Kaiser Daily Health Policy Report

Prescription Drugs | Supreme Court Hears Opening Arguments in Wyeth v. Levine; Some Appear To Support Limited Pre-Emption

[Nov 04, 2008]

The U.S. Supreme Court on Monday heard 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 Minneapolis Star Tribune reports (Minneapolis Star Tribune, 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 U.S. 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, 11/3).

In opening arguments, Levine attorney David Frederick said that Wyeth was aware of the risks associated with push IV injection of Phenergan and did not include adequate warnings on the label. A "reasonably prudent manufacturer" that received reports of amputations among patients who underwent push IV injection of Phenergan would have warned against any use of the practice, Frederick said. He added that the Phenergan label approved by FDA is not "set in stone" and that Wyeth could have added stronger warnings (Savage, Los Angeles Times, 11/4).

Wyeth attorney Seth Waxman in opening arguments said that the Phenergan label included adequate warnings about the risks associated with push IV injection and that FDA approval of the label pre-empts related lawsuits filed in state courts. He said, "The labeling was plainly comprehended and warned about the specific risks of IV administration" (Sherman, AP/Houston Chronicle, 11/3). In addition, Waxman said, "The FDA has to decide what information to provide clinicians," adding, "What it did here is provide ample, lavish warnings about the risk" (Doyle, McClatchy/Houston Chronicle, 11/3).

Comments From Justices
The Supreme Court justices indicated that they "might give drugmakers a partial victory in a fight over lawsuits by patients injured by medicines approved" by FDA, Bloomberg/Philadelphia Inquirer reports (Stohr, Bloomberg/Philadelphia Inquirer, 11/4). According to the New York Times, several justices "appeared open to the idea that pre-emption could follow from the FDA's approval of a drug label -- but only if drug companies remained subject to lawsuits if they failed to disclose new information about potential risks," and others "seemed prepared to allow pre-emption -- but only if the drug agency had considered the particular risk before approving the label" (Liptak, New York Times, 11/4).

Justice Antonin Scalia said that FDA "could not have approved that label" without a presumption that warnings covered administration of the medication with push IV injection (Stohr,Bloomberg/Philadelphia Inquirer, 11/4). In addition, Scalia said, "The name of this game is balancing benefits and costs, and if you simply eliminate drugs which people have real desperate need for ... you're not benefiting the public." Justice Samuel Alito said, "I envision a scheme under which manufacturers who are worried about jury liability of the magnitude that occurred in this case saying, 'Gee, why should we take chances?'" (McClatchy/Houston Chronicle, 11/3).

However, Alito and Justice Ruth Bader Ginsburg "questioned the cost-benefit calculation that allowed the drug to be administered by IV push," the Times reports. Alito said, "On the benefit side of this you don't have a life-saving drug, you have a drug that relieves nausea," and on "the risk side, you have the risk of gangrene" (New York Times, 11/4). Ginsburg said, "No matter what benefit there was, how could the benefit outweigh that substantial risk?" (Bloomberg/Philadelphia Inquirer, 11/4).

The justices "seemed unlikely to rule broadly on the larger issues" in the case, such as "whether the agency and other federal regulators set minimum safety standards that states are free to augment or whether they make judgments about the optimal balance between risks and benefits that states must follow," according to the Times (New York Times, 11/4). The justices likely will make a decision in the case early next year (Bloomberg/Philadelphia Inquirer, 11/4).

Possible Response From Democrats
A Wyeth victory in the case "could be offset" in the event that Democratic presidential nominee Sen. Barack Obama (Ill.) wins the election and that Democrats expand their majorities in the House and Senate, as "new legislation could remedy what the Supremes don't like," according to the Wall Street Journal's "Health Blog." Victor Schwartz, an attorney with Shook Hardy & Bacon and a tort reform advocate, said, "If the Supreme Court gives Wyeth a big win, the trial lawyers have a big war chest and they can go to Congress and get rid of this pre-emption language," adding, "If Obama comes in, it will become history" (Rubenstein, "Health Blog," Wall Street Journal, 11/3).

Editorial
"Diana Levine's story is gut wrenching" but also is the "sort of case that makes bad law," a Wall Street Journal editorial states. "This is not a case about whether a drug company concealed evidence or other misconduct" because the Phenergan label approved by FDA "specifically warned against the risk that became Ms. Levine's reality," according to the editorial. The editorial states, "It is about a drug-approval system that balances the risks of treatments against the risk of not being treated at all."

The editorial adds, "If a known, disclosed medical risk can still lead to a law suit," pharmaceutical companies "can literally be sued for anything." In addition, the editorial states, "No doubt there are trial lawyers and Democrats in Congress who would prefer it that way," but "if we want state juries second-guessing the FDA at every turn, let's pass a law in broad daylight so everyone knows whom to blame when drug innovation stops cold" (Wall Street Journal, 11/4).

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