Johnson & Johnson has come under scrutiny yet again for another one of their business failures. The business being monitored this time is Animas, a branch of Johnson & Johnson that manufactures insulin pumps. Animas is at least the seventh Johnson & Johnson business to come under scrutiny, causing J&J to incur enormous fines and lost revenue. The defects in the pumps, specifically the premature rate of failure of a main component, illustrate two main problems but what is even more disturbing is Johnson & Johnson’s lack of a timely report of these occurrences. A J&J spokesperson said that she did not alert the FDA of these events because they were caused by consumers not using the insulin pumps correctly and ignored warnings that certain parts had come loose.

Johnson & Johnson’s insulin pump, roughly the size of a cell phone, injects insulin into a person’s body through a small needle under the skin. It injects this insulin automatically throughout the day and injects additional insulin before meals depending on the amount of carbohydrates consumed. The problems with these devices lie in the premature failure rate of the keypad that determines how much insulin is released into the body. Johnson & Johnson has decided to use a more durable keypad in future products.

What may be worse than premature failure is that J&J failed to report at least three situations in which the insulin pump failed and caused severe injuries. The FDA requires manufacturers to report adverse reactions or instances of failed devices within 30 days but J&J ignored this requirement. It is known that at least three patients were hospitalized for extremely high blood sugar, coma, respiratory failure, and diabetic ketoacidosis, a life-threatening complication due to a lack of insulin. J&J continued to market and sell these insulin pumps without alerting consumers of these very serious failures. 

Recalls of J&J products cost them $900 million in 2010 alone because numerous products can no longer be sold in stores. This $900 million does not cover the costs of factory upgrades or legal expenses. In reference to the defective insulin pumps, federal regulators have warned Johnson & Johnson that it could potentially face further fines as well as injunction and seizure if it does not correct its violations promptly.