OT: Supreme Court Shields Medical Device Manufacturers from Consumer Lawsuits

[Guest guest]

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

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promotes. In 2007, Adams launched EcoLEDs, a maker of _super bright LED light

bulbs_ (http://www.ecoleds.com/) that are 1000% more energy efficient than

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Adams volunteers his time to serve as the executive director of the _Consumer

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macrophotography and organic gardening.