Liability for Defective Pharmaceutical Products in Pakistani Law.

Byline: Muhammad Akbar Khan, Khalil Kundi and Lutfullah Saqib


The products provided to a consumer should be according his expectations and should fulfill, at the same time, the criteria of merchantability quality1. These products are not supposed to harm or cause any injury to the consumers-at any level or at any stage. Although the pharmaceutical companies have made significant progress in the field of pharmaceutical products in recent era, yet, alongside the benefits, there are risks.2 Pharmaceutical products, by their very nature, affect the bio-chemical behavior of consumers' bodies.3Such products often have side effects which cause injuries to the patients and appear after long time, for example, the case of thalidomide.4The pharmaceutical products, therefore, need more strict laws and regulations for the minimizartion of hazardous products. As an ideal situation, such products should be available in the market free of any sort of defect5or danger to health of patients.

As a matter of fact, Pharmaceutical products are more sensitive and susceptible in nature comparatively to the products of common use. This inherent risk causes latent injuries to the consumers, appears after long time-which are most often neither anticipated by the consumer nor known to the manufacturer through available scientific and technological knowledge. There is no compensation scheme prevailing in Pakistan by the pharmaceutical manufacturers to redress the drug induced injuries. These kinds of schemes are maintained in the developed countries under Insurance cover. The drug induced injuries are compensated from the collective fund, financed by the pharmaceutical manufacturers according the market share. This also decreases the volume of the court litigations which save the time of the manufacturer as well as provide compensation to the injured patients quick.

The low literary rate of the society should be considered by the regulatory authority and such kind of legislation be conducted which could provide strict law and regulation for the manufacturers, as well as, the producers of the pharmaceutical products. The standards and scheme, prevailed in the developed countries, regarding the defective pharmaceutical products and the compensation of damages to the drug induced injuries, be embodied in the national legislation. The concept of liability should also be introduced in the pharmaceutical legal regime, which facilitates the inhabitants of the state. An effective and standard legislation would not only facilitate the consumers but also regulate the pharmaceutical manufacturing industry in the right direction.

Meaning of "Liability" in Legal Context

Liability is, indeed, the quality or state of being legally obligated or accountable; legal responsibility to another or to the society-enforceable by civil remedy or criminal punishment.6 Moreover, it (Liability) is the state which arises when an action is not performed in the way it is legally obliged and, failure of which, held the relevant person responsible for the occurrence. Liability is divided into two categories, namely, the remedial and penal liability which are discharged either by the restoration of the plaintiff to its original status or by punishing the wrongdoer.7 The theory of remedial liability is based on the theory that when the law creates a duty it should also enforce its fulfilment, as reflected in the maxim 'ubi jus ibi remedium' , meaning thereby where there is a right there is a duty.8

Criminal liability, on the other hand, is based on the theory that a man is not criminally liable for his conduct unless the prescribed state of the mind is also present. This principle is reflected in the maxim 'actus non facit reum nisi mens sit rea'; meaning thereby that an act does not make a man guilty for crime, unless his mind be also guilty.9 The liability, focused during the instant research, is the remedial liability; however criminal liability of the corporation may also be slightly discussed. The liability, related to the defective pharmaceutical products, is not found in any codified form to the best knowledge of the researchers. Notwithstanding, the principles of the law of Torts are approached in the courts in cases where the drug induced injuries occurred, but often fails to provide adequate remedies to the injured persons as it has very little scope in Pakistan.10

The Concept of Product Liability in Legal Context

Product liability means a manufacturer or seller's tort liability for any damages or injuries, suffered by a buyer or user, as a result of a defective product and other persons.11 Other persons include seller, importer, distributor, authorized dealer and agent, wholesaler, retailer and supplier.12 These intermediaries may be held legally responsible for any defect, fault and negligence13. Generally, the consumer's claims against the pharmaceutical product are based on the principles available under tort law, contract law or under any statutory provision in a particular country. There are three, broadly, legal principles on the basis of which the manufacturer or the producer of the defective product could be held liable for damages, incurred from the use of that product.14 These three principles include Warranty, Negligence and Strict liability. These three principles or any one of them, of course, can be invoked for getting compensation by the aggrieved party.

Contract Regime

Warranty is the principle, available in both tort law and contract law, by which an injured person can claim damages inst the manufacturer, producer or seller. According to this principle, the injured person would demonstrate to the court that the pharmaceutical product was 'unreasonably dangerous as marketed' because the manufacturer has not given the adequate warning of the drug's risk.15 The injured person would have to show that the seller, expressly or impliedly, made representation about the quality of the product that were ultimately false or misleading in nature..16

The Tort Regime

Negligence is the principle of tort, where the producer of the product is under duty to care owed by one party to another; the breach of which will lead to damage to the plaintiff. The plaintiff must also demonstrate the causal connection between the negligence and the damages incurred.17 Before Donoghue v. Stevenson18 there was a doubt whether the transferor holds any liability for the defect in the product in the absence of any contractual relationship but, the instant case, had established, as a precedent, that in the absence of any contractual relationship and irrespective of the reference to any substantive rules, there are circumstances in which a person owes a duty of care in response of products.19 Manufacturer, retailer, distributor and supplier may be liable for damage to the plaintiff under this principle-if they are found to have breached a duty of care.20

The Strict Liability Regime in the Context of Pharmaceuticals

Strict liability is a principle of both tort law and contract law, which provides that a seller of a product is liable without fault for damage, caused by that product if it is sold in a defective condition that is unreasonably dangerous to the user or consumer.21 Thus, strict liability would mean that pharmaceutical companies would have to pay damages in some cases, even when they had impeccably researched their drugs.22There is no need to prove the negligence or warranty on the part of manufacturer for compensation; however it is sufficient to demonstrate that the fault was in the product which caused injury to the user.

Assessment of Liability for Defective Pharmaceutical Products in Developed Countries

The liability for defective pharmaceutical products, in developed countries, is monitored through classifying them into the 'Over the Counter medicinal products' and 'prescription medicinal products'. The liability for defective pharmaceutical products, in various legal regimes, is briefly introduced in this comprehension. The code and the compendium of rules are prevailed in each jurisdiction in order to curtail the defectiveness of the pharmaceutical products, either during manufacturing process or in its distribution or otherwise, inherently in the product. It is aimed that pharmaceutical products, being susceptible in nature, are supposed to be dealt with one degree strict regulations to protect the consumers and patients from the immediate or inherent side effects causing the injuries on spot, as well as, latent injuries in certain other circumstances.

Under English law, defective pharmaceutical products are dealt with a specific law23 which differentiates pharmaceutical products from other products of ordinary use, generally, dealt under the product liability law.24 Different approaches are applied, with regard to prescription and non-prescription pharmaceutical product, in the United Kingdom. The Pharmaceutical Corporation is obliged, for non-prescription or over the counter products, to warn the end users about anticipated contra indications of its product as well as the inherent side effects.25 The pharmaceutical products, dispensed through a prescription, are not subject to this rule, rather there is another rule which is called, 'The Learned Intermediary' rule.26 The pharmaceutical manufacturers arebound, legally, to communicate to the ultimate consumers the warnings and instructions regarding the use of the product, otherwise, the failure would be considered the negligence of the manufacturer.27

This principle was upheld in the case of Vacwell Engineering vs. BDH chemical.28 In this t case, the producer of Boron Tribromide29, a pharmaceutical product, was held liable for committing severe negligence. The producer did not communicate warnings to the consumers, regarding the explosive nature of the said product. The said sides effects and contra indications of the chemical were disclosed in the scientific journals. Hence, it was...

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