In a warning letter dated April 12, the U.S. Food and Drug Administration criticized Abbott Laboratories (NYSE:ABT) for neglecting to properly investigate and resolve issues related to cybersecurity threats and a battery malfunction in its cardiac devices.
In particular, the FDA accused St. Jude Medical, which was acquired by Abbott earlier this year for $25 billion, of being neglectful despite knowing its devices were equipped with defective batteries. Subsequent to the death of a patient in 2014, 400,000 devices were recalled by the company. However, St. Jude Medical continued to fit patients with the devices within a few weeks of the recall. Continue Reading »