Product liability: how to avoid counterfeit COVID-19 products

Each year, a global operation takes place to tackle the illegal online sale of medicines and medical devices. It involves customs, police, and health regulatory authorities from 90 countries - including the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) - all with the aim to prevent illicit online sales of medicines and medical products.

Recently, the operation has identified a worrying trend of criminals taking advantage of the COVID-19 outbreak by exploiting the high market demand for personal protection and hygiene products. Under the operation:
- Counterfeit face masks and unauthorised antiviral medication were seized.
- More than 34,000 unlicensed and fake products, advertised as “corona spray”, “coronavirus medicines” or, “coronaviruses packages” were seized.
- Globally, 2,000 online advertisements related to COVID-19 were identified.
Variety of counterfeit COVID-19 products

With the ongoing impact of the pandemic, counterfeit products claiming to cure, treat or prevent COVID-19 are still on the rise globally. Such products are wide-ranging and include:
- Fake or expired masks, hand sanitizers and COVID-19 tests
- Herbal remedies and vitamins that claim to cure COVID-19
- Ineffective UV light sanitizer devices claiming to be COVID-19 tests
- Drugs, medical devices, or vaccines
- Teas and essential oils claiming to cure COVID-19.
Given that these deceptive and misleading products have not been evaluated by health regulatory authorities, such as the US Food and Drug Administration (FDA) and the MHRA for their safety and effectiveness, they might be dangerous, seriously harmful and even life-threatening. The ingredients and materials used could cause adverse effects and could potentially interfere with essential medications taken by their users. The fraudulent test kits for COVID-19 could also unknowingly spread COVID-19 or prevent carriers getting appropriate treatment.

Online platforms

During the pandemic, consumers have increasingly turned to online retailers for supplies which they cannot find in stores. In the USA, the FDA has been working with retailers to remove dozens of misleading products online (and from store shelves) and continues to monitor social media and online marketplaces promoting and selling fraudulent COVID-19 products.

In order to ensure the legitimate provenance of pharmaceutical products, online purchasers should:
- Double-check the listing’s URL – if the keywords in the URL are completely unrelated to the product being sold, it is likely to be a fake product.
- Check the shipping time - if this seems overly long from the designated supply jurisdiction, the product may be fake.
- Check if the seller has a low rating or seems relatively new.
- Consider if there is any apparent price-gouging.
- Consider the desirability of the brand as there is a greater risk that its products will be imitated by counterfeiters.
- Be suspicious if there any claims by the product to treat a wide range of diseases.
- Be suspicious of any therapies claimed to be a ‘quick fix’ or a ‘miracle cure’.
- Check if the product has an official CE mark and/or an official UKCA mark.
CE marking – criminal offence and new defence

Criminals that specialise in selling counterfeit products operate without any worry on their accountability. Selling a medical device that does not have a regulatory mark is a criminal offence under the Consumer Protection Act 1987 (the CPA). It is a strict liability offence, which means that a person selling a device with a fake regulatory marking is guilty of an offence even if they did not know that the marking was fake.

However, the Medicines and Medical Act 2021 introduces a ‘defence of due diligence’ into the Medical Devices Regulations 2002. It will be a defence for a person charged with an offence if they can show that they “took all reasonable steps and exercised all due diligence” to avoid committing the offence. In particular, consideration will be given to the steps the defendant took to verify the information and whether the defendant had any reason to mistrust the information.

Comment

Unsafe counterfeit products could present a product liability risk if a consumer suffers an accident or injury. A product liability claim could potentially be made against the innocent manufacturer instead of the counterfeiter. This can result in consequent risks to the manufacturer’s reputation for being associated with defective or deceptive products.

The manufacturer could plead in its defence under the CPA that it was not the producer of the counterfeit product i.e. it did not supply the alleged defective product. However, the manufacturer would need to gather strong supporting evidence, particularly if the counterfeit is a convincing imitation. The manufacturer may, for example, need to instruct experts to prove the difference between the counterfeit product and its own.

As the World Health Organisation advises, manufacturers should work towards preventing, detecting and responding to the risks of falsified medical products. In this regard, it would be wise for manufacturers of COVID-19 products to:
- Review their product lines to identify which products are susceptible to being imitated
- Consider how their products could be made more difficult to imitate
- Improve how to identify their original products via devices such as bar codes
- Monitor internet sales of imitation goods via online retailer websites.