This Is How Much The FDA Cares About Us

I already have little faith in the FDA, considering their track record lately hasn’t been the greatest. Not to mention their fast-tracking of new drugs – where they don’t really test/study anything but just accept big pharma’s word that the drug works and is safe (think Vioxx, Chantix, Gardasil just for recent examples). But this article in Natural News just takes the cake.

This is how much our government, agencies meant to protect the people, really care about us. The FDA is beholden to the pharmaceutical companies and other major corporations. Their primary duty, protecting the citizens from bad foods, drugs, etc. is secondary to making sure big pharma etal get what they want and make a fortune doing it…….our health and lives be damned.

Supreme Court Shields Medical Device Manufacturers from Consumer Lawsuits
Monday, February 25, 2008 by: Mike Adams

(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.

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 prohibits suing device manufacturers in state courts if the device was approved as safe by the FDA. The decision is expected to have ramifications for a large number of pending lawsuits 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.
~snip~
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.

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. 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… ) 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.

Read the FULL STORY HERE.

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~ by swfreedomlover on February 26, 2008.

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