Johnson & Johnson Product Recall

Out of ‘an abundance of caution’, on 18 October 2019, Johnson & Johnson (J&J) was prompted to voluntarily recall 33,000 bottles of Johnson’s Baby Powder, after the US Food and Drug Administration (FDA), on 16 October, identified sub-trace levels of chrysotile asbestos (no greater than 0.00002%) in a single consumer product, sold online and shipped in 2018.^[i]

J&J shares were prompted to fall by 6.2%, the biggest drop since December 2018.^[ii]

Figure: J&J Share Price:

(Source: Hargreaves Lansdown)

This is understandable, as it is the first time in the 130-year history of the household product that it has been recalled and the first occasion that the Regulator has detected asbestos in this particular product.^[iii]

Consequently, major retailers, Walmart, CVS Pharmacy, Target, Walgreens and Rite Aid, stopped selling 22-ounce bottles of Johnson & Johnson Baby Powder involved in the product recall.^[iv]

Since 2003, mineral talc in Johnson’s Baby Powder has originated from China and has been sold in the United States through supplier Imerys Talc America, which recently filed for Chapter 11 bankruptcy protection (we reported this here).^[v]

Mineral talc is mined in close proximity to tremolite asbestos in the earth, but is ‘routinely tested’ for contaminants.

Has the FDA conclusively shown, through its testing, that Johnson’s Baby Powder is contaminated with asbestos?

Despite the fact that US Government officials advised consumers to ‘immediately’ stop using products,^[vi] this only related to bottles contained in lot (#22318RB) – 1 of 2 lots tested by the FDA.^[vii]

Immediately after the decision to recall products was made, J&J opened a ‘rigorous, thorough investigation’ to verify the Administration’s ‘extremely unusual’ findings.

At the time, the manufacturer could not confirm whether the FDA test was a ‘false positive’ (potentially through cross-contamination or uncontrolled testing), nor could it confirm whether the product in question was ‘authentic or counterfeit’. However, spokeswoman, Gloria Sanchez-Contreras, stated that the Administration stood by the ‘quality of its testing and results’ and was not aware of ‘any records pointing to counterfeit Johnson’s Baby Powder in the US market’.

Regardless, in an official statement, the manufacturer assured that:

JJCI [J&J Consumer Inc.] has a rigorous testing standard in place to ensure its cosmetic talc is safe and years of testing, including the FDA’s own testing on prior occasions--and as recently as last month--found no asbestos. Thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos. Our talc comes from ore sources confirmed to meet our stringent specifications that exceed industry standards. Not only do we and our suppliers routinely test to ensure our talc does not contain asbestos, our talc has also been tested and confirmed to be asbestos-free by a range of independent laboratories, universities and global health authorities’.

A Twist in the Tale?

Then, on 29 October, J&J revealed that 15 new tests, ‘rigorously’ conducted by ‘third parties’, had not detected asbestos in Baby Powder samples, including the suspect bottle flagged by the FDA in lot (#22318RB).^[viii] It will not reverse the product recall.

Is this a blessing in disguise?

Steve Musser, Deputy Director for Scientific Operations in the FDA's Center for Food Safety and Nutrition, explained that J&J’s latest tests do not prove that Baby Powder is asbestos free. It simply emphasises the fact that, due to the ‘miniscule size’ of samples taken, the lack of uniform dispersion of contaminants and no ‘standard test’ for asbestos in talc, ‘different samples may yield different results’.^[ix]

Ambiguous as the test results may be, when combined with NHS admonition,^[x] ongoing criminal investigations and a Special Report, conducted by The New York Times and Reuters, which accused J&J of having known, from at least 1971 until the early 2000’s, that its products (mined in Vermont and Italy) were laced with asbestos, the FDA’s recent intervention will likely have a negative impact on J&J’s calm and collected narrative.

As we reported in edition 263 of BC Disease News (here), J&J denounced Reuter’s Special Report as ‘one-sided, false and inflammatory’.

Asbestos in Talc – A Case Study

J&J’s product recall unexpectedly coincided with a new, 33-patient (mostly female) case study, published in the Journal of Occupational and Environmental Medicine,^[xi] which supposedly provides ‘compelling causal evidence’ of a link between mesothelioma and asbestos in talc.

‘Everything points to cosmetic talc being the cause’, said study author and Professor of Occupational Medicine, Epidemiology and Prevention, Dr. Jacqueline Moline.^[xii]

It was significant, in this research, that the ‘only substantial exposure’ to asbestos could have been through use of talcum powder.

Still, it is ‘very difficult to apply the details of one person’s case [or 33] to a larger patient population’, professed Steve Gold, of Rutgers Law School, who assimilated the credibility of this study with ‘a brick in a wall’.

International Product Litigation in Progress

According to a filing with the US Securities and Exchange Commission, as of July 2019, J&J was facing 15,500 product liability claims, in the US.^[xiii]

Last month, J&J was cleared of liability on several occasions, the highlight of which was the overturning of a $110 million Missouri verdict, originally delivered in 2017.^[xiv]

The latest product liability claimant to argue her case at trial, in the US, is Amy Fong,^[xv] a 48-year-old woman who was diagnosed with terminal mesothelioma. Despite overlapping with opening submissions, the product recall was not mentioned by her claimant legal representatives,^[xvi] though the Los Angeles Superior Court jury was made aware of ‘over 50 ... historical bottles of Johnson & Johnson Baby Powder’ which experts say contained asbestos.^[xvii]

Elsewhere, J&J’s Chief Executive (since 2012), Alex Gorsky, has been criticised for stating his unequivocal ‘belief’ that products are not tainted with asbestos. At a deposition, on 3 October, he defended his vague assurances by asserting that he himself had used the product on his son:

‘I did not personally conduct every single test. I can only … gauge it based upon the data and totality that’s been presented to me’.

What about claims brought by individuals in the UK?

Last week, claimant personal injury firm, Leigh Day, revealed that it is currently representing a number of British citizens, who approached the business after receiving a clinical diagnosis of mesothelioma and subsequently attributed their condition to a history of talc-containing product usage.

Leigh Day’s asbestos team is working with US lawyers (acting as ‘co-counsel’) to help male and female claimants commence litigation overseas. Solicitor, Harminder Bains, advertised:

‘It is clear that people in the UK are increasingly alarmed by reports from the US that talc products have been recalled due to traces of asbestos and that links to cancer have allegedly been found. We know that even small amounts of asbestos can cause asbestos-related illnesses which are fatal.

While we are unable to bring claims in the English courts for UK citizens who allege that they have developed serious illnesses after exposure to asbestos in talcum powder and cosmetic powder products, we can help them to bring claims in the US by working with lawyers in the United States’.^[xviii]

One such client is a 45-year-old woman, whose application of talcum powder was cross-generational – a tradition among mothers in her family.

Establishing a New Legal/Corporate Strategy?

Could the product recall encourage more product liability claims?

Wells Fargo Analyst, Larry Biegelsen, believes that it could and is warning his clients that J&J may be prompted to settle pending lawsuits for between $2 and $6 billion, on the premise that 20,000 claims remain, i.e. awards valued between $100,000 to $300,000 per person.

Whereas, Bloomberg Intelligence considers that liabilities could cost the company as much as $10 billion.^[xix]

With Healthcare Equities Strategist, Jared Holz, having calculated that J&J has written down around $10 billion in market value over the past year alone, one has to ask whether less financial damage would be incurred by settling claims as quickly as possible than by hoping to succeed at trial (which, admittedly, they often are)?

That being said, Johnson’s Baby Powder remains a core brand for the company, despite sales accounting for only a small fraction of J&J’s annual revenue. Could J&J afford the inevitable damage to goodwill caused by ‘throwing the towel in’?

 

[i] Ernie Knewitz, ‘Johnson & Johnson Consumer Inc. to Voluntarily Recall A Single Lot of Johnson’s Baby Powder in The United States’ (18 October 2019 Johnson & Johnson) <https://www.jnj.com/johnson-johnson-consumer-inc-to-voluntarily-recall-a-single-lot-of-johnsons-baby-powder-in-the-united-states> accessed 24 October 2019.

[ii] Riley Griffin and Jef Feeley, ‘J&J Recalls Lot of Baby Powder After Asbestos Trace Found’ (18 October 2019 Bloomberg) <https://www.bloomberg.com/news/articles/2019-10-18/j-j-recalls-single-lot-of-baby-powder-after-asbestos-trace-found> accessed 5 November 2019.

Julie Steenhuysen and Lisa Girion, ‘J&J recalls 33,000 bottles of baby powder as FDA finds asbestos in sample’ (18 October 2019 Reuters) <https://www.reuters.com/article/us-johnson-johnson-talc/jj-to-recall-single-lot-of-baby-powder-as-fda-finds-traces-of-asbestos-idUSKBN1WX1L3> accessed 1 November 2019.

[iii] Tiffany Hsu and Roni Caryn Rabin, ‘Johnson & Johnson Recalls Baby Powder Over Asbestos Worry’ (18 October 2019 New York Times) <https://www.nytimes.com/2019/10/18/business/johnson-johnson-baby-powder-recall.html> accessed 24 October 2019.

[iv] Daniel King, ‘Major Retailers Pull J&J Baby Powder After FDA Finds Asbestos’ (25 October 2019 Asbestos) <https://www.asbestos.com/news/2019/10/25/johnson-johnson-baby-powder-recall/> accessed 1 November 2019.

[v] US baby powder recall after authorities discover asbestos trace’ (18 October 2019 The Irish Times) <https://www.irishtimes.com/business/manufacturing/us-baby-powder-recall-after-authorities-discover-asbestos-trace-1.4055562> accessed 25 October 2019.

[vi] ‘Asbestos discovery triggers Johnson & Johnson baby powder recall in US’ (18 October 2019 BBC) <https://www.bbc.co.uk/news/business-50101758> accessed 25 October 2019.

[vii] Owen Dyer, Johnson & Johnson recalls its Baby Powder after FDA finds asbestos in sample BMJ 2019;367:l6118 <https://www.bmj.com/content/367/bmj.l6118> accessed 25 October 2019.

[viii] REUTERS, ‘Johnson & Johnson claims the same baby powder bottle the FDA found asbestos in tested NEGATIVE in 15 new tests - but US regulators stand by their results that triggered a national recall’ (29 October 2019 The Daily Mail) <https://www.dailymail.co.uk/health/article-7627663/Johnson-Johnson-says-new-tests-no-asbestos-FDA-tested-baby-powder.html> accessed 1 November 2019.

[ix] ‘Johnson & Johnson Says New Tests Find No Asbestos in Recalled Baby Powder’ (30 October 2019 TIME) <https://time.com/5713708/asbestos-baby-powder/> accessed 5 November 2019.

[x] ‘Talcum powder and ovarian cancer’ (29 September 2008 NHS) <https://www.nhs.uk/news/cancer/talcum-powder-and-ovarian-cancer/> accessed 7 November 2019.

[xi] Moline J et al., Mesothelioma Associated with the Use of Cosmetic Talc. J Occup Environ Med. 2019 Oct 10. <https://insights.ovid.com/crossref?an=00043764-900000000-98349> accessed 25 October 2019.

[xii] Jamie Ducharme, ‘A New Study Suggests Tainted Talcum Powder Can Cause a Rare Cancer. Here's How That Could Play Out in the Courtroom’ (16 October TIME) <https://time.com/5692129/talcum-powder-mesothelioma/> accessed 8 October 2019.

[xiii] Peter Wells and Hannah Kuchler, ‘J&J recalls batch of baby powder after FDA finds asbestos’ (18 October 2019 Financial Times) <https://www.ft.com/content/03e99cd6-f1a9-11e9-ad1e-4367d8281195m> accessed 24 October 2019.

[xiv] ‘J&J Cleared By Calif. Jury In Talc Cancer Retrial’ (9 October 2019 Law 360) <https://www.law360.com/articles/1208121/j-j-cleared-by-calif-jury-in-talc-cancer-retrial> accessed 8 November 2019.

‘J&J Wins Second Asbestos-In-Talc Trial In A Week’ (11 October 2019 Law 360) <https://www.law360.com/articles/1208998/j-j-wins-second-asbestos-in-talc-trial-in-a-week> accessed 8 November 2019.

Carl O’Donnell, ‘Missouri appeals court overturns $110 million Johnson & Johnson talc verdict’ (15 October 2019 Reuters) <https://uk.reuters.com/article/us-johnson-johnson-appeal/missouri-appeals-court-overturns-110-million-johnson-johnson-talc-verdict-idUKKBN1WU2NT> accessed 8 November 2019.

[xv] Pui Fong, et al., v. Johnson & Johnson, case number BC675449, in Los Angeles County Superior Court.

[xvi] Terri Oppenheimer, ‘48-Year-Old California Woman Blames Her Mesothelioma on Johnson & Johnson’s Baby Powder’ (29 October 2019 Mesothelioma.net) <https://mesothelioma.net/mesothelioma-news/48-year-old-california-woman-blames-her-mesothelioma-on-johnson-johnsons-baby-powder/> accessed 1 November 2019.

[xvii] David Siegel, ‘Latest Johnson & Johnson Talc Powder/Mesothelioma Trial Begins In Los Angeles’ (25 October 2019 CVN) <https://blog.cvn.com/latest-johnson-johnson-talc-powder/mesothelioma-begins-in-los-angeles> accessed 1 November 2019.

[xviii] UK citizens bringing legal claims in the US relating to possible asbestos exposure through talcum powder’ (21 October 2019 Leigh Day) <https://www.leighday.co.uk/News/2019/October-2019/UK-citizens-bringing-legal-claims-in-the-US-relati> accessed 23 October 2019.

[xix] Chad Terhune, Lisa Girion, Mike Spector, ‘Johnson & Johnson CEO testified Baby Powder was safe 13 days before FDA bombshell’ (22 October 2019 Reuters) <https://www.reuters.com/article/us-johnson-johnson-talc-ceo-insight/johnson-johnson-ceo-testified-baby-powder-was-safe-13-days-before-fda-bombshell-idUSKBN1X12GF> accessed 5 November 2019.