Posts tagged medical devices

• FDA Will Review Safety of Insulin Pumps

  Joe Saunders | March 04, 2010 1:51 PM | 0 CommentsSarasota, FL Category: FDA & Prescription Drugs
  

  The FDA will convene a panel of experts to investigate the increasing number of safety problems with insulin pumps. Industry officials note that there are issues with both the hardware and software...

• Correcting Injustice--The Medical Device Safety Act

  John Hopkins | October 26, 2009 10:26 AM | 0 CommentsWest Palm Beach, FL Category: Defective & Dangerous Products
  

  The decision in the Supreme Court case of Riegel v Medtronic created special protection for medical device manufacturers that defied all logic and contradicted 30 years of experience in medical...

• Drug and Medical Device Manufacturers: "It is someone else's fault"

  John Hopkins | September 03, 2009 10:59 AM | 2 CommentsWest Palm Beach, FL Category: FDA & Prescription Drugs
  

  A responsible FDA has brought a drug manufacturer to justice. The FDA has settled with Pfizer over its off label and deceptive marketing of the drug Bextra; $2.3 billion in fines and penalties....

• Patients Need To Be Aware of Medtronic Infuse Use In The Neck

  Eddie Farah | January 17, 2009 11:49 PM | 2 CommentsJacksonville, FL Category: FDA & Prescription Drugs
  

  Medtronic is facing more trouble over its Infuse Bone Graft. A Texas woman is reportedly preparing a lawsuit blaming off-label use of Infuse for injuries she suffered after cervical spine surgery....

• Riegel Preemption Does Not Include 510(k) Approved Medical Devices

  Armand Rossetti | September 10, 2008 3:21 PM | 0 CommentsWest Palm Beach, FL Category: Medical Devices & Implants
  

  In Riegel v. Medtronic, 552 US ___(2008), the Court stated that in 2005, the FDA authorized the marketing of 3,148 medical devices under §510(k), and granted premarket approval (PMA) to just 32...

• FDA Warns of Burns from Dental Equipment

  Diego Madrigal | December 17, 2007 6:28 PM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  The FDA has issued a warning stemming from improperly maintained electrical dental equipment. The poorly maintained equipment can result in third degree burns. In fact, some of the patients even needed to undergo plastic surgery as a result. One of the main reason for the alert directed at dental professionals was that the burns may become apparent only after tissue damage has occurred...

• Sprint Fidelis Pacemaker Had Problems Last Winter

  Joe Saunders | October 25, 2007 8:13 AM | 0 CommentsSarasota, FL Category: Medical Malpractice
  

  Medtronic, the manufacturer of the Sprint Fidelis cardiac defibrillator a.k.a. pacemaker, knew that its medical device had problems with fractured lead wires last winter, according to consumer advocacy group Public Citizen. These defects were reported to the government last winter. According to Dr. Sidney Wolfe, the FDA had received 599 reports of defibrillator malfunctions as of January 10,...

• Sprint Fidelis Defibrillator May Pose More Risk to Young

  Joe Saunders | October 19, 2007 10:44 AM | 0 CommentsSarasota, FL Category: Medical Malpractice
  

  According to a Wall St. Journal article, the Medtronic Sprint Fidelis defibrillator may pose more risk to the young than previously thought. The Sprint Fidelis has had problems with its lead wire breaking causing erratic jolts of electricity to the heart. The wire connects the defibrillator to the heart and is supposed to jolt the heart rhythm back into a normal rhythm. However, the device...

• FDA Approves New Medtronic Stent in Spite of Report

  Joe Saunders | October 11, 2007 5:31 AM | 0 CommentsSarasota, FL Category: Medical Malpractice
  

  In spite of a recent scientific report citing certain health risks, the FDA voted to approve Medtronic's new cardiac stent, Endeavor. Data published a few days before the vote raised questions about the risk of blood clots linked to use of the drug coated stent. However, the FDA panel did suggest the FDA require that Medtronic conduct a 5 year post-approval study to assess the risks...

• US Supreme Court will Decide Pharmaceutical Co.'s Lawsuit Protection

  Patricia Doherty | October 02, 2007 2:51 PM | 0 CommentsOrlando, FL Category: Medical Malpractice
  

  The US Supreme Court announced it will decide a case regarding whether federal regulation of pharmaceutical companies preempts state law. The case the Court will decide arises from a products liaiblity lawsuit against Pfizer's Warner-Lamber unit involving its Rezulin diabetes drug. The FDA ordered Rezzulin off the market in March 2000 because it was linked to hundreds of deaths and cases of...