The Corner

Re: Dan Troy

Rep. Hinchey is not the first to try and (unfairly) demonize Dan Troy. U.S. News ran a hit piece on Dan back in March 2003.

As for the substance of the matter, here is an excerpt from a speech by then-FDA Commissioner Mark McClellan on predatory litigation against drug manufacturers:

The threat of litigation can be an important disincentive to many predatory behaviors that could take advantage of vulnerable patients, and it can help our efforts to enforce the law against such activities. But as the New York Times described it, the lawyers are doing what we want patients and doctors to do: they’re reading the warnings that we put on products, and they’re taking action when we add a warning or withdraw a product from the market based on our analysis of new information. Using the information they get from us, they file a few suits with very sick plaintiffs in states and counties considered favorable to plaintiffs, while building big “inventories” of less seriously ill patients, or even people who have used the drug but are not sick. The point of our warnings and the other science-based information on a medical product labeling is to provide doctors and patients with the up to date scientific information about risks and benefits, so that they can maximize benefits and minimize risks. And we need to learn more about products on the market – even, as with hormone therapies, products that have been on the market for decades.

So instead of pursuing real wrongdoing, our legal system is piling on to our legitimate warnings about the risks of medical products. This is a problem, because all medical products carry risks as well as benefits. This is especially true of the most risky products, like medications for pregnant women or women of childbearing age, or medicines that are given to prevent illness in healthy people, such as vaccines. Because of legal risks, product developers are getting out of these businesses, yet these are precisely the kinds of areas where there is often the greatest medical need. Because of legal risks, providers and manufacturers may be reluctant to develop data on existing patient risks and how they may be prevented. This is a serious public health problem. High quality medical care involves managing risks – including balancing the risks of treatments with the often more serious risks of illnesses. To the extent that our legal system encourages managing litigation risks instead of patient risks, reforms may be needed.

In this context, it is hardly outrageous that the FDA filed a handful of amicus briefs in relevant cases.

Jonathan H. Adler — Mr. Adler is an NRO contributing editor and the inaugural Johan Verheij Memorial Professor of Law at Case Western Reserve University School of Law. His latest book is Marijuana Federalism: Uncle Sam and Mary Jane.

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