FDA Has Second Thoughts About the JET 7 Catheter
Less than a year after it declared the gadget was safe, the Food and Drug Administration (FDA) issued a Class I recall due to the risk of death or serious injury when using a JET 7 Reperfusion Catheter.
Since December 2020, the agency has received hundreds of device failure reports. Many of these failures have caused death or serious injury. Doctors should no longer prescribe or use these devices for stroke patients or anyone else.
In response, Penumbra said it had not received any reports of deaths since last October.
JET 7 Approval
The story of the JET 7’s sudden approval goes back to the 1980s and 1990s. Back then, lawmakers feared that a “drug gap” was developing. The Food and Drug Administration’s approval process usually required the better part of a decade. The approval process in other countries often required half as much time.
So, rather than overhaul and improve the process, FDA bureaucrats enacted the 510(k) fast track shortcut. This approval shortcut is available if a medical device is substantially similar to one already in use or if a new drug is a significant breakthrough in treatment technology.
Both these terms are extremely vague. For example, the FDA could conclude that a first-generation smartphone is substantially similar to an advanced flip phone. These products have much in common, but there are just as many differences. A device like a catheter usually requires more scrutiny.
The “breakthrough therapy” designation is equally subjective. The results of one clinical trial could justify such a label. Often, the complete truth about a clinical trial does not emerge for several years. Furthermore, a manufacturer can often pick the best result out of several trials and use it to obtain fast-track approval.
Despite these obvious problems, the FDA liberally applies the 510(k) shortcut. If a bureaucrat makes a mistake, whether accidentally or intentionally, the only possible remedy is a recall. These recalls are not preventative. They only happen after problems arise.
Issues with the JET 7 Catheter
According to the FDA, the JET 7’s tip cannot withstand the intense air pressure needed to break up large clots. The resulting separation, expansion, rupture, ballooning, or breakage exposes the support coils, causing serious injury. Specific problems include:
- Distal Embolization: The JET 7 system uses a vacuum pump to break up blood clots and prevent strokes. The sudden rush of air often releases debris, like calcium and platelets, into the bloodstream. At a minimum, DE often causes severe pain and partial paralysis. Many of these victims do not know they are sick until advanced symptoms appear.
- Pseudoaneurysm: Defective catheters often cause blood vessels to leak. The blood damages the surrounding tissues. Some pseudoaneurysms, or false aneurysms, go away on their own. Most require advanced surgical correction using an ultrasound detector.
- Radiation Poisoning: To regulate the air flow, the JET 7’s coils are mildly radioactive. As long as they are shielded, there is no danger. If the shield is compromised in any way, many patients develop cancer and kidney failure.
Legally, the JET 7’s tip could be a design defect or a manufacturing defect. Perhaps engineers did not make the tip strong enough to withstand extreme pressure. Or, perhaps there was an error somewhere in the manufacturing process. Either way, Penumbra is strictly liable for the damages its defective JET 7 catheters cause.
Since they could injure thousands of people, defective medical devices are mass tort claims. Only the most experienced pharmaceutical attorneys should handle these matters.
Mass tort claims are like personal injury claims on steroids. Everything is bigger, including the procedural hurdles. Frequently, victim/plaintiffs can outline their claims when they file them. But mass tort claims must go into considerable detail. So, attorneys must amass a great deal of evidence right at the start.
Furthermore, victim/plaintiffs in mass tort claims lose the home field advantage, at least temporarily. Since there are so many victims, courts usually consolidate these claims for pretrial purposes. A single court master usually manages items like procedural motions and pretrial discovery.
This consolidation is not necessarily bad news. Special court masters usually understand complex technical matters about obscure details like distal tip flaws. Additionally, once one claim ends well, the dominoes usually fall in the victim/plaintiff’s direction.
Defective JET 7 Catheters could cause serious injury. For a free consultation with an experienced pharmaceutical attorney, contact Napoli Shkolnik PLLC. We do not charge upfront legal fees and handle these cases nationwide.