The United States Supreme Court has Granted the FDA with Scientific Infallibility!

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From Whiteout Press online news service:

“In a 5-4 vote, the US Supreme Court struck down a lower court’s ruling and award for the victim of a pharmaceutical drug’s adverse reaction. According to the victim and the state courts, the drug caused a flesh-eating side effect that left the patient permanently disfigured over most of her body [1]. The adverse reaction was hidden by the drug maker and later forced to be included on all warning labels. But the highest court in the land ruled that the victim had no legal grounds to sue the corporation because its drugs are exempt from lawsuits.

The story gets to the takeaway line with this fascinating nugget to digest:

“In short, the Court ruled that the FDA has ultimate authority over pharmaceuticals in the US. And if the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions.”

Yes folks, if the Food and Drug Administration says a drug is safe, the subject is no longer open for questioning. The key to understanding this seemingly ridiculous ruling is a little something in American Jurisprudence called “the Supremacy Clause,” which states in effect that where  a State law and a Federal law are found to contradict each other, the State law is rendered invalid. The drug in question is a generic version of a “name brand,” which the FDA has approved. Thus if a State court awards damages to a plaintiff that successfully showed to be harmed by a generic drug, there can be no standing in Federal court because of the “impossibility” of a company following both Federal and State laws at the same time. The corporations realize this and only have to drag the matter before the Supreme Court who will dutifully overturn an otherwise correct judgment. They understand that all they have to do is sell any drug under a generic name and be free of any liability or consequence! But if one investigates just a bit further, what will be discovered? If one is allowed to ask three simple questions, what will we be forced to consider?

Question 1: If the Food Drug Administration is (allegedly)  an “agency of the United States Department of Health and Human Services” that is (allegedly) ” is responsible for (allegedly) protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, bio-pharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), and veterinary products, then why have so many drugs it  has approved of been shown to later be unsafe? One such FDA-approved med that wreaked havoc was Vioxx, which caused fatal heart problems and deaths in the thousands!  If Vioxx had managed to be sold as a generic, then any corporation could do so without much consequence. The question that begs a sensible answer is this: what interests are being served by the Supreme Court and the FDA? The commonwealth of the American Citizens, or the pocket books of Big Pharma Corporations?

Question 2: Scientific Infallibility is (allegedly) impossible. A well-known scientific principle in trying to understand something is direct observation. In a similar case brought before the Supreme Court in 2009 (Wyeth v. Levine) [2], the SCOTUS ruled,

“We conclude that it is not impossible for Wyeth to comply with its state and federal law obligations and that Levine’s common-law claims do not stand as an obstacle to the accomplishment of Congress’ purposes in the FDCA. Accordingly, the judgment of the Vermont Supreme Court is affirmed.”

Justice John Paul Stevens:

“…the intent of Congress in passing the Food, Drug, and Cosmetic Act was to implement a system of minimum standards for assessing when a drug is safe and effective enough to reach the market. It did not mean to pre-empt states from finding that additional steps are appropriate to protect their citizens. The Court agreed with Ms. Levine that although the FDA has technical expertise, it lacks the resources to continuously oversee all of the thousands of drugs on the market. Congress intended that state tort law serve as a supplement to its oversight.”

Did you notice that this earlier ruling contradicts the latest ruling on the same crucial point of responsibility? Who is today’s Supreme Court more sympathetic towards? The American Citizen or the Big Pharma Corporations?

Question 3: Now that pharmaceutical corporations have been given the green light to abuse their position and kill and maim its customers with impunity, who will you turn to when something like this happens to you or your family? You better have deep, deep pockets because there are two things for sure, the FDA and the Supreme Court are not going to help you under the current system and you are definitely going to pay. Common sense has been sold along with your “privilege” of citizenship (which isn’t worth doodley-squat). Proof that there needs to be a new system installed that will benefit everyone equally and not only for those who can buy chief justices just like any common street-walker.

NOTES

[1] According to the court documents, the victim is reported to be “severely disfigured, has physical disabilities, and is nearly blind.” – Mut. Pharm. Co. v. Bartlett, No. 12-142, 2013 BL 166063 (U.S. June 24, 2013)

[2] Wyeth v. Levine

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One thought on “The United States Supreme Court has Granted the FDA with Scientific Infallibility!

  1. This is further evidence that the pharmaceutical industry is too cheap to run proper trials because running trials on humans, monitoring them and taking care of the developing side effects by providing counter measures costs money… thus, the industry uses and abuses the actual customer base instead… This cheap work-around costs lives – or at best, severe damage and illness as we see here. Thanks Darryl, for the exposing this situation!

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