Defective Medical Devices
Every year the Food and Drug Administration (FDA) receives hundreds of thousands of reports pertaining to defective, dangerous and malfunctioning medical devices. These medical device defects result in countless injuries and deaths to unsuspecting patients and consumers.
If you were injured by a defective medical device or product, or if a loved one lost their life as a result of a defective medical device, you may pursue compensation in a personal injury or wrongful death lawsuit.
Examples of Defective Medical Devices
The FDA lists thousands of defective and dangerous medical devices on its website. While some of these medical devices have been voluntarily recalled by the manufacturer, many have not. Why do medical device companies knowingly place their dangerous, defective products on the market? The most common reason: greed.
While some medical devices and products are relatively well known to the public, many lesser known ones, including device components and parts, are not.
Examples of defective medical devices include, but certainly are not limited to the following:
- Knee implants
- Hip implants
- Joint implants
- Pacemakers and ventricular assist devices
- Heart valves
- Cochlear ear implants
- Transvaginal mesh products
- Surgical instruments
- Breast implants
- Shoulder implants
- Contaminated ultrasound gel
- Improper labeling on diabetic blood glucose test strips
- Defective blood glucose monitoring strips
- Defective insulin delivery systems
- Defective dialysis systems, resulting in blood flow impediment and blood clots
- Ventilators that shut down without alarm or notice
- Defective portable oxygen unit that may ignite and burst into flames
- Anesthesia system defects and failures
- Defective saline flush IV syringes - resulting in bloodstream contamination
- Defective patient identification software results in misinformation and potential injury or death
- Ventilator not delivering air for breathing
Duty and Liability of Medical Device Companies
Medical device manufacturing companies have a duty to properly test their products and ensure that they are safe for consumer use before placing them in the market. Numerous parties may potentially share liability for defective products, including the manufacturer, designer, importer, distributor and other pertinent parties.
The manufacturer must notify the FDA in the event of a reportable death, serious injury or malfunction. Hospitals, outpatient clinics, diagnostic centers and other facilities that utilize medical devices also have a duty to report malfunctions, injuries and deaths, as do distributors and importers.
Defective Medical Device Product Lawsuit
If an injury or death occurs as a result of a defective medical device, the victim(s) may pursue compensation in a defective medical product lawsuit, which may be based on the following:
- Design defect – a flaw, miscalculation or other error in the product’s design
- Manufacturing defect – a defect occurs during the manufacturing phase
- Defect in marketing, instructions, warnings and/or information – failure to adequately convey instructions, dangers, risks or potential problems to consumer
Negligent parties may potentially face civil lawsuits and criminal prosecution. The government may use its seizure and injunction powers to protect the public from dangerous products.
Compensatory Damages for Victims of Defective Medical Devices
If you were injured by a defective medical device, you may potentially pursue compensation for past, present and future medical, hospital and rehabilitative expenses arising from the injury. Other damages may include pain and suffering, loss of enjoyment of life, lost income, lost future income, and more. Every case is unique and depends on its facts.
In a wrongful death case, legal surviving heirs include the decedent's spouse, children, parents and others as proscribed by Florida’s Wrongful Death Statute. Compensation may include lost support and services, loss of companionship, mental pain and suffering, reimbursement for funeral expenses, if already paid, and more. The decedent’s estate may also pursue compensation for loss of net accumulations, lost earnings, medical and funeral expenses and more.
You can reach Miami Personal Injury Lawyer J.P. Gonzalez-Sirgo by dialing his direct number at (786) 272-5841, calling the main office at (305) 461-1095, or Toll Free at 1 (866) 71-CLAIM or email Attorney Gonzalez-Sirgo directly at [email protected].
https://www.fda.gov/medicaldevices/safety/reportaproblem/ - FDA medical device reporting
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm - FDA medical device removal database – search for removed, recalled medical devices
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm359566.pdf - manufacturer reporting requirements
http://www.leg.state.fl.us/STATUTES/index.cfm?App_mode=Display_Statute&Search_String=&URL=0700-0799/0768/Sections/0768.21.html Florida Wrongful Death Statute