Articles Posted in Medical Devices

In Buckley v. Align Technology, Inc., a plaintiff brought product liability challenges against the defendant regarding its Invisalign teeth straightening system. This device is a 3D printed product that helps users straighten misaligned teeth. The user receives a customized series of 3D printed mouth inserts that fit snugly around his or her teeth, encouraging the teeth to move in a direction that will help keep them straight. The device is only available by prescription from a dentist.

In this case, the plaintiff saw her dentist for treatment for malocclusion, which is a condition caused by wearing down of the teeth. The plaintiff claimed that the dentist who prescribed her Align product also took the dental impressions of her teeth that are needed to form the custom devices. The defendant received the impressions and created 3D printed molds for the plaintiff to wear. According to the plaintiff, after wearing the product for nearly two years, her condition had not improved.

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Since the Essure sterilization device was approved in 2002 by the U.S. Food and Drug Administration (FDA), over 5,000 reports have been made about injuries stemming from the use of the device. In a recent NPR report, a representative from the National Center for Health Research indicated that Bayer, the manufacturer of Essure, may not have provided the FDA with all the information it had regarding the device’s potential complications at the time Bayer sought approval of the device. Some of this research indicates that the device may fail up to 10 percent of the time.

The pressure to address Essure’s complications heightened earlier this month when Congress drafted a bill calling for the FDA to remove the device from the market within 60 days after numerous women testified at a Congressional hearing about how the device had negatively affected them.

Recently, the FDA’s Obstetrics and Gynecology panel convened to discuss the device and how patients can best assure their safe use of the product. The device is particularly popular due to its status as the only non-surgical and permanent birth control method that the FDA has approved.

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