The Food and Drug Administration took the strongest action possible when it issued a Class I recall of all Penumbra JET 7 Reperfusion Catheters with Xtra Flex Technology.
This recall affects gadgets which were sold or distributed between June 2019 and December 2020. After the FDA received reports of numerous injuries and over a dozen patient deaths, the manufacturer instructed patients to stop using these devices and doctors to stop prescribing them.
In response, Penumbra said it had not received any reports of patient deaths since October 2019. How reassuring.
JET 7 Catheter Issues
During 2020 clinical trials, the JET 7 Catheter removes dangerous blood clots from recovering stroke victims in as little as eight hours. This gadget uses a mildly-radioactive fluoroscope to locate blood clots and suck them away using a vacuum tube. Largely based on the success of these trials, the Food and Drug Administration quickly approved these advanced medical devices.
During the device’s rush to mass production, Penumbra overlooked a design defect and failed to identify and/or correct a manufacturing defect.
The radioactive fluoroscopy causes cancer, especially if the patient has a family history of this disease. Cancer’s survival rates have improved considerably since the late twentieth century. But these improvements depend on prompt diagnosis and expensive treatments.
A manufacturing defect is probably the JET 7 Catheter’s fatal flaw. The tip often breaks off. This device failure often causes:
- Severe hemorrhaging,
- Kidney problems,
- Cerebral infarction, and
- Blood vessel damage.
If a manufacturing or design defect caused injury, a St. Louis defective products attorney can usually obtain substantial compensation for victims. In addition to money for economic losses, such as necessary revision treatments, and noneconomic losses, such as pain and suffering, substantial punitive damages are usually available as well. These damages are usually the only way to convince companies like Penumbra to put patient safety ahead of corporate profits.
Is the FDA an Effective Watchdog?
Although the FDA did the right thing and ordered a recall, many people question whether this agency can effectively protect people.
As discussed above, the JET 7 Catheter’s rapid approval and rushed production probably had much to do with the design and manufacturing defects. The FDA is sometimes complicit in these problems. User fees, which are paid by the companies it regulates, make up about two-thirds of the FDA’s budget. It’s against human nature to bite the hand which feeds you.
Due to this reluctance, dangerous drugs and defective devices frequently slip through the regulatory cracks. In this context, when the federal government drops the ball, it’s up to personal injury attorneys to protect patients.
JET 7 Catheters create serious injuries in people who are already recovering from serious strokes. For a free consultation with an experienced defective products attorney in St. Louis, contact Schultz & Myers, Personal Injury Lawyers. You have a limited amount of time to act.