AP Features, February 1st, 2008
A French investigating judge has filed preliminary manslaughter charges against drugmaker Sanofi Pasteur MSD over side effects of a hepatitis-B vaccine widely used in the 1990s, a judicial official said Friday.
Two managers from drugmakers GlaxoSmithKline and Sanofi Pasteur MSD were also given preliminary charges Thursday of "aggravated deception" for allegedly failing to disclose the side-effects, the official said.
He spoke on condition of anonymity because he was not authorized to speak publicly about the continuing probe.
Sanofi Pasteur MSD is a joint venture between Sanofi-Aventis and Merck & Co.
Prosecutors link the company to the 1998 death of a young woman from complications of multiple sclerosis after receiving a hepatitis-B vaccine made by the company's laboratory.
The managers targeted in the case worked for the companies marketing the vaccine, at the time called Pasteur-Merieux-MSD and SmithKlineBeecham.
Benoit Soubeyrand, medical director for Sanofi Pasteur MSD's French operations, called the charges unjustified, but said the company was cooperating with authorities. He said multiple studies showed no link between multiple sclerosis and the hepatitis-B vaccine.
Some 30 plaintiffs have filed legal complaints over the vaccine since 1998.
In 1994, the French government launched a national campaign urging vaccination against hepatitis-B, and some 25 million adults and children received the vaccine before the campaign was suspended in 1998.
Under French law, the filing of preliminary charges means investigating judges have determined there is strong evidence to suggest involvement in a crime. It gives the investigators time to decide whether to bring the case to trial.
