Supreme Court To Hear Opening Arguments in Case Regarding Drug Safety, Federal Pre-Emption

The U.S. Supreme Court on Monday will hear opening arguments in Wyeth v. Levine, a case that could determine whether patients have the ability to file product liability lawsuits against pharmaceutical companies in state courts, the AP/Boston Globe reports (Sherman, AP/Boston Globe, 11/3).

The case involves Diana Levine, 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 pre-empts lawsuits in state courts filed over alleged problems with the labels (Kaiser Daily Health Policy Report, 10/27).

The pharmaceutical industry, business groups and the Bush administration have filed friend-of-the-court briefs in support of Wyeth, and 47 states and a number of consumer advocacy, medical and other groups have filed briefs in support of Levine (Richey, Christian Science Monitor, 11/3). In addition, two former FDA commissioners, several lawmakers, and the editors of the Journal of the American Medical Association and the New England Journal of Medicine support Levine (Hill, Philadelphia Inquirer, 11/2).

According to the San Francisco Chronicle, supporters of pre-emption maintain that product liability lawsuits "can expose drugmakers to a conflicting hodgepodge of jury decisions in multiple state courts that often contradict the expert judgment of the FDA when it decides what warnings belong on a drug label," but opponents argue that "drug manufacturers must retain responsibility to provide current, accurate warnings to the public" and that state "drug safety laws, enforced through court action, help to hold drugmakers to those obligations" (Tansey, San Francisco Chronicle, 11/2).

The court likely will make a decision in the case in the next few months (Philadelphia Inquirer, 11/2).

Editorial
Supporters of pre-emption "have some merit, but Wyeth and its allies should not prevail in the case," a Washington Post editorial states. According to the editorial, lawmakers are "well aware that state tort lawsuits such as the one filed by Ms. Levine are relatively common," but "they have declined to write into law the kind of shield from lawsuits that Wyeth seeks." The editorial states, "Congress's silence speaks volumes, and the justices should respect that determination," adding, "If Wyeth and other pharmaceuticals want change, they should take their case to Congress" (Washington Post, 11/3).

Opinion Piece
The position that a "decision favoring Wyeth will amount to blanket immunity for drugmakers from liability or injuries caused by their products ... distorts what the Wyeth case is about and the implications of the court's decision," David Ferrera, an attorney with the law firm Nutter McClennen & Fish, writes in a Globe opinion piece.

"This case boils down to the question of who should be empowered to make difficult judgments about the safety, effectiveness and warnings on proper use of a drug," he writes, adding, "Do we want to legitimate an alternative regulatory system, situated in the courts and operating outside the FDA?" According to Ferrera, "If so, companies could face verdicts dictating a different label in each of the 50 states -- hardly a formula for bringing safe and effective devices to a national market."

He concludes, "No regulatory system is foolproof," but the "proper remedy for this situation is to strengthen the FDA, not to ask lay citizens to replace the expert judgment of medical professionals" (Ferrera, Boston Globe, 11/3).

Broadcast Coverage
American Public Media's "Marketplace" on Friday reported on the case. The segment features comments from Levine and Wyeth attorney Bert Rein (Babin, "Marketplace," American Public Media, 10/31).

NPR's "Day to Day" on Friday reported on case. The segment includes comments from Levine, Cheryl Hanna of Vermont Law School and Rein (Dillon, "Day to Day," NPR, 10/31).

NPR's "Morning Edition" on Monday also reported on the case. The segment includes comments from Levine, Levine's attorney David Federick, Rein and former FDA Commissioner David Kessler (Totenberg, "Morning Edition," NPR, 11/3).