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Ninth Circuit:
Marbury v. Madison Doesn’t Bar Suit Against Drug-Maker
Panel Says Political Question Doctrine Is Not Brought Into Play by FDA’s Approval of Anti-Malaria Medicine
By a MetNews Staff Writer
The political question doctrine, which harks to the U.S. Supreme Court’s landmark 1803 decision in Marbury v. Madison, does not bar a putative class action against a biotechnology company that makes an anti-malaria drug that the four named plaintiffs say they were subjected to while in the U.S. military and which they allege caused them to suffer neuropsychiatric side effects, the Ninth U.S. Circuit Court of Appeals has held.
A three-judge panel—comprised of Ninth Circuit Judges Patrick J. Bumatay and Ryan D. Nelson, joined by Seventh U.S. Circuit Court of Appeals Judge David F. Hamilton, sitting by designation—on Tuesday reversed the dismissal-with-prejudice by District Court Judge Trina L. Thompson of the Northern District of California of an action against Genentech, Inc. That South San Francisco-based company distributed the drug in question—mefloquine (marketed under the trade name, “Lariam”)—to U.S. military bases.
The Ninth Circuit affirmed Thompson’s dismissal of the claims against Roche, Inc. and Roche Laboratories, Inc. (which have come to own Genetech and previously provided the drug to bases). The judge determined that California’s long-arm statute does not afford personal jurisdiction over a New Jersey company that lacks a connection to the state.
In ordering a remand, the judges specified that leave to amend is to be granted to clarify allegations as to standing.
Political Question
Thompson recited that “[t]he political question doctrine outlined in Marbury v. Madison…is primarily a function of separation of powers” and concluded that under that doctrine, the product-liability claims put forth by the plaintiffs implicate “nonjusticiable political questions within the appropriate jurisdiction of the U.S. Food and Drug Administration” (“FDA”).
That federal courts may not intrude into matters committed to the discretion of the Executive Branch is a principle laid down by Chief Justice John Marshall in the Marbury decision in which the power of judicial review was proclaimed, but with this restriction:
“The province of the court is, solely, to decide on the rights of individuals, not to inquire how the executive, or executive officers, perform duties in which they have a discretion. Questions, in their nature political, or which are, by the constitution and laws, submitted to the executive, can never be made in this court.”
Thompson said in her April 8, 2024 order of dismissal that under the Food, Drug, and Cosmetics Act of 1936, new drug applications must be acted upon, following a thorough review, by the FDA—which she termed “a highly technical, scientific, and medical agency whose mission is to safeguard the public health by ensuring safety and efficacy of human drugs.”
FDA Approval
Mefloquine was developed by the Army in the 1970s and gained FDA approval in 1989. Thompson commented that “[i]t would be inappropriate for the court to obfuscate a decision made more than thirty years ago by a federal government agency.”
If a court were to second-guess the FDA’s decision, it would “replace its proverbial black robe with a white lab coat,” the judge said. She observed that a court “is unfit to review” the 1989 determination “because it lacks the scientific and clinical expertise of the FDA.”
(The FDA did mandate in 2013 that labels on the drug include warnings as to possible neurologic and psychiatric side effects.)
Ninth Circuit Opinion
In reinstating the action against Genetech, the panel said:
“The district court erred in dismissing Appellants’ products-liability claims under the political question doctrine based on the FDA’s approval of mefloquine. The political question doctrine is a ‘narrow exception’ that applies only when adjudication will ‘certainly and inextricably’ require courts to decide issues constitutionally committed to another branch….Federal and state courts have consistently adjudicated design-defect and failure-to- warn claims regarding FDA-approved pharmaceuticals without treating them as nonjusticiable….The political question doctrine does not bar ordinary product-liability claims merely because the FDA regulates pharmaceuticals.”
The judges added:
“Likewise, it would be premature to invoke the political question doctrine based on the military’s approval of mefloquine. Appellants argue that their claims rest on Appellees’ own conduct without requiring judicial review of military judgments. At this stage, it is speculative to consider how the military dimension of the political question doctrine might come into play. The district court may revisit the issue at a later stage of this litigation.”
The case is Caston v. Hoffmann-La Roche, Inc., 24-2920.
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