McGarity columns on Wyeth vs. Levine Preemption Case
CPR Member Scholar Thomas McGarity had op-eds over the weekend in three Texas newspapers -- the Dallas Morning News, Houston Chronicle and Austin American-Statesman. His topic is Wyeth vs. Levine, last week's blockbuster case from the Supreme Court, in which the Court rejected the Bush Administration's multi-year effort to use the federal regulatory process as a backdoor method of shielding manufacturers from lawsuits brought by customers their products injure.
The case was brought by professional musician Diana Levine, who went to a clinic with a migraine headache, and received nausea medication that eventually resulted in her arm being amputated. Such outcomes were a possibility known to Wyeth, the manufacturer, but the label on the drug, according to the jury that decided the case in Levine's home state of Vermont, failed to adequately warn about how to prevent it from happening. Wyeth argued in court that Levine's case was "preempted" because the FDA had approved its label, thus insulating the company from such failure-to-warn suits brought under state tort law. That's an argument that the Bush Administration made with some regularity over the past several years, in the context of medicine (FDA), cars (the National Highway Traffic …
If you’re a consumer of health and environmental news, you’ve almost certainly heard it said that “children are not just little adults.” The warning comes up a lot in the context of medical research, because children’s bodies metabolize some things differently than do adults. That’s particularly important because somewhere in the vicinity of 80 percent of drugs prescribed for children have never been adequately tested for pediatric use. Lacking viable alternatives, doctors have gotten in the habit of prescribing them off-label. But the lack of testing means that there’s a lot docs can’t know for sure – like, how effective and safe the drugs actually are, what the best dosage is, and more.
The warning comes up a lot in discussions of toxics, as well, because children are often more vulnerable to certain chemicals than adults – for most of the same reasons …
CPR's Tom McGarity has an op-ed this morning in the Austin American Statesman on Wyeth vs. Levine, the Supreme Court case testing an assertion by pharmaceutical manufacturer Wyeth that FDA approval of its proposed drug label shields the company from tort litigation over harm that drug subsequently causes. The Court heard oral arguments on the case on November 3, and a ruling is expected later this term.
The case arose out of one of those medical disaster stories we all fear. Diana Levine went to visit a doctor, complaining of a migraine. Her treatment included an injection of Wyeth's anti-nausea drug, phenergan. The label on the drug carries a caution about the so-called IV-push method of injection -- a shot. The better method is an IV-drip -- where a bottle is hung and the drug introduced more slowly into the vein. The danger is that the drug …
