Rights or Wrongs: Who's on top -- the FDA or the States?
July 23, 2008 12:43
Poised on the edge of a legal precipice are patients' rights as to whether or not they can sue pharmaceutical companies and medical device manufacturers that have been approved by the federal Food and Drug Administration.
In April 2008, the Supreme Court ruled in favor of medical device manufacturer instead of the patient (Riegel v. Medtronic) because the high court determined that a product-liability lawsuit against Medtronic in a state court was preempted because the device had received FDA approval.
This is bad news for patients as they have no legal recourse against defective medical devices or pharmaceutical drugs that are rushed to market without adequately tested pharmaceutical drugs.
The next big decision hanging in the air is Wyeth v. Levine. The Supreme Court will decide the fate of a patient who lost her arm after an injection of Wyeth's drug Phenergan. Can she sue for damages? The Court will decide whether preemption of state tort litigation is
implied by the law, even though it is not explicitly stated.
Don't you think someone has to be responsible for loss of a limb from a pharmaceutical drug?
New Heart Saving Device Technology
June 9, 2008 07:24
New Heart Saving Device TechnologyThe Food and Drug Administration announced approval of a heart pump that has already been in use in 40 other nations worldwide. The Impella 2.5 Cardiac Assist Device that delivers up to 2.5 liters of blood per minute delivered... (Read Article)
Medtronic compares its stent to Abbott's
May 13, 2008 08:55
Medtronic Announced that is is begining a trial to compare the Endeavor stent against Abbott's Xience V stent
The Sprint Fidelis Electrode Recall
April 4, 2008 14:24
Heart disease is a serious matter and that is why one who is under the care of a physician for heart problems will be reliant on ever step of treatment to be effective. In the case of the Sprint Fidelis electrode, many heart patients were seriously let down... (Read Article)
Medtronic Lobbying Efforts
February 28, 2008 12:32
Medtronic, which manufactures medical devices, spent $940,000 in the second half of 2007 to lobby the House of Representatives, according to a disclosure form posted online Feb. 14 by the Senate's public records office. It lobbied on provisions in farming bills that allows medical device sales representatives the ability to train with live animals.
Judicial Panel on Multi-District Litigation
February 27, 2008 12:15
The Judicial Panel on Multi-District Litigation issued a transfer order, transferring all Medtronic Sprint Fidelis case (MDL No. 1905) filed in various federal courts to the District of Minnesota. The Panel's transfer order can be view at http://www.jpml.uscourts.gov/Hearing_Info/Newly_Transferred/MDL_1905-TransferOrder-Corrected.pdf.