EU court rules Boston Scientific must pay pacemaker replacement surgery

[March 05, 2015]  BRUSSELS (Reuters) - U.S. medical device maker Boston Scientific Corp's German arm is liable for the cost of operations to replace potentially defective pacemakers, Europe's top court ruled on Thursday.

The European Court of Justice ruled that, where a medical device has a potential defect, it is possible to classify as defective all products of the same model.

The German company, an importer of Boston Scientific pacemakers and now a subsidiary of the U.S. company, informed physicians in 2005 that a hermetic sealing component might experience gradual degradation, leading to premature battery depletion.

It therefore recommended that doctors consider replacing the devices and agreed to provide replacement devices at no charge to patients.

However, when presented with bills from German health insurers to cover the cost of surgery, Boston Scientific's German subsidiary contested payment.

The European Court was asked by Germany's Federal Court (Bundesgerichtshof) to rule whether a product should be classified as defective based solely on quality controls showing the risk of a problem without having to determine whether a replaced item itself was in fact flawed.

It was also asked to consider whether the manufacturer should bear the costs of operations to replace its products. The court ruled on Thursday the producer should.

(Reporting By Philip Blenkinsop; Editing by Alastair Macdonald)

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