Johnson & Johnson hit with FDA warning letter
January 12, 2012 by MassDevice staff
More regulatory woes as Johnson & Johnson hit with a warning letter from the FDA regarding its insulin pumps.
Animas Corp.’s OneTouch Ping
The FDA issued a warning letter to medical device giant Johnson & Johnson (NYSE:JNJ) saying that the company could face penalties including fines and injunction for failing to report incidents where its OneTouch Ping and 2020 insulin pumps may have caused death or serious injury.
In an inspection of the West Chester, Pa.-based plant, the federal watchdog agency found that J&J’s Animas Corp. never reported on 1 complaint about series patient injury and delayed reporting 2 other incidents to the FDA.
The affected patients were hospitalized with diabetic ketoacidosis – a complication caused when patients lack the insulin to break down blood sugar, high blood sugar, respiratory failure and coma, according to the letter.
The watchdog agency ordered the J&J subsidiary to explain, by Jan. 20, why it kept selling pumps known to fail. The company is also required to submit a plan to ensure that its failure to notify the FDA of devices that may cause serious injury or death in patients doesn’t have a repeat performance.
Animas spokeswoman Caroline Pavis told the Huffington Post that the company failed to report the 3 patient incidents to FDA because they involved patients that weren’t using the pumps as directed.
In 1 case, the patient ignored an alarm signaling that a cap had come off the machine, preventing insulin from being pumped into the body, Pavis told the new site.
Animas’ insulin pump problems are just the latest in a string of bad regulatory publicity for the New Brunswick, N.J. based medical device giant.
Just last week, the FDA ordered Johnson & Johnson, along with 32 other companies, to take another look at complication rates associated with their vaginal mesh products.
The watchdog agency asked a total of 33 companies to conduct 3 years of safety and effectiveness trials under growing concerns after deaths and injuries linked to the products spiked in recent years.
Subsidiary DePuy Orthopaedics could cost the med-tech titan up to $1 billion in lawsuits concerning metal-on-metal hip implants that were found to shed minute metal particles into a patient’s bloodstream over time.
Lawsuits over the ASR implant have piled up across the country, accusing DePuy of manufacturing a defective product, failing to warn patients and doctors of problems with the implant and negligence in designing, manufacturing and selling the product.
- Johnson & Johnson Under Scrutiny By FDA For Delay In Reporting Insulin Pump Problems (huffingtonpost.com)
- FDA: J&J delayed reporting insulin pump problems (sfgate.com)
- FDA: J&J delayed reporting insulin pump problems (seattlepi.com)
- FDA: J&J delayed reporting insulin pump problems (usatoday.com)
- FDA: J&J delayed reporting insulin pump problems (seattletimes.nwsource.com)
- FDA: J&J waited to report insulin pump problems (msnbc.msn.com)
- FDA probes JNJ, Bard and others on transvaginal mesh risks | MassDevice – Medical Device Industry News (earlsview.com)
- FDA: J&J delayed reporting insulin pump problems (mysanantonio.com)
- Health equipment maker Midmark gets FDA warning letter on sterilizers (medcitynews.com)
- Sparta Systems Expert to Speak on Compliance and CAPA with AdvaMed at “Avoiding FDA Warning Letters” Panel (prweb.com)