Allison M. Zieve

Mark Blackburn developed serious kidney disease after taking Lialda. His lawsuit alleged that the manufacturer, Shire, had failed to give physicians adequate instructions about testing patients' kidney function. When Shire asked the Supreme Court to review a decision allowing his claim to proceed, Allison M. Zieve prepared the opposition with his lawyers.

Shire argued that the lower court had allowed changes to the label's Highlights without prior Food and Drug Administration approval. Blackburn's claim concerned the Warnings and Precautions in the full prescribing information. Zieve pointed to the changes-being-effected rules, under which a manufacturer could strengthen qualifying warnings while notifying the agency rather than waiting for permission. She also emphasized the case's unfinished factual disputes: the appeal had allowed a trial, and no final judgment had been entered. The Court declined review in 2023.

As director of Public Citizen Litigation Group and its Supreme Court Assistance Project, Zieve helps public-interest and legal-aid lawyers assess the prospect of Supreme Court review, preserve issues and prepare their briefs. The project offers free assistance with petitions for review, briefs opposing review, merits briefing and practice arguments. For consumers, injured patients, whistleblowers and people protected by regulation, that work can place experienced Supreme Court advocates alongside their existing lawyers when an opponent arrives with a specialized appellate team.

A Public-Interest Appellate Practice

Zieve joined the Litigation Group in 1994 after Brown University and Yale Law School. Ralph Nader and Alan Morrison had founded the Group in 1972. Its earlier work had helped invalidate legislative vetoes, protect lawyers' right to advertise and develop Freedom of Information Act practice. During fifteen years as a staff attorney, Zieve litigated drug and device safety, food labeling, tobacco regulation, consumer financial protection, class-action standards and open government. She became director of the Group and the assistance project in 2009.

She has argued five cases before the Supreme Court. Her work often concerns federal preemption: a manufacturer's contention that compliance with federal regulation displaces a state-law remedy. Other cases turn on whether an appeal can interrupt ongoing litigation, or whether a plaintiff has standing to bring a claim. She has taught as an adjunct at Yale Law School, Georgetown and American University's Washington College of Law, and serves as a senior member of the Administrative Conference of the United States, which studies federal administrative procedure. She is also a member of the American Law Institute.

An Appeal Before Judgment

In Will v. Hallock, Zieve represented a family alleging that federal agents had destroyed computer data used by its software business. The agents asserted that a judgment in the family's related case against the United States barred the suit against them. When the district court allowed the case to continue, they sought an immediate appeal under the collateral-order doctrine, an exception to the rule that parties ordinarily must await a final judgment before appealing.

Zieve's brief distinguished a defense that could be reviewed after judgment from an immunity intended to protect an official from trial itself. Treating the asserted judgment bar as an immediate route to appeal would interrupt the case before the facts had been resolved. The Supreme Court unanimously agreed in 2006 that the agents' appeal fell outside the narrow collateral-order exception. It decided appealability without deciding whether the judgment bar ultimately barred the family's claims.

The Rezulin Patients' Claims

In Warner-Lambert Co. v. Kent, Zieve argued for Michigan patients injured by the diabetes drug Rezulin. Michigan law protected a manufacturer from liability for an FDA-approved drug, subject to an exception for intentionally withholding or misrepresenting information that would have changed the agency's decision. Warner-Lambert argued that federal law prevented the patients from relying on that exception. The Second Circuit rejected the defense, and the manufacturer sought Supreme Court review.

At the February 2008 argument, the Justices questioned the respective roles of the FDA and a state jury. Zieve acknowledged the agency's authority to demand information, impose sanctions and withdraw approval. Those powers, she explained, did not compensate a patient for medical expenses or a death. When Justice Stephen Breyer questioned the consequences of a jury's judgment about the agency's decision, she returned to what the patients sought: "the result is that Ms. Kent and the other Plaintiffs get to litigate their claims."

The Court affirmed the Second Circuit's judgment by an equally divided vote in March 2008. The patients could continue their claims; the disposition did not establish a majority Supreme Court rule on preemption. Zieve's briefs and writing have continued to argue that federal regulation and state remedies can work together: approval addresses the evidence before the agency, while litigation can examine later safety information, inadequate warnings or deceptive marketing. A federal labeling requirement, in her account, need not eliminate the protection supplied by a state consumer statute.

Her writing has appeared in N.Y.U.'s Annual Survey of American Law and Duke's Law and Contemporary Problems. In a 2006 article with physician Peter Lurie, she examined efforts to obtain pharmaceutical data from the FDA under the Freedom of Information Act. The authors described requests for postmarketing study protocols that required lawsuits before the agency began releasing such material on request. They argued for disclosure that would allow physicians and independent researchers to examine safety information themselves.

Public Records and Executive Authority

The Litigation Group represents no corporate clients. Under Zieve's direction, its work has included suits against agencies withholding public records, companies accused of misleading consumers and executive actions alleged to exceed federal authority. On February 4, 2025, the Group filed for Doctors for America after federal agencies removed health information from their websites. A judge ordered temporary restoration a week later. On July 3, the court granted summary judgment for Doctors for America and the City and County of San Francisco, ordered restoration of the webpages on which they relied and vacated the federal policies that had caused the removals. By December 2025, the agencies reported that the required webpages had been restored, and the case is closed.

Zieve and colleague Adam Pulver joined lawyers from Democracy Defenders Fund and Colombo & Hurd in a February 2026 challenge to the administration's "gold card" visa program. They represent the American Association of University Professors and six immigrant professionals who allege that giving priority to wealthy applicants displaces the qualifications Congress enacted. The program treats a million-dollar individual donation as evidence of eligibility within existing employment-based visa categories.

The plaintiffs seek to have the program set aside. Their challenge concerns both the statutory qualifications and the annual limits on visas: moving applicants forward because they can pay would, they argue, delay professionals already waiting for places based on their work and qualifications. The government moved to dismiss the case for lack of standing; the plaintiffs filed their opposition on August 3, 2026, and briefing on that motion remains underway.