The Food and Drug Administration (FDA) recently announced a recall for one type of blood clot removal device. The company Penumbra issued the urgent recall of its reperfusion catheters. The FDA has received reports of 14 deaths linked to these blood clot removal devices. Patients also reported experiencing the following dangerous medical conditions after using the devices:
- Vessel damage
- Cerebral infarction
- Brain tissue damage due to a lack of oxygen
- Ballooning or expansion of the device
- Rupture of the device
- Breakage or complete separation of the device
- Exposure of the device’s internal support coil
Bench testing results showed that the Jet 7 Xtra Flex catheter and the Jet 7Max devices could not withstand the same burst pressures as other similar devices. Indeed, they could not even withstand the same type of burst pressure as some of the other catheters made by Penumbra. The FDA asked Penumbra to issue a widespread notification to health care providers who use the devices. Penumbra sent the notice on July 27th. The notice included label changes that warned about the risks associated with using the device for contrast injection.
Medical device reports stating the harms associated with these products have continued to be filed with the FDA. In some of the reports, doctors had not begun using the new procedures outlined in the warning notification, resulting in patient injuries. As a result, the FDA requested that Penumbra remove these devices from the market, and Penumbra did so by issuing an urgent recall notice.
Has a Penumbra Blood Clot Prevention Device Injured You?
If you or your loved one has suffered an injury from a Penumbra blood clot prevention device, you may be entitled to compensation. Under Alabama law, victims of defectively designed or manufactured medical devices have a right to compensation through filing a product liability lawsuit. In a medical device product liability lawsuit, the victim claims that the device manufacturer, in this case, Penumbra, is liable for his or her injuries because it negligently produced and sold a defective device. Successful plaintiffs will need to prove the following:
- Penumbra knew about the flaws in its blood clot prevention devices and failed to recall the devices promptly
- Penumbra knew about the design flaw and failed to warn users about the harm the device might cause
- The blood clot prevention devices Have a serious design flaw that any reasonable, careful manufacturer would have noticed during the design phase, its pre-production testing, and/or during routine quality control processes
Why You Need an Experienced Lawyer on Your Side
If a Penumbra blood clot prevention device has injured your loved one, you need an experienced lawyer on your side. Additionally, if a Penumbra device resulted in your loved one’s death, his or her estate may be entitled to damages through a wrongful death lawsuit. Product liability lawsuits are often complicated, and they require a thorough investigation along with significant research. Your lawyer will need to delve into the medical research on the products that injured you, depose witnesses, and work with experts who can testify on your behalf.
The more time your lawyer has to investigate your case, the greater the likelihood you can succeed. It is beneficial to hire a product liability lawyer as soon as possible so you can begin investigating your case now. Your lawyer can also ensure that you undergo a thorough medical evaluation and gather all relevant medical documents proving the extent of your injuries.
Contact an Alabama Medical Device Injury Lawyer
You do not want to navigate the product liability process alone. Even if you feel that you are not ready to file a lawsuit, it is worth taking the time to discuss your case with a qualified product liability lawyer as soon as possible. It is important that you know your options. Contact the experienced product liability lawyers at Heninger Garrison Davis today to schedule your free initial consultation.