Update: Johnson & Johnson Knowingly Sells Defective Insulin Pumps
The Animas unit of Johnson & Johnson continued to sell insulin pumps last year after the company knew its defective medical devices were malfunctioning, the U.S. Food and Drug Administration (FDA) said in warning letter it sent to the company on Dec. 27, 2012.
While Animas investigated design failures of the devices, it continued to sell the malfunctioning pumps. Animas began investigating problems with the pumps in April 2011.
In the warning letter addressed to the general manager of Animas Corporation dated Dec. 27, 2011, the FDA blamed the company for failing to explain why it sold insulin pumps after it “had known failures.” The pumps in question, which had keypad malfunctions, are One Touch Ping and 2020.
A spokeswoman for Animas, Caroline Pavis, said the FDA warning letter simply “requested further clarification on our internal quality systems and processes. The insulin pumps we manufacture meet all product specifications.”
Because of the failures of the pumps, Animas changed their designs and bought the manufactured products from a different supplier.
The FDA requires that a company report the finding of a malfunction that could have caused or contributed to a death or serious injury no later than 30 calendar days since the time of the finding. In its letter, the FDA told Animas it failed to do so.
The FDA gave a number of examples of this failure to report these findings within the time period required. It included situations that involved:
- A patient who went into diabetic ketoacidosis
- Another patient that required an insulin drip
- Another in which misuse of the device may have contributed to a serious injury (e.g. coma, respiratory failure, and hypoglycemia)
In its letter, the FDA said the warning could result in fines or affect J&J’s ability to receive federal contracts.
Insulin Pump Lawsuits
If you or a loved one has experienced problems with your insulin pump, you may be able to seek compensation by filing an insulin pump lawsuit. To learn more, contact the defective medical device attorneys at the law office of Aylstock, Witkin, Kreis and Overholtz at (844) 794-7402 for a case evaluation.