FDA Recalls for Defective Medical Devices
Although the US Food and Drug Administration (FDA) keeps close watch over manufacturers and developers of medical devices, there are still some product defects that slip through the cracks. A defect may occur due to an issue with the manufacturing process, a mistake made when designing the product, or errors in the labeling regarding the device’s usage. When a medical device company discovers or is informed of a problem with one of its products, it will usually inform the FDA regarding:
- A correction, which clears up a miscommunication regarding the device; or,
- Removal of the item from the marketplace, so that it no longer poses a risk.
The FDA publishes a List of Recalls, such as one announced on August 16, 2017: A company recently issued a correction and removal of a medical device, specifically a graft, that is intended to repair the primary blood vessel running from the heart down through the chest of a patient. The problem with the thoracic endovascular graft is that blood clots may form inside the device – and therefore inside the patient – after implantation. The recall impacts physicians that use the device in surgery, and patients that received treatment through implantation of the device.
Fortunately, many defective medical devices are recalled before they cause serious injury or death to a patient. However, a product can give rise to a products liability lawsuit if it causes harm to a patient who undergoes surgery, uses a product, or has a device implanted. Discuss your legal options with a personal injury attorney if you have been injured or lost a loved one due to one of the following more common types of defective medical devices.
Metal Hip Replacements
Hip surgery involves implantation of a device that replaces the ball-and-socket joint, usually consisting of a metal ball that fits inside a metal cup. All metal implants are stronger and more durable than ceramic or plastic devices, but they have led to serious health complications for patients who receive them. Victims allege that the metal implants are defective because of their design, which causes them to fail within a few years and release toxic metal debris into the body. They suffered from metallosis, which is a condition that causes swelling, pain, and blood poisoning. Many patients required a second surgery – a painful and expensive procedure called revision – to replace the defective unit.
Thousands of victims have filed lawsuits against manufacturers or metal implants; they sued as individuals instead of under class action rules because not all patients suffered the same injuries. Several manufacturers have completely removed their devices from the market to avoid additional liability.
A patient may require additional structure to strengthen the vaginal wall, for such conditions as pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Transvaginal mesh is a flexible patch used to provide the structure needed to prevent problems associated with these health issues. Some patients began experiencing problems with erosion of the mesh patch, where the material begins to break down and after placement. Many would suffer the recurrence of POP or SUI as a result of the complications, requiring additional surgery. The procedure is quite complex because it involves removal of mesh that has usually become entwined with tissue.
Another dangerous issue caused by transvaginal mesh erosion is the perforation of nearby organs by the sharp pieces that separate from the patch. The punctures can cause internal bleeding, as well as the release of urine and fecal matter into the body.
Victims have pursued the manufacturer of transvaginal mesh in lawsuits for damages, as the complications can cause severe pain and implications upon quality of life. Many of these claims are based upon the failure to warn concept falling under products liability theories. Specifically, they allege that the manufacturer made misrepresentations and failed to adequately inform patients about issues with the mesh in product brochures. Other cases state that the manufacturer failed to warn the physician about complications, and the patient suffered injuries as a result.
IVC Blood Clot Filters
Inferior vena cava (IVC) blood clot filters are tiny, whisk-shaped wires that surgeons insert into a patient to reduce the risk of dangerous blood clots and related complications. The devices are inserted into the main vessel that carries blood from the lower half of the body up to the heart, so that clots do not become dislodged and migrate into the lungs. The FDA started receiving claims of adverse effects from patients with IVC blood clot filters, alleging IVC perforation, punctured organs (including the lungs and heart), and other conditions. The problem was that the devices would become dislodged or break, which resulting in the units moving to other parts of the body. Plus, the devices were only meant to be temporary, yet the surgery to retrieve them proved difficult.
The basis for lawsuits against the two primary manufacturers of IVC blood clot filters is that the companies did not take adequate action, knowing the potential dangers of the devices. Other claims include failure to warn of the dangers, manufacturing defects, and design defects.
Even when manufacturers of medical devices invest considerable resources in ensuring the safety of their product, and work closely with the FDA regarding regulatory requirements, there may still be errors that make the items defective. There may be a product recall to prevent heightened risk to patients, but it may be too late for anyone who suffers an injury or loses a family member due to the defective device. Fortunately, Maryland law allows injured victims to recover compensation for their losses through a products liability lawsuit; loved ones of a person who died as a result of a defective medical device also have rights in a wrongful death or survival action.
Due to the complexities involved with products liability cases, especially those that deal with highly technical medical devices, it is wise to retain an experienced attorney. A products liability lawyer can offer advice on your legal options and assist with pursuing the responsible entities. For more information on products liability cases based upon defective medical devices, please contact the Baltimore law office of Bob Katz.