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Gosh and golly gee willikers, yet another Johnson & Johnson subsidiary, Animas, totally sucks, eh?
Keywords: Johnson and Johnson, Johnson & Johnson, animas, vibe, diabetes, insulin, device, pump
Date Created: 2016, August 4
Animas, a subsidiary of Johnson & Johnson, manufactures and promotes the use of crappy, undependable, defective, rather deadly, diabetes products. Their Vibe and One Touch Ping system have 74 records of DEATH since March of 2012, when I started the site, in the United States Food and Drug Administration Manufacturer and User Device Experience (US FDA MAUDE) Database.
Let's take a quick look at the history of these obviously defective devices...
The device was submitted to the United States FDA under 510K exemption, which means based on a pre-existing, similar product. The US FDA received the application for the device on September 23, 1999 and was approved quite quickly on February 10, 2000. This is yet another device pushed through the FDA on 510K exemption which means no one reviewed the actual product, checked it for dependability, etc. It's quite likely no one at the FDA even turned a unit on before approval. Basically, it was, "Hey FDA people, this works like the others, but different, sort of, but not really much different. Oh, wait, nope, don't test it, we did, it worked fine for us."
In 2005, Johnson & Johnson Animas management was sent a WARNING Letter by the United States Food and Drug Administration regarding infusion pump failures. It clearly stated there were known problems with the device as well as how Animas was handling consumer complaints, which were basically ignored.
"...seventeen (17) design changes (DCNs) that were supposed to address the identified failure either did not correct the known failures or had never been implemented."
In 2011, Johnson & Johnson was sent another WARNING Letter by the United States Food and Drug Administration regarding numerous complaints with accuracy of Animas' diabetes pumps. Part of the warning regarding known problems with Animas diabetes pumps:
"Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties."This letter was also sent to William Weldon, who was then CEO of Johnson & Johnson as well as Alex Gorsky, who was head of Johnson & Johnson Medical Devices segment and is now the current CEO of Johnson & Johnson. Both were well aware the diabetes pumps are faulty and quite literally did NOT solve the problems. Hey-uh, Gorsky: Head's up, uh, "INNOVATION" would be products that work, eh?
It would be sweet to prosecute them for murder of each person that died as a result of using the Johnson & Johnson Animas diabetes pumps, since they are fully aware the infusion pumps are faulty and leading to consumer deaths.
This is a lawsuit slam dunk. The linked documents prove BOTH CEO Weldon and current CEO Gorsky know the infusion pumps are faulty and they continue to be sold, even today....
1. Animas Web Site (2016, ). Home page of Animas web site. Animas. Retrieved from https://www.animas.com/
2. Securities and Exchange Commission (2016, December 28). Johnson & Johnson Form 10-K, Ex 21 Subsidiaries as of December 28, 2014. Securities and Exchange Commission. Retrieved from https://www.sec.gov/Archives/edgar/data/200406/000020040615000004/ex21-subsidiariesxform10xk.htm
3. MAUDE Database (2016, July 29). Manufacturer: Animas Event Type: Death Report Date From: 03/01/2012 Report Date To: 06/30/2016. United States Food and Drug Administration Manufacturer and User Device Experience (MAUDE) Database. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm?start_search=1&productcode=&productproblem=&devicename=&modelNumber=&reportNumber=&manufacturer=Animas&brandname=&eventtype=Death&reportdatefrom=03%2F01%2F2012&reportdateto=06%2F30%2F2016&pagenum=10
4. Timothy A. Ulatowski, Director, Division of Dental, Infection Control and General Hospital Devices, Office of Device Evaluation, Center for Devices and Radiological Health (2000, February 10). 510K Submitted: 09/23/1999 Approved: 02/10/2000. United States Food and Drug Administration. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K993184
5. Peter Muler for Thomas D. Gardine, District Director, Philadelphia District Office, Food and Drug Administration (2005, February 24). WARNING LETTER. United States Food and Drug Administration: Inspections, Compliance, Enforcement, and Criminal Investigations. Retrieved from http://www.fda.gov/iceci/enforcementactions/warningletters/2005/ucm075301.htm
6. Kirk Sooter, District Director, Philadelphia District Director (2011, December 27). WARNING LETTER. United States Food and Drug Administration: Inspections, Compliance, Enforcement, and Criminal Investigations. Retrieved from http://www.fda.gov/iceci/enforcementactions/warningletters/2011/ucm285656.htm