When a patient is injured or dies, the harm can sometimes be traced to a defect in the medical device that was used to prevent, diagnose or treat a patient’s condition or disease. Medical aids and instruments are too often rushed onto the market without proper testing to ensure they are safe and effective when used as intended. By the time a dangerous device’s flaws are revealed, many patients are subjected to serious or fatal injuries. Meanwhile, the U.S. Food and Drug Administration (FDA) approves certain medical devices for market in a manner that requires little direct scrutiny of the new product.
If you think you or a loved one has been injured by your doctor’s use of a defective medical device, it’s important to seek legal assistance. The Chicago defective medical device lawyers of Salvi, Schostok & Pritchard P.C., investigate injuries and deaths caused by faulty medical aids and instruments. We can advise you of your legal rights and options. To schedule a free and confidential consultation, contact us today at our toll-free number or through our online form.
The FDA’s role is to approve medical devices for market in the U.S. after determining they are safe and effective. But the FDA approves many faulty medical products. Congressional hearings in 2008 revealed that the FDA receives 200,000 reports of injuries and 2,000 deaths every year related to medical devices.
The FDA process that allows medical products into the U.S. market is part of the problem.
The FDA classifies medical devices according to the risk they pose. The risk-level classification determines what the manufacturer must demonstrate to gain FDA approval to market the device.
Class III devices are the highest-risk medical devices. The FDA defines these as devices that:
Pacemakers and defibrillators are examples of Class III medical devices.
For FDA approval of a Class III medical device, a manufacturer must demonstrate that the device’s safety and effectiveness was determined in “adequate and well-controlled” clinical trials. This is called the “premarket approval” process.
However, most medical devices approved by the FDA do not require the type of stringent pre-market testing that Class III devices go through. Products classified as Class I and II medical devices because they pose a more moderate risk can be approved through a “premarket notification” that is commonly called the “510(k) process.”
Congress developed this process in 1975 as a faster way to evaluate moderate-risk devices.
To gain FDA approval through the 510(k) process, a medical device manufacturer must merely demonstrate that the device is “substantially equivalent” to a “predicate device.” A predicate is a device already approved for market.
Metal-on-metal hip implants, pelvic mesh kits and pain pumps are examples of Class II devices.
In 2011, the Institute of Medicine (IOM) concluded in an FDA-sponsored study that the 510(k) process should be abandoned because it “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of moderate-risk devices and “cannot be transformed into one.” While many devices approved via 510(k) are safe, the study said, “510(k) clearance does not determine a device to be safe or effective.”
There are many reasons for concern. For instance, a device may be approved based on its “substantial equivalence” to a predicate even though that predicate was recalled by the manufacturer for safety reasons.
This is especially troubling when, according to the watchdog group Public Citizen, recalls for moderate- and high-risk medical devices in the U.S. more than doubled from 2007 to 2011, going from 566 recalls to 1,201.
Once it is in the U.S. marketplace, a defectively manufactured and sold medical device can cause severe pain, infection, inflammation or death. In many cases, the only remedy is to remove the device from the patient’s body. In some cases, a device cannot be removed.
Numerous corrective surgeries and extensive rehabilitation may be required to repair damage caused by defective medical products. The physical injuries often are accompanied by emotional pain and suffering as well.
Patients who have been injured by a defective medical device, or those who have lost a loved one because of a dangerous medical product, generally may seek legal relief through a product liability lawsuit. The manufacturer’s liability may be based on:
A person may pursue a defective medical device lawsuit in a state or federal court. Because these cases often involve patients and families from around the country, they may become part of a class-action lawsuit. They also may be consolidated for pretrial proceedings in what are called “multidistrict litigation,” or MDL, cases. Regardless of how many patients are involved in a legal action, the attorney who represents you in a defective medical device action must ensure your rights and interests are protected at each step of the case.
Everyone in the health care industry plays a vital role in ensuring patient safety and well-being. This includes medical device manufacturers. When a medical product manufacturer fails to live up to its obligations, patients deserve compensation for any harm they suffer.
If you or a loved one has suffered physical or emotional injuries because of a defective medical device, contact Salvi, Schostok & Pritchard P.C., to learn about your legal rights and options. Call us today at our toll-free number or complete our online form.
Our Chicago defective medical device lawyers can provide a free, confidential evaluation of your case and develop a strategy for obtaining the relief you need and deserve.