More than 5,000 lawsuits have been initiated related to faulty hip replacements in the United States, but the frightening thing is that the flawed device came to market because of a regulatory loophole.
The Food and Drug Administration allows devices to come to market without testing on patients if the manufacturer can show there’s a "predicate," a similar device that was approved earlier.
But what if that predicate was pulled from the market when its maker realized it had flaws? Doesn’t matter.
A voluntary recall, not a recall by the FDA, allows the design to be picked up by other manufacturers and survive as a repeat offender. That means the new device maker can sail onto the market — with the wind of a bad product at its back.
Now, House Democrats have proposed a bill to deal with the loophole that allows these faulty designs a second life. It gives the FDA the power to reject devices that are based on flawed designs recalled by manufacturers. It’s a sensible response that places consumer safety first.
In addition to endangering consumers, the loophole undermines the FDA’s credibility. The agency’s safety designation should be above reproach.
Already, medical representatives say the bill is overkill, another regulation to burden manufacturers. But an FDA official who oversees medical devices says the change could make approvals easier, shortening the negotiations about questionable designs. And makers of the new device would have the opportunity to show how earlier errors had been corrected, or no longer relevant.
That’s fair for both seller and buyer. Consumers shouldn’t have to endure the pain and cost of replacing devices that have the same DNA as Brand X.
Submitted by Brandon Smith from
Alt-Market
Americans Will Need “Black Markets” To Survive
As Americans, we live in two worlds; the world of mainstream fantasy, and the world of day-to-day reality right outside our front doors. One disappears the moment we shut off our television. The other, does not…
When dealing with the economy, it is the foundation blocks that remain when the proverbial house of cards flutters away in the wind, and these basic roots are what we should be most concerned about. While much of what we see in terms of economic news is awash in a sticky gray cloud of disinformation and uneducated opinion, there are still certain constants that we can always rely on to give us a sense of our general financial environment. Two of these constants are supply and demand. Central banks like the private Federal Reserve may have the ability to flood markets with fiat liquidity to skew indexes and stocks, and our government certainly has the ability to interpret employment numbers in such a way as to paint the rosiest picture possible, but ultimately, these entities cannot artificially manipulate the public into a state of demand when they are, for all intents and purposes, dead broke.
In contrast, the establishment does have the ability to make specific demands or necessities illegal to possess, and can even attempt to restrict their supply. Though, in most cases this leads not to the control they seek, but a sudden and sharp loss of regulation through the growth of covert trade. The people need what the people need, and no government, no matter how titanic, can stop them from getting these commodities when demand is strong enough.
This process of removing necessary or desirable items from a trade environment leads inevitably to counter-prohibition often in the form of strict cash transactions, barter markets, or “black markets” as they are normally derided by those in power. The problem for economic totalitarians is that the harder they squeeze the masses, the more intricate the rebellion becomes, especially when all they want is to participate in free markets the way our forefathers intended.
The so called “drug war” is proof positive of the impossibility of locking down a product, especially one that has no moral bearing on the people who are involved in its use. Only when a considerable majority of a populace can be convinced of the inherent immoral nature of an illicit item can its trade finally be squelched. During any attempt to outlaw a form of commerce, a steady stream of informants convinced of their service to the “greater good” is required for success. Dishonorable governments, therefore, do not usually engage in direct confrontation with black markets. Instead, they seek to encourage the public to view trade outside mainstream legal standards as “taboo”. They must condition us to react with guilt or misplaced righteousness in the face of black market activity, and associate its conduct as dangerous and destructive to the community, turning citizens into an appendage of the bureaucratic eye.
But, what happens when black markets, due to calamity, become a pillar of survival for a society? What happens when the mainstream economy no longer meets the available demand? What happens when this condition has been deliberately engineered by the power structure to hasten cultural desperation and dependence?
In this event, black markets not only sustain a nation through times of weakness, but they also become a form of revolution; a method for fighting back against the centralization of oppressive oligarchies and diminishing their ability to bottleneck important resources. Black markets are a means of fighting back, and are as important as any weapon in the battle for liberty. Here are just a few reasons why such organizational actions may be required in the near future…
The Mainstream Economy Is Slowly Killing Us
There are, unfortunately, some Americans out there who have not caught on yet to the grave circumstances in which we live. Obviously, the stock market seems to have nearly recovered from its epic collapse in 2008 and 2009, and employment, according to the Labor Department, is on the mend. The numbers say it all, right? Wrong! The numbers say very little, especially when they are a product of “creative mathematics”.
Despite the extreme spike in the Dow Jones since 2010, and all the talk of recovery, what the mainstream rarely mentions are the details surrounding this miraculous return from the dead for stocks.
One of the most important factors to consider when gauging the health of the markets is “volume”; the amount of shares being traded and the amount of investors active on any given business day. Since the very beginning of the Dow’s meteoric rise, the markets have been stricken with undeniably low volume interspersed with all too brief moments of activity. In fact, this past January recorded the lowest NYSE volume since 1999:
http://www.bloomberg.com/news/2012-01-23/stock-trading-is-lowest-in-u-s-since-2008.html
Market volume has tumbled over 20% since last year, and is down over 50% from 2008 when the debt implosion began:
http://blogs.wsj.com/marketbeat/2012/02/24/trading-volume-anemic-this-year/
So then, if trade is sinking, why has the Dow jumped to nearly 13,000? Low volume is the key. In a low volume market, less individual investors are present to counteract the buying and selling of larger players, like international banks. When this happens, the big boys are able to trigger market spikes, or market drops, literally at will. Add to this the high probability that much of the stimulus that the Federal Reserve has regurgitated into the ether probably ended up in the coffers of corporate banks which then used the funny money to snap up equities, and presto! Instant market rally! But, a rally that is illusory and unstable.
Improving employment numbers are yet another financial hologram. As most of us in the Liberty Movement are well aware, the Labor Department does not calculate true unemployment in the U.S. Instead, it merely calculates those people who currently receive unemployment benefits. Once a person hits the extension limit (99 weeks in many states on his benefits, he is removed from the rolls, and is no longer counted in the “official” unemployment percentage. While Barack Obama and MSM pundits are quick to point out the drop in jobless to 8.3%, what they conveniently fail to mention is that MILLIONS of Americans have been unemployed for so long that they have been removed from the statistics entirely, and this condition is what has caused the primary fall in jobless percentages, not burgeoning business growth.
Roughly 11 million Americans who are jobless have nonetheless been excluded from the statistical government tally because of a loss of benefits:
According to the Congressional Budget Office, over 40% of the currently unemployed have been so for over 6 months. It also points out that America is suffering the worst case of long term unemployment since the Great Depression:
http://www.cbo.gov/sites/default/files/cbofiles/attachments/02-16-Unemployment.pdf
More than 10.5 million people in the U.S. also receive disability payments, which automatically removes them from the unemployment count, making it seem as though jobs are being created, rather than lost:
http://www.foxnews.com/politics/2012/02/19/report-millions-jobless-file-for-disability-when-unemployment-benefits-run-out/
Around 8.2 million Americans only work part time, meaning they work less hours than are generally considered to be necessary for self-support. These people are still counted as “employed” even if they work a few hours a week.
True unemployment, according to John Williams of Shadowstats, is hovering near 23%:
http://www.shadowstats.com/alternate_data/unemployment-charts
Combine these circumstances with the ever weakening dollar, price inflation in foods and other commodities, and rocketing energy costs, and you have an economy that is strangling the life out of the middle-class and the poor in this country. It is only a matter of time before the populace begins searching for alternative means of subsistence, even if that entails “illegal” activities.
Government Cracking Down On Freedom Of Trade
I was recently walking through the parking lot of a grocery store and ran into a group of women huddled intently around the back of a mini-van. One of the women was reaching into a cooler and handing out glass containers filled with milk. I approached to ask if she was selling raw milk, and if so, how much was she charging. Of course, they turned startled and wide eyed as if I had just stumbled upon their secret opium ring. Somehow it had slipped my mind how ferocious the FDA has become when tracking down raw milk producers. The fact that these women were absolutely terrified of being caught with something as innocuous as MILK was disturbing to me. How could we as a society allow this insanity on the part of our government to continue?
That moment reminded me of the utter irrelevance of petty law, as well as the determination of human beings to defy such law.
The Orwellian hammer has been thrust in the face of those who trade in raw milk, organic produce, and herbal supplements, while small businesses are annihilated by government dues and red tape. In the meantime, law enforcement officials have been sent strapped to shut down children’s lemonade stands (no, seriously :
http://www.cbsnews.com/2100-500164_162-20079838.html
Government legislation which would give the FDA jurisdiction over personal gardens has been fielded. Retail gold and silver purchases of over $600 are now tracked and taxed. The IRS even believes it has the right to tax barter exchanges, even though they do not explain how bartered goods could be legally qualified as “income”, or how they can conceive of ever being able to trace such private trade:
http://www.irs.gov/newsroom/article/0,,id=205581,00.html
Want to choose what kind of currency you would like to use to protect your buying power? Not if the Department Of Justice’s Anne Tompkins has anything to say about it. After the railroading of Liberty Dollar founder Bernard von NotHaus, she stated:
“Attempts to undermine the legitimate currency of this country are simply a unique form of domestic terrorism…”
“While these forms of anti-government activities do not involve violence, they are every bit as insidious and represent a clear and present danger to the economic stability of this country,” she added. “We are determined to meet these threats through infiltration, disruption, and dismantling of organizations which seek to challenge the legitimacy of our democratic form of government.”
http://www.fbi.gov/charlotte/press-releases/2011/defendant-convicted-of-minting-his-own-currency
As our economic situation grows increasingly precarious in this country, more and more people will turn towards localized non-corporate, non-mainstream business methods and products. And, the government will no doubt attempt to greatly restrict or tax these alternatives. This mentality is driven in part by their insatiable appetite for money, but mostly, it’s about domination. They do what they do because they fear decentralized markets, and the ability of the citizenry to conceive of choices outside the system. Slaves are not supposed to choose the economy they will participate in…
A “black market” is only a trade dynamic that the government disapproves of, and the government disapproves of most things these days. Frankly, its time to stop worrying about what Washington D.C. consents to. They have unfailingly demonstrated through rhetoric and action that they are not interested in the fiscal or social health of this nation, and so, we must take matters into our own hands.
Black Market Advantages
If the events in EU nations such as Greece, Spain, and Italy are any indication, the U.S., with its massive debt to GDP ratio (real debt includes entitlement programs , is looking at one of two possible scenarios: default, austerity measures, and high taxes, or, hyperinflation, and then default, austerity measures, and high taxes. In the past we have mentioned barter networking and alternative market programs springing up in countries like Greece and Spain allowing the people to cope with the faltering economy. Much of this trade is done away from the watchful eyes of government, simply because they cannot afford the gnashing buffalo-sized bites that bureaucrats would take from their savings in the process. When a government goes rogue, and causes the people harm, the people are in no way obligated to continue supporting that government.
Black markets give the citizenry a means to protest the taxation of a government that no longer represents them. In a country stricken with austerity, these networks allow the public to thrive without having to pay for the mistakes or misdeeds of political officials and corporate swindlers. In a hyperinflationary environment, black markets (or barter markets that have been deemed unlawful , can be used to supplant the imploding fiat currency altogether, and energize community markets that would otherwise be unable to function. Ultimately, black markets feed and clothe the grassroots movement towards economic responsibility, and every man and woman with any sense of independence should rally around this resource with the intention to fight should it ever be threatened.
“Legality” is arbitrary in the face of inherent conscience, or what some call “natural law”. Without arbitrary legality, and unjust and unwarranted regulation, many federal alphabet agencies would not exist, including the FDA, the IRS, the EPA, the BLM, etc. These institutions do not matter. What they say has no meaning. What matters is what is honorable, what is factual, and what is right. Our loyalty, as Americans, is to our principles and our heritage. Beyond that, we don’t owe anyone anything. A black market in one place and time is a legitimate market in another. For now, private localized trade is able to flow with only minor interference, but there will come a day when even the most practical and harmless personal transactions will be visited with administrative reproach and vitriol. Alternative market champions will be accused of “extremism”, and undermining the mainstream economy. We will be vilified as separatists, isolationists, terrorists, and traitors. I believe it will be far more surreal than what we can possibly imagine now.
They are welcome to call us whatever they like. Honestly……who cares? Let the paper pushers do their angry little dance. The goal is freedom; in life, in politics, and in trade. If we do not change how this country does business ourselves, the results will be far more frightening than any government agent at our doorstep, and the costs will be absolute…
