By Scott Tibbs, April 8, 2008
Product liability law is a very complex subject, but it basically boils down to this: when a product does not work as advertised and causes harm to the person using the product, the manufacturer is required by the courts to compensate those people harmed by the defective product. But the New York Times reports that in a case working its way through the court system, Johnson & Johnson (backed by the Bush administration) argues that "the FDA. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts."
The Times reports that "high doses of estrogen are known to raise the risk for blood clots that can cause heart attacks and strokes." Internal e-mails and other documents show that Johnson & Johnson knew that a birth control patch delivered significantly higher doses of estrogen than was advertised, and fudged the numbers sweep that fact under the rug. When the higher dose was finally revealed in 2005, prescriptions dropped sharply.
This seems like a pretty open and shut case, at least morally. A product did not work as advertised and allegedly caused health problems and even death in users. If the product is shown to have caused harm, Johnson and Johnson should compensate those damaged. But by shielding drug makers from a lawsuit based on a faulty approval from the Food and Drug Administration, the courts would deny justice.
Basically, Congress needs to step in and pre-emptively order the courts to put aside the doctrine of pre-emption. Even if one could argue that the FDA has the funding and manpower needed to effectively regulate drugs enter the market, mistakes happen. Because the FDA is made up of fallible human beings, it is entirely possible that even with significantly more resources they could make an erroneous approval. If attorneys for plaintiffs uncover facts that show that the product was faulty and the manufacturer knew the product was faulty, the fact that the drug was approved should not shield the manufacturer from damages.
With the 2008 elections on the horizon, Congress has the opportunity to gain a little political traction and (more importantly) implement good public policy with a consumer-protection law. Here's hoping they do just that.