Medical devices continue to be a major safety concern for patients in San
Diego and across the country. In the most recent case, the Food and Drug
Administration has accused Johnson & Johnson’s Animas unit of
continuing to sell insulin pumps after learning they were defective.
In a strongly worded letter to the company, the FDA reprimanded the company
for not adequately explaining “why your firm continued to manufacture
insulin pumps” after they “had known failures.”
This is not the first safety issue for J&J, the world’s second-largest
maker of health-care products, in the past several years. According to certain
media reports, the company has released an alarming nearly 30 product recalls since
The current recall involves OneTouch Ping and 2020 insulin pumps. According
to the FDA letter, inspectors found Animas never reported one complaint
of serious patient injury and delayed reporting on two others. Those patients
were hospitalized with dangerously high blood sugar, respiratory failure,
coma, and a life-threatening complication called diabetic ketoacidosis
caused by lack of insulin to break down blood sugar.
Pursuant to the FDA letter, J&J is required to explain why it continued
to sell the faulty medical devices as well as submit a plan to rectify
its failure to promptly report cases where its device might have caused
or contributed to death or serious injury.
If you suffered from a medical error, don’t hesitate to
San Diego medical malpractice attorney at the Law Offices of Robert Vaage for a free consultation.