I read with interest your C+D blog published on February 11 titled “Let’s make auto-injectors more patient friendly.”
You wrote that when a patient brought her housebound husband’s dry powder inhaler back to your pharmacy, saying “it’s faulty – he needs a new one”, she assured you that it wouldn’t activate. As this patient had been using the inhaler for over 18 months without a problem you presumed it was indeed faulty due to a design flaw that meant the device was prone to clogging up. You supplied a replacement. You contacted the manufacturer, who did not accept any responsibility for the issue.
When you supply something to a patient on an NHS prescription, there is no contract between you and the patient. This means the patient has no rights under the Consumer Rights Act 2015 to say that the inhaler must be of satisfactory quality. I quite understand that, being in a caring profession, you chose to try to provide a new inhaler – but you were not under an obligation to do so. You could have told the patient to get a new prescription.
However, there is a contract between you and your wholesaler containing an ‘implied term’ [a term that wasn’t in the contract, but that a court would assume was intended to be included] saying that the inhaler was of satisfactory quality. In deciding whether you have a claim against the wholesaler, the inhaler’s durability is a factor to be taken into account. You would have to suggest a reason why the problem was not caused by patient misuse. Can you provide evidence that the same inhalers have been returned to you or other pharmacies because they wouldn’t activate?
There is no contract between you and the manufacturer, so you have no rights there. If a design fault means the product was defective and caused the patient injury, the patient could sue the manufacturer under the Consumer Protection Act 1987. For example, a number of patients have filed lawsuits against GlaxoSmithKline over problems they allege arose from taking Seroxat. However, in your case there appears to have been no injury to the patient.
You could consider taking up your concerns about a design fault with the Medicines and Healthcare products Regulatory Agency (MHRA) because regulations say devices must achieve the performance intended by the manufacturer. Alternatively, if you can get hold of someone sufficiently senior at the manufacturer, mentioning the possibility of complaining to the MHRA might change their attitude because large corporations do not like having to report regulatory complaints to their shareholders.
I hope this advice is helpful.
Chair of the Pharmacy Law & Ethics Association
Look out for Xrayser's upcoming response to the letter on C+D.