The great majority of prescriptions in this country are for generic drugs. And generic drugs are cheaper in the US than they are in Europe or many other areas - they're a large and important part of health care. And as time goes on, and more and more medicines move into that category, that importance, you'd think, can only increase.
So a case that's coming before the Supreme Court later this month could have some major effects. It concerns a woman in New Hampshire, Karen Bartlett, who was prescribed sulindac, one of the non-steroidal anti-inflammatory drugs that have been around for decades. All the NSAIDs (and other drugs besides) carry a small risk of Stevens-Johnson Syndrome, which is an immune system complication that ranges from mild (erythema multiforme) to very severe (toxic epidermal necrolysis, and I'm not linking anyone to pictures of that). Most unfortunately, Mrs. Bartlett came down with severe TEN, which has left her permanently injured. She spent months in burn units and under intensive medical care.
But now we come to the question that always comes up in modern life: whose fault is this? She sued that generic drug company (Mutual Pharmaceutical), and won a $21 million dollar judgment, which was upheld on appeal. But the Supreme Court has agreed to hear the next level of appeal, and a lot of people are going to be watching this one very closely. Mutual's defense is that the original manufacturer of the drug (Merck) and the FDA are responsible for these sorts of things (if anyone is), and that they are merely making (under regulatory permission) a drug that others discovered and that others have regulated over the decades.
A case with some similarities came before the court in 2010, Pliva v. Mensing. That one, though, turned on the labeling language, and how much control a generic company had over the label warnings. "Not much", said the court, which limited patients' ability to sue on those grounds. That seems proper, but, as that New York Times article shows, it also has the perverse effect of giving people more potential recourse if they take a drug as made by the original manufacturer as opposed to the exact same substance as made by a generic company, which doesn't make much sense.
This latest case does not argue label warnings; it argues that the drug itself is defective. Now, it does not seem fair that a generic company should have to pay for the bad effects of a drug it did not discover, did not take through the clinic, and did not reap the benefits of during its patent lifetime (when any bad effects in the real world should have become clear). On the other hand, there are problems with going the other way and sending all lawsuits back to the original developers of the drug. After all, sulindac has been on the market since the early 1980s, under the regulatory authority of the FDA, which could have pulled it from the market at any time and has not. The agency has also authorized several generic manufacturers to produce it since that time. From a regulatory standpoint, how defective can it be? Allowing the originating company to be sued for all the generic versions, after such a long interval, would seem to open up a "find the deep pockets" strategy for everyone who comes along. (And as that older post argues, if this is made the law of the land, it will add to the costs of current drugs, whose prices will surely then be adjusted to deal with decades of future liability concerns).
And if I had to guess, I would think that the Supreme Court is going to find a way out of coming down firmly on one side of the issue or the other. A 2008 decision, Riegel v. Medtronic, said that medical device makers were, in some cases, shielded from state-level tort claims because of regulatory pre-emption. (But note that this isn't always the case; nothing is always the case in law, which is so close to a perpetual motion machine that you start to wonder about the laws of thermodynamics). But an earlier attempt to use these arguments in a pharmaceutical case (Wyeth v. Levine) got no traction at all in the court. But to avoid having either of those outcomes in the paragraph above, I still think that the justices are going to find some way to make this more of a federal regulatory pre-emption case, and to distinguish it from Wyeth v. Levine.
And if that happens, it will mean what for Karen Bartlett? Well, it would mean that she has no recourse. Something terrible has happened to her, but terrible things happen sometimes. That's a rather cold way of looking at it, and I would probably not be disposed to look at it that way were it me, or a member of my family. But that might end up being the right call. We'll see.
Update: as detailed over at Pharmalot, the Obama administration has reversed course on this issue, and is now directing the Solicitor General to argue in favor of federal pre-emption in this case. But two former FDA commissioners (David Kessler and Donald Kennedy) have filed briefs in support of Bartlett, arguing that to assume pre-emption would be to assume too much ability of the FDA to police all these issues on its own (without the threat of lawsuits to keep manufacturers on their toes). So there's a lot of arguing to be done here. . .