Medical Malpractice

• Safety Alert for Blood Testing Kit

  Jamie Sheller | January 16, 2006 7:44 AM | 0 CommentsPhiladelphia, PA

  The FDA and Ortho Clinical Diagnostics notified health care professionals of the recall of a blood testing kit. The HBsAg Confirmatory Kit is used to test blood for the Hepatitis B virus. An unknown component in the diluting solution may produce Not Confirmed results for samples found to be positive with the initial test. These false negative results could result in a lack of treatment for...

• More Trouble for Heart Device Manufacturer

  Jamie Sheller | January 03, 2006 8:37 AM | 0 CommentsPhiladelphia, PA

  Guidant Corporation recently received more bleak news from the FDA. Citing concerns about the manufacturing practices of the company, the FDA informed Guidant that it would not approve any more company devices for sale, nor will the FDA approve new contracts to export Guidant heart devices manufactured in its Minnesota plant.This news comes at a time when the company is still reeling from...

• Incomplete Fix for Silicone Gel Implants

  Jamie Sheller | December 16, 2005 9:20 AM | 0 CommentsPhiladelphia, PA

  Mentor Corp., a maker of silicone gel breast implants, is hoping for FDA approval to sell its implants for general cosmetic use. However, the implants have exhibited a problem of leaking silicone oil. A former engineer for Mentor told the FDA that when the company was alerted to the problem, it fixed the demonstration models of the implants that would be used in doctor offices, but not the...

• Johnson & Johnson Going Forward With Purchase of Guidant Corp.

  Jamie Sheller | November 16, 2005 8:25 AM | 0 CommentsPhiladelphia, PA

  Though earlier signs indicated that Johnson & Johnson was no longer interested in purchasing Guidant Corporation, the deal is now going forward. However, the purchase price, at $63.08 a share, is lower than the original agreement for J&J to pay $76 a share for Guidant. The original deal appeared to slow to a halt after J&J issued a statement about Guidant regarding safety concerns and...

• Guidant, Medtronic & St. Jude Devices Earn Subpoenas

  Jamie Sheller | November 16, 2005 8:23 AM | 0 CommentsPhiladelphia, PA

  Guidant Corporation, Medtronic and St. Jude Medical, three big makers of implantable heart devices, acknowledged receiving subpoenas from the United States Department of Justice. Apparently, the Justice Department has launched an investigation into possible violations of federal anti-fraud and anti-kickback statutes. Such violations could involve giving illegal payments or other benefits to...

• Federal Guidant Lawsuits Consolidate in MN

  Jamie Sheller | November 14, 2005 2:04 PM | 0 CommentsPhiladelphia, PA

  On November 7, 2005, cases filed in federal courts around the country against Guidant Corporation, involving their defective heart devices, were transferred to the United States District Court for the District of Minnesota. The transfer was ordered by the Judicial Panel on Multidistrict Litigation. The transfer means that those cases will be centralized in one court and coordinated by one...

• Guidant Pacemaker & Defibrillator Recall

  Jamie Sheller | November 11, 2005 1:35 PM | 0 CommentsPhiladelphia, PA

  Imagine knowing that a device that you depend on to save your life might not work when it's supposed to. Now imagine that the people who made that device knew that it might not work when it is supposed to. Many people have recently been faced with that exact situation, when the Guidant Corporation recalled several models of cardiac defibrillators and pacemakers, due to defects that could cause...

• Defibrillator Defects On the Rise

  Staff Writer | October 19, 2005 4:22 PM | 0 CommentsPhiladelphia, PA

  In a Harvard study funded by the FDA, researchers concluded that recalls this year by defibrillator manufacturers Guidant, Medtronic and St. Jude Medical show a steady rise in the number of failures among the devices. The study shows that nearly one in every 50 defibrillators malfunctions and blames those failures for 31 deaths. In 2002, doctors were replacing almost 21 of every 1000 devices...