The attorneys at the Brannon Law Firm handle medical malpractice cases, including those involving Defective Medical Devices. If you have injured or harmed by a Defective Medical Device you may have a claim for medical malpractice and/or a defective product. It is in your benefit to seek out more information. Information on what Defective Medical Devices are and what it might mean for you can be found below. Additionally, the medical malpractice attorneys at the Brannon Law Firm invite you to contact us, either at 937-228-2306 or 1-800-VERDICT to see if you may have a claim for a Defective Medical Device.
What are Defective Medical Devices?
Medical Devices are any artificial instruments used to help treat medical conditions. Medical Devices can be instruments, apparatuses, appliances, machines, software, or even a material. Medical devices may be used alone or in combination with other medical devices. Medical devices may be designed and used for a number of purposes, such as diagnosis, prevention, monitoring, treatment, alleviation of a disease, compensation for an existing injury or handicap, or to modify anatomy.
Common examples of Medical Devices include:
- Artificial knees and hips
- Artificial hearts
- Intrauterine devices (IUDs)
In today’s world, it is not uncommon for individuals to depend on these various Medical Devices to assist in their everyday life, battle diseases or conditions, or even keep them alive.
However, this reliance can be a serious problem when a Medical Device is Defective. A Defective Medical Device is one that is not working properly and thus is not providing the aid and assistance it is supposed to. This can cause serious injury, illness, and even death.
A Medical Device may be defective due to a couple of different reasons. First, it may be that the manufacturer created the device improperly. There may be a flaw in the design of the device, an error in the manufacturing process, or an implementation factor that the manufacturer forgot to take into account when creating the device. This may mean that all instances of the particular device are defective or that a single individual device is defective. When this is the case, the danger is either from the device not being useful for helping with a problem or causing enough harm that the negatives outweigh the benefits.
Second, it may be that there was an error in the use of the Medical Device by a doctor or medical professional. Many Medical Devices require extra medical steps for their use, such as implanting in the body through surgery, use during surgery, or diagnosis and prescription from a doctor. An error by a medical professional during these extra steps may create issues and cause the Medical Device to be defective; either because the device was not ‘installed’ correctly or because the device now cannot function in a way that will actually benefit the patient.
Below are some examples of Defective Medical Devices.
- Pacemaker – A pacemaker may stop working or fail to keep a proper heart rhythm
- Malfunctioning Device – Such as a pain pump or an insulin pump that administers to much or to little medication
- Heart Valve Implant – These may break or leak, which can result in surgeries and can be fatal
- Infections – Infections may be caused by an improperly made or non-sterilized device, especially those implanted within the body.
- Breast Implants – These and other devices can cause damage to the immune system.
- Metal Hip Replacement – Part of the replacement may fail or break down.
- Transvaginal Mesh – A surgical path implanted in the vaginal wall that has been known to erode and cause organ perforation
- IVC Blood Clot Filter – A small filter put in major arteries to catch blood clots. However, they may sometimes break down, sending metal bits throughout the body.
- Da Vinci Robot – A robot, controlled by a human, used to perform surgery in hard to reach areas. Robot malfunctions and errors by the controlling surgeons have led to serious injuries.
Many Medical Devices are examples of incredible advancements in technology, and provide important aid to those who need it. But it is critical to be sure Medical Devices are working properly and used for their intended purpose. Otherwise, a Medical Device can cause serious harm to those who are depending on them the most.
FDA Approval Process
Medical Devices are classified, controlled, and regulated by the Federal Food and Drug Administration (FDA). This is important for several reasons. First, this means that Medical Devices must go through an approval process set by the FDA before being made available for use. This ‘pre-market’ process is rigorous, requiring the manufacturers to prove that the Medical Device is safe and effective. Most manufacturers will conduct testing in order to ensure the Medical Device is working as intended and is in fact helpful and will not harm anyone. However, testing in both the laboratory and the clinic can only go so far and may not be able to catch everything. Oftentimes, tests may have too few subjects, or important information may only become available at a later date, after the device is approved. The FDA’s approval process is a good thing, but it does not create a 100% guarantee of safety.
Second, this means that when a device is found to be unsafe or dangerous, part of the response is handled by the FDA. Manufacturers are responsible for informing the FDA when they discover a Medical Device is Defective. Often, this will prompt the FDA to issue a recall of the device, in an effort to prevent any more potential harm from being done. While an FDA recall is not a guarantee of a defective device, negligence or medical malpractice, it is important for users of Medical Devices to be aware of, so that they may take steps necessary to protect themselves.
Third, it may mean that some Defective Medical Device cases are not actionable. This means it may not be possible to bring a lawsuit in some cases involving Defective Medical Devices. This is because the United States Supreme Court has ruled that certain manufacturers of medical devices and some medical devices themselves may be protected from lawsuits, provided that they have gone through the FDA pre-market approval process. If the Medical Device has done so and has met the FDA established standards, they may be protected under this ruling. This is not always the case, however, and a lawyer will be better able to discuss the particulars in a client’s individual case and circumstance to determine how this may affect them.
Medical and Legal Significance of a Defective Medical Device
There is a difference in the law between claims made for medical malpractice and those based upon product liability. If the Medical Device is simply improperly made or designed by the manufacturer, then the damage that device may cause is not attributable to the doctor or medical professional. Instead the damage is attributable to the manufacturer of the product. In this circumstance, a claim may be brought against the manufacturer, likely in what is called a products liability case.
However, in other instances of Defective Medical Devices the harm caused to a patient can be attributed to medical malpractice or medical negligence. These instances often occur when a doctor or medical professional has done something incorrect in the diagnosing, prescribing, and handling of a Medical Device. Sometimes, a Medical Device may not actually be necessary or proper for treatment. Prescribing that Medical Device may cause harm due to the device interfering with a condition or performing functions that are actually adverse to the patient.
Because many Medical Devices require extra medical steps, such as surgery to implant the device, there is possibility for medical malpractice or medical negligence when the doctor performing the surgery does so improperly. For example, IVC Blood Clot Filters are often used during surgery to prevent blood clots from traveling to the lungs. However, the Filters are not a long term solution and often should not be left inside the patient. If they are, they may break apart and send dangerous bits of metal throughout the body. Doctors may also ‘install’ Medical Devices incorrectly, which may cause harm or injury, or cause a condition to become worse or be untreated.
It is the responsibility of doctors and other medical professionals to respond to the possibility of a Defective Medical Device in the correct manner. Failure to do so may be medical malpractice or medical negligence.
Seeking Legal Counsel and Guidance
If you have been injured due to a Defective Medical Device you may have a claim against the manufacturer, doctor or other medical providers. The Dayton medical malpractice attorneys at the Brannon Law Firm have the skill and experience to discover whether your health issues are a result of a Defective Medical Device and whether those health issues could have been avoided or prevented. Medical malpractice and medical negligence is preventable. It is caused by the error, improper action, or lack of action by medical professionals. It is important to hold those medical professionals to the proper standards of medical care and to hold them accountable for the harms and losses they may cause. The Brannon Law Firm can help hold those at fault accountable.
Additionally, your treatment may be difficult, both financially and emotionally. Treatments in response to Defective Medical Devices can be intensive and require a large amount of effort and expense. In addition to the illness or condition that required the Medical Device in the first place, you may now have to deal with the injuries or negative effects of the Defective Medical Device. Efforts to fix or reverse the effects of a Defective Medical Device can be severe and long lasting, requiring additional medical treatment, loss of quality of life, loss of income and costly medical bills. It is important to ensure you have the assistance and care that you deserve to live the best life possible. The Brannon Law Firm can help with that process.
At the Brannon Law Firm, we have represented many individuals who were unfortunate victims of a Defective Medical Devices. We have obtained favorable verdicts and settlements on behalf of clients in Defective Medical Device cases. We invite you to contact us, either at 937-228-2306 or 1-800-VERDICT for a free consultation to discuss your potential claims.