Module 17 2024

04/12/2024

Meaning of ‘defect’ (implantable medical devices)

Combined CJEU judgments: German Health Funds litigation against Boston Scientific (Cases C 503/13 & C-504/13 of 5 March 2015) • Individual AIMD is defective if belonging to same group, or forming part of same production, as products found to have a potential defect • Pacemakers subject to advisory action for premature battery depletion • Particularly high requirements for meddevs because of their function and particularly vulnerable patient user group

Defective if product risks have an abnormal, unreasonable character exceeding normal risks inherent in use • German court considered the expectation that a failure rate of close to zero would be reasonable in view of life-threatening risks presented by the product and in spite of specialist medical opinion that a 100% safe pacemaker was impossible • Advocate General: advocated a special “patient safety” category for defectiveness test

23

TOPRA MSc Module 17

23

Design Defect? Wilkes v DePuy International Limited MoM Hip Implant Litigation – 1st instance England (2016)

Total hip replacement femoral neck fracture – design defect alleged because persons generally would not have expected the stem to suffer from early fracture Defendant argued fatigue fracture = rare but recognised risk & noted in IFU – amongst most frequently encountered AEs – stems tested acc relevant British Standard

•

Not defective:

• Product met all relevant mandatory standards and regulatory requirements • Fatigue failure rate complied with relevant BSs • Fact that neck thread could have been avoided fails to take account of possible design disadvantages of such changes – not appropriate to design out entirely the single risk without regard to other design features • Unambiguous and clear IFU warnings re femoral stem fatigue • Small risk of fracture and relatively

•

limited consequences (i.e. revision operation)

24

TOPRA MSc Module 17

24

12