While certain drugs can cause a number of deaths, most pharmaceuticals do not cause mass casualty events. However, in France, one weight-loss pill has been connected to thousands of deaths. In addition, thousands of others have suffered injuries that will be life long. The company that sold the drug and is accused of covering up the harmful effects is being put on trial in France for manslaughter. Not only does the company face possible severe repercussions, but the national regulator in France is under fire for allowing this drug to enter the market. In fact, the French National Agency for Medicines and Health Products Safety is also on trial in an extraordinary step.
The company at issue in the trial is the large French laboratory Sevier. It is one of the largest pharmaceutical companies in the country. It sold the weight loss pill under the name Mediator. From 1976 to 2009, millions of people took this drug in an attempt to help jumpstart their weight loss efforts. However, at the same time, there were some suspected risks to the pill. There was speculation that Mediator caused heart attacks and pulmonary failure.
The heart trouble resulted from the fact that the drug caused high blood pressure. As a result, patients suffered from heart failure or a heart attack. Countless patients ended up hospitalized for heart disease. Thousands of patients have required heart surgery and have sustained permanent heart damage from this medication.
There is some dispute as to the number of deaths caused by Mediator. The Health Ministry claims that approximately 500 people died as a result of heart valve defects that were caused by the pill. However, other estimates range as high as 2,000. The amount of permanently injured greatly exceeds the number of dead. So far, the company has paid over $140 million in claims, which seems small compared to the grave consequences that have been suffered. Some patients who were harmed claimed that they accepted the paltry amounts offered as settlements because they were desperate for the money.
Mediator was originally sold as a drug to treat type-2 diabetes. After some time, it was found that the drug had benefits to suppress appetite. As a result, it began to be prescribed as a weight-loss drug. While the medication was approved in France, it was never approved for use in the U.S. and U.K.
The company is alleged to have not only known of the risks of the drug but to have taken steps to cover up some of the dangerous side effects. One of the accusations at trial is that the state regulator assisted the drugmaker in misleading patients about the severity of the side effects. The indictment charged that the company took steps to hide medical studies that began to detail the dangerous nature of Mediator. The company denies that it hid the studies and claimed that it knew nothing about the catastrophic side effects.
One of the major instances of fraud of which the company stands accused is classifying it as a diabetes drug in order to get it approved for use. Once the drug was approved, the company set out to persuade doctors to prescribe it for the off-label usage of a weight-loss drug.
In the meantime, the drug was allowed to remain on the market for decades, even as the evidence of fatalities and severe injuries began to mount. In the meantime, Sevier made over $1 billion from sales of the pill. It was not until 2007 that one researcher began to document the connection between Mediator and severe cardiac and pulmonary damage. This became a crusade for one lung specialist who uncovered the link and set out to fight a big drug company and the state regulator. At the time that the link was uncovered, there were over 300,000 active prescriptions in France. By 2011, Mediator was ordered off of the market, but not before thousands of lives were lost.
It was at that time that the risks began to become publicly known. This sparked a scandal that over a decade later shows no signs of going away. One of the remarkable questions to be answered is why the drug was never banned in France when it was prohibited in several other European countries where it was previously approved. In a country in which trust in the regulatory system is needed, French people are questioning whether they can have trust in their government to properly regulate the drug market. The FDA has a reputation as a much more stringent regulator that takes active steps to enforce its rules. However, the French regulator has long had a reputation for being lax when it comes to regulation. In reality, the regulator cooperated with the drug company that it was supposed to be regulating, reaching regulatory decisions in concert with the drugmakers.
The trial will last for months as there are 21 separate defendants who are in the dock. There are over 2,600 plaintiffs who are a part of the trial. Charges against the defendants include fraud and manslaughter, and the defendants can face prison time as a result.
Learn more about Drug Lawsuits.