Wednesday, December 28, 2005
A couple of articles about Guidant ICDs
Three new deaths associated with Guidant devices
Dec 15 (Reuters) - Guidant Corp has filed reports with the US Food and Drug Administration about three new deaths associated with short circuits in its heart devices, the New York Times reported on Wednesday.
Citing FDA records, the newspaper said the deaths occurred after Guidant recalled the heart devices in June.
Guidant has faced intense scrutiny in recent months over its failure to inform doctors about potential defects in some of its implantable devices used to manage abnormal heartbeats.
It eventually recalled some of its most lucrative implantable heart devices because of concerns about their safety. Sales have since resumed.
Including the new reports, number of deaths associated with the flaws has reached seven, the Times said. It said doctors and families of heart patients may be more likely to have the units checked for problems after a death because of the increased scrutiny on Guidant.
According to the report, Guidant said it "regularly communicates information about product performance to various stakeholders including physicians and regulatory bodies," and has recently been releasing more detailed information about product malfunctions.
In October, Guidant said it had received a Justice Department subpoena concerning some of those recalled heart devices, which regulate abnormal heart rhythm and protect against heart failure. Two other makers of heart devices also got subpoenas.
Guidant, which is the target of competing takeover offers from Johnson & Johnson and Boston Scientific Corp., was not immediately available for comment.
Publish Date: December 15, 2005
Heart Device's Export Blocked - FDA Questions Rhythm Stabilizers From One
Guidant Plant
By Marc Kaufman
Washington Post Staff Writer
Wednesday, December 28, 2005; A02
The Food and Drug Administration has told Guidant Corp., a maker of medical
devices, that it will not approve new contracts to export heart-rhythm
stabilizers made in its Minnesota plant until the company can prove that its
products are being properly made.
In a warning letter from the agency, the troubled company was also informed
that it had to make significant improvements in its manufacturing practices
before any additional company devices could be approved for sale.
Guidant acknowledged in a statement on its Web site that it received the
formal FDA warning Dec. 23, and that it outlined quality-control issues at
its St. Paul plant. The warning letter covered a broad range of
still-uncorrected problems first identified by the FDA during a September
inspection.
But, Guidant said in its statement that it has "taken a broad, thorough and
systemic review of its quality system and has made substantial steps toward
addressing all" of the FDA's concerns. The company has fulfilled 90 percent
of its upgrade commitments, the statement said.
The intensive FDA inspection followed a series of recalls and warnings
issued for Guidant's heart defibrillators and pacemakers because of reported
malfunctions, some of them fatal. Federal and state officials are
investigating the company, which faces dozens of lawsuits over its recalls.
After the inspection, FDA officials said that the company did not properly
warn doctors about software problems that caused some pacemakers to
malfunction, that company quality control was ineffective at several levels,
and that record-keeping was poor.
FDA spokesman Jason Brodsky said that while Guidant remains out of
compliance with good manufacturing practices at the St. Paul plant, the
agency had no additional product warnings yesterday for patients and their
doctors.
"We're working with the company now to bring them into compliance," Brodsky
said. "There are significant manufacturing concerns, but we have no new
recommendations for use of the products."
Brodsky said that the FDA's refusal to issue new export certificates for the
plant or to approve new device applications is not a new regulatory action
but rather a consequence of the plant remaining out of good manufacturing
compliance.
In the warning letter to Guidant, Minneapolis District Director W. Charles
Becoat said that the company had submitted five letters since early
September outlining its plans to improve the St. Paul plant. Nonetheless, he
wrote, "You have failed to address all of the significant violations . . .
and will receive additional correspondence detailing the inadequacy of your
response."
The company's devices are implanted in cardiac patients and use electric
shocks to correct faltering heartbeats. While the problems of some implanted
defibrillators and pacemakers have tarnished the industry, agency and
industry officials say that failure rates remain low and the devices are
often lifesaving.
Guidant's manufacturing problems have emerged as two larger companies --
Johnson & Johnson Co. and Boston Scientific Corp. -- have negotiated to buy
the company. Johnson & Johnson reduced its offer by almost 20 percent after
the problems arose, and then Boston Scientific countered with an offer
similar to the initial one from Johnson & Johnson.
Guidant stock dropped by almost 3.5 percent yesterday on the New York Stock
Exchange. The decline was the biggest since the price fell almost 5 percent
last month after New York Attorney General Eliot L. Spitzer accused the
company of misleading doctors about a design flaw in its defibrillators.
© 2005 The Washington Post Company
(keywords: Guidant, ICD, defibrillator, pacemaker)
Three new deaths associated with Guidant devices
Dec 15 (Reuters) - Guidant Corp has filed reports with the US Food and Drug Administration about three new deaths associated with short circuits in its heart devices, the New York Times reported on Wednesday.
Citing FDA records, the newspaper said the deaths occurred after Guidant recalled the heart devices in June.
Guidant has faced intense scrutiny in recent months over its failure to inform doctors about potential defects in some of its implantable devices used to manage abnormal heartbeats.
It eventually recalled some of its most lucrative implantable heart devices because of concerns about their safety. Sales have since resumed.
Including the new reports, number of deaths associated with the flaws has reached seven, the Times said. It said doctors and families of heart patients may be more likely to have the units checked for problems after a death because of the increased scrutiny on Guidant.
According to the report, Guidant said it "regularly communicates information about product performance to various stakeholders including physicians and regulatory bodies," and has recently been releasing more detailed information about product malfunctions.
In October, Guidant said it had received a Justice Department subpoena concerning some of those recalled heart devices, which regulate abnormal heart rhythm and protect against heart failure. Two other makers of heart devices also got subpoenas.
Guidant, which is the target of competing takeover offers from Johnson & Johnson and Boston Scientific Corp., was not immediately available for comment.
Publish Date: December 15, 2005
Heart Device's Export Blocked - FDA Questions Rhythm Stabilizers From One
Guidant Plant
By Marc Kaufman
Washington Post Staff Writer
Wednesday, December 28, 2005; A02
The Food and Drug Administration has told Guidant Corp., a maker of medical
devices, that it will not approve new contracts to export heart-rhythm
stabilizers made in its Minnesota plant until the company can prove that its
products are being properly made.
In a warning letter from the agency, the troubled company was also informed
that it had to make significant improvements in its manufacturing practices
before any additional company devices could be approved for sale.
Guidant acknowledged in a statement on its Web site that it received the
formal FDA warning Dec. 23, and that it outlined quality-control issues at
its St. Paul plant. The warning letter covered a broad range of
still-uncorrected problems first identified by the FDA during a September
inspection.
But, Guidant said in its statement that it has "taken a broad, thorough and
systemic review of its quality system and has made substantial steps toward
addressing all" of the FDA's concerns. The company has fulfilled 90 percent
of its upgrade commitments, the statement said.
The intensive FDA inspection followed a series of recalls and warnings
issued for Guidant's heart defibrillators and pacemakers because of reported
malfunctions, some of them fatal. Federal and state officials are
investigating the company, which faces dozens of lawsuits over its recalls.
After the inspection, FDA officials said that the company did not properly
warn doctors about software problems that caused some pacemakers to
malfunction, that company quality control was ineffective at several levels,
and that record-keeping was poor.
FDA spokesman Jason Brodsky said that while Guidant remains out of
compliance with good manufacturing practices at the St. Paul plant, the
agency had no additional product warnings yesterday for patients and their
doctors.
"We're working with the company now to bring them into compliance," Brodsky
said. "There are significant manufacturing concerns, but we have no new
recommendations for use of the products."
Brodsky said that the FDA's refusal to issue new export certificates for the
plant or to approve new device applications is not a new regulatory action
but rather a consequence of the plant remaining out of good manufacturing
compliance.
In the warning letter to Guidant, Minneapolis District Director W. Charles
Becoat said that the company had submitted five letters since early
September outlining its plans to improve the St. Paul plant. Nonetheless, he
wrote, "You have failed to address all of the significant violations . . .
and will receive additional correspondence detailing the inadequacy of your
response."
The company's devices are implanted in cardiac patients and use electric
shocks to correct faltering heartbeats. While the problems of some implanted
defibrillators and pacemakers have tarnished the industry, agency and
industry officials say that failure rates remain low and the devices are
often lifesaving.
Guidant's manufacturing problems have emerged as two larger companies --
Johnson & Johnson Co. and Boston Scientific Corp. -- have negotiated to buy
the company. Johnson & Johnson reduced its offer by almost 20 percent after
the problems arose, and then Boston Scientific countered with an offer
similar to the initial one from Johnson & Johnson.
Guidant stock dropped by almost 3.5 percent yesterday on the New York Stock
Exchange. The decline was the biggest since the price fell almost 5 percent
last month after New York Attorney General Eliot L. Spitzer accused the
company of misleading doctors about a design flaw in its defibrillators.
© 2005 The Washington Post Company
(keywords: Guidant, ICD, defibrillator, pacemaker)
