Court:

OGH 10. 7. 1997 2 Ob 197/97b RdM 1998/18

Topics:

State liability

Defect

Articles:

§ 5, PHG

Facts:

In 1989 the Österreichischer Sanitätsrat (Austrian Sanitary Council) issued a recommendation to cease broadly providing infants with BCG tuberculosis vaccination and to vaccinate only infants endangered to be infected with the disease. This recommendation was passed on to all respectable authorities, under other the Tyrolean regional government. Nevertheless, on recommendation of regional specialists of the sanitary commission, that regional government decided to keep vaccinating BCG on a broad basis.

The WHO had issued warnings concerning vaccinating infants with BCG. Lymphadenitis had been frequently caused by negligently doubling the doses, negligent techniques of vaccination, negligent condition of the vaccine and switching from the BCS standard microbiological strain to the so called Pasteur microbiological strain. Therefore the WHO recommended that only countries that had been successfully using Pasteur kept using it. In no case should it be used in countries where other products had been successfully applied.

In Austria a substance called "BCS-Sec Berna" had been used. When this substance was not available, the third defendant had provided the Austrian government with BCS of the same microbiological strain, BCS- Copenhagen. In July 1990 there was no BCG regular strain available and therefore applications were made for BCG of the Pasteur microbiological strain (Intradermal P) out of an UNICEF contingent. The third defendant was asked to bring expert testimony from the Bundesstaatliche Serumsprüfungsinstitut (federal institute specialized on control of serum examination, BSPI) on the BCG before the product could be used. Nevertheless officers of the federal chancellors department did not wait for this expert testimony to be issued, and orally, without issuing a written notice of release, authorized the use of BCS Pasteur. In the end of September 1990 the third defendant was informed by the BSPI that the respectable vaccine was not suitable for usage according to Austrian law and in November 1990 the BSPI issued an expert opinion informing the Austrian government of the obvious frequency of Lymphadenitis due to applying BCS Pasteur as warned by the WHO and advised the government to discontinue the use of this substance. The Bundeskanzleramt (federal chancellors department) advised various authorities not to use BSC Pasteur any longer.

In the beginning of September 1990 the plaintiff, an infant at that time, was vaccinated with BSC Pasteur and consequently suffered from inflamed lymph nodes. His mother had given her consent without being informed about the potential risks. In the plaintiff's case there was no special danger of him being infected with tuberculosis. He claimed damages for pain and suffering, disfigurement and determination of future damages.

Legal Questions:

Do side effects automatically render a product defective?

Decision:

The first defendant (the Austrian state) was held liable for negligently and with fault reauthorising the use of BSC Pasteur. The second defendant (Krankenanstaltenträger - responsible body for hospital institutions) was liable because the doctor treating the infant did not inform the plaintiff's mother of the risks of the procedure. The pros and cons of the particular vaccination were controversial within expert opinion; the vaccination was neither harmless nor of special need. Side effects and disadvantages of a product, as accepted by the general public, do not automatically render a product defective according to § 5 PHG. If these dangers are not known to those generally using these products, the entrepreneur has to present the product in a way that makes consumers aware of those dangers.