The Scope of Liability
The current news stories about patients infected by contaminated duodenoscopes suing the manufacturer are likely to have broader impact across the medical industry.
The story of patients being infected with antibiotic resistant bacterial (carbapenem-resistant Enterobacteriaceae or CRE) by contaminated duodenoscopes has reached the stage that patients are now suing the medical device manufacturers. Aaron Young, a high-school student still hospitalized at UCLA for his infection, sued Olympus Corp. of the Americas in Los Angeles County Superior Court, alleging negligence and fraud. On 2/25/15 the family of a patient who died also sued Olympus, alleging negligence and fraud.
Under our society’s legal paradigm, if something bad happens, someone is to blame and the question is who. In this case the options are the hospitals, the doctors, the FDA, the scope manufacturers, or the manufacturers of the scope reprocessing equipment.
The doctors are probably in the clear, there is no indication that any of the procedures were conducted inappropriately. The hospitals state that they followed the manufacturer’s cleaning instructions. The news papers have not reported comments from the endoscope reprocessor manufacturers, but they would probably say that their systems work well, but they can only disinfect the scope if it is properly cleaned before hand. The FDA says the complex design makes effective cleaning very difficult if not impossible which is why the plaintiffs are targeting the equipment manufacturers.
The basis of the patient plaintiff’s claim is that Olympus knew that current cleaning methods were inadequate and the suit alleges, ‘the company and its salespeople made false representations to the patient and his physicians concerning the safety of the duodenoscope.’
Whether Olympus is found liable or not will depend on the details or who said or did what, test data, FDA approval etc. etc. which we cannot judge here.
Whatever happens in the court room is however likely to have ripple effects throughout the industry. While Olympus is the largest supplier of duodenoscopes, the other manufacturers are Hoya, Fujifilm and KARL STORZ GmbH & Co.; and what happens to Olympus will impact them too.
The FDA is being criticized for not responding quickly enough to this issue and is being pressured to change its procedures. In the FDA’s defense, More than 500,000 procedures with duodenoscopes are performed in the US each year, many of them treating life threatening conditions, and in 2012 through 2014 the FDA received reports of 135 patients being infected, or about a 0.009% risk. However, in 2011 there were an estimated 722,000 hospital acquired infections in U.S acute care hospitals and of these about 75,000 patients died. The FDA has limited resources and has to choose where it can have the greatest impact.
High visibility negative publicity is not good and hospitals are certainly looking at changing the way they reprocess duodenoscopes and burnish their images. UCLA and the University of Pittsburgh Medical Center are now sterilizing their duodenoscopes with ethylene oxide and both happily report that no more infections have occurred. However, the longer times for EtO sterilization will require hospitals to have a greater inventory of scopes and so will increase costs.
The manufacturers of scope reprocessing equipment, especially those that apparently failed to adequately disinfect the duodenoscopes may also feel the impact as hospitals shift away from their equipment to alternative sterilization methods.
Conclusion: The long term impact of the court cases and widespread publicity are likely to have a broad impact across the medical industry. It will be interesting to see how the effects from these court cases on the industry pan out.