CARDIORENTIS AG v IQVIA LIMITED

CARDIORENTIS AG v IQVIA LIMITED

Cardiorentis failed to prove that any material number of eligibility or protocol deviations in the TRUE-AHF trial were caused by IQVIA's breach of contract or that any such breach rendered the trial data unreliable or the expenditure wasted. The trial results were robust and interpretable, and the scientific community accepted their validity. Cardiorentis's claim for damages failed. However, Cardiorentis was entitled to injunctive relief for access to trial data. IQVIA succeeded in its counterclaim for unpaid invoices, subject to certain deductions.

Parties
Claimant: Cardiorentis AG; Defendant: IQVIA Limited; Defendant: IQVIA RDS, Inc.
Jurisdiction
England and Wales
Judgment Date
10 February 2022
Procedural Posture
Commercial Court Consolidated Claim and Counterclaim / Final Judgment After Full Trial
Outcome
Claim for damages dismissed; claim for injunctive relief granted; counterclaim for unpaid invoices allowed in part.
Legal Topics
Breach of Contract, Supply of Goods and Services Act 1982, Clinical Research Organisation (cro) Obligations, Wasted Expenditure Damages, Injunctive Relief, Interpretation of Clinical Trial Data, Statutory and Regulatory Compliance
Contract Law Clinical Trials Regulation Breach of Contract Supply of Goods and Services Act 1982 Clinical Research Organisation (cro) Obligations Wasted Expenditure Damages Injunctive Relief Interpretation of Clinical Trial Data +1 more

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Parties

Cardiorentis AG

Claimant

IQVIA Limited

Defendant

IQVIA RDS, Inc.

Defendant

Procedural Posture

Commercial Court Consolidated Claim and Counterclaim / Final Judgment After Full Trial

Legal Issues

  1. 1 Whether IQVIA breached contractual and/or statutory duties in conducting the TRUE-AHF clinical trial
  2. 2 Whether any such breach caused Cardiorentis to suffer loss, including wasted expenditure
  3. 3 Whether Cardiorentis is entitled to injunctive relief for access to trial data

Ratio Decidendi

Cardiorentis failed to prove that any material number of eligibility or protocol deviations in the TRUE-AHF trial were caused by IQVIA's breach of contract or that any such breach rendered the trial data unreliable or the expenditure wasted. The trial results were robust and interpretable, and the scientific community accepted their validity. Cardiorentis's claim for damages failed. However, Cardiorentis was entitled to injunctive relief for access to trial data. IQVIA succeeded in its counterclaim for unpaid invoices, subject to certain deductions.

Court Disposition

Claim for damages dismissed; claim for injunctive relief granted; counterclaim for unpaid invoices allowed in part.

Orders

  • Cardiorentis's claim for damages is dismissed.
  • Cardiorentis is granted an injunction for access to TRUE-AHF trial data.