Jacksonville Florida Defective Medical Device Attorneys
Defective Medical Devices
The Food and Drug Administration (FDA) is supposed to regulate the safety of drugs and medical products, including medical devices. Most people assume the agency requires manufacturers submit to a rigorous process before a medical device can be put on the market.
But for many medical devices - that would be a false assumption.
Consumers would be amazed how many medical devices have been grandfathered in by the FDA without any rigorous scrutiny for safety. Other Class I and II medical devices are approved under a flawed FDA loophole (510k), allowed to claim they are "substantially equivalent" to devices already on the market, even though they may include new materials and design.
The FDA’s own web site says "Only a small percentage of 510 (k) s require clinical data to support a marketing clearance by the Food and Drug Administration."
It is ultimately the consumer who provides the data for safety after the defective medical device is already in the marketplace.
There have been many examples of medical devices that have been investigated and recalled.
Defective Medical Devices
The news has been full of stories about "pain pumps" that deteriorate shoulder cartilage, hip and knee implants that are defective, and the defibrillator leads that malfunction and lead to dangerous shocks to heart patients.
Among defective medical devices that have been approved, recalled, or are under investigation:
- Medtronic Heart Device
- St. Jude defibrillators
- Ortho-Evra Birth Control Patch
- Medtronic Sprint Fidelis leads
- Transvaginal mesh
- Kugel Hernia Mesh
- Boston Scientific infusion ports
- Lifesite dialysis
- Fentanyl patch
- Latex gloves
- Implantable contraceptives and intrauterine devices
- Prostheses
- Silicone implants
- Respiratory devices
- Contact lenses and dental care product
- Laser and orthopedic tools
What Patients Need to Know
You would be well-advised to do your own investigation in case you need an implanted medical device or work with a Jacksonville personal injury attorney experienced in medical device product liability.
If you are implanted with a defective medical device, you may have no legal recourse. That’s because due to a U.S. Supreme Court decision, Riegel vs. Medtronic, the device maker cannot be sued for injuries caused by an FDA-approved medical device. Even those not expressly approved by the FDA, but grandfathered in, seem to enjoy the same protection from litigation.
In early 2009, some within the FDA blew the whistle on the medical device approval process to President Obama. They felt the tail was wagging the dog and many medical devices were being approved at the urging of manufacturers and with very little critical oversight. The approval process has seriously failed the public, they said, and these problems will not be fixed by anything other than an overhaul of the approval process, rooting out conflicts, and unethical practices.
Defective Device Claim
A product liability lawsuit can name the designer of the device, the manufacturer, the pharmacy, the distributor, and retailer. Your treating physician can also be sued for malpractice.
At Farah & Farah we’ve brought design defect claims charging that the individual would not have been victimized if the device was designed correctly and was not "unreasonably dangerous." Claims have also been brought that the maker was negligent in the development and manufacture of the device.
The victim of a defective medical device may seek lost wages due to the illness that resulted from the device, and time out of work, both past and future. The loss of companionship and the emotional trauma of pain and suffering can be compensated, and the jury can opt to award punitive damages to punish the device designer or maker for maliciously or intentionally putting a dangerous device into the marketplace.
An action can also be brought against the physician who recommended and implanted the defective medical device.
Mass Tort or Class Action
Medical devices that cause harm to many, including injury, damage, and death, can be pursued by mass tort claims. Mass torts are filed when an unscrupulous corporation disregards the public and puts into the marketplace a medical device that does harm.
A mass tort is unlike a class action because each person has his own claim, even though the court has grouped them as a whole.
You can also pursue a class action in which a few people represent a larger group with similar injuries.
If you have suffered an injury, you may opt to purse an individual lawsuit.
If you have been injured by a dangerous or defective medical product or device, you will want to find an experienced Florida product liability attorney who has expertise in handling medical device liability cases.