Pulmonologist Irene Frachon had alerted French health authorities of heart problems among patients who had taken the drug (AFP Photo/FRED TANNEAU) |
Paris (AFP) - France's medicines watchdog will join a pharma firm in the dock from Monday on fraud and negligence charges linked to the deaths of multiple people prescribed a diabetes pill for weight loss despite safety concerns.
At least
500 people are thought to have died of heart valve problems in France after
taking the drug, Mediator, in a major health scandal that became the subject of
a 2016 French movie called "150 Milligrams".
Legal
experts have concluded the drug may cause as many as 2,100 deaths in the long
term.
The
criminal trial, with 12 individuals in the dock, will focus on 91 victims, four
of them deceased, for whom lawyers believe a link can be shown between their
illness and Mediator.
The
medicine was on the market for 33 years, and used by about five million people.
Though
initially intended for overweight people with diabetes, it was widely
prescribed to healthy individuals as an appetite suppressant.
Safety
alerts were first flagged in the mid-1990s, but the drug was only banned in
France in 2009 -- long after being outlawed in the United States, Spain and
Italy.
Victims
"want to understand how this medicine could have been left on the market
for so long," said Charles Joseph-Oudin, who will represent about 250
complainants in the trial expected to run for six months in the Paris criminal
court.
Drug
manufacturer Servier and nine subsidiaries are charged with fraud for allegedly
concealing Mediator's risks, while the ANSM drug watchdog is being pursued for
negligence and allegedly dragging its feet in suspending the drug.
'Selling
poison'
At the end
of the trial, both risk a fine or an order to compensate victims.
"Servier
knew that it was selling poison," said 71-year-old Joy Ercole, who took
Mediator for six months ten years ago, and said she suffered heart damage as a
result.
"The
unlucky ones, like me, are condemned to a slow death. My life is ruined."
Francois de
Castro, a lawyer for Servier, said the company was "keen to come and
explain that they did not identify the risk before 2009."
Pulmonologist
Irene Frachon had alerted French health authorities of heart problems among
patients who had taken the drug. She published a book in 2010, which became the
basis for a documentary movie.
In 2015, a
civil court found Servier negligent for having left "defective"
medicine on the market.
It ruled
that in 2003 and 2006, when the medicine was prescribed to two claimants,
"the state of scientific knowledge meant the risks of pulmonary
hypertension" and heart valve damage "could not be ignored".
The ANSM,
then known as Afssaps, in 2010 linked at least 500 deaths to Mediator.
Victims
have submitted nearly 10,500 claims for compensation from Servier, and many
have accepted payment in return for not taking part in criminal proceedings.
'Unpunished'
Servier's
website states it has made offers of compensation to more than 3,700 sickened
people for a total amount of 164.4 million euros ($182 million), of which 131.8
million euros have been paid out.
The amounts
range from a few thousand euros per person to a million euros in one case.
About 100
witnesses are expected to take the stand, including Frachon, who told AFP ahead
of the trial it was time for justice to be served.
"We
cannot live in a society where white collar crime goes unpunished," she
said.
The trial
will happen in the absence of a key protagonist: company founder Jacques
Servier who died aged 92 in 2014.
The 12
individuals on trial include Servier's former number two Jean-Philippe Seta,
doctors who were members of Afssaps commissions but were also paid as
consultants for pharma companies, and former senator Marie-Therese Hermange who
is accused of producing a report that was favourable to Servier.
France has
seen its share of medical scandals.
Thee
include 36 baby deaths in the 1970s linked to a contaminated talcum powder,
HIV-contaminated blood given to haemophiliacs in the 1980s, and the recent
discovery that a popular brand of breast implants contained a cheap,
industrial-grade -- not medical-grade -- silicone gel.
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