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Warranties on Medical Devices: Are You Covered?

Fasken
Reading Time 30 minute read Reading Level Level 1
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Despite new drugs, biological products and medical devices having saved lives of thousands, while also dramatically improving the quality of life for tens of thousands more, the industries involved in their manufacture have been the target of some of the largest and most costly products liability actions.[1]

 

The possibility of a products liability suit is playing an increasingly large role in product development, product design, product manufacturing, and product marketing decisions.[2]

 

It has become one of the fastest growing and most economically significant applications of tort law in the United States. Product liability actions against pharmaceutical companies are among the most widely publicized classes of suits in the US and Europe, promoting pharmaceutical companies to lobby vigorously for tort reform.[3] The environment in South Africa is no different.

 

The Regulatory and Compliance framework within the South African Legal sphere has seen some dramatic and much needed changes to include a more holistic approach to how medicines, medical devices and In Vitro Diagnostics (IVDs) are regulated.[4]

 

This article aims to explore the South African legislative context with regards to product liability, the need for formal regulatory requirements relating to warranties and the way forward in ensuring patient safety whilst also giving pharmaceutical companies the means to develop, test and produce products which can alleviate the severe burden of disease through access to essential medicines, medical devices and IVDs for those who need it most.

 

The aim with this review of current Regulatory requirements is to ultimately achieve an outcome where positive and feasible suggestions are made in order to assist the South African Health Products Regulatory Authority (SAHPRA) to address some of the identified potential problematic areas within the Regulatory framework as it currently stands.

 

Creative and innovative processes are required to treat medical devices and IVDs as products with a unique product liability regime. Within this boundary, the discussion will identify the areas in which further debate must take place.[5]

 

One of these approaches is the potential inclusion of specified warranties for specific categories of medical devices.

 

What is a warranty?

 

LAWSA define a warranty as being a “contractual undertaking by a debtor that a certain fact relating to his or her performance is or will be as it is stated or promised to be”[6].

 

According to the ordinary dictionary definition, a warranty (or guarantee) is an undertaking by one of the parties to a contract, breach of which entitles the innocent party to damages but not to terminate the contract. In an insurance contract, a warranty is a promise by the insured party that certain statements are true or that certain conditions will be fulfilled. In commercial transactions involving goods and services, a warranty is a manufacturer’s written promise as to the extent to which defective goods will be repaired, replaced or returned.[7]

 

In this regard, it is a material fact that contracts for the supply of products typically contain warranties as to the quality and attributes of the product.

 

Warranties are dealt with in terms of product liability generally in the South African law of sale under the aedilitian remedies. A seller is liable to a purchaser for any latent defects which make the product or subject matter of the sale unfit or partially unfit for the purpose for which it was intended to be used.[8]

 

In the Mine Health and Safety space, Section 21(1) of the Mine Health and Safety Act (“MHSA”) place a positive duty on Manufacturers to ensure that any article used at a mine must be safe and without risk and that the article complies with all requirements set out in the Act.  This duty includes creating and developing steps, procedures and measures to ensure the article is safe for its intended use.

 

Such steps need to be outlined and described in detail in order to avoid manufacturers being held liable for breach of this Section. Should such a breach be proven, they could face penalties and/or imprisonment. This duty is one relating to the safety and health of the user, and not the commercial lifespan of the device.

 

In the medical device and IVDs Regulations[9] there are many requirements set out for the labelling, advertising and instructions for use as well as the specifics surrounding the area where such label and instructions for use must be placed either on the medical device and IVD itself, or the packaging in which it is contained (including the combination devices where a medicine cartridge is included in the pack for example).

 

There is however no specific regulation which set out any requirements or information relating to warranties for medical devices and IVDs.

 

General application of Warranties

 

In recent years, pharmaceutical companies have faced increased litigation from overseas claimants as a result of the international differences in product liability laws that make them easier targets in the US. Such differences include, but are not limited to, the absence of discovery mechanisms, jury trials (in the US), legal contingency fees and variations in the learned intermediary doctrines in many foreign jurisdictions. This includes the unique legislative framework in South Africa and Africa.

 

The Consumer Protection Act (“CPA”) is the legislative instrument governing liability in respect of defective or unsafe goods and general consumer protection.[10] Product liability claims involve the recovery of damages relating to harm whether property damage or personal injury which is caused by a defective product.[11]

 

While many other countries adopted the concept of strict liability for harm caused by defective products quite some time ago, until the enactment of the CPA, claimants seeking damages for harm caused by defective products under the law of delict in South Africa had to prove that the producer of the products was at fault in some way.

 

As will be seen later on in our discussion, a well drafted and carefully thought out warranty may save manufacturers from unnecessary litigation and may also prevent recalls on their products.

 

Generally speaking, there are only four instances when a consumer can return goods under the CPA which will briefly be discussed.

 

  1. In terms of section 16 of the CPA, if a consumer has bought goods as a result of direct marketing, then for a period of 5 days after receiving the goods, the consumer can return the goods, cancel the entire contract without penalty or receive a full refund.
  2. In terms of section 20 (read with section 19) of the CPA, if a consumer has not had the opportunity to examine or inspect the actual goods received before purchase, they are entitled to inspect the goods on delivery. If on this initial inspection they find that the goods do not meet the ‘type’ or ‘quality’ they could reasonably expect from the agreement or if the goods where made in terms of a special or ‘custom’ order, and they goods do not reasonably conform to the specifications of the order, then the consumer can either refuse delivery, receive a full refund or the consumer can cancel without penalty.
  3. In terms of section 55(3) (read with section 20) of the CPA, if a consumer informs a supplier that the goods are being bought to fulfil a particular purpose, and the supplier advises that the goods will meet this particular purpose then 10 days after receiving the goods the consumer can return the goods if it is not suitable for the particular purpose or the consumer can cancel without penalty.
  4. The supplier will have to pay the costs to return the goods. It is important to note that despite the above, the consumer is not entitled to return goods for any of the above reasons (1)-(3) if: regulation prohibits the return of those goods to a supplier once they have been supplied to a consumer (for reasons of public health or public), or after having been supplied to a consumer, the goods have been partially or entirely disassembled, altered, added or combined with other goods or property.

 

Implied terms may either be implied ex lege or implied from the facts as tacit terms of the contract. The tacit term derives from the common intention of the parties, as inferred from the express terms of the contract, the circumstances surrounding the conclusion of the contract and the subsequent conduct of the parties[12].

 

In terms of section56 (read with section 55) of the CPA, all goods sold to a consumer are sold with an implied warranty of quality, that cannot be contracted out of or revoked. The warranty gives the consumer the right to receive goods that are reasonably suitable for the purpose that they are intended to be used for, are of good quality, free of defects and in good working order and will be durable and usable for a reasonable period of time.

 

If goods are found not to comply with these requirements then, for up to 6 months after receiving the goods, the consumer can return the goods, get the goods replaced or repaired.

 

Potential value of the use of warranties in Medical Devices

 

The World Health Organization (“WHO”) has defined a medical device to be an article, instrument, apparatus or machine that is 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.[13] Medical devices can range from the simplest tools, such as a tongue depressor or bandage, to highly complex machines, such as implanted insulin pumps and Neurostimulators.[14]

 

In our view, the purpose of warranties from a manufacturer’s point of view would be to limit the risk and liability if their products were to fail (although as the manufacturer there is only so much liability one can avoid, it cannot legally be avoided in its entirety).

 

Medical devices play a crucial role in management of modern healthcare needs and with the advancement of technology an increasing number of medical devices are introduced to the market more frequently every year.

 

Impact on medical devices and IVDs from a Regulatory and Compliance perspective

 

When reviewing Section 55 of the CPA from a medical device and IVD perspective, the following areas are potentially problematic:

 

1.  The goods that every consumer is entitled to receive must be reasonably suitable for the intended purpose of the product[15]

 

In cases where a consumer make use of a product in a manner not suitable for the intended purpose, risk is present that there may be failure in the functioning of the product or that the end-user/patient may incur injury as a result or in severe cases, even death. It is an impossible task to expect manufacturing companies, especially with regards to medical devices and IVDs to keep track and or take to task consumers who use their product in any manner not intended.  Sometimes there are two instructions, one from the manufacturer and one from the Doctor/Surgeon. This create confusion with patients when liability claims are instituted in cases where problems arise either after an implantation procedure of a medical device or with the device itself.

 

The unfortunate result of this grey area is that many consumers do not use the product in accordance with the intended use and the moment damage or injury occurs, a legal claim is instituted against the manufacturing company, despite the onus for responsible use being placed on the consumer. Intended purpose does not automatically translate into responsible use and a guarantee does not create a 100% failsafe protection mechanism for any product, but it sets clear boundaries on where each party’s responsibility and liability begins and ends. The difficulty with the CPA is that the liability will in most cases rest with the manufacturer however with medical devices it is not as clear cut.

 

2. The goods must be of good quality, in working order and free of any defects[16]

 

In the current Regulatory environment, there are no specific requirements on how manufacturers of medical devices and IVDs are to prove that this requirement in terms of the CPA has been met. Accordingly, any standard may be imposed by manufacturers, which could potentially fall short of the required standard and leave consumers in a compromising situation. Although the Regulations have conformity assessments, this only relates to the registration of the device and not to the actual use.

 

With information currently available, it appears no warranty on any medical device or IVDs is currently required in terms of the Medicines and Related Substances Act[17] (The “Medicines Act”). SAHPRA has requirements with regards to essential principles of safety and performance, but without specific requirements and guidelines on the inclusion of a warranty, there are bound to be non-adherence to the CPA as a result of the vague circumstances in which the manufacturers are required to place their products on the market. As alluded to, the application of only the CPA on Medical Devices and IVDs may not be ideal. SAHPRA has the perfect opportunity to set out a detailed framework through which the aspects of the products in so far it relates to reliability and safety, is addressed and done in such a manner that leaves no room for own interpretation and subsequent non-adherence.

 

A conformity assessment is required by SAHPRA, the details of which are contained in an official Guideline document.[18] The reasoning being that the medical device or IVD would comply with the above requirement in the CPA, if it has also passed the conformity assessment. This however still provides no indication on the warranty aspect which is essential in providing the consumer with some form of guidance on reliability prior to making the decision to buy the product after it has been registered and approved.

 

A warranty is ultimately used to enable the product to be sold with clear indication for use and period of validity i.e. for the lifetime of the device. Essentially a warranty should be present to prevent injury or harm to the consumer who buys the product, more so in the case of medical devices and IVDS, where some medical devices are implanted into the consumer for an extended period of time – in these instances, the period for which the device is deemed to be able to function properly and provide the required result, must be included in the warranty.

 

Understandably, reluctance may be present with specific devices, since each person’s body react differently to any medical treatment and implanting of medical devices and returning the device is not always an option, because revision surgeries aren’t always the best option. In this regard, most warranties speak to normal wear and tear under normal conditions – there is however nothing “normal “or “typical “when  one considers the inside of the human body. In terms of Section 55(5(a)[19] It is irrelevant whether a product failure or defect was latent or patent or whether it could have been detected by a consumer before taking delivery.

 

3. The goods must comply with the applicable standards under the Standards Act[20]

 

The Standards Act provide for the requirements for the determination of the National Standards relating to the quality of any products sold to a consumer in South Africa. It gives rise and authority to the South African Bureau of Standards (“SABS”) which has as its objective to;-

 

Develop, promote and maintain South African National Standards;

Promote quality in connection with commodities, products and services; and

Render conformity assessment services and maters connected therewith.

 

Despite this strict regulation for safety and reliability purposes, the absence of a formal warranty document providing a guarantee for this very purpose, indicate an area of weakness in how the reliability and safety of medical devices and IVDs are regulated. This is what SAHPRA should address on an urgent basis.

 

Though this requirement links with the Conformity Assessment SAHPRA requires for medical devices and IVDS which are imported and distributed in South Africa, it does not provide any information on the provision of a guarantee in any form, so what recourse do consumers actually have? Manufacturers, importers/exporters and distributors are left without any set guideline on whether or not to provide a guarantee, if they do provide it, what format it must be in and what the duration of such guarantee must be. From research into other jurisdictions, it appears that they too, are silent on these standards. With no set indication being provided, the risk for manufacturing companies increase dramatically as they are left vulnerable to litigation based on the consumer’s right to an implied warranty which may not even be applicable to the specific product on the market. This is a double edged sword. The uncertainty regarding the inclusion of a warranty has already created irregular practices and inconsistency in how products are marketed and sold in the different countries globally. The requirements in the different countries for warranties to be provided for different medical and other devices, create room for error when a manufacturer is packaging their product – it is one thing to have to adhere to different rules and regulation in different countries, but not having any guideline on how to proceed, allows companies to make it up as they go along, which is dangerous.

 

Such warranties have not been included in the South African Life Sciences and Health Industry, and perhaps this would be a blue print for all countries to follow. SAHPRA has the potential to be on the cusp of being a pioneer in this regard.

 

4. The goods will be useable and durable for a reasonable period of time, having regard to normal use[21]

 

The requirement in the CPA for the goods to be useable for a “reasonable period of time” is vague and ambiguous. Risk is created for manufacturers of medical devices and IVDs since what is a reasonable period of time for one specific medical device or IVD, may not be the case for another. Every medical device and/or IVD would have its own risks associated with for example the implanting procedure, usage of the device and anatomical and physiological reactions to the medical device or IVD. Therefore, the requirement under the CPA for a reasonable period of time will not be sufficient. A set guideline with detailed information and rules which provide guidance to manufacturers regarding the provision or a guarantee, the format it should be in and how the guarantee (being a warranty) must read in order for a specific group of medical devices or IVDs to be adequately marketed and sold, is a necessity, not a choice.

 

Risk is created by the lack of clear guidelines, not only for the manufacturer, but also for the consumer who make decisions to make use of medical devices and IVDs without knowing what the confirmed period of reliability of use for the relevant medical device or IVD is. A warranty which provides the guarantee of workmanship, safety and efficacy places the consumer in a position to make an informed decision on whether or not they want to take the risk of using the medical device or IVD, depending on the period the manufacturer indicates the product will be viable and functional.

 

5. The goods are reasonably suitable for a specific purpose that the consumer has indicated to the supplier[22]

 

The potential problem in this section relate directly to what the consumer’s understanding is of the product they are acquiring. The risk involved in this approach is massive considering that medical devices and IVDs are medical products, developed by medically trained personnel, whether medical practitioners doing research or scientists – a consumer without a higher level of understanding regarding a specialized medical device for example, will not be able to indicate to the supplier whether the goods are reasonably suitable for its purpose.   

 

A warranty will cover the pitfall between the consumer’s understanding and the manufacturer’s responsibility when it comes to the risk and liability in cases where there are problems present and damage to the product or injury to the consumer occurs. The consumer should not be given the responsibility and authority to indicate to the supplier whether or not the goods suit the purpose, as they do not have the relevant knowledge to make such a determination. It is extremely prejudicial to expect a consumer to bear this responsibility.

 

All information consumers receive, is contained in the package inserts, which information is detailed in the Regulations for medicines[23] and medical devices and IVDs.[24] In the current environment, the consumer is also covered by an implied warranty of quality, but this is not formally linked with or speaks to the full extent of liability where  medical devices and IVDs are concerned – the room for interpretation and application of this implied warranty on the medical devices and IVDs industry, create a scenario where no guideline or set requirement encourages a “free for all” mentality when something does go wrong in the implanting, usage or reliability of the medical product. The specific purpose of a medical device and/or IVD is determined by the manufacturer of the product through thorough and formal research processes and procedures and then by the medical practitioner who is responsible and in charge of the consumer (patient’s) care – this determination of suitability is not at all for the patient, though the general rule regarding implied warranty places that authority directly in the consumer’s hands.

 

There are many different ways in which the absence of a required warranty create a basis for products with questionable viability for purposes of use may enter the market due to no set principles guiding the manner in which the period of confirmed usage and reliability is recorded.

 

Approach by Foreign Regulators

The United States Food and Drug Administration (FDA)

 

The FDA pervasively regulates drug, biological and medical device companies. The Federal Trade Commission also regulates certain aspects of the health care industry, particularly the advertising of over-the-counter drugs and medical devices[25].

 

In so far the FDA’s requirements are concerned, express information or rules about warranties are absent. Safety and efficacy of the product, whether a medicine, medical device or IVD, is however required and must be proved by means of tests and substantial results and information which must be provided to the FDA prior to the product being considered for approval and market authorization.

 

General Device labelling provisions differentiate between non-prescription and prescription devices[26] and required information include the indication for use, principal intended action of the device as well as the name of the device are among the requirements, which do not differ from what is required in terms of South African regulations regarding labelling of medicines, medical devices and IVDs.

 

The Regulations on labelling of medical devices state that:

“labelling is very important to medical device firms because there is often a direct relationship between device misuse and the labelling, especially in the directions for use. In many cases the labelling may meet the requirements of the regulations,; but is may fail to fully take into consideration the user needs , possible uses other than that indicated, or other factors that may contribute to misuse of the device.”

 

Last mentioned is clearly indicative that not only is a manufacturer expected to take responsibility for the manufacture of the product and ensuring that there are no defects or other mechanical issues, but they are also expected to carry the burden of ensuring the patient uses the product correctly and in line with the intended use.Surely a limitation to liability must exist. The absence thereof would suggest that the manufacturer of any product is automatically responsible for misuse of the product or situations where patients do not understand the indication for use of the product.The scale is tipped heavily in one direction and unfairly so.

 

SwissMedic

 

In Switzerland product liability is governed mainly by the Product Liability Act (PLA), contract law, general tort law and criminal law.[27]

 

According to Article 5(1) of the Therapeutic Products Act, the manufacture of medicines (but not medical devices) is subject to prior authorisation by the Federal Agency for Therapeutic Products (Swissmedic).[28] Swiss law does not provide for a specific liability system in relation to persons injured by medicines or medical devices. Instead, the general liability regime, including both contractual and non-contractual liability (including the manufacturer’s liability) applies. In respect to injuries suffered in connection with medical treatment at public hospitals, cantonal state liability rules apply.[29]

 

Although Switzerland is not a Member State of the European Union, its product liability and product safety legislation to a large extent implements EU legislation. The PLA is based on Directive 85/374/EEC on liability for defective products.[30]Therefore, in addition to the rules of the PLA, the rules of the Swiss Code of Obligations (CO) on contract and tort law can still apply if a product is defective. A claim may be based on different legal grounds. Furthermore, a person responsible for a defective product can be subject to criminal liability.[31]

 

In this regard Article 10(2) of the Ordinance[32] prohibits any advertisement which could “give the impression that the medical product guarantees success in the treatment of disease”.

A producer is liable if a defective product leads to the death or injury of a person, or damage to, or destruction of, property for private use.[33]The Swiss Agency for Therapeutic Products (Swissmedic) is the competent authority in the field of the safety of medicinal products and medical devices. The Act on Therapeutic Products vests Swissmedic with broad competence for ensuring the safety of these products.[34]

 

It appears that several different authorities are competent in the field of product safety in Switzerland and as a result it is often not entirely clear for either manufacturer or distributor which agency has to be notified in the event of product defects or which agency is authorised to enforce legal rules on product safety.

 

Poland

 

In addition to the Act on Medical devices[35], Poland has special rules and regulations regulating pharmaceutical products and devices. There is also the Reimbursement scheme in Poland[36]. Reimbursement eligibility depends on the medicine in question i.e. a medicine is considered either reimbursable (its expenses are fully or partially paid for by a public payer) or non-reimbursable.[37] The main aims of the Act were to rationalize the reimbursement policy and to reduce spending on reimbursed drugs in order to alleviate budgetary pressures.  Similar to other European countries, Poland operates a public health insurance system except their system seems to incorporate more rigorous regulations of medical devices due to the potential consequences on public health in general.

 

Recently in 2014 As a result of the implementation of Directive 2011/83/EU of the European Parliament and of the Council of October 25, 2011 into Polish law, consumer law in Poland changed significantly. The existing legal solutions were revised and civil law terms were unified. Material changes were made to the provisions relating to the implied warranty for defects and warranties, and among other things, the concepts of "lack of conformity of the goods with the contract" and "commercial warranty" (namely, non-code warranty provisions) were abandoned. The changes relating to warranties have affected the medical devices market, especially as current technology often does not allow products to be repaired - only replaced. In the replacement procedure no new warranty may be provided. It is also impossible to change any existing warranty with terms disadvantageous for the consumer (for example, which provide for a shorter warranty period or make the warranty conditional upon the product’s availability in the warehouse).

 

Businesses are now required to inform patients whether or not any contractual warranty exists before they execute a contract. Such information should be communicated in a way that takes into account patients’ disabilities, whether physical (e.g. a hearing impairment), mental, or psychological. In providing this information the patient’s age should also be taken into account, which means the use of just one information template might not be appropriate. In no event should the disability or any special needs of the patient be grounds for applying different terms for their protection (including warranty protection). This is not explicitly stated in the act, but it is supported by the Directive. Thus, an inconsistency with Polish law arises, as the warranty periods vary. The biggest challenge, however, is faced by the manufacturers of medical devices reimbursed by the National Health Fund (such as hearing aids, underarm crutches, leg prostheses and wheelchairs), as pursuant to reimbursement law a manufacturer’s warranty for a medical device for a minimum warranty period defined by law is mandatory.[38]

 

Based on our research, it seems to be the only country to list a warranty period as a regulatory requirement. As a result of this, there seems to be a clash between the Reimbursement Act and the EU Directive on Product liability.

 

Japan

 

The Pharmaceutical Medical Device Association (“PMDA”) is the Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare (“MHLW”) and they are responsible for providing relief compensation to sufferers from adverse drug reaction and infections by pharmaceuticals or biological products. The Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices of Act No. 145 of August 10, 1960 (PMD Act) deal with the safety and efficacy of pharmaceutical products.

 

Approval of medical devices must contain the following data concerning:

  • The development process and conditions of use in foreign countries, etc, Data concerning verification of design and development.
  • Compliance with the standards prescribed by paragraph 3 of Article 41.Data concerning risk management.
  • Manufacturing methods.
  • Clinical study results or data recognized by the Minister of Health, Labour and Welfare as fungible with respect to the same.
  • The plan for post-marketing investigation prescribed by paragraph 1 of Article 2 in the Ordinance on Standards for Post Marketing Investigation and Studies of Medical Devices (Ordinance of the Ministry of Health, Labour and Welfare No. 38 of 2005).
  • Matters to be included in package inserts, etc.[39]

The data required do not indicate a requirement of warranty in the event of product liability and accordingly does not require the manufacturer or applicant to provide a copy of the warranty or any warranty provisions they wish to utilise. It could be argued here that the PMDA can amend the Act to require applicants to provide a document describing how they would limit liability in the case of a product defect.

 

Canada

 

Neither the common law nor the statutory provisions in the common law provinces in Canada impose any specific obligations in respect of particular products or types of products. There is only a general requirement of reasonableness, i.e. for every person that is found to have a duty of care; the standard is to exercise “reasonable care in the circumstances and nothing more.”[40]

 

However, there are numerous statutes and Regulations that prescribe product standards and requirements for a wide variety of goods, particularly medical devices. Significantly, these standards do not define a seller or manufacturers duty of care for purposes of civil liability. Courts in Canada have long recognized that manufacturers of products that are ingested, consumed, or otherwise placed in the body, and thereby have a great capacity to cause injury to consumers, are subject to a correspondingly high standard of care under the law of negligence.[41] The unavoidable consequence is that this area of law has been and is currently unregulated.

 

The European Union

 

Across the European Union medicines and medical devices are subject to the general product liability rules of the EU member states. An exception applies to Germany[42], to a limited extent, to Spain[43] and Poland whose national laws provide for particularly strict liability regimes that specifically apply to medicines.

 

Within the European Union, the general product liability laws are based on a strict liability regime under the national laws of the member states implementing the EU Product Liability Directive 85/374/EC (“the Directive”). Supplemental fault-based liability systems (negligence) under the national laws of torts of practically all EU member states also apply. Both these liability regimes apply in parallel.

 

The strict product liability rules across all member states can nowadays be described as harmonized if not even as rather homogenous, in particular as the Directive does not allow for substantive deviations. As South Africa relies on medical devices developed by non-EU countries such as China and India,[44] reliance on an EU-dependent regulatory scheme such as the Medical Device Regulation does not make sense from a manufacturer’s point of view.

 

The difficulty faced currently especially from a regulatory point of view is that medical device regulation and product liability rules have ineffectively attempted to address both the individual goal of compensation and the social goals of deterrence, punishment and protection. Realignment of the responsibilities of regulation and product liability will lead to a better interaction between the desired goals and the processes by which they can be achieved.

 

Proposed Solutions

 

  1. Consumers often purchase many devices without the knowledge that they are in fact purchasing a medical device – the difference between Medical devices and other general commercial products should be included in how the product is advertised – this will allow consumers to be aware of the nature of medical devices and the unique nature of their composition.
  2. Preventing off-label use by means of exclusionary warranties which restrict liability to manufacturer of the medical device - the government has to make provision for health care in its annual budget, any policies or regulations that affect medical devices ultimately affect public and private health care regimes. The cost of medical care is significantly affected by the cost of medical devices and more so by the cost of litigation relating to defected or off-label use of medical devices.
  3. In the event that off-label use is approved by SAHPRA in specific and controlled circumstances, there should be specific warranties that apply.
  4. Compile set guidelines on proposed warranties for different classes of medical devices and IVDs. The higher the risk, the more specific, clear and strict the warranty - SAHPRA exist for this very purpose. To protect the public by means of thorough Regulation of the Industry in order to ensure safety and efficacy of any medicine, medical device or IVD placed on the market for use by the public.
  5. National insurance for medical devices, which operate the same way as insurance for movable property. The Insurance will cover malfunctions in the medical devices and indemnify manufacturers from any potential product liability claims. Suppliers/Doctors or even Retailers are covered through payment of a premium. Only certain classes of medical devices would require the insurance i.e. it won’t be mandatory for medical devices and IVDs in the low risk category.
  6. Self-service warranty application or programme which assists manufacturers in tailoring their warranty based on the classification of their medical device.


Conclusion


After initial investigation indicated that the South African legislative structure for regulation of Medicines, Medical Devices and IVDs do not have specific requirements for Warranties, comparative research was done in so far this requirement relates to the regulations in this regard in other jurisdictions globally. The findings support the current notion that there seem to be no minimum standard rules for what Warranties for Medical Devices should entail globally. Although most (if not all) jurisdictions have a separate regulatory framework for the registration of medical devices, there seem to be no rules or regulations concerning warranties for medical devices.


The question then presents itself as to whether South Africa should adopt the policies expressed in the EU Directives and the system that is currently in place. We are of the view that when dealing with health care and access to essential medicines and medical devices especially, there is certainly not a one size fits all model. Due to South Africa’s unique socio-economic environment, it may not be advisable for South Africa to form its regulatory environment congruently with the EU.


South Africa’s social and political climate differs substantially from the EU and although South Africa is seen as Africa’s most developed country it is still seen as a third world country. Adopting first world policies for third world countries may not be suitable. It means that SAHPRA is tasked with looking at innovative ways to regulate health care in an equitable manner that balances the rights of the manufacturers and producers of medicinal products and devices as well as those in need of health care.


Ignoring the interface between medical devices and medical care is short-sighted and, in the long run, may reduce innovation and be destructive to values of access to health care and equity among citizens.[45]

 

Martha Smit was supported by candidate attorney, Daniel Mwale, in the compiling of this article.

 

Disclaimer

All information contained in this article is based on information available at the time of going to print. We reserve the right to update and/or change the document should new information and legislation become available which change or affect the content of the article in any way. Research on International legislation was done extensively and only sections of it could be included for purposes of this article.



[1] Washington Post at E1 (Apr. 17, 1986). Hundreds of complaints have also been filed against the manufacturers of DES and birth control pills. For example, over three hundred thousand women have filed claims with the BANKRUPTCY COURT AGAINST a.h.Robins, manufacturer of the Dalkon Shield.

[2] Ibid. See also Product Liability, Research and Development, and Innovation  by W. Kip Viscusi and Michael J. Moore Journal of Political Economy Vol. 101, No. 1 (Feb., 1993), pp. 161-18; Food And Drug Administration Regulation And Products Liability: Strong Sword, Weak Shield  by Jeffrey N. Gibbs and Bruce F. Mackler Tort & Insurance Law Journal Vol. 22, No. 2 (Winter 1987), pp. 194-243.

[3] Choi, H.W, Lee, J.H. Principles and Practice of Pharmaceutical Medicine, Third Edtition: Pharmaceutical Product Liability. 2011. Chapter 55, p688-702.

[4] General Regulations and Regulations relating to medical devices and In Vitro Diagnostic Medical device  (IVDS).

[5] Ibid at note 3. 

[6]  LAWSA Vol 5(1) ‘Contract’ para 447.

[7] Oxford Dictionary definition of “Warranty”.

[8] aedilitian remedies  is a Roman Law term which finds application in the law of sale and essentially refers to two types of action; rescission and restitution as well as acceptance and apportionment. See generally Phame (Pty) Ltd v Paizes [1973] 3 All SA 501. 

[9] Regulations relating to Medical devices and IN VITRO  Diagnostic medical devices (IVDs).

[10] Section 61 of the CPA deals with liability for damages caused by goods and can be described as the product liability section.

[11] D & H Piping Systems (Pty) Ltd v Trans Hex Group Ltd and Another 2006 (3) SA 593 (SCA).

[12] Alfred McAlpine & Son (Pty) Ltd v Transvaal Provincial Administration supra 5314; Botha v Coopers & Lybrand 2002 (5) SA 347 (SCA) 360.

[13] See, Medical Device Definitions, WHO www.who.int/medical_devices/defintions/en/ (Aug. 2014).

[14] Ibid.

[15]  Section 55(2)(a) of the CPA.

[16]  Section 55(2)(b) of the CPA.

[17]  Act No 101 of 1965, as amended.

[18] Guideline on Conformity Assessment Procedures for Medical Devices and IVDs.

[19]  Consumer Protection Act, No 68 of 2008.

[20]  Act No 29 of 1993.

[21] Section 55(2)(c) of the CPA.

[22] Section 55(3) of the CPA.

[23]  General Regulations under the Medicines and Related Substances Act.

[24]  Regulations relating to Medical devices and IN VITRO Diagnostic medical devices (IVDs).

[25] U.S Department of Health and Human Services. Public Health Service. Food and Drug Administration. Medical Devices. Labelling: Regulatory Requirements for Medical Devices.1989

[26] Ibid at note 25.

[27] The Law Reviews. The Product Regulation and Liability Review – Edition 5. May 2018. Accessed at

 https://thelawreviews.co.uk/edition/the-product-regulation-and-liability-review-edition-  5/1168822/switzerland on 7/09/2018.

[28] Lexology. Life Sciences: product regulation and liability in Switzerland. 3 September 2018. Accessed at https://www.lexology.com/library/detail.aspx?g=694a971d-46d1-42cd-a326-b731e74b1707 on 5/09/2018.

[29]  Ibid.

[30]  Ibid at note 27.

[31]  Ibid at note 27.

[32] Articles 31 to 33 of the Therapeutic Products Act and Ordinance on Advertising of Medicines. Accessed at  http://www.halmed.hr/fdsak3jnFsk1Kfa/zakoni/Ordinance-on-the-Manner-of-Advertising-Medicinal-Products-43_15-eng_m-25-en.pdf on 7/09/2018.

[33] Product Liability Act based on Directive 85/374/EEC on liability for defective products.

[34] Ibid at note 27.

[35] Medical Devices Act of May 20, 2010, Journal of Laws of June 17, 2010 no.107, item 679 (“Medical Devices Regime”), which implements, inter alia, the amended Council Directive 90/385 and 93/42

[36] The Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional  Uses and Medical Devices.

[38] “Warranty for Medical Devices in Poland” September 2015 by  Baker & McKenzie at  http://ceelm.com/index.php/poland-legal-review/150-poland/3050-warranty-for-medical-devices-in-poland.

[39]  Prescribed in paragraph 1 of Article 63.2 of the Law.

[40] Stewart v Pettie (1995) , 121 D.L.R (4th) 222 (S.C.C).

[41] Hollis v. Dow Corning Corp. [1995] 4 SCR 634 at 655.

[42] In Germany, the Medicines Act of 1976 at section 84 (Arzneimittelgesetz) applies to claims against pharmaceutical manufacturers to the exclusion of the Product Liability Act.

[43] The general regime on liability for defective products or services is established in Royal Legislative Decree (“RLD”) 1/2007, of 16 November, approving the consolidated text of the General Law on the Protection of Consumers and Users and other complementary regulations. Such regime is found in articles 128 to 146, both inclusive, of RLD 1/2007. This decree applies to medical devices equally and there is no exception.

[44] Stewart Eisenhart, New Medical Device Registration Requirements Issued in South Africa, South Africa   medical device QA/RA blog (Dec. 14, 2016) https://www.emergogroup.com/blog/2016/12/new-medical-device-registration-requirements-issued-south-africa.

[45] “Product Liability and Medical Device Regulation: Proposal for Reform” by Susan Bartlett Foote at https://www.ncbi.nlm.nih.gov/books/NBK218294/.

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