Embattled drug giant, Johnson & Johnson is being probed over complication reports about its Animus insulin pump.
Last year, we wrote that Johnson & Johnson issued a recall for its 2.0 mL Animas Insulin Pump Cartridges over a defect that could leak insulin, causing an under-dosing of insulin, which could lead to high blood sugar and/or diabetic ketoacidosis, both serious conditions that can cause severe adverse reactions, including death. Once considered the gold standard for consumer safety, Johnson & Johnson has been plagued by a seemingly never-ending string of recalls, many over quality issues, as well as investigations into its various units.
Animas Corp. is being investigated and just received a warning from the U.S. Food and Drug Administration (FDA) that if it does not resolve its violations, and soon, it could face fines and sanctions for having sold defective insulin pumps, said The Associated Press (AP). The FDA also warned Animas for delaying release of information concerning serious patient injuries over OneTouch Ping and 2020 pumps, said the AP.
The agency ordered Animas to submit its explanation by January 20, including why it continued to sell the defective pumps, said the AP. Animas must also submit a plan detailing how it intends on rectifying its failure to promptly report those cases in which the device caused or were involved in cases of death or serious injury, said the AP. The December 25 warning letter, which can be accessed at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm285656.htm, was posted online by the FDA this week and addressed to Animas and Johnson & Johnson chief executive Bill Weldon.
The warning letter discussed how Animas delayed reporting on two cases and never reported one case within the 30 calendar day mandate, and that it knew that its device might have caused or contributed to a death or serious injury.
One case involved diabetic ketoacidosis resulting from user error. According to the FDA, this event should have been reported. Another case involved a patient treated with an insulin drip after hospital admission for high blood glucose. The hyperglycemic patient received medical intervention via insulin drip; Animas was made aware of the situation in August 2010, but did not report this to the FDA within the 30 days. Another case was raised in which the device may have been involved in a serious injury as a result of user error. Animas was made aware of the situation November 2010, but did not report the matter to the FDA until last January, well after the 30-day mandate.
The problems follow dozens of product recalls since September 2009; the most recent, just weeks ago, noted the AP. “Any company can have one of these things pop up and smack them, and you can have a bad coincidence when two of them come and smack you three weeks apart. But it’s not bad luck when you have” this many, said Erik Gordon, a professor and analyst at the University of Michigan’s Ross School of Business, reported the AP. “The amazing thing is that Bill Weldon still has a job,” Gordon added. Caroline Pavis, an Animas spokeswoman, told the AP that Animas did not report the three incidents within the 30 days because they all involved incorrect patient use of the devices, but that Animas will now report every patient complaint promptly.