Primodos / Duogynon

Press Release, June 7, 2010
Coalition against Bayer Dangers (Germany)

Primodos: Bayer Schering hit by lawsuit over pregnancy test

victims demand apology and compensation scheme

Bayer Schering, a unit of the chemicals group Bayer, has been hit by a lawsuit over a pregnancy test that allegedly caused birth defects, German news magazine Der Spiegel reports today. Around one thousand children with various birth defects were born to women who used Duogynon in Germany alone, according to Der Spiegel. The case is being seen as a pilot, with many more to follow if it succeeds.

Primodos was prescribed as a hormone pregnancy test in the sixties and seventies. In England the drug was sold under the trademark Primodos. The producer, German company Schering, was taken over by Bayer in 2006.

Already in 1967 the then Committee on Safety of Drugs was warned by a doctor - Dr. Isabel Gal - that foetal abnormalities were associated with the use of hormonal pregnancy testing. In the same year a new and easy method of confirming pregnancy had become available, measuring the level of hormones already present in the body by a simple urine test.

Two medical advisors from Schering Chemical Ltd in Britain were disturbed by Dr. Gal’s findings and examined the details of Primodos sales throughout the country. The Sunday Times later obtained a copy of a letter to Schering´s head office in which the advisors expressed their concern: “We must reach a decision regarding our own product Primodos and its possible relationship to foetal abnormalities. As manufacturers it is our moral duty to do all possible to ensure the safety of the preparations which we market.” The letter went on, “ethically speaking we are not satisfied that sufficient has been done to remove suspicion that has been cast upon Primodos to a sufficient degree, for us to be confident in supporting its continued availability to pregnant women in this country.”

An investigation against Duogynon producer Schering was shelved in 1980, and civil cases brought against the company failed. Now though, the affected children are adults and are demanding an explanation. Der Spiegel also says their legal position improved a few years ago.

By invitation of the Coalition against Bayer Dangers, which has been monitoring Bayer for thirty years, Karl Murphy from Liverpool and John Walmisley Santiago from London spoke at Bayer´s shareholder meeting in Cologne/Germany on April 30. They demanded that the company apologizes to Primodos victims and offers a compensation scheme. Bayer´s board, supervisory board and about 4000 shareholders attended.

The Local, 21 Nov 10

Letters suggest Schering knew of birth defect problems with drug

Der Spiegel reported on Sunday that letters written by scientists in the UK and Germany indicate that concern was being raised about the pregnancy test drug Duogynon (named Primodos in the UK) in 1967 – yet it was still being prescribed until at least 1975.

André Sommer from Pfronten, Bavaria, is suing Bayer for the defects he suffered after his mother took the drug while pregnant with him in 1975. He was born with severe problems with his bladder and sexual organs.

His case will be heard by the Berlin District Court next week, and will include the documents which have recently come to light in which doctors wrote to each other about problems they had observed.

“The seeming relation between the increase in birth defects and the sale of the pregnancy test is pretty alarming,” one scientist wrote on November 1967.

“We have to be extremely careful,” when using the drug with pregnant women, another wrote.

Sommer, a teacher, says he is determined to force Bayer to open its files on the matter.

“Why were these gentlemen talking with each other about this internally, but were silent in public?” he asked.

A Bayer lawyer wrote to the court saying that all claims for information and compensation had run out of time – and that there was never any proof of a link between the use of Duogynon and birth defects. The Local/hc

More information:
· Primodos Campaign:
· Article in Der Spiegel: