This week, officials from the Food and Drug Administration (FDA) announced that a defective medical device made by the medical manufacturing company Olympus was responsible for spreading a deadly “superbug” that sickened 18 patients in a Pittsburgh Hospital and caused the deaths of 21 patients at hospitals in Seattle, Los Angeles, and North Carolina.
In May 2015, a panel of medical experts from the FDA examined several endoscopes made by Olympus and discovered the scopes were defective and riddled with deadly bacteria.
An endoscope is a long, cord-like medical device that has a small camera and light attached to its tip. The device is inserted into a patient’s body so physicians can look internally for health issues, such as cancerous growths or organ damage.
Olympus Alerted to Potential Defects
In 2012, officials from Olympus were alerted to the defective nature of their company’s scopes after a lab technician disassembled one of the devices and found a brown, slimy film inside.
The technician had discovered a tiny crack in a supposedly impenetrable rubber seal around the scope’s camera lens. The crack allowed blood and tissue from numerous patients to collect inside the device and breed bacteria. Because this area was meant to be permanently sealed, it was not able to be cleaned.
Although Olympus officials knew their company’s scopes were defective and full of bacteria, they failed to issue any warnings to U.S. hospitals, nor did they make any attempts to issue a recall.
UPMC Patients Stricken by Deadly Bacteria
Shortly after the lab technician’s findings in 2012, patients at the University of Pittsburgh Medical Center (UPMC) became infected with a type of bacteria known as Carbapenem-resistant enterobacteriaceae (CRE), the same bacteria that was found inside Olympus scopes.
CRE is referred to as a “superbug” because it is completely antibiotic-resistant, and as many as half of all people infected with the bacteria die as a result of its resistance to any known treatment.
Once UPMC personnel discovered that many of the hospital’s CRE infected patients had undergone procedures involving an Olympus scope, they immediately pulled all of the devices out of circulation and tested them for bacteria.
Out of 31 scopes tested, five came back positive for CRE bacteria, even after they had been hand-scrubbed and ran through a powerful disinfecting machine. One of the scopes that was contaminated with CRE was originally linked to all 18 patients who were sickened by the bacteria.
Olympus’ Unethical and Negligent Actions
As opposed to revealing the scopes’ known defects, a representative from Olympus informed the hospital’s staff that the bacterial outbreak was due to improper cleaning. The representative then persuaded the hospital to purchase a cleaning machine made by Olympus, which had a price tag of nearly $25,000.
After a scope that had been cleaned in the new machine tested positive for CRE bacteria, UPMC employees were forced to sterilize all scopes with a toxic gas, which is a costly and time-consuming form of sterilization.
In February 2015, after three years of deceit and dishonesty, Olympus officials announced they were aware of defects in their scopes that may have contributed to outbreaks of CRE in hospitals across the nation.
Upon conduction their own research, FDA experts concluded that 95 complaints, 21 deaths, and 24 extended hospital stays were the result of CRE infections caused by defective Olympus scopes.
If you or someone you love has been the victim of a company’s defective product, contact the defective product lawyers at Schmidt Kramer today. We will listen closely to your story, and we will fight tirelessly to ensure you receive the compensation you deserve.