InMode Ltd., the Israel-based maker of the Morpheus8, BodyTite, and FaceTite aesthetic devices, is defending several active lawsuits. The InMode lawsuits span a federal securities fraud class action over device pricing and FDA reporting, a sexual harassment and discrimination suit by a former sales manager in New York, more than a dozen personal injury claims tied to its devices, and a stayed patent dispute with BTL Industries. The securities case is the furthest along: as of mid-2026, a motion to dismiss the second amended complaint is under submission with the court.
The Securities Class Action
The lead case is Cement Masons and Plasterers Local No. 502 Pension Fund v. InMode Ltd. et al., filed February 14, 2024, in the U.S. District Court for the Central District of California (Case No. 2:24-cv-01219).1SEC.gov. InMode Ltd. Form 6-K Filing It names InMode and four executives: CEO Moshe Mizrahy, CFO Yair Malca, President Shakil Lakhani, and Chief Medical Officer Spero Theodorou.2Saxena White. InMode Securities Complaint The complaint brings claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who bought InMode shares between June 4, 2021, and October 12, 2023.
What Investors Allege
The complaint has two main theories. On pricing, it alleges InMode told investors that devices sold at full price and that the company did not use a “razor and razorblade” model, while in practice offering discounts of 16% to 40% to move inventory. According to the complaint, that discounting hid softening demand and inflated the picture of the company’s financial health.2Saxena White. InMode Securities Complaint
On regulatory compliance, the complaint alleges two FDA violations: off-label marketing and failure to submit injury reports within the required 30-day window.3Stanford Law School Securities Class Action Clearinghouse. InMode Ltd. Securities Litigation Plaintiffs claim Dr. Theodorou pushed sales representatives to market the Morpheus8V as a treatment for stress urinary incontinence without FDA clearance for that use, describing it as a “trojan horse” into the obstetrics market, and acknowledged the lack of approval at a February 2023 internal sales conference while continuing to advocate the use.4Bronstein, Gewirtz & Grossman. InMode Securities Complaint
Where the Case Stands
On September 12, 2025, the court dismissed 19 of the 24 challenged statements but gave plaintiffs leave to replead. A second amended complaint followed on October 14, 2025, keeping the same claims and class period.5SEC.gov. InMode Ltd. Form 6-K Filing InMode moved to dismiss on December 5, 2025. Briefing closed with the company’s reply on February 26, 2026, and on April 20, 2026, the court took the motion under submission and told the parties it would decide without oral argument. InMode has not recorded an estimated liability, saying it cannot yet estimate a range of potential loss.6Stock Titan. InMode Ltd. Form 6-K Current Report
FDA Adverse Event Reporting
The regulatory theory draws on reporting by The Capitol Forum, which found that before February 2023 InMode had never submitted a mandatory Medical Device Report to the FDA’s MAUDE database. Every prior adverse event entry for InMode products had been filed voluntarily by physicians or patients.7The Capitol Forum. InMode Company Only Recently Began Submitting Required Malfunction and Injury Reports to FDA
Between February 15 and February 20, 2023, the company filed seven reports. Several concerned injuries dating back to 2021, far outside the 30-day federal window. InMode attributed five of the seven incidents to “user error.” FDA experts quoted in the reporting said a manufacturer cannot satisfy its reporting duty by blaming the user or by pointing to a voluntary report already in the database.7The Capitol Forum. InMode Company Only Recently Began Submitting Required Malfunction and Injury Reports to FDA
Reports have kept coming. A December 2025 MAUDE filing describes a patient with open facial wounds and scarring persisting more than six months after a Morpheus8 treatment.8FDA MAUDE. Morpheus8 Adverse Event Report, MDR Key 23892162 An October 2025 report documents full-thickness burns and tissue death on a patient’s jawline after treatment with the InMode RF System’s Quantum handpiece; InMode’s investigation concluded the treating physician had not been trained by the company and had exceeded the recommended energy range.9FDA MAUDE. InMode RF System Adverse Event Report, MDR Key 23388652
Personal Injury Claims
The Capitol Forum identified at least 16 personal injury lawsuits against InMode involving permanent nerve damage, facial paralysis, and scarring from devices including the Fractora, Morpheus8, BodyTite, and FaceTite. One suit was brought by former Fox News weather anchor Janice Dean, listed in some filings as Janice Newman, who alleged InMode “unlawfully suppressed reporting of adverse events” and knew of at least eleven Fractora patients whose cases met mandatory reporting thresholds.7The Capitol Forum. InMode Company Only Recently Began Submitting Required Malfunction and Injury Reports to FDA
A January 2023 MAUDE report filed voluntarily by a 45-year-old patient described “unwanted permanent fat loss, changes in my face structure, indentations in my face which will require surgical repair” and severe head pain following a Morpheus8 treatment two years earlier. The securities complaint cites that report as an example of the delayed-disclosure pattern.10FDA MAUDE. Morpheus8 Adverse Event Report, MDR Key 16122341
Harassment and Discrimination Suit
In February 2025, former sales manager Mary-Cathryn Wagner sued InMode (operating as Invasix, Inc.) and several current and former executives in New York state court, alleging a pervasive culture of sexual harassment, gender discrimination, and retaliation.11FFJ Online. Wagner v. Invasix, Inc. d/b/a InMode Ltd., Complaint
Wagner, who worked as a Territory and then Area Sales Manager, alleged that former manager Anthony Iannone subjected her to explicit sexual comments and required her to stay at his home on a business trip. She says she reported the conduct to Regional Sales Director Matt Snyder and Vice President Dan Wilson and that her complaints were ignored; on one occasion, she alleges, managers took her to a strip club after she reported the harassment. The complaint also describes a company group chat led by Wilson in which executives shared lewd images and jokes, including photos from patients’ medical procedures.11FFJ Online. Wagner v. Invasix, Inc. d/b/a InMode Ltd., Complaint
Wagner also alleges she was repeatedly passed over for promotion in favor of less experienced men, called a “diversity hire,” and given manipulated sales quotas after announcing her pregnancy, and that the hostile environment forced her to resign on February 28, 2023.11FFJ Online. Wagner v. Invasix, Inc. d/b/a InMode Ltd., Complaint An amended complaint filed August 13, 2025, added CFO Yair Malca as a defendant, alleging he oversaw HR, had to sign off on investigations of employee complaints, and “personally participated in the numerous failures to investigate” her reports.12FFJ Online. Wagner v. Invasix, Inc. d/b/a InMode Ltd., Amended Complaint The case is active in the Supreme Court of the State of New York, County of Erie.
Patent Litigation
InMode has been on both sides of patent disputes. It settled a case with Candela Corporation in March 2019 over bipolar fractional radiofrequency technology, taking a sublicense that let it keep selling the Fractora and Morpheus8 lines; financial terms were not disclosed.13PR Newswire. Candela and InMode Announce Settlement of Patent Infringement Lawsuit
In October 2023, InMode sued BTL Industries, accusing it of infringing U.S. Patent No. 8,961,511 with the UltraFemme 360 and EmFemme 360 vaginal rejuvenation devices.14PR Newswire. InMode Files Patent Infringement Complaint Against BTL Industries The case was transferred from California to the District of Massachusetts in November 2024.15FindLaw. InMode Ltd. v. BTL Industries, Inc. BTL challenged the patent’s validity at the Patent Trial and Appeal Board, where inter partes review was instituted on all claims in October 2024, and the Massachusetts court stayed the suit in March 2025 pending the PTAB’s final decision.16CaseMine. InMode Ltd. v. BTL Industries, Inc., Case No. 24-cv-12955 BTL filed an appeal to the Federal Circuit (Case No. 26-1223) on December 4, 2025.17RPX Insight. BTL Industries v. InMode
Counterfeit Enforcement
InMode has also won judgments as a plaintiff. In May 2025, the U.S. District Court for the Central District of California entered a default judgment against multiple DHGate sellers trafficking counterfeit Morpheus8 devices and needle cartridges, issuing a permanent injunction against use of the Morpheus and InMode trademarks, ordering infringing listings removed, freezing the sellers’ assets, and awarding damages.18Modern Aesthetics. Federal Court Grants Permanent Injunction to InMode in Counterfeit Device Case
Impact on InMode Stock
The company’s shares have been under sustained pressure. On April 28, 2025, the stock dropped about 12% after InMode reported first-quarter revenue of $77.9 million, a 3% year-over-year decline, and cut its full-year earnings guidance. Management cited a difficult economy, weaker consumer demand, and tariff-related margin pressure.19Stock Titan. InMode Reports First Quarter 2025 Financial Results
On May 6, 2026, shares fell roughly 8% in premarket trading after InMode missed earnings estimates by about 17%, reporting $0.25 per share against a $0.30 consensus, with non-GAAP gross margins down to 75% from 78% a year earlier.20Investing.com. InMode Q1 2026 Slides: Revenue Beats Amid Margin Pressure, Stock Falls By mid-May 2026, analyst consensus for full-year 2026 earnings had fallen 11%, and shares traded around $13.83.21Simply Wall St. InMode Future Growth