Boston Scientific tests 'cowboyish'

The manager of a secret plant run by medical devices group Boston Scientific was deeply concerned that the corporation's rush to copy a suppliers' manufacturing machine would result in defective heart products, according to an internal email obtained by The Irish Times.

Mr Eric B Stenzel, who ran a clandestine plant at Sandyford Industrial Estate in Dublin and later moved operations to Ballybrit, Galway, wrote in a 1999 email that he feared Boston Scientific was pushing too quickly for US government approval of coronary stents it had secretly copied, and was not focusing on safety.

Mr Stenzel wrote to a Boston Scientific employee in Galway that the lack of quality tests was "cowboyish" and that close inspection of the contour of the stents would "open a can of worms". Referring to a conference call the day before, he noted: "There were some disturbing comments that were made that I am not comfortable with." He explained that his Boston Scientific supervisor wanted to submit the stents for US government approval without adequate testing of their compatibility with balloons used to expand the stents into place in a patient's arteries.

"This sounds rather 'cowboyish' to me. We will be asking the Food & Drug Administration \ to approve a line-making product that has not been proven to work," he wrote. He concluded: "In short, it seems like the speed requested to get the line submitted to the FDA takes precedence over doing a thorough job."

Boston Scientific is now being sued in New York for more than $1 billion by Israeli stent manufacturer Medinol, after secretly copying Medinol's coronary stent manufacturing machine, using a Dublin shell company to hide its activities.

Boston Scientific spokesman Mr Paul Donovan said the case was a business dispute between two companies. "Medinol was an unreliable and erratic supplier. Their actions forced us to develop this alternative production line which was allowed by the contract and was specifically called for in the contract," he said.

"We never sold a single stent from this alternative line because we shut it down before it went into production."

It is countersuing Medinol in New York for breach of contract.

In his email, Mr Stenzel said the stents had also not had adequate durability testing. He made his comments after Boston Scientific finished copying the Medinol machine and moved the replicate to a secret warehouse in Ballybrit.

Mr Stenzel added that a close inspection of the stent-making machine's ability to create accurately shaped heart stents would open a can of worms.

In another email, dated April 12th, 1999, Mr Stenzel wrote to two Irish employees to tell them that Boston Scientific was adding BBD, the trade name of its Dublin front company, to its lists of external medical products suppliers, even though Boston Scientific had complete control over BBD.

Mr Stenzel said he wanted to make it look as if BBD was a legitimate external supplier by drawing up a quality manual.

Yesterday, The Irish Times revealed a memo sent to the board of directors by Boston Scientific chief executive Mr Jim Tobin, in which he said that the secret manufacturing plant was only uncovered after the US Department of Justice "tripped over" documents while investigating the corporation's principal manufacturing plant in Galway.

Mr Donovan said last night: "In the end, it is important to remember we did the right thing here throughout, the right thing for the company and for our employees in Ireland.

"Today, we are the largest stent manufacturer in the world and we employ about 4,000 in Ireland making those stents."