ARI SHAPIRO, host:
This is the first Monday in October, the traditional opening day for a new Supreme Court term. So far the court has steered clear of most hot button social issues this year. Still, as NPR legal affairs correspondent Nina Totenberg reports, the justices are planning to address several compelling topics, including immunity for drug companies.
NINA TOTENBERG: While abortion and gay rights may ring people's chimes and fuel political campaigns, the fact is that Supreme Court decisions determining whether individuals have the right to sue at all and on what grounds, those decisions actually affect the lives of far more people and shape the conduct of business in America. Last term, the newly constituted and more conservative Supreme Court gave business a bunch of big victories, essentially barring most investor lawsuits against Enron and similar bad actors in the corporate world, and also barring most lawsuits against medical device manufacturers.
This term, the court has more business and consumer cases on its schedule. Leading the docket is an issue that has long topped the business community's wish list: immunity from lawsuits for drug companies. The shield that drug companies argue protects them from suit is a legal doctrine called pre-emption, meaning that Congress can write laws that give the federal government the exclusive right to regulate something, barring states from getting into the act. Pharmaceuticals are regulated by the federal Food and Drug Administration, but that alone does not pre-empt state lawsuits. And for decades, the courts have ruled that lawsuits can still go forward against drug companies that fail to adequately label and warn consumers and doctors about the dangers of a drug or the dangers in administering it.
The case before the court this term involves warnings about administering a drug called Phenergan, manufactured by Wyeth. A musician in Vermont who was injected with the drug for nausea during a migraine attack sued the company because the method of injection caused gangrene in her arm, and her arm had to be amputated. The Vermont courts found the drug company failed to adequately warn doctors and patients that the injection method used here significantly increased the risk of irreversible gangrene.
Wyeth is arguing that lawsuits like this one are barred because the FDA approved the label. The FDA is for the first time taking the side of the company. The case poses two questions. First, could Wyeth have changed the label, and should it have? And second, if it could or should have changed the label, can injured consumers sue in state court for damages, or is the FDA the sole entity that can take action against the drug company? Former Solicitor General Seth Waxman represents the drug company and argues that juries should not be making such case-by-case judgments.
Mr. SETH WAXMAN (Attorney, Wilmer Hale): The pharmaceutical companies and industry have said if we're going to have a single national economy that competes in any meaningful way, we certainly have to have a world in which a single expert agency will make these balancing decisions.
TOTENBERG: In the past, in administrations Democratic and Republican, the FDA has said that the label it approves is in essence the minimum warning drug companies must provide and that they can do more. Since the FDA gets most of its information from the drug companies themselves, the agency saw lawsuits as an additional check on the pharmaceutical industry. Now, however, the Bush administration has abandoned that position, and as Georgetown law professor David Vladeck explains...
Professor DAVID VLADECK (Law, Georgetown University): Part of the issue in this case is whether the FDA has the capacity to monitor effectively all of the 11,000 drugs on the market, post-approval.
TOTENBERG: Pre-emption is also at the heart of a case that's being argued before the justices today. It tests whether consumers can sue cigarette manufacturers for falsely advertising light cigarettes as less dangerous. Some tobacco industry critics have called the pre-emption defense the "Get Out of Jail Free Card" for tobacco companies that are being sued over light cigarettes in virtually every jurisdiction in the country.
Consumers who have brought suit say the cigarette makers falsely promote light cigarettes as safer. In perhaps the major federal court decision on the issue of light cigarettes as safer, a court here in Washington ruled that the tobacco companies' claim that light cigarettes are less dangerous is not only false but a principal weapon in the industry's efforts to mislead the public about the health risks of smoking. The cigarette companies, however, claim they cannot be sued by individuals seeking damages over deceptive advertising, because the Cigarette Labeling Act gives all regulatory power over cigarette labeling and advertising to the Federal Trade Commission.
If these pre-emption cases present controversies with life-and-death consequences, the court's other major case this fall poses a question that merely makes people mad, namely foul language on TV and radio. In plain but clean English, the issue is whether the federal government can punish TV and radio broadcasters for onetime, fleeting use of the f-word or other similarly offensive words.
Thirty years ago, the court said the Federal Communications Commission could punish repeated uses of the so-called seven dirty words. But two years ago, the agency toughened its rules to make even onetime, fleeting uses of nasty words punishable. The agency deemed indecent FOX Broadcasting's live airing of the Billboard Music Awards when award-winner Cher used the f-word, and a year later when Nichole Richie used the s-word and the f-word. Fox challenged the FCC rule and won in a lower court. The Bush administration appealed to the Supreme Court.
In recent years, the Bush administration has cited national security in arguing largely without success that the courts should not get involved in the rights of suspected terrorists detained in the U.S. or at Guantanamo Bay, Cuba. This term, so far at least, there are no cases involving suspected terrorists. But there is a case testing how far the president and his agencies can go in setting aside environmental laws in the name of national security. At issue is a long-running dispute over the Navy's use of mid-frequency sonar in training exercises off the California coast. Does federal law require the Navy to adopt mitigating steps to minimize damage to whales and dolphins?
The president and his executive agency called the Council on Environmental Quality have gotten around that question by ordering the environmental laws to be suspended on the basis of a national security emergency, namely the need to train thousands of military personnel in the use of sonar. But the federal courts have concluded that there was no emergency, that the administration waited months to appeal its first court loss, and that under federal law the executive branch cannot simply waive federal environmental laws on its own. Now that issue is before the Supreme Court.
There are many other important issues pending before the court, from a major sexual harassment question to a case testing when religious groups are entitled to have monuments on public property. So stay tuned. Nina Totenberg, NPR News, Washington.
SHAPIRO: For more analysis of the new Supreme Court term and for some insight into how the justices might rule in key cases, visit our Web site, npr.org.