Medical Malpractice

• Recall of Boston Scientific Flextome Cutting Balloon Systems

  Jamie Sheller | February 05, 2006 3:00 PM | 1 CommentPhiladelphia, PA

  Boston Scientific is recalling one of its medical devices. The Flextome Cutting Balloon system is used to open blocked arteries or blood vessels. The FDA and Boston Scientific recently recalled the device because one of its parts may separate when the device is withdrawn from the patient. More in-depth surgery may then be required to remove the piece from the artery. Boston Scientific...

• 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...

• 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...

• Woman Awarded $12 Million in Breast Cancer Case

  Jenny Albano | February 29, 2008 8:44 PM | 0 CommentsPhiladelphia, PA

  A women was awarded $12 million by a Philadelphia jury in a terminal breast cancer suit against her two doctors who allegedly did not diagnose the cancer before it had progressed to a terminal stage.According to the plaintiffs attorney, Donna Lee Jones, one of the doctors settled before the trial, but the jury found that the doctor who settled was still 35% responsible for his failure to...

• Micro-bubble contrast agents may cause death or serious cardiapulmonary reactions

  Jamie Sheller | November 16, 2007 10:14 AM | 0 CommentsPhiladelphia, PA

  Reports of death and serious cardiopulmonary reactions to the micro-bubble contrast agents used with ultrasounds has caused the FDA to require revisions to the labels of these products. Micro-bubble ultrasound contrast agents are used in the administration of ultrasounds to view the heart. Definity and Optison are the only micro-bubble products approved for use in the USA. The adverse...

• Recall of Blood Clotting Test Strips

  Jamie Sheller | October 25, 2006 12:38 PM | 0 CommentsPhiladelphia, PA

  Recently, Roche Diagnostics issued a recall of CoaguCheck PT test strips. Patients using anticoagulants or blood thinners have their blood tested to determine clotting time. The strips are used for that purpose, both by patients at home and by medical professionals. Depending on the blood clotting time, corrective measures may need to be taken. A defect in the CoaguCheck PT strips may cause...

• Mechanical Heart Approved for Strictly Limited Use

  Jamie Sheller | September 10, 2006 4:18 PM | 0 CommentsPhiladelphia, PA

  AbioCor, a fully implantable mechanical heart manufactured by Abiomed, Inc., gained FDA approval for very limited use. "Only patients who have advanced heart failure that has affected the left and right ventricles and who are not candidates for a heart transplant will be eligible to receive the device under the agency's Humanitarian Use Device provisions." The mechanical heart is powered by a...

• Defective Infusion Pumps Seized By Federal Agents

  Jamie Sheller | August 29, 2006 1:49 PM | 0 CommentsPhiladelphia, PA

  A supply of Alaris infusion pumps, worth approximately 1.8 million dollars, was seized by United States Marshals. The seizure involved several models of Alaris infusion pumps, and took place at the company's manufacturing plant in San Diego, California. A design defect called "key bounce" could cause the infusion pumps to deliver an over-infusion of medication, which may result in injury or...