Lawsuits Help Ensure Drug Safety, NEJM Editors Say
FDA by itself cannot guarantee drug safety and state-level lawsuits are "a vital deterrent" to help protect consumers against drugmakers that do not disclose all risks associated with a treatment, editors of the New England Journal of Medicine wrote in a friend-of-the-court brief on Thursday, the AP/Orlando Sentinel reports (Alonso-Zaldivar, AP/Orlando Sentinel, 8/15). The brief is related to an upcoming Supreme Court case involving Wyeth.In the case, Wyeth v. Levine, Diana Levine, a Vermont musician who lost her arm after receiving the nausea drug Phenergan, claims that the drugmaker did not adequately disclose the drug's risks. A Vermont court ruled in her favor, awarding her $6.8 million. Wyeth has appealed the ruling and argues that because FDA weighed the risks and benefits of the drug and approved it, the company is not liable -- a legal doctrine known as pre-emption. The Supreme Court case will "test this legal doctrine ... for prescription drugs," the Wall Street Journal's "Health Blog" reports (Mundy, "Health Blog," Wall Street Journal, 8/15).
The editors wrote in the brief that although FDA is seen as "the gold standard" for evaluating drugs, the agency "simply lacks the ability to serve as the sole guarantor of drug safety." If drugmakers were shielded from lawsuits related to their treatments, "FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct," the NEJM editors wrote (AP/Orlando Sentinel, 8/15). The editors note that 23 FDA-approved drugs have been withdrawn from the market since 1997 because of safety risks ("Health Blog," Wall Street Journal, 8/15).
Opposition, Support and Implications
The Bush administration supports pre-emption. Solicitor General Paul Clement wrote in an administration brief that "FDA considers and approves specific labeling for a drug, and the drug manufacturer is generally barred from making unilateral changes to the FDA-approved labeling."
Two former FDA commissioners -- David Kessler and Donald Kennedy -- and 47 state attorneys general opposed pre-emption, according to the AP/Sentinel (AP/Orlando Sentinel, 8/15). Kennedy and Kessler filed a separate brief that said FDA cannot "police the [drug] market on its own" ("Health Blog," Wall Street Journal, 8/15).
According to the AP/Sentinel, "The case is being closely watched because earlier this year the Supreme Court ruled that manufacturers of FDA-approved medical devices were shielded from litigation in state courts." However, David Vladeck, a lawyer who represents Kessler and Kennedy, said that the medical device ruling is different because the law governing medical devices had a pre-emption provision. Vladeck said, "Congress has never put a pre-emption provision in the Food and Drug Act" (AP/Orlando Sentinel, 8/15).
The NEJM brief is available online (.pdf).
