[SaneVax: Formal charges for breach of the manifest duty to ensure safety and disregard for precautionary principles have been filed against Sanofli-Pasteur and the French National Medicines Agency, naming Gardasil as the cause of severe autoimmune reactions experienced by 15-year-old, Marie Océane]
PRESS RELEASE – 25 NOVEMBER 2013
Gardasil Vaccine: Charges Filed against Laboratoire Sanofi Pasteur MSD
Today, the 22nd November 2013, Mr. Jean-Christophe Coubris, defence lawyer for Marie-Océane, has filed charges with the French public prosecutor in Bobigny, in the outskirts of Paris, against both Laboratoire Sanofi Pasteur MSD and the French authority Agence Nationale du Médicament (ANSM), the French National Medicines Agency, for breach of their manifest duty to ensure safety and for disregard of the precautionary and prevention principles.
An initial injection of Gardasil was administered to Marie-Océane, age 15 at the time, on the 11th of October 2010.
This vaccine is advised for the prevention of cervical cancer.
A second injection of the vaccine was administered to Marie-Océane on the 13th of December 2010.
The first clinical symptoms appeared in mid-February 2011 and were rapidly diagnosed as acute disseminated encephalomyelitis or multiple sclerosis.
Marie-Océane was repeatedly hospitalised over subsequent months.
She temporarily lost her sight and the use of her legs.
During one of these crises, her face was completely paralysed.
Treatment at the Bordeaux University Hospital has resulted in a slight improvement in her overall state but with serious after-effects, including among others, the constant fear of yet another ‘flare-up’ of her disease.
As soon as the first symptoms appeared, Marie-Océane’s doctors suspected a link with the Gardasil vaccine.
Marie-Océane’s parents have reported this reaction to the Commission de Conciliation et d’Indemnisation des Accidents Médicaux (CCI) d’Aquitaine (Aquitaine Medical Accident Settlement and Compensation Authority), to establish the cause and effect role of the vaccine.
The conclusions of the panel of experts were received in June 2013.
They stated that there appeared to be a clear link between Marie-Océane’s serious ailments and the vaccine.
“An in-depth analysis of all the information in the file, which included a wealth of references, confirms that Marie-Océane B’s neurological disturbances are consistent with iatrogenic post-vaccinal disease.”
In an announcement published on the 18th September 2013, Mr. Patrick Mairé, Chair of the Aquitaine CCI, stated that Laboratoire Sanofi Pasteur MSD was responsible.
Compensation for Marie-Océane has however been limited by the Authority to only 50% of her claims, alleging that she suffered from a previous unidentified condition supposedly making her genetically vulnerable.
Marie-Océane accuses Laboratoire Sanofi Pasteur MSD of neglecting to inform recipients of the Gardasil vaccine of the risk of central nervous system inflammation while such risk was identified as far back as 2009 in adverse effects reporting.
Marie-Océane considers that by taking no action against Laboratoire Sanofi Pasteur, the ANSM has clearly failed in its role of medicine watchdog.
A Press Conference will be held at the Bordeaux offices of Cabinet Coubris Courtois et Associés, 31 rue du Bocage, Bordeaux, on Monday 26th November at 11am, and will be attended by Marie-Océane and her family.
06 85 41 19 67