First, the details of the case: In the spring of 2000, Diana Levine of Vermont received treatment for migraines which consisted of the painkiller Demerol and Phenergan, an antihistamine manufactured by Wyeth Pharmaceuticals. Phenergan is typically injected directly into the muscle or dripped into the vein through steady doses (a procedure called an “IV drip”). When administering the drug, clinicians must be careful not to expose it to blood in the arteries; doing so causes “swift and irreversible gangrene,” to use an evocative phrase from a September New York Times article on Levine’s case.
Unfortunately, the physician assistant who attended to Levine administered Phenergan neither through muscular injection nor IV drip, but through a process called “IV push”—a direct intravenous shot in the arm. The assistant missed and hit an artery. Over the next few weeks, Levine, who was an avid guitarist, saw her right hand and forearm turn purple and then black—until both were finally amputated.
The court battle is over whether or not Wyeth Pharmaceuticals sufficiently warned against the dangers of IV push on its packaging for Phenergan—packaging that had been approved by the FDA. The drug’s labeling did warn that it was preferable to give Phenergan through IV drip, and warned that “inadvertent intra-arterial injection”—accidentally injecting the drug into an artery—could cause “gangrene requiring amputation.” But nowhere on the Phenergan label was there an express warning that the method of IV push is extremely risky for this very reason.
Thursday, November 06, 2008
Federalism and Pharmaceuticals
There's an interesting Supreme Court case coming up. The case deals with whether drug-makers are liable for side-effects of medications that occur, even after the drug label/warning is approved by the FDA. There's an interesting discussion about patients vs. big pharma on the Healthbeat Blog (via KevinMD):