Since medical devices function on or in the human body, manufacturers must design, produce, and distribute them safely and appropriately.
When this does not happen, whether due to accidental or intentional negligence, patients may be severely injured or killed as a result.
Below, our Los Angeles product liability attorneys discuss recent cases that illustrate medical devices are not always as safe as we think.
What Happens When a Medical Device Fails?
Countless patients rely on medical devices to monitor or maintain a health condition. And in most cases, the medical device works as designed.
There are, however, situations in which medical devices do not operate as intended. This can have catastrophic consequences for patients, including the following:
Medical devices do not only fail in their functionality. When a medical device is not marketed properly—such as through confusing instructional materials—it can have the same devastating impact as a physical malfunction.
Examples of commonly-used medical devices that may be subject to a harmful design, manufacturing, or marketing flaw include, but are not limited to, the following:
Implantable medical devices
Wheelchairs or walking-assistance devices
Shoulder pain pumps
Thousands upon thousands of patients in the United States use these medical devices every year. And while countless patients have benefited from these products, many have also been harmed by devices that shouldn’t have had a defect in the first place.
How FDA Regulations Aim to Reduce Device Failures
You may be thinking, “Well, isn’t it the government’s job to ensure medical devices are made safely?”
The short answer is yes. The U.S. Food and Drug Administration (FDA) is in charge of overseeing the manufacture and issuing regulatory approval for medical devices. The agency is also responsible for responding to reports about harmful medical devices.
They can issue warnings to consumers or order a recall to remove harmful medical devices from the market.
Any manufacturer looking to send a medical device to the market must put their device through the FDA’s regulatory approval process, which is managed by the FDA’s Center for Devices and Radiological Health (CDRH).
The process that manufacturers must go through depends on how their medical device is classified. Medical devices are classified into Class I, II, or III.
Class I: These are devices that present minimal potential for harm to the user.
Class II: These are devices that present a moderate risk of harm to the user. These include powered wheelchairs and some pregnancy test kits.
Class III: These are devices that sustain or support life, are implanted, or present a high risk of illness or injury.
The level of regulatory control increases with higher classifications. For example, Class I devices are exempt from Premarket Notification 510(k), while Class III devices require a higher standard of approval known as Premarket Approval.
The basic regulatory requirements that medical device manufacturers must meet include the following:
Medical Device Listing
Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA)
Investigational Device Exemption (IDE) for clinical studies
Quality System (QS) regulation
Medical Device Reporting (MDR)
The Consequences of FDA Violations
The aforementioned measures aim to ensure that every device sent to the market is safe for consumer use.
There are, however, certain organizations that attempt to send their products to the market without getting the necessary approvals, which can seriously injure or kill consumers.
As such, the FDA has several enforcement actions meant to curtail this behavior, including the following:
Warning letters: These are sent to individuals or firms, advising them of specific noted violations. These letters request a written response as to the steps that the organization will take to rectify the situation.
Seizure: This constitutes an action brought against an FDA-regulated product because it has been altered since its approval.
Injunction: This includes an order by the court that requires the organization to do or refrain from doing a specific act.
Criminal prosecution: This may be recommended in appropriate cases for egregious offenses.
According to the FDA, the following fines may be applicable for each offense:
Up to $100,000 for a misdemeanor by an individual that does not result in death.
Up to $200,000 for a misdemeanor by a corporation that does not result in death.
Up to $250,000 for a misdemeanor by an individual that results in death, or a felony.
Up to $500,000 for a misdemeanor by a corporation that results in death, or a felony.
Despite these precautions by the FDA, safety issues with medical devices persist. The following recent medical device recalls have affected thousands of patients:
Hip Replacement Recall
The DePuy ASR hip replacements were recently subject to a recall due to patients implanted with them experiencing the following symptoms:
Popping or crunching noises emanating from the implant
Sensation that the hip is not “in place”
Inability to perform physical activity
Pain and swelling in the hip, groin, leg, or lower nack
Heightened levels of metal in the bloodstream
DePuy estimates that 10,000 patients will now require revision surgery.
Essure Birth Control
Essure birth control was a device sold to women as a permanent birth control option. Essure used flexible inserts that were placed inside the fallopian tubes. Scar tissue would then form around the inserts to block ovulation.
After insertion, many women reported various health issues to the FDA, including the following:
Pelvic pain and discomfort
Depression and suicidal thoughts
Weight gain or weight fluctuations
Migration of device or components
Breakage of the device internally
In many cases, women reported symptoms that were not discovered in clinical research, which means the product may not have been tested thoroughly prior to distribution to the market.
Seeking Justice After a Medical Device Defect
The aforementioned examples are just a few scenarios of what patients have been put through due to poor market research, testing, and distribution.
Many of these patients have had to undergo additional medical procedures to correct a medical device issue that should not have existed in the first place. As such, they had to foot the bill for manufacturers’ negligence.
If you or someone you love has been harmed due to a medical device’s failure, our Los Angeles product liability attorneys are here to help.
At Shoop | A Professional Law Corporation, we have the experience and resources needed to take on large manufacturers and hold them accountable for their negligence that has brought you harm. We have helped countless clients in complex situations protect their rights against formidable opponents, and our multi-million dollar case results show that we can do the same for you.
Contact us today at (866) 884-1717 to schedule a free consultation with our team.