Merck Wins Lawsuit on Levothyroxine Saga in France

Philippe Anaton. Adapted from Medscape France

March 13, 2019

Two years after a new formulation of synthetic levothyroxine (Levothyrox) was introduced in France for the treatment of hypothyroidism by Merck, the company has won a lawsuit against more than 4000 plaintiffs who had brought a civil action against it, claiming that the changes to the formulation resulted in side effects that caused them ill-health.

Within 3 months of the new formulation's release in 2017, as reported by Medscape French edition, thousands of patients began reporting adverse events such as dizziness, cramps, headaches, and hair loss.

In their civil action, the group of plaintiffs sued the company for "lack of information" when introducing the new formulation and were claiming a sum of 41 million euros for the "moral anxiety" caused by the lack of information on the new formula of the drug.

But last week, on March 5, the District Court of Lyon dismissed the plaintiffs.

"The judge recognized the relevance...of the information system put in place during the transition, between March and September 2017, from the old to the new formula of Levothyrox", according to a statement distributed by the company.

The court said: "It does not appear that Merck...committed any...negligence in the introduction, in March 2017, of the new Levothyrox formula."  

The lawyer for the plaintiffs, Christophe Leguevaques, said: "It seems that the authorities are trying to minimize the severity of the crisis. Instead of withdrawing the medicine, nothing happens. We let the sick face their destiny."

But he vowed to continue the fight: "We lost the first battle but not the war."

30,000 Pharmacovigilance Reports

Levothyroxine is used by approximately 3 million patients in France. Since the new formulation was introduced, more than 30,000 pharmacovigilance declarations have been filed.

Nevertheless, on several occasions the French National Agency for Drug Safety (ANSM) has denied any link between the new formula and the health problems observed in patients prescribed the drug.

In October 2017, in a first opinion, the ANSM concluded that the adverse effects were due to a "thyroid imbalance" caused by the change of treatment and not to the new formula as such.

But a parliamentary mission concluded that Merck did lack information in marketing the new formula, and some supplies of the old formula were reintroduced in France —imported from Germany — following a ruling in a Toulouse court, also in October 2017.

The company supplied 200,000 boxes of the old formula to last through to the end of 2018.

And in November 2018, Merck said it would make available 50,000 more boxes of the old formula for French patients with prescriptions until the end of 2019.

The company insists, however, that this is just a transitional measure to "enable patients to find a durable alternative solution."

More Claims

However, legally speaking, Merck is not out of the woods. In addition to this collective action in Lyon, hundreds of individual civil actions have been launched, with patients claiming a link between the deterioration of their state of health and the new formula.

Moreover, a criminal investigation is ongoing, opened in March 2018. This alleges "aggravated deception, involuntary injuries and endangering the lives of others."

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