California Federal Court Dismisses First Product Liability Case Involving 3D Printed Medical Device

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.

The plaintiff filed a lawsuit against the defendant, claiming that the company falsely advertised, misled, and deceived her into believing that the 3D printed devices would treat malocclusion. The plaintiff’s case sought to define a class of other Ivisalign consumers who had also been deceived. The plaintiff filed an amended complaint shortly after filing the initial complaint, and the defendant moved to dismiss. The court granted the motion but gave the plaintiff leave to amend.

After the plaintiff filed a second amended complaint, the defendant moved to dismiss the lawsuit. In dismissing the plaintiff’s claim yet again, the court discussed the learned intermediary doctrine. In her second amended complaint, the plaintiff alleged that the defendant had evaluated and independently approved her dental impressions, and as a result the defendant bore a duty to warn the plaintiff about whether the device would treat her malocclusion. The court rejected this argument, finding that the defendant “stands in the position of a manufacturer, not a medical evaluator.”

The court next concluded that the plaintiff’s allegations regarding fraud failed to meet the heightened pleading standards in Rule 9(b) of the Federal Rules of Civil Procedure. More specifically, the plaintiff failed to provide any facts other than a brochure showing the specific information the defendant conveyed to her that was misleading or false. The court even rejected the plaintiff’s reliance on the defendant’s website, which stated that the product treats “serious malocclusion.”

According to the court, this was not sufficient to show what types of malocclusion the product can treat or that it can resolve teeth that have been worn down as a result of malocclusion. In fact, the defendant’s product instructions included a statement that the device does not treat malocclusion that requires surgical correction.

If you or someone you know has suffered injuries as the result of a defective medical device, you may be entitled to compensation. At Moll Law Group, our defective device lawyers have helped many injured people throughout the country, including in New York, Florida, and Texas. We are based in Chicago, Illinois, and we offer a free consultation to help you learn more about your rights. Contact us now at 312-462-1700 or contact us online to set up your appointment.