Thousands of lawsuits have been filed against Johnson & Johnson, a company known for its baby products, in recent years – but the most well-known one involves 22 women who alleged that their ovarian cancers have been caused by the baby powder they had been using. After the appeal, by the end of which the amount of money the company had to pay those women was reduced from 4.7 billion to 2.1 billion, Johnson & Johnson took legal steps to present the case before the Supreme Court. The Supreme Court has decided not to consider their case, however, which resulted in leaving in place the last verdict of the Missouri appeals-court.

The link between the illness and the product was supposed to be based on the fact that Johnson & Johnson baby powders contained talc. Talc is oftentimes found in close proximity to asbestos, which is carcinogenic, and in the past the talc has been contaminated with asbestos. It is also worth mentioning, that talk on itself is dangerous while inhaled in large doses but the studies aren’t clear on whether or not it’s carcinogenic on itself.

Although Johnson & Johnson denies that their products are dangerous to health, they will no longer be selling the baby powder containing talc in the US and Canada, focusing instead on the corn-starch-based alternative.

Polish Regulations

In Poland, the cosmetic products such as baby powders are regulated by the Act of October 4, 2018 on cosmetic products (Journal of Laws, item 2227) (hereinafter: Polish Act on cosmetic products). The Act is used to apply the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342 22.12.2009, p. 59) (hereinafter: Regulation 1223/2009) in Poland. While defining the cosmetic product, the Polish Act on cosmetic products in art. 2 section 9, makes a reference to art. 2 section 1 letter a of the Regulation 1223/2009, which states that: ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

Regulation 1223/2009 introduces in article 13, among others, the requirement to notify the product in the CPNP (Cosmetic Product Notification Portal).

Annex II of the Regulation 1223/2009 also names asbestos (reference number 762) as a substance prohibited in cosmetic products.

Official notification of the responsible person to CPNP

As mentioned above, article 13 of Regulation 1223/2009 introduces a requirement of notifying the cosmetic product in the CPNP prior to placing it on the market. The notification is made by the person responsible for placing the product on the market (section 1), including the importer. A distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law also has the requirement within the specified range, to notify the European Commission, which keeps the notification portal, on certain pieces of information (section 3 and 4).

Article 4 of the Regulation 1223/2009 specifies who is the responsible person, when the distributor is considered one, and states that the responsible person ensures compliance with the relevant obligations set out in this Regulation – which are specified further in articles 5 and 6. One of them is to ensure that the product is safe for human health when used under normal or reasonably foreseeable conditions of use (article 3 of the Regulation 1223/2009).

Premises of liability and responsible entities

The premises of civil liability for dangerous cosmetic products are regulated in the Act of April 23, 1964, the Civil Code (i.e. Journal of Laws of 2020, item 1740, as amended) (hereinafter: Polish Civil Code). The responsibility for the damages rests in this case on the producer (article 449(1) of the Polish Civil Code) and, in certain cases, on the manufacturer of the material, raw material or component of the product (article 449 (5) section 1), the person claiming to be the producer by placing his name, trademark or other distinguishing sign on the product (section 2), importer (section 2), a person who in the scope of his business has sold a dangerous product (paragraph 3) and to a third party (article 449 (6)). However, the liability of these entities is excluded in certain cases. Article 449(3) states, that (section 1) the producer is not liable for damage caused by a dangerous product, if the product was not placed on the market by him or the product was placed on the market outside the scope of his business and (section 2) the producer is also not responsible when the hazardous properties of the product were revealed after it was placed on the market, unless they resulted from a reason previously inherent in the product. He is also not responsible if it was not possible to predict the dangerous properties of the product, taking into account the state of science and technology at the time of placing the product on the market, or if these properties resulted from the application of legal regulations. The manufacturer of the material, raw material or component of the product is not responsible when the sole cause of the damage was a defective product design or manufacturer’s instructions (article 449(5) section 1). The person who in the scope of his business has sold a dangerous product is not responsible when within one month from the date of notification of the damage, he will indicate to the injured person the person and address of the manufacturer or the person specified in § 2, first sentence [a person claiming to be the manufacturer], and in the case of imported goods – the person and address of the importer (article 449(5) section 4) or when he indicates who sold him the product (section 5). The producer, the person who claims to be the producer, importer and the producer of the material, raw material or component of the product are jointly and severally liable (article 449(5) section 3).

What is important, the liability for the damages caused by the cosmetic product that is a dangerous product cannot be excluded or limited (article 449(9)). This liability [for a dangerous product] also does not exclude the liability for the damages under general terms, for damages resulting from non-performance or improper performance of an obligation and liability under the warranty for defects and quality guarantee (article 449(10)).

The notion of damage is not limited to the person that bought the cosmetic product – article 449(1) section 3 mentions ‘anyone’ who suffered damage. The said article also specifies that the dangerous product is a product that does not guarantee the safety that can be expected, given the normal use of the product. When it comes to the cosmetic products manufactured nowadays, the inclusion of asbestos through a faulty mining of the talc is a situation where the safety is not guaranteed, especially considering the fact that the research done on multiple cosmetic products that included talc showed no signs of asbestos. When it comes to talc itself, as the research on whether or not it is harmful has not yet given a clear answer, it is a part of Annex III of the Regulation 1223/2009 which regulates substances that can be used in cosmetic products with certain restrictions.

Providing the wrong product composition due to defective product registration may also be the main source of compensation; in the case of Johnson & Johnson’s baby powder, it was alleged in court that the company knew that their product contained asbestos. In such a case, there would also be clear grounds for demanding compensation for the damage caused (Article 445 section 1 in conjunction with Article 445 section 1 in conjunction with Article 415 of the Polish Civil Code) or proper pension (Article 444 section 2 and 3 in conjunction with Article 415 of the Polish Civil Code) under general terms.

Sources:

1. The Act of April 23, 1964, the Civil Code (i.e. Journal of Laws of 2020, item 1740, as amended)

2. The Act of October 4, 2018 on cosmetic products (Journal of Laws, item 2227)

3. The Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342 22.12.2009, p. 59)

4. https://www.gov.pl/web/gis/wprowadzanie-produktow-kosmetycznych

5. Supreme Court Won’t Consider Johnson & Johnson Challenge to Baby Powder Judgment  https://www.wsj.com/articles/supreme-court-won-t-consider-johnson-johnson-challenge-to-2-1-billion-judgment-in-baby-powder-case-11622555345

6. US Supreme Court rejects J&J talc cancer case appeal https://www.bbc.com/news/business-57322979   

7. Supreme Court won’t review $2 billion verdict against Johnson & Johnson in talc powder case https://edition.cnn.com/2021/06/01/politics/johnson–johnson-supreme-court-2-billion-verdict/index.html  

8 Cosmetic product notification portal https://ec.europa.eu/growth/sectors/cosmetics/cpnp_en  

Artykuł Cosmetic products and responsibility for a dangerous product on the basis of Polish civil law pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.