Talcum Powder Lawsuit Update 2019

Talcum Powder FDA News: FDA Deferred To Industry, Ignored Outside Experts Over Talc-Asbestos Concerns For Decades: Reuters

December 4, 2019
Author: Daniel Gala

The United States’ purported chief health watchdog for decades deferred to industry and excluded outside experts when it came to investigating concerns over the presence of asbestos in the talc used in popular consumer products, including Johnson’s Baby Powder, an explosive new investigative report by Reuters has revealed.

According to the report, published December 3, the United States Food and Drug Administration (FDA) has failed in its charge to protect the public by ignoring evidence produced by outside experts and instead allowing the industry to engage in what appears in retrospect to be a troubling level of self-regulation.

“Over the past 50 years, the FDA has relied upon—and often deferred to—industry even as outside experts and consumers repeatedly raised health concerns about talc powders and cosmetics,” Reuters reported. “Again and again since at least the 1970s, the agency has downplayed the risk of asbestos contamination and declined to issue warnings or impose safety standards, according to documents produced in court proceedings and in response to public record requests.”

When questioned about its ineffectiveness in keeping contaminated products off the market, the FDA essentially argued that it was powerless to act and instead is purely reliant on the good will and competence of private companies to sell safe products to consumers.

“We are dependent on manufacturers to take steps to ensure the safety of their products,” the FDA said in March following the voluntary recall of talc-based cosmetics that had been found to be contaminated with asbestos.

Asbestos is a known carcinogen extremely closely correlated with pleural mesothelioma, a particularly painful and deadly form of cancer that afflicts the lining of the lungs.

Johnson & Johnson Talcum Powders

For decades, consumer-goods mega-conglomerate Johnson & Johnson has adamantly denied allegations that its flagship product Johnson’s Baby Powder contains asbestos, continuing to market the powder to the public as “pure”. However, as company documents obtained through prior litigation have shown, Johnson & Johnson’s own scientists had expressed concerns over asbestos contamination internally dating back decades.

Now, thousands of lawsuits have been filed in the United States alleging that years of regular use of Johnson’s Baby Powder caused the plaintiffs to develop mesothelioma or ovarian cancer. Federal talc-cancer claims have been centralized as multidistrict litigation (MDL) in the District of New Jersey. The MDL presently contains more than 15,000 cases.

Despite mounting evidence of the presence of asbestos in J&J talc, the company continues to back its talcum-powder products, both publicly and under oath.

“Throughout the 1970s and ‘80s, the FDA and other regulatory bodies defended talc,” J&J’s Chief Executive Alex Gorsky testified during a sworn deposition given October 3, per Reuters. “FDA agreed overall with the position that we had taken with the safety of our talc.”

FDA Defers To Industry

While J&J for years has used the FDA’s supposed backing to argue for the safety of its talc-based products, the Reuters investigation has revealed that, during that same period, the FDA essentially was relying on J&J’s and the industry’s own assertions about the presence of asbestos.

In this circular example of regulatory capture, J&J’s own experts convinced the FDA that J&J talc-based products did not contain asbestos, an assertion which the FDA accepted for years without conducting its own independent analysis, or even allowing outside experts to present their work for consideration. Then, in a particularly cynical move, J&J would cite the FDA’s tacit approval as evidence of its talcum powder’s safety.

A recent, literal example of this exclusion of outside experts is described in the Reuters report.

“At an invitation-only gathering late last year, U.S. regulators and their guests huddled at a hotel near Washington, D.C., to discuss the best way to detect cancer-causing asbestos in talc powders and cosmetics,” Reuters reports. “The ‘Asbestos in Talc Symposium,’ sponsored by the Food and Drug Administration, was dominated by industry hands: Most of the 21 non-government participants had done work for talc companies, such as testing and serving as expert witnesses and consultants.”

While “[k]ey sessions” at the Asbestos In Talc Symposium “were led by witnesses for Johnson & Johnson in lawsuits alleging the company failed to warn customers that its Baby Powder was tainted with cancer-causing asbestos…[o]thers who sought invitations were turned away, including a physician who had testified against J&J in trials that resulted in billions of dollars in damages against the company.”

This inclusion of industry insiders to the exclusion of outside experts with views contrary to those pushed by the talc-manufacturers themselves reflected decades of standard practice when it comes to the FDA’s supposed oversight of asbestos in talc.

The FDA Finally Commissions Its Own Tests

And what ultimately happened when the FDA, succumbing to pressure from Congress and amid a criminal investigation into J&J’s practices pertaining to asbestos in its talc, actually commissioned its own tests after roughly 40 years of not doing so?

Testing a single 22-ounce bottle of Johnson’s Baby Powder, researchers hired by the FDA discovered asbestos fibers, prompting Johnson & Johnsons to recall 33,000 bottles. “The U.S. Food and Drug Administration is alerting consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos,” the FDA’s statement, released October 18, says.

“During talc mining, if talc mining sites are not selected carefully and steps are not taken to purify the talc ore sufficiently, the talc may be contaminated with asbestos,” the FDA statement explains. “Asbestos is a known carcinogen.”

In its own annoucement, J&J said it was initiating the voluntary recall “out of an abundance of caution” and highlighted that the FDA’s test had detected “sub-trace levels of chrysotile asbestos contamination.”

J&J further emphasized that it could not “confirm if cross-contamination of the sample caused a false positive” and later released its own test results, which the company says only found asbestos in one of the tested samples, and that was supposedly found to be a false positive caused by an air-conditioning unit.

It Didn’t Have To Be This Way

While certain evens have a tendency to look inevitable in retrospect, the Reuters’ investigation identifies a number of key moments where things could have proceeded differently with the regards to the FDA’s approach to regulating talc.

The potential for asbestos to be present in talc first came onto the FDA’s radar in 1971. According to Reuters, that’s when researchers at New York’s Mount Sinai Medical Center identified asbestos in “unnamed brands” of talc powder. In 1973, the FDA, engaging in its own testing, found asbestos in J&J’s Shower to Shower brand talc powder, but never released these findings to the public.

Concerned about the potential revelations of independent testing, Johnson & Johnson and other talc purveyors pushed, through their trade group the Cosmetic Toiletry and Fragrance Association, for industry self-regulation.

Under pressure, the “FDA dropped plans to impose testing and purity standards for talc powders and cosmetics,” according to Reuters. “The trade group published its own test, which was voluntary for companies to use.”

Further, the “written standard for that test acknowledges that it cannot detect most types of asbestos at low levels, nor one common type—chrysotile—at all.”

The form of asbestos identified in the 22-ounce bottle of Johnson’s Baby Powder that prompted the October 2019 recall was, in fact, chrysotile. According to Reuters, “[Chrysotile] also was found in several tests conducted by labs for J&J on its talc from 1972 through 2003.”

Another Chance To Get It Right

Researchers and industry missed another opportunity to avert or at least mitigate today’s talc-asbestos tragedy in the early 1980s, when an enterprising graduate student named Philippe Douillet discovered information in a geology journal suggesting that talc deposits often contain asbestos deposits. Douillet made the connection between this information and the potential hazards it posed for consumers using talc-based powders.

Douillet petitioned the FDA, trying to get the purported consumer watchdog to place an asbestos warning label on talc-based products.

“It was really obvious to me there was a big issue there,” Douillet told Reuters.

However, in considering the warning-label petition, the FDA turned not to its own experts or to independent researchers, but to Johnson & Johnson itself.

“The FDA’s June 1985 risk assessment [in response to Douillet’s petition] relied upon a decade-old letter from [J&J] for the agency’s estimate of the amount of dust babies were exposed to during diapering,” Reuters reported. “That 1974 letter from J&J to the FDA said that, hypothetically, even if babies were exposed to talc powder with as much as 1% asbestos, it would be a far lower concentration than allowed at the time for industrial workers.”

Yet Another Opportunity, But ‘Other Priorities’

In 1994, the FDA again received a petition concerning cancer and talcum powders. Dr. Samuel Epstein, chair of the Cancer Prevention Coalition, requested that the FDA require a warning label on talcum powders highlighting the risk of ovarian cancer.

“In a brief July 1995 letter, FDA acting cosmetics chief John Bailey told Epstein’s coalition that the agency had taken no action because it had other priorities,” Reuters reported.

Following his “public service” at the FDA, Bailey then followed the money into the very industry he had taken a light hand in regulating.

“In 2002, having taken no action on the petition, Bailey moved to the cosmetic trade group, now known as Personal Care Products Council,” Reuters reported. “Now a consultant, Bailey serves as a litigation expert witness to J&J and other talc companies.”

The Fallout

It will never be known exactly how many premature deaths or how much needless suffering could have been prevented if either Johnson & Johnson or the FDA had acted more proactively when faced with evidence, starting at least half a century ago, that the very talc products J&J was marketing for use on babies contained the dangerous carcinogen asbestos.

But what has become clear through hard-fought litigation on behalf of plaintiffs and hard-hitting journalism by investigative reporters is that Johnson & Johnson knew for decades about the potential for asbestos fibers to be present in its talcum-powder products and, rather than act to protect its customers, it chose to actively conceal what it knew and sought to use its clout to prevent regulators from learning the same through independent testing.

Now Johnson & Johnson must face the consequences in the courtroom and in the court of public opinion.

Sources:

Girion, L. and Terhune, C. (3 December 2019). Powder Keg: FDA bowed to industry for decades as alarms were sounded over talc. Reuters

United States Food and Drug Administration (FDA). (18 October 2019). Baby powder manufacturer voluntarily recalls products for asbestos. FDA News Release. Press Announcements

Johnson & Johnson Consumer Inc. (18 October 2019). Johnson & Johnson Consumer Inc. to Voluntarily Recall a Single Lot of Johnson’s Baby Powder in the United States. Company Announcement. Recalls, Market Withdrawals, & Safety Alerts. United States Food and Drug Administration (FDA) website