FDA Personnel Against Lawsuit PreemptionOct 30, 2008 | Parker Waichman LLP
The Associated Press (AP) is reporting that, according to a report from congressional investigators, key “scientists and career employees at the Food and Drug Administration (FDA) opposed agency regulations that weaken consumers' ability to sue drug makers.” The question involves language used in a 2006 drug-labeling rule that “effectively limits when people can sue in state court over injury claims involving medications.” The FDA is claiming that federal regulations “prevail” in conflicts involving state law in a concept known as pre-emption.
Internal documents revealed that career officials opposed pre-emption, according to a report released by Representative Henry Waxman, chairman of the House Oversight and Government Reform Committee. The report also stated that, previously, the agency deemed such private lawsuits as an extra protection against unsafe drugs. "Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis," the report quoted Dr. John Jenkins, who oversees FDA's new drug reviews, as saying. "We know that such an assumption is false."
In the past, patients injured by drugs have won lawsuits against drug manufacturers for failing to warn against certain dangers. Now, in a case scheduled to be argued before the Supreme Court on Monday, a Vermont woman sued Wyeth after she lost her right arm below the elbow after receiving a “high-volume injection of the drug Phenergan,” said the AP. In this case, the woman received an injection that punctured an artery, which allowed gangrene to set in. The argument was that Wyeth was responsible to warn consumers that such injections could have devastating consequences and the state courts agreed, awarding the woman nearly $7 million. Now, Wyeth has appealed, claiming it was protected from such suits and arguing that a state court cannot overrule the FDA's judgment on label warnings, the AP noted.
Meanwhile, FDA scientists have looked at the Phenergan’s risks and benefits—the drug is used to treat nausea and allergies—at the time when it approved the prescribing literature, or label, as a guide for doctors. The FDA was also aware of the risks linked with injecting some forms of Phenergan; however, the “label did not specifically warn about the technique used with Levine,” reported the AP. The AP piece also pointed out that the FDA said in the 2006 and in a 2008 rule, “that state suits could encourage drug makers to propose unnecessary labeling” adding that, “such labeling could result in scientifically unsubstantiated warnings and less use of beneficial treatments.”
The AP article also pointed out that Representative Waxman's staff was able to obtain documents rejecting that warning. Jane Axelrad, an associate director for policy at the agency, wrote: "We rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary," she said. "To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information." According to the AP, the report said the FDA “has yet to provide a complete set of documents” indicating communications between the White House and the agency.”