Many of you have probably heard by now that J&J Animas was hit with a warning letter from FDA recently, and the accusations that they compromised patient safety by continuing to sell insulin pumps with known defects. This sounds pretty scary and negligent indeed. Why would a leading pump company do something so seemingly stupid? We called Animas spokesperson Caroline Pavis to get their side of the story.

Of course it's the job of the company's PR rep to downplay negativity, so we took all of this with a grain of salt. But it's also generally the media's job to scare up a juicy story, so it's quite plausible that the accusations have been blown out of proportion, as the spokeswoman claims. On the other hand, J&J has experienced a string of product recalls running from September 2009 on everything from Tylenol to hip implants that make some analysts wonder why their CEO still has a job.

The full Warning Letter regarding Animas insulin pumps is posted on the FDA's web site here.

Here's the company's viewpoint — and some tips on what Animas pump users should look out for — as communicated by Caroline Pavis:

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DM) The warning letter makes a statement about your pumps being "misbranded." Is that the issue at stake here?

CP) That's some kind of standard language that FDA uses in all correspondence — it really doesn't apply here. There were two issues the FDA was addressing with us: 1) an issue of missing documentation — our MDR (medical device reports) need to be filed within 30 days, and we missed that deadline in a couple of cases, and 2) an issue of documentation about our decision to keep selling our current pumps as we move to a new keypad supplier.

A lot of media reports made this out to be a much bigger issue of compromising patient safety, which really isn't the case.

Can you explain the "reporting issue"? There were three patients who were hospitalized, correct?

One case involved intentional misuse of the product, so we had originally determined it was not reportable.  Two other people went into DKA and had notified us of that, but because of some errors in our computer system that needed updating, we were late reporting them.

We ourselves identified these instances, and we shared this with FDA when came in for an inspection. We did not hide it from anybody. Their response was to send us a warning letter, which is the procedure they have to follow.

To solve the Call Center issue, we implemented a new CRM system in 2011 and made some other quality improvements. We agree that we need to be 100% on time in our reporting. It's not acceptable not to do that.

Were the DKA instances related to the issue of your pump keypads wearing out?

There was no evidence in these cases that the device malfunctioned.

But there was an issue of poor quality of the keypads on your pumps?

We started to receive a lot of complaints from 2020 pump and OneTouch Ping customers about two years into their warranty, that the printing on the buttons starts to wear off, or the rubber had faded, or was cracked or peeling.

We did several health hazard studies, showing that the keypad did not pose a safety or health risk. Still, it's a quality issue, so we had already identified a new keypad supplier, and the models with newer keypads started shipping in Fall of 2011.

FDA just wanted to see more information on our decision to keep manufacturing pumps with the older keypads while we were ramping up.

We responded to all of their concerns in a letter sent on Friday, Jan. 20.

What can Animas pump users do if they're worried about the keypad on their model? Will you offer a replacement unit?

Thee keypad issues will be visibly apparent. For instance, patients may experience a peeling keypad or a cracked screen. If they're within their four-year warranty, they can get a free replacement pump. They should still call in if their pump is out of warranty, and we can discuss options with them. Please call our Animas Customer Technical Support line at 1-877-937-7867 and press option 1, and we will be happy to assist you.

Has this been a PR disaster for Animas?

Thankfully, patients are not getting overly concerned. We want to encourage all patients with concerns to call in. We're committed to patient safety.

So now I'm wondering: is the pump company always responsible or legally liable if a patient goes into DKA? What about human error? Or for example if someone causes an accident, or even kills themselves in a car, can you blame the car maker?

There's a lot of grey area around these instances. But these are medical products with a certain amount of risk built in. We have to be diligent in our training and education.

 

Amen to that. Thank you for the updates, Caroline.

 
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