When a doctor recommends a medical device, they will explain how it works and why it may be beneficial to you. However, most individuals do not have the medical or scientific training necessary to fully grasp these explanations. Medical device manufacturers are thus entrusted with the confidence of both patients and their physicians. But what if an otherwise helpful medical tool does more damage than good? And what if the gadget maker didn’t want physicians or patients to know about these dangers?
Dozens of users have attested that this is the case after having the Anterior Growth Guidance Appliance (“AGGA”) placed. Recently, patients who received an AGGA implant have reported major complications, including tooth destruction, facial deformity, and serious, maybe permanent, injuries. Federal prosecutors have just begun a criminal investigation into the AGGA dental equipment, and the Food and Drug Administration has already started looking into it and related devices.
Problems such as tooth loss, deformity, bone deterioration, and other major injuries sustained by patients who had an AGGA dental device implanted may give rise to a product liability action against the manufacturer. Manufacturers of medical devices are legally obligated to both create a product that is safe for its intended applications and to provide patients with information about any known potential negative effects, as we’ve explained in previous posts. These lawsuits matter for the affected patients, but they’re also crucial for setting a precedent that will force manufacturers to avoid these same actions in the future.
Contact our product liability lawyers at 866-778-5500 or complete our online form for a free consultation.
Injured patients who have had medical implants frequently allege that the item was defective or did not perform as expected. Patients who have brought damage cases over the Anterior Growth Guidance Appliance go even further, claiming that the product’s design rendered it ineffective and that using it resulted in disfigurement and pain. The patients also allege that the device’s maker lied to customers into purchasing a product that couldn’t possibly fix their appearance or health problems.
There are at least 10,000 people who have an AGGA dental gadget implanted in their mouths, according to court documents. Several hundred individuals have sued the firm for product responsibility in the last three years, saying that the AGGA device did not help them and was not designed to provide the claimed benefits or produce favorable results.
An investigation that analyzed the effectiveness and safety of the Anterior Growth Guidance Appliances was conducted earlier this year. It was reported that there was no record of the device being registered with the FDA. Dr. Steve Galella, the device’s inventor, revealed in a deposition that he and his firm never sought regulatory approval from the FDAS for the Anterior Growth Guidance Appliance.
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There are many patients who have been seriously injured due to the implant, and although the AGGA cases are still making their way through the system, these patients would state that the device is not safe. The patients’ claims center on the possibility that the AGGA device can lead to tooth loss, facial deformity, and dental and bone deterioration.
Patients with an AGGA device who have suffered from pain, disfigurement, tooth loss, or other issues caused by the device may be able to bring a product liability claim against the manufacturer of the device, Johns Dental Laboratories, and the designer of the device, Facial Beauty Institute.
Patients who get injuries while using a company’s product may file a product liability claim, which is a kind of personal injury lawsuit. Companies beyond just the designers and manufacturers, like the distributors and retailers, may be held accountable in certain product liability cases.
Businesses that are responsible for creating, distributing, and selling potentially harmful products may be sued in product liability cases. These lawsuits are important for future patients’ safety because manufacturers are the ones that have to ensure that their goods are risk-free and that customers have a good understanding of any possible risks.
Personal injury lawsuits and claims for product responsibility are similar; however, there is one key difference: in product liability cases, the plaintiff often does not have to show that the manufacturer or designer was negligent. This is due to the fact that strict liability is the predominant legal theory used in product liability lawsuits. In a strict liability approach, the injured party need merely show that the defendant either knew or should have known that its goods posed a risk to consumers.
Patients contemplating filing an AGGA lawsuit after suffering harm from the device should not assume that doing so would be a simple process. Companies that create medical devices are usually well-prepared to fight against any patient claims that are made against them since they know the possibility of litigation is high. Patients who are curious about filing a claim for damages related to AGGA exposure should consult a seasoned product liability lawyer at 866-778-5500 or complete our online form for a free consultation.
