F.D.A. Had Report of Short Circuit in Guidant Heart Devices
September 12, 2005 07:09

Months before the Food and Drug Administration issued a safety alert in June about problems with Guidant Corporation heart devices, the agency received a report from the company showing that some of those units were short-circuiting, agency records obtained by The New York Times show. http://www.nytimes.com/2005/09/12/business/12fda.html?th&emc=th

Criminal investigators at the Food and Drug Administration have apparently become involved in the agency's inquiry into how the Guidant Corporation handled problems with its heart devices, said two people contacted by the investigators.http://www.nytimes.com/2005/09/29/business/29heart.html?th&emc=th

"A recent article by Reed Abelson in The Times reveals that many surgeons have ties to manufacturers that are often not revealed to their patients or to hospitals. These connections raise questions as to whether some doctors are choosing devices primarily for the good of their patients or primarily for the benefit of their own bank accounts. The most troubling ties involve consulting fees and royalty payments to doctors who use the devices. Incredibly, sales representatives are sometimes present in operating rooms and help surgeons select devices. Because the representatives are paid commissions, they have a strong incentive to push the most expensive ones. They can make as much from an operation as the surgeon does. Ties between manufacturers and doctors are surely a factor in driving up spending on medical devices. Hospitals, insurers and patients have been squeezed as such costs have soared and companies have earned profits of nearly 20 percent a year. The surgeons say they need close relationships with the manufacturers because doctors can encourage innovations and help perfect medical devices. But several investigations are under way to determine whether some consulting arrangements are in fact little more than unethical or unlawful payoffs for using the devices. The industry's trade association has adopted voluntary guidelines recommending that consultants be hired for their expertise, not their ability to generate business. Perhaps the most important reform would be full disclosure by doctors to their patients, their colleagues and their hospitals of their lucrative contracts with the manufacturers." http://www.nytimes.com/2005/09/24/opinion/24sat2.html

You say Defiberlator, I say Defibrillator. Either way, lawsuits have been filed. Other investigations are underway about Medtronic defibrillators. Class actions have been filed and affected individuals should contact Monheit Law online about their Medtronic defibrillators for more information. Or call toll-free: 866-761-1385 or email: Michael Monheit, Esq.

Monheit Law is assisting individuals in filing claims for recalled-defective Medtronic and Guidant pacemaker or difibrillator. Guidant and Medtronic have issued recalls on certain models. You may be entitled to compensation. Click on the link for further details or call 866-761-1385 Toll Free. Free inquiry. No obligation.

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Guidant is informing physicians of two separate failure modes in its Insignia and Nexus families of pacemakers. Failure is observed most often at implantation. The risk of failure declines with time. When failure occurs, the device can have loss of pacing output or telemetry.

http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/index_e.html