Lawsuits related to endoscope-associated infections have become more common since 2000, according to attorneys at a Pennsylvania firm who have advised GI practices. Not only are device manufacturers and medical facilities being hit with claims, doctors and even support staff—nurses and technicians—also are being named as defendants.
Philadelphia-based law firm Eckert Seamans has extensive experience representing GI groups in such medical malpractice cases. Priority Report asked Eckert Seamans attorneys Peter Hoffman, JD, MA, Andrew Bond, JD, and Alexandra Rogin, JD, to survey cases in Pennsylvania and other states.
Has there been a rise in lawsuits related to endoscope-associated infections since they were recognized as a problem by the FDA and CDC in 2015?
Mr. Bond: There seem to be cases filed as early as 2000, but the majority of the cases we saw were between 2012 and 2016. There is no real way to tell if the number of cases will rise, but there have been no recent changes to legislation or Pennsylvania state law that would prompt a rise in cases.
Some lawsuits have specifically named device makers and medical facilities as defendants. Who else is being named as defendants?
Mr. Bond: From our research, we’ve seen numerous cases in which doctors are named as defendants. There were cases in which it was just the facility named, cases in which both the facility and the doctor were named, and cases in which it was just the doctor. There also have been lawsuits in which they’ve named employees and agents of the facility as defendants—for failing to clean and properly maintain the device—but often that falls under when they name the facility as a defendant.
What legal risks do these individuals face?
Mr. Hoffman: Generally speaking, in Pennsylvania, all physicians have to be insured. If a physician or hospital or group is named in a suit, the first thing they ought to do is notify their insurance carrier and usually the carrier will appoint counsel.
Some of the lawsuits involving endoscopes alleged fraud on the part of the manufacturer. What kinds of allegations do these lawsuits make?
Mr. Bond: The allegations in these types of suits are, essentially, failing to follow the manufacturer’s policies and procedures to disinfect, clean and maintain the scope. In addition, there have been allegations against the facility for failure to have policies for cleaning the device, failure to supervise the cleaning or failure to maintain the device. And there are also general professional negligence complaints: The medical facility wasn’t fulfilling its duty to the patient when it used the device on someone else and then the patient became infected.
Mr. Hoffman: You really can’t prevent the allegations, but you can protect yourself. Work with a consultant or the manufacturer to implement the best policies and procedures to comply with the guidelines. Have written policies and procedures about how you clean and maintain scopes. Work with patients to obtain informed consent prior to using the scope.
Mr. Bond: If you had policies and procedures in place and you were not following them, it is not going to look great in front of a jury.
Ms. Rogin: But if a policy is required by the standard of care and you don’t have that policy, that’s as bad as having a policy and not following it.
Aside from notifying their insurance carrier, what should a doctor or facility do if they face one of these lawsuits?
Mr. Hoffman: The one thing you don’t want to do is go back and falsify records. That would be a very dangerous thing. If you’ve had an incident, you should learn from it. Why did it happen? What wasn’t done? What was done wrong? What should have been done better? Learn from your mistakes and go from there. These types of lawsuits are almost as bad as wrong-side surgery cases. You have to be smart and you have to have an environment that’s safe for the patient.
Do a lot of these cases go to trial?
Mr. Hoffman: Some do, but most do not. The statistics show that 90% or more of all civil lawsuits get settled at some point before there’s a verdict.
How have facilities and doctors fared in cases that went to trial?
Mr. Bond: We haven’t found too many cases that went to trial and resulted in a jury verdict. There was a case in the Southern District of Florida, in which the plaintiff was awarded $750,000 and then $500,000 was awarded to the patient’s wife for damages. In that case, the plaintiff had contracted hepatitis C as a result of a failure to disinfect the endoscope. It all depends on the extent of the plaintiff’s damages. In many of the suits we found, the plaintiff didn’t actually suffer damages; it was just fear of future damages.
Mr. Hoffman: And fear of damages is not always compensable.
How many cases are based on fear of future damages?
Mr. Bond: It depends on what happened at the specific facility, but we saw a fair amount of cases in which people were notified by the practice group that there had been an issue with endoscope cleaning, but there was no proof they had suffered any damages.
Mr. Hoffman: There may be some lawyer on [television] advertising about these cases against the manufacturers, and someone comes in and files a lawsuit against the doctor. These things happen.
Are providers required to notify patients if they’ve been exposed to risk for infection?
Mr. Hoffman: It’s really dependent on what you’re required to do under state statutes, which are very fact-specific. In Pennsylvania, for example, patients have to be notified if they were injured and it was something that would not have been expected. Just because patients were scoped, you wouldn’t have to notify them, as I understand our statute.
If it is required under a state statute, then you have to report it and advise the patient, even if nothing happened, even if there was no damage. Is that going to spring a lawsuit? It may. Is it better to be candid with your patients? There has been a lot written on that. There’s a website called Sorry Works (https://sorryworks.net). But is notifying the patients going to spring a bunch of frivolous lawsuits? Nobody knows what the answer is.
At least one scope maker is facing the possibility of a class action lawsuit over alleged “superbug” infections acquired from contaminated duodenoscope exposure. Could medical facilities with multiple infected patients see the same?
Mr. Bond: We could not find an instance in which such a class had been certified by a judge. There are certain factors required for class certification, such as numerosity of class members and ascertainability of the class; in these instances, courts have found that claims brought by different groups did not meet the class certification requirements.
Are doctors and facilities at risk for criminal or civil penalties from, say, state or federal regulators?
Mr. Hoffman: There’s a potential for civil violations of state regulations if it created an unsafe situation. It would have to be fairly egregious. You could analogize this scenario to the nursing home situation. If inspectors came out and found there was an unsafe situation, there could be repercussions from a state agency. There could be repercussions from the Centers for Medicare & Medicaid Services if they were to investigate and find that there were a number of claims of a particular type at a particular institution.
Is the advice for how to handle a regulator any different?
Mr. Hoffman: Contact your insurance carrier and, even before you do that, contact a sophisticated lawyer who can help guide you through it.