While Johnson & Johnson might be a household name, the names of its subsidiary units are a bit less well known. Names like Ethicon and DePuy fly under the radar for all but those that have been negatively affected by their products’ defects while Johnson & Johnson remains known as the makers of the “no more tears” baby shampoo.
But another Johnson & Johnson unit now finds itself embroiled in a recall action as Sterilmed’s Agilis Steerable Introducer Sheath device was the subject of a Class I recall. A Class I recall is the most urgent recall the FDA can issue and is reserved for those situations where the recalled device or drug can cause serious injury or death if immediate action is not taken.
In the case of the Agilis Sheath, a heart device, a valve can malfunction and allow blood to flow backward through it. This can be, as one could imagine, catastrophic. The recall affects a little over 100 of the devices and only covers those that were made between January and May of last year.
The subsidiary device units of the world’s largest healthcare-related goods provider frequently find themselves at the center of some of the most dangerous public health alerts around the globe. Ethicon, for example, has left a wake of tens of thousands of patients in life-long pain as a result of defects in its surgical and transvaginal mesh devices. This is in addition to concerns that the use of its power morcellators are responsible for the spread of fatal uterine cancers in women who had fibroids removed or had undergone hysterectomies.
DePuy Orthopedic, another Johnson & Johnson unit, is the focus of more than 10,000 claims that its hip replacements were so poorly designed that the metal-on-metal joints used in the device were grinding and releasing metallic fragments into patients’ bloodstreams. That case would later take a turn into the federal criminal justice system as claims emerged that a DePuy sales representative was threatening a doctor’s practice who was testifying as an expert witness. The claims were turned over to the FBI and the public would later learn that this was not the first time that claims of witness intimidation had been brought against DePuy.