Yourlawyer.com (Ancure News) http://www.yourlawyer.com/topics/overview/ancure Sat, 21 Nov 2009 16:53:34 -0800 pixel-app en Guidant Settles Lawsuits http://www.yourlawyer.com/articles/read/6828 Sat, 18 Oct 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6828
The lawsuits had been filed over the past two years against EndoVascular Technologies, a Menlo Park subsidiary owned by medical-device giant Guidant and were dismissed late last month.

Terms of the settlement weren't disclosed. The cases had been filed with U.S. District Judge Jeremy Fogel in San Jose.

``I am not at liberty to talk about the cases at all or what occurred. We did resolve them, in a mutually satisfactory manner,'' said Rachel Abrams, an attorney at Hersh & Hersh, the San Francisco law firm that brought the lawsuits on behalf of nine families, including relatives of two dead patients.

A telephone call to the media spokesman for Guidant, the Indianapolis medical company that owns EndoVascular, was not immediately returned Friday afternoon.

None of the patients who filed the nine suits alleging they were injured by the device lived in the Bay Area. But people who sued the company included Helen Gaines of Missouri, who has suffered chronic pain and the loss of all sensation in her right foot since her procedure to implant the device, called the Ancure endograft, in 1998.

The Ancure device was made by Guidant's subsidiary, EndoVascular Technologies. That division pleaded guilty in June to 10 felonies involving the Ancure device, including making false statements to government regulators. The subsidiary agreed to pay a $92.4 million fine to the government in the largest settlement of its kind to date for failing to report medical device malfunctions to the FDA, as required by law.

The device was made to patch weak spots in a major blood vessel, called the aorta, that runs from the heart through the abdomen. Without reinforcement, weak spots in the aorta can swell like a balloon and burst, potentially causing death from internal bleeding.

In its settlement with the Justice Department, EndoVascular admitted to concealing more than 2,600 incidents where the device malfunctioned or caused serious injury or death from 1999 to 2001.

A Mercury News examination earlier this year found that the numerous Ancure malfunctions that went unreported to the FDA were widely known within the subsidiary. Overall, at least 75 patients died and 991 were injured after receiving the implant, the examination found. The lawsuits charged that, in some cases, the implant was at fault.

At the time Guidant announced it would no longer sell the Ancure device, the company said it would continue to offer long-term assistance to patients with the implants and their physicians. Guidant officials have insisted that the device itself is safe, saying any malfunctions were caused by equipment used to insert the Ancure and those problems were corrected in 2001.

Abrams said another lawsuit asking to be certified for class-action status also is pending before Fogel that asks the company to pay for the cost of mandatory lifelong monitoring for patients implanted with the Ancure device.]]> Guidant Workers' Warnings Met With `Hostility,' Letter Says http://www.yourlawyer.com/articles/read/6391 Wed, 06 Aug 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6391
Written anonymously by seven employees and directed to a Guidant executive in October 2000, the letter was also sent to the Food and Drug Administration. It played a large part in the federal investigation by the U.S. Justice Department that led to a multimillion-dollar settlement against the subsidiary announced June 12.

In the letter, the seven employees outlined a list of design flaws or quality issues surrounding the device, called the Ancure, along with medical practices they said were inadequately tested and put patients' lives at risk.

``Many of us have had concerns for several months and we feel we have exhausted all means of resolution within our own departments, and within the division as a whole,'' the employees wrote in their letter to Michael Gropp, Guidant's chief compliance officer at the company's office in Santa Clara.

The seven employees did not identify themselves because ``we have witnessed others who have initiated important discussions around these same topics to senior staff through the usual and proper channels, only to encounter hostility and ultimately threats to their careers,'' the letter said.

The letter was released by the FDA in response to a request from the Mercury News under the Freedom of Information Act.

The seven employees did not name any senior staff at the subsidiary or at Guidant in the letter.

Plea agreement

Contacted for comment Tuesday, Guidant officials declined to respond directly to points raised in the employees' letter.

``The company resolved its issues with the government in the plea agreement that was reached and announced on June 12. In fact, the `Anonymous Seven' letter was discussed in great detail in the agreement. Therefore, we see no purpose in rehashing matters that have already been resolved,'' Steven Tragash, a spokesman for Indiana-based Guidant, wrote in an e-mail.

In a separate letter Monday to the Mercury News, Tragash wrote, ``Guidant voluntarily contacted the FDA in a timely manner, took the product off the market, overhauled our regulatory and compliance systems and worked tirelessly to correct the problems.''

The Ancure device was made by Guidant's EndoVascular Technologies subsidiary, based in Menlo Park. That division pleaded guilty in June to 10 felonies involving the Ancure device, including misbranding and making false statements to government regulators. The subsidiary agreed to pay a $92.4 million fine to the government in the largest settlement of its kind to date for failing to report medical device malfunctions to the FDA, as required by law.

The Ancure was a device developed by the Guidant subsidiary to repair bulges, known as aneurysms, that can develop in the main artery leading from the heart to the rest of the body. The device was intended to be a better treatment than surgery.

A Mercury News examination has found that Ancure malfunctions that went unreported to the FDA including 12 deaths were widely known within the subsidiary. Overall, at least 75 patients died and 991 were injured after receiving the implant, and lawsuits charge that in some cases, the implant was at fault.

Among the concerns outlined in the employees' letter:

A procedure called the ``broken-handle'' method for removing the outside of the device, if it became stuck in an artery, was not adequately tested.

Even so, the letter said, ``Members of the sales force are currently instructing physicians to use this troubleshooting method with many of the potential risks unknown.''

Problems were reported inconsistently to the FDA. Similar complaints and outcomes were handled differently, the employees said, with the company directing some complaints to the FDA but failing to file others. The letter said one device removed from a patient in 1999 contained a broken hook, which attaches the device to the artery wall.

``An attempt was made to keep this information very quiet'' and was not reported to the federal regulators as required, the workers alleged.

Guidant personnel ``asked to change records before and during an FDA audit, without FDA knowledge.''

The employee refused.

Audit urged

Concerned about these and other problems, the letter said the workers urged an internal audit.

In March 2001, after telling the FDA that its EndoVascular Technologies division had not filed 2,628 incidents of Ancure system malfunctions, Guidant suspended sales of the Ancure system. Five months later, following FDA-approved labeling changes that detailed how to remove the device's handle from the body should it become lodged during insertion, the system was put back on the market.

Guidant officials have said Ancure is safe and any malfunctions involved the system used to implant the device inside the body.]]> Medical Firm's Dangerous Secret http://www.yourlawyer.com/articles/read/6390 Sun, 03 Aug 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6390
But the problems with the $10,000 device, called the Ancure Endograft System, were no secret inside the Menlo Park subsidiary, EndoVascular Technologies, that made it.

Every time a doctor threaded the tubelike device through an incision in the groin and implanted it in a patient's largest artery, a sales representative was there to observe. Every time, a report was phoned in to a voice mail to which dozens of co-workers and managers could listen.

``Just severely tight,'' one sales rep recorded in February 2000, describing a doctor's efforts to push the device through the arteries of a Minnesota man in his 60s, after the doctor's first try had torn through another artery. ``Tight, tight, tight.''

``We did lubricate the outside and that thing was slipperier than snot when it was going in,'' he went on. Still, it stuck again, and the surgeon had to break apart the device's handle to budge it.

The sales rep didn't learn until the next day that the blockage had left the man's legs paralyzed. Eventually they were amputated.

How widely Ancure's malfunctions were known within EndoVascular is one of the most striking findings of a Mercury News examination of the events leading up to the Guidant subsidiary's guilty plea, more than three years after the device was introduced in September 1999. At least 75 patients died and 991 were injured after receiving Ancure implants, according to Food and Drug Administration records. Lawsuits charge that at least some were the result of the implants.

Public records, documents and interviews with ex-employees and others familiar with the federal investigation show there were numerous problems with implanting the Ancure device and reveal a pattern of disregard for federal requirements intended to protect patients from faulty medical devices:

Slow to file

Problems reported much later

EndoVascular maintained a dual system of tracking malfunctions, one for internal use and a second, showing many fewer problems, for complaints reported to the FDA.

Manufacturing changes intended to fix some of the problems were not properly reported to the FDA for review and approval, as required, until after the device was temporarily pulled from the market in the middle of a government investigation.

The dual reporting system ended only after indignant EndoVascular workers sent an anonymous letter to Guidant managers and the FDA.

After receiving the anonymous letter, Guidant launched a series of audits at its subsidiary and found thousands of malfunctions that had not been filed with FDA as required. Even then, Guidant didn't report the results until it learned that the government had opened a criminal investigation.

Guidant executives have acknowledged in a court settlement that its subsidiary intentionally withheld information. But they say the devices placed in 18,000 people worldwide are safe and performing as expected. The problems, they say, involved the parts used to implant the device, not the device itself.

``If you're a patient with an Ancure implant, I want to assure you, and reassure you, that your implant is safe,'' said Guidant's chief executive, Ronald W. Dollens, in a Webcast days after the June 12 plea agreement.

Dollens insisted that the problem was confined to its 300-employee subsidiary, EndoVascular. He said Guidant, a giant of the medical device industry with about 10,000 employees, acted aggressively once the issues came to light, making management changes in Menlo Park and working closely with the FDA. No current Guidant employees are targets of a criminal investigation into individual misconduct that is continuing.

Dollens also announced that the company had stopped making the Ancure device, and sales would end in October.

EndoVascular Technologies was launched in 1989 to develop a device for treating life-threatening bulges in the lower end of the aorta, the main vessel that carries blood from the heart to the rest of the body. Left untreated, aneurysms can burst like an overblown balloon, killing quickly.

For decades, the standard treatment has been radical surgery cutting the belly from breast bone to pelvis, pulling out and moving aside the intestines, then reaching into the body cavity to sew in a polyester patch to reinforce the bulging portion of the aorta.

If all goes well and often it does not patients spend a week in the hospital and require six months to recover. As many as 5 percent die within a year.

EndoVascular's device is intended to avoid the trauma of open surgery. The tubelike patch is implanted inside the aorta, threaded through an artery reached from an opening made in the groin. Patients leave the hospital after a few days and are soon back on their feet.

While major complications were greatly reduced, overall mortality was similar to standard surgery in the days following the procedure.

The Ancure Endograft System is quite complicated. The implant is folded up inside a plastic jacket at the end of a long cable. At the other end of the cable, the surgeon manipulates several wires in the cable to retract the jacket and then unfold and attach the implant to the aorta's walls.

Problems arise

How to remove a stuck device

In interviews, former employees recalled how quickly EndoVascular acted in its early years, before it became part of Guidant, to resolve problems that came up in developing the device.

In January 1995, part way through clinical trials of an early version, the company discovered that tiny hooks on the graft that held it to the aorta's walls were breaking months after the implant.

``They immediately went to the FDA,'' one ex-employee said. ``They halted all scheduled procedures.'' All the patients were called back and followed closely. Redesigning the device and retesting it cost the young company months of time.

In 1996, EndoVascular went public, but it was burning through its cash quickly. In late 1997, Guidant, with headquarters in Indianapolis, acquired it for about $150 million in stock.

Almost immediately, Guidant began installing its own people in key positions.

F. Thomas (Jay) Watkins III, head of Guidant's cardiac and vascular surgery division, became EndoVascular's top executive. As the device neared the market, Richard Rush, another Guidant executive, was put in charge of quality and regulatory affairs. Rush declined to be interviewed; Watkins did not return several calls.

The company won FDA approval for the Ancure system in September 1999. That same day, its chief rival, Medtronic, won approval for its own aortic implant, setting off a battle for customers.

But almost as soon as Ancure hit the market, the company began to hear of problems not seen in the clinical trials.

Doctors often had problems removing the plastic jacket that covered the implant. In one case, records show, a doctor had to discard three devices before finding one that worked. The company failed to report that case for almost a year.

Even worse, the jacket, packed with the tubelike patch, and all the accompanying wires, miniature balloons and hooks used to deploy and attach the device, could get stuck in a patient's arteries. Doctors would sometimes have to open up the patient's belly to remove the device.

Soon the sales reps who observed implantations were leaving voice mails reporting ingenious efforts devised on the spot in operating rooms to remove a stuck device without resorting to major surgery.

One common problem was that one of the wires would get caught, deep inside a patient's body, in the hooks used to attach the device. Surgeons worked with sales reps and came up with a technique to knock loose a stuck wire with a separate wire that had a bent end. They called it the ``hockey stick.''

As a last resort, when one device system was stuck, an enterprising surgeon broke the handle used to insert the device into the body and pulled the many parts out of the patient piece by piece.

The procedure was quickly named for the sales rep and surgeon who devised it, according to people familiar with the federal investigation. Soon sales reps were recommending that surgeons use the ``handle-breaking technique'' when other methods failed to dislodge stuck equipment.

But as word spread through the company, several employees questioned its safety.

In January 2000, those concerns turned to outright alarm in a case that would later be cited in the federal government's prosecution of EndoVascular. In that case, the surgeon lost a long wire inside the patient, where it drifted up an artery toward the heart, records show. The surgeon performed standard surgery, but the patient later died of complications.

According to ex-employees, several workers raised concerns about troublesome cases at monthly quality meetings. Some suggested, for example, that the handle-breaking technique should be carefully studied and reported to the FDA, court records show.

Some workers felt management didn't respond.

Early in 2000, after a meeting of a dozen employees, one engineer e-mailed a memo to a superior proposing the technique be thoroughly tested and the problem reported to the FDA for review and approval. Some testing was done, but the method was not reported, according to court records and accounts by ex-employees.

In July 2000, an inspector from the FDA's San Jose office, Eric Anderson, arrived in Menlo Park to inspect EndoVascular and review its records and procedures.

Anderson, who declined to be interviewed, asked specifically for records of difficulties removing plastic jackets that jammed. He was shown a list of 55 complaints, when the company knew there were more than 200.

Anonymous letter

Workers blow the whistle

After the inspection was completed and only minor infractions were cited, a small group of employees decided to take action.

In October 2000, seven workers sent an anonymous letter to Guidant's chief compliance officer in Santa Clara, Michael Gropp, describing in detail their efforts to alert the company to problems through normal channels. They charged that the company had failed to report numerous problems to the FDA. And they sent a copy to the agency.

EndoVascular soon launched a series of audits that would take months to complete, uncovering thousands of malfunctions not properly reported to the FDA.

Guidant shook up the management at the Menlo Park company, under a new unit called EndoVascular Solutions headed by Beverly Huss.

Though the audits were completed by January, the company did not present the results to the FDA until late March, court records show. That happened only after the company became aware that it was under criminal investigation, said people familiar with the investigation.

Executives at the company say that during that time they were preparing to present their findings to the FDA.

At the same time, in March 2001, EndoVascular announced that it was pulling the Ancure off the market. It became available again in August, after the FDA retroactively approved 10 changes to the Ancure system, including expanded instructions for physicians on how to cope with the common problems.

This June, as part of its criminal guilty plea, the company admitted that it had failed to disclose 2,628 malfunctions to the FDA as required by law, amounting to more than a third of all Ancure patients from September 1999 through March 2001.

Days after the plea was entered, Guidant's Dollens appeared on a Webcast for Wall Street analysts and acknowledged that EndoVascular ``had intentionally failed to report'' malfunctions that either did or were likely to contribute to a death or serious injury.

He tried to put the best light on Guidant's performance, seeming to blame the legal troubles on the culture of its subsidiary.

In subsequent interviews, several former employees said Dollens had ignored the extent to which Guidant had appointed its own people to key positions at EndoVascular. All three members of EndoVascular's board of directors were Guidant executives, according to corporate records.

``We were one company,'' said one former Menlo Park employee, who says she continues to have a high regard for Guidant and for Dollens. ``We were Guidant and not EVT [EndoVascular Technologies] anymore and they made that very clear to us.'']]> Problems With Aneurism Device Well Known, Newspaper Reports http://www.yourlawyer.com/articles/read/6392 Sat, 02 Aug 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6392
An investigation by The San Jose Mercury News found that officials at EndoVascular Technologies, a subsidiary of Guidant Corp., knew about numerous problems with implanting the Ancure device and hid the malfunctions from the Food and Drug Administration. The newspaper examined public records and documents and interviewed former employees and others familiar with the investigation.

Guidant has agreed to nation's largest criminal and civil fine of its kind $92 million - as punishment failing to report malfunctions of Ancure, which is used to cure aneurysms in the blood vessels leading to the heart. Federal prosecutors are still considering whether to bring criminal charges against EndoVascular executives.

At least 75 people died and 991 were injured after receiving the implants, according to FDA records. Twelve of those deaths were associated with malfunctions of the device that were never reported.

Among the newspaper's findings: EndoVascular kept two sets of records, one for internal use and a second showing fewer problems that was used for making reports to the FDA; Manufacturing changes to fix some of the problems were never reported or approved by the FDA until the device was pulled from the market; An internal audit found thousands of malfunctions that were never reported to the FDA, but the company did not report its findings until it discovered the government was conducting a criminal investigation.

Doctors often had problems implanting Ancure, with parts of the device getting stuck in arteries or trouble removing the device's plastic sleeve. In one procedure, the surgeon would break the device apart and remove it piece by piece if it got stuck.

Several employees questioned the safety of the breakage technique, and asked management to test it and report the findings to the FDA. Though there was some testing done, the results were never reported, according to court records and former employees.

A series of audits was conducted after an October 2000 letter sent anonymously by seven workers to Guidant's chief compliance officer in Santa Clara, Michael Gropp. The workers complained that EndoVascular was failing to report malfunctions, and described their efforts to bring the problems to the company's attention. They also sent a copy to the FDA.

The audits were finished in January 2001 but the company did not report its findings to the FDA until late March, when the company found out there was a criminal investigation, according to court records and people familiar with the investigation. The same month, the device was pulled from the market. It became available again that August, after the FDA retroactively approved ten changes to the Ancure system.

Guidant has said the trouble with Ancure was seen only during implantation, and those with the devices currently implanted are not at risk. Guidant is discontinuing production of the product.

Ronald W. Dollens, Guidant's chief executive, said the problems were limited to the EndoVascular subsidiary. ]]> Guidant Required To Have Monitor http://www.yourlawyer.com/articles/read/6306 Thu, 03 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6306
Under the ``corporate integrity agreement'' signed this week, Guidant's subsidiary, EndoVascular Technologies, must hire an independent organization to assess whether the subsidiary is properly reporting information to the Food and Drug Administration involving its device, which repairs weaknesses in the abdominal aorta.

Should the review group find that more than 2 percent of complaints or complications that should have been reported to the government were not, the company will face a $12,000 fine for each violation.

The 36-page pact also mandates training for all Guidant and EndoVascular Technologies sales representatives, marketing officials and customer- or technical-service workers about when regulators must be told about problems involving the company's abdominal-stent-graft devices.

``This will serve to strengthen our existing compliance program,'' Guidant spokeswoman Marie Weller said.

The agreement, which takes effect immediately and lasts for five years, was made with the agency that oversees the FDA, the U.S. Department of Health and Human Services. It is the final step of last month's $92.4 million settlement of federal charges brought against EndoVascular Technologies for problems with its medical device that repairs weaknesses in the abdominal aorta.

EndoVascular Technologies pleaded guilty in June to federal charges that it covered up serious problems with its Ancure stent-graft device, including 12 deaths that went unreported to federal health authorities.

Production stopped

Just days after the guilty plea, Guidant announced it had stopped production of its Ancure Endograft System and would halt sales of the $10,000 device in October. The company, which has about 30 percent of the market for devices to repair abdominal aortic aneurysms, is facing more than a dozen lawsuits, including at least two that seek class-action status.

While stopping Ancure sales, EndoVascular will continue to exist and will be responsible for regulatory and reporting obligations involving the device, which has been implanted in about 18,000 people since the stent graft went on the market in 1999.

According to Guidant officials, malfunctions occurred in the delivery system used to implant the stent-graft device, not in the device itself. Patients who received the implants without complications should not be worried, company officials said. Guidant said it would offer long-term assistance to patients with the implants and their physicians.

Fraud allegations

According to the government's charges, FDA officials first became aware of the allegations of fraud and a coverup in October 2000 when a group of seven anonymous Guidant employees concerned about problems with the device wrote a letter to the agency.

A Guidant investigation concluded the company was out of compliance with FDA regulations and its own internal policies, according to the Justice Department. In March 2001, after telling the FDA that its EndoVascular Technologies division had not filed 2,623 incidents of Ancure system malfunctions, Guidant voluntarily suspended sales of the Ancure system. Five months later, following FDA-approved labeling changes that detailed how to remove the device's handle from the body should it become lodged during insertion, the system was put back on the market.]]> Guidant Sued Over Handling of Aortic Graft http://www.yourlawyer.com/articles/read/6120 Sat, 14 Jun 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6120
The lawsuit, filed Friday in federal court in Indianapolis, accuses Guidant of "material misrepresentations to the market" in the handling of the Ancure aortic abdominal graft.

Attorneys for the plaintiff are seeking class-action status for the suit and asking people who have held Guidant stock between August 2001 and this week to join in.

Guidant subsidiary Endovascular Technologies Inc. on Thursday admitted covering up problems with the Ancure "stent-graft" device that may have led to 12 deaths during aneurysm treatments. The company pleaded guilty to 10 felony charges, including shipping misbranded products and making false statements to government regulators.

Analysts later warned that Guidant, based in Indianapolis, could become vulnerable to more litigation and stiffer regulatory scrutiny of new products.

The Justice Department (news - web sites) has said it is considering filing charges against company executives.


The graft, one of a half-dozen competing devices on the market, is inserted into the aorta to shore up dangerously weakened spots in the artery wall.

The criminal complaint against Endovascular alleged the company misled federal regulators and reported only 172 malfunctions. Prosecutors said Endovascular had records of 2,628 malfunctions, including reports that the incidents may have led to 12 deaths and 57 surgeries to remove the device.

The company said the problems were resolved after the device was voluntarily recalled in March 2001 and before it was reintroduced five months later. ]]> Heart Device's Risk Was Hidden http://www.yourlawyer.com/articles/read/6123 Fri, 13 Jun 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6123
Endovascular Technologies of Menlo Park, a subsidiary of the health-care corporation Guidant, agreed in federal court to pay $92.4 million in criminal and civil penalties for not reporting 2,628 serious malfunctions of its Ancure Device in the first 1 1/2 years of sales.

In addition to the monetary penalty the largest imposed anywhere for failure to report malfunctions of a medical device Guidant agreed to cooperate in an ongoing criminal investigation. Charges against company officials could follow, Assistant U.S. Attorney Matthew Jacobs said.

Jacobs' boss, U.S. Attorney Kevin V. Ryan, said, "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."

An estimated 7,632 Ancure devices were sold nationally between introduction of the device in September 1999, and March 2001, when sales were suspended.

The $10,000 device was reintroduced five months later with amended warnings and instructions.

Although Guidant, which had $612 million in net income last year, may be little known to the public, the company has been at the leading edge of interventional cardiology, one of the most important disciplines of medicine to emerge over the last 25 years.

One of several similar products used in treating abdominal aortic aneurysms, Ancure consists of two portions a graft designed to replace the weakened section of the aorta and a temporary catheter designed to permit insertion of the graft.

In one common malfunction, the catheter became stuck, necessitating slicing of the patient's aorta to remove it.

The company reported 172 failures to the Food and Drug Administration, concealing the true extent of malfunctions from patients, doctors and the public while distributing accurate data to its own officials, according to the charges.

The data showed 12 deaths and 57 cases in which procedures to implant the device had to be converted to major surgery.

The company also admitted its sales representatives, whose presence during Ancure implantations was required by the FDA, had taught doctors an unapproved technique for dislodging stuck catheters.

According to the charges, the technique was devised in part by a sales representative.

A case in which it was used and the patient died provoked seven company employees to file an anonymous tip that brought in the government investigators.

The case did not involve allegations of malfunctioning grafts following successful implantations. The Food and Drug Administration said patients already using Ancure 18,000 worldwide, by the company's estimate were in no special danger.

The company issued a statement Thursday saying "no patient with the Ancure Endograft implant is at risk as a result of this matter, and the implant continues to demonstrate excellent long-term clinical results."

The guilty plea was entered before U.S. District Judge Susan Illston in San Francisco by marketing vice-president Jim Neupert.

"How did it happen?" the judge asked.

Neupert laid the blame on "a series of events" involving faulty devices and individuals who failed to perform their duties.

But Jacobs said the troubles at Endovascular Technologies were "not the result of error" but of fraud, which the government would prove if the company chose to contest the charges.

Neupert agreed.

Before accepting the plea, Illston also required Neupert to acknowledge that the company intentionally misled the government and consumers and that it had been informed of deaths from use of its product.

About 20 private lawsuits involving Ancure are pending in the San Jose division of the same federal judicial district.

Less than a month ago a similar batch of private suits against a competing brand made by Medtronic USA was resolved in San Jose under undisclosed terms.

Shares of Guidant fell $2.75, or 6.4 percent, to $40.56 after the government's charges were announced Thursday.

Guidant still has 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 that would impose certain obligations.

In exchange for the companies adopting those requirements, the details of which must still be approved by the government, Health and Human Services has agreed not to seek to bar the companies from any government programs, including Medicare.]]> Ancure Guidant Endograft System Stent Graft Lawsuit http://www.yourlawyer.com/topics/overview/ancure Fri, 13 Jun 2003 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/ancure DOWNLOAD OUR INFORMATION PACKAGE

Ancure Guidant Endograft System Stent

Guidant Corp has pleaded guilty to covering up malfunctions of its Ancure Endograft System Graft that may have led to 12 deaths and many other complications. The company was charged with failing to report as many as 2,600 malfunctions of the $10,000 device during surgery.

The failure to report the malfunctions prevented the public and physicians from learning about ``recurring malfunctions and other risks.'' The company also was accused of failing to report that other, more invasive surgeries were required after the device failed.

The Company pleaded guilty to 10 felonies and agreed to pay $92.4 million in civil and criminal penalties, to settle the federal charges. According to court documents recently unsealed, federal prosecutors said the device often malfunctioned and the company asked doctors to use it in ways not approved by the government.

In many instances, sales representatives in the operating room asked surgeons, in an effort to remove the lodged device, to break it and remove it a piece at a time. When that failed, the chest would have to be opened.

Ancure is a medical device used to treat abdominal aortic aneurysm without evasive traditional surgical techniques. The medical device, part of the Ancure Endograft System, uses a catheter to insert a sheath through the femoral artery in the leg. The device is designed to allow physicians to operate on the heart without opening the chest. When the device failed open heart surgery was required.

If you or a loved one suffered injuries from an Ancure Endograft System Graft Stent, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>