The low-down on the situation regarding product liability in Norwegian Pharma. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
Norwegian law recognizes the following types of liability
- Criminal liability, for violation of the Norwegian Penal Code or where criminal liability is stipulated by law (such as the Medicines Act, the Dedical Devices Act)
- Liability for breach of contract
- Liability of for torts, including product liability
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
The Product Liability Act (LOV-1988-12-23-104) sets out a strict (no-fault) liability regime for defect products in Norway.
Pursuant to section 2-1 the manufacturer is liable for damages caused by its defective products. A product is defective if when it does not offer the level of safety that a person is entitled to expect, when taking into account inter alia the way the product is marketed, its manifest characteristics, instructions of use, warnings and reasonable intended use of the product.
When it comes to medicinal products some deviating regulation applies, see below under b).
The concept of a manufacturer is defined broadly and encompass all entities that:
- Manufactures the finished products;
- manufactures a component included in the finished product;
- any person who by putting his name, trademark or other distinguishing feature on the product and thus presents himself as its manufacturer;
- the retailer of a product. when it is difficult to identify the manufacturer from the product itself and the retailer does not provide the name or address of the manufacturer within reasonable time;
- the importer of a product imported from outside EEA; or
- the retailer of a product imported from outside EEA, if the importers name or address in Norway is not provided within reasonable time
Liability under the Product Liability Act covers both damages to natural persons and property.
The injured party have to prove the defect, the damage suffered and the a causal link between the defect and the damage suffered. As noted above, the Product Liability Act is a strict liability regime which entails that the injured party does not have to prove the manufacturers negligence.
b) Medicinal Products
The Product Liability Act chapter 3 provides a special regulation for damages to natural persons caused by pharmaceuticals, both for in sale pharmaceuticals and under trials (e.g. clinical trials).
Under the Norwegian regime all manufacturers of pharmaceuticals are obligated to be members of the Drug Liability Association. The members pay a premium to the Drug Liability Association’s product liability insurance. The premium is based on the member’s annual drug turnover. The maximum insurance is MNOK 80 per year, cf. section 3-6. For liability of producer under chapter 2 for defects above this threshold they need additional liability insurance.
The Product Liability Act section 3-3 provides that in case of damages to natural persons caused by pharmaceuticals the Drug Liability Association’s insurance is liable, irrespective of fault and irrespective of whether the damage is caused by a defect. In essence the liability for damages caused by pharmaceuticals are even stricter than the general liability under the Product Liability Act section 2-1.
Unless the damage is caused by a defect (in which case the Drug Liability Association’s insurance is liable unless the exceptions in section 2-2 applies) the Drug Liability Association’s insurance is not liable to the extent the damage is:
- A consequence of a wrong delivery or a mistake of drugs or other negligence at a pharmacist’s, at a physician’s surgery, in a hospital, or by another distributor,
- was caused in some other manner than by the foreseeable use of the drug, including use contrary to a properly issued and specific warning or incorrect use owing to neglect on the part of the physician in the form of a wrong prescription or inadequate advice,
- is a consequence of the drug’s lack of effect or lack of sufficient effect, or
- is due to side-effects which, in view of the injured party’s situation, it is reasonable for him to take the consequences of. In this assessment, emphasis shall be given to his health before use, the importance of the drug to his illness, the anticipated and actual effects of the drug, the nature and extent of the injury and the other circumstances of the case.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Liability under the Product Liability Act extends only to the manufacturer, i.e. the legal entity, or in the case of medicines, the Drug Liability Association’s insurance.
However, criminal liability arising out of damages caused by defective products may be addressed to natural persons, such as the CEO or other corporate executives of the manufacturer. However, all requirements for criminal culpability must be met for the individual person. There is no objective criminal liability for top management.
4. How can a liability claim be brought?
A claim for product liability may be brought through the ordinary courts by the individual harmed. The injured party may file a lawsuit within three years from the day he/she should have been aware of the damage, the defect and the responsible party. The absolute statute of limitation is 10 years from the day the defective product was put on the market for consumers. For medicines, the absolute statute of limitations is 20 years from the day the medicine was put on the market for consumers.
Liability claims for personal injury caused for medicines and medical devices can also be filed through the Norwegian System of Patient Injury Compensation (nw. Norsk Pasientskadeerstatning “NPE”). This a governmental agency under the Norwegian Ministry of Health and Care Services. NPE handles compensation claims from patients who think they may have gotten an injury from error and omission in the health care treatment. NPE handles claims for personal injury caused by medicines on behalf of the Drug Liability Association under the Product Liability Act. The claims handling is free of charge.
There is a board of appeal for personal injury caused by error and omission from HCPs, hospitals etc, e.g. if the dosage and use of the medicines is erroneous. If the personal injury is cause solely by the medicine itself, no such board of appeals exist and appeals have to be filed to the ordinary courts.
5. What defences are available?
The manufacturer may claim that there is no damage, no defect or no causal link between the damage caused and the defect.
In addition the Product Liability Act section 2-2 provides that the manufacturer is not liable if he can prove that he:
- Did not place the product on the market;
- that the defect in the product did not exist at the time the product was placed on the market and that the defect or damage could not have been prevented or limited afterwards; or
- That the defect was caused by the fact that the product is in compliance with invariable governmental rules and regulations
In the case of medicines, there are two defenses. If the liability is based on a defect, the exceptions above applies. If the liability is not based on a defect, i.e. that the defect is based on the separate rules regarding medicines, see question 2 b above the manufacturer may use the defenses mentioned in question 2 b last paragraph.