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Posts Tagged ‘Big Pharma’

Surprise Supreme Court Decision Ends Big Pharma’s Pre-Emption Bid for Legal Immunity

Posted by commendatori on March 5, 2009

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(NaturalNews) In a 6-3 decision, the U.S. Supreme Court has ruled against Wyeth in the Diana Levine case, setting a crucial precedent in the battle against Big Pharma. The ruling ends an important part of the Big Pharma / FDA conspiracy racket that sought to market extremely dangerous (and even deadly) drugs while providing full legal immunity to drug companies, even when those companies actively lied about the safety of their drugs by hiding negative drug studies from the public and the FDA.

The decision has hit Big Pharma hard. The industry, already reeling from layoffs and a loss of innovation, is now facing a wave of lawsuits from potentially hundreds of thousands of people who have been harmed by dangerous prescription medications. The legal path for such lawsuits has now been cleared, and drug companies can no longer claim legal immunity just because they managed to deceive the FDA into declaring their dangerous chemicals were “approved.”

The FDA regime

Three Supreme Court Judges disagreed with the decision, siding with the granting of legal immunity to drug companies: Chief Justice John Roberts and Justices Antonin Scalia and Samuel Alito, who called the decision a “frontal assault on the FDA’s regulatory regime for drug labeling.”

“Regime,” of course, is exactly the right word to describe the FDA’s campaign of medical tyranny against the American People. That even three Supreme Court Justices would vote to enforce this dangerous, corrupt regulatory regime is more than a bit disturbing. Fortunately for the American People, the opinions of these three did not prevail.

Big Pharma has long conspired with the FDA to approve knowingly dangerous (and deadly) drugs that are then marketed to the public through a process known as “disease mongering,” in which drug companies scare up new health conditions in order to convince people they need to be medicated. Practically the entire pharmaceutical industry is based on this unholy alliance between the corrupt FDA (http://www.naturalnews.com/the_fda.html) and a profit-seeking drug industry (http://www.naturalnews.com/big_phar…), and if the Supreme Court had granted Big Pharma immunity on any drug approved by the FDA, it could have unleashed a treacherous era of Big Pharma arrogance and the virtual abandonment of any remaining safety measures by the industry

With full legal immunity, Big Pharma would have been able to market practically any poison as a “drug,” regardless of how many people were killed. Even many of its current drugs are, admittedly, little more than poison. For example, the most popular blood thinning drug sold today — coumadin — is literally made out of the same chemical used in rat poison (http://www.naturalnews.com/021434.html). Many psychiatric drugs given to children today are just re-branded amphetamine street drugs like “speed.”

To the great benefit of the American People (and the lawyers who represent them against drug companies), the Supreme Court has now nailed the coffin shut on Big Pharma pre-emption. Sadly, this decision still cannot raise from the grave all the hundreds of thousands of Americans who have already been killed by dangerous, FDA-approved prescription medications, but perhaps from this point forward, enough lawsuits can proceed that drug companies will either be put out of business or be forced to calculate the economic cost of killing patients while facing a wave of resulting litigation.

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Big Pharma May be Handed Blanket Immunity for All Drug Side Effects, Deaths

Posted by commendatori on November 5, 2008

The Supreme Court may rule that pharmaceutical companies cannot be sued for dangerous or even deadly side effects from their drugs if those side effects arise from an FDA-approved use.

fda-tyrantsUnder a legal argument known as “pre-emption,” the FDA’s approval of a drug absolves companies of any responsibility if that drug later turns out to be dangerous, even if information was concealed from the FDA during the approval process. While courts have rejected this argument for decades, the winds appear to be shifting.

In February, the Supreme Court ruled that makers of medical devices were indeed immune from state lawsuits if their devices had received FDA approval. But that decision hinged on the specific wording of the law that gives the FDA authority over medical devices, and the laws relating to drug regulation are not worded the same way.

Even so, the Bush administration has been actively urging the courts to apply the same principle to drugs. The administration argues that only the FDA is equipped to regulate drugs and decide whether a product is safe, and that judges or juries are not able to make informed decisions on those matters.

The FDA has also recently thrown its support behind pre-emption, reversing a longstanding, de-facto policy of viewing lawsuits as an extra layer of oversight to make up for the agency’s time and budget constraints. Now the agency says that lawsuits over drug side effects could lead to a confusing state-by-state regulatory patchwork that would cause hardship to drug companies and discourage patients from taking certain medications.

Drug companies are using the pre-emption argument as a legal defense in a wide variety of lawsuits, and the Supreme Court is expected to hear such a case, concerning the company Wyeth, in the fall. Before that, however, a lower federal court is expected to rule on whether pre-emption can be used to dismiss lawsuits by more than 3,000 women who claim that they were injured by using Johnson & Johnson’s OrthoEvra birth control patch according to the instructions on the label.

pills4uWhen Johnson & Johnson announced its plans for a birth control patch in 1996, one of the main benefits it claimed the product would provide was the ability to prevent pregnancies through lower doses of estrogen than birth control pills. High doses of estrogen are known to increase women’s risks of blood clots, heart attacks, strokes and death.

But company documents publicized as part of the lawsuits show that in 1999, the company discovered that the patch actually exposed women to significantly more estrogen than the pill, a total of 30 to 38 micrograms per day. Because only about half of the estrogen in a birth control pill actually enters the bloodstream, this means that women using the patch were getting as much estrogen each day as if they were taking a 76 microgram birth control pill.

The FDA banned birth control pills containing more than 50 micrograms of estrogen in 1988.

Rather than reporting this data to the FDA, however, the study’s author instead applied a “correction factor,” reducing the estrogen figures by 40 percent. Although the author claimed this was meant to adjust for differing rates of estrogen absorption, such a “correction” was a deviation from the study procedure previously submitted to the FDA.

fda-pillsIn the final report submitted to the FDA, Johnson & Johnson claimed that OrthoEvra exposed women to only 20 micrograms of estrogen per day. The “correction factor” was referenced only once in the 435-page study report, buried in a complex mathematical formula.

According to internal company emails, other clinical trials conducted before approval suggested that women were experiencing side effects such as breast soreness and nausea due to high estrogen doses, but the company did not warn the FDA that the patch might be delivering more estrogen than advertised. Nor did it tell the agency about other studies, in 1999 and 2003, showing that the patch exposed women to more estrogen than the pill.

When the FDA approved the product in 2001, Johnson & Johnson marketed it as releasing less estrogen than the pill, containing 20 micrograms per day.

The label was not revised until a 2005 investigation by the FDA, following reports of deaths resulting from use of the drug. At that point, the FDA made Johnson & Johnson add a warning that the product “exposes women to higher levels of estrogen than most birth control pills.”

But the company always knew this to be the case, several lawsuits now allege, and is thus responsible for the side effects that resulted: heart attacks, strokes, and even deaths in those who used the patch as directed. Studies have since confirmed that women on the patch may have twice the blood clot risk of women taking birth control pills, and prescriptions have fallen 80 percent, from a high of 900,000 in March 2004 to only 187,000 in February 2007.

But Johnson & Johnson claims that because the FDA approved the drug, the company cannot be held responsible for its effects.

Janet Abaray, a lawyer for one of the plaintiffs, disagrees, saying the company took advantage of the agency’s shortcomings.

“Johnson & Johnson knew that FDA. does not have the funding or the manpower to police drug companies,” Abaray said.

David Vladeck of Georgetown Law School agrees that the FDA has no ability to verify that drug companies are being truthful in their reports.

“These are scientists, not cops,” he said.

Chris Seeger, another plaintiffs’ lawyer, said it would be a mistake to allow pre-emption to let the drug companies off the hook.

“Our lawsuits are the ultimate check against the mistake made by the government, or fraud made by the companies against the government, or just an underfunded bureaucracy stretched thin,” he said.

URL: http://www.naturalnews.com/024688.html

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