Adam L. Walton v. Strong Memorial Hospital ( 2015 )

This opinion is uncorrected and subject to revision before
publication in the New York Reports.
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No. 67
Adam L. Walton,
Appellant,
v.
Strong Memorial Hospital, et al.,
Respondents.
Edward J. Markarian, for appellant.
Barbara D. Goldberg, for respondents.
Healthcare Association of New York State, Inc., amicus
curiae.
READ, J.:
We are "present[ed with] yet another variation among
a myriad of medical protocols, devices and procedures" (LaBarbera
v New York Eye & Ear Infirmary, 91 NY2d 207, 212 [1998]), and
asked whether a fragment from a catheter that was placed in
plaintiff Adam Walton's heart during surgery in 1986 is a foreign
object for purposes of the discovery rule of CPLR 214-a.
Considering the specific facts and circumstances alleged in this
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case in light of our precedents, we conclude that the fragment
qualifies as a foreign object.
I.
Facts
On May 27, 1986, when plaintiff was three years old, he
underwent surgery to correct a congenital heart malformation.
The operation was performed at Strong Memorial Hospital in
Rochester, New York. The operative note states that at the
beginning of the surgery, after the incision was made, a
"[p]olyvinyl catheter was placed within [plaintiff's] left atrium
for recording atrial pressure." The note further relates that,
before plaintiff was released from the operating room to the
surgical intensive care unit,
"[p]olyvinyl catheters were placed within
[plaintiff's] left atrium and right atrium
for recording atrial pressure. Myocardial
pacing wires were placed upon the right
atrium and right ventricle for pacing as
indicated. Two pericardial drainage tubes
were left[,] one anteriorly and one
posteriorly. Hemostasis [i.e., stoppage of
bleeding] was secured[, and t]he incision was
closed . . . ."
On May 30, 1986, the third day after surgery, while
plaintiff was still in the surgical intensive care unit, the
catheters, pacing wires and drainage tubes were taken out of his
body; the nursing progress notes state as follows: "OF NOTE: LA
[i.e., left atrial] line possibly broke off with a portion
remaining in pt [patient], as it was being removed." Plaintiff
was discharged from the hospital on June 7, 1986.
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Fifteen years later, in April 2001, a pacemaker was
inserted into plaintiff's heart; then, a year after that, in May,
2002, he underwent surgery to replace a damaged heart valve with
a porcine (pig) valve. The following year, on March 2, 2003,
plaintiff suffered an embolic stroke; an echocardiogram performed
the next day detected "small mobile filamentous masses" in
plaintiff's heart, which were identified as possibly suture
material, although clots could not be ruled out. Five and a half
years later, on December 2, 2008, plaintiff, by then 25 years
old, suffered a transient ischemic attack, his second that year.
Accordingly, a decision was made to replace his pacemaker's
battery, which was accomplished two days later.
The echocardiogram performed in conjunction with this
last operation revealed "a regular-appearing left atrial foreign
body." As a result, on December 18, 2008, plaintiff underwent
exploratory surgery, and plastic tubing was discovered in his
heart. The surgical pathology report states that the tissue
submitted for analysis was labeled "left atrial line," and
consisted of "a 10.2 cm in length x 0.1 cm in diameter brown
catheter.1 Also received is a 2.0 x 0.1 cm tan catheter.2 At
one of the catheter[s] is tan-white soft tissue adhered to the
catheter." The pathologist's diagnosis was "foreign body, heart,
1
Ten centimeters is slightly less than four inches.
2
Two centimeters is slightly more than three-quarters of an
inch.
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excision: catheter; benign associated fibrous issue with focal
calcification."
By summons and complaint dated November 24, 2009,
plaintiff commenced this action against defendants Strong
Memorial Hospital, University of Rochester Medical Center,
Children's Hospital at Strong and five named physicians
(collectively, defendants). He alleged that, while treating him
from May 26 to June 7, 1986, defendants negligently left a
foreign body in his heart, which caused him to "suffer[] serious
and permanent injuries," and that he "could not have reasonably
discovered the presence of [this] foreign body prior to December
4, 2008." In particular, plaintiff claimed that defendants
negligently left a portion of an atrial catheter in the left
and/or right atrium of his heart, which caused him to suffer a
stroke and transient ischemic attacks, among other serious
maladies.
By answers dated February 2, 2010, defendants asserted
the statute of limitations as an affirmative defense, and by
notice of motion dated March 14, 2012, they moved pursuant to
CPLR 3211 (a) (5) to dismiss the complaint as time-barred.
Defendants contended that this action should have been commenced
by May 30, 1996, or 10 years after they had allegedly failed to
remove the entire catheter, citing CPLR 208 (imposing a 10-year
cap on the commencement of an infant's medical malpractice
action). Further, defendants contended, the foreign object
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exception for medical malpractice actions did not apply. This
exception, codified in CPLR 214-a, provides that although a
medical malpractice lawsuit must normally be brought within two
years and six months 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."
Although plaintiff sued within one year of discovery of the
tubing, defendants took the position that the catheter was
necessarily a fixation device, not a foreign object, because
"[it] was intentionally placed inside the plaintiff during the
operation and served a continuing medical purpose beyond the
procedure itself."
In opposition to the motion, plaintiff submitted the
affidavit of a physician specializing in internal medicine and
cardiovascular disease, who opined that the catheters were
"placed to permit monitoring of arterial and venous pressures for
management of fluid replacement, blood pressure, and prevention
and/or treatment of congestive heart failure"; and "[had] no
treatment function, but rather, simply serve[d] as a conduit for
information from the cardiovascular system to a machine situated
outside the body that is capable of analyzing that information
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and displaying the results on a monitor." Accordingly,
plaintiff's expert concluded, the catheters were not "'fixative
device[s],' as that term is used in medicine," 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."
Supreme Court granted defendants' motion, and dismissed
plaintiff's claims with prejudice (37 Misc. 3d 539 [Sup Ct, Erie
County 2012]). The judge rejected defendants' "fundamental
argument" that "an object, irrespective of its nature or purpose,
is always a 'fixation device' so long as it was intended to serve
some continuing treatment purpose after the procedure in which it
was placed in the body has concluded" (id. at 547-548). Supreme
Court explained 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. The
affidavit from plaintiff's expert further
confirms the futility of attempting to
characterize this catheter as a 'fixation
device'" (id. at 548).
The judge then considered whether the catheter,
although not excluded as a fixation device, was a foreign object.
Based on our decision in LaBarbera, he felt "compelled to
conclude that the catheter . . . [was] not a 'foreign object'
because, in the first instance, it was left in the plaintiff's
body deliberately with a continuing medical purpose" (id. at
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549).
The Appellate Division agreed the complaint was
untimely and so unanimously affirmed, but employed slightly
different reasoning (114 AD3d 1289, 1290 [4th Dept 2014]). The
court concluded that, in light of our decisions in Rockefeller v
Moront (81 NY2d 560 [1993]) and LaBarbera, the catheter, which
was deliberately inserted into plaintiff's heart to monitor
atrial pressure, was a fixation device within the meaning of the
statute. We granted plaintiff leave to appeal (23 NY3d 903
[2014]), and now reverse.
II.
Background
Flanagan
In Flanagan v Mount Eden Gen. Hosp. (24 NY2d 427
[1969]), the doctor inserted surgical clamps in the body of
plaintiff Josephine Flanagan (Flanagan) during the course of gall
bladder surgery in 1958. Eight years later, in 1966, after
experiencing severe abdominal pain, Flanagan consulted another
physician, who discovered by X-ray analysis that the clamps
remained in her body. They were surgically removed, and shortly
thereafter, Flanagan brought a medical malpractice action against
the hospital and the estate of the doctor who had operated on
her.
The defendants moved to dismiss the complaint as
untimely, Supreme Court granted the motion and the Appellate
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Division affirmed (29 AD2d 920 [1st Dept 1968]). Deviating from
our reluctance to create common law exceptions to a statute of
limitations (see Schwartz v Heyden Newport Chem. Corp., 12 NY2d
212 [1963] [the plaintiff's cause of action accrued when the
harmful chemical was injected into his body, not when its
deleterious effects were discovered 15 years later], cert denied
374 U.S. 808 [1963]; Conklin v Draper 229 App Div 227 [1st Dept
1930] [the statute of limitations began to run when arterial
forceps were left in the plaintiff's abdomen during surgery, not
when the malpractice was discovered more than two years
afterwards], affd 254 NY 620 [1930]), we reversed. We held that
"where a foreign object has negligently been left in the
patient's body, the Statute of Limitations will not begin to run
until the patient could have reasonably discovered the
malpractice" (Flanagan, 24 NY2d at 431).
We commented that at the time Conklin was decided, "no
other jurisdiction had a contrary rule" (id. at 430), and
reasoned that cases like Schwartz, which involved negligent
medical treatment and medication, were fundamentally different
from those where a foreign object is left in a patient's body;
specifically, "[i]n the latter[,] no claim can be made that the
patient's action may be feigned or frivolous . . . [and] there is
no possible causal break between the negligence of the doctor or
hospital and the patient's injury" (id.). Further, this species
of alleged malpractice "does not raise questions as to
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credibility . . . [or] rest on professional diagnostic judgment
or discretion"; and a foreign object like a clamp "retains its
identity so that a defendant's ability to defend a 'stale' claim
is not unduly impaired" (id. at 431).
Lower Court Decisions After Flanagan
Subsequent to our decision in Flanagan, plaintiffs
quite naturally pushed for expansion of this new precedent, and a
number of courts obliged. For example, in Dobbins v Clifford (39
AD2d 1 [4th Dept 1972]), the Appellate Division applied a
discovery rule in an action involving an operation performed in
1966 to remove the plaintiff's spleen, which resulted in damage
to his pancreas not apparent until 1970. Although this fact
pattern did not involve a foreign object by any stretch of the
imagination, the court determined that "the rationale in
Flanagan" (id. at 3 [emphasis added]) called for the statute of
limitations to run from the plaintiff's discovery of the cause of
his injuries rather than the date of the alleged malpractice
because
"the same fundamental factors are present . .
. [; namely,] an act of malpractice committed
internally so that discovery is difficult;
real evidence of the malpractice in the form
of the hospital record . . . available at the
time of suit; professional diagnostic
judgment is not involved[;] and there is no
danger of false claims (id. at 3-4; see
William Samore & Robert J. Tymann, 1972
Survey of New York Law, Torts, 24 Syracuse L
Rev 551, 560 [1973] [noting that "(t)he
importance of (Dobbins) lies in its expansive
extension of prior case law. It is obvious
that the 'foreign object' category was not
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originally intended to include damaged
organs"]).
Similarly, in an earlier case, Murphy v St. Charles
Hosp. (35 AD2d 64 [2d Dept 1970]), the Appellate Division applied
Flanagan to save an otherwise time-barred action involving a
prosthesis surgically inserted into the plaintiff's hip and femur
in 1963. The prosthesis broke in 1967, forcing the plaintiff to
undergo surgery for removal of the fragmented and displaced
appliance. The court concluded that the foreign object in
Flanagan was "akin to the prosthesis [in Murphy] . . . since both
involve the surgical insertion of a medical device . . . [and]
there is the same minimization of prejudice to a defendant in the
preparation of his case because of the availability and
identifiability of the real evidence involved" (id. at 67; but
see Schiffman v Hospital for Joint Diseases, 36 AD2d 31 [2d Dept
1971] [declining to extend Flanagan or apply Murphy to a case
where the plaintiff alleged the misreading of biopsy slides], lv
denied 29 NY2d 483 [1971]). Additionally, Flanagan was extended
by a court to a case where the plaintiff sought damages allegedly
caused by exposure to a defective isotope (see Le Vine v
Isoserve, Inc., 70 Misc. 2d 747 [Sup Ct, Albany County 1972]; but
see Fonda v Paulsen, 79 Misc. 2d 936, 939, 940 [Sup Ct, Albany
County 1974] [declining to adopt the "plaintiffs' interesting and
novel theory that negligently undetected cancer (was) a 'foreign
body' within the purview of Flanagan" because "(t)he Court of
Appeals specifically . . . failed to adopt a broad discovery test
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. . . for all malpractice cases regardless of whether a foreign
object (was) involved"], revd on other grounds 46 AD2d 540 [3d
Dept 1975]).
The Adoption of CPLR 214-a
In 1975, Governor Hugh L. Carey proposed and the
Legislature enacted CPLR 214-a, one of a number of reforms aimed
at making medical malpractice insurance more affordable in New
York State (see generally L 1975, ch 109). CPLR 214-a, in
combination with an amendment to CPLR 214 (6), reduced the
statute of limitations for medical malpractice actions from three
years to two years and six months, and also continued, but sought
to curtail, Flanagan's discovery rule for foreign objects.3 In
his Program Bill Memorandum, the Governor explained that although
"the Court of Appeals sought to make it
emphatically clear that its decision [in
Flanagan] should be limited to foreign
objects and should not become a 'discovery'
rule . . . , 'intermediate appellate courts
rapidly sought to broaden it into a
'discovery rule.' For example, they applied
[Flanagan] to instances where fixation
devices were inserted in a patient's body for
the purpose of treatment and to chemicals
introduced in the body for the purpose of
treatment. The most damaging expansion was
to a situation where nothing was introduced
3
CPLR 214-a also continued the "continuous treatment"
doctrine that we embraced in Borgia v City of New York (12 NY2d
151 [1962]), but sought to prevent manipulation of the date when
the statute of limitations began to run; specifically, section
214-a provides that "[f]or the purpose of this section the term
'continuous treatment' shall not include examinations undertaken
at the request of the patient for the sole purpose of
ascertaining the state of the patient's condition."
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into the patient's body but malpractice
occurred in that while treating one organ the
doctor caused damage to another.4 It is
obvious that this latter extension has a
potential of bringing virtually all medical
malpractice cases under the discovery rule.
This measure would correct these abuses by
limiting the discovery statute to 'foreign
objects' and specifically excluding therefrom
chemical compounds, fixation devices and
prosthetic devices" (Governor's Program Bill
Mem, Bill Jacket, L 1975, ch 109 at 4).5
CPLR 214-a took effect on July 1, 1975. We first
discussed the new statute in Matter of Beary v City of Rye (44
NY2d 398 [1978]), which consolidated for appeal five separate
tort claims. There, we reversed Matter of Smalls v New York City
Health & Hosps. Corp. (55 AD2d 537 [1st Dept 1976] [lesion caused
by a cervical myelogram allegedly negligently performed in 1973])
and Merced v New York City Health & Hosps. Corp. (56 AD2d 553
[1st Dept 1977] [allegedly negligent failure to suture a
fallopian tube during a sterilization operation in 1971]). In
both cases, the Appellate Division had determined, with two
Justices dissenting, that the plaintiffs' notices of claim were
timely filed by extrapolating from Flanagan's rationale to
4
The Governor's Program Bill Memorandum is obviously
referring to Dobbins here, and CPLR 214-a's exclusion of
"prosthetic aid[s] and device[s]" is presumably intended to
abrogate Murphy. Appellate cases that were decided before 1975
and extended Flanagan to create a discovery rule for fixation
devices and chemical compounds are not so easy to identify.
5
The Governor's proposed bill also included a six-year
outside limit to an exception from the basic statute of
limitations for medical malpractice lawsuits. The Legislature
did not endorse this approach.
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justify a discovery rule. With reference to the plaintiff in
Merced, we observed that although she
"advance[d] the argument . . . that
considerations similar to those which
motivated the [C]ourt in Flanagan should be
applied with like effect to the far different
circumstances in her case . . . [,] the
enactment of CPLR 214-a . . . clearly
interdicted the extension of the 'foreign
object' exception . . . . By expressly
prohibiting the inclusion of chemical
compounds, fixation devices and prosthetic
aids from the embrace of the term 'foreign
object' and by limiting the time within which
an action based on the presence of such an
object in the body of a patient may be
commenced to one year from the date of its
discovery, the Legislature left us no room
but to conclude that it intended that
Flanagan not be broadened beyond its existing
confines" (44 NY2d at 414-415 [emphases
added]; see also Thornton v Roosevelt Hosp.,
47 NY2d 780 [1979] [refusing to extend
Flanagan to a strict products liability
claim]; Goldsmith v Howmedica, Inc., 67 NY2d
120, 123 [1986] [holding that the general
time-of-commission accrual rule applies in a
medical malpractice action brought against a
physician who implanted a prosthetic device
that malfunctioned eight years after
surgery]).
The IUD Cases in the Lower Courts and Rodriguez
Subsequent to CPLR 214-a's enactment, a number of cases
arose addressing whether intrauterine devices (IUDs) were foreign
bodies. IUDs are plastic or metal objects that are inserted into
a woman's uterus to prevent pregnancy, and the placement of an
IUD is a nonsurgical intervention. In the most common fact
pattern resulting in litigation, a doctor inserted an IUD into a
plaintiff's womb without detecting and removing a previously
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placed IUD. In the earliest of the reported cases, Supreme Court
agreed with the defendant that an IUD was a fixation device
because it was "fixed within the woman's body," but held that
"when the second IUD was placed in the plaintiff's body the first
IUD became, or took on the character of a 'foreign object'
because it then had no function to perform, no longer belonged in
the body and should have been removed as expected by the patient"
(Darragh v County of Nassau, 91 Misc. 2d 53, 54-55 [Sup Ct, Nassau
County 1977], affd 63 AD2d 1010 [2d Dept 1978]; see also Ooft v
City of New York (80 AD2d 888 [2d Dept 1981] [same]; Sternberg v
Gardstein, 120 AD2d 93 [2d Dept 1986] [an IUD became a foreign
object when not removed, as intended and agreed upon, during an
operation involving an abortion and tubal ligation
sterilization]; cf. Szakalski v Aubry (148 AD2d 972 [4th Dept
1989] [holding that an IUD contained within a surgically removed
pelvic mass was a fixation device, and not reaching the
plaintiff's argument that the IUD was "transformed" from a
fixation device into a foreign object when she was erroneously
advised that the IUD had probably been expelled]).
The issue finally reached us in Rodriguez v Manhattan
Med. Group (77 NY2d 217 [1990]). Plaintiff Evelyn Rodriguez
(Rodriguez) had an IUD inserted in her uterus in 1980; two years
later, when she and her husband decided to start a family, she
visited a doctor to have the IUD removed. The doctor examined
Rodriguez and could not locate the IUD; he then ordered X-rays of
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Rodriguez's lower abdomen, which did not show the IUD. He
therefore advised Rodriguez that she could attempt to conceive
without any medical intervention. By the spring of 1986,
Rodriguez, who had not become pregnant in the meantime, was
experiencing heavy vaginal bleeding, leading her to consult
another doctor. This physician ordered a sonogram, which
revealed that the IUD inserted in 1980 was embedded in the
vaginal wall. The IUD had to be removed surgically.
Rodriguez and her husband then sued the doctor who
examined her in 1982 and his employer, claiming that the doctor
had acted negligently in failing to locate the IUD. The
defendants interposed the statute of limitations as an
affirmative defense, and the plaintiffs responded that the
limitations period did not begin to run until the IUD's discovery
in Rodriguez's body in 1986. Holding that the IUD was a fixation
device and therefore not a foreign object within the meaning of
section 214-a, Supreme Court dismissed the complaint, and the
Appellate Division, with two Justices dissenting, affirmed (155
AD2d 114 [1st Dept 1990]).
The plaintiffs took the position that although the IUD
was a fixation device when originally implanted in Rodriguez's
body, the IUD became a foreign object once the doctor left it in
place after Rodriguez specifically directed him to remove it.6
6
Because of the way the plaintiffs argued Rodriguez, we had
no occasion to discuss whether or why an IUD is a fixation device
within the meaning of CPLR 214-a.
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We disagreed with the "notion of a transformation in a 'fixation
device's' character resulting from a physician's postinsertion
negligence[, which was] evidently derived from a legal theory
pertaining to undetected and unremoved IUDs" popular in some
lower courts (id. [citing Sternberg, Ooft and Darragh, among
other cases and commentary]).
Summing up, we observed that the plaintiffs' theory was
"flawed" because it disregarded Flanagan's "context";
specifically, in Flanagan,
"the patient was suing the practitioners who
had actually left the surgical clamps in her
body and the focus of her claim was that very
act. Here, . . . there is no claim against
the physician who actually inserted the IUD;
instead, [the] plaintiffs are seeking
recovery from a different treating physician
on the theory that his treatment of
[Rodriguez] in connection with the previously
inserted IUD was negligent. . . . Indeed, the
gist of [the] plaintiffs' claim, i.e., a
negligent failure to detect the continued
presence of a previously inserted device, is
most logically classified as one involving
misdiagnosis -- a category for which the
benefits of the 'foreign object' discovery
rule have routinely been denied" (id. at 222-
223 [internal citation omitted]).
Finally, we noted that the "special analytical factors . . .
deemed significant in Flanagan" cut against a discovery rule and
that, in any event, the Legislature's adoption of CPLR 214-a
"preclude[d] our adoption of a more flexible discovery rule for
these (IUD) cases even if considerations similar to those which
motivated the [C]ourt in Flanagan [c]ould be applied with like
effect" (id. at 223-224 [internal quotation marks omitted]).
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Rockefeller
We next grappled with the foreign object exception in
Rockefeller, where a suture was affixed to an organ (the vas
deferens) not properly involved in the hernia repair surgery that
plaintiff Mark Rockefeller (Rockefeller) underwent in 1971 as a
four-year-old child. The error was discovered in 1989, when
Rockefeller and his wife sought to discover if there was a
medical reason why she was unable to become pregnant. After an
attempt to repair the damage to the vas deferens proved
unsuccessful, Rockefeller and his wife brought an action for
medical malpractice against the doctor responsible for the suture
and the hospital where he performed the hernia operation.
Supreme Court rejected the defendants' motions to dismiss on
statute-of-limitations grounds, holding that the suture was a
foreign object; the Appellate Division, with two Justices
dissenting, agreed (182 AD2d 160 [3d Dept 1992]). The defendants
appealed.
Because the alleged malpractice occurred before CPLR
214-a took effect, the timeliness of Rockefeller's lawsuit was
governed by the three-year limitations period in former CPLR 214
(6) and decisions interpreting the foreign object exception as
articulated in Flanagan. Additionally, because Rockefeller was
an infant when the alleged malpractice occurred, he was entitled
to the benefit of the infancy toll in CPLR 208 as it existed
prior to July 1, 1975. Ultimately, though, the timeliness of his
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action turned entirely on whether the suture was a foreign object
(see Rockefeller, 81 NY2d at 564 n 2).7
We observed that when deciding whether an item of
medical paraphernalia is a foreign object,
"the 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'" (id. at 564).
In support of the proposition that the courts considered fixation
devices in general and sutures in particular to have been "exempt
from coverage under the judicially created 'foreign object' rule
7
In a related context, we have held that the maximum 10-year
extension of the statute of limitations which CPLR 208, as
amended in 1975, imposes on infants in medical malpractice
actions runs from the initial negligent act, not from the end of
any period of subsequent continuous treatment (see Matter of
Daniel J. v New York City Health & Hosps. Corp., 77 NY2d 630
[1991]; see also McDermott v Torre, 56 NY2d 399 [1982]; David D.
Siegel, NY St L Dig No. 328 at 2 [June 1991]). Here, defendants
asserted that, by virtue of CPLR 208, the statute of limitations
lapsed 10 years after the catheter fragment was allegedly left in
plaintiff's heart; however, they apparently never contended (and
surely did not argue on appeal to us) that plaintiff's claim was
untimely even if the catheter was a foreign object because the
discovery exception, instead of postponing accrual, merely tolled
the statute of limitations. Accordingly, we have no occasion to
consider and express no opinion about the interplay of CPLR 208
and CPLR 214-a in a case involving a foreign object left in an
infant after surgery and discovered more than 10 years later.
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prior to enactment of CPLR 214-a" (id.), we cited Lombardi v
DeLuca (71 NY2d 838 [1988], affg 130 AD2d 632 [2d Dept 1987] ["A
fixation device, in this case, suture 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'"]). Lombardi addressed sutures
placed in plaintiff Mildred Lombardi's abdomen during an
operation performed in 1966, remnants of which were discovered
during exploratory surgery in October 1975.
Analogizing to Rodriguez, we concluded that
"a claim based on a medical professional's
deliberate implantation of a 'fixation
device' [here, sutures] in the wrong place
does not transform it into a foreign object.
Such a claim is more readily characterized as
one predicated on negligent medical
treatment, which, like misdiagnosis, is a
category of malpractice not covered by the
'foreign object' rule" (81 NY2d at 565).
Stated slightly differently, Rockefeller's claim was "more
accurately characterized as a challenge to [the doctor's] medical
judgment and treatment -- i.e., his placement of the suture --
and not as one predicated on [his] failure to remove medical
material that should have been extracted at the close of the
operation" (id. at 566). Obviously (if obliquely) referring to
the legislative purpose animating CPLR 214-a, we reiterated the
importance of restricting the foreign object exception to "the
narrow confines announced in Flanagan," and pointed out that
"only in circumstances where a foreign object is negligently
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'left' in the patient's body without any intended continuing
treatment purpose will the discovery rule be available to delay
the running of the Statute of Limitations" (id.)
LaBarbera
In May 1986, plaintiff Peter LaBarbera (LaBarbera)
underwent a procedure described in the operative record as "total
nasal reconstruction with placement of silastic stents." During
the surgery, the doctor placed a 2 cm x 6 cm silastic stent,
described as a device made of biologically inert, implantable
material, in LaBarbera's left nasal cavity and sutured the stent
in place; he then packed the area with gauze. Within two weeks
following surgery, the doctor removed the gauze, but left the
stent. In the ensuing months, LaBarbera suffered from dizziness
and voiced persistent nasal and respiratory complaints. He
claimed that the doctor who performed the nasal reconstruction
had misdiagnosed the cause of these ailments and erroneously
treated him for allergies. In October 1992, LaBarbera alleged,
the stent was discovered and determined to be the cause of his
symptoms; it was surgically removed the next month.
LaBarbera brought suit against the doctor who had
implanted the stent and the hospital where the operation had been
performed. His expert opined that the stent should have been
removed about 10 days after surgery, when it "no longer
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function[ed] to maintain a bodily structure."8 Both parties'
experts agreed that the stent was a fixation device because it
had been intentionally placed in LaBarbera's nose "to provide
support for the internal structures of the nose that were the
subject of the operation and to prevent scarring" (the defendant
doctor's expert); and/or as "a part of the medical procedure . .
. used to maintain a bodily structure" (LaBarbera's expert).
Supreme Court dismissed the action as untimely,
concluding that the nasal stent was a fixation device; the
Appellate Division, with one Justice dissenting, agreed (230 AD2d
303 [1st Dept 1997]). The dissenting Justice considered the
stent to be a foreign object "based on a physician's failure to
make certain that all temporary holding devices -- clamps,
temporary stents, and others -- have been removed from the body
at the close of a single -- albeit several-stage -- medical
proceeding" (id. at 311 [Murphy, P.J., dissenting]).
We characterized the issue presented by LaBarbera's
appeal as "whether a plastic stent, placed in [LaBarbera's] nose
for postsurgery healing purposes, constitutes a 'foreign object'
8
In his answer to the complaint, the defendant doctor denied
LaBarbera's allegation that the "the foreign body [i.e., the
implanted silastic stent] should have been removed within several
days after the procedure." Moreover, the defendant doctor's
expert said nothing about whether or under what circumstances the
sutured-in stent should have been taken out of LaBarbera's nose.
He stated simply that "[i]t is intended that the stent remain in
the patient's nose after surgery is completed to serve a
continuing treatment purpose."
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that would avoid the bar of the statute of repose" (91 NY2d at
208). We concluded that the stent was 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
"'negligently "left" in the patient's body without any intended
continuing treatment purpose'" (id. at 212, quoting Rockefeller,
81 NY2d at 566, citing McLaughlin, Practice Commentaries,
McKinney's Cons Laws of NY, Book 7B, CPLR C214-a:3 at 603 ["(i)t
has become relatively clear that a foreign object is one that the
doctor does not intend to leave inside the body"]). Here, we
concluded, the stent was not "'left'" in LaBarbera's nose;
"[r]ather, it was put there only to be removed after it had
served its postsurgery healing purposes. . . . [T]he key feature
is the uncontroverted protocol of insertion as part of a
continuing treatment modality" (id. at 212-213 [emphasis added]).
Accordingly, we disagreed with both LaBarbera's theory that "the
relatively short and ordinarily definite nature of the stent's
time in the nose should allow it to be treated as a 'foreign
object,'" and the "'multistage procedure' exception (i.e., that
the surgical procedure continued until the packing was removed)"
advanced by the dissenting Justice of the Appellate Division (id.
at 213).
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IV.
Analysis
Several general principles may be distilled from our
cases considering the foreign object exception: (1) tangible
items (clamps, scalpels, sponges, etc.) introduced into a
patient's body solely to carry out or facilitate a surgical
procedure are foreign objects if left behind (Flanagan and dicta
in Rockefeller and LaBarbera); (2) the alleged failure to timely
remove a fixation device does not transform it into a foreign
object (Rodriguez and LaBarbera); (3) nor does a fixation device
become a foreign object if inserted in the wrong place in the
body (Rockefeller); (4) failure to timely remove a fixation
device is generally akin to misdiagnosis (Rodriguez), and
improper placement of a fixation device is most readily
characterized as negligent medical treatment (Rockefeller); and
(5) the Legislature, in enacting CPLR 214-a, directed the courts
not to exploit the rationale supporting Flanagan to expand the
discovery exception for foreign objects beyond the rare Flanagan
fact pattern, and explicitly commanded that chemical compounds,
fixation devices and prosthetic aids or devices are never to be
classified as foreign objects (Beary [Merced], Rodriguez,
Rockefeller, LaBarbera and the legislative history of CPLR 214-
a).
As discussed, most of our post-Flanagan cases have
dealt with ultimately unsuccessful attempts by plaintiffs to
circumvent the exclusion of conceded or obvious fixation devices
from the foreign object exception/tolling provision of CPLR 214-
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a. Not surprisingly, then, defendants in this case advocate a
very expansive definition of a fixation device, intended to sweep
in the catheter placed in the left atrium of plaintiff's heart
during surgery and allegedly incompletely removed three days
later while he was being cared for in the surgical intensive care
unit. Specifically, defendants interpret Rockefeller and
LaBarbera to hold that "any device that is intentionally left in
a patient's body for purposes of continuing treatment is a
'fixation device,' and not a 'foreign object,' [because t]he
appropriate focus should not be on the specific function that a
device was intended to perform, but whether the device was
intentionally inserted as part of a continuing treatment
modality."
We specifically stated in Rockefeller, though, that
"[i]n determining whether an object which remains in the patient
constitutes a 'foreign object,' courts should consider the nature
of the materials implanted in a patient, as well as their
intended function" (81 NY2d at 564 [emphasis added]). The suture
in Rockefeller and the nasal stent in LaBarbera were undeniably
fixation devices -- the suture performed a securing function and
the stent, a supporting function. Because the suture and the
stent were fixation devices, they were intentionally placed for a
continuing treatment purpose. In short, every fixation device is
intentionally placed for a continuing (even if temporary)
treatment purpose, but it does not follow that everything that is
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intentionally placed for a continuing treatment purpose is a
fixation device. Otherwise, there would have been no reason for
the Legislature to separately identify and exclude prosthetic
aids or devices from the ambit of the foreign object exception,
because prosthetic aids or devices are also intentionally placed
to serve a continuing medical purpose. Defendants' overly-broad
proposed definition of a fixation device divorces statements in
Rockefeller and LaBarbera from their context.
Here, the catheter inserted in the left atrium of
plaintiff's heart performed no securing or supporting role during
or after surgery. As explained by plaintiff's expert, and
uncontroverted by defendants, the catheters functioned like a
sentinel, allowing medical personnel to monitor atrial pressure
so that they might take corrective measures as required; the
catheters were, in the words of plaintiff's expert, "a conduit
for information from [plaintiff's] cardiovascular system."
Because the catheters under the facts of this case are therefore
not fixation devices (or chemical compounds or prosthetic aids or
devices), they are not categorically excluded from the foreign
object exception in CPLR 214-a.
The question then becomes whether the catheters are
analogous to tangible items like the clamps in Flanagan or other
surgical paraphernalia (e.g., scalpels, sponges, drains) likewise
introduced into a patient's body solely to carry out or
facilitate a surgical procedure. We conclude that they are,
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although we recognize that factual differences exist between this
case and Flanagan.
First, the clamps in Flanagan were inadvertently left
behind at the conclusion of the surgery, before the plaintiff
left the operating room. Here, a catheter fragment was allegedly
allowed to remain in plaintiff's heart when medical personnel
removed the catheters, drainage tubes and pacing wires, which
were placed in plaintiff's body during surgery. This occurred
three days following surgery while plaintiff was being cared for
in the hospital's surgical intensive care unit. Second, the
doctor in Flanagan apparently forgot to retrieve the clamps
before closing the patient's incision. In this case, by
contrast, the catheter was not forgotten; instead, its removal
was allegedly botched. Thus, medical personnel did not intend in
the first instance to leave any tubing in plaintiff's heart,
although it is presumably possible (there is no way to tell from
the nursing progress notes) that a judgment was made that any
catheter fragment left behind was too inconsequential to present
a significant risk, or that plaintiff's condition was too fragile
to tolerate exploratory or retrieval efforts, at least at that
juncture.
These particular variations on the Flanagan fact
pattern do not, in our view, make this case meaningfully
different or expand the foreign object exception beyond its
legislatively-limited scope. Like the clamps in Flanagan, the
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catheter was introduced into plaintiff's body during an operation
for an instrumental purpose. Unlike the clamps, the catheter
remained in plaintiff's body for a few days after surgery, but
not for "postsurgery healing purposes" as was the case with the
nasal stent in LaBarbera (91 NY2d at 212). Instead, the catheter
served a monitoring function. Leaving the catheter in
plaintiff's body post-surgery did not convert a surgical device
into a fixation device any more than leaving the IUD in Evelyn
Rodriguez's body converted a fixation device into a foreign body.
The "nature of the materials" and their "intended function"
remained constant in both cases (Rockefeller, 81 NY2d at 564).
And the fragment, of course, served no purpose whatsoever; it
certainly was not a fixation device, however defined.
Fundamentally, if the facts are as alleged, plaintiff -- like
Josephine Flanagan -- left the hospital after an operation with
therapeutically useless and potentially dangerous surgical
paraphernalia lodged in his body.
Accordingly, the order of the Appellate Division should
be reversed, with costs, and defendants' motion to dismiss the
complaint as time-barred denied.
* * * * * * * * * * * * * * * * *
Order reversed, with costs, and respondents' motion to dismiss
the complaint as time-barred denied. Opinion by Judge Read.
Chief Judge Lippman and Judges Pigott, Rivera, Abdus-Salaam,
Stein and Fahey concur.
Decided June 10, 2015
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