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Big Pharma May be Handed Blanket Immunity for All Drug Side Effects, Deaths
David Gutierrez
NaturalNews
Tuesday, Nov 4, 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.
Under 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.
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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.
When 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.
In 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.
Sources for this story include: www.nytimes.com.
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16 Responses to “Big Pharma May be Handed Blanket Immunity for All Drug Side Effects, Deaths”
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November 4th, 2008 at 6:23 am
Pro-corporate America!
November 4th, 2008 at 7:20 am
So let’s say the FDA loses a class action case in court to the tune of $100B. Who pays the settlement? American tax payers? Isn’t this a scam just to shift liability from corporations to tax payers? Or am I missing something?
November 4th, 2008 at 8:20 am
Perish the thought but if your child dies from a vaccination, did you know you cannot sue anyone?
Because vaccine manufacturers have no liability they can do whatever they want, and they do! This is deadly crap! For example they put mercury in it. There is no known safe level of very poisonous mercury and it has been blamed for causing autism.
One argument against injections is to claim a religious exemption. You are not allowed to put crap in God’s temple! Here is a link. I hope it helps to save someone’s life!
http://www.vaclib.org/exemption.htm
Now they want to expand this lack of liability to all drug companies? This is insane!
November 4th, 2008 at 10:07 am
Can you sue the FDA?
November 4th, 2008 at 11:39 am
Now, folks, this could be good news. It means that we don’t need the FDA. Now we can legalize drugs, girls can use RU486 (the abortion pill), hip resurfacing can be done instead of hip replacements (research Indian medical techniques the FDA won’t approve), & Universities won’t be allowed to hold the patton on drugs for 10 years until they allow it to be turned into a generic drug. I know that the cures – er, treatments, can be worse than the disease, but I’m tired of the red tape. Nothing is safe anymore. Not our water, not our air, & certainly not our food. Has anyone noticed that the word cure can be used for the economy, but not when it comes to illnesses?
November 4th, 2008 at 12:15 pm
They are covering theirselves because there will probably be alot of new deaths with the crap they are trying to force on all of us.
November 4th, 2008 at 3:14 pm
if theese schmucks at the FDA can’t even do their jobs, why give them such athoritative power? also why fund them? i think big pharm sholuld be crucified if their products cause harm to people seeking medicine…here’s one that had me rolling… i saw an advair commercial (athsma pill) that said it increaces the risk of athsma related deaths! shouldn’t someone get hung out to dry if their product kills people with the symptoms it professes to suppress? arrrgh!
November 4th, 2008 at 3:22 pm
Silverpixie, it means nothing of the sort! The FDA is not going away, it’s just absolving drug companies of any responsibility whatsoever. It will still be impossible to take natural things that work wonders but are banned. It will still be impossible to get drugs w/o seeing a doctor (unlike most nations where you just go to the pharmacy and get what you need).
What it does is make drug companies completely untouchable when they start deliberately poisoning the drugs (there are plans to reduce the human population by quite a lot, after all…I can’t think of a better way to do so).
We shouldn’t be taking drugs anyway, at least not “legal” ones!! LOL
November 4th, 2008 at 3:23 pm
You can’t sue the FDA.
November 4th, 2008 at 5:46 pm
I once worked as a clinical trial monitor for a medical device company. When I pointed out that the product didn’t do what it was supposed to and that most of the guidelines for the trials were not being followed, I was asked who I worked for by the CEO of the company, the FDA or the company? When I said I was working for the patient, I was promptly laid off. I was told it was for financial reasons and that I was the last one hired. However, I later found out that the complaint I made to the FDA was followed through and the company no longer is in business. This was in the 90’s. I am sure now the FDA wouldn’t even bother to follow through. It is ALL about the almighty dollar. I still work in medicine and see fraud quite a bit. Sad, I say……
November 4th, 2008 at 6:49 pm
Excellent timing after they released the human sterilization vaccine known as ‘Gardasil’.
November 5th, 2008 at 3:03 am
The FDA has shown that it cares not for the citizens of this country. Much recent and past research points to this.
You can bet, I will get no flu shot or take no medicines that I’m not already familiar with or have not taken before. If you can’t sue the people that make the meds that make you ill, what good are their meds?
Time to let Big Pharma know that they do not own our bodies, and they do not dictate what we need to do to heal them. That’s a personal matter.
The FDA needs to be closed down and revamped with real doctors who care about health, not money.
November 5th, 2008 at 4:54 am
Why do you need the FDA?
James 5:14
Is any one of you sick? He should call the elders of the church to pray over him and anoint him with oil in the name of the Lord.
November 5th, 2008 at 10:51 am
the timing is perfect for the pharm companies, every drug commercial i have seen in the last month boasts a list of side affects that contain numerous fatal reactions.
The FDA is a sham they they just give approval to the highest bidder and they definitely dont give a crap about the safety of the public only about the prosperity of whatever drug companies are willing to pay them off.
Since when did death become a acceptable side effect when your treating a condition or disease that in many cases is not even life threatening?
November 5th, 2008 at 11:21 am
Are you a thinking person?
Would you do business with a person who discloses half the truth, because they are not obligated to tell you the whole truth even thought it can and WILL directly affect the only life you have?
There are more than one enemy involved. First of all selfish greed and lack of integrity towards their fellow man, on the part of both the government sector for the money they get from HUGE companies (of course after their generous tax breaks) and the companies lack of integrity towards their fellow man and their selfish greed to exploit the personal desires of the public for that “better life” they think they will get through strategically using words to lead the thinking of the public.
Because of not having solid and strong deterrent measures of accountability in place and with the billions of dollars backing Huge companies and government they can freely and without feeling any pang of conscience of what they(big companies and government) exploit you and I the “common folk”, to get what they want Money, Power, and Prestige. Add to that, the public is very uneducated about the drugs, (there isn’t FULL disclosure), their PERSONAL responsibility and that of the company and the FDA. There is so much to read and not all is commonly understood. A person has to question whether the material being read is fairly and objectively written. How is a person really able to know. Then there is the time issue. That being said and certainly there could be volumes more added, what kind of bill would YOU write and submit for approval to protect you all those whom you love? Write it! Find others who support it. All of you sign it. Hold information meetings. Get that ball rolling now! There is power in numbers – YOU THE PEOPLE
November 5th, 2008 at 8:08 pm
OVER 700 MILLION PEOPLE HAVE DIED ALREADY AND NOW THIS? LMFAO! EUGENICS ANYONE? THIS IS NOTHING NEW AND IT WILL CONTINUE ON A LARGER SCALE WITH OBAMA. GET READY FOR THE REAL NEW WORLD ORDER PEOPLE!!