April 5, 2019

Procedural issues in medical lawsuits

On April 1, 2017, the Gelli – Bianco law, or Italian Law no. 24 of March 8, 2017, hereinafter the “Law”, is now in force, bringing significant changes in medical liability.

Specifically, the Law provides a twin-track approach for seeking damages, separating the healthcare provider liability (doctors, nurses and all the other individuals providing health services in healthcare facilities) from health facility liability (hospitals and clinics). This now allows the patient to decide whether to sue the healthcare provider (and/or their insurer) or the healthcare facility (and/or its insurer). Additionally, the Law requires healthcare facilities and providers to carry insurance. When the patient chooses to sue the healthcare facility or its insurer, the latter may then start a recovery action against the healthcare provider. However, this does not apply if the healthcare provider is not enrolled in the public health service. In the case of a private entity acting with a contractual relationship to the patient, the latter may not trigger the twin-track approach.

The healthcare provider’s liability is a tort liability, as detailed in Section 2043 of the Italian Civil Code. Consequently, the patient bears the burden of proving the healthcare provider’s unlawful conduct, the unfair damage he or she suffered, and the causal link between the healthcare provider’s conduct and the damage allegedly suffered. The statute of limitations in such cases is 5 years.

The healthcare facility’s liability, on the other hand, is contractual, as detailed in Sections 1218 and 1228 of the Italian Civil Code. In this case, the patient need only provide evidence of the damage he or she suffered, alleging the breach of the contractual duty, while it falls to the healthcare facility or its insurer to prove that the doctor was diligent or that the malpractice was caused by an unforeseeable event, unavoidable with ordinary professional care. The statute of limitations in such cases is 10 years.

This twin-track approach, which leaves the patient with a heavy burden of proof when he or she is seeking damages against the healthcare providers, shows that one of the political aims of the Law is to shift the claims towards the facilities, reducing disputes against doctors. The underlying rationale of this provision is to curb the phenomenon known as “defensive medical decision making” (that is, healthcare providers ordering unnecessary treatments (positive defensive medicine) or avoiding risky treatments (negative defensive medicine) to reduce their exposure to damages claims).

The Law also introduces a procedural rule aimed at reducing medical malpractice lawsuits, as well as the costs and time involved.

To this end, Section 8 of the Law introduces mandatory ADR as a prerequisite to bringing a claim to court. Regardless of who the respondent is, before initiating full proceedings, the claimant must trigger a preliminary technical expertise assessment (this particular ADR – consulenza tecnica preventiva in Italian – is established in Section 696-bis of the Italian Code of Civil Procedure). In the absence of this preliminary request, the proceedings will be declared inadmissible.

With these preliminary proceedings, the court will require a technical expert to carry out a twofold task: ascertain the cause of the alleged malpractice, and then submit a settlement proposal to the parties. The aim is to have, as quickly as possible (within six months from the filing of the application), a technical opinion from an expert appointed by the court that might help the parties to settle the ligation or, in the worst case scenario, to have a technical opinion to be used in the ensuing ordinary proceedings.

As mentioned earlier, the technical expert’s report should include a settlement proposal. To this end, Section 15 of the Law specifies that the appointed expert “must have appropriate knowledge and experience in the area of conciliation; skills developed even as the result of specific training courses” (Section 15 of the Law – free translation). When the parties reach an agreement, the minutes of the proceedings are immediately enforceable. However, if the parties do not reach an agreement, each of them can initiate the ordinary proceedings, in which the expert’s opinion will be used as evidence.

The respondent (the insurance company, the healthcare facility or the healthcare provider) is required to attend this ADR. Any party that fails to attend will pay the fee for the expert’s opinion, as well as an additional fine, regardless of the outcome of the proceedings. If the respondent is the insurance company, prior to filing the expert’s opinion, it must offer a sum for compensation or explain why such compensation is not due. If the insurer fails to make such an offer and the patient’s claim is upheld in the ordinary proceedings, the judgment is served by the relevant Italian regulatory body (IVASS), which may impose a penalty against the insurer.

Overall, it is clear that medical disputes are largely based on technical information and involve a high degree of uncertainty, making it almost impossible for a judge to render their decision without the assistance of a court-appointed expert who can technically assess the performance of the healthcare provider. In this regard, considering the technical nature of the proceedings, the heart of the decision is mostly in the hands of the expert. In light of this, enforcing a procedure that allows a technical assessment to be obtained in a short period of time and prior to the start of ordinary proceedings could actually be a sensible way for the parties to settle their dispute amicably before going to court.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
...
Read more
Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

Close
October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
Search by...
Search
Follow us on
Follow us on