On 10 February 2022, Mr Justice Butcher handed down judgment in the case of Cardiorentis AG v IQVIA Ltd v IQVIA RDS, Inc. [2022] EWHC 250 (Comm). Following a 7-week trial in the Commercial Court, Mr Justice Butcher dismissed Cardiorentis’ claim for wasted expenditure of about €100 million and awarded judgment in favour of IQVIA Ltd on unpaid invoices. Neil Kitchener QC, Laurence Emmett QC and Patricia Burns, instructed by Cooley (UK) LLP, represented the successful IQVIA defendants.
The claim concerned IQVIA’s conduct of a Phase 3 clinical trial of a drug that was hoped to revolutionise treatment for acute decompensated heart failure.
The decision is a landmark decision in the pharmaceutical industry. This was the first time an English court (or, it is thought, a court of any other common law jurisdiction) has given detailed consideration to the duties of the parties involved in the conduct of a clinical trial and in particular the nature and standard of care required by a clinical research organisation. The Court had to consider complex issues of biostatistics and cardiology, as well as clinical research practice.
The judgment also contains an important exposition and application of the law relating to claims for wasted expenditure.
You can view the Judgment here.