Buckman v. Plaintiffs' Legal Committee

531 U.S. 341 (2001)

From our private database of 46,500+ case briefs, written and edited by humans—never with AI.

Buckman v. Plaintiffs’ Legal Committee

United States Supreme Court
531 U.S. 341 (2001)

Facts

Plaintiffs’ Legal Committee (plaintiffs), a group of patients injured by use of an orthopedic bone screw device during their spine surgeries, sued Acro-Med Corporation (Acro), a consulting company that assisted the device manufacturer to get premarket approval from the Food and Drug Administration (FDA). The patients alleged that Acro made fraudulent representations to the FDA about the devices’ intended use and that, as a result, the devices were improperly given market clearance and were subsequently used to the patients’ detriment. Acro had sought FDA-approval under the § 501(k) process, which allows a new medical device to get approved by establishing its similarity to a predicate device (one already on the market) and thereby avoid the more rigorous and time-consuming premarket application process. Acro twice sought § 501(k)-approval for the bone screw device for use in spinal surgery and was denied each time by the FDA because the device lacked substantial equivalence to a predicate device. Acro then split the device into its component parts and renamed them “nested bone plates” and sought § 501(k)-approval for use in long bones of the arms and legs. The FDA approved the devices for this purpose. The district court initially dismissed the claims for being preempted by the Food, Drug, and Cosmetic Act of 1938 (FDCA) as amended by the Medical Device Amendments of 1976 (MDA) then after the Supreme Court’s decision in Medtronic, Inc. v. Lohr on grounds that the claims constituted improper private rights of action under the FDCA. The Court of Appeals for the Third Circuit reversed, and Acro sought a writ of certiorari in the Supreme Court.

Rule of Law

Issue

Holding and Reasoning (Rehnquist, C.J.)

Concurrence (Stevens, J.)

What to do next…

  1. Unlock this case brief with a free (no-commitment) trial membership of Quimbee.

    You’ll be in good company: Quimbee is one of the most widely used and trusted sites for law students, serving more than 832,000 law students since 2011. Some law schools even subscribe directly to Quimbee for all their law students.

  2. Learn more about Quimbee’s unique (and proven) approach to achieving great grades at law school.

    Quimbee is a company hell-bent on one thing: helping you get an “A” in every course you take in law school, so you can graduate at the top of your class and get a high-paying law job. We’re not just a study aid for law students; we’re the study aid for law students.

Here's why 832,000 law students have relied on our case briefs:

  • Written by law professors and practitioners, not other law students. 46,500 briefs, keyed to 994 casebooks. Top-notch customer support.
  • The right amount of information, includes the facts, issues, rule of law, holding and reasoning, and any concurrences and dissents.
  • Access in your classes, works on your mobile and tablet. Massive library of related video lessons and high quality multiple-choice questions.
  • Easy to use, uniform format for every case brief. Written in plain English, not in legalese. Our briefs summarize and simplify; they don’t just repeat the court’s language.

Access this case brief for FREE

With a 7-day free trial membership
Here's why 832,000 law students have relied on our case briefs:
  • Reliable - written by law professors and practitioners, not other law students
  • The right length and amount of information - includes the facts, issue, rule of law, holding and reasoning, and any concurrences and dissents
  • Access in your class - works on your mobile and tablet
  • 46,500 briefs - keyed to 994 casebooks
  • Uniform format for every case brief
  • Written in plain English - not in legalese and not just repeating the court's language
  • Massive library of related video lessons - and practice questions
  • Top-notch customer support

Access this case brief for FREE

With a 7-day free trial membership