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Pharmaceutical Legislation

With regard to pharmaceutical legislation we almost exclusively look after cases in relation to pharmaceutical drug liability. But only in exceptional cases for the following reasons:

In 2002 the liability legislation of the § 84 AMG was revised with the introduction of a so-called causality assumption of § 84 paragraph 2 AMG, whereby drug user difficulties when proving causality should be made easier.

However, this did not succeed. Besides the causality assumption in favor of the users of the pharmaceutical drug the legislators also introduced an exclusion assumption. With this the pharmaceutical company can nullify the causality assumption by naming only one other possible cause for the injury or damage. In reality the intended proof facilitation in favor of the drug user is therefore futile.

In 2006 the so-called Vioxx cases began. They concern a drug utilized for rheumatism but which lead to heart attacks and strokes and was therefore removed from the market. The Federal High Court with verdict from 26.03.2013 – VI ZR 109/12 finally dismissed a case in relation to this. In the verdict the Federal High Court rightly pointed out that the introduction of the causality assumption due to the exclusion possibilities will remain fruitless in many cases.

To the best of our knowledge since the new legislation not a single pharmaceutical company has been sued successfully. The new legislation did not lead to an improvement of the proof related situation for the person damaged through pharmaceutical drug use. In the US in comparison the producer of the drug Vioxx had to pay 6.87 billion US $. In Germany all patients damaged through Vioxx will remain empty handed, especially after the Federal High Court verdict from 26.03.2013.

In the light of this new legislation as lawyers specialized in medical liability we can no longer recommend the enforcement of compensation entitlements from damages caused by pharmaceutical drugs. How poorly this legislation revision was carried out is demonstrated by the fact that the Federal High Court was unable to provide clarity on the matter until 7 years after. Up to then several unresolved legal issues had to be decided. Until the end it remained unclear how exactly the legislation of § 84 AMG was to be interpreted.

From our point of view we can only recommend the enforcing of entitlements in exceptional cases in the future. In fact, only when no other cause than the pharmaceutical drug is conceivable as having caused the damage, e.g. contaminated blood. As a result, the revision of the § 84 AMG is pointless and did not improve anything for pharmaceutical drug users.

Two exceptions should be mentioned: the drug Levimir, an insulin generic drug, which led increasingly to loss of adipose tissue at the injection site. In this case the Federal High Court presented an intended positive decision to the European High Court. A decision is expected in 2015.

In addition the antidepressant drug Zoloft is mentioned. Here the pharmaceutical producer in the patient leaflet failed to mention an increased danger of suicide in relation to the drug. This presents a violation of the duty to inform. In this case the pharmaceutical company would have to present substantiated facts that the suicide would have happened in any case.

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