Burden of Proof for Defect
Causation
Claim for Disclosure
Damages for Pain and Suffering
Damage Caps
Enactment and Applicability
Comment
On April 16 2002 the German Parliament passed the Second Act of Parliament on the Amendment of the Law of Damages. The act lays down far-reaching amendments to the law of damages and results in a significant change of the liability regime for drugs, to the detriment of manufacturers. This update examines the key amendments to the Drug Act.
Under the new law, the burden of proof for the cause of the defect of a pharmaceutical product lies with the manufacturer. The manufacturer must prove that the damaging defects were not caused during development or manufacture. Under the current law, a person who brings a claim based on a damaging side effect must prove that the source of this side effect lies in the development or manufacture of the product in question. This provision has now been reversed.
Previously, under the strict liability regime the plaintiff had to prove a causal nexus between the alleged damage and the individual pharmaceutical product. Now, subject to the assumed capacity of the pharmaceutical product to cause the particular damage, causation is presumed. The claimant must only prove the general probability of causation and the product will then be deemed to have caused the harm, shifting the burden to the defendant, who must show that the harm was caused by other factors. In its defence, the manufacturer may not invoke a potential causation between the damage and another drug (Section 84(2)(4) of the Drug Act, as amended). However, an exception to this rule applies in cases where pharmaceuticals of different manufacturers are involved and where a manufacturer of another product which could possibly have caused the damage is excluded from liability for other reasons than causation - that is, because the side effects are acceptable considering the benefit-risk assessment.
A drug's general capability to cause the damage must be determined considering the following factors:
- content and dosage of the drug;
- type and duration of the intended use;
- time interval between the damage and the drug's administration;
- type of damage;
- the claimant's health at the time that the drug was administered; and
- all other circumstances which may in the individual case indicate or exclude causation (Section 84(2)(2) of the Drug Act, as amended).
Pursuant to Section 84 of the Drug Act, as amended, the claimant may request that the manufacturer and/or the competent authority provide the following information:
- known effects, side effects and drug interactions;
- known suspected cases of side effects and drug interactions; and
- any further information relevant to the analysis of the acceptability of damaging side effects.
The claimant need not prove causation, or the prerequisites for the presumption for causation, in order to substantiate the claim for information, because the latter is intended to enable the claimant to substantiate his or her claim with the help of the information obtained. Therefore, a plaintiff is only required to state and prove the damage and facts which indicate that a drug of the defendant caused the damage within the scope of the intended use. No full evidence is required; the judge need only review the plausibility of the claimant's statement. A claim for information will be unsuccessful if the requested information is not necessary in order to substantiate a damage claim. The onus is on the manufacturer to prove that this is the case. Again, the judge need only review the plausibility of the parties' statements; no formal evidence is required.
The failure to provide for a (counter) claim for disclosure in favour of the manufacturers and authorities has been criticized not only by the pharmaceutical industry, but also by the Federal Council, the opposition in the German Parliament, the German Judiciary and the Lawyers Association. Nevertheless, the new legislation does not provide for such claims.
With respect to the content of the information that must be provided, Section 84(1)(3) of the Drug Act, as amended, refers to the general provisions on claims for information in Sections 259-261 of the Civil Code. As a result, the manufacturer must supply documents to support the information and, upon request, swear an affidavit to the extent that the information is complete and true.
If the requested information must be kept confidential due to statutory law requirements, or if its confidentiality is supported by an outweighing interest of the manufacturer or a third party, the plaintiff's request may be denied.
Damages for Pain and Suffering
For the first time, the strict liability regime under the Drug Act includes damages for pain and suffering (Section 87 of the Drug Act, as amended, and Section 253(2) of the Civil Code, as amended).
The Drug Act's damage caps have been adjusted from deutschmarks into euro and increased. Damages are capped at €600,000 for individual physical injury and €120 million for serial damages caused by the same drug.
The new legislation will enter into force on August 1 2002. In principle, it will apply only to cases in which the damage occurs after this date. The increased damage caps under the Drug Act will apply only to cases in which the damaging event occurs after December 31 2002.
Another exception applies with respect to the claim for information. After August 1 2002, a claim for information may also be raised by claimants who suffered allegedly drug-induced damages prior to the enactment of the new law, as long as there is no final decision denying the claims. As a result, in pending drug liability litigation as well as with respect to claims known or not known to the manufacturers, claims for information may be raised by the plaintiffs as from August 2 2002, irrespective of when the damage occurred.
Despite significant criticism, the draft was implemented without substantial changes. Manufacturers will have to be prepared to defend claims for information and disclosure in pending cases, due to the retroactive effect of this type of action. The new law significantly reduces the options of pharmaceutical companies to defend claims for compensation.
For further information on this topic please contact Detlef Hass or Ina Brock at Lovells by telephone (+49 89 290 120) or by fax (+49 89 290 12 222) or by email ([email protected] or [email protected]).