Medical devices, known to be defective, continue to be used in the treatment of patients who may be severely injured or die as a result.
Medical errors and malpractice mistakes made by doctors as well as hospitals, nursing care facilities, and other health care providers are considered to be the number one cause of preventable death in this country.
We’ve discussed the dangers of medical errors — and the very great risk for those seeking medical treatment in Indiana or Illinois that they will die as a patient who falls victim to an error made by his or her doctor, nurse, or care provider – before. See:
- Fatal Medical Errors: Medical Mistakes Leading Cause of Death in the United States.
- Danger of Dying from Medical Error: Patient Safety and Preventable Malpractice Deaths
- Medical Error Cause of Patient Death: the Malpractice Epidemic.
Now, another component to this travesty facing those who are injured in accidents, or fall ill, and need medical treatment is becoming clear: widely used medical devices, known to be defective, have been and continue to be used in the treatment of patients today.
Medical Device Injuries: Death from a Dangerous Medical Device
More and more, medical care involves products that are manufactured for use in treating the human body. These include all sorts of devices, such as:
- pacemakers
- surgical staplers (and staples)
- pelvic mesh
- pumps (such as an intra-aortic balloon pump)
- ventilators
- implants (e.g., dental; breast).
December 2019: How Many Deaths from Heart Devices?
On December 24, 2019, the non-profit health news service Kaiser Health News published an article written by Christina Jewett entitled “Reports of Patients’ Deaths Linked to Heart Devices Lurk Below Radar.”
In its latest expose, KHN reveals that the Food and Drug Administration (FDA) reporting system is failing to share vital information with the general public – including doctors — about dangers involving certain cardiac medical devices. The FDA has collected the information but it remains hidden from general view.
Specifically, the December article reveals that fatality statistics regarding these heart devices are not available for review.
Of importance to both patients and providers is the reality that failing to share vital medical device risk information with the general public (including doctors and health care professionals) is not new to the FDA.
Hidden From the Public: 5.7 Million Medical Device Injuries Revealed
Back in March 2019, KHN published another expose involving the lack of information regarding harm resulting from certain medical devices as reported to the FDA. More hidden information of dangerous medical devices was discovered by KHN.
Read, “Hidden FDA Reports Detail Harm Caused By Scores of Medical Devices,” written by Christina Jewett and published on March 7, 2019, by Kaiser Health News.
KHN revealed the FDA had “exemptions” for 100+ medical devices from federal reporting rules. This meant that “[d]octors, researchers and even device-safety experts were unaware that for 20 years the FDA accepted 5.7 million reports through its “alternative summary reporting” program.” In response, the exemptions were removed and the data released by the agency.
A few months ago, the FDA published its hidden database as a result of KHN’s revelations. Shockingly, the secret database contained almost six million (5,700,000) reports of medical device injuries.
The formerly secret medical device injury reports are online in a searchable database called “MAUDE” (Manufacturer and User Facility Device Experience).
Malpractice and Product Liability: Medical Device Injury or Death
It is becoming clear that many medical devices used here in Indiana, Illinois, and the rest of the country are flawed or defective in some way, posing a risk of serious harm or death to the patient. Another concern involves the knowledge of the health care providers regarding these medical devices and their risk of harm.
While doctors may have been shielded from knowledge of a device’s danger while the FDA reports were hidden, once the FDA data is released then the doctor has a duty to know about its risk. Doctors and hospitals will have a duty of care regarding future use of these devices. They will also have a duty to warn those who were patients treated with these now-known-to-be-dangerous medical devices.
Claims for Deaths or Serious Injury Due to a Medical Device
For anyone who has been the victim of harm from a medical device, please know that in the aftermath of these preventable events, both Illinois and Indiana state laws provide avenues for justice for the victim and his/her loved ones.
- First, when someone dies as the result of a medical device, the legal consequences may include liability for both the manufacturer and distributor of the product itself. An investigation into the product must be undertaken to learn the scope of product liability for the faulty medical device.
- Additionally, the hospital and doctor may be liable for their negligence in either (1) failing to know of the risk of harm prior to its use or (2) failing to warn of its use once they knew, or should have known, that the device posed a risk of harm to the patient. These cases may seek damages available under medical malpractice laws defined by Indiana and Illinois (which are different for each state).
Patients and their loved ones may suffer both extensive physical injury (requiring hospitalization, medical treatment, rehab, etc.) as well as psychological harm (therapy, etc.). The scope of their claims (damages) as well as the identification of those responsible (liability) must be determined after detailed investigation and analysis based upon the state law that applies to the situation.
For more, read:
- Medical Error Cause of Patient Death: the Malpractice Epidemic
- Hospital Malpractice: Patient Deaths during Hospital Stay in Indiana or Illinois
- Medical Malpractice in Illinois and Indiana: Botched Surgeries, Nursing Home Neglect, and More
- Public Citizen Report on Doctor Discipline by State Medical Boards: It’s Not Good and Risk of Medical Malpractice Remains High
If you or a loved one are the victim of a medical device injury, then please be aware of the need to investigate your circumstances to determine your rights as well as your risk of injury should the device still be in use. Medical errors are understood to be the leading cause of death in this country. Please be careful out there!
