Animas Corp Receives Warning Letter from the FDA

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.

Federal regulators have warned Johnson & Johnson that it could face fines and other sanctions for selling faulty insulin pumps and delaying disclosures of serious injuries to diabetics who were using its OneTouch Ping and 2020 pumps. The FDA ordered the Animas Corp. unit of J&J to explain why it kept selling pumps known to fail and also to submit a plan to rectify a failure to promptly report cases in which its device might have caused or contributed to death or serious injury.

Insulin pumps, which are about the size of a cellphone, automatically inject small amounts of insulin through a tiny needle under the skin throughout the day to keep diabetics' blood sugar at a safe level. Patients program the device to inject additional insulin right before a meal or snack, according to the amount of carbohydrates about to be eaten.

Animas spokeswoman Caroline Pavis said in an interview that the company did not report the three patient incidents to FDA as required within 30 days because each involved patients not using the pumps according to directions. In one case, she said, the patient ignored an alarm signaling the cap had come off the insulin cartridge inside the device, preventing insulin from being pumped into the body. She said Animas will now report all patient complaints promptly.

In the issue with the Animas insulin pumps, some pump keypads for controlling how much insulin is injected were deteriorating prematurely, leading to failures. "We decided to go with a new keypad because it's more durable," Pavis said.

But while Animas was lining up the new keypad supplier, it was still selling the older ones. The FDA demanded documents about the company's decision to do that.

David Rosen, a former FDA staff member who's now an attorney at Foley & Lardner advising clients on FDA regulatory issues, said companies must continuously evaluate a product's safety over its life span.

"A company the size of J&J should have infrastructure in place to process, review and classify complaints, because they could be indicative of a larger issue with the product," he said. "It's a little disconcerting that they didn't have their act together in that regard."

The FDA's warning letter states that the initial Animas response to the problems cited in the August inspection report was not adequate. Pavis said Animas hopes to respond before the Jan. 20 deadline.

The letter states that if the company doesn't promptly correct the violations, it could face seizure, injunction, and fines, and could be denied future contracts from federal agencies. Pavis could not say how much business Animas does with government Medicare and Medicaid programs.