When a doctor suggests that a medical device may help you, they’ll explain a little bit about how the device works; however, truly understanding how any given device works often requires either a medical or scientific background which most patients, understandably, do not have. Thus, patients, as well as their doctors, place a tremendous amount of trust in companies that design and manufacture medical devices. But what happens if a medical device ends up causing more harm than good? And what if the manufacturer of the device didn’t want doctors or patients to know about these risks?

According to dozens of patients, this is exactly what happened with the Anterior Growth Guidance Appliance (“AGGA”). Patients who had an AGGA implanted have recently begun reporting that they’ve experienced tooth damage, facial disfigurement, and other serious—and possibly irreversible—injuries. Indeed, federal prosecutors have also recently opened up a criminal investigation into the AGGA dental device, and the Food and Drug Administration has also initiated an investigation into the AGGA device as well as other devices that share a similar design.

Patients who had an AGGA dental device implanted and have since experienced tooth loss, disfigurement, bone decay, or other serious injuries may have a product liability claim against the company. As we’ve discussed in other posts, manufacturers of medical devices have a legal duty to not only design a product that is safe for its intended uses but also to warn patients about all known possible side effects. While these cases are important to individual patients, they are also essential to ensuring that future patients are spared similar outcomes by holding manufacturers to a high standard.

Is the AGGA Dental Device Safe?

While the AGGA lawsuits are still currently working their way through the system, the many patients who have suffered serious injury as a result of the implant would say that it is not safe. The basis for the patients’ complaints is that the AGGA device can cause bone decay, tooth loss, facial disfigurement and other related injuries.

What Is the Problem with the Anterior Growth Guidance Appliance?

Patients who report experiencing injury after having any medical device implanted often claim that the device does not work as advertised. However, those patients who have filed Anterior Growth Guidance Appliance injury lawsuits go a step further, asserting that the device could not work based on the way it was designed and that the product caused them to suffer painful injuries and disfigurement. The patients also claim that the manufacturer of the device misled consumers into paying for a device that had no possibility of improving their underlying health condition or appearance.

Are Anterior Growth Guidance Appliances FDA Approved?

Earlier this year, an investigative report looked into the safety and efficacy of the Anterior Growth Guidance Appliance devices. This report concluded that there was “no record of the AGGA being registered with the FDA.” Indeed, in a court deposition, Dr. Steve Galella, the creator of the device, admitted that neither he nor his company ever submitted the Anterior Growth Guidance Appliance to the FDA for approval.

How Many People Have AGGA Dental Devices?

According to court records, there are at least 10,000 patients who had an AGGA dental device implanted in their mouths. Over the past three years, several dozen patients have filed product liability lawsuits against the company, claiming that the AGGA device did not work and could not have achieved the advertised results based on the product design.

Can Patients Who Were Injured By an AGGA Dental Device Sue the Company?

Yes, patients who had an AGGA device implanted and subsequently experienced pain, the loss of teeth, disfigurement, or other complications may be able to pursue a product liability claim against the company that designed the AGGA device, the Facial Beauty Institute, as well as the company that manufactured the device, Johns Dental Laboratories.

A product liability claim is a type of personal injury case brought by a consumer, in this case, a patient, who was injured by a company’s product. Most product liability lawsuits are brought against the company that designed or manufactured the product; however, in certain situations, other companies, such as retailers or distributors, may be liable.

Product liability cases seek to hold companies that design, manufacture or sell a defective or dangerous product financially responsible for any harm caused by the product. These cases are necessary to protect future patients because manufacturers are in the best position to ensure that their products are safe and that consumers are reasonably aware of any potential dangers the product presents.

While product liability claims are similar to other personal injury cases, there is a major difference: typically, plaintiffs do not need to prove that the manufacturer or designer was negligent in product liability cases. This is because most product liability cases are brought under the theory of strict liability. Under a strict liability analysis, a patient only needs to prove that a company’s product was dangerous or defective or that the company failed to warn the patient about known risks associated with the product.

Patients who were injured by the Anterior Growth Guidance Appliance and are currently considering an AGGA lawsuit should not take this to mean that these cases are easy to prove. The companies that design and manufacture medical devices are well aware of the litigation risk they face and are almost always prepared to defend against any claim filed by patients. Thus, patients interested in learning more about an AGGA injury lawsuit should reach out to an experienced product liability attorney for assistance.