Läkemedel räddar inte alltid liv - Om ansvaret för läkemedelsskador i svensk rätt

Detta är en Uppsats för yrkesexamina på avancerad nivå från Lunds universitet/Juridiska institutionen

Sammanfattning: In case of personal injury, individuals who have been injured by pharmaceuticals have three options for compensation: via the Tort Liability Act (SKL), the Product Liability Act (PAL) or the Pharmaceutical Insurance (LFF). This means that those injured by pharmaceuticals have the opportunity to base their claim for damages on three different types of responsibility grounds; culpability, strict liability, and a "no-fault insurance". The latter types of liabilities have been introduced as part of the legislator's efforts to improve the possibility of compensation for those injured by pharmaceuticals. However, it has been disclosed that injuries from pharmaceuticals constitute a particular type of injury, which from the perspective of the injured part, is not suitable for the SKL's causality issues or PAL's grounds for discharge. Therefore LFF is nowadays the better option for pharmaceutical injuries. The essay's thesis has therefore been to investigate the injured party's opportunities for compensation according to SKL, PAL and LFF for pharmaceutical injuries. The purpose of the essay is also to explain the extent to which PAL or LFF can be reformed in order to improve the opportunities for compensation of pharmaceuticals without such a change being in conflict with EU law. In order to achieve this purpose, an investigation has been required regarding the legislative history, the differences between SKL's, PAL's and LFF's grounds of accountability, and, finally, how EU law affects private claims for compensation concerning pharmaceutical injuries. As a result of this, the essay depicts the diversity in current law regarding private claims for pharmaceutical injuries. In order for a victim to be entitled to compensation of SKL, they must prove that there is a causal connection between the injury and the allegedly caused deed. In addition, the injured party must show that the person who caused the damage has been careless. If the injured party chooses instead to base its claim for compensation on PAL, he must prove that the injury is caused by a defect product. In cases where it is possible to determine that a defect product caused the injury, PAL provides better cover for those who suffered from pharmaceutical injuries compared to SKL. A major disadvantage regarding PAL is that known and unknown side effects can be considered system damages and development damages, which are excluded according to PAL. Finally, victims may choose to base their claim for compensation on LFF. In many ways, LFF provides better cover for those who suffer from pharmaceutical injuries compared to SKL and PAL. This is due to the fact that LFF is a "no-fault insurance", which grants injured parties compensation regardless of whether the injury has been caused by carelessness or a defect product. In the final reflection different solutions are identified within the chosen questions. However, the proposed measures to provide improved protection for individuals in case of pharmaceutical injuries are limited by the Product Liability Directive. Although PAL's prerequisites is not allowed to deviate from the legal concept of the directive, there is a legal scope for Sweden to legislate a responsibility for development errors. Due to the fact that the exception for development errors poses a major disadvantage for individuals, the possibility of allowing manufacturers to be responsible for such errors according to PAL is considered. Finally, various proposals are being discussed to improve the possibility of compensation from LFF regarding the insurance's optionality and warranty cap.

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