FDA: J&J delayed reporting insulin pump problems
(AP) -- 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 Food and Drug Administration ordered J&J's Animas Corp. unit to explain why it kept selling pumps known to fail and also to submit a plan to rectify its failure to promptly report cases where its device might have caused or contributed to death or serious injury.
In a Dec. 27 warning letter posted online by FDA Tuesday, the agency wrote to Animas and J&J CEO Bill Weldon that inspectors found Animas, which is based in West Chester, Pa., never reported on one complaint about serious patient injury and delayed reporting on two others. Those patients were hospitalized with dangerously high blood sugar, respiratory failure and coma, and a life-threatening complication called diabetic ketoacidosis caused by lack of insulin to break down blood sugar.
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 a separate issue, 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 LLP 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 problems follow a string of nearly 30 product recalls announced by New Brunswick, N.J.-based Johnson & Johnson from September 2009 through last month. They have included millions of bottles of Tylenol, Motrin and other nonprescription medicines for children and adults, prescription drugs for seizures and HIV, faulty hip implants and contact lenses that stung the eyes. Reasons for the recalls ranged from contamination with metal shards and glass particles, to nauseating odors and inaccurate levels of active drug ingredients.
"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. "The amazing thing is that Bill Weldon still has a job."
The recalls cost J&J $900 million in 2010 alone in lost revenue from products not being in stores, plus millions more for factory upgrades and legal expenses. The FDA and Congress have been investigating the handling of the manufacturing problems and the recalls by a company that stresses in its corporate credo its responsibility to the doctors, patients and parents who use its products.
J&J has said there have been no reports of serious patient harm from the recalled products, although it's now being sued by a couple alleging their toddler died from taking a "super dose" of defective Children's Tylenol.
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 the Medicare and Medicaid programs.
On Wednesday, Johnson & Johnson shares fell 7 cents to close at $65.13.
©2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
- Johnson & Johnson gets FDA warning on marketing Aug 24, 2010 | not rated yet | 0
- FDA found bacteria in lots for recalled Tylenol May 04, 2010 | not rated yet | 0
- J&J, FDA leaders take heat for 'phantom' recall Sep 30, 2010 | not rated yet | 0
- Johnson&Johnson expands Tylenol recall Jan 15, 2010 | not rated yet | 0
- CEO: J&J let down public, must work to build trust Aug 27, 2010 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
If you became brain-dead, would you want them to pull the plug?
16 hours ago I'd want the rest of me to stay alive. Sure it's a lousy way to live but it beats being all-the-way dead. Maybe if I make it 20 years they'll...
MRI bill question
May 15, 2013 Dear PFers, The hospital gave us a $12k bill for one MRI (head with contrast). The people I talked to at the hospital tell me that they do not...
Ratio of Hydrogen of Oxygen in Dessicated Animal Protein
May 13, 2013 As an experiment, for the past few months I've been consuming at least one portion of Jell-O or unflavored Knox gelatin per day. I'm 64, in very...
Alcohol and acetaminophen
May 13, 2013 Edit: sorry for the typo in the title , can't edit I looked around on google quite a bit and it's very hard to find precise information on the...
Marie Curie's leukemia
May 13, 2013 Does anyone know what might be the cause of Marie Curie's cancer
Genetic variations within and between populations
May 12, 2013 This paper (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1893020/) asserts these two different conclusions: ---Quote--- Thus the answer to the...
- More from Physics Forums - Medical Sciences
More news stories
Europe's medicines watchdog said Friday the benefits of acne drug Diane-35, also widely used as a contraceptive, outweigh the risk of developing blood clots in the veins—when correctly prescribed.
Medications 16 hours ago | not rated yet | 0
Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology AG today announced that the first healthy volunteer has been dosed in a Phase 1 clinical trial with their ...
Medications 17 hours ago | not rated yet | 0
(Medical Xpress)—An aspirin a day may not always keep heart disease away, say two University of Florida cardiologists. But a new algorithm they have developed outlines factors physicians should weigh as ...
Medications May 16, 2013 | 3.5 / 5 (2) | 0 |
(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard ...
Medications May 15, 2013 | not rated yet | 0
Big names in medicine are set to give an upbeat assessment of the war on AIDS on Tuesday, 30 years after French researchers identified the virus that causes the disease.
1 hour ago | not rated yet | 0
For combat veterans suffering from post-traumatic stress disorder, 'fear circuitry' in the brain never rests
Chronic trauma can inflict lasting damage to brain regions associated with fear and anxiety. Previous imaging studies of people with post-traumatic stress disorder, or PTSD, have shown that these brain regions can over-or ...
2 hours ago | not rated yet | 0 |
The neural machinery underlying our olfactory sense continues to be an enigma for neuroscience. A recent review in Neuron seeks to expand traditional ideas about how neurons in the olfactory bulb might encode information about ...
13 hours ago | not rated yet | 0 |
(Medical Xpress)—What if the quality of your work depends more on your focus on the piano keys or canvas or laptop than your musical or painting or computing skills? If target users can be convinced, they ...
14 hours ago | 3.7 / 5 (3) | 0 |
In 2008 researchers from the University of Southern Denmark showed that the drug thioridazine, which has previously been used to treat schizophrenia, is also a powerful weapon against antibiotic-resistant bacteria such as ...
11 hours ago | 3.7 / 5 (3) | 0 |
(Medical Xpress)—Working with lab mice models of multiple sclerosis (MS), UC Davis scientists have detected a novel molecular target for the design of drugs that could be safer and more effective than current FDA-approved ...
11 hours ago | 5 / 5 (2) | 0 |