Law is one of those funny things that seems to rumble along in the background to most people’s lives without them ever really thinking too much about it. Until they need it, that is. Then you find it has crept up behind you and is shouting, “Boo!” — makers of medications to treat heart attacks, please note.
So it is with the idea of pre-emption. Suppose you buy a product. Since this site talks about Zoloft, you buy some Zoloft — one of the Selective Serotonin Reuptake Inhibitors used to treat depression. Now why might you buy this Zoloft? It would usually be on the advice of your regular doctor. He or she examined you and gave you a prescription for Zoloft. Now how did the subject come up in connection with your mood problems? Did you see those TV adverts a few years back, “Zoloft for everything”? Or were friends talking about it? However you or your doctor came to know about it, you bought that Zoloft.
Alongside some of the biggest brands in the world, the law lays down what is usually a simple idea — product liability. If you buy our hypothetical Zoloft and it injures you, you can sue the manufacturer and recover the money to pay for the medical bills and any other losses you suffered. The money will not take away the pain (emotional or psychological) but it can help you feel better. I can just hear those little wheels turning over in your brain — the millions who have died from smoking tobacco or that nice little old lady, Stella Liebeck, who was burned by hot coffee from McDonald’s. Well suppose you actually took Zoloft and it injured you, you could sue. I mean, Zoloft is a product, right?
Well, the latest example of the “three strikes and you’re out” rule is currently playing in the Supreme Court. Some lawmakers have been giving the pharmaceutical companies immunity from liability unless they defrauded the Food and Drug Administration. I can see how impressed you are. The FDA is there to protect your interests. If a medication or a medical device is not fit to be allowed out on the market, the FDA can refuse to approve it, put black box warnings on the label or withdraw the medication/device from the market. So, the argument goes that if the experts at the FDA approve a medication or a device, that pre-empts your right to use product liability laws to claim damages. Unless the manufacturer deceived the FDA, of course.
So the first strike came in in February, 2008 Riegel v. Medtronic, Inc. where the Justices held that the pre-emption clause in the Medical Device Amendments of 1976 bars common law claims for injuries caused by a medical device approved by the FDA. Then came Warner-Lambert v. Kent in March where the Justices tied 4-4 on the validity of a Michigan law barring suits against drug companies for FDA-approved products. So now we are waiting for the decision in Wyeth v. Levine which is due to be heard this autumn. This deals with whether the failure of a manufacturer to warn the FDA that one of their products may be dangerous amounts to fraud and so allows the product liability claim. Put another way: suppose that the makers of Zoloft knew that their medication could harm you, but did not tell anyone about it. Should you be allowed to sue?
It sounds so simple. They should be liable because they knew it was dangerous. McDonald’s had 700 customers being burned by their hot coffee and did not serve it cool or warn people. If Zoloft is dangerous, it should be a slum-dunk case against the makers. Yet the lawmakers in various states around the US have been busy protecting pharmaceutical companies from just this kind of action. It makes the game of politics and special interests all the more interesting to watch. How do you want the Supreme Court to rule?
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