Is this the next David & Goliath battle against a pharmaceutical giant? A German man born with severe birth defects blames it on Duogynon, a drug that can still be bought in pharmacies. Thousands of other potential victims will be watching the Ber
BERLIN - The product can still be bought in pharmacies. The names may be different and the amounts reduced, but the substances are the same. Duogynon is on trial in Berlin – and if what plaintiffs say is true, it paints an awful picture of a drug responsible for people being born without bladders and genitalia, and with deformed extremities.
This could end up becoming another Contergan – thalidomide – a drug that was developed by the German pharmaceutical company Grünenthal and sold as a sleeping pill from the late 1950s through the early 1960s.
Like Contergan, Duogynon has been on the market for decades. It was also prescribed to pregnant women. And the Berlin courtroom looks awfully similar to the one in Contergan cases in the 1960s: with crippled people deformed at birth lined up against a huge pharmaceutical firm. David vs. Goliath.
But the Duogynon case is playing out differently. Class-action lawsuits don't exist in Germany, so the story has become highly personal. It's the fight of a primary school teacher, Andre Sommer, 35, against pharmaceutical giant Bayer, the mother company of Schering, which sold Duogynon in Germany and other countries in the 1960s. Sommer's mother took the hormone drug, prescribed by her gynecologist, in 1975 when she was pregnant.
When her son Andre was born, doctors in the small Bavarian hospital were "dumbfounded by what they saw," says Sommer. The infant's bladder was outside of his body, and instead of a penis "there was nothing."
During the first four years of his life, Sommer underwent nine surgeries. Today, he may have an artificial urinary track – the result of a 13th operation undergone seven years ago - but he still has to wear a urine bag.
When Sommer's mother took Duogynon, it was new on the market and considered highly innovative -- a new-fangled pregnancy test when testing kits and blood tests were still unheard of.
A lifetime of blame
After taking the pills, Sommer's mother experienced discharges and stomach aches. Eight months later Andre was born, deformed. "My mother immediately made the connection to the drug, and to this day she blames herself for my handicaps," Sommer says.
Three years ago, his parents showed him a file of newspaper clippings they'd collected for the past 20 years. There were hundreds of pages devoted to just one subject: Duogynon. Hundreds of stories of people – mainly in Great Britain – whose mothers had taken the Schering-produced drug and who had birth defects.
Sommer first sued Bayer two years ago. It was unsuccessful. He had mainly gone to court to find out more about the case, to establish his right to information; he was seeking the right to consult internal company documents. The court ruled that the matter exceeded the statute of limitations, which made sense procedurally but did not address what Sommer was legally trying to achieve.
Since that first court case in 2010, his case has become famous and Sommer has received about 5,200 e-mails. Most of them are from mothers of children with birth defects, or women who miscarried after they took Duogynon – and women who used the drug to abort. "I answer every single e-mail," Sommer says. "I am trying to find out what happened to my parents – I have to find closure for something that has haunted my mother for decades."
Sommer's court case is a pilot case, a model case. If he's successful, unknown numbers of people in Great Britain and Germany will file their own lawsuits. "What we are looking for is the right to consult the files, and compensation," says Sommer. "But it's not about money. I just want to know what happened back then, how and why that could happen to me. What did the people working at Schering in the 1970's really know about the side effects of Duogynon? What were the problems exactly and why, despite these issues, didn't Schering take the product off the market?"
Some documents have come to light. They show that employees of the company's branch in Great Britain had warned their German colleagues and even recommended that the product be taken off the market. A former employee said he was willing to testify in the Sommer case about the doubts circulating in the company at the time.
By the mid-1970s some experts saw a connection between Duogynon and infants with birth defects but other couldn't find a link. Finally, a study published by the medical journal The Lancet came to the conclusion that statistically, the number of babies deformed because of Duogynon and those born with deformities naturally was the same. According to the study, the heart problems, the missing extremities, and the deformities had nothing to do with Duogynon.
"Studies like that, that look to establish a relation between birth defects and a drug, don't really mean all that much," says Christian Fiala, a Vienna-based doctor and expert in gynecology and neo-natal medicine. "Women who give birth to babies with birth defects will try to find reasons for the defects – often by identifying a guilty party. Many of them focus their attention on drugs and their alleged side effects."
In the 1960's when Duogynon first came on the market, abortion was illegal. Women would look for any way to terminate a pregnancy. "Many women took untold quantities of different pills and other drugs," Fiala says. Statistically, the result was a noticeable increase in aborted fetuses, miscarriages, still-born-babies and birth defects. And determining the medical causes in those cases is no longer possible.
"The hormones in Duogynon are the same as those still used to this day in various types of birth control pills," says Fiala. "I find it difficult to imagine short-term exposure to these substances could have caused so many defects."
While thalidomide victims often present the same visible deformities with stunted extremities, the alleged Duogynon malformations take different forms. Many experts find it difficult to find a connection between a single hormonal substance and handicaps like congenital heart disease, water in the brain, malformed extremities, lack of genitalia, or being born with an open stomach or back.
Andre Sommer's case will most likely not prove that the Schering drug is without the shadow of a doubt the cause of the defects. He himself isn't expecting it to. What he wants is to know the truth about why he was born the way he was. "We want Bayer to make the relevant documents available; we want Bayer to talk to us," he says adding: "If they do, I'm willing to waive my compensation."
He is asking for 55,000 euros. He has already invested several tens of thousands of euros in the case. "I have a small child, a wonderful family," he says, "and I don't intend to spend the next 30 years of my life suing Bayer. But I also know one thing: I want to see the files that decided my fate."
Read the original article in German.
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