Monthly Archives: April 2015

The last event of our HEALTH INNOVATION ACADEMY is coming up!

On May 21, 2015 our HEALTH INNOVATION ACADEMY series will hold its last event. Join us to hear speakers on the topic of networks for innovation at Via Francesco Sforza 28, Milano (Aula Milani) followed by drinks.

As always, the event is organized in cooperation with the hospital IRCSS Cà Granda – Ospedale Maggiore Policlinico di Milano and with Politecnico di Milano – e-Health LAB – Informatica BioMedica e Sanità Digitale

To find out more about the May 21 program or about HEALTH INNOVATION ACADEMY’s past events, click here:

EMA Issues New Guidelines to Prevent Medication Errors

On April 14, 2015 the European Medicines Agency (“EMA”) released two drafts of good practice guides aimed at improving the reporting, evaluation and prevention of medication errors. The new guides are addressed to regulatory authorities, as well as the pharmaceutical industry.

Medication errors generally refer to unintended mistakes in the processes of prescribing, dispensing or administering of medicinal products in clinical practice and according to EMA they account for an estimated 18.7 – 56% of all adverse drug events among hospitalized patients.

The first guide released by EMA provides an overview of the main sources and types of medication errors, as well as measures to minimize the risks that such errors are made. The second guide, on the other hand, focuses on suspected adverse reactions caused by medication errors, providing guidance and recommendations on how to record, code, report and assess such errors.

The guidelines from EMA recommend a number of actions to marketing authorization holders, including the periodical reporting of information concerning medication errors. Recommendations to the industry include periodical safety update reports and risk management plans to be adopted for each marketed pharmaceutical product. The overall scope of these reporting obligations is to implement a real-life continuous evaluation of the risks and benefits of all medicines placed on the European market.

The two draft guidelines are now open to comments from all relevant stakeholders: the public consultation procedure will expire on June 14, 2015. The final version of the guidelines is expected to be finally adopted later in 2015.

More information and the new draft guides can be found here:

Medical Malpractice: Contractual or Tortious Nature?

The Rise of Medical Malpractice Cases and of Defensive Medicine.  Over the last two decades, medical malpractice has become a prominent issue in the Italian healthcare debate. Medical malpractice litigation has dramatically increased, with dire reflections on prices and availability of professional liability insurance. Insurance premiums have rapidly risen and insurers have often been unable to provide insurance coverage to physicians. As a consequence, physicians have been adopting changes to their practices, by taking allegedly unnecessary precautions or by refusing treatments that may be in the patients’ best interests but may also give rise to their  complaints (the so-called phenomenon of “defensive medicine”).   Different Interpretations of Malpractice by Courts.  Such phenomenon has been exacerbated by the fluctuating approach taken by civil courts in dealing with medical malpractice cases. In fact, Italian Courts have been advancing different interpretations on the nature of the relationship between a physician and a patient.

  1. Medical Malpractice as a Tort. Until 1999, liability arising from medical malpractice was deemed to be a tort. Interpreters believed that the absence of a formal agreement between the parties would trigger tort liability. As no contractual relationship was established between  physicians and patients, the latters, as injured parties, could rely  exclusively on proceedings based on section 2043 of the Italian Civil Code[1]. In light of this interpretation, medical negligence was considered to be a violation of a general duty of care, while patients bore the burden of proving damages suffered, a medical act negligent and a causation link between the two.
  1. Medical Malpractice as Contractual Liability. The above view has been gradually replaced by several opposing theories, which lean towards a contractual interpretation of the relationship between physicians and patients. Accordingly, medical negligence is currently held to be the failure to fulfil a specific obligation, and liability arising from such failure has been considered as contractual liability.

The more convincing approach to define the nature of physician’s liability was introduced by the Italian Supreme Court (Corte di Cassazione) with judgment no. 589/1999. According to such judgment, physicians can be held contractually liable under the theory of  “social contact” (contatto sociale). Such theory is based on the contractual liability of physicians for breaching the duty to protect patients’ health. Given the contractual nature of medical responsibility, damages can be awarded to patients if they produce evidence of the breach of contract committed by physicians, unless  physicians are able to prove that such breach is a result of conditions not attributable to them. In other words, physicians bear the burden to prove the exact fulfilment of the contractual obligation.   A New Statutory Provision on the Role of Guidelines in Medical Practice.  By enacting Law no. 189/2012, the Italian legislator has tried to counter the spread of defensive medicine. Section 3 of the aforementioned Law states that: “The health professional who, in her medical practice, adheres to guidelines and best practices accredited by the scientific community cannot be held criminally liable for ordinary negligence. In such cases however she remains subject to the obligation set out by section 2043 of the Civil Code. The judge, even when determining damages, shall take due account of the conduct referred to above”.   Renewed Controversy on the Nature of Medical Malpractice.  Reference to section 2043 of the Italian Civil Code in Law no. 189/2012 has sparked a new debate among scholars and in courts, some of which maintained that the legislator clearly meant to endorse the tort liability theory. For example, the Court of Milan[2] has recently stated that the theory of “social contact” has been repealed by the 2012 statutory provision and that, absent a specific contractual relationship established between patients and physicians, malpractice must be deemed a tort liability.   Others[3] have pointed out that the provision of Law no. 189/2012 merely states that, in the event of ordinary negligence, the obligation to compensate damages remains, without referring to the nature of medical liability, and that nothing in the statutory provision appears to be in conflict with previous case law on the contractual nature of medical liability.   The “social contact” theory therefore still stands, but the phenomenon of “defensive medicine” has yet to find a solution. [1] Section 2043 of the Italian Civil Code translates as follows: “Any willful or negligent fact causing to a third party an unfair damage triggers the obligation to reimburse such damage”. [2] Decisions no. 9693 of July 23, 2014 and no. 1430 of December 2, 2014. [3] For example, the Italian Supreme Court states this view in its decisions no. 8940 of April 17, 2014.

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.