The product liability arising due to the use of pharmaceuticals is a very sensitive issue in comparison with any other kind of product liability, since it is directly related to human health. Manufacturers, importers, distributors, warehouses and pharmacies all participate in the marketing and sale of pharmaceuticals, and because the market structure and chain of supply is so complex, and as there is no contractual relationship between the patient and the manufacturer, an injured patient cannot bring an action directly against a pharmaceutical manufacturer based on contractual liability. Due to the absence of any contractual liability, claims arising out of these damages in this respect are remedied on the basis of tort liability or strict liability. Therefore, liability of pharmaceutical manufacturers is rather unclear under Turkish legal doctrine, because no separate piece of legislation or legal provision regulates pharmaceutical product liability.
Generally, a pharmaceutical manufacturer's liability arises if:
- there is a counterfeit medicine;
- this medicine is placed on the market;
- damage results from the use of the medicine; and
- there is a casual link between the use of medicine and the damage resulting from the use of the medicine.
The injured patient should therefore set forth his claims based on the facts stipulated above and initiate legal action on the basis of either the Code of Obligations or Consumer Legislation.
Under Turkish Law, legal issues related to the product liability of a pharmaceutical manufacturer may be covered by Article 41 of the Code of Obligations or Article 4 of the Consumer Protection Law, and the Regulation on Liability for Damages for Defective Products ("Regulation No. 25137"). Injured patients may either claim damages based on either Article 41 of the Code of Obligations or Article 4 of the Consumer Protection Law.
The liability in Article 41 of the Code of Obligations is based on tort, and the pharmaceutical manufacturer will be held liable for the damages occurring due to his fault or negligence. Other than these conditions, the damage should be caused in an unlawful manner, and there should be a reasonable causal link between the damage and use of the medicine. The patient bears the burden of proving that the liability requirements are fulfilled in this type of liability. However, due to the complex nature of pharmaceutical products, it is difficult for the patient to prove that the damage is the result of the manufacturer's fault. According to established precedent, in determining the manufacturer's liability the court will refer to recent developments in science to alleviate the claimant's burden of proof.
Injured patients may also bring claims based on Article 4 of the Consumer Protection Law, which regulates product liability. Liability arising from pharmaceutical products may be covered under general product liability. The type of liability indicated in the Consumer Protection Law is strict liability, which focuses on the product rather than the manufacturer or fault of the manufacturer. While the Consumer Protection Law does not clearly specify the category of liability into which the product liability falls, Regulation No. 25137 states that it is strict liability.
In accordance with Article 4 of the Consumer Protection Law, the consumer is entitled to claim indemnity from the manufacturer-producer in the event that the defective good causes death and/or injury and/or harm to other goods used. However, this article does not clearly mention the strict liability of manufacturers, since it focuses on defective goods.
The Ministry of Industry and Trade has adopted Regulation No. 25137 based on Article 4 of the Consumer Protection Law. Article 6 of Regulation No. 25137 explains the strict liability of the manufacturer thus: "The manufacturer-producer shall indemnify the consumer when the product is defective, even if the manufacturer was not negligent in making that product defective." However, since the Consumer Protection Law serves as the legal basis for Regulation No. 25137, and the legislature may only create a legal sanction by regulation to the extent that it is grounded in a law, Article 6 of Regulation No. 25137 does not provide valid legal grounds for strict liability in product liability. Therefore, the patient again bears the burden of proving the actual damage, the defect in the product, and the causal relationship between defect and damage.
Furthermore, according to Article 7 of Regulation No. 25137, the producer cannot be held liable in certain cases if:
- the product has not been put on the market for sale;
- the product was not manufactured for sale;
- the defect causing the damage was not present at the time the product was put on the market;
- the defect was caused by the technical design of the product; or
- the state of the scientific and technical data at the time the product was put on the market did not allow discovery of such defect.
The injured patient has the right to claim damages for three years. Pursuant to Article 4 of the Consumer Protection Law: "Claims which arise from any damages caused by defective goods are subject to a statute of limitations of three years. Such claims cannot be made after the ten-year period following the day on which the good that caused the damage was launched in the market." However, the question is: who can predict when the side effect of said medicine will be revealed?
Due to its complexity, the legislation in force makes it very difficult for patients to bring certain claims over pharmaceutical product liability. From the patient's perspective, it is the patients' fundamental right to know the legal grounds on which they are entitled to claim damages. The pharmaceutical manufacturers' concern is to foresee the extent to which they are liable, in order to assess their risks and costs. The doctrine strongly suggests that separate legislation regulating product liability should be enacted to resolve this ambiguity.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
