Medical device manufacturers tend to rush products onto the market – sometimes without adequate testing to ensure that the device is safe and effective when used properly. By the time a medical device is revealed to be flawed, many patients may have already been subjected to serious injury or died.
The Oklahoma product liability attorney at Burch, George & Germany, P.C., can help Oklahoma residents who have been injured or lost a loved one due to a defective medical device. Oklahoma medical malpractice attorneys can provide a consultation about your case free of charge. Call or contact us online today.
Most medical devices reviewed by the U.S. Food and Drug Administration (FDA) before entering the marketplace are cleared through a process called “premarket notification,” or the 510(k) clearance process.
The 510(k) process requires a medical device manufacturer seeking approval for a new product to merely state that it is “substantially equivalent” to a “predicate device,” or a device already approved for market.
When the FDA assesses the substantial equivalence of a device, it generally does not require evidence of safety or effectiveness. The new device is presumed to be as safe and effective as the previously approved device.
Recently, the FDA asked the Institute of Medicine (IOM) to conduct an independent review of concerns about the 510(k) process. The IOM report recommended development of a new regulatory framework for approving medical devices.
According to the IOM, the 510(k) process “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of medical devices and “cannot be transformed into one.”
The IOM also said that a robust review of devices already in use was essential. The IOM said the FDA should develop and implement a comprehensive strategy to collect, analyze and act on the post-market performance of medical devices.
In other words, our country’s primary program for ensuring the safety of new medical devices before and after they are put on the market is flawed.
Typically, it is patients’ reports about problems, independent scientific research, release of manufacturers’ documentation or a combination of events that prompts the FDA to direct the removal of a faulty medical device from the market through a recall. Unfortunately, this happens after the device has been used in many patients and a pattern of adverse reaction, injury or death has become identifiable.
Two cases illustrate this:
The FDA acknowledged this problem with metal-on-metal hips in January 2013 after approximately 500,000 hip-implant patients in the United States had undergone corrective surgery because their metal-on-metal hip implants had failed prematurely.
Patients have a right to seek compensation for injuries they have suffered due to defective medical devices by pursuing a personal injury claim (or a wrongful death claim if a loved one has died after being treated with the device).
A lawsuit would allege that the manufacturer knew or should have known its medical device was defective or faulty and that it failed to adequately warn consumers about the risks.
These cases often become part of wider, nationwide litigation. For instance, one’s complaint may be entered into a single class-action lawsuit involving many similarly harmed plaintiffs, or it may be consolidated with other lawsuits in multidistrict litigation (MDL) in a federal court.
A review of your case by the product liability lawyers of Burch, George & Germany, P.C., can help you to understand your options and determine the best course of legal action for you and your family. Get started by calling or contacting us online today. We can provide a free case review. If you need help filing a birth injury lawsuit, you may as well contact our birth injury attorney.
For More Information: