Pre-Emption Leading New SCOTUS Term

Defective Drugs


The Supreme Court is back in session, and at the top of the docket is the looming question of pre-emption. Does Congress have the right to write laws giving the federal government an exclusive ability to regulate laws that bar states from joining in things like lawsuits? The main issue in this new term is immunity from lawsuits for drug companies.

Right now Big Pharma is regulated by the Food and Drug Administration, but this doesn’t necessarily mean that state lawsuits are pre-empted. In fact, courts have ruled literally for decades that lawsuits against drug companies can go forward for failing to warn consumers or doctors about the dangers of using or administering certain drugs. Big business has been trying for a while now to have drug companies shielded from lawsuits.


One of the cases before the Supreme Court involves the drug Phenegran and its administration, made by Wyeth. After being injected with Phenegran for nausea during a migraine, a Vermont musician developed gangrene due to the method of injection. She then had to have her arm amputated. A Vermont court found that Wyeth did not properly warn doctors and patients that the type of injection method used posed an increased risk of irreversible gangrene. Wyeth argues that lawsuits, like the one brought forward, are barred since the FDA had already approved the label. What’s concerning to consumers and industry critics here is that, for the first time ever, the federal government is siding with the company.

In the past, when the FDA has approved labels, it gives them the absolute minimal warning the drug companies must provide. According to the FDA, the drug companies can do more. This can be problematic since the FDA gets information on the drug labels from the company marketing them. They have said in the past that lawsuits were an “additional check” on the drug industry.

Light Cigarettes

Another case being argued today is that of light cigarettes. The question is can consumers sue cigarette manufacturers that falsely advertise light cigarettes as less dangerous than other cigarettes? Those behind the suit claim that cigarette manufacturers have suggested this claim and the federal court ruling found that the tobacco companies’ claims are not only false, but mislead the public about smoking and health risks.

According to tobacco industry critics, pre-emption for cigarette companies is seen as a way for them to avoid lawsuits in every jurisdiction in the country. Because the cigarette labeling act has given all regulatory power over the advertising and labeling of cigarettes to the Federal Trade Commission, the cigarette companies claim they cannot be sued by individuals.

Both of these cases will likely have announcements in the near future which will affect the way big business acts with regard to their products and how they view the public who buys them. Because the Supreme Court has been notoriously big business friendly as of late, lawsuits against large companies may become more difficult for individuals to win.

Related articles:

This law review article dealing with preemption and the ability of generic drug manufacturers to update their labels -

This article explores the scope of FDA jurisdiction and the relationship between the FDA and states -

This law review article explores whether the courts have given the FDA too much deference -