New York City Defective Medical Device Attorney
The medical devices we have today can save lives and extend quality of life for decades. But there is also a dark side. Medical devices are very profitable, and they are often rushed to market without the full testing that consumers might expect to be required. A defective medical device can cause irreversible or fatal injury. When a defective medical device causes injury or death, the device maker can be held financially responsible through a product liability lawsuit. You and your family deserve full and fair compensation. the Law Offices of Eric R. Bernstein, P.C. can help.
Examples of Defective Medical Devices
Medical devices that have been litigated due to defects that harm patients include:
- Bladder sling/Transvaginal mesh
- Breast implants
- Drug eluting stents
- Essure
- Heart valve implants
- Hernia mesh
- Hip replacement
- IVC filters
- Implanted defibrillators
- Intrauterine contraceptive devices (IUDs)
- Knee replacement
- NuvaRing
- Power morcellators
- Pacemakers
- Pain pumps
- Sanitary wipes
- Shoulder replacement
- Surgical robots
Defective Medical Device Injuries
Defective medical devices can cause a wide range of injuries. The types of harm depend partly on the type of device and what it was used for. Some defective medical devices can cause sudden death when they malfunction. Others cause injuries more slowly, often involving destruction of internal tissues and severe infections, or the spread of cancer. When the defective device is an implanted device, it may be too dangerous to try to remove it, or it may not be possible to fully remove it even with multiple surgeries.
Examples of the harm that can be caused by defective medical devices include:
- Device migration
- Severe infection
- Sepsis
- Damage to surrounding tissue
- Damage to surrounding bone
- Loss of use of a limb
- Amputation
- Inflammatory response
- Allergic reaction
- Spread of cancer
- Heart attack
- Multiple revision surgeries which may not be successful
- Pacemaker, defibrillator, or similar device fails to perform
- Pacemaker, defibrillator, or similar device activates when it should not
- Recurrence of the condition the device was meant to correct
- Chronic pain
- Significantly decreased quality of life
- Permanent disability
- Death
Expedited Clearance for Devices
Many medical devices are allowed to go to market without going through the standard U.S. Food and Drug Administration (FDA) approval process. Instead, if the new device is “substantially similar” to an existing device, it can go through the faster 510(k) clearance process. The new device does not go through the rigorous testing and approval process, and can be cleared for market even if the approved device it is similar to is known to be defective.
In 2011, the Institute of Medicine (IOM) found that 71% of Class 1 device recalls, from 2005 – 2009, were of devices cleared through the 510(k) clearance process.
If you or someone you love has been harmed by a defective medical device, New York product liability attorney Eric R. Bernstein is here to help. Please, call the Law Offices of Eric R. Bernstein, P.C., at (212) 683-1530 or email us today to schedule your free initial consultation.
