Drug makers can be sued for injury claims even though their products and labels are approved by the federal government, the U.S. Supreme Court decided Wednesday.
The case centered around a woman who lost much of her arm following a botched injection. The woman claimed that the warnings on the drug label were not substantial enough. The drug manufacturer, however, contended that the company could not be held responsible since the drug and the label were approved by the Food and Drug Administration (FDA).
In a 6 to 3 ruling, the court sided with the woman saying that under FDA regulation drug companies are responsible for the content of their labels, reports The New York Times. To read more click here.
Drug companies like Pfizer and Wyeth can run but cannot hide. It is simply untrue that, as Wyeth attorney Rein asserts in a written statement:
“The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product’s label.”
Drug companies ‘negotiate’ vigorously with the U.S. Food and Drug Administration (FDA) over the text of the warning label which accompanies each drug to the marketplace. Drug companies such as Pfizer and Wyeth hold the results of their clinical trials close, keeping from the public and the FDA analysis of clinical data which link the use of their drugs to serious adverse events and deaths. Is it still true that potential tragedies for a ‘few’ American consumers become the ‘cost of doing business’ for Pfizer and others as they have practiced a strategy of lobbying to dilute FDA enforcement while also hiding behind it’s ‘expertise’ as an insulation against litigation? Answer before today’s supreme court ruling: Yes! Today’s supreme court decision upholding a cash award for Ms. Levine may be an early warning signal to pharmaceutical companies such as Pfizer and Wyeth to take far more responsibility for what is contained in and omitted from their warning labels. These drug companies have failed in their attempt to lead the public into believing that a chronically hog-tied Food and Drug Administration maintains ultimate legal and moral responsibility for the safety of the American public from harmful and deadly side-effects. How long did Pfizer think it could succeed with this strategy knowing how many deaths and other serious side-effects are suffered by its ‘customers?’ To pharmaceutical companies everywhere: If your product maims and kills people, you will be exposed and will pay either in negative publicity or cash or both.