September 30th, 2010

Continental European Legislative and Judicial Trends: German Federal High Court Decision: Causal Link Between the Use of Medication and the Occurrence of a Bodily Injury

Posted at 2:00 AM ET

2010_legislative_thumb-2David Lewin, Managing Director
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In March of 2010, the Federal High Court of Justice (Bundesgerichtshof, in the following,”High Court”) handed down an interesting judgment regarding causality between the use of a medication and bodily injury suffered by the patient (Judgment of March 16, 2010, VI ZR 64/09). (1)  In addition, in this context the High Court reviewed the problem of contributive causation as well as the applicability of the principle of prima facie evidence.

The Facts

Beginning in 1993 the claimant in this case suffered pain and was medicated with various anti-inflammatory pain relievers. Since February of 2001 he has taken the analgesic “X” which was distributed on the German market by the defendant in this case. The claimant suffered a serious heart attack shortly after shovelling snow on January 13, 2010, at age 73.

In 2004, following the discovery of significant health hazards associated with the use of “X,” the distributor of the product (and defendant) removed the product from the market.

The claimant sued the defendant for his material damage and claimed compensation for pain and suffering (immaterial damages). He argued that his heart attack was solely caused by the medication “X,” which he had used on a daily dose of 25 milligrams since February of 2001. Furthermore, he alleged that the patient information leaflet supplied by the defendant was insufficient. With reference to already existing results from medical studies, the claimant argued that the defendant would have been obliged to take “X” off the market as early as 2000.

The Findings

The lower courts dismissed the claim. The claimant was admitted to appeal, but the High Court upheld the prior judgments.

Missing Causal Link

The High Court ruled that the claimant, who was charged with the burden of proof,did not successfully provide evidence of the fact that the use of “X” had been the cause of the heart attack. In addition, the High Court decided that the claimant could not invoke any relief of the onus of proof in this case, i.e., the claimant had
to bear the full burden of proof.

The High Court stated that the consideration of evidence by the lower courts with regard to the question of causality was free from legal faults. A medical expert provided a report and testimony during the hearing based on the findings of the available medical studies at the time. These findings showed no probable contributive
causation from the use of “X” in this case. The medical expert was convinced that the age of the claimant combined with the preceding overstrain was the more probable reason for the heart attack. The lower courts had followed this argument.

Applicability of the Prima Facie Evidence Principle

The High Court further had to rule on the question of whether or not the principle of prima facie evidence was applicable in favor of the claimant. According to German law this principle is applicable if the occurrence of an injury is the typical consequence of a breach of duty with regard to general experience of life. For example, this principle has been applied in cases of AIDS patients who had been de facto infected with HIV-contaminated blood products during a blood transfusion.

The assumption being that these patients neither belonged to a HIV-endangered risk group nor were they exposed to an increased infection risk by means of their individual lifestyles.

The High Court held that these cases were not comparable to the present case at hand. However, the court did not decide the question of whether and under which conditions the principle of prima facie evidence could be applicable in a case where a patient, after the taking of a medication associated with a specific risk, suffers
bodily injury corresponding to that specific risk. The High Court ruled that the principle of prima facie evidence fails if proven or undisputed facts lead to the assumption that a breach of duty yields consequences that are out of the ordinary. In the case at hand, such facts, according to the High Court’s point of view, were given with regard to the claimant’s significant personal risk factors, which were, in particular, his progressed age and the particular strain of snow shovelling. The High Court held that under these circumstances the principle of prima facie evidence could not justify the claim.

Reversal of the Burden of Proof

The last legal aspect of the present judgment deals with the question of whether or not a reversal of the burden of proof could apply in this case. The courts have established this remedy in the area of medical malpractice in cases of gross faults in treatment. In such cases the medical practitioner had to release himself from the accusation of a gross fault for reasons of equity.

However, the High Court held that the present case is not comparable to medical malpractice cases. In addition, the High Court referred to a previous judgment of the same Senate, holding that the principle of reversal of the burden of proof with regard to cases of medical malpractice could not be transferred to product liability claims based on the violation of the duty to give warning of specific risks.

Different Legal Situation

The decision in this case could have been different since the German legislator on July 19, 2002 had enacted an amendment of sec. 84 para. 2 of the German Medicines Act (Arzneimittelgesetz - AMG). This new regulation introduced an absolute liability and thereby a supposition of causality in favor of any patient suffering bodily injury in connection with the taking of medication. According to the appropriate transitional
rule, this new regulation was applicable for all bodily injuries caused by drugs beginning July 31, 2002.

As the claimant had suffered his heart attack in January of the said year, the High Court, in accordance with the lower courts held that the case of the claimant had to be judged on the basis of the previous version of sec. 84 of the German Medicines Act. Therefore, the full burden of proof regarding the causality remained with the
claimant.

Conclusion

This case gave the High Court the opportunity of confirming its prior jurisdiction with reference to the various forms of the burden of proof. In many similar cases, the burden of proof is the decisive factor for the judgment - in this case, nevertheless, it worked against the claimant. However, the claimant’s legal position is unsatisfying, as the judgment might have been different if the claimant had suffered his heart attack only seven months later and had not overstrained shortly before. Then he could have been entitled to the alleviation of the burden of proof enacted by the German legislator in the German Medicines Act in 2002.

Beyond that, it remains to be seen whether the High Court will have another opportunity to rule on the question of whether prima facie evidence will apply to cases governed by the German Medicine Act in its current version.

Footnote:

1 Cf. BGH [2010] VersR 627 et. seq.

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