J&J Baby Powder Withdrawn in US After Years of Cancer Litigation

Kristin Jenkins

May 21, 2020

Johnson & Johnson has announced that it will wind down distribution of talc-based baby powder in the United States and Canada as part of a move to prioritize products needed to fight the COVID-19 pandemic and in response to flagging sales.

The New Jersey–based company maintains that its decision is not based on concern about the possibility that talc causes cancer or the high cost of ongoing litigation with cancer patients.

"Johnson & Johnson remains steadfastly confident in the safety of talc-based Johnson's Baby Powder," J&J said in a statement released May 19.

"Decades of scientific studies by medical experts around the world support the safety of our product. 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.

Retail sales of existing talc-based baby powder inventory will continue until shelves are empty, according to J&J. Cornstarch-based baby powder will remain available in North America. In addition, both talc-based and cornstarch-based baby powder products will continue to be available in other countries "where there is significantly higher consumer demand for the product."

As previously reported by Medscape Medical News, more than 16,000 talc-related lawsuits in the United States allege that Johnson's baby powder and other talc-containing products increase risk for cancer, and J&J has been ordered to pay billions in legal costs and settlements.

In Canada, a recent government-led review of the scientific evidence concluded that talc could be "harmful to human health," and a screening assessment tool was drafted that would prohibit or restrict the use of talc.

Experts Emphasize No Link to Cancer

Ovarian cancer experts who were approached for comment emphasized that J&J's decision to pull its talc-containing baby powder from the North American marketplace doesn't change the fact that contemporary studies have not demonstrated a statistically significant association between talc exposure and ovarian cancer risk.

"I think that this decision to remove talc-based powders from the US market likely reflects both the decreasing use of talc products and the desire of the company to avoid future litigation," said Dana R. Gossett, MD, MSCI, of the University of California, San Francisco. "It doesn't fundamentally change the existing scientific data or their interpretation. The scientific data still do not demonstrate a clear relationship between talc use and genital cancers."

Gossett is the coauthor, along with Marcela G. del Carmen, MD, MPH, of Harvard Medical School in Boston, Massachusetts, of an editorial that accompanied results from the largest reported investigation to date of the use of talc-based products and the risk for ovarian cancer.

Published in January in JAMA and reported at the time by Medscape Medical News, that study did not demonstrate a statistically significant association between the two. However, the study authors and outside experts who were approached for comment agreed that no definitive conclusions could be drawn from the study, which was underpowered to detect small increases or decreases in ovarian cancer rates.

The absence of J&J baby powder on store shelves in North America "hopefully signifies the beginning of the end to an ongoing controversy regarding the association between talc exposure and ovarian cancer risk," said Don Dizon, MD, professor of medicine at Brown University and director of womens' cancers at Lifespan Cancer Institute, Providence, Rhode Island.

The beginning of the end to an ongoing controversy... Dr Don Dizon

"The truth is, we will never get 100% clarity because no randomized clinical trial will ever be conducted," Dizon told Medscape Medical News. "They [J&J] are responding to external pressures that have forced their corporate hand."

The fact that international sales of J&J's talc-containing baby powder will continue suggests the move may be a response to legal challenges the company has faced in the United States, Dizon pointed out. The company's talc supplier recently declared bankruptcy, he added, noting that this would significantly affect the supply chain.

"These imply, more than anything else, [that] J&J is not ceding acknowledgment that talc causes ovarian cancer," said Dizon.

In October 2019, a case involving a retired Indiana college professor who alleged his cancer was caused by the baby powder he had used for decades was reported. J&J's chief executive, Alex Gorsky, testified in court for the first time that the company's baby powder and other talc-containing products were safe, citing "thousands of tests and studies." He also said he was not aware that any of the talc-containing products contained asbestos, a known carcinogen.

Thirteen days later, the US Food and Drug Administration announced that its independent testing of talc powders and cosmetics for asbestos had identified trace amounts in J&J's baby powder. The health conglomerate recalled 33,000 bottles of baby powder in the United States for possible asbestos contamination, and the company's share price dropped $6.

The US Justice Department and the US Securities and Exchange Commission also launched inquiries, including a criminal grand jury investigation, into J&J's claims about the safety of its powders. An avalanche of lawsuits from people with cancer who had used the products soon followed.

In February, a New Jersey jury awarded $37.2 million in compensation and $750 million in punitive damages to three men and one woman who had mesothelioma. The four said that use of the company's talc-containing baby powder when they were diapered as infants was to blame.

"We will continue to vigorously defend the product, its safety, and the unfounded allegations against it and the company in the courtroom," J&J said at the time. "All verdicts against the company that have been through the appeals process have been overturned."

In October 2019, as reported by Medscape Medical News, a Missouri appeals court overturned a 2017 judgment against J&J, which had awarded $110 million to a woman who said she developed ovarian cancer after decades of use of J&J's talc-based products for feminine hygiene.

The company is appealing the verdict of a July 2018 class action lawsuit in St. Louis, Missouri. That judgment awarded a record $4.69 billion to 21 women who developed ovarian cancer after using J&J's talc-based products.

Gossett has reported a relationship with Bayer. Dizon has disclosed no relevant financial relationships.

Follow Medscape Oncology on Twitter for more cancer news: @MedscapeOnc.

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