No lawsuit currently targets the iovera nerve-freezing device itself. Searches for an iovera lawsuit almost always lead to litigation involving Pacira BioSciences, the company that owns the device: a securities fraud class action tied to a patent loss on Pacira’s much larger product EXPAREL, and a series of patent infringement cases against generic drug makers. The device’s own legal record is limited to two labeling recalls from before Pacira bought it and a small number of adverse-event reports filed with the FDA.
What’s on the Iovera Device’s Own Record
The iovera system is a handheld cryoneurolysis device that freezes peripheral nerves to block pain, most often used for knee osteoarthritis. The FDA first cleared it through the 510(k) pathway in March 2017, with additional clearances in February 2018 and May 2022.1FDA. 510(k) Premarket Notification K1618352FDA. 510(k) Premarket Notification K220656 Pacira acquired the device in April 2019 through its purchase of original developer MyoScience.3Pacira BioSciences Investor Relations. Pacira Completes Acquisition of MyoScience
Two Class 2 recalls have been reported for iovera, both under MyoScience and both about labeling rather than the device malfunctioning. In June 2013, three units shipped with European labels missing required U.S. regulatory statements; a company representative relabeled them at the two affected sites and none had been used on patients.4FDA. Recall Z-1781-2013 In July 2015, 12 boxes of iovera 155 Smart Tips were recalled for a printed expiration date that was wrong, and customers were told to quarantine the affected stock.5FDA. Recall Z-2201-2015 Both recalls were terminated once the corrections were made. No recalls have been reported since Pacira took over.
Clinical trial data submitted for the original clearance showed no serious device-related or procedure-related adverse events in 121 patients. The most common lingering side effects past 30 days were numbness (about 15%), tenderness at the treatment site (about 12%), and localized pain (about 7%).1FDA. 510(k) Premarket Notification K161835 A 2024 scoping review of 465 participants across seven studies described most adverse events as “mild and self-limiting.”6National Library of Medicine. Scoping Review of Cryoneurolysis Adverse Events
Post-market reports in the FDA’s MAUDE database include a few more serious incidents. A February 2023 report classified as a “serious injury” described an iovera Gen 2 handpiece that overcooled a treatment site and caused a freezer burn about the size of a dime; a manufacturer representative reportedly called it a “known issue” tied to a programming problem with the Gen 2 device.7FDA MAUDE Database. MAUDE Adverse Event Report 16447075 A 2021 report described a 67-year-old patient who had not regained normal sensation after a 2019 iovera treatment prior to a knee replacement.8FDA MAUDE Database. MAUDE Adverse Event Report 11392022 None of these reports has led to a publicly reported product liability lawsuit.
The Pacira Securities Class Action That Shows Up in Searches
The lawsuit most likely to surface when people search for an iovera lawsuit is not about iovera at all. It is a securities fraud class action against Pacira driven by a court ruling on EXPAREL, the company’s non-opioid injectable painkiller and its largest product.
In August 2024, a federal judge in New Jersey found one of EXPAREL’s key patents, U.S. Patent No. 11,033,495, invalid on grounds of obviousness and anticipation in a case brought by generic drug maker eVenus Pharmaceuticals. Judge Madeline Cox Arleo ruled that the concentration levels claimed in the patent were so close to those in prior art that a skilled chemist would have expected them to behave identically.9GovInfo. Pacira Pharmaceuticals v. eVenus Pharmaceuticals, Civil Action No. 21-19829
Pacira’s stock dropped when the ruling was disclosed on August 9, 2024. Investors then filed Alvarez v. Pacira BioSciences, Inc. (D.N.J. No. 2:25-cv-00322), alleging that Pacira and its executives made false or misleading statements about the strength of EXPAREL’s patent protections during the class period of August 2, 2023 through August 8, 2024, in violation of Sections 10(b) and 20(a) of the Securities Exchange Act.10BusinessWire. PCRX Investors Have Opportunity to Lead Pacira BioSciences Securities Fraud Lawsuit The Western Pennsylvania Teamsters and Employers Pension Fund was named lead plaintiff.11Bloomberg Law. Pacira Beats Investor Suit Based on Painkiller Patent Litigation
On February 6, 2026, Judge Stanley R. Chesler dismissed the case with prejudice. The court found the investors had failed to show Pacira’s executives did not believe their own optimistic statements about the patent litigation, and held that the company was not required to disclose litigation setbacks before the final ruling.11Bloomberg Law. Pacira Beats Investor Suit Based on Painkiller Patent Litigation12Law360. NJ Judge Tosses Pacira Investor Suit Over Patent Loss The lead plaintiff filed a notice of appeal in March 2026, docketed at the U.S. Court of Appeals under Case No. 26-1500.13PACER Monitor. Alvarez v. Pacira BioSciences, Inc. et al Iovera is not part of the case.
Pacira’s EXPAREL Patent Fights With Generic Drug Makers
Pacira is also actively suing generic drug developers to defend EXPAREL’s patents. In April 2025, the company announced a settlement with Fresenius Kabi USA, Jiangsu Hengrui Pharmaceuticals, and eVenus Pharmaceuticals that resolved patent litigation across federal courts in New Jersey, Illinois, and the Federal Circuit.14Pacira BioSciences Investor Relations. Pacira BioSciences Announces Settlement of U.S. Patent Litigation The Federal Circuit dismissed Pacira’s related appeal on April 10, 2025.15U.S. Court of Appeals for the Federal Circuit. Order Dismissing Appeal, Case No. 24-2334 Pacira recorded a $7 million legal settlement charge in 2025 tied to these cases.16Pacira BioSciences Investor Relations. Pacira BioSciences Reports Fourth Quarter and Full Year 2025 Financial Results
A new round opened in November 2025 when Pacira filed patent infringement lawsuits against The WhiteOak Group (a subsidiary of Zhejiang Haichang Biotechnology) and Qilu Pharmaceutical in the U.S. District Court for the District of Delaware. Both had filed abbreviated new drug applications for generic EXPAREL along with Paragraph IV certifications challenging Pacira’s patents.17Pacira BioSciences Investor Relations. Pacira BioSciences Files EXPAREL Patent Infringement Lawsuits The filings triggered an automatic 30-month stay of FDA approval under the Hatch-Waxman Act. The case is before Judge Jennifer L. Hall, with a five-day bench trial scheduled for October 2027.18CourtListener. Pacira Pharmaceuticals, Inc. v. The WhiteOak Group, Inc., Case No. 1:25-cv-01445 Again, iovera is not involved.
Bottom Line for Patients and Clinicians
As of mid-2026, there is no publicly reported product liability, patent, or regulatory lawsuit targeting the iovera device. The device’s legal footprint is limited to the two pre-acquisition labeling recalls and the handful of MAUDE adverse-event reports described above. The active Pacira litigation that dominates news alerts on the company concerns EXPAREL, a separate product with its own patents, manufacturing, and regulatory history. If you were checking whether an iovera treatment carries an active legal cloud over the device, the answer from the current public record is no.