This morning’s New York Times carried a story which addressed the question of whether medicines licensed by the FDA should be above and beyond state product liability law. In legalese, it asks whether the federal Food, Drug & Cosmetics Act “pre-empts” state law.
The NY Times tells the story of a Vermont musician who was forced to have her arm amputated because it became gangrenous after the inappropriate injection of a prescription drug, Phenergan. Suffering a migraine, the musician had gone to her doctor for a treatment which she had undergone many times.
The risk of gangrene from Phenergan is known. That’s why it’s usually administered via intra-muscular injection or intravenous drip. However, in this case, the physician’s assistant used “IV push” (what I suppose we might call, in a different context,”mainlining”). However, he missed the vein and injected an artery instead. The result was gangrene, and amputation.
Who is responsible for this tragedy? According to the article, the FDA-approved label fully disclosed the warning. Suing the manufacturer, Wyeth, in Vermont court, the musician’s lawyers argued that the label was not good enough for Vermont law, and the state Supreme Court has agreed.
The FDA and Wyeth have appealed to the U.S. Supreme Court, arguing that the manufacturer could not have complied with both Vermont law and the FDA’s labelling requirement.
I am (thankfully) not a lawyer, so cannot anticipate who will or should win the case, but I do believe that the status quo results in a regulatory fragmentation that is harmful to the public.
The musician claims that she was unaware of the risk of “IV push”. But of course she was: no patient reads the label of a medicine injected in a clinic or doctor’s office. That is why they are prescription drugs. And that is why the pre-emption should stand.
First, Wyeth had no choice about how to sell its drug. The Durham-Humphrey amendments (1951) to the Food, Drug, & Cosmetics Act give the FDA the power to determine when a drug must be sold by prescription.
Second, it is understandable that a manufacturer cannot put on “extra” labelling on top of its drug’s FDA-regulated label. “Overcrowding” the label could lead to the FDA claiming that the manufacturer was not in compliance with FDA regs.
Third, the practice of medicine and associated health professions (such as physician’s assistant) is regulated by the states. So, a state’s tort law should govern the penalty levied for malpractice – but it can go no further. Interstate commerce is regulated by Congress.
Without pre-emption, drug-makers might limit their liability by forbidding physicians in high-risk states from prescribing certain medicines. However, it is far from clear that this could be legally enforced. It would also turn medical practice upside down: There has been a national, generally accepted, U.S. Pharmacopeia since 1820.
Perhaps a better answer would be to unzip the Durham-Humphrey amendments, and allow drug-makers to decide whether their medicines should be sold via prescription or over-the-counter (OTC), as prevailed before 1951.
That way, medicines sold OTC would expose their manufacturers to somewhat greater liability than those sold via prescription, for which the physician would bear a greater share of liability.