Boston Scientific suspends sales of seven defibrillators

US medical devices maker Boston Scientific Corporation on Monday announced that it halted sales of its implantable defibrillators after failing to inform federal regulators to changes made in manufacturing of its best-selling devices.

Boston Scientific said in a statement that it has stopped shipment and is recalling unused units of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).

Boston Scientific played down the problem, which took the industry by surprise, by saying that it failed to submit some manufacturing process changes for Food and Drug Administration (FDA) approval.

Although the Natick, Massachusetts-based company said that it has identified two instances of changes that, while successfully validated, were not submitted to the FDA, it refused to describe the process changes that made it halt sales of its best-selling devices on the ground that they are proprietary.

The halt in sales involve seven brands of defibrillators, implantable devices that regulate heart beats and also send electrical pulses to the hearts of patients when it senses cardiac arrest.

These devices generated approximately 15 per cent of Boston Scientific's 2009 sales of $8.2 billion.

Medical device makers are required by law to inform regulators if any significant changes are made to life-sustaining devices like defibrillators, however the Boston Scientific claims that that it has no indication that the manufacturing process changes pose any risk to patient safety.
But analysts are stunned at the company's negligence since it would be very well aware of the rules or was it that the company looking at profits, deliberately chose not to wait for the necessary approvals.
 
''A planned process review revealed that two manufacturing process changes were not submitted for FDA approval," said Ray Elliott, president and CEO of Boston Scientific.
"We are acting voluntarily and expeditiously to resolve this situation, and we have seen no evidence of any risk to patient safety. We apologise for the inconvenience these actions will cause patients and physicians," he added.

Boston Scientific got into the defibrillator business through the 2006 acquisition of Guidant Corporation for $27-billion, (See: Boston Scientific beats J&J to acquire Guidant for $27 billion)  but it also ended up paying more than a billion dollars in settling lawsuits filed against Guidant. (See: Boston Scientific to pay J&J $1.73 billion in patent settlemen  and  Boston Scientific pays $22 million to settle DOJ probe on kickbacks)

Analysts estimate that the company stands to lose around $5 million per day by suspending sales of its defibrillators.

Boston Scientific holds a 15-per cent market share of the defibrillator market in the US, while Minneapolis-based Medtronic, the world's largest device maker holds 45 per cent and Minnesota-based St. Jude Medical holds 23 per cent.