Lexion Medical Receives $12.3 Million on July 10, 2018, of which $10 Million was a PUNITIVE DAMAGE AWARD, from SurgiQuest, a Subsidiary of CONMED, the Manufacturer of the AIRSEAL® Insufflator, for False Advertising.
In an Unusual Move, Conmed DID NOT Appeal the Jury and Federal Court's Findings.
Apparently, Conmed decided that the evidence against them was so convincing that they decided not to contest the ruling to the higher court.
ST. PAUL, Minn., July 11, 2018 /PRNewswire/ -- In a legal maneuver, SurgiQuest made themselves the plaintiff from the original lawsuit filed by Lexion Medical and ultimately became known to the Delaware Court as SurgiQuest Inc. versus Lexion Medical, LLC.
Lexion contested and prevailed on all three major false advertising claims under the Lanham Act, made by SurgiQuest/Conmed and the AIRSEAL® unit. The most egregious, according to CEO Patrick Spearman of Lexion Medical, was the claim that the AIRSEAL® unit did not introduce unfiltered air into patients during laparoscopic and laparoscopic robotic surgical procedures with their AIRSEAL® insufflator (the gas is normally at an operating pressure of 15 mm Hg).
The Jury's Verdict, and Federal Judges Order (filed on May 16, 2018) validated that the AIRSEAL® unit introduced large amounts of unfiltered room air into the patients abdomen during laparoscopic procedures. Scientific studies presented at trial proved that subcutaneous emphysema was caused in 12 out of every 73 patients* who were subjected to the AIRSEAL® unit, while AIRSEAL® falsely reported to doctors, nurses, hospital staff members and to their own sales people that air was never introduced during a surgical procedure with their AIRSEAL® unit. This number is unacceptable by all industry standards for subcutaneous emphysema (Sub-Q), and worse, because with AIRSEAL® the Sub-Q contains both AIR and CO2, and not the industry standard gas of just CO2 which the body absorbs quickly and in a matter of hours, instead Sub-Q with AIRSEAL® can last for even days due to air entrainment. As one example of Sub-Q, an Expert Witness Doctor, formerly the President of The Society of Laparoscopic Surgeons (SLS), testified that he had seen a male patient, post surgery, with a scrotum the size of a "basketball" due to subcutaneous emphysema caused by the AIRSEAL® insufflator. Some of the same studies also proved increased incidence of pneumomediastinum and pneumothorax.
Since the trial and subsequent Jury's verdict, a scientific study presented at the American Society of Anesthesiologists concluded that the same air introduced by the AIRSEAL® unit into patients, complained by Lexion Medical in their suit, proven to cause unusual high amounts of patient subcutaneous emphysema, caused air embolisms in swine models using the AIRSEAL® unit (CO2 Pneumoperitoneum Contamination with Air During Laparoscopic Surgery: Valveless (AIRSEAL® - emphasis supplied) versus Conventional Insufflation Systems, Herrmann MD, et al. Those Medical Professionals who understand air embolisms, know that these air embolisms in rare circumstances can even cause death to patients in some instances. Lexion Medical CEO Patrick Spearman, was quoted as saying that, "A number of lawyers told me that one would think that hospitals who continue to use a product that they know can hurt people would be putting themselves at a high liability risk by continuing to do so given the Federal Court's and the Scientific Communities findings."
Second, the Jury concluded, and the judge agreed, that the advertising statements made by SurgiQuest and their AIRSEAL® insufflator unit's ability to remove virtually all hazardous smoke from the operating room so that doctors and the OR staff would not have to be subjected to carcinogenic and other harmful gases was FALSE. Evidence presented by expert testimony proved that virtually zero carcinogenic or harmful hazardous smoke gases were removed. It appears doctors were deceived because the particle filter used in the AIRSEAL® unit removed smoke particles only and therefore gave the surgeon a clearer view while doing their surgical procedure, but he/she was told by SurgiQuest/Conmed that AIRSEAL® removed hazardous smoke which we now know to be completely false, leaving doctors and the OR staff exposed to these hazardous smoke gases and carcinogenic gases.
Lastly, the Jury concluded that SurgiQuest/Conmed targeted Lexion Medical's customers and their unique patented Insuflow® device that heats and humidifies gas and has been scientifically proven to reduce post-operative pain in patients, reduce hypothermia and preserve the patient's peritoneal tissue. SurgiQuest claimed that their AIRSEAL® product performed the same function as the Lexion Medical Insuflow® device when in fact it did precisely the opposite by stealing vital peritoneal fluids from the patient and not adding any moisture whatsoever. The AIRSEAL® unit claimed that it added heat and humidification to the patient with their insufflation device and the Federal Jury and Court concluded that they falsely made these heat and humidification representations and that no such heat and humidification were added to the patient with the AIRSEAL® insufflator.
Further, the Jury and Court concluded that SurgiQuest either Intentionally or Recklessly engaged in unfair competition.
September 2009, Journal of Endourology, Herati, Amin, et. al, A New Valvle-less Trocar for Urologic Laparoscopy: Initial Evaluation
June 2010, Laparoscopy and Robotics, Herati, Amin, et. al, Use of Valveless Trocar System Reduces Carbon Dioxide Adsorption During Laparoscopy When Compared with Standard Trocars
August 2012, Journal of Urology, Hillelsohn, Joel, et. al, Masked Pneumothorax: A Risk of Valveless Trocar Systems
2013, Journal of the Society of Laparoscopic Surgeons, Celik, Hatice, et. al, Massive Subcutaneous Emphysema in Robotic Sacrocolpopexy Laparoscopy: Initial Evaluation
AIRSEAL® is a registered trademark of Conmed/SurgiQuest Inc.
Insuflow® is a registered trademark of Lexion Medical, LLC.
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SOURCE Lexion Medical, LLC