An important bit of research carried out by Chicago-based legal consulting firm Zagnoli McEvoy Foley (ZMF) is published this week in the National Law Journal. The research indicates that the "FDA's positive halo effect which benefited pharmaceutical companies at trial" is all but gone (Jurors' view of FDA has soured in recent years - subscription only).A 2006 nationwide survey of 404 jury-eligible Americans showed that less than one-third held a positive perception of the FDA. Earlier surveys had shown that "FDA approval could absolve a pharmaceutical company of guilt in a juror's eyes, as a result of the "rubbing off" of the FDA's perceived credibility". Now that's the important bit - the FDA is no longer effective at absolving companies from corporate criminality.
So what to do......
Well make it impossible for anyone to bring legal action against a drug manufacturer for harm caused by one of its products - so long as that product has FDA approval - even in cases of scientific fraud, the concealing of data, misrepresentation of data, or breaches of scientific procedure by the company (FDA regulations make it harder to sue drug companies).
"Beginning at the end of this month, the new regulations would pre-empt nearly all action by patients in state courts against drug manufacturers for unanticipated injuries resulting from the use of their products. This immunity would apply even if a company failed to warn prescribers or patients adequately about a known risk, unless a patient could prove that the company intentionally committed fraud—a very hard test to meet,"
Be scared. Be very very scared.
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The Food and Drug Administration approves, for purposes of this article, pharmaceuticals and medical devices for use by American Citizens, theoretically, due to their flawless expertise and excellent judgment regarding the safety and quality of such items, as determined by this Department of Health and Human Services division. Considering the progressive acknowledgement of potentially deadly aspects of such approved meds and devices, more are getting removed from the market or are receiving very strict limitations on their use, which are called black box warnings, the FDA appears to not even exist for its original purpose.
The drug companies, for example, presumably in a rush to get their new med to market because of its patent life limitations, has for close to 20 years now paid the FDA to speed up the approval process with so much money that the pharma industry now provides nearly half of the FDA’s budget. This occurs due to the Prescription Drug Users Fee Act, which began in 1992. In my opinion, this creates a relationship between the two as client and provider. So clearly fallacies exist with the FDA’s approval process, as noted with the damage that has been done by the products it has approved to ideally benefit human health. Unfortunately, there is a standard, legal, and judicial doctrine called Pre-emption that protects the makers of damaging products from responsibility and exonerates them from any liability from the damage they may have caused to those who used their products.
Here’s why this happens: Pre-emption means that federal law is and will always be supreme over state law due to the U.S. constitution and its supremacy clause, yet the FDA lacks such a clause itself. So what does this term have to do with pharma companies avoid being charged by the victims for the liability from those harmed? The FDA is a Federal Administration. Since the FDA are flawless experts and a Federal Administration, the FDA and the makers of harmful products cannot be blamed for the damage they may have caused others, because the so called experts, the FDA, approved such products. And Federal Law along with the Supreme Court and the Bush Administration agree that the drug makers should not be liable. I smell cronyism with this arrangement.
The FDA has itself admitted it cannot do what it is required to do because of lack of resources, they say, which is to manage, supervise, and regulate with thorough and complete oversight the pharma and med. device companies. This in itself should raise the attention of the government to replenish this association because of their importance to the public. Since this is not the case, the FDA depends on the good faith of the saints of the pharma industry to disclose their product flaws once discovered and immediately. If this was done, then harmful drugs would likely cause less damage to others. Certainly, patients and doctors cannot be completely aware of such risks as the environment described exists presently, as they can be and are uninformed possibly of the knowledge and information of the drugs available.
However, patients do head to court for relief, rightfully so, for compensation from their suffering from such flawed products. A plus to this activity, regardless of its success, is that it becomes a catalyst for discovery and disclosure of the collusive ones, which are the pharma industry and the FDA, one could conclude.
On a more positive note, a recent pre-emption case involving Medtronic came to light which displeased the U.S. citizens thanks to certain media sources free of fear, apparently, so congress has pledged to pass a bill reversing this removal patient rights regarding such situations, which were both announced earlier this year, so the harmed ones can respond without the restrictions of their government, as they should. At the same time, however, GSK and Pfizer won their preemption cases regarding anti-depressant lawsuits just last month.
Our Health Care System is too important to accept wrongdoing and allow corruption regardless of the amount or severity. Awareness and action by U.S. citizens in time, I hope, will not allow such things to occur in the future again of a similar nature. Because presently, it appears apathy is our greatest weakness for such evil to exist.
“Justice shines by its own light.” --- Cicero
Dan Abshear
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