The media are (justifiably) interested in the Bush administration’s (or, if you prefer, the “Bush regime’s”) rushing a bunch of new rules into the Code of Federal Regulations that would “pre-empt” states’ product-liability laws. According to the Wall Street Journal, these rules “could block product-safety lawsuits by consumers and states.”
The article notes that the Food & Drug Administration (FDA) used to support the right to sue in state court. However, after President Bush took over, the FDA changed its approach. It immediately asserted that its regulations pre-empt state product-liability law, and developed a so-called Physician Labelling Rule to formalize its stance. In lay language, the FDA claims that if a drug-maker sells a drug that is labelled in accordance with the FDA’s requirements, state laws cannot impose a higher standard.
As I have already discussed, this will come to a head once the U.S. Supreme Court hears Levine vs. Wyeth, a case in which the Vermont Supreme Court rejected the claim of FDA pre-emption and concurred with a product-liability award to a patient who took a drug made by Wyeth.
In my previous post, I argued that pre-emption makes sense, because the drug trades in interstate commerce (a federal responsibility). However, I noted that the patient was free to sue the health professional who administered the drug (and the clinic where she worked) under state law (and had successfully done so).
Having read and thought some more about it, I am reconsidering.
Daniel E. Troy was the Bush-appointed lawyer at the FDA when the agency started to assert pre-emption. In a book recently published by the American Enterprise Institute, Mr. Troy makes a cogent and compelling argument in favor of FDA pre-emption.
But cogent and compelling are not necessarily convincing. Mr. Troy’s argument is largely based on the perspective that the FDA is a body of experts who are the best-placed to know what warnings to put on a label for a medicine. Apparently, this gives the FDA some sort of monopoly over good information: Nobody else should interfere – not even the manufacturer!
Mr. Troy gives examples, including prescription tetracycline and over-the-counter smoking-cessation products, where the manufacturers asked for more cautionary labels, partly in response to concerns about states’ product-liability laws, and the FDA refused them.
As well as debunking the claim that it is too expensive or complicated for drug-makers to add more warnings to labels than the FDA demands, this suggests that it is the FDA that is putting the drug-makers at risk, by refusing to allow them to add warnings to their labels that will bring them into compliance with states’ product-liability laws.
Don’t get me wrong: I understand that these laws often establish “jackpot justice” create “judicial hellholes” which drive prices up and kill innovation. Indeed, my colleagues, Hovannes Abramyan and Lawrence McQuillan, even rank the states according to their litigiousness. (Even worse, this blog-entry comes perilously close to contradicting Mr. McQuillan’s position on pre-emption.)
But I think that the place to address these problems is the statehouses. After all, that’s where we address medical malpractice by physicians, and we know that good reform attracts physicians from other states.
Also, I don’t think that we should accept the FDA as a monolithic know-it-all with unconstrained power to control information between drug-makers, prescribing physicians, and patients.
I’m sure that this won’t be my final word on pre-emption, but I want to make sure that I’ve questioned all my assumptions before I back myself into a corner!
Product-Liability Law: Is “Pre-emption” the Right Question?
John R. Graham
The media are (justifiably) interested in the Bush administration’s (or, if you prefer, the “Bush regime’s”) rushing a bunch of new rules into the Code of Federal Regulations that would “pre-empt” states’ product-liability laws. According to the Wall Street Journal, these rules “could block product-safety lawsuits by consumers and states.”
The article notes that the Food & Drug Administration (FDA) used to support the right to sue in state court. However, after President Bush took over, the FDA changed its approach. It immediately asserted that its regulations pre-empt state product-liability law, and developed a so-called Physician Labelling Rule to formalize its stance. In lay language, the FDA claims that if a drug-maker sells a drug that is labelled in accordance with the FDA’s requirements, state laws cannot impose a higher standard.
As I have already discussed, this will come to a head once the U.S. Supreme Court hears Levine vs. Wyeth, a case in which the Vermont Supreme Court rejected the claim of FDA pre-emption and concurred with a product-liability award to a patient who took a drug made by Wyeth.
In my previous post, I argued that pre-emption makes sense, because the drug trades in interstate commerce (a federal responsibility). However, I noted that the patient was free to sue the health professional who administered the drug (and the clinic where she worked) under state law (and had successfully done so).
Having read and thought some more about it, I am reconsidering.
Daniel E. Troy was the Bush-appointed lawyer at the FDA when the agency started to assert pre-emption. In a book recently published by the American Enterprise Institute, Mr. Troy makes a cogent and compelling argument in favor of FDA pre-emption.
But cogent and compelling are not necessarily convincing. Mr. Troy’s argument is largely based on the perspective that the FDA is a body of experts who are the best-placed to know what warnings to put on a label for a medicine. Apparently, this gives the FDA some sort of monopoly over good information: Nobody else should interfere – not even the manufacturer!
Mr. Troy gives examples, including prescription tetracycline and over-the-counter smoking-cessation products, where the manufacturers asked for more cautionary labels, partly in response to concerns about states’ product-liability laws, and the FDA refused them.
As well as debunking the claim that it is too expensive or complicated for drug-makers to add more warnings to labels than the FDA demands, this suggests that it is the FDA that is putting the drug-makers at risk, by refusing to allow them to add warnings to their labels that will bring them into compliance with states’ product-liability laws.
Don’t get me wrong: I understand that these laws often establish “jackpot justice” create “judicial hellholes” which drive prices up and kill innovation. Indeed, my colleagues, Hovannes Abramyan and Lawrence McQuillan, even rank the states according to their litigiousness. (Even worse, this blog-entry comes perilously close to contradicting Mr. McQuillan’s position on pre-emption.)
But I think that the place to address these problems is the statehouses. After all, that’s where we address medical malpractice by physicians, and we know that good reform attracts physicians from other states.
Also, I don’t think that we should accept the FDA as a monolithic know-it-all with unconstrained power to control information between drug-makers, prescribing physicians, and patients.
I’m sure that this won’t be my final word on pre-emption, but I want to make sure that I’ve questioned all my assumptions before I back myself into a corner!
Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.