US government probes talc safety as ruling expands corporate liability

By IM Staff
Published: Friday, 29 September 2017

Cancer sufferer awarded damages from J&J while US Food & Drug Administration establish research to clarify the relation between talc and ovarian cancer. Initially named on the same lawsuit, Imerys dropped from the case and US talc mining association said to be unaffected by ruling.

A US federal government review has been ordered into the potential link between talc and ovarian cancer following an "influx of adverse event reports". 

In August, a jury in the Los Angeles Superior Court ordered personal care product manufacturer Johnson & Johnson (J&J) to pay $417m to Eva Echeverria, who claimed she developed the disease after using its talc-based products for feminine hygiene purposes.

The verdict, which included an order for $70m compensation and $347m in punitive damages, was the largest in a series of lawsuits against J&J alleging that it failed to adequately warn consumers about the cancer risks associated with its talc-based items.

Echeverria’s lawyer, Mark Robinson, said: "J&J’s [documents] show that J&J knew [about the risks], in the '60s,'70s, and '80s and '90s and never warned [consumers]."

J&J is facing almost 5,000 similar cases across the US and has already been ordered to pay damages in excess of $300m by juries in earlier hearings.

FDA launches investigation

The US Food & Drug Administration (FDA) said in August that it has commissioned its own research to establish if there is a link between talc and cancer, acknowledging that "talc’s effects on female genital system tissues have not been adequately tested". The project, funded by the FDA’s Office of Women’s Health, is expected to take two years to complete.

On announcing the research project, the FDA said its research will "help to fill some of the existing data gaps, in the molecular and genetic events associated with early ovarian oncogenesis, as these are largely unknown."

The announcement marks a significant change in policy for the federal agency. In 2014, it denied a citizen’s petition asking for a label to be put in talcum powder warning of a possible link to ovarian cancer.

The FDA’s Office of Cosmetics and Colors undertook a review of epidemiologic publications on the use of talcum powder and ovarian cancer as part of the agency’s response to the petition and "did not find such a link in our review of the scientific literature at the time". 

"However, in part because of the continuing influx of adverse event reports associated with talcum powder, we are taking another look at the latest scientific literature and are beginning our own laboratory research study to determine if such a link between talc and ovarian cancer might now be determined," a spokesperson said.

Regarding the cases already underway against talc product manufacturers, the FDA said it does not comment on "possible, pending or ongoing litigation".

A number of US legal firms have urged anyone suffering from cancer that they believe was caused by use of talc to join the class action to fight manufacturers, of which J&J is the most prominent and is the only company sued over cancer claims to date.

A spokesperson for J&J said: "We have no higher responsibility than the health and safety of consumers who rely on our products. Our confidence in using talc is based on a long history of safe use and more than 30 years of research by independent researchers, scientific review boards and global regulatory authorities".

J&J has said it will appeal the Echeverria verdict, "because we are guided by science, which supports the safety of Johnson’s Baby Powder." 

Imerys dropped from case

France-headquartered Imerys, the world’s largest mineral talc producer, was initially named on the same LA lawsuit as J&J but was dismissed from the case prior to trial "due in part to the court’s finding that talc is not an inherently dangerous substance," explained a spokesperson for Imerys Talc North America.

"Imerys is committed to the safety of its talc and utilises a rigorous set of proprietary methods in producing talc to ensure its safety," the company said. "The consensus of government agencies and professional scientific organisations that have reviewed the safety of talc over the last 20 years is clear: talc is safe under conditions of normal use."

Imerys also pointed out that occupational exposure to talc has not been listed as a known or suspected human carcinogen by the International Agency for Research on Cancer (IARC), the National Toxicity Program (NTP), the Occupational Health and Safety Administration (OSHA), the American Congress of Governmental Industrial Hygienists (ACGIH) or the European Commission.

Miners shrug off risk to business

Jim Frederick, assistant director of health, safety and environment for the United Steelworkers Union which represents more than 800,000 active members in the US and Canada – including miners – said he and his colleagues had been "cognisant of legal activity in this area over recent years" and were striving to address health and safety concerns.

"One of our goals is to make sure workplaces are safe and what comes out of them is safe from a public health perspective. When health and safety issues are raised, we often hear it will cause facilities to have less work but, in reality, that hasn’t been our experience."

"It seems to be pretty much business as usual." A spokesman for the US National Mining Association said, adding that "the [Echeverria] ruling, to my knowledge, has absolutely no bearing on or implications for US mining operations."

The UK-based Cosmetics, Toiletry and Perfumery Association (CTPA) has stressed that it takes the issue seriously and is being guided by scientific consensus on talc’s safety.

"The cosmetic talc industry has actively supported major scientific studies into the properties, use and safety of cosmetic talc, providing evidence of its quality and purity," the body stated. It said it had had a dedicated cosmetic talc specification since the 1960s. In 1996 industry completely revised the methods of measurement to accommodate modern detection methods and to set the highest standards for cosmetic talc usage. This standard was last reviewed in 2016.

"Statistically robust prospective epidemiology studies on large populations of women have clearly shown that talc is not a carcinogen to the ovary," said the CTPA.  "There is no known physiological mechanism by which talc can plausibly migrate to the ovaries from the perineum," it added.