Allison M. Zieve

The Lialda label recommended an evaluation of renal function before treatment began and periodically during it. Blackburn's suit against Shire, filed in June 2016, alleged that the Warnings and Precautions section of the full prescribing information should have called for monthly creatinine tests in the three months after a patient started the drug and quarterly tests for at least a year after that, and it pointed to the drug's labeling in the United Kingdom. The Eleventh Circuit held that federal law did not preempt the claim. When Shire asked the Supreme Court to take the case in June 2023, Allison M. Zieve, director of Public Citizen Litigation Group and its Supreme Court Assistance Project, became Blackburn's counsel of record there, with Jonathan H. Waller, Keith Jackson and Robert R. Riley Jr. of Birmingham.

Shire read the Eleventh Circuit's unpublished decision as letting a manufacturer rewrite a label's Highlights section without the Food and Drug Administration's prior approval. The brief in opposition answered that the court had held only that the Highlights section did not stand in the way of a change to Warnings and Precautions under the changes-being-effected regulation, which lets a manufacturer add or strengthen a warning without waiting for the agency's approval. The decision set no binding precedent, the brief added, and it came on summary judgment, with facts in dispute and no trial yet held. On October 2, 2023, the Court denied review.

Pages Taken Down

On January 20, 2025, an executive order directed federal agencies to use the word “sex” in place of “gender” in their policies and documents, and the Office of Personnel Management told agency heads to take down websites that promoted “gender ideology.” The Centers for Disease Control and Prevention, the Food and Drug Administration and the Department of Health and Human Services removed webpages and datasets, among them reports on HIV prevention, a CDC page of reproductive-health guidance for clinicians and an FDA study of sex differences in the clinical evaluation of medical products.

On February 4 the Litigation Group sued for Doctors for America, which represents more than 27,000 physicians and medical trainees, and Zieve entered her appearance for the doctors. A week later Judge John D. Bates ordered the agencies to restore the pages and datasets the doctors had identified, writing that “These doctors' time and effort are valuable, scarce resources.” The City and County of San Francisco joined the suit. On July 3, 2025, Judge Bates ruled for the plaintiffs on their claims that the personnel office had exceeded its authority and that its memorandum and the health department's guidance were arbitrary and capricious; he vacated both and ordered the websites restored as they had stood on January 29, 2025. The agencies filed their last status report on December 12, 2025, reporting the pages restored, and the case is closed.

A Place in Line

A September 2025 executive order created the “gold card.” A foreign individual who gives at least $1 million, or a corporation that gives $2 million, plus a $15,000 processing fee, becomes eligible for a limited number of EB-1 and EB-2 employment-based immigrant visas, with priority processing, whether or not the applicant meets the criteria Congress set for those categories. Both categories are capped each year.

On February 3, 2026, Zieve and her colleague Adam Pulver, with Democracy Defenders Fund and the firm Colombo & Hurd, sued in federal court in Washington for the American Association of University Professors and six professionals from abroad who had applied, or planned to apply, for those visas under the statute's criteria. The plaintiffs ask Judge Richard J. Leon to set the program aside as beyond the administration's authority, contrary to the Immigration and Nationality Act and adopted without notice and comment, and in May the United Auto Workers joined an amended complaint. The government moved to dismiss for lack of standing. The plaintiffs' August 3 opposition answers that each gold card visa is “a visa unavailable to statutorily eligible applicants in that category,” and that a gold card applicant fills out a form that takes about five hours and is processed in weeks, while an applicant under the statute's criteria spends months assembling evidence for a review that can run past twenty-eight months.

From Providence to the Marble Steps

After Brown University and Yale Law School, Zieve joined Public Citizen Litigation Group in August 1994. Her cases there have covered drug safety, food labeling and tobacco, consumer safety and financial protection, open government, federal preemption and class-action standards, often involving the FDA and other federal agencies. In July 2009 she succeeded Brian Wolfman as the Group's director and took charge of its Alan Morrison Supreme Court Assistance Project, which since 1990 has helped lawyers with cases before the Court, most often at the petition stage.

She has taught at Yale Law School, Georgetown University Law Center and American University's Washington College of Law, is a senior member of the Administrative Conference of the United States, and has written for N.Y.U.'s Annual Survey of American Law and Duke's Law and Contemporary Problems. Her 2006 article there with the physician Peter Lurie, “Sometimes the Silence Can Be like the Thunder,” followed Public Citizen's Freedom of Information Act requests for the FDA's drug data. When Public Citizen asked for the protocols of the safety studies the agency can require after approving a drug, the FDA refused until it had been sued twice, and afterward released such protocols on request.

An Appeal Before Judgment

Susan Hallock owned a computer software business that she and her husband, Richard, ran from their home. Customs agents with a warrant searched the house and seized the computer equipment, software and disk drives. No charges followed; the equipment came back damaged, all the stored data, including trade secrets and account files, was lost, and the Hallocks were forced out of business. After a judgment in the family's suit against the United States under the Federal Tort Claims Act, the agents argued that the Act's judgment bar foreclosed the Hallocks' constitutional claims against them. When the district court refused to apply the bar, the agents appealed at once under the collateral-order doctrine, an exception to the rule that appeals wait for a final judgment, and the Second Circuit took the appeal.

Zieve argued for the Hallocks on November 28, 2005. Justice Anthony M. Kennedy asked what significance she gave the word “complete” in the statute's “complete bar,” and she answered, “I don't think complete bar means anything more than bar.” The defense turned on the order of the suits, she told Justice Stephen G. Breyer, and “preclusion defenses are not immediately appealable.” On January 18, 2006, the Court agreed unanimously. Justice David H. Souter likened the judgment bar to “the defense of claim preclusion, or res judicata,” and held that a refusal to apply it could not be appealed before final judgment; the Court sent the case back with instructions to dismiss the agents' appeal for lack of jurisdiction.

The Rezulin Patients' Claims

Rezulin, Warner-Lambert's drug for type 2 diabetes, reached the market in 1997; in March 2000 the company stopped selling it in the United States. A 1995 Michigan statute shielded the maker of an FDA-approved drug from product-liability suits unless the plaintiff proved that the company had intentionally withheld or misrepresented information the agency required and that the FDA would not have approved the drug had it been given accurate information. Eighteen patients with serious liver damage sued under that exception. The Second Circuit held that federal law did not preempt it, and in Warner-Lambert Co. v. Kent the company asked the Supreme Court to reverse. On March 3, 2008, with Chief Justice John G. Roberts Jr. taking no part, the Court divided four to four, which affirmed the Second Circuit's judgment without setting a precedent, and the patients' claims went forward.

Zieve argued for the patients on February 25, 2008, against Carter G. Phillips for Warner-Lambert and Daryl Joseffer of the Solicitor General's office, who supported the company. She granted that the FDA could sanction a company, ask it for different information or withdraw a drug's approval; none of that, she said, would help a family whose breadwinner had died, or a patient who could no longer earn a living and faced huge medical bills. Justice Breyer put it to her: “Who is more likely to be right?” “With respect, I don't think that's the question,” Zieve answered. If a Michigan jury was wrong about what would have happened, “the result is that Ms. Kent and the other Plaintiffs get to litigate their claims.”