Whose Body is It Anyway
Below is a MRR and PLR article in category Reference Education -> subcategory Legal.
Whose Body is It Anyway?
Summary:
Would you entrust your health and longevity to an understaffed, underfunded government agency? Probably not.
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The U.S. Food & Drug Administration (FDA) already wields significant control over your health, but its power might increase. This autumn, the U.S. Supreme Court will play a pivotal role in this issue, rooted in the Vermont Supreme Court decision in Levine v. Wyeth.
In April 2000, Diana Levine, a professional musician, was treated for a severe migraine and nausea. A hospital staff member injected her with Phenergan, a nausea medication, which led to a catastrophic outcome?"she lost her right arm below the elbow.
Levine sued Wyeth, the maker of Phenergan, claiming the warning label, despite complying with FDA standards, was inadequate. A jury awarded her $6.8 million. Wyeth appealed, seeking refuge behind the FDA's authority. The Vermont Supreme Court ruled against Wyeth, stating the manufacturer was obligated under state law to enhance the warning label, despite the FDA's ambiguous stance on label revisions.
Preemption in Focus
The U.S. Supreme Court case centers on preemption: whether federal law overrides the ability of victims like Levine to seek damages in state courts. The argument is that FDA approval should grant immunity to drug manufacturers against personal injury lawsuits for labeling failures. As the New York Times put it, drug companies seek a "legal shield" to avoid accountability.
Major corporations often preach accountability, but evade it when it implicates them. This situation is alarming.
The FDA?"a resource-strapped agency?"is being considered for expanded control over our health. An independent review highlighted in USA Today noted the FDA's staffing hasn't grown in 15 years, leaving it in "fire-fighting" mode rather than proactive management.
If the Supreme Court sides with Wyeth, upholding preemption, it would strip citizens of a crucial legal recourse for incidents like Levine's.
The Political Dimension
Politics also play a role, notably under the Bush administration, which acted quietly to block state law claims. In January 2006, new FDA regulations aimed to hinder personal injury claims in state courts.
The FDA asserts it’s the expert authority ensuring drugs are safe and effectively labeled, in essence saying, "If we say it's safe, it's safe." However, the same FDA struggles with food import inspections, raising questions about its reliability.
Beyond legal complexities, human error and an overburdened agency monitoring an ever-growing number of drugs could deny citizens their rights in case of medical disasters.
In May, the Congressional Committee on Oversight and Government Reform held hearings on preemption. Chairman Rep. Henry Waxman expressed concern, warning that if pharmaceutical companies, the FDA, and the Bush administration prevail, the vital incentive for safety?"liability?"would vanish.
Whose body is it, really? Yours, or the FDA's?
Onward.
Richard Alexander
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