Strict liability for damages caused by health products confirmed by the Czech Supreme Court


On 26 May 2011, the Supreme Court of the Czech Republic issued a decision dealing with the issue of strict liability for damages caused by a pharmaceutical product that was not itself defective and that was applied correctly by medical staff. Although not groundbreaking, this decision will likely become the leading case law on this subject, replacing the old decision of the Slovak Supreme Court of the then Czechoslovakia dating back to 1974.

The case involved a patient suspected of being infected with erysipelas or herpes zoster who was treated with a penicillin injection.  Even though penicillin was prescribed correctly and there was no problem with the manner of application, the patient developed a Hoigné syndrome (a known reaction to intramuscular procaine penicillin administration) resulting in a post-traumatic stress disorder.

The court confirmed that the concept of strict liability under Section 421a of the Czech Civil Code would apply to such cases, rather than the general fault liability that could be imposed only if malpractice of a health care provider had been involved. Liability under Section 421a of the Civil Code relates to any damage "caused by circumstances which have their origin in the nature of a device or another thing which is used in performing an obligation". The law explicitly states that there can be no exemption from such liability and that such liability applies also to the rendering of health, social, veterinary and other biological services.

According to the court’s decision, this type of strict liability occurs when a particular injury results from circumstances that directly arise from the nature of a drug – e.g. in a situation when, after correct application of the drug, its active ingredient causes an adverse reaction leading to a health injury. It is completely irrelevant whether such risk is commonly associated with the use of a particular drug, whether the adverse effects occur rarely or even whether the potential adverse effects are known. In addition, it is not possible to make any distinction between the effects of known drug characteristics and the manner of its administration during medical treatment (which the lower court did in this case).

It follows that in order to establish strict liability under Section 421a Civil Code, it is necessary to prove merely (i) that damage occurred, (ii) its origin in the nature of a device or other object that was used in performing an obligation, and (iii) a causal link between the two. No limitation, exclusion or liberation from such liability is possible. It is clear that, in the vast majority of cases, this liability will arise on the part of health care providers who will only with great difficulty be able to pass it on to manufacturers. In order to protect themselves from such liability, they will therefore need to resort to either contractual protection or, more likely, insurance.