segunda, 29 abril 2019

Mutualising development risks: strict liability within the field of clinical trials

VolverOne of the principles, and the fundamental purpose, of the insurance agreement is “risk mutualisation”. This principle, together with transfer and distribution principles, allows to bear the costs of a risk by means of an insurance agreement.

At BELZUZ ABOGADOS Insurance Law Department, we accept that, within the field of biomedical research, and specially, in clinical trials with drugs, risk insurance has proved to be essential (i) in ensuring the sustainability of the damage repair system and (ii) in contributing to the sustainability and economic feasibility of the research system itself.

In short, civil liability insurance in the field of clinical trials with drugs, allows mutualizing the development risks.

In the health field it has been refused to apply a strict liability scheme, introducing a “personal liability” such as the due diligence standard or lex artis ad hoc. However, in certain fields of Life Sciences, where the risk taken by the person is generally higher, the damage repair mechanisms have ended re-establishing the strict civil liability: as it is the case of clinical trials with drugs.

This re-establishment of strict civil liability, in the field of clinical trials with drugs comes from article 10 of the Spanish Royal Decree 1090/2015, of 4 December, ruling clinical trials with drugs (hereinafter, the “RD 1090/2015”) (1) .

Thus, section 1 of article 10 of the RD 1090/2015 establishes the rebuttable presumption (admitting evidence to the contrary) deeming that the suffered damages by a participant during a clinical trial and the following year to the treatment completion are a consequence of the clinical trial, after one year from the treatment completion, the subject will have to prove the causal relationship between the damage and the drug under trial.

The same article 10, in section 2, states that compensatory damages shall be “(…) the costs arising from the impairment of the health or physical condition of the person subject to the clinical trial, as well as the economic prejudices that arise directly from such an impairment, provided that it is not inherent to the pathology under study or the evolution of the illness as a consequence of the treatment’s inefficiency.” This list (not numerus clausus) is added to the duty of compensating physical damages (temporary or final) that may suffer the subject as a consequence of the trial.

Thus, the liability regime of clinical trials in Spain modifies the traditional distribution of the burden of proof: it requires from the harmed party to prove the existence and reach of damages, but discharges from the obligation of proving the causal relationship; the defendant (usually the developer) shall be liable for the burden of proving the lack of causal relationship between the claimed damages and the drug under trial.

The structure of the legal defence of the developer (or its insurance company), in any case, will be focused in breaking the causal relationship between damages and the effects of the drug under trial, linking it either (i) with the pathology suffered by the harmed party, or (ii) with the side and/or limited effects of the drug treatment prior (or concurrent) to the trial.

For all these reasons, the recent Ruling of 28 December 2018 (EDJ 2018/721219) by the Barcelona Provincial Court reminds that “in the scenarios of strict liability as in the case of laboratories and the clinical trials that they carry out, the traditional criterion of fault is substituted by the risk (periculum), in a manner that there is no need to charge the caused damaged to its causative agent through wilful misconduct or fault, but just to assign a cause-effect relationship (…).”

The Barcelona Provincial Court warns that the rebuttable presumption in the causal relationship does not preclude that the petitioner must prove the reality and reach of damages.

Following this, the court reviews the evidence presented on appeal and concludes that no causal relationship may be established between severe clinical deterioration and the death of the subject, and the drug given during the clinical trial; to this end, the Provincial Court used the chronological criterion, adequate causation (the deterioration caused by the base pathology of the patient, Alzheimer), and the exclusion factor (existence of other causes of greater intensity that explain the final result) in order to rule out the causal relationship between the experimental drug and the fatal result. The Barcelona Provincial Court concluded that the death was a consequence of the base pathology: Alzheimer.

In a less controversial case, the Madrid Provincial Court, in the Ruling of 7 October 2014 (EDJ 2014/211110) ruled out the alleged causal relationship between damages and the drug under trial, when pointing that “(…)it is been proved that it was not so because placebo is an innocuous substance that didn’t produce any toxicity or abrasion to the patient, the latter could only be a cause of Gentamicin (…) we are before a consequence “inherent to the pathology subject to this study” or included “within the adverse reactions typical of the medicine prescribed for such a pathology, as well as the evolution typical of the illness as a consequence of the inefficiency of the treatment”, which is why no liability whatsoever may be caused (…).”

Uncertainty around causal relationship, in all cases, impairs the enforceability of the rebuttable presumption and leads to the declaration of strict liability (see Ruling of the Contentious-Administrative Court of 20 March 2014 from the Madrid High Court of Justice (EDJ 2014/46967)).

The strict liability regime applicable to damages caused within the context of a clinical trial does not exclude the concurrent application of other liability regimes. In this sense, it is necessary to establish whether the damages cause is a breach of the lex artis by the participating professionals or a failure of the health system (eg. errors in dosage or drug administration, incorrect follow-up of the base pathology, complications and/or poor standard treatment of the illness…).

In these scenarios, in addition to the strict liability regime applicable to the damages caused by the drug under trial, any other personal liability regime may be enforceable, such as the professional liability of medical and nursing staff or the liability for property damages of the Public Administration (see, among others, the Ruling of the Contentious-Administrative Court from the Madrid High Court of Justice of 13 September 2018; EDJ 2018/674016).

Lastly, it should be noted that the strict liability regime provided for in the RD 1090/2015 is not enforceable in the criminal jurisdiction where wilful misconduct fault or negligence are required in order to establish existing liability.

This way, in the Order of the Barcelona Provincial Court of 16 February of 2009 (EDJ 2009/33348) it was reminded that: “(…) at most, a potential liability for civil or administrative damages, but never, precisely because specifically refers to “unless proved otherwise”, a criminal liability where, as it is common knowledge, a strict liability does not exist (…).”

To sum up, with a view of mutualizing the development risks, the lawmaker has provided a strict liability regime within the field of clinical trials with drugs that forces to focus the legal defence in aspects such as: (i) the effect of the morbidity process suffered by the participant, (ii) its evolution, (iii) the potential side effects of the prior and/or concurrent drug treatment and, lastly, (iv) the lack of a causal relationship between side effects that the drug may cause and the claimed damages.


(1) The Spanish Royal Decree 561/1993, of 16 April, under which the requirements for carrying out clinical trials with drugs are established (“RD 561/1993”), and the Spanish Royal Decree 223/2004, of 6 February, ruling clinical trials with drugs (“RD 223/2004”), excluded from compensatory damages any “(…) side effects of the medicine prescribed for such pathology (…)”. The fact that the new RD 1090/2015 removes this addition does not preclude that damages are not deemed non compensatory, as they arise from the needed treatment of the pathology suffered by the trial subject.

Departamento Direito dos Seguros | Madrid (Espanha)

 

Belzuz Abogados SLP

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