Distilbène®: 20 Years of Legal Battle

Distilbène® is the trade name for a synthetic hormone (also known internationally as DES or diethylstilbestrol) prescribed in France between 1950 and 1977 to pregnant women to prevent miscarriages. In 1977, 6 years after the U.S. Food and Drug Administration (FDA) advised physicians to discontinue prescribing diethylstilbestrol to pregnant women because of its link to a rare vaginal cancer, UCB Pharma (the manufacturer of Distilbène® in France) decided to make public that the use of this drug was contra-indicated in pregnant women.  It is estimated that 200,000 French mothers have been prescribed DES and have given birth to 160,000 DES exposed daughters and sons. The number of children whose grandmother were given DES during pregnancy (DES 3rd generation) is yet to be assessed.

DES lawsuit lawyer imageEven though many French women have suffered from the devastating side effects of Distilbène®, very few have understandably taken their case to court. DES trials are long, complicated, expensive and painful for the DES victims and their families. Battling in court against giant and powerful pharmaceutical companies is not an easy thing to do when you also have to deal with health issues such as cancer and infertility linked to your DES exposure.  According to Mrs. Martine Verdier, French lawyer who specializes in DES court cases, only 150 to 170 lawsuits have been initiated by Distilbène®’s victims over the past fifteen years. Until 2009, many DES daughters who had filed lawsuits against UCB Pharma and Novartis who respectively distributed Distilbène® and Stilbestrol-Borne® in France were unsuccessful because they were unable to produce the documents proving that their mum had been prescribed the toxic and carcinogenic drug diethylstilboestrol.

A few landmarks in the French DES legal battle history

1991:

  • First lawsuits against UCB Pharma from French women with genital cancers whose mothers had been prescribed Distilbène® during pregnancy (14 years after Distilbène® stopped being prescribed in France and 20 years after DES stopped being prescribed in the USA).

2002:

  • May 24th – Victory for two DES daughters. After eleven years of court battle, the Tribunal of Nanterre recognizes UCB Pharma’s responsibility in the cancer developed by two DES victims. They are granted 15,244 euros in damages. UCB Pharma makes an appeal against the court decision.

2004:

  • April 30th: The Court of Appeal of Versailles confirms the responsibility of UCB Pharma in the 2002 above cases.
  • The number of lawsuits increases. However the court decisions remain inconsistent because of the difficulties for victims to prove the link between their cancer and Distilbène®.
  • December 17th: The Tribunal of Nanterre condemns UCB Pharma to pay 310,000 Euros in damages to the family of a deceased DES victim before the end of the procedure.
  • December 21st: A women who has developed cancer is unsuccessful in Marseille. The court says she can not prove that her mother was prescribed Distilbène® so no link can be established. Yet her body affected by this rare vaginal cancer called adenocarcinoma, so typical of DES exposure, is the ultimate proof. She appeals.

2006:

  • March 08th – The Court of Cassation confirms the responsibility of UCB Pharma in the Marseille court case.
  • March 19th – Three women won their cases against UCB Pharma and Novartis, who had requested the cancellation of the court decision during an appeal in a view to request an expertise, arguing that the victims should have provided the original DES prescriptions.
  • October 13th – The Court of Nanterre condemns UCB Pharma to pay 344,000 euros to the family of a young woman who died of cancer before the end of her trial.

2009:

  • September 24th – Turning point – The Supreme Court reverses the burden of proof, forcing UCB Pharma and Novartis to prove that their product is not responsible for the health issues of the DES victims who are taking their case to court. It is a massive step forward in the history of French DES legal battles since it allows women not to be dismissed when they can’t show proof that diethylstilbestrol have been prescribed to their mum. The Court however, gives victims who can’t show the original drug prescription the opportunity to pursue either Novartis or UCB Pharma and claim for compensation. The pursued laboratory now has to prove that the victims did not take their drug, but the competitor’s. UCB Pharma distributed Distilbène® which was by far the main drug used in France whilst Novartis distributed Stilbestrol-Borne®. So it is expected that the battle between UCB Pharma and Novartis is going to be fierce. Novartis won’t want to share responsibilities and compensations costs when their drug’s sales represented only 2% of the market share compared to 98% for UCB Pharma.
  • The same year, the Court also condemns UCB Pharma to pay “compensation provisions” of 70,000 Euros to a young disabled girl of 12 and 60,000 Euros to her parents.

2011:

  • June 09th – First victory for DES third generation – The Versailles Court of Appeal confirms the decision of the Court of Nanterre made in April 2009 and recognizes a link between taking Distilbène® and disability in the third generation, giving the grandson of a woman who was prescribed Distilbène® 1.7 million Euros in damages.

I wish the decision of the Court of Appeal of Versailles will encourage other victims to engage in this legal battle but it takes more than courage to file a lawsuit for such a complex and difficult journey against what seems to be a lost battle. I really admire the victims and their families who took their DES cases to court and thank them, as well as their lawyers, for allowing justice to make progress not only for them but for many other victims who may consider going to court in the future.

Distilbène®: 20 Years of Legal Battle is just a quick overview of the main dates in the history of DES French lawsuits. These lawsuits won’t bring back the DES daughters who died from cancer to the families affected by di-ethyl stilbestrol. They won’t repair the long term damages of this toxic drug but if nothing else they show that DES is not something invented by the media, or something that DES exposed individuals, like myself, should feel guilty about. We are victims and we deserve that justice is made.

I am missing important information and this blog post doesn’t highlight enough the pain and suffering the victims and their families had to go through to seek justice and get compensation. If you are considering filing a DES lawsuit make sure you seek expert advice and professional support from your local DES Action group.

Sources: Réseau DES France, Le Point.fr

More DES DiEthylStilbestrol Resources

Victory for a DES 3rd generation victim : the pharmaceutical company condemned

June 09th 2011 marks a turning point in France for DES victims with a court verdict in favor of a DES Grandson who was born prematurely. This great news has been welcomed by the DES community and Action Groups from all corners of the globe. Fran Howell, DES Action USA Director, commented: “Louis’ win is a huge victory and around the world people are celebrating with him and his family“. We are all so happy for Louis and his mother Hélène.

Below is a translation of a Réseau D.E.S. France press communication –  June, 10th 2011

Court case on DES 3rd generation Versailles court of appeal image
Court case on DES 3rd generation - Versailles court of appeal

After a first judgement against UCB Pharma, the Appeal Court of Justice confirmed the first verdict on June 09th 2011 : 1,7 million euros damages are to be paid to Louis’ family.

Hélène was born in 1958. Her mother was prescribed Distilbène® during her pregnancy, making her one of the 80,000 French “DES daughters“. In 1990, during the 6th month of her pregnancy, Hélène gave birth to Louis, severely premature and suffering from important sequels : his handicap is assessed as 80% ; he can neither read nor write, moves in a wheel-chair and needs constant help. He is yet another victim of the drug Distilbène®…  taken by his grandmother in the 50’s !

We share Hélène’s satisfaction and relief that the prejudice has at last been recognized by the Appeal Court to enable her family to live onwards. She can now sleep at night knowing that her son’s future is assured.

This decision is all the more important that it is the first time the the Appeal Court has judged a DES Distilbène® case concerning the 3rd generation.

This victory is consecutive to a well-prepared medical file which proves :

  • a prescription of Distilbène® to Hélène’s mother
  • that Hélène’s pregnancy was closely controlled because of her in utero DES exposure
  • Louis’ medical follow-up was in conformity to the 1990 protocols
  • that Louis’ condition has no other cause than his premature birth.

Finally, we are satisfied that the Versailles Court of Appeal confirmed the responsibility of UCB Pharma for their lack of diligence in commercializing Distilbène® on the market.

We again hope that this decision will bring a term to the difficult struggle for justice, started by Hélène in 2002.

In France, Distilbène® and Stilboestrol® (the commercial names for the diethylstilboestrol synthetic hormone – DES in abbreviation)  was prescribed to 200 000 pregnant women to avoid miscarriages. 160 000 children were born from these pregnancies. For the “DES daughters”, the side effects are : sterility, miscarriages, premature births, cancers…

Sources: Article courtesy of Réseau D.E.S. France

Can the Mediator scandal lead to justice for drug victims ?

The drug Mediator remained on the market from 1976 until 2009 when the risk of fatal heart disease was known since the 1990s. French health experts now believe that Mediator developed for treating overweight diabetics, could have killed between 500 and 2,000 people before it was finally banned.
It stayed on the market despite a succession of warnings over its side-effects, which include heart valve disease and pulmonary hypertension. It was also hugely misprescribed, with doctors routinely handing out Mediator as an appetite-suppressant for people with common or garden weight problems.
A compensation fund was established by the French state for victims. But Mediator is not the first drug scandal!

Below is a translated article from Anne Levadou, President of Réseau D.E.S. France published in the Independant Web Newsletter “Rue 89”, June 08th 2011.

In order to avoid any major reform, the government is trying to convince us that the present Mediator scandal is the first major medical disaster. But let’s not forget that this is far from the first one : Thalidomide, Distilbène® came before Mediator… with every specific crisis, our society tries in the best of cases to find some specific reply. At the worst, to forget it.

Health precedents

The incoherence in dealing with health disasters leads to injustice and discrimination. The massive media coverage of the Mediator affair is parallel to the silence surrounding other victims. The denial of justice is not acceptable, for example, for the victims of Distilbène®, while this DES example is taught as a “model” of the mistakes not to be made.

Distilbène®, massively given to pregnant women until the 80s (1977 in France), has the perverse impact of not only affecting the women taking it, but even more affecting their children, and even grandchildren.

Let’s not forget also the victims of Lyell and Stevens-Johnson syndromes, rare reactions to drugs, leading to major damage to the skin and mucous membranes. It is inadmissible that all these victims – because their pathology is due to some other drug – should be “forgotten” and receive no compensation.

For the victims : a struggle against obstacles

Having no other choice, all these victims have to support, at their own costs and in media silence, years of personal procedures, medical examinations and cross-examinations in order to hope at the end to receive some recognition of the pharmaceutical company’s responsibility and some compensation for their injuries. At the issue, some discover that, because the risk was mentioned on the leaflet, that they have no legal recourse and their case is rejected.

However, as for Mediator, the serious effects have been proved. The permanent damages on health are the results of drugs or treatment approved by the official sanitary and political administrations and financed by the collectivity. Drugs represent an undeniable progress in our society, and the pharmaceutical industry contributes to the national wealth, but the serious side effects are in balance with the benefits made.

A “mutual pooling” of risks would be logical

Why not to-day, use the Mediator case to move towards a general response on the principle of global responsibility linked to the risks of taking drugs? The government must use this scandal as a lever to progress towards some definitive social solution to what is proved a collective risk.

The profits for pharmaceutical companies from the commercialization of a drug is assured by the solvency of the National Health Service which is itself financed by health insured tax payers. In the same way as professional risks, the costs of compensation for the victims could be automatically paid by the industries creating the risk. The mutual pooling of a collective risk, by the pharmaceutical companies concerned, would offer a double advantage : guaranteeing rapid compensation for the victims, but also, encouraging these companies to develop prevention measures.

The dissuasive effects of “class actions”

The Mediator scandal should also lead towards the possibility for victims to take collective legal action. The absence of collective procedures (“class action”) results in unfair personal struggles. While the victims of medical scandals are hoping for collective replies, why was this subject completely absent from the recent Drug Survey Symposium? It is certainly interesting to talk for hours about the code of ethics for drug representatives, or about providing doctors with updated information : whereas there would be an immediate auto-regulation effect from the sword of Damocles effect of “class actions” on pharmaceutical companies.

There is now an open choice : either our society offers a definitive response concerning the responsibility of drugs, or we will once again discover in a few years, or even in a few months, yet another drug scandal. As victims and citizens, we are expecting a wide-scale reaction and a truly political solution. Without this, Mediator will simply remain just another scandal.

Sophie Le Pallec, President of Amalyste association
Anne Levadou, President of Réseau D.E.S. France
Jean-Pierre Sueur, Senator of Loiret, France