News tagged with 'Medical Devices'

Medtronic Sprint Fidelis Defibrillator Lead is implicated in more deaths than previously reported, admits the company.  That updated count was released after a federal judge dismissed about 700 cases against Medtronic citing the Riegel decision affirming federal preemption and a shield for device makers.

Lawmakers heard from those injured by medical devices in Washington, as a film and rally was held in support of the Medical Device Safety Act, currently before Congress. It would lift the shield devicemakers currently have from lawsuits. 

The Medical Device Safety Act introduced into Congress, would allow consumers to hold manufacturers of defective medical devices accountable, even if the device has been approved by the FDA. 

New guidelines by U.S. health officials allow companies such as Merck & Co. and GlaxoSmithKline to tell doctors about unapproved uses of medicines– even when it involves off-label uses that have not been approved by the U.S. Food and Drug Administration (FDA).

Vaginal mesh surgery sounded like a good idea to correct urinary incontinence that comes from childbirth, but so far there are at least 32 lawsuits filed against Mentor's ObTape and more are in the pipeline. The FDA reports 1,000 adverse reports from manufacturers concerning complications.

A federal judge, dismissed several lawsuits on behalf of thousands of patients with Medtronic heart-defibrillator wires citing a February decision that federal law “preempts” product-liability lawsuits under state law, effectively precluding such cases.

Prescription drug advertisements are supposed to be regulated by the FDA for content, but there are no requirements to review the ads before consumers see them.  So the FDA is asking consumers to help report misleading and false ads with this web site. 

Two former employees of Medtronic Inc. have filed a whistle-blower lawsuit against the company, alleging it paid spine doctors to use a bone graft product in a way not yet approved by the FDA.  

Cleveland Clinic, one of the nation’s leading medical centers, will announce this week on its Web site, the decision to fully disclose all of its scientists’ and doctors’ financial ties with drug companies and medical device makers.

Johnson & Johnson will acquire the troubled Mentor Corporation, the subject of a multitude of lawsuits concerning its ObTape product and breast implants.

A new study finds MP3 and iPod headphones may dangerously interact with implantable defibrillators and heart pacemakers. Researchers suggest patients with defibrillators and pacemakers not keep headphones in their shirt or coat pocket near the chest or around their neck when not in use.

Should corporations be given complete immunity from liability for dangerous and defective products? 

Consumers are increasingly wary about what FDA approval means in light of food and product recalls, unsafe drugs and novel new foods that go virtually unregulated. Yet "FDA approved" is increasingly carrying the weight of the law of the land, stripping you of your right to go to court.  

What Does FDA Approval Mean?  While that promise has traditionally meant an assurance of safety, the FDA is having a difficult time keeping up with its responsibilities. At the same time, "FDA approved" is increasingly being used to strip consumers of their right to take defective products to court.

Injuryboard is trying to raise the profile on federal pre-emption, the legal argument raised by vaccine makers to auto manufacturers to block your access to the courts.  Some in the business community believe its a good idea to streamline government and help corporations stay profitable.