Product Liability: Turkey

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An insight about product liability in Turkish Pharma. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for USD 99.

 

53. What types of liability are recognized in your jurisdiction?

Medicinal product liability arises from the Code of Obligations as tort liability and contractual liability, as well as from the Consumer Protection Law.

To claim under tort law, the claimant must prove the existence of an unlawful act, fault by the perpetrator, damage and causal link between the act and damage (Article 49, Code of Obligations).

Contractual liability can arise from a breach of contract (typically concluded between the consumer and the retailer), or from a product defect (Article 219, Code of Obligations).

The Code of Obligations also recognizes the liability of the proprietor or manager of an enterprise exposing imminent danger and of the principal for misconduct by auxiliary persons in the exercise of his duties.

Product liability currently falls under the Regulation on the Liability of Damages Raised from Defective Products. However, if the Draft Code on Product Safety and Technical Regulation enters into force, the conditions will become less strict.

 

54. How do these types of liabilities apply to the manufacturers of medicines and devices?

These types of liabilities apply to the manufacturers of medicines and devices under the Code of Obligations and Consumer Protection Law. Under the Code of Obligations, these types of liabilities can be reflected as tort liability by the lack of contractual relationship between the consumer and the manufacturer. This kind of an action in tort can be based on risk liability where only the manufacturer is liable or on auxiliary person liability where the manufacturer is deemed liable for damages caused by its employees or other auxiliary persons during their employment or business (Article 66, Code of Obligations).

The manufacturer is also liable towards consumers for the repair or exchange of the defective product (Article 11/2, Consumer Protection Law).

If the Draft Code on Product Safety and Technical Regulation comes into force, the product’s manufacturer or importer will be deemed responsible for any loss and damage by product liability.

Physicians can also be pursued through malpractice lawsuits.

 

55. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Potential liability also extends to distributors and retailers. Distributors can have liability towards consumers under the Consumer Protection Law where the distributor/seller fails to deliver the goods in conformity with the agreement (Article 9, Consumer Protection Law). In other words, delivers defective products.

Distributors may also face product liability on other grounds if the Draft Code on Product Safety and Technical Regulation enters into force in its current form.

Retailers can face liability under both contract law and consumer law. The sale contract between the consumer and the retailer prevents consumers from suing manufacturers because of the lack of a direct contractual relationship. Therefore, the consumer can pursue product defect claims, as outlined in the sales contract, or as foreseen under the Code of Obligations (if there is no provision in the contract).

The retailer’s liability continues even if it is unaware of the defects.

 

56. How can a liability claim be brought?

For tort liability claims which includes auxiliary person liability and risk liability, a two-year limitation period applies, beginning from when the claimant becomes aware of both the damage and identity of the person who caused the damage (Article 72, Code of Obligations) and in any case 10 years at most.

A two-year limitation period applies for contractual liability raising from defective products (Article 231, Code of Obligations), unless the seller accepts a longer period. However, if the product was sold with a gross fault, the two-year limitation period does not apply.

Under the Consumer Protection Law, a two-year limitation period applies from the date the consumer received the defective product. However, a longer term can be agreed. No limitation applies if the defect was hidden via gross fault or fraud.

 

57. What defences are available?

Various defences exist against product liability claims. Generally, in those cases, claimants fail to establish causation. Therefore, this is an important point for defendants to focus on. Equally, the statute of limitations often acts as a bar to claimants.

 

 


Click the following links to read more legal articles from Turkey:

  1. Regulatory Pricing and Reimbursement Overview;
  2. Preclinical and Clinical Trial Requirements;
  3. Marketing, Manufacturing, Packaging & Labeling, Advertising;
  4. Traditional Medicines and OTC Products;
  5. Product Liability;
  6. Patents & Trademarks;
  7. Regulatory Reform