Two former laboratory managers involved in the marketing of an expired anticancer drug were sentenced, Tuesday, September 14 in Paris, to suspended sentences of six to twelve months.
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They will also have to compensate up to 37,000 euros the family of a young patient, victim in particular of a prejudice of anxiety, and will have to pay to the National Order of Pharmacists, civil party, 10,000 euros in compensation. Alain Bouaziz, 67, was given a one-year suspended prison sentence - a harsher sentence than that required by the public prosecutor who had asked for eight months - and a fine of 30,000 euros. His nephew Valéry Monin, 57, was sentenced to a six-month suspended sentence and a fine of 15,000 euros.
The two directors of the Genopharm group, responsible in the early 2000s for the marketing of the anticancer drug Thiotepa, were judged for "
non-compliance with good manufacturing practices
", "
marketing without marketing authorization
" and "
deception on the quantity in active principle of a good
”.
The Paris Criminal Court has attached their sentences to a ban on practicing in the pharmaceutical sector for five years.
100,000 non-compliant vials distributed
At the hearing on June 30, the defense pleaded for an acquittal - or a dispensation from the sentence - arguing that the two men were unaware that the Thiotépa distributed after 2009 was out of date and under-dosed. Me Joëlle Benayoun-Orliange, lawyer for Mr. Bouaziz, considered that it was a judgment "
of extreme severity
", specifying that his client had the "
intention to appeal
". "
Exhausted by ten years of legal combat, Valéry Monin does not yet know if he will appeal,
" said his colleague, Me Marie-Laure Ingouf. Romain Dinparast, lawyer for the family of the young patient compensated, said he was "
extremely satisfied
" with this decision, described as "
symbolic more than financial
", "
which alleviates their suffering and their anguish
”, noting that the“
emotional prejudice
”of the parents had also been taken into account.
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The Thiotepa scandal, used since the 1960s in the fight against ovarian, bladder and breast cancer, but also against certain childhood cancers, erupted in March 2011 when the German manufacturer of the product, the Riemser laboratory, had warned the health authorities that expired bottles were circulating on the market.
Nearly 100,000 non-compliant bottles, displaying falsified expiration dates, were distributed until September 2011, mainly in France.
However, no expert has been able to link a negative evolution of cancer to this expired drug, the bottles of which had an insufficient dosage of active principle. However, the court rejected the Riemser laboratory's request for civil action. Me Ingouf was delighted by noting that his client Valéry Monin had underlined the "
bad faith
" of the laboratory throughout the procedure. Me Eric Weill, lawyer of the laboratory, nevertheless judged the convictions "
satisfactory
".
