Case: Wyeth v. Levine

Date: Monday November 3, 2008

Issue: Are states preempted from imposing more stringent labeling requirements than what the FDA imposes on drug manufacturers?

Background: This is the second preemption case of the term and the third the Court will hear in less than a year. In April 2000, Diana Levine went to her local health center for treatment related to a severe migraine headache and nausea. A physician assistant at the health center gave her the Wyeth drug Phenergan for the nausea and administered it intravenously by the IV push method. Unfortunately, the syringe injected into Levine's arm apparently missed the vein because within a couple of weeks the forearm turned gangrenous and had to be amputated.

The FDA is the federal agency responsible for monitoring and mandating warning labels on drugs. Accordingly, it reviewed Phenergan and first approved its use in 1955. Follow-up reviews in decades since eventually led to a warning label that noted the risks of the IV push method (including gangrene) but did not prohibit its use.

After reaching settlements with the health center and its workers, Levine filed suit against Wyeth in Vermont state court. She claimed the label did not sufficiently address the risks associated with taking Phenergan intravenously. The jury found in Levine's favor and awarded her $7.4 Million. The Vermont Supreme Court upheld the jury's decision concluding that there was no conflict between the interests of the federal and state governments. It wrote the "FDA and the state share the purpose of encouraging pharmaceutical companies to alter their drug labels when they are inadequate to protect consumers."

Wyeth maintains that the FDA and only the FDA can properly weigh the benefits and risks associated with drug labeling. And it contends that Congress intended for the FDA to have the final word — thus preempting drug manufacturers from a myriad of state laws that could impede commerce or confuse the consumer. Levine says Congress intended for the FDA mandate to be supplemented by state action.

But in a similar preemption case decided in February, the Court sided 8-1 in favor of a medical device manufacturer. And on October 6th, the justices — while not impressed with the FDA's oversight of tobacco — appeared to be leaning against Maine's claim that they could force changes on cigarette labels. Thirty briefs have been submitted to the Court, only eight of them in support of Wyeth. Those include the United States Chamber of Commerce and the Bush Administration. Briefs supporting Diana Levine have come in from AARP, the editors of the New England Journal of Medicine and 47 states.

Case: Ysursa v. Pocatello Education Association

Date: Monday November 3, 2008

Issue: Does the First Amendment prohibit a state legislature from removing the authority of state agencies to make payroll deductions for political activities under a statute that is concededly valid as applied to state government employers?

Background: This case is similar to the Locke v. Karass case heard on October 6th in that it deals with the scope of state law as it relates to the deduction of funds from paychecks used to support labor unions. In 2003, the Idaho legislature passed a law prohibiting local governments from deducting money from paychecks to support union-affiliated political activities. This law was presumably targeted towards teachers, firefighters and other local government employees who are also union members. The law did not change longstanding policy allowing for the direct deduction of union funds (i.e. dues) but stipulated those funds could not be used for political activities. The Ninth Circuit overturned the law as it related to municipal workers saying the state had no authority to pass legislation dictating how "political subdivisions" such as counties could or could not conduct its affairs in this matter.

Case: Carcieri v. Kempthorne

Date: Monday November 3, 2008

Issue: To what extent does the Indian Reorganization Act (IRA) preclude Rhode Island (and other states) from exercising control over certain parcels of its land?

Background: When is now? Is it 1934 when the word "now" was used in the passage of the IRA, or does it mean now as in current efforts to enforce that law? If you've made it this far then you might be interested to know that this case centers on a 31-acre parcel of land owned by the Naragansett Tribe. The tract was placed under federal control at the request of the tribe and therefore beyond the reach of state law — to the dismay of lawmakers in Providence. The state says because the Naragansett weren't a recognized tribe in 1934 they are not covered by the IRA. So far the federal government has found success arguing "now" refers to the current effort to enforce the law. An interesting internal battle has brewed on who will argue this case in front of the Court. In October, the Providence Journal reported that Rhode Island Gov. Donald Carcieri wants to have noted Washington D.C. lawyer Ted Olson represent the state. But the town where the dispute rests insists on having its own lawyer present the case. The Rhode Island Supreme Court Chief Justice has sided with the local lawyer.