What are medical device recalls?
Modern medical devices such as cardiac defibrillators, drug eluting stents, pacemakers, and other devices can save lives when they work as intended. Unfortunately, defects in manufacturing, design, or marketing can turn a lifesaving product into a deadly one – and unsuspecting consumers pay the price.
Manufacturers and the FDA will often issue recall notices when a defective and potentially dangerous product is identified. However, in order for the problem to become known, an innocent consumer has to suffer – and the recall may not come soon enough to prevent hundreds of injuries and even fatalities.
Some of the more recent instances of defective medical devices have included:
- Stents inserted into arteries to help regulate blood and oxygen flow. Some stents are coated in medication to prevent inflammation, which can be harmful to people with certain allergies or medical conditions. As a result, many consumers suffered serious side effects including anaphylactic shock and blood clots.
- Defective batteries in pacemakers and defibrillators. Batteries used to power these devices became defective after an expiration date, but many of the consumers who used them and medical providers who implanted them weren’t aware of the potential for battery failure.
- Patches used to repair ventral hernias. The coil ring of the patch was designed to fold down in order to be inserted during surgery and spring open once in place. However, some of the rings broke during insertion, causing perforated bowels and other dangerous intestinal problems.
Medical Device Recall Lawsuits
Companies that manufacture medical devices have an obligation to provide safe and reliable products that work as advertised. Even when they do work, there are often side effects and other risks associated with using them. The law requires that manufacturers disclose known issues about risks of any side effects, malfunctions or other problems. When devices are defective, or contain inadequate warnings of side effects, the manufacturers, distributors, and resellers can be held liable.
Medical devices can be considered defective based on several different criteria, depending upon where the problem occurred. Medical devices, just like any consumer product, must fall into one of three categories in order to be considered defective:
- Design defect – the product was designed improperly, resulting in the breakdown in function that caused the injury.
- Manufacturing defect – the product may have been designed correctly, but an error occurred during production which caused the device to malfunction.
- Marketing defects, including failure to warn – the product was marketed in a misleading manner, or the product label or other accompanying literature failed to warn of potential side effects.
If you or a loved one has been injured by a defective medical device or product, you may be entitled to compensation from those responsible for your injury by failing a product injury claim or lawsuit. If a loved one has died, the surviving spouse or other family members may be entitled to bring a wrongful death action against the responsible parties. Damages can include:
- Compensation for past and future medical expenses
- Loss of past and future earning
- Pain and suffering
- Emotional distress
- Punitive damages awarded to punish the responsible parties
Medical Device Recall Attorneys
If you or someone you love has been seriously been hurt by a defective medical device that has been recently recalled, contact an attorney right away. Depending on the nature of the device involved, there may have been many others injured and class action litigation may be pending. An experienced medical device recall attorney can advise you whether to pursue your own claim or join an existing class action lawsuit. You have only a limited time to file a claim, however, so you must act quickly.