US FDA has sent a warning letter to Johnson and Johnson subsidiary Animas Corporation relating to its failure or delay in reporting a number of complaints relating to two of its insulin pumps.
FDA’s letter, which can be found here, details three occasions when the company had received information pertaining to its products in which devices that it markets “may have caused or contributed to a death or serious injury”.
Of the three complaints one involves an absence of any report to FDA when one was clearly mandated. This case involved a patient in whom the device “may have been a factor” in onset of diabetic ketoacidosis as a result of user error.
In the second and third cases, the company failed to make FDA aware of complaints within the mandated 30 day period. In neither event was there any evidence that the device in question malfunctioned and indeed in one case user error was again clearly identified as the cause of the patient suffering coma, respiratory failure and hypoglycaemia.
Bit harsh isn’t it?
In none of these cases was a clear link to the product established other than by implying that user error was the cause. While of course companies are obliged to report all such events to their regulatory body, it’s harsh to see J&J being pilloried for what are relatively minor non-conformances. Such is the way of the news-hungry world however, and when you’re name’s Johnson & Johnson and you’ve already suffered one of your divisions (DePuy) facing the huge expense and commercial harm of the very well publicised problems with it’s all-metal hip prostheses, then you know what’s coming. This knuckle rap for a J&J division by FDA relates to that division’s inadequacies in medical device reporting, inadequacies which one would expect they will have addressed by now, but which re-emphasise the fact that regulators are really pretty hard on this stuff, whatever the media may choose to report about lax practices in medical device regulatory enforcement.