Jan. 15, 2019
An Ultherapy lawsuit filed against Ulthera, Inc., and Merz North America, Inc., will move forward, at least partially, after the judge denied the defendants’ motion to dismiss the lawsuit. The lawsuit, filed by Georgia Tryan and Marilyn Echols, on behalf of themselves and others, alleges that Ulthera and Merz used false and misleading marketing to convince patients to use the skin treatment.
Patients rely on medical device makers to provide honest and accurate information regarding their products. When device makers fail to do so, they put the health and safety of patients at risk. At Cutter Law, we are committed to holding medical device makers accountable for their products and their marketing, and ensuring patients have access to medical devices that have been properly tested and approved and are safe for use.
Ultherapy uses a focused ultrasound applied to various areas of the patient’s body to encourage the patient to produce extra collagen. The goal of Ultherapy is to make the skin appear tighter and reduce the appearance of wrinkles. The ultrasound is delivered to the patient at a depth of 1.5 millimeters, 3 millimeters, or 4.5 millimeters. The Ulthera system, used to treat skin on the patient’s neck, chin, eyebrow, and chest, was made by Ulthera, which was bought by Merz North America in July 2014.
Although the makers of Ultherapy recommend patients receive between 300 and 325 Ultherapy bursts each treatment, data submitted to the FDA in support of the treatment application was allegedly based on only 50 lines of treatment. When the FDA allowed Ultherapy on the market, it did so based on safety data from patients who received far less treatment than the makers ultimately recommended using. This constitutes off-label use of the device and while off-label use is not illegal, it is illegal for medical companies to market their products off-label.
Ultherapy Side Effects
Some patients who have undergone Ultherapy treatment have reported side effects including nerve damage, eye herniation, muscle deterioration, and vision loss. Such Ultherapy face injuries can have a significant impact on a person’s quality of life.
One Ultherapy lawsuit filed in 2015 against a doctor and Ulthera alleged a patient lost 90% of the vision in her right eye after she agreed to be a live model of an Ultherapy demonstration at a surgical conference. Immediately after the procedure, the patient reportedly experienced difficulty with her vision and after seeking treatment at a hospital, underwent cataract surgery to restore the vision in her eye. Despite undergoing surgery her vision has not been fully restored, according to her lawsuit.
In the lawsuit under consideration for dismissal, the defendants filed a motion to dismiss the lawsuit based on FDCA preemption, arguing that any claims regarding marketing should be sent to the FDA for its interpretation of whether the marketing was false and/or misleading.
Plaintiffs allege if they had known the treatment was approved through the 510(k) clearance—meaning the product is allowed on the market if it is substantially similar to another product that has already been approved—they either would not have used Ultherapy or would have paid less for it.
In considering the defendants’ motion to dismiss, the judge ruled partially in favor of the plaintiffs, denying the motion except for the request that injunctive relief allegations—those related to possible future injury—be stricken. The defendants argued that the plaintiffs cannot show they would rely on Ultherapy marketing in the future because they had knowledge that Ultherapy was not FDA-approved. The judge agreed with that argument and dismissed injunctive relief from the lawsuit while allowing the suit to continue.
Cutter Law has filed lawsuits on behalf of patients who were harmed by Ultherapy treatment. Our skilled attorneys are highly experienced in lawsuits against medical device manufacturers and have obtained hundreds of millions of dollars for our clients. We are committed to protecting the rights of our clients and people harmed by medical device companies that put profits before people.
If you or someone you love have experienced Ultherapy problems and suffered Ultherapy damage, contact an attorney at Cutter Law today for a no-obligation consultation. Our attorneys are available to answer your questions and explain your rights. We go the extra mile to ensure you receive justice for your injuries.