Supreme Court To Hear Case on Whether FDA Approval of Rx Protects Manufacturers From Liability Lawsuits Filed in State Courts

The U.S. Supreme Court during the 2008-2009 term, which begins on Monday, will hear cases that question "whether a federal regulation can trump state law," such as a case that could determine whether FDA approval of medications protects manufacturing companies from product liability lawsuits filed in state courts, the Chicago Tribune reports (Oliphant, Chicago Tribune, 10/6).

The case, Wyeth v. Levine, involves Diana Levine, a Vermont woman who lost her hand and forearm to gangrene after she received an injection of the nausea medication Phenergan into an artery during a push IV injection, which is more potent and takes less time to act than a traditional injection. The Phenergan label, which FDA approved, includes a push IV injection as an option for administration but warns about risks associated with the practice, such as gangrene. Levine filed a lawsuit against Wyeth in state court in Vermont over alleged problems with the Phenergan label, and a jury ruled in her favor. The Vermont Supreme Court upheld the decision. In an appeal to the Supreme Court, Wyeth argued that FDA approval of medication labels precludes lawsuits in state courts filed over alleged problems with the labels (Kaiser Daily Health Policy Report, 10/3).

The Bush administration has expressed support for Wyeth in the case, and 47 states have expressed support for Levine (Sherman, Pittsburgh Post-Gazette, 10/5). Almost 30 groups and federal lawmakers have filed friend-of-the-court briefs in the case (Doyle, McClatchy/Raleigh News & Observer, 10/4).

According to the New York Times, the case "is perhaps the most significant case of the term" (Liptak, New York Times, 10/5). "The court has been very receptive in recent years to arguments that federal law trumps ... state regulation in a number of areas," such as a case earlier this year in which the court ruled that FDA approval of certain medical devices protects manufacturers from product liability lawsuits filed in state courts (Pittsburgh Post-Gazette, 10/5). Erwin Chemerinsky, a dean at the University of California-Irvine School of Law, said that a decision in favor of Wyeth in the case would "make it extremely difficult, if not impossible, for people injured by pharmaceutical drugs to be able to sue" (Egelko, San Francisco Chronicle, 10/6).

Editorials
Summaries of two editorials related to the Wyeth and Altria cases appear below.

• Los Angeles Times: The Wyeth case and other cases that the Supreme Court will hear are "important," but they "pale in significance" to those heard last year, a Los Angeles Times editorial states. According to the editorial, the "importance of some of this term's cases is lessened" because they involve "not the meaning of the constitution, on which the court has the final say, but the interpretation of federal statutes -- which Congress can rewrite if it disagrees with the court's understanding of its handiwork" (Los Angeles Times, 10/6).
  
  
• New York Times: The Supreme Court should agree that the "smokers' suit can go forward," a Times editorial states. However, the "court's conservatives have been on a campaign to close the courthouse door to people with legitimate legal claims" and "have expanded a variety of doctrines to send wronged parties away empty-handed, including ... 'pre-emption'" (New York Times, 10/6).
  

Letter to the Editor
The decision by the Supreme Court earlier this year that FDA approval of certain medical devices protects manufacturers from product liability lawsuits filed in state courts "does not grant immunity for medical device makers" but "instead reaffirms well-established federal law," Stephen Ubl, president and CEO of the Advanced Medical Technology Association, writes in a Boston Globe letter to the editor. He writes, "For decades, patients have been able to sure and recover damages if they are harmed by a device that was defectively made or approved based on knowingly falsified or incomplete data submitted" to FDA, adding, "Nothing about the court's decision changes that." According to Ubl, "FDA has pre-emptive authority with only about 2% of medical devices."

He writes, "The alternative to pre-emption is a move from a deliberate multiyear, science-based review and national approach to determining device safety to a patchwork of determinations based on jury deliberations in individual cases made without regard to patient access to critical medical technologies." Ubl concludes, "An environment fostering different safety standards in different states at different times would only impede development and access to new lifesaving technologies" (Boston Globe, 10/6).

Broadcast Coverage
NBC's "Nightly News" on Sunday included a preview of the Supreme Court term, including the Wyeth case. The segment includes comments from Levine and attorney Bert Rein, who represents Wyeth (Williams, "Nightly News," NBC, 10/5).

NPR's "Morning Edition" on Monday also included a preview of the Supreme Court term, including the Wyeth case. The segment includes comments from former Solicitor General Seth Waxman, an attorney for Wyeth, and David Vladeck, a professor at Georgetown University Law Center (Totenberg, "Morning Edition," NPR, 10/6).