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Brazil Fines Drug Firm in Pill Case

July 1, 1998

SAO PAULO, Brazil (AP) _ Brazil fined Schering AG $2.5 million after 10 women became pregnant while taking phony birth control pills.

The fine followed reports by women from the state of Sao Paulo that they became pregnant after taking the fake Microvlar contraceptives manufactured by Schering, officials at Brazil’s Justice Ministry said Wednesday.

A spokesman for the German drug maker said the bogus pills were intended solely to test out new packaging equipment. The placebo tablets, made of lactose and sugar, were supposed to have been incinerated after the tests, but were stolen and sold illegally.

Police chief Sergio Abdalla said he was certain the phony contraceptives were stolen as they were transported to the incinerator.

Schering officials took nearly a month to notify authorities after an anonymous letter sent together with a package of the fake pills notified the company in May of the problem. Rainer Bitzer, president of Schering’s Brazilian subsidiary, said the company first conducted its own investigation and found no placebos on the market.

``Only after the first pregnant woman called to complain did we realize the problem was bigger than we had imagined,″ Bitzer said. ``We made a mistake in not notifying authorities immediately.″

Asked what Schering would do about the pregnant women, Bitzer said, ``we will contact each one of them and study the situation case-by-case. We will assume our responsibility.″

Schering is not related to Madison, N.J.-based Schering-Plough Corp. However, the incident has caused problems for the United States drug maker, which has spent more than $1 million in a Brazilian advertising campaign to notify consumers that the two companies are not related, according to a Brazilian newspaper Folha de Sao Paulo.

Bitzer told the newspaper that 650,000 packages, containing 21 pills each, were used to test the new packaging equipment.

It is still unclear exactly how many packages were stolen and distributed.

One of the women, a mother of three who has a heart disorder, said her doctor had warned her that another pregnancy could endanger her life.

``My life is hanging by a thread,″ Roseni dos Santos Nunes, one of the women who took the placebo and got pregnant told the Folha de Sao Paulo.

Her doctor prescribed Microvlar in February, she said, ``and now I don’t know what I’m going to do.″

The packages of fake pills were easily identifiable because they had no production or expiration date stamped on them, Bitzer said, but government officials contended that was not enough to protect the consumer.

``There was no reason for the consumer to reject a product with no clear warning stamped on its packaging,″ Nelson Faria Lins D’Albuquerque Junior, head of the Justice Ministry’s Consumer Protection Department, said in a statement.

Schering must pay the fine within 30 days and will be investigated for possible violations of consumer protection law, including misleading advertising and endangering the lives of consumers.

Depending on the outcome of the investigation, expected to be completed within a month, Schering could have its license to produce Microvlar suspended and may even be shut down.

Schering was not immediately available to comment on the fine or the investigation.

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