Supreme Court Shields Medical Device Manufacturers from Consumer Lawsuits
_http://www.naturalnews.com/022713.html_
(http://www.naturalnews.com/022713.html)
NaturalNews) The U.S. Supreme Court has ruled that medical device
manufacturers cannot be sued for injuries caused by their products if those products
were pre-approved for use by the FDA.
The court ruled that Charles Riegel, who was injured in 1996 when a balloon
catheter made by Medtronic Inc. burst while being inserted into one of his
coronary arteries during an angioplasty, could not sue the company for damages.
In doing so, the Supreme Court upheld a ruling by a U.S. appeals court and
an earlier ruling by a trial court in New York.
I discuss the disastrous consequences of this issue in great detail in a new
_podcast_ (http://www.naturalnews.com/podcast.html) (#11). Click here to
listen: _http://www.naturalnews.com/Index-Podcasts.html_
(http://www.naturalnews.com/Index-Podcasts.html)
Hiding behind a legal technicality
Medtronic, which no longer makes the balloon catheter in question, said that
the fault was with the doctor, who used the device contrary to the operating
instructions. The company also said that the doctor made an error in using
that type of product for a patient in Riegel's condition. But rather than
ruling in Medtronic's favor merely for the one specific instance, the court
dismissed the case entirely, saying that _federal law_
(http://www.naturalnews.com/federal_law.html) prohibits suing device manufacturers in state courts if
the device was approved as safe by _the FDA_
(http://www.naturalnews.com/the_FDA.html) . The decision is expected to have ramifications for a large number
of pending _lawsuits_ (http://www.naturalnews.com/lawsuits.html) against
manufacturers of devices such as breast implants, defibrillators, artificial heart
pumps and valves, drug-coated stents, spinal cord stimulators, and
prosthetic hips and knees.
Because there is no federal law that allows consumers to sue medical device
manufacturers for damages, state courts have become a common venue for such
suits.
The legal reasoning behind the court's decision centered on the wording of
the 1976 Medical Device Amendments law. The law, which set in place an FDA
pre-approval process for _medical devices_
(http://www.naturalnews.com/medical_devices.html) , explicitly prohibited states from putting in place "any
requirement" that is "different from, or in addition to" FDA requirements. In an 8-1
majority, the court ruled that allowing citizens to sue device companies in
state courts amounts to "a requirement" that undermines the FDA approval
process.
Writing for the majority, Justice Antonin Scalia wrote that the FDA may
approve devices "that present great risks if they nonetheless offer great
benefits in light of available alternatives." In other words, there is no
requirement that devices actually achieve any reasonable level of safety for all
patients. To receive FDA approval and be immunized from lawsuits, medical devices
merely have to keep alive slightly more people than they kill.
It would be inappropriate to empower juries second-guess these FDA decisions
without full access to data about the benefits of technologies, Scalia said.
This is the Supreme Court's way of saying that medical device safety is
define solely by the FDA, and if the FDA says something is safe, the fact that
such devices actually kill people does not in any way disprove the device's
safety.
A jury "sees only the cost of a more dangerous design, and is not concerned
with its benefits; the patient who reaped those benefits are not represented
in court," he wrote. This is a clever way of saying that products that kill
some consumers -- but not all -- are safe enough to be granted blanket
immunity because there are some survivors. It's a ridiculous position, of course,
and it's never applied to natural remedies.
Note that if an herb kills even ten people in the entire country, the FDA
immediately leaps to the conclusion that the herb is "unsafe at any dose.";
(Google the history of the FDA's ephedra ban for details.) But medical devices
and pharmaceuticals are held to an entirely different standard: They must only
avoid killing more people than they kill! The fact that some people survived
the treatment is apparently sufficient to justify all those who died! This is
precisely what Justice Scalia is saying in this decision.
A whisper of sanity from Justice Ginsburg
Dissenting Justice Ruth Bader Ginsburg disagreed with the logic that the
ability to sue companies constitutes an unfair "requirement."
"Congress, in my view, did not intend [for the 1976 law] to effect a radical
curtailment of state common-law suits seeking compensation for injuries
caused by defectively designed or labeled medical devices," she wrote.
The purpose of the law, according to Ginsburg, was to prevent states from
imposing confusing additional regulatory processes on top of the new federal
standard. Prior to 1976, the absence of a federal regulatory process for
medical devices had spurred many states to initiate their own.
Senator Edward Kennedy, one of the sponsors of the 1976 law and head of the
Health, Education, Labor and Pensions Committee, agreed with Ginsburg's
analysis. "In enacting legislation on medical devices, Congress never intended
that FDA approval would give blanket immunity to manufacturers from liability
for injuries caused by faulty devices," Kennedy said. "Congress obviously needs
to correct the court's decision. Otherwise, FDA approval will become a green
light for shoddy practices by manufacturers."
The _Supreme Court_ (http://www.naturalnews.com/Supreme_Court.html) ruling
applies only to medical devices pre-approved under the process set in place by
the 1976 law, not to devices grandfathered in under a separate process, in
which the FDA decides that a product is "substantially equivalent" to one that
was already on the market prior to 1976. In 1996, the Supreme Court ruled
that manufacturers of those devices can indeed be sued by states.
Devices that undergo the FDA pre-approval process, and thus are exempted
from lawsuits under the current ruling, tend to be more technologically
advanced, expensive and risky than older devices.
Under the new ruling, device manufacturers that fail to follow FDA
specifications can still be sued in state courts. In addition, lawsuits or
prosecutions can be brought against companies for violations of state laws that are the
same as federal laws, just not state laws with different requirements.
Supreme Court's decision will unleash a wave of shoddy medical devices that
could kill tens of thousands
Allison Zieve, the lawyer who represented Riegel's family, said that the
court's ruling will have a dangerous effect on the quality of medical devices.
Because the threat of lawsuits is a primary incentive for manufacturers to
make sure their products are as safe as possible, the removal of this threat
will lead to more dangerous devices staying on the market.
"By minimizing the incentive, the Supreme Court's decision poses a risk to
the safety of medical devices," she said.
This is crucial to understand: When medical device manufacturers are granted
blanket immunity that protects them from all lawsuits, they no longer have
any reason to make their products safe. They only need to seek FDA approval,
not genuine product safety, and FDA approval is a political process, not a
scientific one, so achieving such approval for unsafe medical devices is simply
a matter of paying off the right people, fudging the right scientific
studies, and filling out the paperwork. The FDA grants its approval to deadly
products on a regular basis. (Just look at Vioxx, Rezulin, and all the other deadly
drugs approved by the FDA...)
Remember: The FDA serves the interests of corporations, not the _American
people_ (http://www.naturalnews.com/American_people.html) . When it comes down
to a question of public safety vs. corporate profits, the FDA favors the
_corporations_ (http://www.naturalnews.com/corporations.html) in nearly every case.
Now, with the U.S. Supreme Court handing medical device manufacturers
blanket immunity, the American public has absolutely no legal recourse for the harm
caused by dangerous medical devices, even if they are defective!
What's next? Immunity for Big Pharma of course
The Bush administration, which supported Medtronic in the current case, has
announced its intentions to seek similar lawsuit immunity for _drug
companies_ (http://www.naturalnews.com/drug_companies.html) . This would make it
impossible for consumers to sue drug companies for the harm caused by
pharmaceutical side effects, unleashing a new era of blanket immunity for the very
corporations that are now poisoning the American population with dangerous and
deadly synthetic chemicals.
Drugs are regulated under a different law than medical devices: the Food,
Drug, and Cosmetic Act of 1938. Unlike the 1976 medical device law, the Food,
Drug and Cosmetic Act does not explicitly prohibit alternate state
regulations. But according to the Bush administration, the ban is implicit.
The Supreme Court will consider whether to grant this immunity to drug
companies on Monday, in the case of Warner-Lambert Co. V. Kent. (See
_http://www.law.cornell.edu/supct/cert/0..._
(http://www.law.cornell.edu/supct/cert/06-1498.html) ) If the drug companies win this case, it will unleash a chemical
holocaust on the American people, where the most dangerous chemicals imaginable
are patented, marketed and sold to unsuspecting consumers, with absolutely no
legal recourse for those harmed or killed by such products. The American
people will find themselves chemically and financially enslaved to the drug
companies, poisoned by an evil conspiracy of greed between Big Pharma and the FDA
while being stripped of their right to justice thanks to the U.S. Supreme
Court.
Listen to my podcast (#11) to learn what happens next:
_http://www.naturalnews.com/Index-Podcasts.html_
(http://www.naturalnews.com/Index-Podcasts.html)
Hint: The coming collapse of _America_
(http://www.naturalnews.com/America.html) is accelerating, and the people running this country will not stop until
every right is stripped, every person is drugged, every dollar is stolen and
every wage earner is forever indebted to a system of disease management that
is intentionally designed to prevent health and keep the population in a
state of chronic disease (and mental weakness).
The U.S. Supreme Traitors
That the U.S. Supreme Court would take away the rights of consumers to sue
medical device manufacturers for the harm caused by their dangerous devices is
not even the issue here: It's the fact that the U.S. Supreme Court is
WILLING to take away such consumer rights! It means the Constitution is deemed
irrelevant, and its last-ditch protectors have now sold out to the corporations.
The U.S. Supreme Court is now operating as a band of traitors who have
surrendered the future of this nation to the corporations. Today, it's with medical
device manufacturers, tomorrow it's with pharmaceuticals, and in another
year, it could be for any product or service that is "approved" by a government
regulator.
Essentially, the U.S. Supreme Court has announced its intent to enslave the
U.S. population and grant total power to the corporations and the corrupt,
centralized regulators (like the FDA and USDA) influenced by those corporations.
You've just lost your country, folks. Good luck trying to get it back. The
corruption is now so deep that the U.S. Supreme Court no longer protects the
People. The very concept of "We the People" is now history.
The new message to the People is simply this: Take your medicine. Don't ask
questions. Pay your taxes. Do what you're told, vote for who you're told, and
don't demand any more rights.
And if you're killed by a medical device, rest in peace with the knowledge
that someone else wasn't.
###
About the author: Mike Adams is a holistic nutritionist with a mission to
teach personal and planetary health to the public He has authored and published
thousands of articles, interviews, consumers guides, and books on topics
like health and the environment, impacting the lives of millions of readers
around the world who are experiencing phenomenal health benefits from reading his
articles. Adams is an honest, independent journalist and accepts no money or
commissions on the third-party products he writes about or the companies he
promotes. In 2007, Adams launched EcoLEDs, a maker of _super bright LED light
