Defective Medical Devices Recalled to Prevent Further Injuries
In 2017 alone, there were millions of medical device units involved in Class I recalls, initiated by the U.S. Food and Drug Administration (FDA). Many of these devices are put to market under a pre-approval process and not properly tested before they eventually cause injuries to American consumers and recipients. All too often, defective medical devices are recalled only after they cause serious health problems to patients and face lawsuits for producing, marketing and distributing dangerous products to the public.
In the United States, the FDA may initiate a “recall” when a device manufacturer takes a correction or removal action to address a problem with a medical device that is deemed hazardous or violates FDA law. Recalls most often occur when a medical device is defective, or poses health risks.
With medical devices, a recall usually does not mean that you can return the product to the company. In implanted devices, for example—knees, hips, shoulders, abdominal mesh—the situation is more complex and may involve implant replacements and revision surgeries. When an implanted device has the potential to fail unexpectedly, companies may recommend that patients remove the device.
Recalls can lead to the following types of actions:
Many of the medical devices on the market may be inadequately tested, and victims and attorneys have the right to file claims against negligent companies. When a company injures patients with defective medical devices, lawsuits may be necessary to restore financial losses and other damages incurred.
Joe Lyon is a highly-rated Cincinnati product liability lawyer and Ohio medical device attorney who has successfully represented individuals throughout the country in complex product liability litigation.
The Lyon Firm works with medical specialists and engineers to determine the root cause of medical device failures.
Recalls are classified into three categories by the FDA to indicate the relative degree of hazard presented by the medical device. The classes are described as such:
Types of medical devices recalled in the last few years include:
The FDA maintains a database that records thousands of adverse event reports associated with medical devices. Some patients may face greater health risks than others, though device implants almost always carry some level of complication risk. Common injuries and complications of defective medical devices include:
Due to safety pitfalls in the FDA approval process for new medical devices, many defective products injure American consumers each year. As a result, injured patients and experienced product liability attorneys are forcing medical device companies to claim responsibility and compensate the many victims.
If you or a loved one has suffered an injury due to a defective medical device and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.