U.S. Subpoena Opens a New Front in Investigation ofGuidant Heart Devices_NYT

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[sSRI-Research] U.S. Subpoena Opens a New Front in

Investigation of Guidant Heart Devices_NYT

 

 

 

 

U.S. Subpoena Opens a New Front in Investigation ofGuidant Heart

Devices_NYT

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

The New York Times reports that federal prosecutors had merged their

inquiry with an earlier one by the FDA, have subpoenaed documents

under seal in a Texas lawsuit involving Guidant Corp. " The subpoena

shows that the government is investigating Guidant for possible

violations of health care statutes..Two legal specialists, after being

told of the statutes cited in the subpoena, said their broad range

indicated the serious nature of the investigation. Guidant, based on

findings, could face civil or criminal charges. "

 

The documents reveal that:

 

" Guidant first became aware of polyimide-related failures in early

2002 in the Prizm 2 DR, but the company waited until May 2004 to

notify doctors about the flaw, after it became aware that The New York

Times was about to publish an article about the device. "

 

Barry Meier of The Times, who first broke the story of the flaw in

Guidan'ts defibrilator--and was first to inform the public about the

company's concealement of that potentially fatal flaw from doctors and

the public, [1] reports that the Justice Department subpoena seeks

records that were initially produced under seal in the Texas lawsuit.

 

Those company documents were released this month by the case's

presiding judge, Judge Jack Hunter.

 

***The judge cited a Texas law barring the sealing of court records

related to safety issues.***

 

" They are investigating in the broadest possible way, " said Joan

Krause, a director of the Health Law and Policy Institute at the

University of Houston. " They are looking at potential fraud involving

government plans like Medicare, private health plans and employee

benefit plans. "

 

This may be the legal watershed for putting the public interest into

product liability legal contests that involve public safety issues.

 

It may be especially fitting that a Texas law may become the statutory

model for putting safety into the driver's seat of drug / vaccine /

and medical device disputes.

 

1. See: By BARRY MEIER, Maker of Heart Device Kept Flaw From Doctors,

May 24, 2005

http://www.nytimes.com/2005/05/24/business/24heart.html?ex=38597200 & en=417b87c\

bafc388 & ei=P70

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

 

 

http://www.nytimes.com/2006/01/28/business/28device.html?_r==1 & emc==eta1 & pagewan\

ted==print

THE NEW YORK TIMES

U.S. Subpoena Opens a New Front in Investigation of Heart Devices

By BARRY MEIER

January 28, 2006

 

Federal prosecutors have opened a new front in their investigation

into the Guidant Corporation by issuing a subpoena seeking records

disclosed in a Texas lawsuit that indicate the company knew that some

heart devices could catastrophically fail.

 

The subpoena, issued Tuesday by the United States attorney in

Minneapolis, specifically sought Guidant documents disclosed this

month in a Texas state court. Among other things, the records indicate

that company executives debated whether to warn doctors that some

heart defibrillators could short-circuit. The records suggest that

Guidant might have sold potentially flawed devices.

 

The document request, which was served on lawyers representing

plaintiffs in the Texas case, also indicated that federal prosecutors

had merged their inquiry with an earlier one by the Food and Drug

Administration's Office of Criminal Investigations. The subpoena shows

that the government is investigating Guidant for possible violations

of health care statutes.

 

Two legal specialists, after being told of the statutes cited in the

subpoena, said their broad range indicated the serious nature of the

investigation. Guidant, based on findings, could face civil or

criminal charges.

 

" They are investigating in the broadest possible way, " said Joan

Krause, a director of the Health Law and Policy Institute at the

University of Houston. " They are looking at potential fraud involving

government plans like Medicare, private health plans and employee

benefit plans. "

 

A spokesman for Guidant, Steve Tragash, said yesterday that the

company had no comment on the latest document request. Guidant has

said that it did nothing wrong and that it made all required reports

about product problems to the F.D.A.

 

Jeffrey N. Wasserstein, a lawyer in Washington specializing in health

cases, said, " I'd be a little worried. " The lawyers said neither was

involved in the Guidant case.

 

The latest disclosure comes amid a turbulent rush of news involving

Guidant, the nation's second-biggest maker of heart devices after

Medtronic, just days after it agreed to be acquired by Boston

Scientific for $27 billion, or $80 a share.

 

Yesterday, Guidant reported that its fourth-quarter earnings fell

sharply from the year-earlier period, a result of heart defibrillator

recalls and lost sales. On Thursday, Boston Scientific received an

unusually strong warning from the F.D.A. about some of its procedures,

which could result in the delayed approval of new products.

 

In trading yesterday, Guidant shares fell $1.54, to close at $73.72.

Boston Scientific fell $1.62, to $21.63. Because of considerations

involving the value of Boston Scientific stock that underlie the

Guidant plan, the deal's value has dropped somewhat.

 

The newest Justice Department subpoena was sent to a plaintiff's

lawyer, Robert Hilliard of Corpus Christi, who is representing two

heart patients in a claim against Guidant. He provided a copy to The

New York Times and said in a telephone interview that a federal

investigator had asked him to retain all Guidant documents produced in

the case.

 

A spokeswoman from the United States attorney's office in Minneapolis

did not return a telephone call yesterday seeking comment.

 

The Justice Department's inquiry, which began in October, is focusing

on Guidant's handling of safety issues related to defibrillators known

as the Prizm 2 DR, the Contak Renewal and the Contak Renewal 2. Small

numbers of the devices have short-circuited, a malfunction related to

the use of insulating material known as polyimide that can deteriorate

when exposed to moisture.

 

In October, Guidant disclosed that it had received a federal subpoena,

but it is not clear whether it received the latest document request.

 

A defibrillator is a life-saving device intended to sense and

electrically disrupt potentially fatal heart rhythms. A short circuit

can render the device useless. At least seven patients are known to

have died in incidents in which the devices shorted, though the number

is probably higher because physicians only recently became aware of

the problem.

 

Guidant first became aware of polyimide-related failures in early 2002

in the Prizm 2 DR, but the company waited until May 2004 to notify

doctors about the flaw, after it became aware that The New York Times

was about to publish an article about the device.

 

The Justice Department subpoena specifically mentions Guidant

documents that relate to a more recent episode involving the Contak

Renewal and Contak Renewal 2.

 

The records were initially produced under seal in the Texas lawsuit

but they were released this month by the case's presiding judge, Judge

Jack Hunter of State District Court in Corpus Christi, who cited a

Texas law barring the sealing of court records related to safety

issues. The Times obtained the documents after it filed a motion

seeking the release of all safety-related records in the case, and it

published a recent article about them. Guidant has appealed Judge

Hunter's decision.

 

The records released by Judge Hunter indicated that in October 2004,

more than two years after the Prizm 2 DR problem, Guidant confirmed

that a small but growing number of Contak Renewals were also shorting

out because of polyimide degradation.

 

The documents include a hand-written annotated chronology related to

the Contak Renewal that was apparently composed by the head of

Guidant's cardiac unit, J. Frederick McCoy Jr. It suggested that

Guidant executives debated in January 2005 whether to alert doctors to

the Contak Renewal problem.

 

At the time of the debate, one entry also states " Informed Ron

Dollens: Guido Neels of the development, " an apparent reference to

Guidant's chief executive and chief operating officer at the time;

both men have since retired. Mr. Dollens declined, through a company

spokesman, to comment. Mr. Neels, reached by telephone, also declined

to comment.

 

The released documents, hand-dated Oct. 20, 2004, apparently projected

that existing inventories of Contak Renewals would run out in

mid-November 2004. The company did not disclose the Contak Renewal

problem until June 2005, after the F.D.A. had opened an inquiry.

 

Guidant has previously said that it did not issue earlier alerts about

the devices because the number of failures had been too small.

 

Asked this month about the Texas documents, Guidant issued a statement

about the records, stating that they showed that the company had,

among other things, taken " responsible action during an ongoing

investigation " of the devices and that it had " aggressively evaluated

product performance and communication thresholds. "

 

Yesterday, Mr. Tragash, the company spokesman, declined to respond to

more questions on the documents.

 

Copyright 2006The New York Times Company

 

 

 

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