Some unintended foreign bodies left post-op in the body never create any problems. Some are associated with continued risk. And the law is all over the place in terms of how long a surgeon or facility is liable, if at all.
A recent New York case illustrates this point.
In New York, an adult has 2 ½ years from the date of the negligent event to initiate a medical malpractice case; an infant has 10 years. Now for the foreign body exception. The foreign object exception provides that such a case may be commenced within one year of the date of this discovery. This naturally extends the typical statute of limitations. A time frame limited to one year a patient discovers a foreign body could be decades after the original procedure.
A three year old underwent surgery to correct a congenital heart malformation. Intra-op, a catheter was placed in the left atrium to record pressures. Naturally, the patient had a collection of other lines that were placed and remained in-situ post-op. Three days post-op, while still in the ICU, lines were removed. The nursing notes stated the left atrial line possibly broke off and it was possible a portion remained in the body. Eight days later the boy was discharged from the hospital.
At age 18, he had a pacemaker inserted.
One year later he had valve replacement (with pig’s valve).
One year later, the patient suffered an embolic stroke. An echocardiogram revealed “small mobile filamentous masses” in the heart – “possibly suture material though clots could not be ruled out.”
At age 25, the patient suffered two transient ischemic attacks. His pacemaker battery was replaced.
An echocardiogram done at the time the battery was replaced revealed a left atrial foreign body. (Note, this was 22 years after his original surgery.) Exploratory surgery was performed and plastic tubing was identified and removed. The pathologist documented the catheter was 0.1 cm in diameter and 12 cm. in length.
The inevitable lawsuit caught three hospitals and five doctors in its net.
The defendants tried to defend arguing that the lawsuit was well beyond the statute of limitations. They argued that the foreign body exception did not apply because of how the “foreign body” was defined by New York law. The foreign object exception does not apply to “chemical compounds, fixation devices, or prosthetic aids or devices.” They argued that the catheter was a “fixation device”, not a foreign object, because it was intentionally placed inside the boy during the operation and served a continuing medical purpose beyond the procedure itself.
That’s creative lawyering.
The plaintiff argued that the catheters were placed to permit monitoring of pressures for management of fluid replacement, blood pressure, and prevention and/or treatment of congestive heart failure. The plaintiff continued the catheters had no treatment function, but rather, simply served as a conduit for information about the cardiovascular system. The young man’s expert concluded the catheters were not fixative devices because they did not secure body tissues one to another, or at least provide support to some structure within the body on either a permanent or temporary basis.
The patient lost. The court reasoned that the catheter was not a foreign object (and not entitled to lengthening the core statute of limitations) because it was left in the boy’s body deliberately with a continuing medical purpose.
The case was appealed.
No surprise.
The Appellate Division affirmed employing slightly different reasoning. The appellate court concluded that the catheter, which was deliberately inserted into the boy’s heart to monitor atrial pressure, was a fixation device within the meaning of the statute.
Onward to the highest Court of Appeals in NY. It reversed.
The court concluded that tangible items, such as clamps, scalpels, and sponges, introduced into a patient’s body solely to carry out or facilitate a surgical procedure are indeed “foreign objects” if left behind.
And, yes, fixation devices are not considered foreign objects. A failure to timely remove a fixation device (such as pedicle screws) does not transform it into a foreign object. Every fixation device is intentionally placed for a continuing (even if temporary) treatment purpose, but it does not follow that everything that is intentionally placed for a continuing treatment purpose is a fixation device.
The court reasoned that the catheter inserted in the patient’s left atrium was not a “fixation device.” It noted the catheter performed no securing or supporting role during or after surgery. The catheter was placed for an instrumental purpose, specifically, to allow medical personnel to monitor the boy’s atrial pressure. The catheter was analogous to tangible items like clamps introduced into a patient’s body solely to carry out a surgical procedure. Medical personnel did not intend to leave any tubing in the boy’s heart. The catheter remained in the boy’s body a few days after surgery, but not for post-surgery healing, only monitoring. The retained catheter fragment served no purpose. The court concluded that the boy left the hospital after an operation with therapeutically useless and potentially dangerous surgical paraphernalia lodged in his body.
The case was sent back down to the lower court to rule on the merits of claims of negligence.
Yes, a retained catheter is not a fixation device.
Walton v. Strong Mem’l Hosp., 2015 WL 3593821 (N.Y. June 10, 2015)
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It’s not clear whether the nurse who noted the possibility of a broken intra-atrial catheter alerted the surgeon, and family. If the pediatric surgeon was made aware of the catheter-removal complication and felt that observation, rather than thoracotomy, might be in the best interest of this 3 y.o.child, he could have had the opportunity to discuss the situation openly with the child’s parents. I’ll bet this never happened.
Children born with cardiac anomalies may have a lifetime relationship with a cardiothoracic team of specialists. If the broken catheter was under continuous observation, exploration and removal at the age-19 valve replacement surgery may have been performed.
This patient had countless ultrasounds and CT scans. I’m miffed that this remained undetected until a battery change ultrasound at age 25. The decision to urgently remove the possibly asymptomatic fragment of catheter is also not clear.
Thank you.
Where were the radiologists? The tubing that was left behind undoubtedly had radio opaque material and should have been seen on routine cxr. This would be hard to see initially with all the lines and wires but subsequently, it would have been clearly visible well before the first stroke.
A sad miss.
Foreign bodies ARE left in the body. they are not “retained bodies” The patient’s body did not retain the foreign object – the surgical team forgot the item in the patient. While it is true that the risk related to the forgotten item varies by what it is and where it was forgotten, it is still negligent to leave it behind.