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The US Supreme Court Rules
[By Staff Reporters]
Did you know that the US Supreme Court just ruled that makers of medical devices – like implantable defibrillators or breast implants – are immune from liability for personal injuries as long as the Food and Drug Administration [FDA] approved the device before it was marketed and it meets the agency’s specifications?
Background
In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the FDA overrides most claims for damages under state law, but because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards, according to the New York Times.
The Ruling
The decision does not foreclose lawsuits claiming that a device was made improperly, in violation of Food and Drug Administration [FDA] specifications, while cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them.
Devices subject to the premarket approval process, and thus affected by the court’s opinion, tend to be more technologically advanced and expensive, while examples of devices that have been the subjects of recent lawsuits include an implantable defibrillator, a heart pump, a spinal cord stimulator, a drug-coated stent, an artificial heart valve, and prosthetic hips and knees.
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Assessment
The Bush administration plans to continue its push for pre-emption from personal injury suits in another FDA case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits.
And so, is this ruling a boon for trial lawyers or patients; both or neither?
Conclusion
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Filed under: Drugs and Pharma | Tagged: Drugs, FDA, Health Law & Policy |
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FDA warns doctors of danger from fake drugs
Health care providers ordering meds should view ‘too good to be true’ offers with suspicion, agency says.
http://healthyliving.msn.com/health-wellness/fda-warns-doctors-of-danger-from-fake-drugs-1
http://www.physiciansnews.com/2014/09/24/fda-tells-doctors-to-watch-out-for-fake-dugs/?utm_source=9.24.14&utm_campaign=11713&utm_medium=email
PharmD
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Former FDA Chief Cites 5 Things To Watch On Drug Approvals And Keeping Drugs Safe
1. Faster drug approvals, being advocated by Trump and others, don’t necessarily mean less expensive drugs.
2. A law passed in December should streamline drug approvals — in a positive way.
3. But Califf has concerns about maintaining drug safety standards and ensuring thorough clinical trials.
4. Faster, better drugs can’t be approved if the FDA is understaffed, he argued.
5. The FDA is using big data to track the safety of drugs already on the market — and it plans to do that a lot more.
Source: KHN
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