Liability for malpraxis under the Romanian law provisions – a

case study

1. The concept of "malpraxis"

 what defines the medical profession and what gives its specificity?
 the medical profession is or should be granting to those involved
in the medical act dignity and requires devotion; nothing but a
fair exchange;
 it's a permanent challenge to those involved
 deals directly with the most sensible area of a human being:
their sufference; that makes any doctor a somewhat Godlike
creature; the risk is they believe that themselves;
 to prevent the risk, the medical profession requires a permanent
supervision and control exercised upon the professionals
exercised by the society through means of a complex system of
moral and legal constraints

 What is the malpraxis and what are its backgrounds?

 definition: cases of medical negligence in exercising the
professional duties;
 brief history;
 negligence is including any failure to comply:
 the knowledge
 the competence
 the expertise standards that an average doctor should fulfil.
 due to its broad scope, the concept of malpraxis, has thereby
generated extreme situations; the American exemple;
comparison to the European system of extrajudicial reparation
for medical error

 Why would and should be malpraxis be associated with the medical

act?
 The medical doctor is a independent professional
 The knowledge required is of high level and very specific
 A proffessional control of the standards within the profession
needs to exist
 The malpraxis regulates precisely the control systems of the
society upon the quality of the medical act

 The view of the Romanian law with regards to he malpraxis

concept; the malpraxis covers more than the responsibility of the
 medical professional; its scope is extended to the medical intentional
or caused by negligence error in performing a medical act or by
refusing it, thereby causing a prejudice to the patient

2. General legal frame of the Romanian legislation in the

matter of malpraxis

 the incident legal provisions in the matter of malpraxis:

 Law no. 95/2006, concerning the reform of the medical system,
Title XV, referring to the liability of doctors and medical
personnel for the acts connected to the exercise of their
profession
 The legal provisions within the Civil Codex regulating the civil
responsibility: art. 998-999 C.Civ
 special laws: Law no. 46/2003 concerning the patient’s rights,
Law no.100/1998, Law no. 248/2004 ruling the legal status of
medical doctors and the activity of the Romanian College of
Medical Doctors (hereafter referred to as CMR) and the Law no.
263/2004 ruling the legal status of medical professionals other
than doctors and the activity of the Romanian Association for
Medical Assistants and Nurses

 responsibility for medical malpraxis – general frame

 the goal of the medical activity: assuring the health by illness
prevention as well as by promoting, maintaining and recovering
the health of individuals
 the physician is an independent professional in what the
professional decision is concerned
 the physician is controlling, supervising and directing the activity
of the auxiliary medical personnel

 what are the physicians responsible for?

 failure to comply to professional regulations and acting in
disrespect of the professional dignity and honor
 failure to observe and respect the patients' rights:
 the right to request and accordingly receive medical
treatment
 the right to be informed as to any aspects of the treatment or
investigation and to express their consent accordingly
 right to personal data protection
 rights concerning the process of human reproduction
 the physician is basically responsible for any damage caused to
pateints through professional error to patients undergoing
treatment or investigations; professional error may be caused by:
 negligence
 imprudence
 insufficient professional knowledge
 failure to respect patient’s rights legally stated

 physician's liability exemption cases:

 nosocomial infections
 defects of the medical devices where they were aware of their
existence
 the use of materials or substances outside their validity period
 buying goods or contracting services from providers/producers
that do not have a malpractice insurance

3. The responsibility for malpraxis – a complexe

responsibility

 the professional responsibility

 the medical doctors are held liable for the failure to comply to
the legal frame of the profession, deontology, profession
related acts performed in disrespect of the commonly
accepted standards
 the procedure
 complaint addressed to the CMR
 the Permanent Council of the respective CMR forwards the
complaint to the Discipline Comission
 the Discipline Comission issues a decision
 the doctor, the patient, the Health Ministery or the president
of CMR can appeal the decision within 15 days, to the
Superior Discipline Comission
 the later can be appealed by the physician to the
Administrative Section of the Tribunal
 the sanctions that the Discipline Comission can impose on the
physician
 warning
 qualified warning
 fine (100 – 1500 RON) payable in 30 days from the Discipline
Comission's decision. Failure to pay it leads to suspending the
right of exercising the profession
 interdiction to exercise the profession for a set period
 exclusion from the profession
 the civil responsibility
 definition – one's obligation to repair the damage caused to
another individual by their acts
 general conditions
 the unlawful act
 the damage
 the causal link between the act and the damage
 the guilt
 the act is not one of those that benefit from the exemption
from liability, such as stated by law
 relevant reports
 the doctor – patient relationship
• the doctor is responsible for any damage inflicted on a
patient, caused by the personal conduct and failure to
observe the legal provisions and legal rights of the patient
 the doctor – hospital relationship
• the hospital is held to repair the damage caused to
patients by the acts of its medical personnel
• the hospital preserves the right to obtain the payment
made to the victim, from the author of the illegal conduct,
as long as and to the extent that it can provide proof on
the fulfillment of its own legal obligations
 the doctor – assistant relationship
• based on a subordination report
• the doctor is entitled to exercise control and direction over
the acts of the latter
• the basis of the responsibility of the doctor is of objective
nature, with no regard whatsoever to the fault of the
doctor
• by providing proof that he is not in fault in respect to the
damage suffered by the victim, the doctor is not bound to
repair any damage

 when and how is the doctor held responsible under the civil law?
 When the unlawful act is the result of the infringement of the
• Professional principles
• Legal rights of the patient
• Legal provisions governing the general standards of
knowledge and competence
 the civil responsibility is proportionally limited accordingly to
the personal guilt
 the physicians are not responsible for the damages caused by
• nosocomial infections
 • defects of the medical devices where they were aware of
their existence
• the use of materials or substances outside their validity
period
• buying goods or contracting services from
providers/producers that do not have a malpractice
insurance
 the procedure
 each district in the territory has a Comission for Monitoring
the Professional Competence and the Malpraxis Cases
 the victim or the heirs of the victim may forward a complaint
to the above
 the Comission appoints a group of experts for rulling upon the
case
 the appointed experts are due to realize a full report on the
case within 30 days
 based on the report, the Comission issues a decision within
the following 3 months
 the decision is communicated to all those involved within 5
days from its issue
 The decision may be appealed within 15 days from the
communication to a Court
 As stated by the current regulations, this procedure appears
as complementary, not compulsory, the victim of an
erroneous medical act being entitled to claiming the
reparation directly in front of a Civil Court

 the penal responsibility

 principle: none of the other forms of liability does not exclude the
responsibility under the provisions of Criminal Law
 general conditions:
 the unlawful conduct is incriminated under the provisions of
the criminal law
 the incriminated conduct is of a high social peril
 guilt, as perceived by the criminal law
 what is likely to attract the penal liability of he medical doctor?
 Acts of the doctor, performed with the violation of legal
provisions
 Failure of the doctor to perform acts that were required under
the legal provisions

4. The Malpraxis insurance

 the malpraxis insurance – a legal obligation

  the law imposes the obligation of a malpraxis insurance to the
medical dotors as well as to the medical auxiliary personnel
 what does the insurrance cover (the risk is covered by the Insurance
Company)
 damage caused by medical malpractice
 Court expenses where applicable
 when is the Insurance Company not entitled to claim the payments
made from the insured doctor
 the medical care act was performed in special observance of the
patient’s interest
 there were no available data or investigations possible due to the
state of medical emergency observed in the victim’s state
 the victim could not cooperate in the sense of informed consent
and the wait for a legal representative would’ve seriously
endangered the life of the patient (art. 666, alin.2, lit a)
 when is the Insurance Company entitled to turn against the medical
professional for recovering the damage (the "risk" is covered by the
professional)
 the "error" was intentional
 who is responsible when the doctor is not responsible?
 In the situations emphasized above, in which the medical doctor
in not liable for the reparation of the damage, the medical unit or
the medical material provider are going to be held responsible
for paying the damage
 Still, the unit or the provider might and normally will turn onto
the medical professional trying to recover at least part of the due
payment
 In such an event, the malpraxis insurrance is going to cover the
same situations as above, only this time in relation with the
claims of the unit or of the medical service provider

5. Case study – the single dose vials (SDV)

 SDVs – use, misuse and risks

 Use – administration of contrast media in radiology
 Prefilled contrast media syringes simplify the tasks associated
with contrast injection in computerized tomography
technology
 set volume and concentration of contrast agent in a power
injector compatible syringe
 reduces the possibility of contamination or misadministration
 prefilled syringes of contrast media offers one way to increase
technologists' efficiency while improving their job satisfaction
  prevents some of the risk of MDVs (multiple dose vials), such
as
• iatrogenic infections
• incorect labeling
 Misuse – the multiple use of SDVs
 Possible factors
• Costs
• Lack of knowledge
 Although sterilized and thoroughly cleansed after the first use,
as single-use materials, their multiple use has not been
intended as it might have side-effects
 Risks of the multiple use of SDVs
 Cross-contamination – some parts of the injection circuit are
re-used; even if the vials used are multi-dose, the syringes
and the anti-reflux valves are not
 Infringement of the legal provisions - the product was not
used according to the specification of the product, thereby a
transfer of liability operates, the new subject of liability being
the one responsible for the decision of re-using a single-use
material and the person applying it; the original labeling as CE
has no further practical importance, as the product has been
used outside the safety provisions issues from the producer
 malpraxis issues raised by the misuse of SDVs
 cross-contamination due to misuse of SDVs might seem as
integrating within the scope of the art. 643 paragraph 3, lett. a)
of Law no. 95/2006, when stating the cases in which the medical
professional is not responsible: nosocomial infections
 still, the medical professional is responsible for
• not respecting the patient's rights (i.e. informed consent) –
assimilated by the law with the malpraxis
• art. 644 a), final part – the medical institutions are to be
held responsible in events of prejudices caused by
nosocomial infections unless they could prove the
latter being the result of an external event, out of
their power of control
♦ the quoted legal texts instate a legal presumption of
guilt for the institution, but it’s only a relative
presumption, therefore subject to contrary proof
 in the event of re-using a single-use device, thus using it against
the provisions of its producer, a transfer of warranty for hidden
defects is operating at this moment, from the producer towards
the end-user
 the insurance company can subsequently to its payment
towards the third party, turn for the entire amount paid,
 towards the holder of the warranty for hidden defects.
(art.666, par.2, lett.b)
 indirect intention form the doctor – leads to art. 666, par.2, lett
a) of the Law no. 95/2006, stating that the insurance company
has the right to claim the payment from the responsible persons
in event of their intentional trespassing of generally accepted
medical standards
 the product was labeled as “single-use” – therefore, even
sterilized after initial use, it cannot be assimilated to a new
one, thus, the risk of cross-contamination being foreseeable
and accepted by the doctor
 cases where the “damage” resulted is actually the death of a
person
 incriminated by the Penal Codex under either art.183, as
harms resulting in the death of a person, or under art.178,
par.2 (if the death of the person resulted from the negligence
or imprudence of the author and by the infringement of the
legal provisions concerning a given profession), as
manslaughter;
• sanctioned by prison between 5 and 15 years, or 2-7 years
respectively
• For a medical professional, complementarily the exclusion
from profession would also operate ope legis
• any other sanction that the CMR would find appropriate, for
by this kind of behaviour the doctor has flawed severely
the dignity and respectability of the profession
 other possible result would be the harming of the person, thus
involving the application of any of the following: art. 181, 182,
184, Penal Codex, depending on the number of days needed for
recovery in a hospital and the existence or inexistence of
intention
 Additional sanctions can be applied
 termination of wrok contract by the institution
 any other labor law sanction it might find suitable
 any of the professional sanctions shown above
 the insured doctor is very likely to be considered by the
Insurance Company as a client of higher potential risk and
thereafter be subjected to additional payment for a new
contract, when the current one would expire