-
A-Material element of the infringement:
1.
Penally, to market brackets not fulfilling the requirements
of the regulation on the medical devices, is likely to raise the
offence
of fraud envisaged, with the L.213-1 article of the code of consumption:
" will
be punished of a two years imprisonment to more and of a penalty
of 37 500 euros to more
or one of these two punishments
only, whoever, that is or not bounded by the agreement, has misled
or tried to mislead the contractor, by some means or process that
it is, even by the intermediary of a third:
1° either
on the substantial nature, species, origin, qualities, the composition
or the content
of useful principles of all goods;
2° either
on the quantity of the thing delivered or their identity by the
delivery of other goods
than previously defined in the contract;
3° either
on the operating requirement, the risks inherent in the use of the
product, controls carried out, the instructions or
the precautions to take;
1
[ L.213-2 article of the code of consumption envisages the doubling
of the punishments, in particular if the offences resulted of
the use of dangerous goods for the health of the man or the
animal, or if the offence or the attempt at offence envisaged
with the L.213-1 article were made using fraudulent indications
trying to make believe to a former and exact operation.]
This infringement, can be charged to whoever, without distinction
between the defrauders, merchants or consumers, nor between the commercial
or civil contracts.
2. The fraud would relate here to the purpose (brackets) of a contract
between the laboratories which do not have a certificate of EC marking
and their customers.
In
the business known as of "contaminated blood",
accused were declared guilty of fraud because of no respect of the
provisions
of the articles L.661 and following (new L.1221-1 and following) of
the code of the public health service (Cass. crim. June 22, 1994,
JCP 1994 II 22310, score Mr.-L.Rassat).
In
a very extensive idea, case-law retains that the concept of fraud "consists
of a lie made during the formation or execution of the contract, and
in that only, since it is not necessary that it is resulted from it
a damage. The lie can be purposely or not, but in practice, it generally
results from reserves ".
3. The contractual lies are not all punishable. The L.213-1 article
referred to above gives a long enumeration of it.
So, your competitors which are freed from the obligations which
fall to them, could be possibly be blamed for having made this infringement
in connection with:
(a)
Substantial quality:
The Supreme court of appeal admitted that substantial
qualities of a foodstuff can result from data registered in the national and
Community regulations or the uses (Cass. crim., March 30, 1994, JCP
1994 IV 1672).
In
the situation which occupies us, substantial qualities of the brackets
emanate from directive
93/42 the EEC and its transposition
in the law. Considering the orthodontists who "make them recycle",
or more generally the companies which do not apply knowingly or not
this standard, the offence of fraud could be made up.
(b)
Of the risks inherent in the use of the product:
This
type of lie was evoked, with that of the operating requirement,
at the time of the lawsuit known
as of contaminated blood, against
an importer of toys "provided with a label mentioning their
conformity to the obligatory standards wrongfully" (CA Paris, March 18,
1992, Juris-Dated 1992-020822) thus also, at the sides of the fraud
on substantial qualities, in connection with an electric material
not answering the safety requirements (Cass. crim. April 10, 1997,
JCP 1997 IV 1780).
"The importation, the placing on the market, the putting into
service or the use "of brackets nonin conformity with the above
mentioned texts "obligatory or safety standards", would
thus constitute also a fraud, on the risks inherent in the use of
the product.
(c) Of controls carried out:
The
case-law knew the case of an importer of toys, author of the first
placing on the market, which "claimed wrongfully that
their conformity to the obligatory standards had been checked",
which was prosecuted and condemned on the base of this infringement
(CA Paris, March 18,
1992, cf supra).
For
the brackets, the fact of conferring to a batch, which has escaped
the control required with appendix
IV of the decree of 1995 relating
to the medical devices, the number of another having undergone successfully
this control, would amount "claiming wrongfully that conformity
to the obligatory standards of the first batch was checked",
which constitutes there still the offence of fraud on controls carried
out.
4. It is useful here to lay stress on all the interest of the judgement
of March 18, 2000 of the Court of Appeal of Montpellier, on the involuntary
discharge from hospital of the Supreme court of appeal (June 19, 1999),
directly aiming the re-use of medical devices at single
use.
If the doctors having re-used medical devices (probes of electrophysiology)
were released of the count of fraud, it is only because the reproached
acts were held at one period during which the circulars (nonlawful)
prohibited the resterilisation of medical devices of single use, according
to the labelling of the manufacturer. At the time of the infringement,
there was not standard, and thus, no failure to this one. Nevertheless,
the litigious facts were described as fraud on substantial qualities,
like on the ability employment and the risks inherent in the use of
these medical devices.
You will note that the mistakes of your competitors could reasonably
be appreciated by the courts as being constitutive of the offence
of fraud.
- B Intentional element of the infringement:
1. It is in addition, necessary to identify the will of the author
of the offence. The L.212-1 article of the code of consumption, resulting
from the law of July 21, 1983, lays out with its 2nd
subparagraph that:
" the
person in charge for the first placing on the market of a product
is held to check that
this one is in conformity with
the regulations in force."
2.
Thus, the courts will condemn the prosecuted person who not checked
the conformity of her goods with the rules, written or usual, which
govern its manufacture or its importation, this one having taken the
risk to mislead her contractors in violation of the article L.212-1.
It does not matter it calls upon her good faith (Cass. crim. April
7, 1999, Juris-Data 1999-001673).
For example, was condemned the importer of this material of tools
not meeting the applicable standards, which it had not checked (Cass.
crim. 10 April 1997, above mentioned), or the person in charge for
the setting on sale of toys nonin conformity with the safety requirements
(Cass. crim. 7 April 1999, above mentioned).
