EU Issues Preliminary Ruling on Allegedly Defective Pacemakers, Defibrillators

As Reported & Reviewed by Hunton & Williams on the ACC Website

“On 5 March 2015, the European Court of Justice issued a preliminary ruling on two issues arising under the EU Product Liability Directive in a case involving defective pacemakers and defibrillators. Despite the wide range of issues arising under this directive, the Court has had only a few occasions to construe its ambiguous terms. This case, however, provided an opportunity to the Court to settle key issues relating to the defect test and the scope of damages compensable under the directive . . .”

“Apparently, the Court believes that medical devices do not meet safety expectation entitlements where no actual patient injuries have occurred due to device malfunctioning, and the statistical chance that a device functions properly is over 99%.”

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