ACTA OTORHINOLARYNGOLOGICA ITALICA 2020 Jun 10 [Online ahead of print]; doi: 10.

14639/0392-100X-N0674

Review

Are errors in otorhinolaryngology always a sign

of medical malpractice? Review of the literature and
new perspectives in the SARS-CoV-2 (COVID-19) era
Gli errori medici in otorinolaringoiatria sono sempre indici di colpa medica? Revisione
della letteratura e nuove prospettive nell’era SARS-CoV-2 (COVID-19)
Polychronis Voultsos1*, Antonio Oliva2*, Simone Grassi2, Debora Palmiero2, Antonio Gioacchino Spagnolo2
1
Department of Medical Ethics, Aristotle University of Thessaloniki, Thessaloniki, Greece; 2 Department of Healthcare Surveillance
and Bioethics, Catholic University of the Sacred Heart, Rome, Italy
*
P. Voultsos and A. Oliva contributed equally to this work.

SUMMARY
In medical practice, during certain procedures that usually are not regarded highly demand-
ing, some skill-based errors, that might not be considered as medical malpractice, may
occur. In fact, such errors can be caused by factors beyond the physician’s control.A review
of Greek case law regarding medical malpractice in otorhinolaryngology was performed
to identify cases of lawsuits that concerned medical errors during routine procedures. The Received: February 7, 2020
analysis of the cases showed that some medical errors may cause serious complications, Accepted: May 5, 2020
even if deviation from the standard of medical care is minimal. Thus, in some cases it may
be difficult to make a distinction between preventable and unpreventable complications. Correspondence
Certain medical errors from routine medical procedures might be considered unpreventable Antonio Oliva
and, therefore, classified as almost no-fault errors. A brief commentary regarding opportu- Department of Healthcare Surveillance and Bio-
nities to further improve the medical liability system after the SARS-CoV-2 emergency is ethics, Catholic University of the Sacred Heart,
largo Francesco Vito 1, 00168 Rome, Italy
also given.
Tel. +39 06 30154249, +39 06 30157033
KEY WORDS: medical error, medical malpractice, negligence, otorhinolaryngology, E-mail: [email protected]
COVID-19
Funding
This work has been supported by Linea D1 Fondi
RIASSUNTO di Ateneo Università Cattolica del Sacro Cuore to
In ambito medico legale, durante alcune procedure non particolarmente complesse, posso- Antonio Oliva.
no verificarsi errori che potrebbero non essere necessariamente ricondotti a colpa medica.
La ragione è che tali errori possono essere causati da fattori che vanno oltre il controllo Conflict of interest
del medico. È stata fatta una revisione della legislazione greca, riguardante casi di colpa The Authors declare no conflict of interest.
medica in otorinolaringoiatria, allo scopo di identificare i casi giuridici riguardanti errori
medici durante tali procedure. L’analisi dei casi ha evidenziato che alcuni errori medici How to cite this article: Voultsos P, Oliva A,
possono causare complicanze serie, anche in caso di errori minimi che deviano di poco Grassi S, et al. Are errors in otorhinolaryngology
dallo standard di trattamento. Per questo motivo, in alcuni casi può essere difficile distin- always a sign of medical malpractice? Review of
guere tra complicanze prevedibili e non prevedibili. Alcuni errori, che si verificano durante the literature and new perspectives in the SARS-
procedure mediche di routine, potrebbero essere considerati non prevedibili e per questo CoV-2 (COVID-19) era. Acta Otorhinolaryngol
classificati come errori “quasi” senza colpa. Viene infine fornito un breve commento sulle Ital 2020 Jun 10 [Online ahead of print]. https://
opportunità di migliorare ulteriormente il sistema di responsabilità medica dopo l’emer- doi.org/10.14639/0392-100X-N0674
genza SARS-CoV-2.
© Società Italiana di Otorinolaringoiatria
PAROLE CHIAVE: errore medico, colpa medica, negligenza, otorinolaringoiatria, e Chirurgia Cervico-Facciale
COVID-19
OPEN ACCESS

This is an open access article distributed in accordance with

Introduction the CC-BY-NC-ND (Creative Commons Attribution-Non-
Commercial-NoDerivatives 4.0 International) license. The
In Ear-Nose-Throat (ENT) surgery, errors can be committed even by a skill- article can be used by giving appropriate credit and mentio-
ning the license, but only for non-commercial purposes and
ful surgeon. However, otorhinolaryngology is a medical specialty with a low only in the original version. For further information: https://
rate of malpractice. In a recent study of the American College of Surgeons, it creativecommons.org/licenses/by-nc-nd/4.0/deed.en

1
P. Voultsos et al.

was found that only 12% of otolaryngologists had received fatal reflex reaction) performed in the post-operative phase
claims against them in the past two years 1, while a Danish and under emergency conditions.
study found an increasing trend in the number of otorhino-
laryngology malpractice claims. Case 1
In this specialty, complications are seldom severe, but are Judgment No. 1135/1993 of the Greek Supreme Court
strongly surgery-related  2, and, therefore, proper technical (“Areios Pagos”) regards the case of an otolaryngologist
and non-technical skills and full compliance with guidelines who was trying to stop a heavy nasal bleeding that occurred
and international standards are pivotal to avoid malpractice during a septoplasty. Therefore, he was putting pressure
litigation 3. “ENT Today” reported in October 2013 that, dur- using forceps directly on a piece of gauze, which he had
ing the period 2007-2011, 53% of allegations against otolar- inserted into the nasal cavity, against the bleeding area.
yngologists were associated with “improper performance of He applied too much pressure on the forceps, causing its
surgery”. Among 40 claims lodged in the UK for malpractice shift towards the upper part of the nasal cavity, breaking
related to tonsillectomy (TE) during the period 1995-2010, the cribriform plate of the ethmoid bone. This resulted in
the most common injury was postoperative bleeding, fol- a hole through which the endocranial and nasal cavities
lowed by nasopharyngeal regurgitation (a potential injury communicated. Thus, a large volume of air entered the en-
of the glossopharyngeal nerve that may occur during ENT docranial cavity, causing swelling of nasal mucosa and the
surgery)  4. A German study, which included the 50 most right sinus, resulting in radiological finding of an hyper-
common inpatient ENT surgical procedures (septoplasty, TE dense mass at the right caudate nucleus of the endocranial
with or without adenoidectomy (AE), etc.), detected “surgi- cavity, communicating hydrocephalus of the lobe, menin-
cal malpractice” in 6.1% of all cases  5. The complexity of goencephalitis and inflammation of the brain ventricles due
ENT surgery, along with individual anatomical variations to antibiotic-resistant staphylococcus and Candida fungus.
and the close proximity to critical anatomical structures, may The otolaryngologist who performed the operation aban-
explain why some severe complications should be consid- doned the patient without informing the director. Diagnosis
ered inevitable, even for the most skilled – and experienced of the complication was done by CT performed six days af-
surgeon, especially in the case of transnasal surgery and ter surgery. The surgeon was aware of what had happened,
functional endoscopic sinus surgery (FESS) 6. In these cases, and hence, he should have informed the other physicians
such errors may be classified as “almost system errors” and treating the patient. The Court sentenced him to a term of
considered as unpreventable adverse events. In this paper, 18-months detention.
we discuss three Greek cases of errors in Otorhinolaryngol-
ogy, showing the main technical and medico-legal issues. Case 2
Our aim is to underline that not all technical errors should be Judgment No. 3127/2009 of the Three-Member Court of
always considered as medical malpractice. Appeal of Thessaloniki concerned an excessive tissue re-
section during a TE under local anesthesia that resulted
in impaired function of the glossopharyngeal nerve (with
Case descriptions
subsequent rhinolalia aperta, reduced mobility and sensory
A review of the Greek legal database was performed over disturbances to the soft palate and facial arches). The injury
the period of the past 15 years. Three cases of medical of the glossopharyngeal nerve was established through an
malpractice, due to erroneous maneuvers of ENT surgeon, expert report two years after the surgery. The surgeon was
were identified (summarised in Tab. I). More specifically, found guilty.
two concerned erroneous surgical maneuvers resulting in
injury to anatomical structures. One case concerned medi- Case 3
cal maneuvers (which caused laryngeal injury and, hence, a In Judgment No. 4639/2002 of the Three-Member Court of

Table I. Case summaries.

Cases Procedure Claimed error Conviction
1 Septoplasty Rupture of the cribriform plate of the ethmoid bone 18-months detention
2 Tonsillectomy Excessive tissue resection resulting in impairment of the glossopharyngeal Guilty (unknown)
nerve function
3 Abrupt insertion of the suction device Fatal injury of the laryngeal aperture (stimulation of the vagus nerve and 1-year detention
cardiac arrest)

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 Are errors in otorhinolaryngology always a sign of medical malpractice?

Appeal of Athens, a physician on duty was sentenced to a et al. stated that “the inferior turbinate and vertical middle
term of 1-year detention for having inserted, in an “abrupt turbinate attachment may be used to guide the extent of
and unskillful manner”, the metal nozzle of the tube of a cartilage resection”  15. Some of these landmarks may not
suction device used to remove excretions that had accumu- be totally reliable. Schultz-Coulon recommend the use of
lated postoperatively in the airways of a 16-year-old female a microscope to obtain optimal visualization and sparing
patient who underwent surgery for turbinate hypertrophy of the junction area between the lamina quadrangularis and
and removal of a small nasal spine. Insertion of the nozzle perpendicularis. It is not clear whether under those particu-
may cause complications such as injuries and uncontrolled lar circumstances it would be possible even for a very skill-
stimulation of the vagus nerve that may lead to cardiac ar- ful, experienced and diligent surgeon to be aware of the
rest and death, which is the case in question. Post-mortem borderline between due and excessive pressure exerted on
examination revealed injuries to the laryngeal aperture, the cribriform plate of the ethmoid bone. In addition, it is
confirming their iatrogenic nature. worth mentioning that the cribriform plate is so thin that it
can be broken during the intra-operative phase without the
Discussion surgeon noticing it.
Regarding case 2, nerve lesions may occur during ENT
Regarding case 1, septoplasty is one of the most common surgery due to errors in surgical procedures, resulting in
operations in ENT surgery 7 and cerebrospinal fluid (CSF) deterioration of the patient’s quality of life. In TE with or
leak is one of its possible complications  7. When it occurs without adenoidectomy (AE), injuries of the shaft or tonsil-
after septoplasty, it is mainly attributed to a cribriform plate lar or lingual branches of the ninth cranial nerve may de-
defect inadvertently caused by a physician during the surgi- velop, resulting in dysgeusia and ageusia as well as motor
cal procedure (iatrogenic complication) 7,8. Fractures of the disorders of the soft palate, resulting in rhinolalia aperta,
cribriform plate are related to poor technique or inadvert- regurgitation, or a combination of both  16. Velopharyngeal
ence, such as in the following cases: poor angling of dis- insufficiency following TE is reported in the literature, and,
section forceps, elevation of forceps beyond the ethmoid hence, preoperative evaluation of the anatomical variations
roof 9 and forceful removal of the perpendicular plate 10 of in the velopharynx is recommended 16. A very rare but dis-
the ethmoid (by applying a multidirectional force). “Slit- tressing type of lesion to the ninth cranial nerve due to TE is
shaped dehiscence at the horizontal lamella of the cribri- the underdiagnosed secondary glossopharyngeal neuralgia.
form plate” may also be observed 10. Surgeons should con- When the dissection starts in the incorrect surgical plane
sider the occurrence of an undiagnosed encephalocele 11 or during TE, injury of the ninth nerve may possibly occur
meningoencephalocele formation after septoplasty 12. because of the proximity of the nerve’s course to the ton-
In Judgment No. 1135/1993 of the Supreme Court, the sillar fossa  16. Not only there is a close proximity between
surgeon’s inadvertence resulted in perforation of the cribri- the cranial nerves and the area where TE is performed, but
form plate in attempting to control bleeding that occurred there are also different motor and sensory pathways in the
during septoplasty. In our opinion, this case is exemplary same nerves  16. Therefore, the same medical error may re-
because the serious complication might be viewed as be- sult in complications that could be classified into differ-
ing “in all likelihood unavoidable”, provided that the sub- ent severity. Lesions of the superficial petrol nerve endings
jective perception of the surgeon (who was under stress) may occur during TE. Lesion to the hypoglossal nerve oc-
played an essential role. To avoid the occurrence of a CSF curs less frequently during TE in comparison with lesion of
fistula, multidirectional forces should not be applied and the glossopharyngeal nerve because of the deep anatomi-
accurate preoperational knowledge of the possible ana- cal position of the nerve. A lesion to the hypoglossal nerve
tomical variations would be essential  13. Importantly, the can hardly ever occur without serious concurrent bleeding,
ethmoid roof level may be different on each side (right and given the proximity of the nerve to carotid artery branches.
left)  14. Bony structures in the anterior cranial fossa are During TE, an injury of the aberrant courses of the internal
very thin and dura mater is tightly attached to them  7. In carotid artery may occur.
the case of a CSF fistula, the symptoms appear immedi- As in this specific case, “excessive tissue resection” may
ately after septoplasty. CSF leakage typically occurs after occur in TE, resulting in nerve injuries. However, there may
12-22 weeks 10. Notwithstanding, Soni et al. reported a case be cases where it may be (almost) impossible for a very
of CSF leakage that occurred 2 weeks after septoplasty  11. skillful, experienced and diligent surgeon to distinguish the
During septoplasty (especially endoscopic septoplasty), a due tissue resection from the excessive one. It is known that
surgeon may use some anatomical landmarks in order to in the area of the pharynx, inside the same nerves, there
reduce the probability of complications. Interestingly, Seth are different sensory and motor pathways and it is difficult

3
P. Voultsos et al.

to make accurate detection of the anatomical course of a negligence-based error may be blurry. This may be due to
nerve, especially of its branches and endings. Therefore, it a variety of factors such as: fallibilities and risks inherent
is necessary having a great awareness of which nerves are in excellence of a medical specialty, fallibilities inherent in
at risk. It is also to be noted that aberrant vessels may run the physician’s mind and environmental factors that may
close to the oropharynx, rhinopharynx and the tonsil fossa. influence the physician, as well as the interaction among
Thus, some nerve injuries in ENT surgery might be classi- these factors. Subjective perception plays a leading role,
fied as ‘in all likelihood unpreventable’. for example, when the physician should have performed a
In case 3, the Court of Appeal of Athens concluded that the “careful penetration of an instrument” or should have ex-
defendant conduct was neither as diligent nor as accurate as erted a “mild” pressure on a delicate and brittle anatomic
it should have been. In fact, the physician inserted abruptly structure to stop the bleeding. A surgeon may be involved
the nozzle of the suction device tube. The negligence was in medical litigation for an unavoidable complication due
considered gross since the breach of duty consisted in a to “unpredictable” situations (e.g. those due to the “idio-
clear and significant deviation from the standard of care and syncrasy”, the particularities of the patient, or spontaneous
occurred in a phase of the procedure in which no particular movement of the patient’s body during a surgical proce-
technical or non-technical skills were required to achieve a dure). Additionally, a physician may find himself acting
good outcome (the consequences of error would have been under the influence of situational factors (e.g. conditions of
likely avoidable if the required attention had been paid). extreme stress). Regarding the case of a physician who ex-
erts a certain pressure on an anatomical structure, the focus
General medico-legal concerns should be put on the physician’s awareness of that pressure.
We may assume that, when pressure has been exerted on a
Negligence usually includes doing something that an or- thin bone surface, the degree of awareness may be deter-
dinary, reasonable and prudent practitioner would not do, mined by analogous situations experienced before. Moreo-
or not doing something that a person like that would do ver, such influences may result from dynamic and complex
considering circumstances and knowledge. In case that interactions between factors such as the physician’s bio-
the “objective bystander” reconstruct (ex post) the micro- rhythm, stress, distress and other (mostly environmental)
movements of a particular surgical procedure, some of factors. These factors may deprive a physician of abilities
them might be found to be erroneous, while they are not, in not only to perfectly reflect and ponder, but also to be fully
all likelihood, foreseeable from the perspective (ex ante) of aware of what he/she is doing.
an ordinary physician of the relative specialty, because of Certain routine medical error cases should not be consid-
their high complexity. A physician who committed an erro- ered medical malpractice because of their complexity and
neous maneuver should be regarded as he made a “mistake difficulty. In order to classify them as “too much complex
of fact”, by reducing or eliminating the physician’s civil and difficult”, every single event of the medical procedure
liability or criminal culpability, only in the case in which an should be strictly analyzed, as well as the circumstances
ordinary, reasonable, and prudent physician, working under under which the procedure was carried out. The adverse
similar circumstances, could not adapt micro-maneuvers to events that result from erroneous medical maneuvers con-
the conditions of the particular patient. There are cases of sidered “in all likelihood unpreventable” should be classi-
erroneous medical maneuvers, occurring during routine fied as almost no-fault errors. Sohn remarks that negligence
procedures, in which a sharp line of distinction between is not at the centre of most medical errors 17, thus implying
medical negligence and no-fault error may be extremely that most of them are, in reality, system errors.
difficult to be drawn. It is difficult to rule out with certainty
that a given erroneous medical maneuver was practically
unavoidable and hence constitutes a “no-fault error”. The
The no-fault compensation system
preventability of an erroneous maneuver may be estab- The no-fault compensation system seems to better serve the
lished with the probability, according to which a maneuver purposes of civil medical liability, which is focused on the
might be classified as (almost) negligence (in case of high patient (namely, on restoration of damage) rather than the
degree of preventability) or (almost) no-fault error (in case physician (namely, on indictment and sentence or payment
of low degree of preventability). of compensation). Sohn stated that probably “a more ra-
In cases 1 and 3, the adverse event may be viewed as “in tional system would focus more on the goals of compensa-
all likelihood unpreventable”, whereas in case 2 it may be tion and improvement, rather than on punishment for those
considered “in average likelihood” unpreventable. The line who err”  17. Notwithstanding, medical negligence is con-
drawn between unwitting no-fault error and inadvertent sidered a failure to meet a requisite standard of care 17. This

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 Are errors in otorhinolaryngology always a sign of medical malpractice?

is probably the main reason why French Jurisprudence of unpreventable) technical medical errors resulting from rou-
the courts oscillated between two positions: the obligation tine medical procedures should not be regarded as medical
of the physician to guarantee a safe result by correctly car- negligence, the implementation of the “no-fault” system
rying out a surgical procedure, and the obligation to satisfy would be considered as a necessary reform of the medical
the standard of care, which correspond to the rules of “good malpractice system. Importantly, the particularities of each
medical practice” and prudence 18. In Italy, medical tort and single case should be examined carefully and precisely in
criminal law were radically reformed by Law N. 24/2017. order to establish if the given case of medical error would
This law can be considered a “safe harbour law”: when be eligible for compensation through the so-called “no-
a physician commits an error and the error causes injury fault compensation system” or not. The so-called “system
and avoidable harm to the patient, he cannot be considered errors” would be more fairly addressed through the “no-
criminally liable if full compliance with national guidelines fault” compensation system. Generally speaking, system
or international/national best practices (e.g. international errors are errors for which the responsibility is institutional
guidelines) is proven. Obviously, this “safe harbour” can- rather than individual. Sohn states that system error is an
not be granted in cases of gross negligence (when the con- “occasional”, “simple”, “unwitting”, “unavoidable” human
duct significantly deviated from the standard of care). Re- error 17. A system error is attributable to the healthcare sys-
garding tort law, when the defendant committed the error in tem or bureaucracy, such as organisational error (staffing,
a public or private hospital, the plaintiff (the patient) must failure to have expert mentorship, etc.) or improper pro-
prove breach of duty (while, before the Law N. 24/2017, cesses (drug carts set out improperly, etc.). A kind of sys-
in many cases the defendant had to prove his innocence). tem error might be physicians having to be on call for sig-
This rule is not valid in cases of lawsuits directly against nificant periods of time without enough rest. Importantly,
hospitals: when this occurs, the hospital has to prove that the line of distinction between system error and individual
the claim is unfounded. This shift of the burden of proof is error may be blurry when it comes to technical human er-
substantial, because it aims to deflate the lawsuits against rors resulting from difficult, complicated and complex sur-
physicians but, at the same time, allows patients to obtain gical procedures such as those examined before. It is ar-
compensation directly from hospitals 19. gued in the literature that the “no-fault” system has more
It is important to mention a current and critical problem benefits compared to the negligence-based model, by re-
worldwide, namely severe acute respiratory syndrome ducing the costs of litigation and improving patient care (21).
coronavirus 2 (SARS-Cov-2). This outbreak began with Moreover, the “no-fault” system serves the interests of all
a cluster of cases of pneumonia in Wuhan (December 31, the stakeholders involved in medical malpractice: patient,
2019) and increasingly spread globally, with the World physician, healthcare system and the whole community. It
Health Organization declaring a pandemic (March 11, is further argued that there is a strong public interest in the
2020). During this critical period, the Italian Government implementation of the “no-fault system” 17. Not surprising-
introduced Decree-Law N. 18 (March 17, 2020) in order ly, the “no-fault” system seems to be better applied when
to reduce the impact of Covid-19 and strengthen Pub- it comes to injuries caused during ultra high-risk surgical
lic Health through its reorganisation. In fact, in the most procedures, in which surgeon negligence is difficult to as-
highly affected regions of the country, many hospitals (both certain  22. This may happen even if the surgeon is experi-
public and private) have been turned into Covid-centers 20. enced, skillful and prudent 23.
However, Decree-Law N. 18 provides nothing about medi- As emerged from the documents retrieved from the pro-
cal liability, and therefore an amendment has been recently ceedings of the trials, the overriding and ultimate goal of
proposed. This concerns the abolition of both civil and all the claimants was not economic, namely, they wanted
criminal liability for medical errors, occurring in this criti- to achieve the punishment of physicians who erred. Some
cal time, except in cases of serious professional misconduct claimants wanted to find out what really happened. Thus, in
and willful misconduct. Moreover, according to this pro- case of a medical error that might be viewed as almost “no-
posal, cases of serious professional misconduct would be fault” error, the claimants’ goal may not be, most likely,
assessed by taking into account the number of patients in the punishment of the physician. As a consequence, many
need of care and availability of medical resources (health claimants might seek noneconomic types of redress. In ad-
professionals, medical devices) considering the emergency dition, the amount of the compensation sought might be
situation in which the medical staff is working. However, lower and there might not be criminal cases against physi-
this amendment is currently under consideration, and has cians. Interestingly, according to the “no-fault system” the
not been approved. extent of compensation is generally lower than that con-
In general terms, since unpreventable (or in all likelihood cerning the tort system, and therefore with budgets similar

5
P. Voultsos et al.

to the costs of the tort system more patients would be com- compensation in a timely manner, disclosure of the errors).
pensated. Finally, it is crucial to bear in mind that, contrary Of note, however, the “no-fault” system’s alleged disadvan-
to the negligence-based system that “objectifies” medical tages would in all likelihood remain unobserved, provided
liability and according to the “no-fault system”, physicians that the tort system will keep compensating the majority of
might be unpunished, and hence would be strongly dis- medical errors. Our ambition is to offer an instrument to
couraged from practicing “defensive medicine”  17, which make better judgments about medical liability. However,
represents a huge cost for Public Health 24. The “no-fault more work is needed to increase awareness of this topic,
system” benefits both physicians and patients, and fosters a especially after the SARS-CoV-2 emergency. During this
good relationship between them  21. In this perspective, the critical period, the Italian Government introduced Decree-
patient’s trust in the doctor would be strengthened, leading Law N. 18 (March 17, 2020) in order to reduce the im-
to an improvement in the quality of healthcare. Moreover, pact of Covid-19 and strengthen Public Health through its
it also promotes the public interest by reducing the huge reorganisation. This document also concerns the proposal
costs of litigation and those of “defensive medicine” 21,25,26. regarding the abolition of both civil and criminal liability
These two aspects especially concern surgeons compared for medical errors, occurring in this critical time, except
to clinicians, since they have a higher risk of medico-legal those cases of serious professional misconduct and willful
events  27 since they are involved in surgical procedures misconduct. Although this amendment is currently under
which, in most cases, are at high risk of errors due to their consideration and is not still approved, it represents a good
complexity and difficulty. Moreover, in support of the no- opportunity to further improve the medical liability system
fault compensation system, the 1982 President’s Commis- in Italy as well.
sion for the Study of Ethical Problems in Medicine and
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