medical device lawyer

Defective medical devices can cause serious injuries. These injuries can be permanent or even result in death.

Manufacturers should not rush to push a product to market at the expense of a patient’s life.

If you have an injury from a defective medical device, a medical device attorney can help you.

At Wade Injury Law, our attorneys have lots of experience with defective medical device cases. We will prepare a strong defense and help get you the compensation you deserve.

Common Types of Defective Medical Device Cases

Defective medical devices fall under product liability law. With these cases, you don’t need to prove negligence. Instead you must prove that there was a defect, and that it caused in your injuries when used. There are several types of defects that you should know:

Design Defect: This is a defect in how the product was designed.
Manufacturing Defect: This is when the design was fine, but something went wrong in the manufacturing phase. This could include cheap parts or incorrect process steps.
Recall Failures: There was an FDA recall, but the company kept selling and making the device. There could be punitive damages awarded.
Instruction Failure: There was failure to warn of dangers during the device’s use.

Statistics on Defective Medical Devices

According to Food and Drug Administration (FDA), injuries, disabilities, and death from defective medical devices is increasing.

The industry has grown over the past two decades, but it has doubled in size during the last 10 years. The medical device industry made $74 billion in revenue in 2001. By 2009, the industry made in $148 billion in revenue — a huge increase in less than a decade.

Medical devices fall under one of three classifications:

Class I Devices: Viewed as low risk by FDA. This includes products like dental floss, exam gloves, and bandages.
Class II Devices: These have a higher risk than Class I devices. They include products like powered wheelchairs, surgical drapes, and infusion pumps.
Class III Devices: These have the most risk and are “life sustaining” with strict regulatory controls. Some Class III devices include cerebellar stimulation, pacemakers, artificial heart valves, and more.

The push to approve Class III Devices has rising. Manufacturers have increased what the products can do, expanding the market base. This happens through supplemental pre-market approvals (PMAs). The downside of this is the potentially negative results when used on patients. Data shows that PMA supplements are growing each year by an average of 11%. With that comes an increase in negative events from defective medical devices. Between 2005 and 2009 alone, reports of adverse events increased by 88%.

Some products with the most negative event reports fall under these areas:

  • Radiology devices
  • Cardiovascular devices
  • Neurology devices
  • Orthopedic devices

In these categories, some of the more common defective medical device and product cases involve:

  • Pacemakers
  • Trans-vaginal mesh
  • Heart stents
  • Defective hip replacement
  • Robotic surgery injuries
  • Defibrillators

FDA Information on Medical Device Recalls

The FDA posts summaries of the most serious recalled defective medical devices. The products on their list have the biggest chances of causing serious health problems or death.
The database shows Class I medical device recalls and some Class II and III ones. If you have a specific device you are searching for, look at the Medical Device Recalls Database.

Examples of some recent medical device recalls include:

SOLOPATH Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System

These are single use devices that help place catheters or other medical devices from a patient’s blood vessel to an artery in their hip or thigh. This is a Class I recall due to the risk of a tip to dislodge from the outer rim of the sheath. This results in a loss of the smooth transition from the tip’s surface to the sheath’s outer surface. Using an affected device can cause vessel tears, hemorrhages, or vessel disruption. These problems could ultimately cause death.

EV1000 Clinical Platform, EV100 Clinical Platform NI, EV100 Clinical Platform CS

These track a patient’s blood pressure and pulse during surgery. It is a Class I recall due to the risk of fluids to leaking into the AC power outlet. This could result in an electrical short circuit, meaning the device could stop working or cause a fire.

Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter

Health care providers use these to enlarge the opening between the atria. Its purpose is to help increase oxygenated and de-oxygenated blood mixing to improve a baby’s oxygen levels. It is also used to decompress one of the atria when it’s blocked, preventing draining. This can improve blood flow and cardiac output.

They are being recalled due to a possibility of difficulty in balloon deflation. The potential result is balloon fragmentation, or it could detach. This could result in heart damage, a stroke, organ damage, or even death.

What Do You Do If You Find a Device is on the Recall List?

First, read the entire recall notice. The recall release lists the affected model numbers, lot numbers, manufacturing dates, and distribution dates. If your product falls outside of the report’s parameters, it is not being recalled — at least not yet. There is information on who to notify and report the device to. Once you’ve done these steps, it’s contact a dangerous medical device attorney for more help.

Contact a Defective Medical Device Attorney

If you’ve been injured from a defective medical device, contact Wade Injury Law right away. Delaying can weaken your health and the strength of your case.
Our defective medical device attorneys will fight for you and get you the compensation you deserve.

If you’ve been injured from a defective medical device, contact Wade Injury Law right away. Delaying can weaken your health and the strength of your case.

Our defective medical device attorneys will fight for you and get you the compensation you deserve.