Tag Archives: strict liability

Artificial intelligence and robotics: a report reflects on legal issues

With its report issued on May 31, 2016 by the European Parliament (“Report”), the European Union has stepped into the debate on how to deal with artificial intelligence and robotics (“AI&R”). The ultimate goal of the European Parliament is to set forth a common legal framework that may avoid discrepancies arising from different national legislations, which would otherwise create obstacles to an effective development of robotics.

The Report introduces ethical principles concerning the development of AI&R for civil use and proposes a Charter on Robotics, composed by a Code of Ethical Conduct for Robotics Engineers, a Code for Research Ethics Committees and Licenses for Designers and Users.

Furthermore, the Report suggests the creation of a European Agency for AI&R, having an adequate budget, which would be able to generate the necessary technical, ethical and regulatory expertise. Such agency would monitor research and development activities in order to be able to recommend regulatory standards and address customer protection issues in these fields.

The Report, which recommends to the Commission to prepare a proposal of directive on civil law rules on robotics, illustrates many of the issues that society could face in a few decades regarding the relationship between humans and humanoids. In fact, a wide range of robots already can, and could even more in the future, affect people’s life in their roles as care robots, medical robots, human repair and enhancement robots, doctor training robots, and so on.

A further development that may be concerning for lawyers is connected to the announcement, a few days ago, by the University College London that a computer has been able to predict, through a machine-learning algorithm, the decisions by the European Court of Human Rights with a 79% accuracy. Will this result in a more automatic and predictable application of the law?

In order to secure the highest degree of professional competence possible, as well as to protect patients’ health when AI&R is used in the health field, the Report recommends to strengthen legal and regulatory measures such as data protection and data ownership, standardization, safety and security.

One concern arising from the Report is civil liability arising from the use of robots. Should the owner be liable for damages caused by a smart robot? In fact, in the future, more and more robots will be able to make “smart” autonomous decisions and interact with third parties independently, as well as cause damages by their own. Should such damages be the responsibility of the person who designed, trained or operated the robot?

Some argue in favor of a strict liability rule, “thus requiring only proof that damage has occurred and the establishment of a causal link between the harmful behavior of the robot and the damage suffered by the injured party”.

The Report goes even further by asking the Commission to create a compulsory insurance scheme for owners and producers to cover damage potentially caused by robots and a compensation fund guaranteeing compensation for damages, but also allowing investments and donations in favor of robots.

Exciting times lay ahead of us. It remains to be seen if the current legal principles will be sufficient or if new ones will actually be necessary.

Defective Medical Devices: an Interesting Decision by the ECJ

On March 5, 2015 the European Court of Justice (“ECJ”) delivered a ruling on product liability that could have consequences for manufacturers of medical devices.

FACTS OF THE CASE. The quality control system of a company selling pacemakers and implantable defibrillators in Germany found that a component utilized to hermetically seal pacemakers may experience a gradual degradation. That defect could lead to premature battery depletion, resulting in loss of telemetry and/or loss of pacing output without warning. In light of such circumstances, the manufacturer issued a warning recommending physicians to replace the implanted pacemakers with others provided free of charge. At the same time, the manufacturer also recommended physicians to turn off a switch in the defibrillators.

PROCEEDINGS. The insurance companies, covering patients whose pacemakers or defibrillators had been replaced, instituted legal proceedings to obtain reimbursement of costs relating to such replacements. The German High Court raised a preliminary question before the ECJ asking whether the devices that had been replaced may be classified as defective, despite lack of evidence that the actual product implanted was defective, on the basis of the corrective measures recommended by the manufacturer. Moreover, the German Court asked whether costs of replacing those pacemakers and defibrillators could be classified as damages, for which the manufacturer may be liable pursuant to the Product Liability Directive[1].

ECJ RULING. In its ruling, the ECJ stated that, in order to determine whether or not the manufacturer was liable, (i) the function of such products, (ii) the vulnerability of patients utilizing them, (iii) the costs borne to replace them, and (iv) the costs relating to turning off the switch of defibrillators had to be taken into account and balanced. In this respect, the ECJ observed that even the potential lack of safety of those products gave rise to the manufacturer’s liability, in light of safety standards that patients could expect from that kind of products and the abnormal possibility of damages to patients, who would be at risk of death. In addition, and in more general terms, the ECJ affirmed that costs borne to replace potential defective devices may constitute damages inasmuch as the expenses incurred are necessary to remedy the defect. However, such a judgment, as pointed out by the ECJ, pertained to the merits of the claim, and must therefore be ascertained by a national Court.

CONSEQUENCES OF THE RULING. Under the Product Liability Directive claimants must produce evidence of the defect, damages arising therefrom and a causation link between the two. By contrast, the ECJ’s decision establishes that even potential defects may be considered as defects. As a consequence, consumers appear to be relieved from the burden of proof that products are actually defective. By the same token, manufacturers’ right of defense seems to be compressed, as – when there are corrective measures recommended by them – the ruling does not leave any room for proof of lack of liability.

WHAT WILL BE THE IMPACT OF THE RULING.  The ECJ’s approach to product liability adopted in the ruling at hand appears to be skewed towards consumers’ protection. A cynical reading of the ECJ’s judgment may even prompt manufacturers to be reluctant to “admit their own mistakes” and issue safety warnings regarding their products! As often happens with legal issues affecting innovation and health policies, balancing of interests is key.

[1] Council Directive 85/374/EEC of July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products. According to the Directive, the producer is liable for damages caused by a defect in his product.