Devices / products:
The insured manufactures insulin pumps. There is a fault in the pump, which leads to incorrect dosages of insulin being administered to several patients, causing hypoglycaemia. The injury results in the death of one adult patient and severe and permanent brain injury to a paediatric patient. A class action is brought against the insured alleging a product defect caused the bodily injuries.
A patient alleges that the insured’s wheelchair malfunctioned causing them to be ejected from the chair. The patient sustained a serious head injury resulting in permanent cognitive impairment. A claim is made on behalf of the patient by their spouse for substantial losses including loss of earnings and care/assistance for life.
Clinical Research Organisation - financial loss
- The claimant corporation makes a claim against the insured Clinical Research Organisation (CRO) alleging that there was a dosing error during Phase II of a clinical trial. It is claimed this resulted in a substantial delay in the trial, the need to repeat part of study and the failure for the claimant to be the first in the market place with the new drug. A competitor of the claimant is able to get their product through trials and to marketing and sales stage a year before the claimant, leading to a substantial professional indemnity claim being filed against the insured CRO for the financial losses suffered.
Clinical trials - bodily injury
- A Phase I trial for an immunomodulatory drug resulted in severe reactions in all six participants within hours after the product was administered. The participants experienced effects similar to a severe allergic reaction, requiring hospitalisation for a month or more. Claims are made under the no-fault compensation scheme. Multiple compensation payouts are required for all the participants.