I want a new drug

The issue of tort reform continues in Oklahoma, as evidenced by pending legislative efforts. We also are seeing national efforts concerning tort reform, particularly surrounding the pharmaceutical industry. In recent years, pharmaceutical companies have taken the position that a plaintiff should not be able to sue for injuries based on allegations of inadequate warnings on labeling materials. Since what is on the label is determined by the FDA, pharmaceutical companies have maintained that state law claims for injury are “pre-empted” by federal law, because the FDA is the sole authority for label approval.

As in other states, Oklahoma plaintiffs frequently sue pharmaceutical companies claiming that because they didn’t receive adequate or accurate warnings, they took medications that they wouldn’t otherwise have taken – medications they say hurt them. On March 4, the U.S. Supreme Court dealt a blow to the pharmaceutical companies’ position on this issue when it upheld a $7-million verdict in the case of Levine v. Wyeth.

In Levine, the U.S. Supreme Court said patients can sue pharmaceutical companies for failing to provide adequate safety warnings and, in doing so, upheld a $7-million jury award to a musician whose arm was amputated after being injected with an anti-nausea medication manufactured by Wyeth. In a 6-3 decision, the court said pharmaceutical companies are not shielded by the FDA’s approval of a treatment and its labeling information. Though Justice John Paul Stephens, who authored the opinion, wrote, “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” the door is significantly and arguably left open for a pre-emption argument in cases where the FDA explicitly considered and rejected a requirement for stronger warnings. Whether that happens or not, the ability to defend cases on the basis that the FDA has the exclusive oversight now is limited by this decision. In that regard, Justice Stephens specifically mentioned that the FDA has “limited recourses” and suggested that pharmaceutical product liabil8ity cases “uncover unknown drug hazards.” He also mentioned that it is the manufacturers and not the FDA that bear primary responsibility for drug labeling.

What is the impact on Oklahomans? In spite of the perceived conservative, pro-business makeup of the current U.S. Supreme Court, a significant avenue of tort reform in the pharmaceutical field was dealt a blow by the Levine case. Previous signals from the U.S. Supreme Court, particularly in connection with related medical device cases, suggested that the court was willing to restrict the ability of plaintiffs to bring state law-based claims for injuries arising from the use of pharmaceutical products. Though that wasn’t the case in Levine, pending tort reform legislation in Oklahoma may ultimately “win the day” through caps on damages and restrictions on the ability to bring a lawsuit in Oklahoma and on attorneys fees.

Perhaps Huey Lewis was peering into the future of tort reform in the pharmaceutical age when, in the 1980s, he sang these prophetic lyrics: “I want a new drug/One with no doubt.”