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?

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.

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.

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.

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.

In article , wrote:

I highly douby anyone would want airplanes to be regulated to the
extent that medical devices are, though we are getting close.

The last I knew (circa 2002), the FAA paid more attention to the certification
aspects of software than the FDA did.

--
Bob Noel
(goodness, please trim replies!!!)

wrote:
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.



I said PART of the reason. In the EAA chapter I am a member of, nearly
all the builders have said at some point along the way that part of the
reason they are building was so that they could modify and maintain
their own airplane and make it the way they wanted it. Building your
own gets you out from under a lot of the testing that goes into type
certification.

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.

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.

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?