Anna Elizabeth Jacomina Wagener v Pharmacare Ltd

The appellant in the first appeal underwent shoulder surgery at a private hospital. During the surgical procedure, a local anaesthetic called Regibloc Injection (manufactured and marketed by the respondent company) was administered. Following the surgery, the appellant suffered necrosis of the tissues and nerves underlying the site of the operation, and paralysis of the right arm. A virtually identical suit was brought by the appellant in the second appeal, another alleged victim of Regibloc. The appellant sued the respondent manufacturer, alleging that the Regibloc administered was defective and caused the injury. The main claim was based on the allegation that the respondent had a legal duty as manufacturer and that the Regibloc was unsafe for use, resulting in necrosis and paralysis. An alternative claim alleged negligent manufacture. The respondent excepted to the main claim, arguing it disclosed no cause of action as it failed to allege fault and purported to impose strict liability on the manufacturer. The exception was upheld by Fourie AJ, and the appellant appealed with leave.

• Whether a manufacturer can be strictly liable in delict for harm caused by defective manufacture of a product where there is no contractual privity between the manufacturer and the injured person
• Whether the common law remedy (the Aquilian action requiring proof of fault) is adequate to protect the constitutional right to bodily integrity
• Whether the courts should develop the common law to impose strict product liability on manufacturers
• Whether such development should be judicial or legislative

The appeal was dismissed with costs, including the costs of two counsel. The exception to the main claim (based on strict liability) was upheld. The appellant's claim could only proceed on the alternative basis alleging negligent manufacture.

In South African law, a manufacturer is not strictly liable in delict for harm caused by defective products in the absence of contractual privity with the injured person. Liability for such harm requires proof of fault (negligence) in accordance with the principles of the Aquilian action. The extension of strict liability from the contractual warranty context (as in Kroonstad Westelike Boere Ko-operatiewe Vereniging Bpk v Botha) to delictual claims is not permissible because contract and delict are separate branches of law with distinct principles. The imposition of strict product liability, if it is to occur, must be effected by the legislature through comprehensive statutory regulation, not by the courts on a case-by-case basis, because: (1) it would constitute a radical rather than incremental departure from established legal principle; (2) it raises numerous complex questions regarding scope, application, defences, and remedies that require comprehensive investigation and stakeholder consultation; (3) judicial imposition would have retrospective effect on substantive law, creating potential injustice; and (4) the subject requires the type of detailed, comprehensive, and prospective regulation that is properly the function of the legislature. The Aquilian remedy remains adequate to protect the constitutional right to bodily integrity, particularly given the availability and potential for development of res ipsa loquitur and the possibility of reversing the onus of proof regarding negligence in appropriate cases.

The Court made several significant obiter observations: (1) It suggested that the courts may in future develop greater readiness to draw prima facie inferences of negligence in cases of alleged defective manufacture where expert evidence is difficult for plaintiffs to acquire, particularly regarding substances administered to the human body that have effects contrary to the manufacturer's stated aims. (2) The Court indicated that it might be appropriate in future, for reasons of policy, practice and fairness, to place the onus on the manufacturer to disprove negligence (citing National Media v Bogoshi as an example of such onus reversal in defamation). (3) The Court noted that even where a manufacturer shows that a latent defect could not have been detected by reasonable examination, an inference may nevertheless be justified that somebody in the manufacturing process must have been at fault (referring to Grant v Australian Knitting Mills). (4) The Court observed that even under a strict liability regime, a plaintiff would still face significant evidentiary challenges in proving that the product was defective when it left the manufacturer's control, requiring expert evidence and potentially complex scientific analysis. (5) The judgment noted that the manufacture of medicines has been subject to recent extensive statutory regulation without strict liability having been imposed (referring to the Medicines and Related Substances Control Act 101 of 1965 and its replacement by Act 132 of 1998). These observations provide guidance for future development of product liability law within the existing fault-based framework.

This is a landmark decision in South African product liability law. It definitively rejected the judicial imposition of strict liability on manufacturers for defective products, confirming that the Aquilian action requiring proof of fault remains the appropriate remedy. The judgment demonstrates the Constitutional Court's approach to common law development under section 8(3) and 39(2) of the Constitution - development must be incremental and principled, not radical. It establishes clear boundaries between judicial and legislative functions in developing the law, particularly in complex commercial areas requiring comprehensive regulation. The decision has shaped subsequent product liability litigation in South Africa and clarified that any move to strict product liability must come through legislative intervention (as has occurred in other major jurisdictions through statutes like the UK Consumer Protection Act 1987 and the European Product Liability Directive). The judgment also provides important guidance on when res ipsa loquitur may apply in product liability cases and opens the door for incremental development of that doctrine and potentially the reversal of the onus regarding negligence in appropriate circumstances.