In light of some concerns with Covid-19 vaccines, Professor Robert Vivian and Dr Albert Mushai discuss what it takes to classify a product as being defective.

The Covid-19 pandemic is a public health risk of unprecedented proportions. It forced governments to adopt previously unimaginable responses such as locking down economies and prohibiting travel. At the same time, it also put pharmaceutical companies under pressure to develop vaccines within the shortest possible time. To its credit, the pharmaceutical industry responded in a record time and accomplished in months a feat that normally takes years. This was nothing short of remarkable.

We have seen several vaccines against the coronavirus enter the drugs market in recent months, raising hope that the end of the current abnormal way of living is near. However, recently concerns have surfaced about the side effects and by implication safety of the Oxford-AstraZeneca vaccine, one of the first Covid-19 vaccines to enter the market.

Several countries including Ireland, Denmark, Norway, Bulgaria, Iceland, the Netherlands and Germany have announced that they are suspending the use of this vaccine amid concerns that it is associated with blood clots.

At this point, there is no evidence whatsoever that there is a problem with the AstraZeneca vaccine as a product. All the countries that have suspended its use have been quick to point out that their action is only precautionary. Nevertheless, the developments around this vaccine raise an important question – what does it take for a product to be classified as defective? Alternatively, what does defective mean?

The word defective, for purposes of product efficacy, means one of three things. Firstly, a product is defective if it is wrongly manufactured. This is called defective manufacture. In this dimension of defect, the focus is on the manufacturing process.

Secondly, a product is defective if its design is incorrect or defective.

Finally, a product is defective if the producer or manufacturer fails to provide adequate instructions and warnings on how best to use it. This dimension of defect is a failure to warn. This implies that there could be nothing wrong with the manufacture and design of the product. Nevertheless, the product becomes defective because it lands on the market with inadequate instructions for its safe use.

Any one of these three is enough to render a product defective and, by implication, attract possible liability under consumer protection laws of various countries.

The processes and procedures followed before a product lands on the market vary depending on the nature and type of product. Some products undergo a more rigorous process of certification than others.

Vaccines and medical drugs tend to be the most scrutinised before their certification for use by the public. This means that there are various parties involved, from the manufacture and trial of the drug or vaccine to its final authorisation for public use. And things can go wrong at any of the stages in the product-development value chain.

When a product is defective, the question of liability automatically arises. In other words, who should bear the blame for the defect and its consequences. The scope of liability depends on the nature of the product and its intended use. Some products are of limited use. Therefore, a defective agricultural seed variety will produce a different liability profile to a mass-used product such as a vaccine.

In addition, some products move faster in the market compared to others thereby making efforts to contain the damage much harder. Liability for a defective drug, especially one earmarked for mass use like a vaccine against a global virus, is perhaps the most challenging and fearsome. This is because the harm caused by a defective drug could remain latent for a considerable time or its effects could go beyond the actual recipients.

Most countries worldwide have consumer protection statutes that make manufacturers, designers, distributors and marketers of products strictly liable for harm caused by a defective product. This means liability to compensate those harmed by the product requires no proof of fault or negligence.

Strict liability works on the premise that once there is evidence of a defect in the product and the defect is associated with the harm suffered by the consumer, the supplier or producer of the product is duty-bound to compensate the victim.

Harm from a defective product is a subject that no longer falls within the domain of the common law in many countries. The need to protect consumers is the main reason used to justify the use of strict liability in this area. A common feature of the consumer protection legislation seen in many countries is the wide range of potential defendants. More often than not, the consumer can choose from a wide range of parties to sue.

Therefore, the consumer can claim compensation from a distributor as opposed to a manufacturer.

The reason for extending the range of potential defendants is to make it convenient for the injured consumer to claim compensation from a party closest to him/her. Often these defendants are jointly and severally liable to the consumer meaning the consumer can choose to claim full compensation from one (several) or all of them (jointly).

Joint and several liability also cater for situations where several parties could have played a part in the production of a product but it is not clear where actual blame lies for the defect in the product.

In a majority of cases, and certainly in the case of the development and manufacture of a vaccine, the producers tend to operate with products liability insurance. Products liability insurance is a form of third-party liability insurance that protects the insured against losses arising from harm caused by a defect in a product.

Typically, this type of insurance covers bodily injury, death, property damage and consequential caused by a defective product. A defective product can cause different types of harm depending on its type – for example, bodily injury, death, property damage, consequential loss, and product recall costs, where it is necessary or is a legal requirement to remove the product from the market.

With some products, it may be necessary to replace or repair the defective product. Over and above these claims and costs, there may also be fines and penalties payable to regulatory authorities. In most cases, products liability insurance does not cover all these loss types.

Products liability claims can cause serious damage to a firm and its prospects. In fact, there are many examples of firms that failed to recover from the fallout following the release of a defective product onto the market. A critical determinant of the scope of insurance coverage one could get is the market where one looks to buy the insurance. In developed insurance markets, one can get sophisticated insurance products covering a wider range of risk situations that could potentially arise in the process of developing a vaccine. This is most likely to be the case with all the pharmaceutical companies involved in the development of Covid-19 vaccines.

The development of drugs has historically been a rigorous process not prone to result in the distribution of unsafe products. There is no reason to believe that the same rigour was lacking in the development of Covid-19 vaccines. Indeed, it is highly unlikely that the AstraZeneca and other Covid-19 vaccines available so far are defective. In all likelihood, we’re probably just seeing “teething” problems that normally accompany the introduction of a new product in the market. Let’s hope this is the case. The consequences of a vaccine of this nature turning out to be defective are too ghastly to contemplate.

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