Lyon court dismisses controversial Levothyrox case

The case had been brought by 4,113 people who claim that they have become ill and seen a return of their thyroid disorder symptoms after Merck altered its existing Levothyrox and released a “new formula”.

It had become so large that the hearing had been forced to open in a concert hall in Lyon to accommodate the 4,113 plaintiffs, and had widened to include the more serious charge of manslaughter after a woman died, allegedly from complications linked to the new Levothryox formula.

Problems with the new drug first started to emerge in France in summer 2017, with patients claiming that they had seen a return of negative symptoms, and some even alleging that their thyroid cancers had returned due to the new drug not working as effectively as the old one.

Pending an investigation, in October 2017 French health minister Agnes Buzyn ordered 130,000 boxes of the old formula nationwide, half of which sold out within two days.

But Merck has always maintained that its new formula is “bioequivalent (medically identical)” to the old one, and that only non-active ingredients of the drug were changed, to conform to new medication rules from medical safety agency l'Agence Nationale de Sécurité du Médicament (ANSM).

ANSM itself has conducted its own independent analysis of the drug and found it to be “good quality”.

Florent Bensadoun, legal director at Merck, welcomed the Lyon court’s decision this week, calling it a “balanced and founded judgement”.

He said: “The court recognised that Merck had not had a lack of information [and] had scrupulously and respectfully communicated strictly within regulations.

“Merck has [always] used the official channels traditionally used to communicate [with patients] about a drug, and that is through health professionals.”

He said that while the company was not legally permitted to communicate directly with patients, it had sent a total of 300,000 messages to around 100,000 health professionals on the issue since the start of the controversy.

Mr Bensadoun said that Merck recognised “the high emotion” surrounding the case.

He said: “We hear this emotion and we deeply respect it. Merck’s position on this judgement does not in any way seek to deny the feelings of the patients.”

But Maître Lèguevaques, lawyer for the plaintiffs, described the court’s dismissal as “an enormous disappointment, which gives the impression that the court did not hear or understand”.

The lawyer added: “We feel that the court simply repeated Merck’s arguments. When we read the 20-page judgement, we were very surprised to find most of Merck’s arguments, and very few of ours.

“All of this has been brushed under the carpet because they believe that they must protect the laboratory, and ANSM, and they think the ill people should just make do and get on with it.”