Pharmaceutical companies may be handed blanket immunity for all drug side effects and deaths!
WASHINGTON -
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.
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 regime has been actively urging the courts to apply the same principle to drugs. The Bush regime 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.
Ed. Note: The even more chilling aspect of this potential ruling is that most doctors don't know anything more about the drugs they prescribe than what is contained in the circulars those nice people from the pharmaceutical companies give them. For example, FDA-approved Vioxx increases the chances of heart attacks and strokes and has caused numerous deaths. The drug has since been recalled.