Monday, December 13, 2004

Drugs as "Unavoidably Unsafe" products

I have a huge range of topics that I could explore following the previous post, but I decided to first discuss in part the topic of torts, and answer the question posed earlier – why are pharmaceuticals treated differently from all other consumer goods, when it comes to harming user? The phrase to remember is “unavoidably unsafe products.

Pharmaceuticals have a special "carve-out" from product liability laws, because there is no way for them to exist without someone experiencing harm when taking them - side effects or "adverse events." There would be no drug industry if they were evaluated by the courts the same way a toaster manufacturer would. The link above discusses the different ways that a product can be found to be defective. Manufacturing defects are the first that come to mind, but if there is an alternative design for a product that would make it less hazardous, then there can be a Design defect. If the product is sold with inadequate instructions or warnings, it may have a Warning or Labeling defect, even if the product itself can remain on the market. The question for drugs is in the risk/benefit ratio - is the drug a net health benefit for medicine, to justify its risk? That depends on how severe and frequent the side effects are, and what the drug is used for. We accept far more dangerous side effects like leukopenia from chemotherapy medications than we would from an anti-histamine.

These definitions were codified in a document called the Restatement of Torts (Second) and the sequel, the Restatement of Torts (Third) in 1962 and 1997 respectively. The American Law Institute wrote these documents, to try to create a uniform approach to torts that state courts could adopt, but they have all interpreted the Restatements with shades of difference, keeping lawyers (and law professors) at full employment.

This link will take you to a case that had the manufacturer of Accutane as the defendant. Scroll down a bit to the section titled "IV. Analysis" and there's a nice summary of the Restatements, including Section 402A of the Second Restatement which deals with product liability, and Comment k, which deals with unavoidably unsafe products, including drugs.

If you’re a pharmacist, there's and excellent review of pharmacist liability here, at Medscape. You have to register to see the article, but it's free. If you prefer not to, Google has the article cached a huge document available that gives the latest stats on the utilization of drugs in the US. The .pdf is 14.4 MB, but you can look at individual sections, or an executive summary, if that suits you. We're taking more drugs than ever, more people are taking multiple drugs, yadda yadda. Any surprises here? It's good to know the scale of what we are here to discuss, however, so take a look.

Rep. Pete Stark of California, who gave us the Stark Ethics in Patient Referrals Act (Stark I and II), wrote an article last Friday concerning drug re-importation from Canada, reprinted widely. I have nothing more to add to the article at this time, other than to note the absence of dead Canadian bodies piling up outside of Vancouver pharmacies.

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