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#1
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This should apply to airframe manufacturers too
From CNN:
The U.S. Supreme Court, in an 8-1 ruling Wednesday, said federal medical-device regulations prevent patients from bringing state product-liability lawsuits unless a medical-device company violated U.S. Food and Drug Administration regulations. "This decision shows that the extensive degree and nature of FDA regulation necessarily means that its scientific decisions may not be second-guessed by unscientific state juries," said Daniel Troy, a partner at Sidney Austin LLP and a former FDA legal counsel. It would seem to me that the manufacturers of certificated aircraft could argue for a similar protection since the aircraft must meet stringent tests and design parameters in order to recieve a type certificate from the FAA. Heck, they could even use this ruling in favor of Medtronic to support their case. Piper, Cessna, Lycoming, Textron, anybody out there listening? |
#2
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This should apply to airframe manufacturers too
Ray Andraka wrote:
From CNN: The U.S. Supreme Court, in an 8-1 ruling Wednesday, said federal medical-device regulations prevent patients from bringing state product-liability lawsuits unless a medical-device company violated U.S. Food and Drug Administration regulations. "This decision shows that the extensive degree and nature of FDA regulation necessarily means that its scientific decisions may not be second-guessed by unscientific state juries," said Daniel Troy, a partner at Sidney Austin LLP and a former FDA legal counsel. It would seem to me that the manufacturers of certificated aircraft could argue for a similar protection since the aircraft must meet stringent tests and design parameters in order to recieve a type certificate from the FAA. Heck, they could even use this ruling in favor of Medtronic to support their case. Piper, Cessna, Lycoming, Textron, anybody out there listening? I highly douby anyone would want airplanes to be regulated to the extent that medical devices are, though we are getting close. -- Jim Pennino Remove .spam.sux to reply. |
#3
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This should apply to airframe manufacturers too
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#4
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This should apply to airframe manufacturers too
Ray Andraka wrote:
From CNN: The U.S. Supreme Court, in an 8-1 ruling Wednesday, said federal medical-device regulations prevent patients from bringing state product-liability lawsuits unless a medical-device company violated U.S. Food and Drug Administration regulations. That's clear enough... "This decision shows that the extensive degree and nature of FDA regulation necessarily means that its scientific decisions may not be second-guessed by unscientific state juries," said Daniel Troy, a partner at Sidney Austin LLP and a former FDA legal counsel. That's one lawyer's opinion and I think you have to accept it as-such. I would speculate that the decision was more about keeping medical-device manufacturers from going broke from lawsuits. Remember that sick people are using the device and sick people sometimes die. It would seem to me that the manufacturers of certificated aircraft could argue for a similar protection since the aircraft must meet stringent tests and design parameters in order to recieve a type certificate from the FAA. Heck, they could even use this ruling in favor of Medtronic to support their case. Piper, Cessna, Lycoming, Textron, anybody out there listening? I don't think you can take it that far. Some people *need* to have pacemakers. If all the pacemaker companies are sued out of existence, many more people will die. Based on that, perhaps a pacemaker company deserves an extra level of protection in order to keep the greater number of people alive. I don't think the argument follows for aviation. |
#5
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This should apply to airframe manufacturers too
Ray Andraka wrote:
wrote: I highly douby anyone would want airplanes to be regulated to the extent that medical devices are, though we are getting close. I'd argue that the certification process for an airframe to obtain a type certificate is pretty close. That is part of the reason the homebuilts have become so popular. You mean requirments like implanted devices have to be tested in environments that could never occur in a living human body? My opinion is the certifaction requirements have little directly to do with why most people build a homebuilt. I would think the top reasons, in no particular order, a The satisfaction of building things with your own hands and knowing it is built correctly. The desire to own something not commercially available. Saving money. -- Jim Pennino Remove .spam.sux to reply. |
#6
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This should apply to airframe manufacturers too
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#7
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This should apply to airframe manufacturers too
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#8
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This should apply to airframe manufacturers too
Jim Stewart wrote:
Ray Andraka wrote: From CNN: The U.S. Supreme Court, in an 8-1 ruling Wednesday, said federal medical-device regulations prevent patients from bringing state product-liability lawsuits unless a medical-device company violated U.S. Food and Drug Administration regulations. That's clear enough... "This decision shows that the extensive degree and nature of FDA regulation necessarily means that its scientific decisions may not be second-guessed by unscientific state juries," said Daniel Troy, a partner at Sidney Austin LLP and a former FDA legal counsel. That's one lawyer's opinion and I think you have to accept it as-such. I would speculate that the decision was more about keeping medical-device manufacturers from going broke from lawsuits. Remember that sick people are using the device and sick people sometimes die. It would seem to me that the manufacturers of certificated aircraft could argue for a similar protection since the aircraft must meet stringent tests and design parameters in order to recieve a type certificate from the FAA. Heck, they could even use this ruling in favor of Medtronic to support their case. Piper, Cessna, Lycoming, Textron, anybody out there listening? I don't think you can take it that far. Some people *need* to have pacemakers. If all the pacemaker companies are sued out of existence, many more people will die. Based on that, perhaps a pacemaker company deserves an extra level of protection in order to keep the greater number of people alive. I don't think the argument follows for aviation. A certificated airplane has supposedly passed a number of tests to certify that it is airworthy and safe to fly by a competent pilot. The FAA goes through great pains to make sure that the airplane meets those requirements. As long as the manufacturer meets the requirements stipulated in the type certificate, the airframe has essentially been blessed by the feds as safe. If something comes up that proves to be unsafe, the Feds issue an AD against the airframe to correct or prevent the unsafe condition, in some cases grounding entire fleets. The manufacturer is not free to make changes to the certified design without getting an approval on the changes from the Feds, which usually involves more testing. If the medical community can get a pass on the liability of its products under the claim that the government approved the device or drug, then any other industry who's products are regulated to the point where they cannot be used without the Fed's blessing should be allowed the same degree of liability protection. The fact is most aircraft accidents are caused by pilot error, not by manufacturing or design defects, yet when it happens, the manufacturers are invariably sued, and usually lose because uninformed jurors second guess the engineering that went into the design of the airframe and components. Never mind those designs require rigorous testing before they get approved by the government. This is virtually the same situation as the one this decision shields the medical device and drug manufacturers from. The bit about people needing a medical device is immaterial to my statement. There are legitimate needs to fly as well. Anyway, I think this could be used as a camel's nose under the tent if played right. |
#9
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This should apply to airframe manufacturers too
Bob Noel wrote:
The last I knew (circa 2002), the FAA paid more attention to the certification aspects of software than the FDA did. Yep, my experience as well. |
#10
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This should apply to airframe manufacturers too
Jim Stewart wrote:
I don't think you can take it that far. Some people *need* to have pacemakers. If all the pacemaker companies are sued out of existence, many more people will die. Based on that, perhaps a pacemaker company deserves an extra level of protection in order to keep the greater number of people alive. I don't think the argument follows for aviation. Same could be said for aicraft component manufacturers. For example the carburetor on my Cherokee Six was manufactured by Precision Airmotive, which is the sole source for parts for that carburetor. Precision also made the carburetors for the majority of the piston powered aircraft in the fleet. They got sued last fall for an outrageous sum and abruptly pulled out of the aircraft carburetor business because they could no longer obtain liability insurance. The tight federal regulation over aircraft has prevented any significant improvements to the pre-WWII carburetor design used on these aircraft. The design is 80 years old, has been installed on tens of thousands of aircraft, and is proven with millions of hours of flight time. Without anybody making spare parts, the likelihood of failures will increase as existing parts are repaired instead of being replaced, exposing more people to potential crashes. How is this materially different than your example with the pacemaker company? |
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