Alabama Product Injury Lawyer Blog

The San Francisco Chronicle had an Editorial piece in todays paper addressing the upcoming argument before the Supreme Court regarding the issue of federal preemption. It is a legal concept which is not so easily understood unless you are mired in the works of the justice system. Essentially federal preemption, as is explained in the editorial, is the argument that federal law or regulation preempts any state law to the contrary. As an example, if there is a federal law making it illegal to possess video games (both my sons would have to leave the country), a state could not make a law which makes it legal to possess video games.

In the litigation world, when a state court jury makes a determination that a corporation is liable for putting a defective product in the market, that is considered the state making law. In the particular case going before the Supreme Court, a state court jury found a drug manufacturer liable to a plaintiff who lost who arm when the drug Phenergan was given to her intravenously. The jury found that Wyeth, the manufacturer of the drug, knew about this potential problem, but didn't warn about it in the label for the drug.

Wyeth is now arguing that federal regulations, i.e. those instituted by the FDA, preempt state law. Therefore,the argument goes, since the FDA approved of the warning, a state court jury cannot come back and say...well even if the FDA thought the warning was OK, we the jury do not and you need to pay for the damages that has caused. The theory behind this concept is that the regulatory agencies are protecting the public and they are better educated about these issues and the agency should be the final decider (a "George Bushism") regarding whether a warning is sufficient or not.

That is all well and good if the agency is given all the information it needs to properly make those decisions. However, at least when it comes to the FDA, we know that is not the case. The rules of the FDA generally only require the manufacturer to provide proof that drug does what the manufacturer said it does (what is termed the efficacy of the drug), and only advise of any significant safety issues that were learned during the pre-market testing of the drug. Specifically, the drug company is not required to provide the FDA with ALL the testing it has done on the drug; only the testing that proves it works as proposed needs to be provided to the FDA. So if during pre-market testing some of the studies done don't come out as the manufacturer likes, they can just be "deep sixed" as they say. Bottom line, the concept of preemption might work if the agency had ALL the necessary information needed to make an educated decision. However, that is not the reality.

Because this is a technical legal argument, the average man or woman on the street is not really paying attention. However, if the Supreme Court finds under the circumstances of this upcoming case that there is federal preemption, the next time that average man or woman goes to his or her attorney describing how their child took their own life due to a drug, the only response they will hear is ..."Sorry you don't have a case." Your right to legal redress in a court of law before a jury of your peers no longer exists. The federal government, and the courts have taken that away. By that time unfortunately it may be too late.