Earlier this year, Johnson & Johnson voluntarily recalled its baby powder after FDA testing found traces of asbestos in a sample purchased online. In October, the pharmaceutical company released a statement claiming that 15 tests of the same sample the FDA examined, completed by third-party agencies, contained no asbestos.
The FDA contests these assertions. In an interview with Reuters, the government agency supports the recall and stands by its initial results.
This incident marked the first time Johnson & Johnson had to recall its long-popular baby powder, even though tests going back multiple decades have identified small amounts of asbestos. The company removed 33,000 bottles of its product, which were produced and sold in 2013. The FDA’s testing of a bottle sold online found chrysotile asbestos amounting to roughly 0.00002 percent. In response, the FDA asked Johnson & Johnson to recall items from this particular lot.
What’s Behind Inconsistent Test Results?
It could be easy to dismiss Johnson & Johnson’s claims as corporate greed. However, a statement from the FDA explained that asbestos fibers are not evenly distributed throughout talc samples. As a result, different tests of the same sample may have different outcomes.
Another Reuters report found that a paid witness and former baby powder tester for Johnson & Johnson is also contracted by the FDA. Due to this conflict of interest, Johnson & Johnson doubts the validity of these lab results.
Andreas Saldivar, the laboratory director for AMA Analytical Services, Inc., has supported Johnson & Johnson’s assertions since the company started facing litigation in 2017 over the contents of its baby power. Saldivar backed up the company’s claims about the absence of asbestos in the baby powder.
Specifically, Saldivar tested the product on behalf of Johnson & Johnson in 2010 for the FDA and his results at the time indicated no presence of asbestos. However, Saldivar’s lab also tested the same product directly for the FDA earlier in 2018 and discovered asbestos fibers in an unmarked sample.
The depth and testing used for the lab’s 2010 report also recently came to light. At the time, the lab had mainly tested the asbestos contents of materials used for old buildings, but had no experience examining talc specifically. AMA claims to have tested 102 total samples relatively quickly, using a process called transmission electron microscopy (TEM) to examine the contents of each product. It’s estimated AMA spent just five minutes on each sample.
Because of this, the FDA warned at the time that the tests were inconclusive and shouldn’t be taken as absolute.
Other labs typically spend anywhere from a half hour to a full day assessing a large sample of talc. Saldivar testified on behalf of Johnson & Johnson that AMA found no traces of talc in its baby powder. Since then, Saldivar claims he has served as a witness in 20 to 30 cases involving Johnson & Johnson’s baby powder.
In 2019, AMA produced a 16-page report for the FDA. Based on its recent assessments, the lab identified six asbestos fibers in a sample weighing under a gram. While the amount tested is still small, the lab believes that millions of asbestos fibers could be present in a single gram.
Because of these conflicting results, Johnson & Johnson has tried to discredit Saldivar. The company has since released a statement claiming other third-party labs have examined the same product and have yet to come across asbestos. Yet, this motion reflects Johnson & Johnson’s strategy since the 1970s: The company disputes outside labs getting involved, even though Johnson & Johnson’s own testers have periodically identified small amounts of asbestos in raw talc samples.
As far as the thousands of pending trials are concerned, lawyers estimate that Saldivar’s latest findings could be another blow to Johnson & Johnson, who have already lost a handful of claims and have had to pay plaintiffs roughly $5 billion.
Over the past two years, multiple courts have sided with the plaintiffs, including one case in which 22 women claimed regular use of Johnson & Johnson’s product is responsible for their ovarian cancer diagnoses. In other cases, Johnson & Johnson decided to settle with the plaintiffs.
Other legal experts believe the FDA’s recent findings aren’t applicable to past instances, as mesothelioma and other cancers take years to develop. Yet, a study published recently in the Journal of Occupational and Environmental Medicine identified a correlation between regular baby powder use and the development of malignant mesothelioma, after 33 subjects who regularly used talcum-based baby powder came down with the fatal condition.
Retailers are Taking Action
Since the recall, a few retailers have decided to remove all 22-ounce bottles of Johnson & Johnson’s baby powder from their shelves. To date, Walmart, CVS and Rite Aid have opted out of selling this product to customers, for fear of potential asbestos contamination. However, the action is expected to be temporary.
Asbestos exposure doesn’t always mean an individual will contract mesothelioma or another cancer, but it increases an individual’s odds of developing the conditions at a later date, according to figures from the CDC. Exposure through construction and other occupations may be responsible for anywhere from 12,000 to 15,000 deaths per year.
For years, consumers were left in the dark concerning the presence of asbestos in talc-based baby powder. If you believe you developed mesothelioma or cancer as a result of exposure, it’s time to hold these manufacturers accountable. To bring your claim to the product liability lawyers at Trantolo & Trantolo, give us a call today.