A pharmaceutical company (sponsor) hired a
CRO to manage the distribution of drugs for a double blind clinical trial. Due to a distribution error, the CRO allegedly caused too many participants to receive the placebo instead of the active ingredient under investigation. The regulatory authority deemed the trial’s resulting data flawed, preventing the sponsor from obtaining market approval for the drug.

A pharmaceutical firm hired a CMO to manufacture epinephrine mist. A Class III product recall resulted from the CMO’s alleged failure to test the mist for all microbial specifications. The pharmaceutical firm sought damages for breach of contract and negligent misrepresentation.

A dental device company retained a university to conduct a dental implant clinical trial. The university allegedly breached the clinical trial contract by failing to provide information required, such as the implantation date; the date the patient was examined; and a description of the implant tissue quality and the amount of bone growth. Additionally, the university allegedly failed to follow the protocol: one patient exceeded the age limit, one implant was too close to the patient’s sinus cavity, and in one instance the wrong cement was used.