreras said. The products are a tiny percentage of the thousands of personal care products available for sale.

- With inputs from Reuters, New York Times News Service Ltd.