Market dynamics and legal implications: analysing product liability in Africa’s medical device sectors

Amala Umeike

Stren & Blan Partners, Lagos

amalaumeike@strenandblan.com

Introduction

In 2022, 5,826 product liability suits were filed in the United States’ federal district court and appellate court with a significant number of the suits being driven by medical and pharmaceutical litigation.[1] Similarly, nations in Africa are witnessing an influx of product liability suits within the pharmaceutical sector. This is prompting them to take urgent and decisive steps to address product liability issues and uphold standards of consumer protection.

The 21st century has so far witnessed unprecedented levels of pharmaceutical innovation, especially with regard to the invention of medical devices. However, while these devices hold immense live-saving potential, they can also cause enormous damage when defective or used incorrectly.

What is product liability?

Product liability is the legal liability a manufacturer or trader incurs for producing or selling a faulty product. The British Institute of International and Comparative Law defines it as the civil liability of manufacturers, suppliers, and other players (eg, distributors and retailers) for personal injury or damage to property caused by a defective product.

The overarching goal of product liability laws is unequivocally consumer protection. Despite the absence of specific legislation addressing product liability in Africa, various laws exist to safeguard the rights of the consumer and to provide recourse in cases involving defective products or services which pose risks of injury or harm.

Product liability and medical devices

The World Health Organization defines a medical device as ‘an article, instrument, apparatus or machine used in the prevention, diagnosis or treatment of illness or diseases, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health purpose.’[2] Without medical devices, medical practitioners would struggle to deliver timely interventions and personalised care, leading to increased illness and mortality rates.

The above notwithstanding, medical devices pose a significant amount of risk to patients if they are defective or malfunctioning. It is therefore clear that the production and introduction of medical devices into the marketplace should be subject to heightened scrutiny compared to other products, given the critical role they play in healthcare.

Legal regimes for medical device liability in Africa

Nigeria

In Nigeria, the Federal Competition and Consumer Protection Act, 2018 (FCCPA) protects consumer rights and fosters fair market practices.[3] It should be noted that the provisions of the FCCPA override the provisions of any other law in matters relating to competition and consumer protection.

Other consumer protection laws include the Standards Organisation of Nigeria Act (SONA), the Sale of Goods Act (SOGA), and the National Agency for Food and Drugs Administration and Control Act (NAFDACA). The NAFDACA provides clear guidelines for the registration of imported medical devices by stating that all medical devices in Nigeria must be registered in accordance with the Act and other related legislation.[4]

All these laws contain relevant provisions to ensure quality standards of medical devices in Nigeria, and also provide standards and warning requirements that a manufacturer must fulfil before its products are permitted access into the Nigerian market. Any breach of such standards may be used to establish product defect.

South Africa

At first glance, the legal framework in South Africa has demonstrated greater efficacy in pursuing product liability claims against manufacturers of faulty medical devices. In 2015, the country implemented significant changes to its regulatory framework for medical devices through the Medicines and Related Substances Amendment Act (Act 14 of 2015). This Act established the South African Health Products Regulatory Authority (SAHPRA) as the central body responsible for overseeing the safety and efficacy of various products, including medical devices. The regulations require manufacturers, importers, and distributors to obtain licences specifically for medical devices, categorised based on the risk level of the device and its intended use. Actions can also be brought against other parties in the supply chain, including distributors and suppliers based on the principles of delict law.

Kenya

In Kenya, the Pharmacy and Poisons Board (PPB), established under the Pharmacy and Poisons Act (Chapter 244), takes on the crucial responsibility of regulating medical devices. Their core focus lies in governing pharmacy practices, trading of drugs, poisons, medical products, and health technologies. Importers of medical devices must obtain certificates of conformity for their cargo through the Kenya Bureau of Standards (KEBS) before applying for import permits from the PPB.

Ethiopia

For Ethiopia, medical device liability is regulated by the Food, Medicine and Healthcare Administration and Control Authority of Ethiopia, which requires manufacturers to demonstrate that the product is fully compliant with essential safety principles.

Angola

Angola has a number of regulations regarding its pharmaceutical industry practices. However, there is no specific regulatory system targeted to address the use of medical devices. This is left to its Ministry of Health, which ensures that imported medical devices meet the required standards.

Mitigating the risk of product liability claims: strategies for medical device manufacturers in Africa

The world has been grappling with a staggering number of medical product liability cases, stemming from concerns of product safety, manufacturer negligence, and defects in medical devices which pose injury to others. Consequently, many medical and global pharmaceutical companies have paid huge amounts in settlements to resolve lawsuits and compensate the individuals affected. In light of these claims, global pharma must take proactive steps to mitigate risks. Some ways in which medical manufacturers can avoid product liability claims include the following:

Legal and regulatory compliance

Medical device manufacturers must remain compliant and up-to-date on relevant laws, regulations, and standards governing product safety and liability in the various jurisdictions they hope to serve. It will be necessary to employ the services of a legal team to ensure that the company is in full adherence to all the legal requirements, and can immediately advise on any upcoming regulatory changes or interpretations that could negatively affect the company.

Compliance audits and due diligence procedures

Medical device manufacturers should conduct regular compliance audits to assess the effectiveness of internal controls and procedures relating to the safety of their products for use. Due diligence reviews of potential business partners, suppliers, and acquisitions to assess their compliance with legal and regulatory requirements is also recommended. Based on the findings of these audits, the company can develop remediation plans which can immediately address deficiencies that could lead to potential risk or liability.

Contractual protections

Medical device manufacturers can avoid risking product liability claims through the execution of contracts with suppliers, distributors, and other parties involved in the supply chain. These contracts can include provisions that allocate responsibility and liability in the event of product defects or injuries, including indemnification clauses, limitations of liability, and warranty disclaimers designed to protect the manufacturer from legal claims.

Defences available to healthcare and pharmaceutical companies to navigate product liability lawsuits effectively

When confronted with product liability suits in Africa, medical device manufacturers may rely on the following defences.

Assertion of product integrity

In the Nigerian case of Boardman v Guinness (Nig) Ltd,[5] the plaintiff attributed food poisoning to the bottle of stout he had consumed earlier, which contained certain sediments. Despite lab findings of bacteria, the court ruled in favour of the manufacturer, citing adherence to internationally recognised brewing standards. Therefore, a company may counter an allegation of product defect by contending that the injury did not arise from any fault in their product, but rather from external factors.

Contributory negligence

The principle of contributory negligence is the first and oldest defence to negligence claims, and can apply in product liability suits. Where the manufacturer can show that the plaintiff’s actions contributed to the harm they suffered by any measure, it will mitigate the company’s liability.

Third-party involvement

If a component or part of the product is sourced from another manufacturer, liability may shift accordingly if the defect is traced to that component. However, this shift necessitates explicit contractual agreements between the primary manufacturer and the third party. Furthermore, if damage is caused by a malicious third party rather than a product defect, the manufacturer may not be held liable, as established in Shell Petroleum Development Company of Nigeria Ltd v Otoko and Ors.[6]

Informed assumption of risk

Companies in a product liability suit can also argue that the consumer(s) knowingly assumed the risk associated with their use of the product. The legal maxim relied on here is volenti non fit injuria, which means ‘to a willing person, it is not a wrong’. Therefore, anyone who knowingly and voluntarily risks using a product that can cause them some harm cannot successfully claim an action for injuries received. This was the case in John Holt v Leonard Ezeafulukwe,[7] where despite warnings and official disposal of spoiled fish, the consumer knowingly selected from the compromised stock, leading the court to reject their claim.

Limitation of action

In a product liability action, the defence of filing beyond the statutory time limit stipulated by the governing statute emerges as a potentially robust legal argument for the party facing the lawsuit. Such issues are considered pivotal by courts in Africa and as such, cases may be dismissed for being statute-barred due to actions initiated beyond the prescribed statutory period. In Nigeria, for instance, the maximum allowable time frame uniformly is six years.[8] Under South African law, claims must be brought within three years.[9] Kenyan law stipulates that claims must be brought within six years.[10]

Conclusion

Advancements in the medical devices industry have revolutionised healthcare, particularly within African markets. However, the potential for such devices to cause harm necessitates stricter regulations and robust legal frameworks. The potential consequences are wide-ranging, from minor disruptions or temporary setbacks in business activities to the extreme outcome of a complete shutdown, often resulting from a court decision. In light of these risks, it becomes imperative for manufacturers to take necessary measures to minimise exposures and effectively manage potential product liability crises. Medical device manufacturers operating within African must also prioritise strict adherence to legal and regulatory requirements, alongside implementing comprehensive quality control measures. This fosters a more robust and secure environment for both manufacturers and consumers within African’s healthcare sector.

In the event of a dispute arising from product liability claims, Alternative Dispute Resolution (ADR) mechanisms have been found to be an invaluable tool in discreetly resolving issues of this nature as they provide a less public platform of dispute resolution. In doing so, businesses can navigate these challenges with a strategic and informed approach, safeguarding their operations and reputation in the face of product liability concerns.