Guidant letter about risks never sentJun 7, 2006 | AP
Newly unsealed court documents show Guidant Corp. drafted a letter warning doctors of a dangerous electrical malfunction in some of its devices designed to restore a normal heartbeat, but the letter was never sent.
Instead, the company issued a more routine and less-targeted "product update" after learning of a short-circuiting problem that had occurred in some units of two defibrillator models a flaw that could prevent a device from delivering a potentially lifesaving shock to the heart.
The documents, unsealed over Guidant's objection in a product liability lawsuit in Texas, also show Guidant officials who devised the company's communications strategy worried about creating "undue alarm" about the electrical problem, fearing it could lead to surgeries to remove the potentially faulty devices procedures that might carry more risk than leaving the devices in.
The timeliness and content of Guidant's safety notifications and its decisions to continue selling potentially faulty products are the focus of government investigations and more than 100 class-action and individual lawsuits.
A memorandum of a June 2005 meeting about a product recall shows Guidant executives told regulators that they believed there was a low risk of further problems from the flaw, despite two patient deaths at that point.
The company ultimately ended up recalling 88,000 defibrillators starting that month, including the two models at issue in the warning that was never sent to doctors. Guidant also has recalled or issued safety warnings for more than 200,000 pacemakers. At least seven deaths have been linked to the devices.
Guidant is now owned by Natick-based Boston Scientific Corp. as a result of a $27 billion acquisition completed in April.
Boston Scientific spokesman Paul Donovan said officials at Guidant "understand and acknowledge the need for more timely and transparent communication."
"We are committed to doing a better job of communicating with patients and physicians," he said. "We continue to implement new standards for product performance communication and to enhance our quality and design systems."
Donovan confirmed the warning letter was never sent to doctors.
The letter was first reported Wednesday by The New York Times, which intervened in the product liability lawsuit in attempt to seek access to records. A judge ordered the release of the documents on Monday .
The letter, also obtained by The Associated Press, is among documents referenced in an e-mail that a St. Paul, Minn.-based Guidant official sent to a colleague discussing "a list of types of communication as we first contemplated what became the product update on shorted leads" a reference to defibrillators' electrical leads.
Under the heading "Proposed Letter," the draft is dated "January XX, 2005" and begins, "Dear Doctor XXX: Guidant's product monitoring system has identified a rare performance issue with certain cardiac resynchronization therapy defibrillators (CRT-Ds). We believe that proactive communication of all relevant information will enable better management of patients that use this therapy. Please review this information carefully."
The letter referred to potential problems in the two Contak Renewal defibrillator models, but said other models were not susceptible because they had a different design. The letter recommends procedures during routine checks of patients with implanted devices.
The "product update" that was sent to doctors instead of the letter advised them to be alert for electrical problems but didn't single out the Renewal model.
One communication strategy document under the heading "desired results" warns, "Do not create undue alarm (explants)" a reference to surgeries to remove implanted devices because of potential problems.
Another document sheds light on how Guidant portrayed the problems to the Food and Drug Administration. A memo from a June 30, 2005, meeting that the company requested to discuss the FDA's handling of a recall of three defibrillator models says "Guidant stated there is no evidence of a trend. There have only been two deaths involving two different implantable defibrillators and they feel that there is not a reasonable probability of serious adverse health consequences or death."
The documents released Tuesday were among 600,000 pages of Guidant records submitted in the first product liability case stemming from the recalls, which is set to go to trial Sept. 18 in Neuces County District Court in Corpus Christi, Texas.
Judge Jack Hunter on Monday ruled that Guidant had improperly designated as confidential the documents in one trial exhibit, saying he didn't believe the company's claims that the documents included trade secrets.
An appeals court on Tuesday denied Guidant's challenge of Hunter's ruling. The judge also gave Guidant until the close of business Wednesday to decide which of the additional 600,000 pages of documents beyond those released Tuesday may have been improperly designated as confidential.