When Medical Devices Do More Harm Than Good...

Every day, people in Florida experience personal injury due to faulty or inoperable medical devices. Sometimes, these medical device tools malfunction due to a factory or manufacturer oversight which causes a defective product, and sometimes a medical patient can suffer from a mishap occurring during a medical procedure. If proper precautions weren’t taken to protect the patient before, during, or after the procedure, the negligent parties can be held responsible. The medical device injury attorneys at the Coye Law Firm have experience with these types of claims and are here to help. 

A medical device injury is a personal injury for people suffering because of medical devices that are supposed to alleviate medical issues. These can include medical devices such as: 

  • Pacemakers
  • Defibrillators
  • Artificial joints
  • Prosthetic limbs and accessories
  • Stents or catheters
  • Medical pumps
  • Medical vaginal mesh
  • Other recalled or defective device

Medical Devices and the Law

The US Center for Device and Radiological Health (CDRH) within the US Food and Drug Administration (FDA) is responsible for overseeing that medical devices are safe and effective. The FDA has developed a system of prioritizing to ensure that each device receives the appropriate level of scrutiny, however an FDA approval is not a guarantee of safety and does not shield a manufacturer from liability.

The manufacturer typically is required by law to inform the physician of the health risks involved, but it may be the medical staff’s responsibility to explain these risks to the patient. Generally, medical devices are safe and efficient and do not result in a medical device injury, but unfortunately there are cases where people become injured. The experienced attorneys at the Coye Law Firm want to assist anyone who has suffered a personal injury due to a faulty medical device.

Reporting a Faulty Medical Device

If you have experienced an injury as a result of a defective medical device, seek appropriate medical attention immediately. Do not risk your health in an emergency. The Safe Medical Device Act of 1990 requires that all deaths, serious injuries, and malfunctions which medical professionals suspect may be related to medical devices must be reported to the FDA and the manufacturer, and sometimes the distributor. It is also recommended that consumers make an individual report as well. You can find additional information about timeframe and forms needed to report a death, injury, illness, or malfunction of a medical device at the FDA’s site.

Medical Device Recalls

The FDA monitors reports of problems with medical devices and alerts health professionals and the general public when they need to ensure the proper use of devices and safety of patients. At times, the FDA will recall products from the market if sufficient information is provided substantiating that decision.

To find out about the latest communications about medical device safety and medical device recalls from the FDA, visit their site here.

Contact an Attorney

When you’re injured you need to devote your energy to recovering. You could pursue a personal injury claim against the medical staff, device manufacturer, or the FDA, but you may also be dealing with a dispute from your health insurance, or conflicts with a disability or workers compensation claim. The more complicated your case becomes, the more you may want to consider speaking with an attorney. 



Call 407.648.4940 or contact Coye Law Firm today for a free consultation about your case.

The expert injury attorneys at Coye Law Firm are experienced with Florida, New York, Michigan, and District of Columbia law and are here to help the injured.

If you'd like to learn more about injury law and your rights, read my book, Sharing the Secrets, Learning the Lies: A Guide to Florida Personal Injury

From this book you will learn… 

  1. The ONE THING you must do within 14 days of your accident (page 46)
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  4. 6 critical steps you must take after an accident (chapter 7)
  5. Why you should not trust the insurance company’s repair shop (page 78)
  6. How to choose the right doctor (chapter 5)
  7. A claim you could make against your own insurance company if your car is damaged, but not totaled (page 87)
  8. The secrets to getting a fair settlement (chapter 10)
  9. An 8-step breakdown of the normal process for lawsuits (page 121)
  10. The one 4-letter word that might cost you (chapter 12)
  11. How to start gathering the most important evidence you need (page 75)
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