“…is there any need to state that the present cases are taking place against the specific background of an increase in the number of health scandals involving health products, in particular implantable medical devices such as artificial hip joints, cardiac leads, knee joints or breast implants?”- Advocate General Bot

The European Court of Justice published its long awaited decision in Boston Scientific Medixintechnick v AOK Sachsen-Anhalt on 5th March 2015.

Background

The EC Product Liability Directive 85/374/EEC was adopted in 1985 and was implemented into UK law by the Consumer Protection Act 1987 (CPA). This came in the wake of the Thalidomide Scandal, and was a move across the European Union to establish a harmonised regime to strike a fair balance between the economic interests and rights of big business versus an accessible recourse for injured consumers.

The CPA introduced a strict liability regime or, in other words, it removed the need for an injured Claimant to establish that the producer or supplier of a product was negligent (or at ‘fault’) if it harmed them due to some “defect”: something that had proved to be an uphill struggle for Claimants in previous headliner cases brought in negligence.

The legislation defines that a product is 'defective' if 'the safety of the product is not such as persons generally are entitled to expect' taking into account 'all the relevant circumstances'. Simple, right? Wrong.

For many years, Defendants in product liability claims in the UK have argued that Claimants should be put to a high level of proof, only entertaining cases where a Claimant could prove the precise nature of the defect in science and its exact mechanism of failure in the patient.

Over the years, several lower tier Courts have narrowly interpreted sections of the CPA whilst continuing to revert back to the ways of old by seemingly re-introducing principles of negligence by the back door.

Very few CPA cases have actually gone to trial, but recent decisions such as Alan Peter Ide & ATB Sales Ltd -v- Lexus Financial Services T/A Toyota Financial Services (UK) PLC & Sandra Russell , heard in the Court of Appeal, indicate that a broader application of the Directive is taking place.

The ECJ’s decision in Boston Scientific continues in that vein.

The Case 

The ECJ in Boston Scientific looked at three cases involving:

  • A pacemaker where it was thought that the sealing component might experience a gradual deterioration which could lead to premature battery depletion, resulting in loss of telemetry and/or loss of pacing output without warning.
  • An implantable cardioverter defibrillator where it was thought that a magnetic switch may stick in the closed position and that, if the device’s magnet mode was activated, this could prevent the treatment of ventricular or atrial arrhythmias.

The ECJ tasked itself with looking at ‘whether an active implantable medical device must be regarded as defective where it belongs to a group for which the risk of failure is significantly higher than normal or where a defect has already occurred in a significant number of products of the same model.’

To put it more simply, can someone’s medical implant be ‘defective’, entitling them to a claim for damages if replaced, if that product range has been recalled due to higher than expected failure rates for a specific reason, even if that person’s particular implant seems to be functioning perfectly well.

The ECJ ruled that it could.

Advocate General Bot noted that “The fact that a certain product belongs to a defective product group suggests that it has potential for failure itself which is at odds with what a person is entitled to expect as regards patient safety”.

Reference was also made to the vulnerable situations of patients requiring medical implants and the particularly high safety requirements to be expected of those products in the circumstances.

Commentary 

In my view, this case is a landmark decision in that it suggests:

  • that a product could be regarded as “defective” for the purposes of the CPA even if it has not yet failed, i.e. if it is subject to a product recall;
  • that the level of safety of medical devices to be legitimately expected by the public should be an extremely high one, taking into account the vulnerable situations of certain patients who need medical implants.

It also strengthens the arguments that it is not necessary for a Claimant to prove the exact nature of defect or its mechanism of failure within the patient in order for him/her to bring a successful claim.

The opinion of AG Bot also specifically makes reference to the fact that this case was decided against the backdrop of a number of health scandals involving health products, in particular implantable medical devices such as artificial hip joints, cardiac leads, knee joints or breast implants.

Whilst this is something that many consumers have been arguing is the correct interpretation of the CPA for many years, it should serve as the writing on the wall for those seeking to put producer/supplier’s rights at the top of the agenda.