EU Court Orders Boston Scientific To Pay For Pacemaker Replacement Surgeries
By Jof Enriquez,
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The European Court of Justice recently ruled that Boston Scientific must pay the costs of surgeries to replace defective pacemakers in Germany.
The EU court said in its ruling that Boston Scientific is liable for the full cost of surgeries for replacing all implanted faulty devices in the same class, even though only a few units in the same product line were potentially defective. The actual devices in the case were replaced and discarded without being analyzed. But the court said that it does not matter, because the potential defect was already proven.
"Accordingly, where it is found that such products belonging to the same group or forming part of the same production series have a potential defect, it is possible to classify as defective all the products in that group or series, without there being any need to show that the product in question is defective," the court said in its ruling.
The court also said in the decision that surgeries to replace defective products such as pacemaker and defibrillators "constitutes ‘damage caused by death or personal injuries’ for which the producer is liable, if such an operation is necessary to overcome the defect in the product in question."
Moreover, the court said that, considering the vulnerability of patients with serious diseases using medical devices such as pacemakers and defibrillators, the safety requirements for these devices are thus expected to be held particularly high.
Boston Scientific's German subsidiary had informed doctors in 2005 that quality checks revealed that a hermetic sealing component in a class of pacemakers might experience gradual degradation, leading to premature battery depletion, according to Reuters. The subsidiary then advised doctors to replace affected implanted pacemakers and agreed to pay for device replacements at no extra charge to patients.
However, Boston Scientific later refused to reimburse German insurers for the costs associated with replacement surgeries, according to Reuters. The insurance companies brought the matter to Germany's Federal Court (Bundesgerichtshof), which later asked for a ruling from EU's top court, the European Court of Justice.
Boston Scientific recently issued a statement announcing its intention to appeal the EU court's decision.
“Boston Scientific dedicates significant resources to deliver safe, high-quality products for patients,” said Kelly Leadem, a spokesperson for Boston Scientific, according to the Boston Globe. “We plan to appeal the ruling and are not providing further comment at this time.”
According to the Globe, the defective devices in the case were manufactured by Guidant before the company was acquired by Boston Scientific in 2006. Since then, Boston Scientific had to deal with product recalls involving Guidant products, as well as a recently settled case against Johnson & Johnson over the acquisition of Guidant.