Yourlawyer.com (Guidant Defibrillators News)

Boston Scientific Settles Probe Over Defibrillators

Mon, 09 Nov 2009 00:00:00 -0800

Last year we wrote that a prominent physician from the Minneapolis Heart Institute Foundation had expressed concern about test guidelines for a next-generation heart defibrillator under development at the time by Medtronic, Inc., Boston Scientific Corporation, and St. Jude Medical, Inc. Now, Bloomberg News is reporting that Boston Scientific has agreed to pay nearly $300 million to settle an investigation conducted by the U.S. Justice Department on the medical device maker’s Guidant unit and how it handled cardiac devices and manipulation of third-quarter financial results.

Boston Scientific is planning on paying $296 million—approximately one-fifth of its “cash on hand”—and Guidant is planning on pleading to two criminal misdemeanors, said Bloomberg News. The misdemeanors involve not appropriately advising the U.S. Food and Drug Administration (FDA) regarding issues concerning some of its implantable cardioverter defibrillators (ICDs), according to Bloomberg News. Apparently, the investigation involved some advisories that Guidant distributed on its product prior to being acquired by Boston Scientific, said Bloomberg News. The acquisition took place in April 2006.

ICDs represent a $5 million dollar market, with over 160,000 such devices implanted each year in the U.S., said the StarTribune.com previously, which explained that the devices are about the size of a stopwatch and work to stop sudden cardiac arrest by shocking the heart back into rhythm. One ICD device runs about $30,000 said TwinCities.com.

Dr. Robert Hauser is considered somewhat of an industry expert and is best known for his involvement in the Guidant defibrillator recall in 2005 in which he and colleague Dr. Barry Maron exposed safety concerns about a Guidant defibrillator after a patient died following implantation with the Guidant device, reported the StarTribune.com last year. That revelation was followed by a recall involving thousands of defibrillators and pacemakers, and prompted increased review into how “medical device malfunctions are tracked and monitored by the FDA,” noted the StarTribune.com.

In 2007, Boston Scientific agreed to a settlement of over $240 million for over 8,000 lawsuits that claimed Guidant did not reveal problems with its ICDs. The 2005 recall was ultimately broadened to include some 109,000 defibrillators, said Bloomberg News, which also noted that Guidant likely knew back in 2002 that the ICDs were defective, but hid that fact to protect sales.

News of the defects were reflected in lowered sales and Minneapolis prosecutors looked into how Guidant handled the device and if Food, Drug, and Cosmetic Act violations occurred with its Ventak Prizm, Contak Renewal, and Contak Renewal 2 defibrillators, reported Bloomberg News. As part of the federal deal, Guidant is to plead to the misdemeanor charges over its not including data on the ICDs’ issues in its reports to the FDA, according to a Boston Scientific statement, explained Bloomberg News.

Meanwhile, in other news, the medical device giant stated that it received a subpoena from the U.S. Department of Health and Human Services’ Office of Inspector General in late September that is seeking information concerning contributions made to charities that are associated with physicians and physicians’ relatives.

Boston Scientific Settles Probe Over Defibrillators

Thu, 01 Jan 2009 00:00:00 -0800

Defective Guidant Defibrillators Maker Boston Scientific Agrees to Pay $195 mill

Mon, 16 Jul 2007 00:00:00 -0700

Boston Scientific, the maker of Defective Implantable Guidant Heart Defibrillators, will pay $195 million to settle thousands of lawsuits filed by patients who said they were never informed about potential flaws in the defibrillators. The settlement includes around 4,000 claims brought by patients around the country that had been consolidated for trail at the US District Court in Minneapolis. The trial was scheduled to begin on July 27.

The lawsuits involved in the settlement are unusual, because the patients filing them were never actually injured by defibrillators. Rather, these were patients who either had their units removed after hearing of the defibrillators’ problems, or claimed to have suffered emotional injuries as a result of the worry their devices caused. The judge assigned to the case allowed the suits to go forward because the trail could have set important precedents regarding a manufacturer’s responsibility for informing patient about potential product defects.

Guidant Corporation, which was acquired by Boston Scientific in 2006, first knew of problems with the Guidant Defibrillators in 2002, but did not publicly acknowledge those flaws until 2005. An implantable defibrillator uses electricity to regulate heart rhythm. Unfortunately the Guidant defibrillators failed to work due to faulty insulation.    At least seven patients died as a result of the defect.

Even after Guidant corrected the problem with the defibrillators, the company continued to ship the older versions of the device. In the end, thousands of additional patients were exposed to serious danger.   In 2004, sales of Guidant defibrillators totaled $1.8 million, leading many to conclude the company was motivated more by profit than concerns for patient safety. The actions of Guidant have attracted the scrutiny of the Justice Department, where it is the subject of an ongoing investigation.

Guidant issued an initial recall for its defibrillators on June 16, 2005. At the time, the recall covered 50,000 devices and six models: Prizm 2 DR, Model 1861; Contak Renewal, Model H135; Contak Renewal 2, Model H155; Prizm AVT Vitality; Renewal 3 AVT; and the Renewal 4 AV.   A year later, Guidant expanded the recall to several other models, including the Ventak Prizm 2, Vitality and Vitality 2 Implantable Cardioverter Defibrillators. In total, 109,000 devices were included in the recalls. Implantable defibrillators have been prone to defects, with Medtronic and St. Jude Medical, two other major manufactures of the devices, issuing recalls in the past.

Boston Scientific, which has seen its stock plunge ever since it acquired Guidant for more than $27 billion, has hopes that news of the settlement will help its sagging fortunes. The $195 million settlement is far less than the $732 million Guidant had in reserve for lawsuits related to the defibrillator defects. Boston Scientific’s profits have taken a hit due to sagging sales of implantable defibrillators, a well another of its major products, coronary stents. As a result of all the defibrillator recalls, worldwide sales for those devices fell from $6 billion to less than $5.6 billion.
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Boston Scientific recalls defibrillators

Wed, 11 Apr 2007 00:00:00 -0700

Boston Scientific Corp. has recalled some of its defibrillators, the FDA confirmed on its website.

A posting on the FDA's website detailed that on April 5, Natick, Mass.-based Boston Scientific recalled approximately 73,000 implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators, due to a flaw in the devices that can cause the batteries to wear out sooner than expected.

The company said that most patients would not be affected by the recall, but should contact their physicians about what steps to take next.

As of March 30, the company said it confirmed 19 field events with Guidant's devices, mostly related to premature battery depletion. There were no serious injuries or deaths reported.

Boston Scientific (NYSE: BSX) maintains a cardiac rhythm-management unit in Arden Hills that it acquired with Guidant Corp. It also has a Maple Grove facility that focuses on interventional cardiology technology, such as stents.

Boston Scientific / Guidant Recall: Questions & Answers

Tue, 10 Apr 2007 00:00:00 -0700

On April 5, Boston Scientific/Guidant recalled approximately 73,000 Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). A faulty capacitor in these devices can cause the batteries to deplete sooner than expected. Most patients will not be affected by this recall, but patients with one of the recalled devices should contact their physicians about what steps to take next. Please see the questions below for additional information.
What exactly is affected by this Boston Scientific/Guidant recall?

Guidant is recalling approximately 73,000 Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) that are distributed worldwide. The affected devices distributed in the US include the Contak Renewal 3 HE CRT-Ds (Models H177 and H179); Contak Renewal 3 CRT-Ds (Models H170 and H175); Vitality 2 DR ICDs (T165); Vitality 2 VR ICDs (T175); Vitality AVT ICDs (A155); Vitality DS DR ICDs (T125); and Vitality EL DR ICDs (T135). Guidant merged with Boston Scientific in April 2006.

What is the problem with these devices?

A capacitor in the affected devices could malfunction, leading to premature battery depletion.

How serious is this?

As of March 30, 2007, Boston Scientific has confirmed 19 field events with Guidant’s devices, mostly related to premature battery depletion. There were no serious injuries or deaths reported.
What should patients do who have one of the recalled devices?

FDA is aware that this news may cause patients to be concerned. The chance that a given patient is affected by this problem is very small. However, FDA will make sure patients have access to new information as it becomes available.

Patients who are unsure if they have a device affected by this recall should:

Contact their physician
Contact Boston Scientific Technical Services at 1-800-CARDIAC;
Go to Guidant’s Product Performance Resource Center web site at http://www.guidant.com/ppr/advis/2007_04_05.shtml. Patients will need to know the model and serial number of their device to use this web site.

Patients who have a device affected by this recall should consult with their physician on the next steps to take. A patient’s physician is in the best position to help decide what is best because physicians receive current information on these devices and also have access to the individual patient’s medical history.

Do the recalled devices need to be explanted (removed) from the patients?

No. In most cases, routine follow-up is all that will be required. In some cases, more frequent device checks may be advised. Only in rare cases, will a device need to be removed prematurely from a patient.
What are Boston Scientific’s recommendations for physicians?

If a patient has a device with a degraded capacitor, the time from implant to 2.65 volts (Middle of Life 2 / MOL2) will be reduced. To determine whether a patient may be at risk for a reduced ERI to EOL time, it is important to note when 2.65 volts (MOL2) was observed. For each patient:

Review patient records to assess battery voltage.
If battery voltage is above 2.65 volts (MOL2), continue to follow patient every three months per device labeling.
If battery voltage is at or below 2.65 volts (MOL2), determine the time between device implant and this observation.

If the time from implant to 2.65 volts (MOL2) is greater than 27 months (Note: For VITALITY® EL / 2 EL / HE devices, this value is 32 months), the patient is not at risk for a shortened ERI to EOL time, and this advisory no longer applies.
If the time from implant to 2.65 volts (MOL2) is 27 months or less (Note: for VITALITY EL / 2 EL / HE devices, this value is 32 months), the patient should be followed monthly until ERI. For devices that require monthly follow-up, replace the device within 30 days after ERI is displayed as ERI to EOL time may be shortened.

Note: In geographies where available, the LATITUDE® Patient Management System can facilitate patient monitoring and also provide automatic notification when the device reaches a battery status of ERI.

FDA is committed to immediately providing all important risk information we receive, as soon as we receive it. Physician feedback is very valuable to us. Please tell us what you are seeing and any concerns you have.
How is Guidant related to Boston Scientific?

Guidant Corporation merged with Boston Scientific Corporation on April 24, 2006. Guidant Corporation became the Cardiac Rhythm Management division of Boston Scientific Corporation. The products being recall are labeled with the Guidant name.
When did FDA learn about this latest recall?

Boston Scientific notified FDA about the problem with these devices on March 23, 2007. On April 5, Boston Scientific issued a product advisory to physicians to alert them to the problem with the Guidant ICDs and CRT-Ds listed above and provide recommendations for patient treatment.

What will FDA do now?

FDA has determined that the product advisory constitutes a recall. FDA will be monitoring the recall to ensure that the firm’s actions are adequate to protect the public. FDA will ensure that information for patient care is made available. Information about the recall, and any updates, will be posted on FDA’s website
Does the current recall relate to Guidant's May 2006 recall?

The May 2006 recall involved problems with a faulty capacitor from the firm’s supplier. While the company’s current recall also deals with a faulty capacitor from the supplier, the failure modes and patient outcomes differ from those described in the May 2006 recall. Therefore, the current recall is being treated as a new recall and not as an extension of the May 2006 recall.
Does this recall mean Guidant still hasn’t corrected its problems?

FDA’s December 2006 inspection of Guidant indicated that the GMP issues previously cited by FDA appeared to have been adequately addressed. However, a GMP inspection evaluates a company’s systems at one point in time only and cannot necessarily predict how these systems will perform in the future. Therefore FDA will continue to look at individual Guidant products and recall patterns to ensure that quality systems remain in place to identify and address any problems that may occur in the future. FDA’s Quality System regulation requires firms to identify device problems both before and after distribution. When a problem is discovered, the firm must conduct an investigation commensurate with the significance and risk of the problem. These investigations can determine whether there is a problem, the extent of the problem, and how best to address it. This determination can be viewed as a Quality System that is working as intended.

Glitch prompts recall of Boston Sci Defibrillators

Tue, 10 Apr 2007 00:00:00 -0700

Boston Scientific is recalling about 73,000 implantable cardiac defibrillators because of a problem with some device batteries, but a company official said Tuesday that the issue might affect just a small subset of patients with the devices.

A notice posted Tuesday about the recall by the U.S. Food and Drug Administration also noted, "Most patients will not be affected by this recall."

The devices in question contain a faulty capacitor that can cause batteries to deplete sooner than expected. The problem has resulted in no serious injuries or deaths, the company says, and the early battery depletion issue can safely be handled with increased monitoring by physicians.

ICDs are $30,000 implanted devices that can shock a failing heart back into rhythm. Boston Scientific manufactures implantable defibrillators and pacemakers at a facility in Arden Hills.

The local division was rocked by a series of high-profile product recalls in 2005 and 2006, when Indianapolis-based Guidant Corp. owned it. Doctors said the latest recall, by comparison, raises a minor issue for patients.

"I think this problem is manageable and poses minimum risk for patients provided they have adequate follow-up," said Dr. Robert Hauser, a cardiologist with the Minneapolis Heart Institute. "It is less worrisome than earlier recalls because the battery depletion can be detected and corrective action (replacement) taken before the ICD fails."

While the clinical impact of the latest recall
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seemed small, Tim Nelson, an analyst with Piper Jaffray Cos. in Minneapolis, said he worried that the news would add to the string of negative reports about implantable defibrillators, nonetheless.

"A lot of patients are going to be notified, and there's a potential fear factor that could arise as the media starts to publicize this," Nelson said. "The real impact could be on the length of time it takes for the industry to start growing again."

In a letter sent to physicians April 5, Boston Scientific asked doctors to check the voltage level and age of the potentially affected devices. That process should determine large groups of patients for whom the product advisory does not apply, said Annette Ruzicka, spokeswoman for Boston Scientific's Arden Hills division.

The remaining patients will need to be checked more frequently and, ultimately, could require replacement devices a few months earlier than normal, Ruzicka said.

"We actually have a recommendation for physicians that eliminates patient risk," she said. "Most of the patients who have these devices will never even be affected or need to know about this."

Nonetheless, Boston Scientific also sent letters to patients, notifying them about the battery-depletion problem. The issue has surfaced in 19 devices since the last quarter of 2006, the company says.

"There is a very low likelihood that a component within your defibrillator may cause the battery in your device to use energy faster than expected, which could reduce the amount of time available for replacement," the company wrote in the letter to patients. "No patients have been harmed; however, some devices have required early replacement."

Natick, Mass.-based Boston Scientific purchased Guidant last year. The controversy involving earlier ICD recalls involving the local division dates back to 2005, but continues to depress the market for implantable cardiac defibrillators.

The current recall includes various models of Guidant's Contak Renewal 3 device, as well as five versions of its Vitality ICD product. The recall is unrelated to a May 2006 recall at Guidant that also dealt with a faulty capacitor, according to the FDA notice.

The agency encouraged patients with recalled devices to contact their doctors about what steps to take next.

"In some cases, more frequent device checks may be advised," the FDA said. "Only in rare cases will a device need to be removed prematurely from a patient."

Defective Guidant Defibrillators Continue to Haunt Boston Scientific

Mon, 11 Sep 2006 00:00:00 -0700

According to recent SEC filings, Boston Scientific Corp. now faces about 477 individual and 72 class-action lawsuits over recalled Guidant defibrillators. Boston Scientific purchased Guidant earlier this year for $27 billion, after outbidding Johnson & Johnson. Both companies pursued Guidant even though the company had just recalled thousands of defibrillators and pacemakers. J&J’s decision not to match the higher offer appears to have been fortuitous, as Boston Scientific has already reserved $381 million to fund Guidant related lawsuits, and some legal experts believe the company’s liability could actually be much greater.

The first trial surrounding defective Guidant defibrillators is set to begin in Corpus Christi, Texas on September 18, 2006. The plaintiffs in this are two patients who had Guidant’s Ventak Prizm 2 defibrillator implanted 2001. While both plaintiffs are still alive, they live with the fear that the devices can fail at anytime. Many patients in their same situation have elected to have the defective devices removed and replaced with new models. The removal and insertion of these devices does require risk, making it a difficult decision for patients to decide on the best course of action.

Plaintiffs argue that Guidant knew about the defects in their defibrillators for three years before they informed doctors about the problems. The defibrillator defects didn’t come to light until the death of a 21-year-old college student was reported. The student had a Guidant defibrillator implanted because he suffered from heart disease. Guidant acknowledged that the defibrillator short circuited causing his death. The company also told his doctors that it was aware of 25 other cases in which the defibrillator had been affected by the same flaw. However, Guidant’s executives said the company did not see a compelling reason to issue an alert to physicians because the unit’s failure rate was very low and replacing the devices might pose greater patient risks.

The Guidant defibrillator recall included the following models:Guidant Prizm 2 DR, Model 1861, Guidant Contak Renewal, Model H135, Guidant Contak Renewal 2, Model H155, Guidant Prizm AVT Vitality AVT Renewal 3, Guidant AVT Renewal 4 AVT, Guidant Contak Renewal 3 and 4, Guidant Renewal 3 and 4 AVT and Guidant Renewal RF.

The recalled defibrillators are known as implantable cardioverter-defibrillators or ICD’s. These devices are implanted under the skin of patients to manage sudden cardiac death due to ventricular fibrillation. ICD’s are used to treat patients at risk of recurrent, sustained ventricular tachycardia or fibrillation. When an ICD detects ventricular tachycardia or fibrillation, it shocks the heart to restore the normal rhythm. When working properly, ICD’s have been very useful in preventing sudden death in patients with known, sustained ventricular tachycardia or fibrillation. New studies are being conducted to learn if ICD’s can be used to prevent cardiac arrest in high-risk patients who haven’t had, but are at risk for, life-threatening ventricular arrhythmias.

www.newsinferno.com

FDA Update Statement On Boston Scientific/Guidant Pacemakers And Defibrillators

Mon, 17 Jul 2006 00:00:00 -0700

The FDA met last week with Boston Scientific/Guidant to discuss the firm's recent announcement that several models of pacemakers and implantable defibrillators should be removed from hospital inventories because they have the potential to malfunction due to failure of the capacitor, which controls how the device holds its power supply. FDA fully supports the company's recommendation that physicians perform follow-up exams of patients with devices that may be susceptible to this malfunction. Problems may include intermittent or permanent loss of therapy, premature battery depletion or other malfunctions. FDA is closely monitoring the situation and met with Boston Scientific/Guidant to discuss their plans to investigation the problem, inform physicians and resolve the problem as quickly as possible.

"While information about the problem with these devices is still very preliminary, FDA is committed to keeping the public informed," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. "We support Guidant's decision to notify physicians and hospitals early in the investigation, and we believe that retrieval of non-implanted devices is a prudent first step. Analysis of returned devices may uncover clues that will allow Guidant to make further recommendations to physicians regarding patient care. Early public notification was one of the important recommendations that emerged from last fall's meeting of the Heart Rhythm Society."

Boston Scientific/Guidant has confirmed five reports of device malfunction among some 27,200 patients worldwide in whom these devices were implanted. One malfunction occurred at the time of implantation. In four cases, the patients needed to have the device replaced. The patients lost consciousness in two of these cases. There are no reported deaths.

Boston Scientific/Guidant has identified certain lots of a supplier's low-voltage capacitor as the likely source of the problem. The affected products include certain models of the Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality and Vitality 2 implantable cardioverter defibrillators. These devices were manufactured by the company's Cardiac Rhythm Management Group, formerly Boston Scientific/Guidant's CRM business, and implanted in patients between December 2005 and June 2006. For more information, a letter to both patients and physicians regarding this notification is available at guidant.com/physician_communications.

Boston Scientific/Guidant is actively investigating the capacitor failure to determine the cause, the rate of occurrence, and the time to failure. Over the next 60 days, the company's engineers will be testing the retrieved devices and analyzing the results. The company will communicate its findings to the FDA and physicians as soon as they are available.

In the meantime, as a cautionary step, Boston Scientific/Guidant has notified physicians to schedule appointments with patients implanted with affected devices as soon as possible. Physicians should examine the patient to identify any problems and to obtain information concerning when and under what circumstances these devices may fail.

"We encourage patients who have been contacted by their physicians because they may have one of the affected devices to follow their recommendation and make an appointment to have the device checked as soon as possible," Dr. Schultz said.

"The Heart Rhythm Society applauds this proactive, collaborative effort to inform patients and physicians about the most recent device notifications. This is a monumental step in providing optimal patient care and is based on the Society's draft recommendations released in April," said Anne B. Curtis, M.D., FHRS, Immediate Past President, Heart Rhythm Society. "We believe the most important step is for patients to contact their heart rhythm specialist to determine the best course of action."

FDA is interested in receiving information about problems with any devices and encourages hospitals and the public to submit reports directly to MedWatch, the FDA's voluntary reporting program. Reports may also be submitted by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.

Boston Scientific Announces Physician Communication Related to Products in Its CRM Group

Mon, 26 Jun 2006 00:00:00 -0700

Contact:
Paul Donovan
508-650-8541

Boston Scientific Corporation (NYSE: BSX) today announced that it is providing safety information and retrieving a specific subset of pacemakers, cardiac resynchronization pacemakers and implantable cardioverter defibrillators from its sales force and hospital inventories. The specific subset of devices includes INSIGNIA and NEXUS pacemakers, CONTAK RENEWAL TR/TR2 cardiac resynchronization pacemakers, and VENTAK PRIZM 2, VITALITY, and VITALITY 2 implantable cardioverter defibrillators. These products are manufactured by the Company's Cardiac Rhythm Management (CRM) Group, formerly Guidant's CRM business. Boston Scientific acquired Guidant on April 21.

Boston Scientific CRM has recently identified a supplier's low-voltage capacitor that is not performing to the company's expectations. A capacitor is an electrical charge storage component. Some capacitors from specific lots may perform in a manner that leads to device malfunction, including intermittent or permanent loss of therapy or premature battery depletion. To date, a total of five confirmed events have been reported out of approximately 27,200 implanted devices from this subset. One event involved a device malfunction discovered at the time of implant. The other four events involved devices that were implanted and subsequently required replacement.

Patients with affected pacemakers may experience intermittent or permanent loss of output or telemetry, or premature battery depletion. Patients with affected defibrillators may experience inappropriate sensing or premature battery depletion. There have been no reported patient deaths associated with this issue. There have been two reports of pacemaker patients experiencing syncope associated with loss of pacing output.

Engineering analysis is ongoing and the company will further communicate on this issue when it has additional information. Implanting and following physicians are being asked to schedule an in-clinic follow-up visit as soon as possible for all patients with implanted devices from this subset to assess device function. At this follow-up visit, physicians should look for behaviors that may be indicative of capacitor malfunction such as premature battery depletion, intermittent or permanent loss of therapy or telemetry, fault codes, pacing or sensing abnormalities, or loss of daily measurements.

"Boston Scientific believes in notifying physicians in a timely, transparent and responsible manner," said Jim Tobin, Boston Scientific President and Chief Executive Officer. "This action reflects Boston Scientific's industry-leading commitment to implementing recommendations made by both the Heart Rhythm Society and the Independent Panel Commission chaired by Dr Robert Myerberg. Boston Scientific is the only CRM company that has committed to implementing these recommendations, which it believes are in the best interest of patients and physicians."

Physician communications can be viewed in their entirety at http://www.guidant.com/physician_communications/.

FDA ups risk of Guidant defects

Fri, 23 Jun 2006 00:00:00 -0700

A potentially deadly short-circuiting problem with implantable defibrillators made by the former Guidant Corp. may be far more common than initially indicated, according to an analysis by federal regulators.

Guidant's implantable heart devices may fail about 10 times more often than the company had projected last year, according to a U.S. Food and Drug Administration analysis released in a Texas lawsuit. A judge in a product-liability lawsuit involving Guidant's defibrillators recently unsealed the FDA document dated June 16, 2005.

"This doesn't raise my concern level any higher than it already was which was pretty high," said Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute.

In May 2005, Hauser and two Heart Institute colleagues went public after Guidant refused to warn other doctors about its defibrillator. Instead of delivering a sharp jolt to their 21-year-old Minnesota patient's heart, which had gone dangerously out of beat, the $30,000 device apparently short-circuited and the patient died.

Since then, Guidant has been hit by a series of safety alerts, recalls, investigations and lawsuits. The company recalled 109,000 defibrillators because of a variety of problems last year.

Guidant's heart devices are made in Arden Hills. Natick, Mass.-based Boston Scientific bought Guidant earlier this year.

"My major concern is why the FDA didn't release this information at the time, a year ago," Hauser said.

FDA spokeswoman Julie Zawisza declined to say why the agency didn't release its higher estimate. The agency is still evaluating the defect problem, she said.

Officials with what is now Boston Scientific's Guidant unit stood by their original estimates.

"Throughout this period, the observed occurrence rate has remained well within our projection at less than 1 percent," Boston Scientific spokesman Paul Donovan said in a recent interview.

After Guidant began its recall last year, it said no more than 292 of the units were likely to break down. But the FDA said "most" of the 16,000 recalled Contak Renewal defibrillators may have damaged insulation within five years of use, and 40 percent of those damaged devices would fail to produce an adequate electrical shock in a medical emergency. At that rate, at least 3,200 Renewal units would be likely to fail.

The reason there are not more reports of death due to the short-circuiting problem may be that most of these patients die outside the clinic or hospital and their device is not sent back to the manufacturer to be checked out, according to the FDA memo.

"We have no surveillance process for discovering" fatal defibrillator malfunctions, the memo said. "We do not know the death rate associated with this defect. It is probably greater than reported and may be much greater than reported."

The Texas case is one of some 340 product-liability cases in the courts so far, and the company thinks more than 3,000 patients eventually may pursue claims, according to a Boston Scientific filing with securities regulators last month. The FDA's higher projection now may hurt Boston Scientific in lawsuits by patients who received the devices.

"This is as damaging a document as we're going to come across," one of many lawyers representing patients suing Guidant, said in a recent interview. "It flies in the face of all the excuses Guidant has been giving for not telling patients to take these devices out immediately."

Guidant letter about risks never sent

Wed, 07 Jun 2006 00:00:00 -0700

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.

Report: Guidant considered warning doctors

Wed, 07 Jun 2006 00:00:00 -0700

The Guidant Corp. reportedly considered warning physicians last year about serious defects found in some heart defibrillators produced by the company.

Guidant executives have defended their decision not to warn physicians about the defects because doing so might have placed patients at risk for unnecessary device replacement, The New York Times reported Wednesday.

But newly released company records from January 2005 indicate the company drafted a letter to physicians in which the Minnesota-headquartered Guidant warns of defects in two of its defibrillators. The letter informs physicians the company had recalled all of the affected devices that had not yet been implanted.

But the letter was never sent and more heart patients received the defibrillators known as the Contak Renewal and Contak Renewal 2, The Times said.

The draft letter and other records released this week by a Texas state judge might have legal and financial consequences for the Massachusetts-based Boston Scientific Corp., which acquired Guidant in April, the newspaper reported.

20 insurers sue over defective defibrillators

Fri, 02 Jun 2006 00:00:00 -0700

When countless Southwest Florida heart patients received a letter last year informing them that their Guidant defibrillators were defective, they rushed to their doctors hoping for a replacement.

But, they’ve learned that changing the devices can be even more dangerous.

“When you are talking about changing out devices, patients undergo significant risk,” said Dr. Erick Burton, a Lee Memorial Health System cardiac electrophysiologist, who’s removed 20 to 40 defective defibrillators. “The risk of surgery from taking out the device might be riskier than device failure.”

Now these patients require a lifetime of close monitoring by doctors, which is hitting health insurance companies hard as they pay for that care.

To recoup some of those losses, 20 of Blue Cross and Blue Shield’s 38 plans nationwide have filed a lawsuit against Guidant Corp. for an undisclosed amount. Blue Cross and Blue Shield of Florida is one of the plaintiffs.

“It is just a matter of protecting the company,” said Valerie Rubin, spokeswoman with Blue Cross and Blue Shield of Florida.

The lawsuit alleges that Guidant, based in St. Paul, Minn., knew the defibrillators were defective as early as 2002 but did not issue the recall until 2005. During those years, the company continued to sell, manufacture and market the devices. About 24,000 defective Guidant defibrillators were used.

The devices are implanted in patients with congestive heart failure, abnormally fast heart rhythms or irregular heartbeats to shock their hearts into a regular rhythm.

“The subject devices are defective in a number of ways, including short circuiting, causing the devices to stop functioning entirely for a period of time up to 24 hours,” the lawsuit states. “When subject devices resume working after this period, if at all, all of their computer memory has been erased so the malfunctions are not detectable by physicians, hospitals, medical practitioners or patients.”

There have been 26 documented failures, the lawsuit alleges, and contends countless others that went undetected.

Each year, about 64,000 defibrillators are inserted into patients, according to the American Heart Association.

Insurance companies suing Guidant Corp.

Blue Cross and Blue Shield Association in Illinois
Blue Cross and Blue Shield of Alabama
Blue Cross and Blue Shield of Florida
Blue Cross of Idaho Health Service, Inc.
Blue Cross and Blue Shield of Michigan
Blue Cross and Blue Shield of Rhode Island
Blue Cross and Blue Shield of Tennessee
California Physicians’ Services Blue Shield of California
Excellus Health Plan of New York
Health Care Service Corporation, which covers part of Illinois
Health Care Service Corporation in New Mexico
Health Care Service Corporation in Texas
Health Care Service Corporation in Oklahoma
Horizon Blue Cross and Blue Shield of New Jersey
Louisiana Health Service and Indemnity Company Blue Cross and Blue Shield of Louisiana
Premera Blue Cross of Washington
The Regence Group of Oregon
Wellmark Blue Cross and Blue Shield in Iowa
Wellmark Blue Cross and Blue Shield in South Dakota

Boston Scientific Finds Battery Problem in Some Devices

Mon, 15 May 2006 00:00:00 -0700

Boston Scientific Corp. on Monday said it had notified doctors that some of its implantable cardiac devices, which it acquired as part of its purchase of Guidant Corp. last month, could be at risk for early battery depletion.

Boston Scientific, whose shares fell about 1 percent, said the problem occurred in a single lot of 996 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillator devices that had been implanted in patients globally. No deaths or injuries were reported.

Boston Scientific said 30 of its Guidant devices had been returned by May 8, and it had received an additional 46 reports of devices that remained implanted but showed signs of premature battery depletion.

The devices, which contain a faulty component from the single manufacturing batch, are in the Vitality DS, Vitality AVT and Vitality 2 ICD lines, and the Contak Renewal 3, Contak Renewal 4 and Contak Renewal 4AVF lines of CRT-Ds.

In information posted on its Web site, Boston Scientific advised doctors to schedule follow-up appointments as soon as possible with patients who had received the devices and contact the company for instructions to determine remaining battery life of the devices.

The battery problem came to light after an overall review of Guidant's product lines, Boston Scientific said.

Boston Scientific also advised doctors of two device malfunctions linked with implantation of Guidant defibrillators in an unusual position.

Planting one of these devices below the chest muscle, rather than below the skin, can result in mechanical stress to an area of the titanium case that can cause the product to malfunction, the company said. The uncommon technique could affect devices in the Renewal 3, Renewal 4 and Vitality HE product lines.

The two patients whose devices malfunctioned underwent successful replacement procedures, Boston Scientific said.

Boston Scientific is currently working to resolve a warning letter from the U.S. Food and Drug Administration over quality control issues. The Guidant division also faces its own FDA warning letter over its ICDs.

Replacing Heart Device Found Risky

Wed, 26 Apr 2006 00:00:00 -0700

Surgery to replace potentially defective heart defibrillators carries an unexpectedly high rate of serious complications, including death, according to a study published today.

The research in the Journal of the American Medical Assn. showed that one in 50 patients needed to have the replacement device removed because of severe postoperative infections.

Dr. Andrew D. Krahn of Canada's University of Western Ontario and one of the study's authors said the overall complication rate was three to five times higher than expected. "We were absolutely surprised by these numbers," he said.

Two other studies in the journal tracked the annual malfunction rate of defibrillators, which started rising in the late 1990s as the devices became more complex but began falling in 2002. It is now less than 1%.

Taken together, the three studies paint the fullest picture yet of the risks to patients of removing or retaining a defibrillator recalled by its manufacturer.

The reports come amid controversy about defibrillators, devices used to steady heartbeats or jolt the hearts of those in cardiac arrest.

Medtronic Inc. and Guidant Corp. last year issued warnings about flaws in their defibrillators.

Guidant also faces a Justice Department inquiry related to its safety alerts. The company told the Food and Drug Administration about electrical problems with its Ventak Prizm 2 DR device but did not give that information to patients and doctors.

About 135,000 patients receive a defibrillator each year to help prevent a sudden heart attack. The devices differ from pacemakers, which are older, less complex devices that use tiny currents of electricity to regulate slow heartbeats.

Krahn said doctors had long believed the complication rate for defibrillator surgery ranged from 1% to 2%, about the same as for routine operations.

But his study of 533 patients at 17 Canadian medical centers who elected to have their defibrillators replaced after a safety recall found that 43 patients, or 8.1% of the total, suffered infections and other complications within three months of their surgeries. Of those, 31 patients, or 5.8%, had severe complications and two died. Ten patients with bad infections needed to have replacement devices removed.

The study was the first to examine the rate of complications associated with replacing defibrillators, a procedure typically performed every five to seven years to replace batteries.

Krahn couldn't explain why the complication rate was so high. The study suggests patients and their doctors should weigh the risks of complications before removing defibrillators after a safety alert, he said.

"When you start changing out a device with a risk of problems well under 1%, you could be causing more complications than you are saving," said Dr. Anne B. Curtis, president of the Heart Rhythm Society and a University of South Florida professor.

The second study examined cases of malfunctions requiring replacement that were reported to the FDA from 1990 to 2002. Researchers found that as the devices became smaller and more complex, the malfunction rate rose to a peak of 36.4 per 1,000 in 2001, or nearly 4%, from a low of 7.9 per 1,000 in 1996, less than 1%.

The average malfunction rate of defibrillators during the 12 years of the study was more than four times that of pacemakers over the same period. Results of the study, conducted by Dr. William H. Maisel of Beth Israel Deaconess Medical Center in Boston and researchers from the FDA, were first reported at a medical meeting in September.

The third study, conducted by Maisel, looked at malfunctions reported to patient registries in the United States and Demark from 1988 to 2004. As in the FDA study, the malfunction rate peaked in 2001 but fell to 7.4 per 1,000 in 2004, less than 1%.

Although the drop was encouraging, Maisel said, defibrillators were not as reliable as pacemakers, which had a malfunction rate of 1.3 per 1,000 in 2004. He said patients with the devices should be monitored.

Studies show implanted heart device can malfunction, but removal's risky

Wed, 26 Apr 2006 00:00:00 -0700

Implantable defibrillators, which can deliver a life-saving shock to people with damaged hearts, have had a roller-coaster record of reliability, as the rate of malfunctions fell in the early years, rose in the late 1990s and recently declined again.

Compared with pacemakers, which are simpler and serve a different purpose, implantable defibrillators are five to 20 times more likely to malfunction and need replacement.

At the same time, people who learn that the device implanted in their chest may have a defect should think hard before having it replaced. Switching it out may be more risky than leaving it in.

Those are among the conclusions of three studies being published today in the Journal of the American Medical Association that shed light on the hazards of implantable cardioverter-defibrillators (ICDs), perhaps the hottest medical device of the past decade.

The number of ICDs implanted in Americans has more than tripled from about 54,000 in 1999 to 168,000 last year. Sales are increasing 15 to 18 percent a year and are expected to continue rising as the population ages and the number of medical conditions shown to benefit from ICD use grows.

An ICD is sometimes likened to having a miniature ambulance crew inside the chest. The device can detect an abnormal heart rhythm, determine whether it can be ``converted'' to a normal rhythm with a shock and then deliver the jolt if the answer is yes, and it keeps a record of what it has done.

The devices cost about $20,000. The implantation procedure costs about $10,000 in physician and hospital charges.

The wires that deliver the life-saving shocks are snaked into the heart through a vein and then attached to an electronic box, smaller than a pack of cards, placed under the skin of the upper chest. The procedure requires no open-heart surgery and usually is done by a cardiologist.

The new studies did not address the value of ICDs. Everyone involved agreed the devices constitute a big advance in therapy that has saved the lives of tens of thousands of people who otherwise might have died while waiting for a handheld defibrillator to arrive.

Pacemakers are used primarily to speed up the heartbeat. They deliver short, low-power pulses, not shocks, are less complicated than ICDs and have been in use longer.

Two of the studies were headed by William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston. After a study he did suggested that malfunction rates for ICDs were rising, the Food and Drug Administration, which licenses the devices, asked him to study the issue further.

Maisel and his collaborators examined device-makers' reports of ICD and pacemaker malfunctions for the years 1990 through 2002. They calculated the number of ICDs and pacemakers that malfunctioned and were replaced per 1,000 of the devices implanted each year. (This does not represent an individual's chances of getting a defective device.)

For pacemakers, the malfunction rate declined from 9 per 1,000 implantations in 1993 to 1.4 per 1,000 in 2002. For ICDs, it fell from 39 per 1,000 implantations in 1993 to 8 in 1996, but then rose to 36 per 1,000 in 2002.

A study of three registries of ICD and pacemaker implantations -- in North America, Denmark and Britain found the same trend but extended it longer and found a marked decline in malfunctions from 2002 through 2004.

A trade organization for device-makers, the Advanced Medical Technology Association, said its records show the malfunction rate for ICDs last year was about 1 per 1,000 implanted -- and that about half the problems would simply delay a shock by several seconds.

In the third study, Andrew Krahn, a cardiologist at the University of Western Ontario, examined the rate of complications in people who were told their ICD might have a chance of failing.

In 17 Canadian hospitals over a one-year period, 2,915 patients received such a notice, and 533 (18 percent) decided to get the devices replaced. Of them, 31 (6 percent) had complications and two died. During that year, only three malfunctions occurred in the devices for which ``advisories'' had been issued. None of those resulted in death or serious illness.

Risk cited in replacing heart device

Tue, 25 Apr 2006 00:00:00 -0700

A new study suggests that for some patients with implanted heart defibrillators that have been recalled by the manufacturer, replacing the device might be riskier than leaving it in.

Canadian researchers found a much higher than expected rate of surgical complications in people who had their potentially faulty defibrillators replaced.

As a result, some patients "might want to hang out and wait and see what happens," said study co-author Dr. Andrew Krahn of the London Health Sciences Center in Ontario.

Six percent of the 533 patients who decided to have their recalled defibrillators replaced over a 12-month period suffered major complications, including two deaths, the study found.

In contrast, the risk of failure among recently recalled defibrillators has been estimated by the manufacturers at just 0.009 percent to 2.6 percent. And not every failure is deadly.

The study, published in Wednesday's Journal of the American Medical Association, provides the first estimate of the risk of major complications from replacement surgery. That is important information for patients and doctors faced with the decision of whether to leave a possibly defective device in the body or replace it.

Implantable defibrillators can be as small as a half dollar and are placed surgically under the skin of the upper chest. Vice President Dick Cheney is among the thousands of Americans who have one.

When the device senses a dangerous and potentially deadly irregular heartbeat, it sends electrical impulses to jolt the heart back to normal. It can correct a heart that beats too fast, as in ventricular tachycardia, or quivers chaotically, a condition known as ventricular fibrillation.

A total of 270,000 defibrillators have been recalled since January 2005, though it is unclear how many were inside patients and how many were on the shelf, according to the Food and Drug Administration. About 80,000 patients received the implantable devices in 2004.

Krahn said the rate of complications from surgical removal will surprise doctors, because replacing a defibrillator is considered a minor procedure.

"It's typically performed with a local anesthetic and sedation. It takes an hour or less," he said. "Most patients return home the same day."

The researchers studied 2,915 patients who were tracked by 17 Canadian hospitals in 2004-05. All the patients had devices that were recalled by manufacturers, Canada's national health system or the FDA.

Only 18 percent decided to undergo replacement surgery. Infection, bruising or bleeding required a follow-up operation in 31 of those patients. Two patients died.

"That risk is much higher than we initially thought," Krahn said.

The researchers did not follow the people who decided against replacement to see whether anything actually went wrong with their defibrillators.

The findings are applicable to the U.S. because American medical practices are similar to those in Canada, Krahn said.

"We probably should leave more of these alone if they appear to be functioning normally," said Dr. Anne Curtis, president of the Heart Rhythm Society, a nonprofit group of heart specialists, and chief of cardiology at the University of South Florida. Curtis was not involved in the study.

The Heart Rhythm Society plans to release draft recommendations Wednesday on pacemakers and implantable defibrillators. The draft will include guidelines to help doctors respond to recalls, Curtis said.

Implantable defibrillators, which cost between $30,000 and $40,000, contain batteries, insulated wires, memory chips, magnetic switches and other parts that can go awry. But some flaws are worse than others.

While some people might die because the device doesn't deliver the necessary shock, other devices might have a flaw that merely causes the battery to run down early, something that can be caught during routine monitoring.

And some people who have defibrillators don't need them as much as other patients do. Some patients are implanted with the devices as a preventive measure and have never actually suffered from fibrillation.

Doctors and patients often decide to leave a potentially faulty device in place after weighing the details of the recall and the patient's health. Krahn said some patients may decide they cannot risk a device failure, and may go ahead with replacement surgery.

Dr. Dan Schultz, director of the FDA's Center for Devices and Radiological Health, praised the study.

"This will allow the agency, as well as manufacturers and professional societies, to develop guidelines based on actual evidence, and to provide better advice to patients and doctors in the future," Schultz said.

After a recall, manufacturers provide free replacements. But insurance companies must pay for the surgery, which can cost thousands of dollars.

Krahn reported that he has financial ties to two device makers, Medtronic and Guidant. But he said that the study was conducted without funding or influence from industry, and that his consulting work does not involve the defibrillators.

Guidant cautions doctors to check some defibrillators

Mon, 13 Mar 2006 00:00:00 -0800

Guidant Corp., which is being acquired for $27 billion by Boston Scientific Corp., cautioned doctors Monday to check the voltage on certain implantable defibrillators after the company received several reports of defective devices.

The Indianapolis-based medical device maker issued the warning for its Contak Renewal 3 RF and Contak Renewal 4 RF models of defibrillators, which are devices that shock the heart back to a normal rhythm.

Guidant said it had received 39 reports from doctors saying defibrillators that had been tested before being implanted had a lower-than-expected battery voltage. None of the 39 devices were put into patients.

The voltage decline is related to a sustained, low level current that can only occur during storage and shipment before implantation. The company said about 4,000 Contak Renewal 3 RF and Contak Renewal 4 RF models have already been implanted, but it has not received any reports of this particular voltage problem.

Guidant said that the Food and Drug Administration may classify the notification to doctors as a product recall.

The company reminded doctors to check their inventory for the defect and to always perform the voltage check before implanting the device.

The notification follows a long line of product woes for Guidant that started in the summer when the company recalled thousands of pacemakers and defibrillators for a variety of reasons.

KEY DATES IN GUIDANT'S STRUGGLE

Sun, 26 Feb 2006 00:00:00 -0800

May 25, 2005: Guidant Corp. reports 26 cases of failure, including the death of a young Minnesotan — from its Ventak Prizm 2 DR Model 1861 implantable defibrillator. The advisory coincides with a New York Times article saying the company waited years to warn physicians about problems with Guidant defibrillators.

June 17: Guidant voluntarily issues a worldwide safety advisory for seven types of defibrillators.

June 24: Guidant issues a second worldwide safety advisory, warning doctors to discontinue use of five models of defibrillators.

July 1: The Food and Drug Administration classifies Guidant's safety advisories as recalls.

July 18: Guidant warns doctors that nine pacemaker models made between 1997 and 2000 may need to be replaced.

July 22: Guidant says a programming change it had recommended to fix flaws in some defibrillators actually increased the chances of malfunctions in three models.

Aug. 1: The FDA approves the relaunch of Guidant's top-selling defibrillator, the Contak Renewal 3.

Sept. 22: Guidant issues recalls or safety advisories for nearly 170,000 of its top-selling Insignia and Nexus pacemakers. It notifies doctors the failure rate for two defibrillators — the Contak Renewal and Contak Renewal 2 — was nearly triple what it had earlier estimated.

Sept. 29: Citing sources it did not name, the New York Times reports the FDA has started a criminal investigation of Guidant.

Oct. 25: U.S. attorney's offices in Boston and Minneapolis issue subpoenas to Guidant, Fridley-based Medtronic and Little Canada-based St. Jude Medical for an inquiry into possible violations of "anti-kickback" and "false claims" statutes and whether doctors and clinics received inducements to use the devices.

Nov. 3: New York Attorney General Eliot Spitzer sues Guidant, alleging the company concealed information about a design flaw in a defibrillator.

Jan. 24, 2006: The U.S. attorney's office in Minneapolis subpoenas Guidant for records disclosed in a Texas lawsuit that indicate the company knew that some heart devices could catastrophically fail.

Feb. 23: FDA inspectors cite Guidant's Arden Hills plant for failing to correct quality problems and belatedly notifying regulators about a design change in implantable defibrillators.

Guidant Cited for Manufacturing Violations

Thu, 23 Feb 2006 00:00:00 -0800

Medical device maker Guidant Corp. waited more than a year to tell federal regulators that it had repaired software in a line of defibrillators, according to inspection documents released Thursday.

An inspection report by the Food and Drug Administration said a flaw in Prizm, Prizm 2 and Vitality pulse generators caused the defibrillator to stop regulating patients' heart beats.

Indianapolis-based Guidant developed software to fix the problem in May 2004, but did not submit the change to the FDA until August 2005, inspectors said.

Inspectors discovered the omission this month as part of their 21-day examination at Guidant's St. Paul, Minn., facility.

Fred McCoy, head of Guidant's cardiac division, acknowledged in a deposition last month that the company also did not get FDA approval to fix possibly fatal problems in Ventak Prizm 2 Model 1861. Of the two changes Guidant engineers made to that defibrillator, only one was disclosed in company filings.

The company waited three years to disclose problems with the defibrillator.

The FDA, U.S. Department of Justice, the Securities and Exchange Commission and several state agencies are investigating Guidant over its recalls this summer.

Since June, Guidant has issued recalls or safety advisories for 88,000 defibrillators and more than 200,000 pacemakers. At least seven deaths have been linked to the devices.

The company also faces 60 class action lawsuits and another 145 individual suits from its recalls.

In a statement, Guidant executives said they would file a response to the FDA's latest finding by early next month.

"The company has already completed much of the work it believes is required to address the observation on a system-wide basis," officials said.

Guidant's St. Paul facility has been the focus of the federal investigations and inquiries into the company's manufacturing process.

In late December, the FDA sent Guidant a warning letter saying the company failed to resolve all the problems the agency discovered during an earlier inspection.

Deposition sheds light on Guidant defibrillator case

Wed, 22 Feb 2006 00:00:00 -0800

After a Guidant Corp. defibrillator failed to jolt a Minnesota student's heart back to life during cardiac arrest last year, the victim's doctors demanded an explanation from the Indianapolis medical device maker.

It offered one, saying its implantable defibrillator suffered from a short-circuiting glitch that the company fixed in 2002 by "rerouting" a wire in the tiny, battery-powered device. A top Guidant executive now tells what that repair entailed: applying some medical glue to the electrical wire.

"Sounds like rerouting to me," said Fred McCoy, the president of Guidant's cardiac rhythm management division in St. Paul, Minn., in a recent court deposition, according to legal documents provided to The Indianapolis Star.

McCoy's deposition, conducted by an attorney who is suing Guidant on behalf of defibrillator patients, contains the first lengthy comments to become publicly available from any Guidant executive about the series of quality problems that hit its defibrillator and pacemaker lines last year.

The problems prompted federal investigations of Guidant's handling of the incidents and nearly derailed the company's attempt to sell itself, although it now has lined up a new buyer. The product recalls also gave rise to dozens of lawsuits against Guidant by patients, including the first case scheduled for trial, on April 10 in Neuces County, Texas.

McCoy, a former Eli Lilly and Co. executive who has headed Guidant's defibrillator and pacemaker business since 2000, defended Guidant's actions under questioning from Robert Hilliard, the Corpus Christi attorney who is representing two defibrillator users in the upcoming jury trial.

Hilliard released the deposition this week. Some of the questions and answers were blacked out by Guidant in court-allowed editing. Some of McCoy's comments are likely to become points of contention in the trial, at which Guidant will face charges it failed to tell patients about potentially fatal flaws in defibrillators they relied on to help shock their weakened hearts into regular rhythm. Plaintiffs are expected to ask for a large damage award, possibly running into the millions of dollars.

The rerouting issue is significant because Guidant documents suggest the company didn't actually do a formal rerouting of the wire found to have short- circuited in its Prizm 2 defibrillators, a once-popular defibrillator that no longer is sold. Guidant told two Minnesota doctors last spring it did a rerouting of the wire, Hilliard said, citing a company presentation to the doctors.

Despite the claim, "Changes to route the feedthrough wire away were determined to be not cost-effective," an April 2005 Guidant memo obtained by Hilliard said.

McCoy, however, argued in his deposition that some glue the company applied to the wire amounted to rerouting it. "Patient safety is more important than cost considerations" at Guidant, McCoy said, downplaying the memo that referred to the fix not being cost-effective.

Guidant spokesman Steven Tragash said the company does not comment on litigation in which it is involved, so it had no comments on the deposition.

In other comments made in the deposition, taken Jan. 4, McCoy:

Denied any personal knowledge of the short-circuiting problem until May 2005, when the company finally revealed it to doctors and patients.

Couldn't say what was meant by "random event," a term Guidant used in an internal document to describe the short- circuiting problem and partially justify its decision to not issue a public alert.

"It's a troublesome term," McCoy said. He said the company also opted not to issue a public alert because the Prizm 2's reliability was still better than expected, despite at least two deaths from the short-circuiting problem.

Insisted he wouldn't want to be told about a rare but potentially fatal flaw in a defibrillator if it were implanted in his own chest. "The answer would be no," McCoy said. "But I appreciate that some (people) would (want to be told)."

Couldn't explain why Guidant claimed in a medical device report filed with the Food and Drug Administration in 2004 that it had gotten FDA approval for fixing the short-circuiting problem. "That seems to be in error," McCoy said of the claim.

Guidant fixed the problem in 2002 without obtaining FDA approval, he said.

Hilliard said he believes the law required Guidant to get FDA approval for making design changes in its Prizm 2 defibrillator, and he aims to make that argument in the trial. If Guidant didn't get FDA approval for the redesigned Prizm 2s, that means it was illegally selling an unapproved medical device, he said.

Hilliard said he also intends to highlight McCoy's comment that he wouldn't want to know about a rare fatal flaw in a defibrillator he himself was using.

"I lost my respect for him when he said that. Even the president of Ford would want to know if his Pinto would explode if hit from behind," Hilliard said.

He said Guidant has shown "no serious indications" it wants to settle the case before trial.

Guidant exec says FDA incorrectly told about defibrillator fixes

Wed, 22 Feb 2006 00:00:00 -0800

A Guidant Corp. executive acknowledged the medical device maker made changes to one of its defibrillators in 2002 and later incorrectly told federal regulators it had no effect on the product's performance.

Still, Fred McCoy, head of Guidant's cardiac rhythm management division, said in a deposition released this week that he didn't think the faulty defibrillator was responsible for patients' deaths.

"This particular failure mechanism does not have the capacity to kill a patient," McCoy said during a January deposition. "It may be unable, as a device, to save the patient."

The defibrillator, a Ventak Prizm 2 Model 1861, was among some 88,000 recalled by the Indianapolis-based company since June. Guidant also recalled or issued safety warnings for more than 200,000 pacemakers. At least seven deaths have been linked to the devices.

The first product liability case stemming from the recalls is set to begin April 10 in Corpus Christi, Texas.

In the 168-page deposition, McCoy said Guidant made two repairs to the Ventak Prizm 2 in 2002 to correct it from short circuiting. But neither modification was approved by the U.S. Food and Drug Administration, and only one was disclosed - in an annual report. In that filing, Guidant said the alteration had no affect on the device's performance.

In a filing two years later, the company incorrectly said it had received FDA approval to make the changes.

Guidant executives waited nearly three years to publicly disclose the flaws, and continued selling some of the defective models.

Bob Hilliard, who is representing two patients in the case, said McCoy's testimony could prove that Guidant sold an unapproved defibrillator - a violation of federal law.

"They've hung out every single doctor in the country if the device was unapproved," Hilliard said Wednesday.

FDA spokesman Stephen King declined to comment.

Guidant, which Boston Scientific officials hope to acquire by the end of next month, faces state and federal regulatory investigations as well as 60 class action lawsuits and another 145 individual suits from its recalls, according to documents filed Wednesday afternoon with the Securities and Exchange Commission.

A message was left by The Associated Press with Guidant spokesman Steve Tragash, who has said previously that the company does not comment on pending litigation.

McCoy, the Guidant executive, said he wasn't told about problems with the devices until May 2005. He also said if he were a patient about to receive one of the devices, he would not want to know if it had a specific problem that could be deadly.

"As an individual, I would not want to know," he said. "But I can concede many would."

Joe Duffey, the Florida-based producer of an online support site for defibrillator patients and their families, said he was surprised by McCoy's statements.

"If someone wants to keep their head in the sand, that's their business," he said. "But personally, I would want all the information available so I could make a reasoned decision with my doctor. Guidant has a responsibility to the end user to tell us what the heck is going on so we can make an informed judgment. That's what they deprived people of.

Guidant reports 18 more device failures

Fri, 30 Dec 2005 00:00:00 -0800

The Food and Drug Administration, in a letter to physicians, said it has received 18 more reports of Guidant heart implants failing.
Guidant now has reported 67 failures since problems surfaced with its implantable defibrillators in June. Seven deaths have been linked to the implant failures.

Indianapolis-based Guidant reported 14 more clinical failures with its Contak Renewal defibrillators, bringing total failures for that device to 35. Guidant also reported four more failures of its Ventak Prizm defibrillators, bringing its total to 32.

Guidant posted its own letter to physicians, detailing the additional failures, on Dec. 21. The letter was dated Dec. 20.
Guidant spokeswoman Annette Ruzicka, when asked to comment, referred to those letters on Guidant's Web site.

Since June, Guidant has recalled more than 100,000 of its defibrillators.

The company is undergoing scrutiny from the FDA to see if it followed reporting requirements. Dozens of lawsuits have been filed against Guidant, alleging it concealed vital information from patients.

The suits claim Guidant should not have waited to disclose the weakness in some of its devices, which it discovered in 2002.
Shares edged down 29 cents Thursday to close at $64.85.

Guidant is being wooed as a merger partner by two rival companies, Johnson & Johnson and Boston Scientific.

Guidant Gets FDA Warning Letter on Facility

Tue, 27 Dec 2005 00:00:00 -0800

Guidant Corp., one of the nation's top makers of pacemakers and heart defibrillators, said Tuesday that it received a warning letter from federal regulators regarding its operations in St. Paul, Minn.

Guidant said the warning, which comes from the Food and Drug Administration, is for the company's manufacturing, research and sales center in St. Paul. The FDA finished an inspection of the center, known as the company's Cardiac Rhythm Management facility, in September.

Guidant received the FDA's warning letter last Friday. The letter indicates that the FDA won't grant any of the company's requests for exportation certificates to foreign governments, or approve the company's applications for certain medical devices until Guidant takes steps to resolve the agency's concerns.

Guidant said it has thoroughly reviewed its St. Paul system and has made substantial steps toward addressing all the FDA's observations that prompted the warning letter. The company also said it believes it can fully address the FDA's concerns without seriously affecting its business.

The company disclosed in September that the FDA had raised some concerns about its St. Paul operations. The company said at the time that it planned to improve its product labeling and provide more frequent and detailed product performance reports, but Guidant hadn't yet received a response from the FDA.

Guidant's Device Failure Rate Revealed

Mon, 26 Dec 2005 00:00:00 -0800

Officials at Guidant Corp. projected that as many as 15 of every 10,000 of its Prizm 2 DR implantable heart defibrillator might fail per year, leading to death in some cases, but did not tell doctors or regulators about the problems, according to documents filed in a Texas state court.

The documents show the company estimated that the effects from short circuits in its Prizm 2 DR device could be life-threatening in about 12 percent of those cases, The New York Times reported Saturday.

The Guidant documents were filed Thursday in a Texas state court in Corpus Christi by attorney Robert C. Hilliard, who is representing plaintiffs who sued Indianapolis-based Guidant, claiming it failed to warn them about the possible defects.

A Guidant spokesman did not immediately return a call Sunday seeking comment. The company said in an e-mail to the newspaper that it does not comment on pending litigation.

In addition, New York State and the city of Bethlehem, Pa., have sued Guidant seeking reimbursement for device-related health care costs.

One of the records shows the company estimated that about 15 units out of every 10,000 were likely to short-circuit, the newspaper reported, citing the documents. Of those, about one in 10 would experience either death or a life-threatening episode.

Since June, Guidant has recalled or issued warnings about 88,000 heart defibrillators and almost 200,000 pacemakers because of reported malfunctions. The company is under investigation by federal and state officials and faces dozens of lawsuits over its recalls.

Report: Guidant knew of device's faults

Sat, 24 Dec 2005 00:00:00 -0800

Flaws in a heart defibrillator were known by manufacturer Guidant, but were viewed as acceptable within a statistical realm, the New York Times reports.

The Indianapolis-based company filed papers in a Texas court indicating officials were aware in 2002 that the consequences of the defibrillator's electrical failure were rare, but could be "life threatening." Despite that assessment, Guidant kept selling potentially flawed devices and did not notify doctors about the defect until last spring, when the problem was about to be made public by the Times, the newspaper said.

At least seven people have died because of the flaw, and Guidant has since recalled 80,000 implantable defibrillators in June. In September, Guidant recalled 380,000 pacemakers.

A chart on the document submitted to the court shows the company's acceptable failure rate was about 15 devices a year, a rate of slightly more than one a month.

"For Guidant, these people are numbers," said Dr. William Maisel, chairman of the Food and Drug Administration advisory committee that reviews heart devices. "Their descriptions are full of numbers. But for me, these patients are people."

Three more deaths are linked to faulty Guidant defibrillators

Thu, 15 Dec 2005 00:00:00 -0800

Three more patients with recalled defibrillators manufactured by Guidant Corp. have died, bringing the total number of known deaths linked to the faulty products to seven, officials with the troubled medical device maker said.

The additional deaths were reported to federal regulators in August, September and November, according to reports Guidant filed with the Food and Drug Administration.

One patient died July 28. It was not immediately clear when the other patients died.

All three had defibrillators with damaged or faulty wiring, according to the federal reports.

Overall, five patients with faulty Contak Renewal or Contak Renewal 2 defibrillators have died, as well as two patients with the Ventak Prizm 2 defibrillator, Guidant spokeswoman Annette Ruzicka said Wednesday.

Guidant said in a statement that it continually collects and analyzes information about the performance of its products.

Since June, Guidant has recalled or issued warnings about 88,000 heart defibrillators including its top seller, the Contak Renewal 3 and almost 200,000 pacemakers because of reported malfunctions. Pacemakers use mild electrical current to speed a slow heartbeat; defibrillators use a bigger jolt to correct life-threatening irregular heartbeats.

The company is under investigation by federal and state officials and faces dozens of lawsuits over its recalls. FDA spokeswoman Julie Zawisza declined to comment on the reports.

Guidant contractor gets subpoena about devices

Tue, 22 Nov 2005 00:00:00 -0800

Accellent Inc., a contract manufacturer for heart-device makers including Guidant Corp., said it received a U.S. Justice Department subpoena for information related to a probe of Guidant defibrillators.

The subpoena is connected to an investigation by the U.S. Attorney's office in Minneapolis that last month prompted a separate subpoena to Guidant, Wilmington, Mass.-based Accellent subsidiary, Accellent Corp., said Monday in a filing with the U.S. Securities and Exchange Commission.

Indianapolis-based Guidant said Oct. 25 it received a subpoena from the Minneapolis office seeking information on three defibrillators: Ventak Prizm 2, Contak Renewal 1 and Contak Renewal 2. The company's heart-device operations are in Arden Hills.

Defective heart devices leave taxpayers with bills

Sat, 19 Nov 2005 00:00:00 -0800

Gregg Gruis remembers how thankful he was to be alive after doctors implanted a defibrillator in his chest to shock his weakened heart into beating but now he sometimes feels like giving up.

His first defibrillator gave out in May of 2003 after two years, short of the unit's expected four-to seven-year life span, and a second defibrillator was surgically removed in March after it was found to have flaws. This summer his third device also was recalled. On top of that, because of a labyrinth of hospital charges not unraveled until this week, Gruis has delayed more treatments for the past eight months in the face of tens of thousands of dollars in medical bills.

"Someday I'm not going to wake up," said Gruis, 58, who has undergone 10 shock treatments during the past six years in failed attempts to regulate the beating of his heart. "I didn't want to leave my wife with all these bills."

To make matters worse, Gruis also has been caught up in the largest-ever recall of defibrillators and of pacemakers that keep the heart beating. Since June, more than 200,000 devices made by Guidant Corp. have been recalled, as well as another 80,000 units manufactured by Medtronic Inc. Both companies reportedly knew of defects for at least two years but continued selling the devices until the U.S. Food and Drug Administration removed them from the marketplace this summer. Neither company returned telephone calls for this story.

Although the manufacturers are giving reimbursements to replace some of the recalled devices, it is patients, private insurance companies and ultimately taxpayers who are picking up the tab for hospital and doctor fees in the change-out surgeries.

Medicare, the federally funded program that helps pay health care costs for people with disabilities and those over age 65, is covering much of the costs, as is Medicaid, which provides assistance for the needy, aged, blind and low-income families. Federal officials in Washington, D.C., refused to disclose how much has been paid but said reimbursements are under negotiations with the device manufacturers.

It's probable that because many patients are elderly, the bulk of the change-out surgeries are being paid for by the federally funded insurance plans, said Daron Cowley, spokesman for Intermountain Health Care, or IHC, Utah's largest hospital chain.

For instance, nearly 70 percent of the 72 patients undergoing change-out surgeries at IHC hospitals this year were covered by Medicare or Medicaid. And at the University of Utah hospital, four of five patients were covered by Medicare. At IHC, 18 patients had private insurance, and another five had no insurance and were given charitable care. In all cases, manufacturers issued full rebates for replacement heart devices or donated units to uninsured patients. The IHC charges ranged from $2,800 to $31,000. The average hospital tab was less than $6,000.

Gruis' hospital bill came to nearly $111,000 at Salt Lake Regional Medical Center in March, including a charge of $84,000 to replace his defibrillator, Model 7274 Marquis made by Medtronic Inc. His warranty stated that Medtronic would not cover a replacement device made by another company. Two months later his Guidant unit also was recalled. Bills from the first change-out surgery caused him to postpone more treatments because his IHC insurance paid only $36,000 of the costs, leaving him with a tab of more than $75,000. Medicare paid nothing.

Gruis is a Wall-Mart greeter whose sales career ended in 1997 when an uninsured motorist ran a red light on Bangerter Highway and crashed head-on into his car. He suffered brain damage and then heart problems that worsened with each successive surgery. Finances since the accident have been tight. He pays $500 a month to remain on his wife's IHC policy.

"I've always been an optimistic person," said Gruis, "but there are some days where I just want to give up."

On Wednesday, questions about Gruis' bills were finally unraveled after what he said were repeated calls to his private insurer, Medicare representatives and Salt Lake Regional. Basically, he owes nothing because the hospital had written off more than $75,000 in an adjustment that came after Medicare refused payment.

Dawn Booth, spokesperson for Salt Lake Regional, said it is standard practice for hospitals not to send out zero-balance statements to patients. "It is up to insurance companies and Medicare not hospitals to send out explanations of benefits," she added.
    Conversely at IHC, spokesman Daron Cowley said hospitals in its system routinely mail zero-balance statements to patients.
    Gruis now must schedule a date for a three-day hospital stay to determine if medication may help his weakened heart. His second recalled defibrillator, which remains implanted in his chest, has been turned off so that it no longer regulates the top portion of his heart.

"Why are patients, taxpayers and private insurance companies paying to replace these defective devices?" asked Gruis. "Why aren't the manufacturers responsible?"

Another implant patient, Zina Lewis, 39, of Park City, who faces surgery next week to replace a defective Guidant pacemaker, said patients can go into debt paying insurance deductibles, travel costs and time out of work during hospital stays along with the worry of reaching insurance caps that range from $1 million to $2 million. Since her teens when her first pacemaker was implanted, she's had medical expenses totaling $750,000.

"I am now under my husband's IHC policy and we have some distance yet before we reach our maximum, but I'm also in my 30s. What happens when that runs out?" she asked. "Why should the private payers, Medicare and the taxpayers, have to pay for marketing and sales of fraudulent devices that are known to be failing at increasing rates?"

Lewis was unable to get information on the reliability of the lead wires that connect her device to her heart until late this month when Guidant issued a statement indicating the leads are more likely to fail than its recalled pacemakers or defibrillators. The report cited 179 cases involving lead wires that failed. By contrast, the company said its heart devices have experienced only five failures.

New York Sues Guidant for Fraud in Alleged Cover-up of Defibrillator Defects

Sat, 05 Nov 2005 00:00:00 -0800

New York Attorney General Eliot Spitzer has filed a law suit in N.Y.S. Supreme Court (Manhattan) against the medical device maker Guidant Corp., alleging that it covered up problems with one of their implantable heart defibrillators, a device that uses electric shocks to normalize the heart beat in patients with abnormal, and potentially fatal, heart rhythms.

The 11-page complaint states that Guidant’s Ventak Prizm defibrillators were flawed thereby causing 28 of them to stop working without warning. As a result of this serious malfunction, one patient died of cardiac arrest when his defibrillator short-circuited and failed to deliver the jolt of electricity that could have saved his life.

The complaint also alleges that Guidant failed to alert medical professionals to the flawed devices despite the fact that it was fully aware of the problem since 2002.

The 13,900 recalled Ventak Prizms were all made prior to April of 2002. Warnings have been issued for 88,000 defibrillators and 200,000 pacemakers because of reported malfunctions. To date, doctors have replaced many of the faulty defibrillators. Many patients, however, are torn between having additional surgery and gambling that their device is not one of the defective ones.

In May, Guidant disclosed the information about the flaw just prior to the publication of a New York Times article regarding the defect. While Guidant has offered $2,500 to cover the cost of replacing recalled units, the actual cost of replacing a heart defibrillator through surgery is considerably higher than that amount.

“Concealment of negative facts that might influence a consumer to purchase another manufacturer’s product is the essence of fraud,” said Spitzer in an issued statement. Spitzer, who has gained a reputation for his tenacious enforcement of consumer and shareholder rights, is seeking damages for harm suffered by patients and their health plans.

This is just the latest lawsuit to be brought against the company but it may turn out to be the most significant one to date since Johnson & Johnson is already contemplating abandoning its planned $25.4 billion acquisition of Guidant. Several private lawsuits were previously filed against the manufacturers over the defibrillators.

Feds Probing Heart Device Firms

Wed, 26 Oct 2005 00:00:00 -0700

The Justice Department has started a broad investigation into whether makers of implantable heart devices have offered payments or other inducements to doctors or others as a means of promoting use of their products, a major manufacturer said late Tuesday.

Medtronic Inc., the nation's biggest maker of pacemakers and defibrillators, said it had received a subpoena from the U.S. attorney in Boston seeking information related to the provision of payments or other benefits to people like doctors who help decide which company's products to use.

Additionally, federal prosecutors have subpoenaed rival heart device makers St. Jude Medical Inc. and Guidant Corp., seeking documents related to implanted pacemakers and defibrillators, the companies said Tuesday.

The three medical device makers, all of which have a strong presence in the Twin Cities, said the civil subpoenas came from the U.S. attorney's office in Boston. Additionally, Guidant, in a statement, said it received a subpoena from the Minneapolis U.S. attorney's office.

Medtronic said it was asked for documents about products such as pacemakers and compliance materials related to fraud and anti-kickback statutes, the Fridley-based company said in a statement Tuesday. Little Canada-based St. Jude, ranked No. 3, said it was subpoenaed for documents on general industry practices since January 2000, according to a U.S. Securities and Exchange Commission filing earlier Tuesday.

Guidant's release said the Minneapolis subpoena requests documents relating to the company's Ventak Prizm 2 defibrillator and Contak Renewal pacemaker. Guidant is based in Indianapolis, but it develops its heart devices in Arden Hills. Guidant, the second-largest maker of heart devices, said its subpoena from the Boston U.S. Attorney's office requested documents on pacemakers and related products.

All three companies said they would cooperate with the requests. Medtronic spokesman Rob Clark and Guidant spokesman Steven Tragash didn't return phone messages to their offices after business hours. St. Jude spokeswoman Angela Craig declined to say which documents were sought. She said the subpoena was "a broad request."

Pacemakers use a mild electrical current to speed a slow heartbeat, while defibrillators jolt hearts that have life-threatening irregular beats.

In news releases, none of the companies said what prompted the subpoena, but heart devices have come under increasing scrutiny in recent months.

Dhulsini De Zoysa, an analyst with S.G. Cowen & Co., citing company management, said last month that criminal investigators for the Food and Drug Administration questioned two former Guidant employees.

Guidant recalled some of its cardiac defibrillators June 17 because of reported failures and at least two deaths. The recall involved 50,000 devices, including a model that developed flaws the company fixed in 2002. A week later, Guidant told doctors to stop using five models with another defect. No injuries or deaths were reported in that case.

On Aug. 25, the Food and Drug Administration said it was conducting comprehensive inspections of Guidant's factories. The agency said it couldn't reveal how extensive the inspections would be or how long they may take.

Last week, Medtronic said its Endeavor drug-coated stent failed to keep heart arteries open as effectively as Johnson & Johnson's Cypher in the first head-to-head U.S. study comparing the devices.

Johnson & Johnson has signaled it may seek to reduce its December offer to buy Guidant for $25.4 billion. J&J, the world's biggest maker of medical devices, has said it's considering "alternatives."

Guidant Reports Six More Cases of Heart Device Failures

Fri, 14 Oct 2005 00:00:00 -0700

Guidant Corp. told U.S. regulators that it learned of six additional failures of implantable heart defibrillators since issuing a July notice about the devices used to regulate cardiac rhythms.

The failures occurred in the Contak Renewal and Renewal 2 models, the Food and Drug Administration said in an update posted Thursday on the agency's website. The two devices were among models included in warnings Guidant sent to doctors in June, which the FDA classified July 1 as recalls.

Guidant's cardiac rhythm management division is based in Arden Hills.

The new reports of failures bring the total worldwide to 21, including three cases in which patients died, Daniel Schultz, the director of the FDA's Center for Devices and Radiological Health, said. Guidant's June warnings affected 109,000 defibrillators and prompted the FDA and doctors to assess how to better notify doctors and consumers about risks of heart devices.

Guidant reported the additional cases to physicians and on its website last month.

FDA Study Shows Defibrillator Malfunctions are on the Rise

Mon, 26 Sep 2005 00:00:00 -0700

The U.S. Food and Drug Administration (FDA) has released its review of implantable cardioverter defibrillator (ICD) and pacemaker (PM) malfunctions for the period from 1990-2002.

The findings were presented at the Heart Rhythm Society “Policy Conference on Pacemaker and ICD Performance” in Washington, DC.

The study found that thousands of patients were affected by PM and ICD malfunctions during the 12-year period, and that malfunctions were directly responsible for 61 confirmed deaths. While the study found a decrease over time in the annual number of malfunctioning pacemakers that were removed and replaced in patients (4.6 per thousand), there was an increase in the number of malfunctioning ICDs (20.7 per thousand), especially during the last three years of the study, when more than 50% of the reported malfunctions occurred.

Potential reasons for the increase in ICD malfunctions include the increased complexity of the ICD devices, manufacturing challenges posed by this complexity, and increased reporting by physicians. The authors stated that ICDs are a rapidly changing technology. Over the past 10 years, ICDs have shrunk in size, provided more therapeutic features, and increased their memory. The decrease in size has brought modifications to battery, capacitor, and circuitry design that may account for some of the malfunctions.

The study also concluded that careful monitoring of device performance is needed. That may include requesting more detailed information from manufacturers before the devices are approved for marketing and while they are in use by the clinical community. Another important step is finding ways to communicate more effectively with physicians and patients when the devices malfunction.

“The FDA is committed to continuing to improve the quality of information that patients and doctors have to make decisions about the safe and effective use of these critical, life-saving technologies,” said Scott Gottlieb, MD, FDA Deputy Commissioner for Scientific and Medical Affairs. “Pacemakers and ICDs have saved many lives and the benefits of the devices clearly outweigh the risks. All sophisticated medical devices like these have certain risks. Our challenge remains to uncover these risks, measure them, and make information available to patients and doctors to help guide their personalized decisions about where the benefits of technologies like these outweigh known or potential risks from their use.”

In preparing this report, the FDA reviewed 366 PMA annual reports, covering hundreds of pacemaker and ICD models. In light of the findings, the FDA is considering doing analyses like this for ICDs and pacemakers on a periodic basis, so they can monitor the malfunction trends.

The FDA is also taking other steps to address the troubling information found in their report. They have begun to better coordinate their pre and post-market regulation of the devices, insuring that products are closely monitored after they are in clinical use. They are also considering asking manufacturers for more comprehensive data, and they are exploring ways to better communicate with physicians and patients.

The FDA has also established a defibrillator working group which is exploring the best way the FDA can make information about defibrillator recalls available to physicians and patients.

The FDA stressed that the vast majority of reported malfunctions did not lead to death or serious injury, and were detected in time to ensure that patients would continue to receive therapy when it was needed.

“It is important for patients to understand that there is no action that they need to take as a result of this report. It does alert FDA that there is a trend that needs to be addressed and points out the need for the agency to improve the way it regulates these products, and we are doing just that,” said Daniel Schultz, MD, Director of FDA’s Center for Devices and Radiological Health (CDRH).

The FDA has the following top-priority actions underway:

·Increasing CDRH’s ability to obtain critical information about medical device failures so they can communicate this information clearly and rapidly to both physicians and patients, allowing them to make informed medical decisions.

·For ICDs in particular, the formation of a working group so information can be quickly reviewed and evaluated by staff, and shared more rapidly with the public.

·Operational changes in CDRH’s post-market program to track the performance of medical devices once they each the market and are in general use. These changes include targeting resources to inspect firms that manufacture potentially higher risk devices, the design of an electronic system for adverse event reporting, and developing guidance for companies to insure that annual reports provide the types of information required for prompt and efficient review by the FDA.

FDA: Defibrillator Defects on the Rise

Fri, 16 Sep 2005 00:00:00 -0700

Malfunctions in implanted heart defibrillators were on the rise even before this summer's massive recall by Guidant Corp., government and Harvard University scientists reported Friday.

About 20 of every 1,000 defibrillators implanted are malfunctioning, and defects led to 31 deaths between 1990 and 2002, concluded research sponsored by the Food and Drug Administration.

The deaths represent only a fraction of the more than 400,000 defibrillators implanted during those years, but a troubling number nonetheless as regulators grapple with how to better ensure the safety of hard-to-replace devices.

Despite the defects, defibrillators "have saved many lives and the benefits of the devices clearly outweigh the risks," said Dr. Scott Gottlieb, an FDA deputy commissioner.

But, the study "does alert FDA that there is a trend that needs to be addressed, and points out the need for our agency to improve the way it regulates these products, and we are doing just that," said Dr. Daniel Schultz, FDA's medical device chief.

The study came as the FDA and cardiac specialists opened a daylong meeting Friday to discuss safety problems with implanted defibrillators and pacemakers, and how to decide which frightened patients need to have the devices surgically replaced when manufacturers learn that some parts might fail.

That can be a tough balancing act: Failures are rare, and ways to predict whose implant will fail don't always exist, while surgery to remove and replace the implant itself is risky.

But it's of growing public concern, because since January, the nation's three leading defibrillator makers: Guidant, Medtronic and St. Jude Medical have issued recalls or safety warnings affecting more than 200,000 defibrillators.

Guidant in particular has come under fire after acknowledging that it waited three years before alerting doctors and some 24,000 patients about an electrical system defect with one of its recalled models ultimately linked to two deaths.

FDA is considering changes to the way it monitors such devices, Schultz said.

The study, conducted for FDA by Dr. William Maisel, a Harvard medical professor, found that from 1990 to 2002, there were 2.25 million pacemakers and almost 416,000 implanted cardiac defibrillators, or ICDs, implanted in the United States. More than 17,000 of them 8,834 pacemakers and 8,489 ICDs had to be surgically removed because of confirmed malfunctions, Maisel found.

These were not simple problems like battery depletion. Eighty percent were device hardware problems, such as with electrical connections.

More disconcerting than the actual number, FDA said, was the trend: In the mid-1990s, some 7.9 ICDs per 1,000 implants were replaced because of malfunctions. That rose to a high of 38.6 per 1,000 implants in 2001 before dropping slightly to a rate of 20.7 the following year.

More than half of the malfunctions occurred during the study's last three years.

In contrast, the rate of replacement for malfunctioning pacemakers steadily dropped during the study, to a low of 1.4 per 1,000 implants.

There were 30 confirmed deaths due to malfunctioning pacemakers during the 12-year period, a lower rate than for defibrillators because so many more pacemakers were implanted.

Pacemakers use mild electrical current to speed a slow heartbeat. Defibrillators use a bigger jolt of electricity on hearts that go into life-threatening irregular beats. Pacemakers have been around for decades, but only since the mid-1990s have ICDs become fairly common and these devices are becoming increasingly complex, as manufacturers make them smaller and add pacemaker features.

These likely are low estimates, FDA officials said Friday. The study tracked only surgically removed devices for which the manufacturer later confirmed a malfunction. Moreover, doctors aren't required to report malfunctions even if they suspect a patient death was due to one and not to the underlying heart disease, a sometimes difficult distinction.

Parker & Waichman, LLP, Files Class Action Lawsuit on Behalf of Victims of Defective Guidant Defibrillators

Fri, 12 Aug 2005 00:00:00 -0700

Parker & Waichman, LLP (http://www.yourlawyer.com) announces that, along with Douglas & London, P.C., it has filed a class action lawsuit on behalf of victims of defective defibrillators manufactured by Guidant Corporation (NYSE: GDT).

The suit was filed in The United States District Court for the Eastern District of New York.

Additionally, the Judicial Panel on Multidistrict Litigation has scheduled a hearing for September 29, 2005 in Asheville, North Carolina regarding a motion to consolidate federal cases against Guidant Corporation. Parker & Waichman, LLP continues to provide free case evaluations to all victims of defective Guidant defibrillators; case evaluations may be requested at www.guidantdefibrillatorsrecall.com or http://www.yourlawyer.com/practice/overview.htm?topic=Guidant%20Defibrillators.

Guidant Corp. recently recalled 11 of its defibrillator models due to malfunctions; the recall affected approximately 88,000 implanted devices.

The malfunctions occurred when a magnetic switch inside the device became stuck and prevented the device from operating properly. The affected defibrillator models are: Contak Renewal (model H135), Contak Renewal 2 (model H155), Ventak Prizm 2 DR (model 1861, Vetak Prizm AVT, Vitality AVT, Renewal AVT, Contak Renewal 3, Contak Renewal 4, Renewal 3, Renewal 4 AVT and Renewal RF.

At the time of the recall, Guidant Corp. issued specific reprogramming instructions and recommendations to physicians that were intended to correct the defect. However, on July 22, Guidant Corp. said that one of the recommendations made may significantly increase the risk that the Ventak Prizm, Vitality and Contak Renewal device models would malfunction.

The defects associated with these Guidant defibrillators first surfaced in the company’s August 2003 annual report. However, the company did not notify patients nor doctors about the defects until June 2005. The New York Times reported that Guidant failed tell doctors and patients for three years that the VENTAK PRIZM 2 DR model contained a flaw that caused some defibrillators to short-circuit. However, Guidant stood by its decision to continue selling the PRIZM 2 DR for months, declaring that the original device was still reliable.

About Multidistrict Litigation

Multidistrict litigation is a procedure utilized in the Federal Court system where all pending civil cases of a similar type, filed throughout the Federal District Courts in United States, are transferred to one federal judge for the purpose of pre-trial discovery. The decision of whether cases should be transferred is made by a panel of seven federal judges appointed by the Chief Justice of the United States Supreme Court. The Judicial Panel on Multidistrict Litigation meets periodically to review requests that cases be consolidated for pretrial matters, pursuant to 28 U.S.C. § 1407, a law passed by Congress.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. With offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. For more information on Parker & Waichman, LLP please visit: (http://www.yourlawyer.com) or call 1-800-LAW-INFO (1-800-529-4636).

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Guidant May Face Senate Scrutiny

Sun, 31 Jul 2005 00:00:00 -0700

At first blush, it might seem a bit unusual that the chairman of the Senate Finance Committee has taken a sudden interest in a series of heart device recalls by Guidant Corp.

Though a big-money business, defibrillators and pacemakers hardly seem the purview of one of Congress' most powerful bodies.

But no one in the medical technology industry was terribly surprised this month when Sen. Charles Grassley asked the Food and Drug Administration (FDA) for documents relating to the recent recall of some 150,000 heart defibrillators and pacemakers.

As Grassley pointed out in two recent letters to FDA Commissioner Lester Crawford, his committee has jurisdiction over Medicare and Medicaid programs, which provides health insurance for more than 80 million Americans and often pays for the sophisticated devices.

In the past year, Grassley, 72 and a farmer by trade, has emerged an ardent critic of the FDA, which regulates the drugs and devices approved for use in the United States.

The Iowa Republican began conducting oversight of the embattled regulatory agency after concerns surfaced about how it handled the suicide risks of teenagers using antidepressants and the cardiovascular risks associated with the painkiller Vioxx.

Now Grassley has requested copies of annual post-approval reports for the models of defibrillators and pacemakers that were the subject of Guidant safety alerts in recent weeks. These reports, he said, are not available to the public, even though they might contain important performance data about the devices.

He asked Crawford to explain why these reports are not posted on the FDA's website, and whether the agency is reconsidering procedures for surveillance of devices once they're approved and widely available to the public.

Indianapolis-based Guidant, which makes its heart devices in Arden Hills, came under fire after the death in March of a 21-year-old Grand Rapids college student, Joshua Oukrop, whose heart condition was treated in 2001 with one of the company's defibrillators. It was subsequently revealed that his model of defibrillator had an electrical flaw that was remedied in 2002 action that was reported to the FDA.

However, neither Oukrop nor his doctors were told that he was implanted with a potentially faulty device until it was too late. Other physicians and patients were not notified until May of this year when his doctors went public with their concerns about the device.

The controversy raises questions about when doctors should be told about device malfunctions, and to what extent. Fred McCoy, president of Guidant's cardiac rhythm management business, said this week that it's clear doctors want more information and that the company is more than willing to provide it.

Asked specifically about Grassley's questions for the FDA, McCoy said in an interview that "Guidant is an open book. We'll follow that process wherever it leads, it's certainly not something we're concerned about."

Grassley also asked Crawford to describe the agency's disclosure policy regarding post-approval documents for devices not only for defibrillators and pacemakers, but for all devices.

The dissemination of post-approval information about drugs and possible harmful side effects has long concerned the senator. He declined, through a spokeswoman, to be interviewed.

"The job for Congress, the FDA and consumer advocates is to get to the bottom of drug safety procedures and figure out, once and for all, what it'll take to make sure Americans can trust what's in our medicine cabinets," Grassley said in a speech to the Consumer Federation of America last March.

"Better-informed patients and doctors can make informed decisions about whether a drug is right for them," he said.

Grassley has also questioned whether the FDA is too cozy with the pharmaceutical industry, and has called for changes that he says would bring greater responsiveness and transparency to the agency.

In that vein, Grassley and Sen. Christopher Dodd, D-Conn., have introduced legislation creating a publicly accessible national data bank of clinical trial information. In addition, the two have introduced a measure to establish an independent office for drug safety within the FDA that would regulate drugs once they're on the market. Both bills are pending.

Grassley's efforts have gained support from several consumer groups including Ralph Nader's Public Citizen, which has battled the FDA for decades.

"The FDA is getting direct cash, over $200 million a year, from industries [it regulates] and it has a very detrimental effect of the ability of the FDA to protect the public," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

Whether Grassley's recent request for device-related documents will result in committee hearings or legislation is unclear at this point. His spokeswoman said a decision about whether hearings will be held "will be made as the process unfolds."

Wolfe supports the idea of a public forum to discuss these issues. "I'm sure there are a lot more things that the FDA knows or that the company knows about the Guidant or many of these other disasters that would only come out if there's a public hearing where pointed questions were asked and the people answering them fearing perjury if they lied or gave incomplete answers," he said.

An FDA spokeswoman said Friday that the agency would "carefully consider" Grassley's request.

Guidant Says Defibrillator Fix May Make Things Worse

Sat, 23 Jul 2005 00:00:00 -0700

Guidant Corp. issued an urgent warning to doctors today saying a recommendation it issued just last month to fix a problem in three of its implantable defibrillators may actually make matters worse.

The notice affects a subset of patients with implanted defibrillators sold under the names Ventak Prizm AVT, Vitality AVT and Contak Renewal AVT.

On June 17, Guidant issued a warning letter saying that some of the devices were subject to locking up. At that time, 20,950 of the devices had been implanted, and two failures had been investigated by the company.

One of the company's recommendations to fix the problem included a programming change.

But on July 11, a third device reportedly locked up in a U.S. patient. The device had been reprogrammed according to Guidant's earlier recommendations. The patient was not injured but the defibrillator had to be replaced.

The company said it is investigating additional "events," including a possible injury.

The latest warning may be considered a recall by the Food and Drug Administration, Guidant said. The company determined that one of its original programming recommendations can actually increase the risk of failure in some of the defibrillators.

When these devices enter what's called a "latched state," they won't detect arrhythmias. Communication with the devices won't work properly. And they may continue delivering therapy "independent of patient need," according to the corrective action letter Guidant issued to doctors. If latching has occurred, the device should be replaced, the company said.

Doctors were advised to schedule a follow-up visit as soon as possible for patients whose defibrillators were reprogrammed according to the company's June recommendations, as well as certain other patients with specific device settings. The company has issued new programming recommendations.

Guidant is working on a software fix for the Vitality AVT and all Renewal AVT devices. It expects the fixes to be available early in the fourth quarter, pending FDA approval. No software update is pending for the Prizm AVT, as the company estimates that few will be in service by the time one would be developed and approved.

Additional information is available at 1-866-484-3268, and www.guidant.com/physician_communications/AVT_2.pdf.

Guidant: Original Fix For Defibrillators May Increase Risk

Fri, 22 Jul 2005 00:00:00 -0700

Guidant is backtracking on some advice it gave to doctors last month concerning problems with its implantable defibrillators. The company now says the recommendations may actually increase risk to patients.

Guidant
Contak Renewal 3 implantable defibrillator

Implantable defibrillators are pacemaker-like devices that shock the heart back into a normal rhythm when they detect abnormal heartbeats. On June 17, Guidant issued safety warnings on 11 models of its defibrillators because of malfunctions. That affected about 88,000 implanted devices.

The devices malfunctioned when a magnetic switch inside the device got stuck and prevented the device from providing treatment. Guidant has now updated recommended programming changes for the units.

The devices are:

VENTAK PRIZM 2 DR (Model 1861) ICDs manufactured on or before April 16, 2002

CONTAK RENEWAL (Model H135) and CONTAK RENEWAL 2 (Model H155) CRT-Ds manufactured on or before August 26, 2004

VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT ICDs (All series numbers)

Earlier this month, the company also issued safety warnings on nine pacemaker models.

For more information, contact Guidant at (866) 484-3268 or visit Guidant.com

Guidant Revises Safety Recommendations For Some Defibrillator Models

Fri, 22 Jul 2005 00:00:00 -0700

Guidant Corp. issued an urgent warning to doctors today saying a recommendation it issued just last month to fix a problem in three of its implantable defibrillators may actually make matters worse.

The company said a programming change it suggested to physicians in June may "significantly increase" the risk that a magnetic switch in the Ventak Prizm, Vitality and Contak Renewal devices would become stuck and prevent them from providing treatment.

Defibrillators are pacermaker-like devices that shock a heart back into normal rhythm when a rapid, irregular beat is detected.

The company said Friday it found that a malfunction had occurred in one of the devices after it was reprogrammed. In that instance, the patient was not injured, but had to have the device replaced. Guidant said it is now investigating other instances of malfunction, including a possible injury.

Guidant last month issued safety warnings on 11 models of its surgically implanted defibrillators, affecting about 88,000 of the devices, after two malfunctions. The company on Monday issued warnings on nine of its implantable pacemaker models.

The earlier defibrillator malfunctions resulted in two patient deaths, and the U.S. Food and Drug Administration classified Guidant's safety warnings about the devices as recalls. The agency also plans to assign its highest priority recall to some number of the pacemakers, FDA spokeswoman Julie Zawisza said Friday.

The FDA continues to work with Guidant to address the programming problems with its defibrillators, she said.

"We are working with the firm to better understand the nature of the software problems so that they may be fixed as soon as possible," Zawisza said.

The Indianapolis-based company said it notified physicians Friday that its programming recommendations heightened the risk of malfunctions in the three models, but did not elaborate on what alternative recommendations it may have made.

Messages left Friday seeking comment from Guidant officials were not returned.

Guidant's most recent announcement came a day after it reported its second-quarter profit dropped 15 percent, led by the costs of recalling and replacing its implanted defibrillators. Guidant has offered to pay for replacing or reprogramming the faulty devices and has anticipated taking a $113 million charge associated with the actions.

John Putnam, a senior vice president and analyst with Stanford Group Co., said the programming problem was "unfortunate" but not entirely surprising considering the complexity of the cassette tape-sized defibrillators.

"When you think about a defibrillator, they're really computers, 24-7. They're pretty sophisticated and it's not surprising, I guess, that they had an additional problem," Putnam said.

Shares in Guidant, which has agreed to be acquired by New Brunswick, N.J.-based Johnson & Johnson for $25.4 billion, fell 35 cents to close at $69.28 in trading on the New York Stock Exchange.

GUIDANT CORP. SUED FOR WRONGFUL DEATH OF ELDERLY DEFIBRILLATOR PATIENT CLASS-ACTION LOOMS

Fri, 15 Jul 2005 00:00:00 -0700

It was only a matter of time before the lawsuits arising out of the Guidant heart defibrillator debacle began. Moreover, the individual lawsuits will undoubtedly spawn one or more federal or state class-actions on behalf of the approximately 24,000 people who are living with one of the defective devices implanted in them.

In Jacksonville, Florida a wrongful death action has been brought on behalf of the estate of a 75-year-old man, Robert Earl Smith, who died when his defibrillator allegedly failed to shock his heart back into normal rhythm after he collapsed.

In addition to the lawsuit on behalf of the estate, Mr. Smith’s son also wishes to have a class-action declared so that all of the affected patients can have their rights adjudicated in one action.
According to Newsday.com, there are presently similar lawsuits in federal and state courts in Indiana.

There is no doubt that, while Guidant Corporation maintained its internal heart defibrillator (the Ventak Prizm 2 DR) was safe and extremely reliable, it was fully aware of an electrical problem in thousands of those devices which could cause them to short-circuit when needed.

On May 24, Guidant disclosed for the first time that it had waited three years before disclosing it had been aware of the electrical problem that had caused some 28 of these defibrillators to malfunction. The revelation came in the form of an alert to physicians which was not issued until Guidant learned that The New York Times was about to publish a story on the defibrillator.

In March, a 21-year-old college student, Joshua Oukrop, who required a defibrillator because he suffered from a genetic heart disease, died while on a spring break bicycling trip. These events prompted an investigation by the FDA.

As the story developed, however, the number of potentially defective defibrillators still in use reached almost 50,000; the 28,900 with the electrical problem and another 21,000 which could malfunction due to a computer memory error (the Vertak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT ICD). There had been 2 reports of failures associated with these other models. Neither report involved injury or death.

Then, a third problem came to light with respect to another potential short-circuit risk associated with the Contak Renewal (Model H135) and the Comtak Renewal 2 (Model H155). Out of those 16,000 devices, 15 reports of failures had been received including one involving a death on May 30.

As a result, Guidant issued recalls for all of these devices. The Ventak Prizm 2 DR should be monitored and will be replaced if necessary by Guidant at no charge. For the models with potential memory errors, Guidant is recommending an in office programming change that can reduce the risk until Guidant is able to design a software solution. The remaining devices should be monitored at three-month intervals and undergo a complete trouble-shooting procedure if a yellow warning screen appears on the programmer.

Many experts are now questioning a monitoring system which essentially leaves the question of disclosure, with respect to potential flaws in such critical medical devices, entirely to the manufacturer.

The current system is seen as problematic for a number of reasons. First, the ultimate decision may be based not only on patient safety issues but, also, on extraneous considerations such as potential legal liability and loss of market share to competitors. Second, the FDA does not collect comprehensive data on these devices after they are approved. Finally, hospitals and doctors do not notify the FDA about all device-related problems. Reporting of such incidents is spotty at best.

Currently, a group of doctors who treat heart-related problems are considering setting up a task force to develop proposed guidelines with respect to physician alerts.

In the Guidant case, it seems clear that the impending expose by the New York Times, instead of 2 deaths and 45 reported failures, prompted the manufacturer’s belated revelations. Attorneys who are suing Guidant as well as many of their clients see Guidant’s long delay as a damaging admission by the company which they believe must be held accountable for its actions.

None of this, however, even begins to address the problem of some 50,000 heart patients with implanted defibrillators being very jittery about their safety. Simply stated, since the purpose of an electrical heart defibrillator is to shock an irregularly beating heart back into proper rhythm, any malfunction can be extremely serious. In fact, if normal heart rhythm is not restored, death will result within minutes.

For this reason, heart specialists are anticipating a flurry of office visits and telephone calls from patients who have one of the recalled defibrillators. Doctors are advising patients to remain calm and not to assume that their particular device must be removed and replaced immediately.

The FDA is advising affected patients to consult with their doctors to discuss the recall especially if they have recently received a defibrillator shock.

FDA Preliminary Public Health Notification: Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators

Thu, 14 Jul 2005 00:00:00 -0700

This is to provide clinicians with current information and guidance concerning malfunctions occurring with Guidant’s PRIZM 2 and CONTAK RENEWAL implantable cardioverter defibrillator (ICD) devices, which were the subjects of a Class I recall announced by FDA on July 1, 2005.

The affected devices are:

* VENTAK PRIZM® 2 DR, Model 1861, manufactured on or before April 16, 2002
* CONTAK RENEWAL®, Model H135, manufactured on or before August 26, 2004
* CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004.

The malfunction that is the subject of the recall causes damage to the device’s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail. At this time it is not possible to provide accurate estimates of the failure rate for these devices, but at least two deaths attributable to this failure mode have been reported.

Recommendations:

If this failure mode is demonstrated to have occurred, the device should be replaced. However, the FDA is not making a recommendation on whether patients who have one of these devices should have it replaced under other circumstances. We believe that this decision must be made by the patient in consultation with his or her physician, and should be based on the patient’s condition, medical history, and other pertinent factors.

We recommend that you:

1. Contact each of your patients affected by the recall, and advise coming in for an evaluation if he or she has not been seen recently. Discuss with the patient the factors that will enter into the decision regarding replacement, including medical history, the risks of replacement, device battery status, and the likelihood that this patient will require the defibrillation or pacing features of the device in the future. You may wish to provide a copy of FDA’s “Advice to Patients with VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators” http://www.fda.gov/cdrh/medicaldevicesafety/atp/071405-guidant.html to your patients.

If the device is to be left in place, advise patients to:

• continue with their regularly-scheduled follow-up appointments;

• contact you as soon as possible if they receive a shock from the device;

• go immediately to your office or clinic, or to an emergency room, if they hear a “beeping” noise coming from the ICD, because this may mean that the device is damaged.

2. Verify normal device function at every patient visit, using routine clinical follow-up procedures.

• If a shock was delivered since the prior follow-up visit, check for out-of-range values in the “Last Delivered Shock” impedance as stored in the device’s memory.

• Follow the manufacturer’s instructions for evaluating warning screens encountered during interrogation of the patient’s device.

• Also check for other indicators of device malfunction, including loss of the telemetry, programming, or interrogation functions, loss of tachyarrhthmia detection and therapy, and a decrease in pacing output.

3. In order to better characterize the failure rate, it is essential that you return all explanted devices to the manufacturer for analysis, regardless of the reason for explant. All returned devices, including those that are still functional at the time of explant, are analyzed by the company to better understand their performance. In the case of patients who die with an implant, we strongly encourage interrogation and, if possible, explantation and return of the ICD.

4. Because there are no signs of impending device failure, and there is no test that predicts whether any particular device will fail, FDA has concluded that there is insufficient evidence at this time to support the value of a commanded shock.

Failure Mode Information

Guidant’s laboratory analysis has determined that a breach in insulation surrounding a high voltage wire within the lead connector block, in conjunction with other circumstances, can allow undesirable shunting of energy to the active titanium case during shock delivery. Diversion of energy away from heart tissue may trigger a programmer screen message upon next interrogation, warning clinicians that full energy was not delivered to the heart during the last shock delivered. If sufficient shock energy is diverted to internal circuitry, it may render the device inoperative, preventing telemetry and delivery of additional shock therapy or bradycardia pacing. Bench testing has shown that the number of shocks delivered does not affect the likelihood of device failure.

In some of the malfunctioning devices investigated by Guidant, a yellow programmer warning screen describing low shock lead impedance or a shorted shocking lead condition was observed upon programmer interrogation post-shock. In each case, clinical evaluation of the lead system did not confirm a lead issue and for this reason each device was explanted and returned to Guidant for analysis. In some of the other cases, the yellow screen did not appear, as circuitry damage prevented programmer telemetry.

In some of the cases, a problem was identified during in-clinic cardioversion for atrial fibrillation. In the remaining cases, patients were away from the clinic, but a warning screen or loss of telemetry was observed when the patient returned to the clinic immediately following shock delivery or for a scheduled office visit.

Reporting Adverse Events to FDA

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of a Guidant ICD, you should follow the reporting procedure established by your facility. Prompt reporting of adverse events can improve FDA’s understanding of and ability to communicate the risks associated with devices and assist in the identification of potential future problems.

We also encourage you to report adverse events related to ICDs that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm. Consumers can also report directly to MedWatch.

If you have questions for FDA, please contact the Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 301-594-2968, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 301-594-0650 and we will return your call as soon as possible.

FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the safety notification is released by subscribing to our list server. To subscribe, visit: http://list.nih.gov/archives/dev-alert.html.

Sincerely yours,

Dan Schultz Signature

Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration

Guidant Defibrillators Get Highest Warning

Sat, 02 Jul 2005 00:00:00 -0700

A malfunction in some of the Guidant Corp. defibrillators recalled last month could cause serious injury or death, the government said in classifying 20,000 of the devices as the most urgent type of recalls.

The Food and Drug Administration is not urging that the recalled defibrillators be removed. But it used Friday's action to urge patients to contact their doctors to decide appropriate next steps.

Guidant recalled a series of defibrillators last month. The new FDA action lists a portion of them as Class I recalls, the most serious type — a move that may help doctors in deciding how aggressively to notify and treat their patients.

Replacement surgery is risky, too, cautioned FDA medical device chief Dr. Daniel Schultz in a teleconference.

"It's important to understand that in most cases these defibrillators work well and save many lives," Schultz said. "We believe very, very strongly that those decisions need to be made between the patient and the doctor."

The FDA is investigating how Guidant notified the agency and the public of the problem, said Timothy Ulatowski, FDA's medical device compliance chief.

"We are continuing to evaluate the circumstances surrounding the notification by Guidant," he said. The agency will announce its findings in "a matter of weeks, not months."

Now listed as a Class 1 recall are three models: Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155.) The FDA said about 20,600 of these devices are still believed to be implanted; at least two patients have died.

The devices, about the size of a mini-cassette tape, sense an irregular heartbeat and shock the heart back into proper rhythm. But these models can develop an internal short circuit that prevent it from working.

The problem is caused by deterioration of electrical insulation in the device, and there's no way to predict which ones will fail, the FDA said.

Listed as a lower-priority Class II recall Friday are the Guidant models Ventak Prizm AVT, Vitality AVT and Renewal AVT. A Class II recall means that any injury caused by a malfunction should be temporary or reversible.

About 21,000 of these devices are implanted worldwide, including 18,000 in the United States. There are two confirmed malfunctions with these models; neither resulted in injury, the FDA said. Guidant has said this defect can be detected and fixed non-invasively.

Also given a Class II priority are Guidant's newest models, the Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RF brands. A magnetic switch may become stuck, inhibiting the ability to treat certain irregular heartbeats unless doctors fix it, also possible non-invasively. Four such malfunctions have been confirmed among about 46,000 implanted devices; a fifth is suspected, FDA said.

Tones sounded by the device signal the malfunction; patients who hear those tones should go to the emergency room, the FDA said.

Guidant, based in Indianapolis, Ind., has a $25.4 billion acquisition offer pending from Johnson & Johnson.

Shares of Guidant stock were down in afternoon trading.

FDA ISSUES HIGHEST LEVEL (CLASS I) WARNING REGARDING HEALTH RISKS ASSOCIATED WITH THREE OF THE RECALLED GUIDANT IMPLANTABLE DEFIBRILLATOR MODELS AS WELL AS A CLASS II WARNING AS TO EIGHT OTHER MODELS

Sat, 02 Jul 2005 00:00:00 -0700

The purpose of an implanted defibrillator is to shock an irregularly beating heart back into proper rhythm. If that is not done, death will result within minutes. For this reason, any defect or malfunction involving such a device is extremely serious.

On Friday, the FDA issued a series of Class I, II, and III warnings (recall classifications) with respect to the 11 models of implantable defibrillators that have been recalled by Guidant Corporation. The warnings apply to those devices which are still implanted and are classified in terms of “probability that the device failure could lead to adverse health effects.”

While the FDA is not recommending the removal of any device that is already in use, it has made it clear that the risks associated with the various recalled defibrillator models are quite serious. Affected individuals are urged to contact their doctors to discuss and decide upon the best course of action for them.

CLASS I

PRIZM 2 DR, CONTAK RENEWAL, and CONTAK RENEWAL 2 Devices

In a Class I recall, there is a reasonable probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death.

The FDA has classified the actions taken by Guidant for these models of their defibrillators as Class I recalls.
Guidant has determined these devices can develop an internal short circuit when attempting to deliver an electrical shock to the heart, preventing the treatment of abnormal heart rhythms. The problem is caused by deterioration of electrical insulation in the device and can only be detected after the device has already malfunctioned.

The device does not give any sign of impending failure and there is no test that predicts whether the device will fail.

There have been two deaths reported to the FDA associated with these 42,000 affected devices worldwide (20,600 are still implanted).

The affected devices are:

•   PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
•   CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
•   CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004

“A Class I recall designation does not necessarily require removal of the defibrillator. These recalls require Guidant to disclose the device malfunction to patients and doctors while providing additional instructions for safe use of the devices.”

The FDA is not recommending the removal and replacement of these models. “FDA believes that this decision must be made by the patient in consultation with his or her physician, based on the specific medical situation of the patient.”

Replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision.

Guidant previously informed patients and physicians about the defibrillator problems and has provided additional instructions for safe use of the devices. Guidant’s recommendations include:

•   If you are not sure which model you have, or if you have other questions regarding your device, you should consult with your physician.
•   Continue to keep your normal doctor appointments.
•   If you feel a shock, contact your doctor as soon as possible.
•   If you or others hear “beeping” from your device, go immediately to your doctor or the emergency room.

CLASS II

VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL AVT Devices

For a Class II recall, the malfunctioning product may cause temporary or medically reversible adverse health consequences, however the probability of serious adverse health consequences is remote.
The FDA has classified the actions taken by Guidant for these models of their defibrillators as Class II recalls.
These Guidant devices are subject to a memory error which, in rare cases, may limit available therapy. Of the 21,000 devices implanted worldwide (18,000 in the U.S.), two incidents have been confirmed, neither of which resulted in death or injury.

The defect can be detected by medical evaluation of the device and Guidant is recommending the device be reprogrammed during the patient’s next doctor visit. Guidant is developing an additional non-invasive software solution for this problem, which is expected by the end of the year.

CLASS II

CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF Devices

The FDA has classified the previous actions taken by Guidant regarding these devices as a Class II recall.
“These devices are subject to a component failure that in rare cases may limit available therapy. A magnetic switch in these devices may become stuck in the closed position, which in some cases inhibits the device’s ability to treat ventricular or atrial tachyarrhythmias (abnormally fast heart rhythms) and also accelerates battery depletion.”

Four occurrences have been confirmed out of approximately 46,000 devices; a fifth occurrence is suspected but cannot be confirmed. “In the four confirmed cases, patients and/or physicians were alerted to the condition by audible device tones signaling that the magnetic switch was closed. Based on this information, it is important that patients who hear tones from their device immediately contact their physician or go to the hospital emergency room.”

As a precautionary measure, Guidant has recommended that physicians discontinue implanting these devices until further notice. For devices already implanted, Guidant has recommended that physicians change “Enable Magnet Use” to “OFF.” This will ensure appropriate therapy to treat the patient’s abnormally fast heart rhythm.
The FDA has requested physicians support Guidant’s efforts to acquire additional information about the performance of these devices. Specifically, the FDA has asked doctors to test these devices at the time they are no longer in service and, if possible, return them to the manufacturer for analysis.

Physicians or patients who have experienced a problem with any of the affected defibrillator models should send a report to the FDA's MedWatch program and to Guidant.

See http://www.fda.gov/medwatch/index.html for filing information or call 1-800-FDA-1088 (1-800-332-1088).
Guidant has posted information for patients and physicians on its web site at http://guidant.com/physician_communications/.

If you have further questions, you may contact Guidant at 1-866-GUIDANT (1-866-484-3268).
On May 24, Guidant disclosed it had waited three years before disclosing it had been aware of an electrical problem that had caused some 28 of 28,900 Ventak Prizm 2 DR defibrillators to malfunction. The death of a 21-year-old college student was associated with this model.

As the story developed, the number of potentially defective defibrillators still in use reached almost 50,000; the 28,900 with the electrical problem and another 21,000 which could malfunction due to a computer memory error (the Vertak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT ICD). .

A third problem then came to light with respect to another potential short-circuit risk associated with the Contak Renewal (Model H135) and the Comtak Renewal 2 (Model H155). Out of those 16,000 devices, 15 reports of failures had been received including one involving a death on May 30. As a result, Guidant issued recalls for all of these devices on June 18.

Less than a week after that major recall, Guidant announced five more of its defibrillator models had a potential electrical defect (faulty switch) that could cause a malfunction. Those models are the Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF.

Guidant advised doctors to stop implanting these devices until further notice. Currently, however, some 46,000 of them are already in use.

Guidant acknowledged the FDA may classify this advisory as a recall. Although no deaths have been reported, as many as five devices have malfunctioned.

Many experts openly questioned a monitoring system which essentially leaves the question of disclosure, with respect to potential flaws in such critical medical devices, entirely to the manufacturer.

As a result, the Heart Rhythm Society will prepare a set of guidelines with respect to physician alerts and other actions that should be taken by defibrillator makers when they identify a pattern of malfunctions in the devices even if those failures are rare. The Society represents a branch of cardiology known as electrophysiology and is made up of cardiologists who specialize in implanting defibrillators.

FDA Puts Guidant Recall In Class 1

Sat, 02 Jul 2005 00:00:00 -0700

Guidant Corp. can't seem to get out of the bad-news column.

On Friday, the Food and Drug Administration placed three models of the company's implantable cardioverter defibrillators (ICDs) in its highest risk category.

The FDA's Class I ranking means users of the device could suffer death or serious injury if the device fails. Guidant advised physicians about the possibility of problems with the devices last week.

"Malfunctions in these devices can lead to serious consequences, and it's important for patients to call their doctor for additional information and personalized service," said the FDA's Dr. Daniel Schultz, director of the agency's Center for Devices and Radiological Health. "However, it's also important to understand that in most cases these defibrillators work well and save lives."

The FDA said it was not making a recommendation to remove and replace the affected ICDs. It said that decision should be made by patients and their physicians because replacement itself could pose a risk. Two deaths in a population of 42,000 implanted patients have been reported. About 21,000 of the ICDs remain implanted.

Now listed as a Class 1 recall are three models: Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155.) The devices sense an irregular heartbeat and shock the heart back into proper rhythm. But those models can develop an internal short circuit that prevent them from working.

The problem is caused by deterioration of electrical insulation in the device, and there's no way to predict which ones will fail, the FDA said.

The FDA gave Class II status to eight other models of Guidant ICDs. Class II means a user could suffer temporary or medically reversible injuries if the device fails.

Guidant's headquarters are in Indianapolis, but its Cardiac Rhythm Management division is based in Arden Hills.

Wall Street has been watching Guidant's recall woes very carefully in light of its pending acquisition by health care behemoth Johnson & Johnson for $25.4 billion.

In trading Friday, Guidant's shares dropped $1.57 to close at $65.73.

Information already disclosed

But industry analysts said Friday's FDA-related news was only a reiteration of information that Guidant already had disclosed. Its effect on the J&J transaction? "Zero," said Thomas Gunderson of Piper Jaffray.

"It's all just about semantics," Gunderson said of the FDA announcement. "The news is out. The 'damage' has been done. The valuation has been imputed. I wasn't surprised, and Johnson & Johnson is smarter than me. I don't think Johnson & Johnson cares what the FDA calls them."

The FDA is investigating how Guidant notified the agency and the public of the problem, said Timothy Ulatowski, FDA's medical device compliance chief.

"We are continuing to evaluate the circumstances surrounding the notification by Guidant," he said. The agency will announce its findings in "a matter of weeks, not months."

Listed as a lower-priority Class II recall Friday are the Guidant models Ventak Prizm AVT, Vitality AVT and Renewal AVT. About 21,000 of those devices are implanted worldwide, including 18,000 in the United States. There are two confirmed malfunctions with those models; neither resulted in injury, the FDA said. Guidant has said this defect can be detected and fixed non-invasively.

Warning tones

Also given a Class II priority are Guidant's newest models, the Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RF brands. A magnetic switch may become stuck, inhibiting the ability to treat certain irregular heartbeats unless doctors fix it, also possible non-invasively. Four such malfunctions have been confirmed among about 46,000 implanted devices; a fifth is suspected, FDA said.

Tones sounded by the device signal the malfunction; a patient who hears those tones should go to the emergency room, the FDA said.

Parker & Waichman, LLP Investigating Guidant Defibrillator Claims after Receiving Hundreds of Inquiries from Patients Nervous About the Risk of Device Failure

Mon, 27 Jun 2005 00:00:00 -0700

Parker & Waichman, LLP (www.yourlawyer.com) announces that it has commenced an investigation into defective defibrillators manufactured by Guidant Corporation (NYSE: GDT).

The investigation comes after the firm was contacted by hundreds of concerned patients following Guidant’s recall announcement for thousands of defective implantable cardioverter defibrillators, or ICD’s. Parker & Waichman, LLP is offering free case evaluations to all cardiac defibrillator patients as many patients do not know their exact defibrillator model. To receive a free case evaluation, please visit: http://www.yourlawyer.com/practice/overview.htm?topic=Guidant%20Defibrillators .

On June 16, 2005 Guidant announced that, in conjunction with the FDA, it was recalling 50,000 faulty cardiac defibrillators due to life threatening malfunctions in the devices. Seven Guidant ICD models were part of this recall, including the VENTAK PRIZM 2 DR, VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT, RENEWAL 4 AVT, CONTAK RENEWAL (Model H135) and the CONTAK RENEWAL 2 (Model H155).

In a company press release, Guidant said the PRIZM 2 model has had 28 reports of failure and one death in the 26,000 devices built before April 2002. The CONTAK model has 15 reports of failure and one death in the 16,000 devices built before August of 2004. Both the PRIZM 2 and CONTAK models have a flaw that causes the defibrillators to short circuit and fail to deliver a shock to the heart. The VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL 4 AVT ICDs were being recalled because of a memory error that has caused two confirmed malfunctions in 21,000 implants. This error requires the devices to be reprogrammed.

Less than one week after the major recall was issued, Guidant issued an advisory warning about five more of its defibrillator models which have a potential electrical defect (faulty switch) that could cause a malfunction. Those models are the CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF. There are some 46,000 of these devices already in use. Guidant acknowledged that the FDA may classify this advisory as a recall.

In its August 2003 annual report, Guidant first informed the FDA of problems with its defibrillators, but the company never notified patients or doctors about the defects. It has been alleged that the company only notified patients and doctors about the defects after learning that the New York Times was preparing an article on May 23, 2005 about the faulty devices. The New York Times reported that Guidant failed tell doctors and patients for three years that the VENTAK PRIZM 2 DR model contained a flaw that has caused some defibrillators to short-circuit . However, Guidant stood by its decision to continue selling the PRIZM 2 DR for months, declaring that the original device was still reliable.

“It certainly appears that Guidant became aware that their defibrillators were defective some time ago, but they chose to hide the problems from patients and doctors,” said Herb Waichman, founding partner of Parker & Waichman, a law firm committed to helping people with defibrillators explore their legal options. “This is an egregious example of a company putting profits over patient safety. How a company could continue to sell faulty heart devices while knowing that device failure can lead to loss of life is a question that our clients would like answered.”

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide with offices in New York and New Jersey. Parker & Waichman, LLP has helped thousands of clients receive fair compensation for injuries resulting from defective medical products. For more information on Parker & Waichman, LLP please visit: (http://www.yourlawyer.com) or call 1-800-LAW-INFO (1-800-529-4636).

CONTACT:
Parker & Waichman, LLP
David Krangle, Esq.
1 (800) LAW-INFO (800-529-4636) (toll free)
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THE NEWS KEEPS GETTING WORSE FOR GUIDANT AS IT ANNOUNCES AN ADDITIONAL 46,000 DEFIBRILLATORS HAVE POTENTIALLY SERIOUS ELECTRICAL DEFECTS

Sat, 25 Jun 2005 00:00:00 -0700

On May 24, Guidant disclosed it had waited three years before disclosing it had been aware of an electrical problem that had caused some 28 of 28,900 Ventak Prizm 2 DR defibrillators to malfunction. One death that of a 21-year-old college student, was associated with this model.

As the story developed, the number of potentially defective defibrillators still in use reached almost 50,000; the 28,900 with the electrical problem and another 21,000 which could malfunction due to a computer memory error (the Vertak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT ICD). There had been 2 reports of failures associated with these other models. Neither report involved injury or death.

Then, a third problem came to light with respect to another potential short-circuit risk associated with the Contak Renewal (Model H135) and the Comtak Renewal 2 (Model H155). Out of those 16,000 devices, 15 reports of failures had been received including one involving a death on May 30. As a result, Guidant issued recalls for all of these devices on June 18.

Many experts openly questioned a monitoring system which essentially leaves the question of disclosure, with respect to potential flaws in such critical medical devices, entirely to the manufacturer. As a result, the Heart Rhythm Society will prepare a set of guidelines with respect to physician alerts and other actions that should be taken by defibrillator makers when they identify a pattern of malfunctions in the devices even if those failures are rare. The Society represents a branch of cardiology known as electrophysiology and is made up of cardiologists who specialize in implanting defibrillators.

Now, less than a week after the major recall, Guidant announced five more of its defibrillator models had a potential electrical defect (faulty switch) that could cause a malfunction. Those models are the Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF.

Guidant has advised doctors to stop implanting these devices until further notice. Currently, however, some 46,000 of them are already in use. Guidant acknowledged the FDA may classify this advisory as a recall. Although no deaths have been reported, as many as five devices have malfunctioned.

The FDA Advisory encourages patients with these defibrillators to discuss the matter with their doctor. Any adverse events or problems should be reported to the FDA at www.FDA.gov/medwatch/ or 1-800-FDA-1088. Additional information about this potential issue is available for physicians and patients at 1-866-GUIDANT (1-866-484-3268) (24/7) and http://www.guidant.com/physician_communications/RENEWAL3_RENEWAL4.pdf.

Guidant Tells Doctors To Not Use Five Defibrillator Models

Fri, 24 Jun 2005 00:00:00 -0700

Guidant Corp. on Friday issued its second safety advisory in a week about its implantable defibrillators, telling doctors to stop using five of its models because a faulty switch could cause them to malfunction.

The five devices included in the latest announcement are the Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF. About 46,000 of the devices are in use, the company said.

Guidant said doctors "should discontinue implants of these devices pending further notice."

The company said it had informed federal regulators of its action and that the U.S. Food and Drug Administration may classify it as a recall. Officials with the FDA were not immediately available for comment.

The devices listed Friday have had at least four malfunctions. A fifth suspected case has not been confirmed, but no patients have been injured, Guidant said.

Guidant's defibrillator division is based in Arden Hills, Minn.

Guidant last week said five other models had flaws. It said some of those devices have memory problems and can be reprogrammed without removal, but nearly 29,000 of the defibrillators - 20,000 implanted in U.S. patients - can't be fixed externally.

At least two patients with those defibrillators have died, and the company said those devices had failed at least 45 times.

An implantable defibrillator is intended to sense an irregular heart rhythm and shock the heart back into correct beating.

The five defibrillator models cited by Guidant on Friday have a magnetic switch that can become stuck in a closed position, preventing the device from treating irregular heart rhythms. The faulty switch can also limit a defibrillator's battery life.

"Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients," company spokesman Steve Tragash said in a statement. "The actions taken today and over the last several weeks reflect our commitment to expand physician and patient communication."

Guidant said physicians should reprogram the five defibrillator models included in Friday's announcement so that their magnet use is off. Patients who hear tones from the defibrillators should go to the emergency room immediately.

At least 74,900 Guidant defibrillators worldwide are now under a company warning. The Renewal 3 and 4 AVT models were included in both announcements, but Guidant did not provide a breakdown of how many of those devices were in use.

Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action about Implantable Cardiac Defibrillators

Fri, 24 Jun 2005 00:00:00 -0700

Guidant Corporation said today it is voluntarily advising physicians about important safety information regarding certain devices. Guidant apprised FDA of this action, and FDA may classify this action as a recall. At this time, Guidant is in the very early stages of a diligent evaluation of the component failure described below. Guidant will continue its evaluation and communicate further as more information is learned.

As a precautionary measure, physicians should discontinue implants of these devices pending further notice. This communication advises physicians and their patients of safety information and is intended to limit adverse events. Physicians should use this information to decide how best to treat their patients.

The devices impacted are:

CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF

Guidant has determined that the devices listed above are subject to a component failure that may limit available therapy. We have determined that a magnetic switch in these devices may become stuck in the closed position, which in some cases inhibits the device's ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion. Four occurrences have been confirmed out of approximately 46,000 devices; a fifth occurrence is suspected but cannot be confirmed. In the four occurrences in which the device was implanted, patients and/or physicians were alerted to the condition by audible device tones that signaled the magnetic switch was closed. These four occurrences have resulted in device replacement. One occurrence occurred prior to implant. To date, there have been no patient injuries beyond device replacement.

It is Guidant's recommendation to physicians that they consider programming "Enable Magnet Use" to "OFF" to ensure that appropriate therapy to treat ventricular and atrial tachyarrhythmias will be provided in the event that the magnetic switch becomes stuck in the closed position. In addition, patients should contact their physicians or go to the hospital emergency room immediately if they hear tones from their device.

Guidant continues to investigate this issue and will provide any additional information that may help physicians and patients.

Guidant recently announced its intention to establish an independent panel of experts to recommend guidelines for when to disseminate information to physicians and patients about life-sustaining implantable devices. Guidant plans to cooperate with and enlist the support of other interested parties, including the Food and Drug Administration, patient advocates, and physician societies.

IN THE WAKE OF DEFIBRILLATOR RECALL, CARDIOLOGISTS GROUP TO PREPARE GUIDELINES FOR MANUFACTURERS TO FOLLOW WHEN PATTERN OF MALFUNCTIONS IS DISCOVERED

Thu, 23 Jun 2005 00:00:00 -0700

The sudden recall of almost 50,000 implanted defibrillators manufactured by Guidant Corp. on June 17 has many experts questioning a monitoring system which essentially leaves the matter of disclosure, with respect to potential flaws in such critical medical devices, entirely to the manufacturer.

The current system is seen as problematic for a number of reasons. First, the ultimate decision may be based not only on patient safety issues but, also, on extraneous considerations such as potential legal liability and loss of market share to competitors. Second, the FDA does not collect comprehensive data on these devices after they are approved. Finally, hospitals and doctors do not notify the FDA about all device-related problems. Reporting of such incidents is spotty at best.

As a result, the Heart Rhythm Society will prepare a set of guidelines with respect to physician alerts and other actions that should be taken by defibrillator makers when they identify a pattern of malfunctions in the devices even if those failures are rare. The Society represents a branch of cardiology known as electrophysiology and is made up of cardiologists who specialize in implanting defibrillators.

In hindsight, there is no doubt that, while Guidant Corporation maintained its internal heart defibrillator (the Ventak Prizm 2 DR) was safe and extremely reliable, it was fully aware of an electrical problem in some 29,000 of those devices which could cause them to short-circuit when needed.

On May 24, Guidant disclosed for the first time that it had waited three years before disclosing it had been aware of the electrical problem that had caused some 28 of these defibrillators to malfunction.

As the story developed, the number of potentially defective defibrillators still in use reached almost 50,000; the 28,900 with the electrical problem and another 21,000 which could malfunction due to a computer memory error (the Vertak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT ICD). There had been 2 reports of failures associated with these other models. Neither report involved injury or death.

A third problem came to light with respect to another potential short-circuit risk associated with the Contak Renewal (Model H135) and the Comtak Renewal 2 (Model H155). Out of those 16,000 devices, 15 reports of failures had been received including one involving a death on May 30.

In issuing the recall, Guidant stated the Ventak Prizm 2 DR should be monitored and will be replaced if necessary by Guidant at no charge. For the models with potential memory errors, Guidant is recommending an in office programming change that can reduce the risk until Guidant is able to design a software solution. The remaining devices should be monitored at three-month intervals and undergo a complete trouble-shooting procedure if a yellow warning screen appears on the programmer.

British Regulators Issuing Guidant Alert

Thu, 23 Jun 2005 00:00:00 -0700

British regulatory officials have held "urgent discussions" with Guidant Corp. in recent weeks regarding the company's delayed notice of problems with several models of heart defibrillators that may malfunction.

After a meeting in London on Tuesday, a spokesperson for the Medicines and Healthcare products Regulatory Agency (MHRA) said formal medical device alerts are being prepared for doctors in Britain regarding several models of implantable defibrillators made by Indianapolis-based Guidant. The company's cardiac rhythm management division, which makes the devices, is based in Arden Hills.

Implantable defibrillators stopwatch-sized devices that shock an errantly beating heart back into rhythm have been at the center of a controversy in the United States since May over when doctors should be notified about potential flaws in devices.

The British regulator says about 1,628 of the recalled devices have been sold in the United Kingdom although it is unclear how many of them have actually been implanted in patients.

Although Guidant fixed a short-circuit problem in its Ventak Prizm 2 DR (model 1861) defibrillator in April 2002, doctors in the United States were not informed about the problem until May 23. The next day, media reports surfaced regarding the flaw, which may have been a contributing factor in the death of a Grand Rapids college student last March.

MHRA said it was first informed by the company of the issue on May 25.

In a statement, Guidant said it "continues to work closely with its physicians partners, the [Food and Drug Administration] and other regulatory authorities to ensure proper reporting and communication regarding product safety."

The MHRA is a government body similar to the U.S. Food and Drug Administration responsible for ensuring that drugs and devices that reach the British market meet standards of safety, quality and efficacy.

MHRA expects manufacturers to immediately report any deterioration in the performance of a device that has led to the death of a patient or deterioration in a patient's health.

Additionally, if incidents occurring outside Europe lead to corrective action on devices sold within Europe, the MHRA says the manufacturer should notify the agency.

"MHRA were not informed in 2002 of design changes made to the [Guidant] device nor of any of the non-U.K. incidents that initiated the change process," said Gillian Peacock, MHRA press officer.

Peacock said there have been no adverse incidents regarding the recalled Guidant defibrillators in Britain.

The devices include the Ventak Prizm 2 DR (model 1861); Contak Renewal (model H135); and Contak Renewal 2 (model H155), which could short-circuit. Also, the Ventak Prizm AVT; Vitality AVT; Renewal 3 AVT and Renewal 4 AVT models may have a software problem that needs a programming change.

Guidant Defibrillators Short Circuiting Death Recall Injury Lawyers

Thu, 23 Jun 2005 00:00:00 -0700

Guidant Defibrillators

The affected devices distributed in the US include the Contak Renewal 3 HE CRT-Ds (Models H177 and H179); Contak Renewal 3 CRT-Ds (Models H170 and H175); Vitality 2 DR ICDs (T165); Vitality 2 VR ICDs (T175); Vitality AVT ICDs (A155); Vitality DS DR ICDs (T125); and Vitality EL DR ICDs (T135).

What is the problem with these devices? A capacitor in the affected devices could malfunction, leading to premature battery depletion. How serious is this? As of March 30, 2007, Boston Scientific has confirmed 19 field events with Guidant’s devices, primarily related to premature battery depletion. There were no serious injuries or deaths reported.

On December 14, 2005 Guidant announced that 3 more patients with recalled defibrillators made by Guidant have died, bringing the total number of known deaths linked to the faulty products to seven. Guidant is under investigation by federal and state officials and faces dozens of lawsuits over its recalls. Guidant Corp. on October 14, 2005 told U.S. regulators that they received reports of 6 additional failures of implantable heart defibrillators since issuing a July notice about the devices used to regulate cardiac rhythms.

The failures were in the Contak Renewal and Renewal 2 models, the FDA said in an update posted 10/13/05 on the agency's website. The two devices were among models included in warnings Guidant sent to doctors in June, which the FDA classified July 1 as recalls. The new reports of failures bring the total worldwide to 21, including three cases in which patients died, Daniel Schultz, the director of the FDA's Center for Devices and Radiological Health, said.

Other News
Guidant Corp. has recalled several models of its cardiac defibrillators due to defects in the devices and numerous reports of device failure and death. The defibrillator recall and its follow-up advisory combined affect approximately 74,900 devices worldwide. The implantable cardioverter defibrillators, or ICDs, are intended to sense irregular heart rhythms and to send an electrical pulse to the heart to shock it into beating properly. The Guidant defibrillator defects include short circuiting, problems with the magnetic switch and computer memory problems. The defect that causes short circuiting of the device has caused two deaths to date, including the sudden death in March 2005 of a 21-year-old college student. Following are details of the models affected by the recall and the follow-up advisory:

2005 Recall
June 16, 2005 - Guidant recalled 50,000 defibrillator devices including the following models:

Prizm 2 DR, Model 1861, manufactured on or before April 16, 2002
Contak Renewal, Model H135, manufactured on or before Aug. 26, 2004
Contak Renewal 2, Model H155, manufactured on or before Aug. 26, 2004
Prizm AVT Vitality
Renewal 3 AVT
Renewal 4 AVT

June 24, 2005 - Guidant issued an advisory about additional defibrillator devices including the following models:

Contak Renewal 3 and 4
Renewal RF

Guidant claims that it discovered the short circuiting defect in 2002 and changed the manufacturing of the devices that year to correct the defect. However, Guidant continued to sell the old defective devices without notifying doctors that improved ones were available. Defibrillators cost approximately $25,000 apiece. Guidant’s 2004 defibrillator sales totaled $1.8 billion, signaling that until recently, Guidant may have been more motivated by profits than by patient safety.

Heart patients with a defibrillator who are unsure if their device is one of the malfunctioning models should contact their doctor as soon as possible to determine if their model requires replacement, if their device can be reprogrammed, or if their device is not affected by the recently announced safety issues.

2006 Recall
On June 26, 2006, the FDA and Guidant informed all patients and medical professionals that Guidant’s Ventak Prizm 2, Vitality and Vitality 2 Implantable Cardioverter Defibrillators have been associated with five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Patients who have these particular ICD devices may experience inappropriate sensing or early battery depletion.

If you or a loved one suffered injuries from a Guidant Defibrillator, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.