Representation in an International Dispute Concerning a Medical Device Supply Agreement

Lee & Ko is representing a Taiwanese medical device supplier in appellate proceedings arising from an international civil dispute against a Korean diagnostic kit manufacturer in connection with a medical device supply agreement.

The dispute concerns the supply of COVID-19 antigen rapid diagnostic test kits to the Taiwanese market during the COVID-19 pandemic. The key issues include performance of contractual obligations, alleged deficiencies in product performance, and the corresponding scope of payment obligations under the agreement. In the first instance, the court ruled against the supplier, finding that no defect in the rapid diagnostic kits had been established. Following its appointment at the appellate stage, Lee & Ko has undertaken a comprehensive review of the trial court’s reasoning and overall analytical framework.

In the appellate proceedings, Lee & Ko is addressing not only issues of contractual interpretation relating to claims for payment, but also a range of complex legal and technical questions. These include applicable medical device performance standards, the adequacy of quality management systems, and the extent to which actions taken by overseas regulatory authorities may influence the assessment of civil liability.

Drawing on its understanding of Taiwan’s regulatory framework and academic environment, the firm has worked in close coordination with local regulatory and academic experts to obtain authoritative expert opinions. These materials have been carefully integrated into the appellate strategy to ensure that the court is presented with a scientifically grounded and legally coherent analysis.

This case represents a multifaceted cross-border dispute involving international distribution arrangements, product performance issues, and foreign regulatory considerations. In the appellate proceedings, Lee & Ko is systematically organizing both the factual record and the governing legal principles, and advancing persuasive arguments from legal and technical perspectives to support a reasoned and balanced determination.