Medical Devices
October 29, 2007
FDA Approves New Heart Device for Heart Surgery
The FDA has approved a new heart device called the Gore Helix Septal Occluder. The new heart device is to help people who have a hole in their heart. “The trick to the device is to have a patch through a small incision in the groin.
A hole in a woman's heart she had since birth. It is common heart defect as many kids are born with this type of condition of having a hole in the heart. Patients born with congenital heart defects are followed throughout their lives by cardiac specialists and later on in life often need heart surgery.
The problem is there is an abnormal hole in the wall between the upper chambers of the heart, causing blood to improperly flow from the left side of the heart to the right, forcing the right side of the heart and lungs to over exert to compensate for the problem.
Using the new device, a doctor creates a patch that fills the hole restoring normal circulation of blood to the heart. This is a new less invasive way compared to traditional open heart surgery.
Some patients can go home the same day with this new way of doing heart surgery.
If left untreated this congenital heart defect can cause the heart to enlarge, or weaken, leaving the patient at risk for serious conditions like pulmonary hypertension, heart failure, or stroke.
Posted by Michael Monheit at 01:40 PM | Permalink | Comments (0) | TrackBacks (0)
October 28, 2007
Heart Leads Not Scrutinized Like Defibrillators
Representative Henry A. Waxman (D-Calif.) and chairman of the Committee on Oversight and Government Reform asked the FDA why defibrillator leads were not tested and scrutinized like defibrillators.
Waxman asked the FDA to provide information about how it determines how much to test leads before marketing and why the agency does not give leads the same scrutiny that it has given in recent years to other heart devices like defibrillators.
A defibrillator is an implanted device that sends out a jolt of electricity to restore a wildly beating heart to normal rhythm. Medtronic, the lead maker, disclosed that a widely used heart lead produced by the company was fracturing and preventing the flow of electricity between the heart and defibrillator.
Some experts believe that the Medtronic lead was prone to fracturing because it was the thinnest lead ever made by the company and might not have been durable enough. Defibrillator leads are known to fracture, but neither the FDA nor device makers have developed effective ways to track such episodes.
The FDA’s Center for Devices and Radiological Health may be reviewing whether to require more strenuous laboratory testing of such products before they go on the market.
Posted by Michael Monheit at 01:42 PM | Permalink | Comments (0) | TrackBacks (0)
January 10, 2007
Medtronic Insulin Pump Fails and Diabetic Woman Now Brain Dead
A Washington woman with Type 1 diabetes suffered severe and permanent brain damage. Her family sued Medtronic Inc. — the parent company of the insulin pump's manufacturer — alleging the pump was unsafe. Medtronic had already sold 150,000 insulin pumps in the United States.
The pump, about the size of a cell phone, had a safety feature designed to stop the insulin flow in emergencies. But the feature wasn't on. The pump had been shipped to the woman with the option turned off. The device's instructional video devoted only 15 seconds to it, saying nothing about why the feature should be used.
What happened to the woman could have yielded insight into the pump's design and instructions, alerting patients and health-care providers to the importance of this safety feature, originally called a dead man's switch.
But when Medtronic settled the lawsuit three years ago, the entire court file was improperly sealed, hiding every allegation and discovery behind an electronic password.
What's more, Medtronic failed to disclose the woman’s injury to the federal government, which uses such reports to spot problems with medical devices and to protect the public.
Nationally, other lawsuits have also accused Medtronic of reporting lapses. Medtronic, a Fortune 500 company with annual sales of $11 billion, makes all kinds of medical devices. Other lawsuits have alleged that Medtronic failed to make timely warnings to the public and physicians about problems with implantable heart defibrillators and with the tubing on insulin pumps.
According to the U.S. Justice Department, the company agreed last summer to pay a $40 million fine to settle civil allegations that it provided kickbacks to doctors, to encourage them to use its spinal products. The kickbacks included sham consulting and royalty agreements, as well as lavish trips. (Full Story)
Posted by Michael Monheit at 02:51 PM | Permalink | Comments (0) | TrackBacks (0)
December 13, 2006
Medical Device Litigation Seminar
Which "life-saving" medical devices actually threaten lives? As the number of drug and medical devices recalls increases, understanding the nature, frequency, and potential risk factors becomes more critical for attorneys who represent people injured by the very products they depend on.
The seminar is a must for every lawyer taking on a giant pharmaceutical company. Learn new jury de-selection strategies, hear the latest developments in current pharmaceutical litigation cases, and discover new litigation tactics—all the critical tools you need to help prepare a case against the pharmaceutical and medical device industry. The seminar is presented by the Association of Trial Lawyers of America (ATLA) on November 17-18 in Las Vegas.
Posted by Michael Monheit at 06:48 AM | Permalink | Comments (0) | TrackBacks (0)
November 20, 2006
Medical Devices Need to be tracked
The Association of Trial Lawyers of America (ATLA) is urging the Food and Drug Administration (FDA) to adopt stricter standards for tracking medical devices. ATLA submitted constructive changes in response to the FDA's request for comments on its Unique Device Identification (UDI) policies.
Posted by Michael Monheit at 10:10 AM | Permalink | Comments (0) | TrackBacks (0)
