Guidant Admits That It Hid Problems of Artery Tool

[Guest guest]

http://www.nytimes.com/2003/06/13/business/13DEVI.html?th

 

Guidant Admits That It Hid Problems of Artery Tool

 

June 13, 2003Guidant Admits That It Hid Problems of Artery ToolBy KURT

EICHENWALD

 

 

A division of one of the country's largest makers of medical devices pleaded

guilty yesterday to 10 felonies, admitting that it lied to the government and

hid thousands of serious health problems, including 12 deaths, caused by one of

its products.

 

The sweeping case against the division of the device maker, the Guidant

Corporation, resulted in $92.4 million in criminal and civil penalties, the

largest ever imposed against a maker of medical devices for failing to report

problems to the government.

 

The problems with the device, which was used to treat a weakened blood vessel in

the abdomen without surgery, centered on the system used to insert it. The

equipment could become lodged, potentially requiring emergency surgery to remove

it. In some cases, it was broken into pieces before being removed — a technique

devised by sales representatives. Guidant hid results that its product failed to

work properly about one of every three times it was used.

 

As part of the plea, the Guidant division, Endovascular Technologies, also

agreed to cooperate in investigations against executives who might have been

involved in wrongdoing. As part of that agreement, the company waived

attorney-client privilege, meaning that statements made by any employees to

company lawyers during the investigation will now be available as potential

evidence.

 

But the company's legal troubles are far from over. It already faces a number of

lawsuits from individuals, and thousands of patients whose procedures did not go

as expected could still bring cases. It must also complete aspects of a civil

settlement with the Department of Health and Human Services, which would allow

it to avoid exclusion from government programs like Medicare.

 

Guidant, which had $612 million in net income last year, may be little known

among the public, but it has been at the leading edge of one of the most

important disciplines of medicine to emerge over the last 25 years. That field,

known as interventional cardiology, uses tiny devices called stents to remove

the obstructions in coronary vessels that can lead to chest pain.

 

In 1999, Guidant brought out a new type of graft intended to strengthen the

aorta, the main vessel that comes from the heart, as it passes through the

abdomen. A weakening of that vessel, known as an abdominal aortic aneurysm, is a

potentially life-threatening condition that frequently occurs in people with

heart disease. Soon after the introduction of the product, the Ancure Endograft

System, the company was aware of significant flaws in the system used to insert

the device but decided not to notify the Food and Drug Administration of the

scope of the problem, as required under federal law, according to the charges,

which were filed in Federal District Court in San Francisco.

 

Guidant pulled the Ancure device from the market in March 2001, made changes and

reintroduced it five months later. The company said in a statement yesterday

that because the initial risk from the device came from the equipment used to

insert it, patients who have the device are not in danger. Guidant, based in

Indianapolis, said that the device continued to demonstrate positive long-term

results for patients.

 

The charges against Endovascular Technologies, a wholly owned subsidiary that

Guidant acquired in 1997, describe a company that allowed marketers to influence

its scientific decisions when faced with a public health risk. Indeed, the

charges say, sales representatives devised a method of their own to deal with

problems, telling doctors to physically break into pieces the system used for

inserting the graft while it was in a patient's vessel.

 

Guidant has still more steps to take before the government's civil case is

resolved. As part of the agreement with Health and Human Services, both Guidant

and its subsidiary are required to put in place corporate integrity agreements.

In exchange for adopting those requirements — the details of them are still

subject to approval by the government — Health and Human Services has agreed not

to seek to bar the companies from any government programs, including Medicare.

 

Shares of Guidant fell $2.67, or 6.2 percent, to $40.56.

 

Law enforcement officials hailed the plea, which they said exposed failures that

had placed patients at serious risk.

 

" Because of the company's conduct, thousands of patients underwent surgeries

without knowing the risks they faced, and their doctors — through no fault of

their own — were unprepared to deal with those risks, " said Kevin V. Ryan, the

United States attorney in San Francisco. " These actions were criminal, and I am

happy to say that today, for the first time in more than three years, the public

will be able to learn the truth. "

 

Medical specialists expressed both surprise and concern about the criminal

charges. " Whenever a company has a serious ethical, and in this case legal,

lapse, it always raises concerns across the product line, " said Dr. Steven

Nissen, a cardiologist at the Cleveland Clinic.

 

Still, Dr. Nissen, who has worked with a Guidant project in the past, expressed

surprise at the plea, saying that the company had always struck him as ethical.

 

But Nancy Hersh, a lawyer who represents seven patients who were injured and the

families of two who died after the procedure to insert the device, described the

criminal plea as an important step forward. " It's absolutely fantastic, not just

for my clients, but for the F.D.A. and for the safety of the public, " Ms. Hersh

said.

 

Historically, doctors dealt with abdominal aneurysms through complex surgery.

That entailed opening the abdominal cavity, moving aside the patient's internal

organs, finding the aorta and locating the aneurysm — a spot where the vessel is

weakened and balloons out. Once that is found, the surgeon would attach a graft

to strengthen that point in the aorta. If left untreated, the aorta could burst

and cause death.

 

The newer method advanced by Guidant avoided the dangers and complications of

surgery. With it, a doctor inserted a catheter containing a polyester graft into

an artery in the groin, then threaded it through the body until it reached the

aneurysm.

 

The F.D.A. approved Guidant's device on Sept. 30, 1999 — the day a rival product

also received approval. But even before the approval date, the charges say,

company employees knew that doctors were finding the delivery system difficult

to use.

 

Soon after sales began in the United States, the charges say, doctors and others

began to report to the company malfunctions with the delivery system, resulting

in its becoming lodged in the body of the patient. As a result, doctors were

forced to perform surgery — opening up the abdominal cavity — simply to remove

the delivery system.

 

Faced with these difficulties, the charges say, sales representatives, who were

often present when the procedure was performed, began telling doctors to break

off the handle of the delivery system if it became stuck and extract it in

pieces. The charges say that solution was devised in part by the sales

representatives themselves, with no testing to prove it safe or effective.

 

In one procedure, conducted in January 2000, the handle-breaking technique was

performed unsuccessfully and the patient died. Though employees insisted that

this meant the procedure had to be tested, Endovascular Technologies failed to

do so and continued to recommend that doctors break the handle.

 

Each significant problem was required to be reported to the F.D.A., but the

company failed to do so. Indeed, in July 2000, an F.D.A. inspector asked for

records of all instances in which the delivery system experienced problems. The

company turned in a list of 55 complaints. Throughout the life of the device, it

submitted 172 reports of problems.

 

But, the complaint said, the real number was much higher: 2,628 additional

reports of problems, out of a total of 7,632 devices that were sold.

 

The full scope of the problem finally came to the attention of the F.D.A. in the

fall of 2000, when seven anonymous employees sent a letter providing details

about the failures and problems that were occurring. On March 16, 2001, Guidant

removed the device from the market.

 

Seven days later, the company disclosed to the F.D.A. that thousands of patients

had experienced serious problems from the delivery system.

 

The company made changes and put the device back on the market in August 2001.

 

Copyright 2003 The New York Times Company

 

 

Gettingwell- / Vitamins, Herbs, Aminos, etc.

 

To , e-mail to: Gettingwell-

Or, go to our group site: Gettingwell

 

 

 

Free online calendar with sync to Outlook.