D. Miller & Associates, PLLC is representing individuals injured by Johnson & Johnson’s Animas insulin pumps. The Animas unit continued to market and sell insulin pumps even after learning of malfunctions with the devices. The US Food and Drug Administration (FDA) faulted Johnson & Johnson for not adequately explaining why they had continued to manufacture the insulin pumps, fully knowing that they had design failures. This prompted a company investigation by the FDA and design changes to the pump.
Animas Insulin Pumps Used For Type 1 Diabetes
Insulin pumps are used for Type 1 Diabetes, which accounts for approximately 5-10% of all Diabetes cases. Type 1 Diabetes is sometimes referred to as “juvenile diabetes.” The pumps have been shown to malfunction, giving the wrong dosage of insulin to the user which can be fatal. Since the pumps are used mainly by teens and young adults, these reports are being taken especially serious by the FDA.
Johnson & Johnson, the world’s second-biggest seller of health-care products, has been issued a number of FDA warnings and safety recalls in the past 2 years. The issues with Animas’ One Touch Ping and 2020 pumps, follows recalls of dozens of over-the-counter medicines and faulty artificial hips. As a result, Johnson & Johnson has agreed to give the FDA expanded oversight over three manufacturing plants.
Patients Using Animas Pumps Were Injured
In addition to manufacturing the defective pumps, Animas failed to quickly report three incidents to the FDA in which patients using Animas pumps were injured. Those patients were hospitalized with dangerously high blood sugar, respiratory failure and coma, and a life-threatening complication called diabetic ketoacidosis, caused by a lack of insulin to break down blood sugar. The FDA reported that in one incident, there was no evidence of the pump malfunctioning while the other two incidents involved “human error.”
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