Patient Protection Against Unsafe Medical Devices in German and U.S. Law

RAin Dr. Antonia Oblinger LL.M. (Tulane)

doi:10.5771/9783748916260

Summary

The work examines the extent to which regulation and product liability law in Germany and the U.S. encourages manufacturers to bring safe and innovative medical devices to market and how product safety could be further increased in both legal systems. The safety standard is defined in the light of product safety, availability, cost and innovation - and thus taking into account the interests of both manufacturers and consumers. With these aspects in mind, each legal system and its economic and practical effects are first examined separately and then compared. A particular focus lies on the analysis of the interplay between regulation and strict product liability law.

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Bibliographic data

Copyright year: 2025
ISBN-Print: 978-3-7560-0884-1
ISBN-Online: 978-3-7489-1626-0
Publisher: Nomos, Baden-Baden
Series: Schriften zum Bio-, Gesundheits- und Medizinrecht
Volume: 61
Language: English
Pages: 744
Product type: Book Titles

Titelei/Inhaltsverzeichnis No access Pages I - CXVIII
1. Chapter 1: Insights into medical device safety through comparative law No access
2. Chapter 2: Abstract No access
3. Chapter 3: Scope No access
1. Chapter 1: Enhancing medical device safety by regulation No access
2. Chapter 2: Enhancing medical device safety by product liability law No access
3. Chapter 3: Interplay of medical device regulation and litigation No access
4. Chapter 4: Excursus: private lawmaking and voluntary standards No access
1. 1. 1. 1. A. Statutory definition of medical devices No access
      2. B. Medical software and medical applica-tions No access
      3. C. Delimitation of medical devices to drugs and biologics No access
    2. II. Combination products No access
  2. § 2: Rationale and history of medical device regulation No access
  3. 1. I. The FDA as a regulatory authority No access
    2. 1. A. Device classes No access
      2. B. Classification process No access
    3. 1. A. Safety and effectiveness standard No access
      2. B. Clinical evaluation No access
      3. C. Market access for devices with substantial equivalence to a predicate No access
      4. D. Market access to medical devices without a substantially equivalent predicate No access
    4. 1. Postmarket surveillance No access
        Reporting obligations No access
        2. Data gathering and exchange by the FDA No access
      2. B. Enforcement by the FDA No access
    5. V. Summary No access
2. 1. § 1: History and policy of product liability No access
  2. § 2: Medical devices as products No access
  3. 1. 1. The design-defectiveness tests No access
        Additional requirements for design defects No access
        Privileged exception for prescription devices No access
        Comment k defense No access
        2. Manufacturing defect No access
        Addressee of the warning No access
        Duty to warn No access
        Adequacy of the warning No access
        4. Interplay of design defects with appropriate warnings and instructions No access
      2. 1. The relation between safety and procedural legal instruments No access
        The Barker presumption No access
        Presumption based on regulatory compliance and non-compliance No access
        Presumption of knowledge in failure to warn cases No access
        Presumption that the defect existed at the time when the medical device left the manufacturer's hands No access
        Established theories to prove defectiveness based on circumstantial evidence No access
    2. 1. 1. Cause-in-fact and proximate cause No access
        2. General and specific causation in medical device cases No access
        3. Evaluation No access
      2. B. Proof of causation No access
    3. 1. A. Compensatory damages No access
      2. 1. Substantive requirements of punitive damages No access
        Judicial approaches to the limitation of punitive damages No access
        Economic approaches to limit punitive damages No access
        3. Regulatory compliance defense against punitive damages No access
    4. 1. 1. The concept of preemption No access
        2. Preemption of medical device tort claims No access
      2. B. The state-of-the-art defense No access
    5. V. Summary No access
1. 1. 1. 1. A. Statutory definition of medical devices No access
      2. B. Medical software and apps No access
      3. C. Medical devices without an intended medical purpose No access
      4. D. Delimitation of medical devices No access
    2. II. Combination products No access
  2. § 2: Rationale and history of regulation of medical devices No access
  3. 1. 1. A. Legal requirements No access
      2. B. Appointment of the notified body No access
      3. C. Monitoring and enforcement powers of the responsible authority No access
    2. 1. A. Device classes No access
      2. B. Classification system No access
    3. 1. A. Safety and performance requirements No access
      2. B. Clinical evaluation No access
      3. Conformity assessment based on a quality management system (Annex IX) No access
        Conformity assessment based on production quality assurance (Annex XI Part A) No access
        Conformity assessment based on a quality management system (Annex IX) No access
        Conformity assessment based on product conformity verification (Annex XI) No access
        Conformity assessment based on the quality management system (Annex IX) No access
        Conformity assessment based on product conformity verification (Annex XI in conjunction with Annex X) No access
        Additional requirements for special Class IIb devices No access
        4. Conformity assessment regarding Class III devices No access
        5. Assessment No access
    4. 1. Postmarket surveillance duties of the manufacturer No access
        Vigilance duties of the manufacturer No access
        2. Data gathering by the competent authority No access
        3. Monitoring by the notified body No access
      2. B. Enforcement power No access
    5. V. Summary No access
2. 1. § 1: History and policy of product liability law No access
  2. 1. I. Implants as products No access
    2. II. Classification of stand-alone medical software as a product No access
  3. 1. 1. Enumerated criteria to concretize legitimate safety expectations No access
        Other criteria No access
        Assessment No access
        2. Original defect types No access
        Compatibility of the decision with the ProdHaftG No access
        Effects of the Boston Scientific decision on medical device safety No access
        4. Interplay of design defects or manufacturing defects and failure to warn claims No access
      2. 1. Presumptions and theories regarding design and manufacturing defects No access
        2. Presumptions regarding failure to warn claims No access
    2. 1. A. Substantive requirements No access
      2. B. Proof of causation No access
    3. 1. 1. Economic losses No access
        2. Non-economic damages No access
      2. B. Punitive damages No access
    4. 1. A. Defect did not exist at the time when the product was put into circulation No access
      2. B. Compliance with mandatory regulations No access
      3. C. Development risk defense No access
    5. V. Summary No access
1. 1. § 1: Body responsible for medical device oversight No access
  2. 1. I. Device classes No access
    2. II. Classification process No access
  3. 1. I. Standard of review No access
    2. II. Clinical evaluation No access
    3. 1. A. Review of Class I devices in Germany and the U.S. No access
      2. B. Review of U.S. Class II devices and German Class IIa devices No access
      3. C. Review of U.S. Class III devices and German Class IIb to III devices No access
      4. D. Exceptions from the review process No access
  4. 1. 1. A. Surveillance and reporting duties of the manufacturer No access
      2. B. Data gathering and exchange by the regulatory body No access
    2. II. Enforcement No access
  5. § 5: Summary and key takeaways No access
2. 1. § 1: Medical devices as products No access
  2. 1. 1. A. Predictability No access
      2. 1. Safety-relation and safety standard imposed by the design defect No access
        2. Interplay of design defect and medical device regulation No access
      3. C. Achievable standard of safety No access
      4. D. Proof No access
      5. E. Analysis and summary No access
    2. II. Manufacturing defect No access
    3. 1. A. Addressee of the warning No access
      2. B. Duty to warn No access
      3. C. Adequacy of the warning No access
    4. IV. Part of a product series that has an unreasonably high failure rate No access
    5. V. Interplay of design defect and failure to warn claim No access
  3. § 3: Causation No access
  4. 1. I. Compensatory damages No access
    2. II. Punitive damages No access
  5. § 5: Summary and key takeaways No access
Part VI: Prospects No access Pages 739 - 744