On Monday, defendants including Zeltiqs Aestehtics, Inc. and AbbVie Inc. moved to dismiss a lawsuit brought by a recipient of fat removal treatment using a medical device marketed by them.
According to the motion, filed in the Northern District of California, the device,the CoolSculpting System, is used “for the treatment of visible fat bulges in various parts of the body. It uses controlled cooling to target and freeze (thereby killing) fat cells under a patient’s skin, and the body removes those dead fat cells”
The plaintiff underwent treatment using the device at her physician’s office in January 2018. She alleged that after, she suffered from paradoxical hyperplasia (PH), which is “enlarged and sometimes hardened tissue masses that cause disfigurement.”
According to the motion, “The crux of her allegations is that “Defendants failed to appropriately and/or adequately warn all physicians, healthcare providers, and the public… of the risk of developing post-surgical growths, including but not limited to PAH, from the use of the CoolSculpting device.”
The defendants argued that healthcare providers had been adequately warned, citing a warning on the user manual under “rare adverse events.” The defendants asserted that they had no responsibility to convey this risk to the public. They argue that under both state and federal law, producers of this kind of product hold no responsibility in regards to informing the public about adverse risks; this responsibility falls on the physician, and any failure on the physician’s part to disclose that information cannot be assigned to the manufacturer.
AbbVie and the defendants also addressed arguments that there was a feasible design alternative that would have a reasonable probability of preventing harm and injury. However, the defendants say that no actual, concrete solutions were cited by the plaintiff and the actual defect was not mentioned. The plaintiff did provide concrete evidence in regards to manufacturing design errors, but defendants say that the specific recall mentioned was made in response to an issue with its error messaging system. Defendants claim that the error messaging system would have no effect on the frequency that users experience PH.
The defense is represented by Squire Patton Boggs.
