Typically, strokes are either the deadliest or least deadly cardiovascular episodes. Thanks to the advent of advanced catheters and other medical devices, the stroke survivability rate has increased substantially since the 1990s.
However, these devices can frequently do more harm than good. Often, in their rush to build a better mousetrap, device makers take dangerous shortcuts, and people get hurt.
Most medical device companies only care about profits. We only care about your health and safety.
Forcing these companies to pay compensation is the best way to accomplish this goal.
Since these companies care so much about their bottom lines, affecting their profits is the only effective way to keep people safer.
The Penumbra JET 7 Catheter and FDA Approval
Along with a pump and tubing, this catheter is part of Penumbra’s mechanical thrombectomy set.
This process uses a vacuum pump to clear blood clots.
The JET 7 also uses low levels of radiation to detect severe clots. Penumbra claims that this procedure can remove blood clots from stroke patients in as little as eight hours.
Mechanical thrombectomy is a complex and controversial process which is designed for stroke patients who do not respond to anti-clot medications.
These drugs cannot handle certain large clots. Other patients cannot tolerate the side-effects of powerful blood thinners like Pradaxa.
JET 7 approval was just as controversial as its operation.
The Food and Drug Administration fast-tracked this device under Section 510(k)’s Substantial Equivalent provision.
If a device is substantially equivalent to one already on the market, the FDA presumes the new gadget is safe.
Although the rules clearly define SE products, the application of these rules is subjective.
And, there is basically no oversight.
A bureaucrat unilaterally decides what is equivalent and what isn’t. Furthermore, the features which make the new product unique often make it dangerous. That was the situation in this case.
Complications and Side Effects
Generally, the more moving parts any machine has, the more problems develop. Advanced features on the JET 7 have caused issues like:
- Anaphylactic reactions due to contrast media,
- Acute occlusions and air embolisms (obstructed arteries),
- Distal embolizations (air in an artery),
- Embolisms (fat deposits in arteries),
- False aneurysm (leaking arteries),
- Severe hemorrhaging or bruising,
- Kidney damage,
- Blood vessel perforation, and
- Radiation exposure.
Additionally, an inordinate number of moving parts increases the risk of a manufacturing defect. If all the parts are not machined just right, they do not work together properly.
So, if a JET 7 catheter injured you, the issues could be a design defect or a manufacturing defect. Our team carefully evaluates your case before we take action.
Your Claim for Damages
In terms of liability, there is little difference between a design and manufacturing defect. Product makers are strictly liable for both problems. In terms of proof, however, there is a big difference.
Napoli Shkolnik has the resources to partner with medical engineers and other such professionals to establish design defects.
These experts must clearly point out the flaw to jurors.
Frequently, these problems are quite subtle.
Additionally, many courts require victim/plaintiffs in design defect claims to prove that the manufacturer knew about and rejected a safer alternative design.
To establish manufacturing defects, Napoli Shkolnik often partners with boots-on-the-ground experts.
These individuals reveal how tiny errors in the manufacturing process are magnified and become serious threats to patient safety.
These claims are difficult to defend in court. Usually, the manufacturer must convince jurors that the risk was so small that it did not justify even a generic warning.
Alternatively, the manufacturer could claim the doctor did not insert or use the device properly. Both defenses are hard to establish, and the manufacturer has the burden of proof.
If successful, victim/plaintiffs are entitled to compensatory damages for medical bills and pain and suffering.
Moreover, jurors often award significant punitive damages in these claims. Such damages are available if victim/plaintiffs prove, by clear and convincing evidence, that the manufacturer intentionally disregarded a known risk.
In this context, this process often involves failing to warn patients of a known possible side-effect.
Advanced medical devices like the JET 7 catheter often involve serious risks which the manufacturer does not fully disclose.
For a free consultation with an experienced pharmaceutical litigation attorney, contact Napoli Shkolnik PLLC. We handle defective medical device claims on a nationwide basis.