Servier and its president are on trial in France, charged with misleading patients and health authorities about a weight loss drug.

Mediator (benfluorex), widely prescribed as an appetite suppressant, is believed to have caused over 500 deaths by heart valve failure.

The drug was withdrawn in France a decade after its withdrawal on safety grounds in Spain, Italy and the US.

Servier is accused of misleading French doctors about the risks of Mediator, whose prescription was supported by a government subsidy.

In addition to the criminal charges, several hundred civil plaintiffs are seeking damages of €100,000 each.

Servier’s President Jacques Servier, aged 90, and four other executives risk prison sentences of up to four years.

A second French trial, dealing with allegations of negligence and corruption, may follow.

Mediator, originally developed as a diabetes drug, was taken by up to 5 million people in France between 1976 and 2009 to assist weight loss.

The alleged failure of the French healthcare regulator to investigate the drug’s risks has prompted comparisons with the PIP implant scandal.

As with that case, the Mediator scandal has prompted questions about safety regulation at EU level.

Lawyer Charles Joseph Oudin commented: “Servier let people use a toxic product for years. There is no debate about it.”

The Chair of the European Medicines Agency’s committee for approving new drugs has resigned suddenly with immediate effect.

Dr Eric Abadie, who has led the Committee for Medicinal Products for Human Use (CHMP) since 2007, stood down after his position at the French healthcare regulator AFSSAPS was questioned.

The regulator has come under scrutiny for allowing the continued sale of Mediator after it had been withdrawn for safety reasons elsewhere.

Concerns have also been raised about the Agency following the controversy over breast implants manufactured by French firm PIP.

Dr Abadie noted in his public declaration of interests with the EMA that he had no links to any pharmaceutical company or health organisation. However, a spokesman said his decision was related to his position at the AFSSAPS, where he works as a scientific advisor to its Director General.

A spokesperson for the EMA said an election for a new chair for the CHMP would happen in “due course”.

In the meantime, Dr Tomas Salmonson, currently the vice-chair of the CHMP, will lead the Committee to ensure a continuity of operations. The next meeting is scheduled for April 16-19.

Tighter medical device regulation could not have prevented the PIP breast implant scandal, according to a UK regulatory lawyer.

Regulatory processes cannot defeat a deliberate violation of the law, such as the French company PIP’s use of industrial rather than medical grade silicone, Dev Kumar of law firm Bristows commented.

Meanwhile, a Commons Health Select Committee has challenged the NHS decision to provide only PIP implant removals but not replacements, on the grounds that it forces patients to undergo an avoidable follow-up operation.

The PIP implant scandal has rocked the European medical device industry and led to calls for tighter regulatory controls and better surveillance.

This coincides with changes to the European regulatory framework for medical devices arising from other scandals, including the high failure rate of metal-on-metal hip implants.

“The House of Commons’ Health Select Committee’s report on the PIP breast implants has once again brought the medical device regulatory system to the forefront of everyone’s attention,” said Dev Kumar.

“The report, which also mentions the safety concerns of metal-on-metal hip implants, suggests that the CE mark requirements and regulatory framework are strengthened.

“The timing of the PIP case and Select Committee report are all the more relevant as they have surfaced at a time when the European Commission is drawing up proposals to revise the regulatory system for medical devices. Currently, these include plans to improve and strengthen the regulatory framework through the introduction of measures for more pre-market testing and post-marketing surveillance.

“However, the PIP case concerns a company that intentionally chose to use an industrial, as opposed to a medical grade, silicone filler. No regulatory system, however robust, can guarantee against a further incident of this nature occurring if there is deliberate intent to circumvent the law.”

The question of how the NHS should assist patients who received PIP implants from private clinics remains contentious. Current NHS policy is that such patients can have the implants removed, but not replaced, on the NHS if the clinic will not help.

However, a Commons Health Select Committee argued that to save patients from being operated on twice, the NHS should remove and replace the implants but impose a charge of about £1,500 for the latter procedure.

The DH responded by saying that requiring patients to pay for an NHS treatment would set a dangerous precedent.