Mediator (benfluorex) case
A serial health disaster caused by a diabetes drug used as an appetite suppressant, withdrawn in 2009, which led to an ONIAM compensation scheme in 2011 and a criminal conviction of the manufacturer upheld on appeal in 2023.
The Mediator case is the serial health disaster caused in France by benfluorex, an amphetamine derivative sold from 1976 to 2009. Prescribed for diabetics, it was widely used as an appetite suppressant. It caused heart valve disease and pulmonary arterial hypertension. Irène Frachon, a pulmonologist in Brest, documented the link; the drug was suspended in November 2009. Death estimates range from 500 to more than 2,000, depending on the study. The amended budget law of July 29, 2011, set up a dedicated scheme, opened at ONIAM on September 1, 2011. A panel of experts rules on causation, then the liable party makes an offer; if it refuses or offers too little, the office pays and recovers from it. By March 2016, 9,019 claims had been filed and 2,142 of the 6,473 opinions issued were favorable. The criminal case followed. The Paris criminal court convicted Servier on March 29, 2021, of aggravated deception and involuntary manslaughter and injury, with a 2.7 million euro fine. The Paris Court of Appeal, on December 20, 2023, added fraud and raised the fine to about 9 million euros. It also ordered repayment of some 415 million euros to the national health insurance fund and to supplementary insurers; an appeal to the Cour de cassation was lodged. For a pharmaceutical product liability underwriter, the file shows the weight of third-party payer recoveries. It also shows the length of the tail, and the effect of a public fund that makes filing free for the victim.
On December 20, 2023, the Paris Court of Appeal upheld the manufacturer's conviction for aggravated deception and involuntary manslaughter, and added fraud against the social security bodies. The amount owed to the health funds and supplementary insurers, around 415 million euros, far exceeds the fines. For a manufacturer's insurer, this third-party payer recovery item is often excluded or sublimited, and it is what sets the size of the loss.
Mediator scandal, benfluorex, Mediator case France, benfluorex compensation scheme
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