For those just tuning in... If you're wondering why there were charges of Wrongful Death, Product Liability and Negligence filed against Masimo (Looney vs. Moore, Masimo, et al)...
June 2004..... In a letter announcing the use of the Radical-7/SpO2 technology to monitor hundreds of premature infant subjects in a then-pending clinical trial named "SUPPORT", Masimo made the following reassuring commitments:
"The researchers have required that the actual number be displayed below 85% and above 95%. The alarm will sound at 84% and 96%."
Michael T. Petterson, Sr. Director Clinical Research, Masimo Corp
James Cronin, Vice President Regulatory Affairs, Masimo Corp
http://www.citizen.org/documents/2146_June 30, 2004 Masimo Letter re Pulse Oximeters.pdf
2004 - 2009..... 1,300 premature infants and approximately 23 institutions participated in the SUPPORT trial. Unfortunately, 237 of the infants who participated died. Hundreds more sustained permanent physical and neurological injuries including total blindness.
March 2013....The Federal Office for Human Research Protections (OHRP) determined "that the informed consent document for this trial failed to adequately inform parents of what risks their babies might face via study enrollment." The OHRP found that parents weren't informed how enrollment in the study might increase babies' risk of blindness and death, risks that before the study, Masimo and the researchers should logically have known could increase through enrollment.
April 2013...Parents of the deceased filed a personal injury complaint against Masimo and others involved. According to the complaint, “Masimo rigged the oximeter so that it would not reveal the actual oxygen level, and would not sound an alert when levels were too high or too low.”
https://cases.justia.com/federal/di...e/2:2013cv00733/147528/30/0.pdf?ts=1390620735
August 2015.... US District Judge Karen Bowdre dismissed the case on summary judgement, plaintiffs demand for trial by jury denied. Plaintiffs filed an appeal.
December 2016.... 11th Circuit Court of Appeals to hear oral arguments 12/13/16