In medical malpractice cases, plaintiffs aren’t allowed to hold doctors on the hook forever. At some point, they must either file a claim for negligence or let it go and give up their right to seek compensation. That’s what statutes of limitations are all about. Patients have a certain period of time, a window of opportunity if you like, to file suit, or they must forgo their right to do so in the future. Now, as far as windows go, there are sticks that a plaintiff can prop in the window sash to keep this window of opportunity open for a longer time. They are called tolling provisions. One such tolling provision is the “foreign object rule.” It allows the patient 1 year (the period of time varies by state) after the object was discovered during which to initiate the suit even if the window of opportunity has passed. The rule essentially keeps the window open when an unknown foreign object has been left behind inside the plaintiff. Fair enough. I mean, how can you go after someone if you don’t know about something he did wrong? However, it must be fair to both sides; the law does not apply to objects intentionally left behind such as surgical screws, prosthetic implants, and the like. Walton v Strong Memorial Hosp , 2015 NY Slip Op 04786 (NY Ct. App., 6/10/15), is a really good case if one wants to understand the nuances of this rule and how it could apply to orthodontics.
The facts are convoluted, but essentially, when the plaintiff was 3 years old, he needed heart surgery. A catheter was placed in his heart; upon its removal, a small piece broke off and remained behind. Fast forward about 22 years; several heart procedures and surgeries later, the plaintiff discovered the offending piece of catheter and commenced suit against the original doctors and hospital. Obviously, this was well past the expiration of the statute of limitations. The plaintiff claimed that the foreign body exception should apply and toll the time period from expiring, thus allowing his suit to proceed. The question was, because the catheter was intentionally placed during the surgery and intentionally left in for a time afterward, should it be considered a fixation device and therefore not a foreign body within the meaning of the statute?
New York’s CPLR 214-a is the statute dealing with this issue, and it states that
…actions have to be brought within 2½ years of the “act, omission or failure complained of… where the action is based upon the discovery of a foreign object in the body of the patient, [it] may be commenced within one year of the date of such discovery or of the date of discovery of facts which would reasonably lead to such discovery, whichever is earlier…. For the purpose of this section, the term ‘foreign object’ shall not include a chemical compound, fixation device or prosthetic aid or device.”
In determining whether the piece of catheter was a fixation device, the initial trial court ruled that
[t]he catheter here does not fit the concept of a “fixation device” under any commonly understood meaning or technical sense. It served no fixative or fixation purpose. Its nature is not one which closes or fixates anything within a patient’s body. As to whether or not it was a foreign object, the court noted that “the catheter was not a ‘foreign object’ because it was left in the plaintiff’s body deliberately with a continuing medical purpose.”
The appellate court reversed the trial court, and this appeal ensued. The court then went through a lengthy history of the evolution of the foreign body rule and ultimately noted that chemical compounds, prosthetic aids, and fixation devices are not to be considered as foreign objects. To clarify it further, the court gave an example of an intrauterine device that when implanted is a fixation device and is therefore not a foreign body. However, if a new doctor misses the fact that the intrauterine device is there and implants a second one, the first one becomes a foreign body because it has no function to perform and does not belong in the body.
In trying to clarify the distinction, again the court looked at a case in which during a hernia repair, an intentionally placed suture that was expected to remain in the patient indefinitely was inadvertently tied around the vas deferens, causing the patient to become sterile. Ultimately, the cause of the inability to procreate was discovered, and the court had to decide whether the suture was a foreign body, thus tolling the statute of limitations. The New York Court of Appeals, citing other cases, held that
…courts should consider the nature of the materials implanted in a patient, as well as their intended function. Objects such as surgical clamps, scalpels, and sponges are introduced into the patient’s body to serve a temporary medical function for the duration of the surgery, but are normally intended to be removed after the procedure’s completion. By contrast, items which are placed in the patient with the intention that they will remain to serve some continuing treatment purpose constitute “fixation devices.”
…[S]uture material, intentionally placed in the body and not left there in the course of some later procedure in which it should have been removed, does not constitute a “foreign object.”
…[A] plastic stent, placed in [the] nose for postsurgery healing purposes… is not a foreign object based on “the same dispositional criterion used in Rockefeller —intentional insertion of a therapeutic item for postsurgery continuing treatment purposes,” whereas a foreign object is [one that is] “‘negligently “left” in the patient’s body [when it has no] intended continuing treatment purpose.’” It has become relatively clear that a foreign object is one that the doctor does not intend to leave inside the body [ although it may be intended to be left for a short period of time ]. (Clarification added. Cits. Omit.)
In summarizing this difficult distinction, the court stated that the nature and purpose of the implanted material is what needs to be evaluated. Sutures and stents are fixation devices; the first serves to secure a structure, and the second to support another structure. Both were placed with one of those purposes, to be able to continue treatment during the healing or reparative phase, albeit for different periods of time. The key is that whereas every fixation device is intentionally placed, it does not mean that everything that is intentionally placed for a continuing treatment purpose is a fixation device. The bottom line was that the tolling provision applied, and the case was allowed to proceed.
Let’s talk about foreign bodies in orthodontics. We have all seen buried separators. They are intentionally placed for a particular purpose to be removed after achieving a particular result. Occasionally, the patient reports that it fell out; we believe him, don’t go on a treasure hunt, and eventually find it when the patient returns with a significant periodontal defect. Fortunately, these lesions resolve quite well once the offending elastomeric is removed. All of this would occur within a relatively short time and not apply toward tolling a statute of limitations; it is merely an example of what constitutes a foreign body. The same thing applies to the rubber band placed around 2 central incisors to close a diastema. Again, no question, it’s a foreign body to be sure.
The nature of contemporary orthodontics leads us next to temporary skeletal anchorage devices. They are fixation devices, no question. They are placed to remain for various periods of time and then ultimately to be removed (most of the time but not always). However, screws (whether 1 unit or part of a miniplate assembly) can break; pieces can be left behind. Imagine a small fragment, a millimeter or so of the tip of a screw, inadvertently finding a home in someone’s sinus. Imagine that over time some medical condition develops, who know what—hey, we’re imagining this. Imagine that the statute of limitations has run its course. Imagine that the ear-nose-throat physician ultimately performs a surgical procedure to address whatever the medical issue is. Imagine that the offending piece of the screw is now discovered. (Imagine how proud John Lennon would be for my having used the word “imagine” so many times; but I digress.)
This is how the foreign object rule would be used to circumvent the statute of limitations in orthodontics. In 1964, the Rolling Stones sang “Time Is On My Side,” and for most of us practicing today, time is on our side vis-à-vis this issue. It usually is… except when it isn’t.