Product liability case in The Netherlands: Blood products: Development Risk Defence Succeeds

Hartman v Stichting Sanquin Bloedvoorziening

District Court of Amsterdam, 3 February 1999

The plaintiff underwent cardiac surgery during which he was given blood, from which he contracted HIV. He claimed that the product was defective under the Directive and also that the defendant was negligent if he placed reliance on a statement made by the donor that he belonged to a group with an increased AIDS risk. In disposing of the negligence claim, the facts were that the donor declared that he did not belong to a group with an increased AIDS risk and the court found that the defendant was not negligent in relying on this statement. Special circumstances might have shown the contrary, but there was no such evidence produced. In relation to the strict liability claim, the court found that the product was defective, that the defence of compliance with mandatory regulation was not made out, but that the "development risks" defence was made out.

Defect

The court held that the relevant test was the safety level that the general public should expect. It took into account the vital importance of blood products and the fact that there are no alternatives. Accordingly, the court held that the general public expects and should expect that blood products in the Netherlands are and were 100% HIV free "for some time now" (the donation was made in May 1996 and the transfusion in June 1996). The court said that the fact that there is a very small chance that HIV is transmitted during a blood transfusion is not common knowledge and therefore the general public does not have, or should not have, this expectation. Accordingly, a blood product which is not HIV free is a defective product in the Netherlands.

Compliance with mandatory regulations

The defendant argued that it had to comply with the Blood Products Regulation (Regeling Bloedproducten) which required that the collection, preparation, storage, packaging, labelling, transport and delivery of blood products is conducted in such a way that the recipient's health is not damaged and must act in accordance with the guidelines of the Council for Blood Transfusion (College). The College guidelines require blood banks to comply with its guidelines and "can deviate from them in exceptional cases and only when there are well-founded reasons and only if the quality is not negatively affected".

The court held that since blood banks are allowed to deviate from the guidelines, the Regulation left enough room that it was impossible to speak of mandatory government regulations for the purposes of relying on this defence. It explicitly left unresolved the argument that the defendant had no reason to deviate from the guidelines.

Development risks defence

The donation was made on 29 May 1996, supplied by the defendant's predecessor to the hospital on 5 June 1996 and given to the plaintiff on 6 June 1996. The next time that the donor donated blood, on 1 October 1996, the results of the HIV-1-2 screening test showed that he had contracted HIV. Accordingly, an archived sample taken on 29 May 1996 was tested. The HIV-1-2 screening test was negative, as was the HIV p24 antigen test. An HIV-1 RNA test was then done, the first time the results were positive (just above detection level) and when this was repeated the results were negative (just below the detection level) which led to the conclusion that the results of these tests were dubious. The defendant notified the hospital that the donor had tested positive, after which a test on the plaintiff was done and was positive.

There was some discussion of a quarantine method, but this was dismissed as being unable to eliminate the infection risk and technically impossible to apply in practice on a large scale, and so irrelevant.

It was undisputed that the HIV-1 RNA test was elaborate, still in an experimental stage and not approved nor validated as a screening test. There was a report from the Paul Ehrlich Institute that the test was not at a stage of development that its implementation could be recommended. Accordingly, the court concluded that it was practically speaking impossible for the defendant to have discovered the defect, and the defendant had acted in accordance with the scientific and technical knowledge.

For informtaion on any product liability issues please contact Chris Hodges on Tel 0171 367 2738 or e-mail [email protected]