Hagens Berman has filed a class-action lawsuit against Cynosure Inc. for selling its SculpSure Non-Invasive Body Contouring Platform for more than $150,000 to hundreds of physicians, med spas and aesthetic surgery practices under false information about the effectiveness of the device and the painfulness and safety of the fat-reduction procedure. The company marketed its SculpSure machine as an effective, pain-free and quick method of using laser technology to reduce fat in a patient's midsection. In reality, however, the device is effectively useless for the purpose for which it was intended due to the unpredictable and often excessive pain it caused patients, the multiple rounds of treatments it required, and the unsatisfactory results it produced.
The FDA cleared Cynosure to market its SculpSure device in mid-2015, and by fall of 2015, the company engaged in a motivated campaign to sell SculpSure nationwide, including promotional videos, brochures and sales representatives. Cynosure's fraud and misrepresentations have caused small businesses to suffer extensive damages as they are left with unusable machines that have cost them hundreds of thousands of dollars.
The misrepresentations that Cynosure made include statements that:
- SculpSure could effectively reduce fat with just one 25-minute treatment, that the treatment was virtually painless and easily tolerated
- the procedure did not require anesthesia
- a physician and/or trained staff member did not need to be present during the entire procedure to monitor the patient comfort level and adjust the treatment levels
- no follow-up or additional treatments were necessary.
According to the complaint, SculpSure rarely achieves results in patients with just one 25-minute procedure. Furthermore, effective treatment with the device can only be accomplished by turning the power level so high that it can cause significant and intolerable pain such that the procedure must be stopped. The procedure delivers "unpredictable and inconsistent" treatment, the suit states, rendering practices that have purchased the SculpSure machines unable to recommend the treatment to patients in good faith.
"To do otherwise would be encouraging these patients to undergo a procedure despite having little insight into whether they will see results, how many treatments they will need, or whether they can even tolerate the full 25 minutes," the complaint states.
When initial results from SculpSure did not live up to the marketing hype from Cynosure, the company introduced a "Treat to Complete" treatment plan and advised doctors to manage a patient's “expectations that multiple treatments may be part of the treatment plan,” which directly contradicted its pitch that SculpSure offered a one-and-done solution for patients. "Furthermore, Cynosure directed physicians and practitioners to raise the power levels on the machine to compensate for the poor results. However, at these increased power levels, many patients could not make it through the procedure without experiencing significant pain. Practitioners reported that patients would jump off the treatment table or ask the doctor to stop because they could not tolerate the procedure," the lawsuit states.