The act of recalling a product does not itself constitute an injury in most cases, but if you were injured by a medical product that was recalled you may have a legitimate defective device claim.
Medical device lawsuits are often like a cross between medical malpractice and defective product injury cases. In some of these cases the device designer and manufacturer, not the doctor, is liable for the injury. In other cases, a doctor or surgeon may be negligent for using a dangerous device or failing to warn a patient of a device they know poses a risk due to previous reports and patient experiences.
Why Do So Many Dangerous Medical Devices Make It to Patients?
There are a couple different ways medical devices gain FDA approval. One of them is the 510(k) process, which doesn’t require extensive clinical testing or regulator scrutiny. The majority of recalled medical devices gain 510(k) approval rather than the more stringent FDA premarket approval (PMA).
The 510(k) process isn’t new. The prevalence of dangerous devices passing through the process has been going on for decades. One study that looked at medical devices for a 20-year period between 1992 and 2012 found an undeniable correlation between 510(k) approval and recalls. During that time:
- 77,164 medical devices were approved through 510(k) compared to just 19,139 through PMA
- 11 percent of the 510(k)-approved devices were for orthopedic medicine
- 8 percent of 510(k)-approved devices were recalled compared to just 1.6 percent of PMA-approved devices
- It was 11.5 more likely for a 510(k)-approved orthopedic devices to be recalled than a PMA-approved device
Another study found that approximately 98 percent of the 161 foot and ankle orthopedic medical devices that were recalled between 2007 and 2017 gained approval through the 510(k) process. Only one PMA-approved foot and ankle device was recalled in that time. Why were those 161 foot and ankle devices recalled?
- 39 percent of device broke during or after implantation
- 37 percent of devices had problems with sterility
- 30 percent of devices were improperly labelled
- 27 percent of devices were poorly designed
- 22 percent of devices had a high enough rate of manufacturing defects to justify a recall
Many of the recalled devices had overlapping causes, hence the numbers add up to more than 100.
Why Did the FDA Create the 510(k) Process?
The approval process, which dates back to 1976, offered a way for medical device manufacturers to get their products to market faster and more affordably if they could show their device was substantially equivalent to existing approved devices. Essentially, if a similar device that does the same type of thing underwent a more rigorous approval process, there’s an assumption that this new device will be safe too.
However, just because two devices share some characteristics and do the same thing doesn’t mean they’re made equal. A 510(k) hip implant device might be manufactured with different materials, undergo a less rigorous quality assurance processes or fail to adhere to an array of medical device manufacturing best practices compared to a similar PMA hip implant.
Who Is Responsible for an Injury Caused by a Defective Medical Device?
The most obvious target for litigation in medical device cases is the manufacturer, but they’re not always the sole culprit. In fact, there may even be scenarios where a surgeon’s mistake during implantation was the primary cause of device failure. In most cases, the liable parties can include the:
- Manufacturer
- Surgeon or prescribing doctor
- Inpatient or outpatient hospital or clinic that implanted the device
- Device supplier
Medical malpractice is different from a product liability case stemming from a failed medical device that causes an injury, but they can be related. If your personal injury attorney and the hospital’s insurance company find that the doctor did nothing wrong during the surgery, it likely won’t be a viable medical malpractice case, but it could still be a defective device case.
In order for medical malpractice to occur, it’s necessary to show the surgeon:
- Didn’t act reasonably during your procedure
- Failed to meet the standard of care (they made a mistake a properly trained surgeon shouldn’t have made)
- You suffered serious damages due to their mistake
If a surgeon knowingly implants a device that isn’t reliable and failed to warn the patient of the risk, that is potential grounds for a medical malpractice case. It’s even possible for a surgeon to use a previously recalled device, in which case the manufacturer might not be liable (if they had already issued a voluntary recall) but the surgeon would be liable.
If you aren’t sure who is responsible for your medical device injury, a medical malpractice lawyer may be able to assist.
Getting Help After a Medical Device Injury
Cases involving defective medical devices are complicated and painful. They often cost families tens of thousands of dollars in extra medical costs and require painful revisionary surgeries for patients.
Determining who should be held accountable in these cases isn’t always easy, which is why it’s important to work with a personal injury attorney experienced in both medical malpractice cases and medical device injury cases.
At the Weycer Law Firm in Houston, we thoroughly investigate each client’s situation and work with medical experts to build the strongest case possible. Call us at (713) 668-4545 for your free case evaluation.
