Just some of the varied injuries which may result from defective medical devices include:
- Orthopedic injuries and blood conditions from failed hip or knee prostheses
- Burns and organ/nerve trauma including organ perforations from malfunctioning electrocautery and other devices used in surgical procedures
- Retention of parts of the medical device if they break off and lodge within a person’s body
- Cardiopulmonary arrests and paralysis secondary to failed intraoperative monitoring equipment
- Brain injury from failed respirators and cardiac monitoring devices, or their alarm systems
DEFECTIVE MEDICAL DEVICES
Medical devices can be quite diverse; from sophisticated computerized and wifi capable medical equipment to the most basic of medical supplies such as gloves or tongue depressors. The US Food and Drug Administration (FDA) sets requirements and oversees the Current Good Manufacturing Practice (CGMP) relative to medical devices. The FDA also evaluates the efficacy, function and safety of medical devices before they are marketed to and used by the public and healthcare community. The Medical Device Reporting program (MDR) requires reporting to the FDA of any incidents where a medical device may have contributed to or caused a serious injury or death as well as any other deficiencies of a device which might constitute a “defective medical device”.
RECALLS OF DEFECTIVE MEDICAL DEVICES
If the FDA determines that a there is a problem with a medical device that is in violation of FDA standards and/or regulations or otherwise defective or a risk to the health of the intended user/recipient, a recall is can be implemented. The FDA uses a three-level system classifying the risk of harm from a medical device:
- FDA Class I is a reasonable probability that exposure to, or use of the product may cause serious consequence to health, or death.
- FDA Class II is a probability that exposure to, or use of the product may cause medically reversible or temporary health consequences, or the remote possibility of serious health consequences.
- FDA Class III is the least serious in nature, classified as exposure to or use of the medical device is not likely to cause adverse consequences to health.
The Safe Medical Devices Act of 1990 (the SMDA) was enacted on November 28, 1990. This law was precipitated by an FDA finding that a significant number of medical device recalls were required secondary to faulty product design. One study on defective medical devices recalled by the FDA found that product malfunction and manufacturer errors accounts for the majority of recalls.
Some categories of medical devices recalled in recent years include those used in the following fields of medicine:
- Cardiovascular (including various cardiac stents)
- General hospital care
- General surgery (including hernia, gynecologic and other surgical meshes)
- Plastic surgery
- Neurology
- Anesthesiology
- Infectious Disease
- Orthopedics (especially hip and knee prostheses)
We have come to rely upon and trust the integrity of medical devices used in our healthcare, and consider them generally to be safe, beneficial and not a source of risk or harm. However, unfortunately, due to defective design, inadequate warnings and/or testing, improper use or other shortcomings in medical products, many hazards may exist which could result in significant injury to a patient, and even death.
LEGAL HELP FOR MEDICAL DEVICE DAMAGE IN NEW JERSEY
Blume Forte Fried Zerres & Molinari has been serving the people of New Jersey since 1929. If you or a loved one have suffered injury, a worsened health condition, or died because of a defective medical device in New Jersey, you can contact us to evaluate your potential claim and possibly to pursue compensation for applicable damages. Our firm has represented numerous clients who were injured due to defective medical devices. Contact one of our skilled product liability lawyers at (973) 635-9339 for a no-cost consultation and case evaluation.