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Schering Directors Face Charges

August 6, 1998

SAO PAULO, Brazil (AP) _ A state prosecutor filed criminal charges Wednesday against two directors of the local subsidiary of German pharmaceutical giant Schering AG, whose placebo birth control pills are blamed for several unwanted pregnancies.

Some 20 women have reported unwanted pregnancies after taking Microvlar contraceptives that were intended solely to test out new packaging equipment. The tablets, made of lactose and sugar, were supposed to have been incinerated after the tests, but were stolen and sold illegally.

Prosecutor Pedro Manoel Ramos said he filed charges against the company’s chief executive officer, Rainer Bitzer, and its industrial director, Valter Schenk, for violations of consumer law.

``They are responsible for the company’s failure to identify the placebos as such, for failing to promptly notify authorities that the tablets had been stolen, and for the distribution of a product unfit for human consumption,″ Ramos said by phone.

``This constitutes gross negligence,″ he added.

If a judge accepts the charges, Bitzer and Schenk will be tried and could face prison terms of more than seven years.

Neither Bitzer nor Schenk were available for comment, but a company spokesman said the firm would appeal.

The company has already appealed a $2.5 million government fine for taking more than a month to notify health authorities that the test contraceptives had been stolen.

In a recent interview with the Folha de Sao Paulo newspaper, Bitzer 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.″

Some 650,000 packages, containing 21 placebos each, were manufactured. It is unclear how many packages were stolen and distributed, or how the plan was carried out. Several people have been questioned in connection with the theft, but no one has been arrested.

The government has barred Schering, which also manufactures drugs for prostate cancer and leukemia, from selling Microvlar until it comes up with new packaging and recalls all its contraceptives on the market _ real and placebo.

Schering is not related to Madison, N.J.-based Schering-Plough Corp., which has launched an advertising campaign to notify consumers of that fact.

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