Freeman v. Hoffman-La Roche, Inc.

Supreme Court of Nebraska
618 N.W.2d 827 (2000)

ELI5:

Rule of Law:

A manufacturer of an FDA-approved prescription drug is not automatically shielded from strict liability for a design defect. Instead, the "unavoidably unsafe" product doctrine (Restatement (Second) of Torts § 402A, comment k) is an affirmative defense that the manufacturer must prove on a case-by-case basis by showing the drug was properly made with adequate warnings, its benefits outweighed its risks, and it could not have been made safer.

Facts:

On September 23, 1995, Aimee Freeman sought treatment from her physician for chronic acne.
Her physician prescribed Accutane, a drug designed and manufactured by Hoffman-La Roche, Inc. (Hoffman).
Freeman took Accutane for approximately two months, from late September through November 20, 1995.
As a result of taking the drug, Freeman developed multiple serious health problems, including ulcerative colitis, inflammatory polyarthritis, and optic nerve issues.
Freeman alleged that Hoffman knew Accutane posed significant health risks but misled the medical community and patients with incomplete information and misrepresentations about the drug's safety.
Freeman and her physician relied upon these alleged misrepresentations when deciding to use Accutane.

Procedural Posture:

Aimee Freeman filed a petition against Hoffman-La Roche, Inc. in the district court (trial court) alleging seven theories of recovery for injuries sustained from using Accutane.
Hoffman filed a demurrer, arguing the petition failed to state a cause of action based on the precedent set in McDaniel v. McNeil Laboratories, Inc.
The district court sustained the demurrer, dismissing the action but granting Freeman leave to amend her petition to allege fraud in the FDA approval process.
Freeman declined to amend her petition and stood on her original filing.
The district court dismissed Freeman's action with prejudice.
Freeman, as appellant, appealed the dismissal to the Supreme Court of Nebraska.

Premium Content

Subscribe to Lexplug to view the complete brief

You're viewing a preview with Rule of Law, Facts, and Procedural Posture

Issue:

Does a prescription drug manufacturer's compliance with FDA approval processes, as a matter of law, shield it from strict liability claims for design defects under the 'unavoidably unsafe' product doctrine outlined in Restatement (Second) of Torts § 402A, comment k?

Opinions:

Majority - Connolly, J.

No. A prescription drug manufacturer's compliance with FDA approval processes does not, as a matter of law, shield it from strict liability for design defects. The court overruled its precedent in McDaniel v. McNeil Laboratories, Inc., which had established a rule of near-blanket immunity for FDA-approved drugs. The court reasoned that the McDaniel rule represented a minority view that had not held up over time and that societal interests in drug development could be served without such broad immunity. The court rejected the Restatement (Third)'s restrictive "reasonable physician" test (§ 6(c)) as having no basis in case law and being too difficult for plaintiffs to meet. Instead, it adopted the majority approach of applying comment k of the Restatement (Second) as a case-by-case affirmative defense, requiring the manufacturer to prove the drug's benefits outweighed its risks and that it could not have been made safer. The court also adopted the 'learned intermediary doctrine' from the Restatement (Third) (§ 6(d)) for failure-to-warn claims, stating the duty to warn runs to the physician, not the patient.

Analysis:

This decision fundamentally alters Nebraska's products liability landscape for prescription drugs by overruling the long-standing, manufacturer-friendly precedent of McDaniel. It moves Nebraska law from a minority position of blanket immunity to the majority, case-by-case approach for the "unavoidably unsafe" defense. This shift makes it significantly more feasible for plaintiffs to pursue design defect claims against pharmaceutical companies, as the burden now falls on the manufacturer to affirmatively defend its product's risk-utility balance rather than relying solely on its FDA-approval status. The court's selective adoption of parts of the Restatement (Third) (the learned intermediary doctrine) while rejecting others (the design defect test) shows a modernizing trend to align with national jurisprudence while tailoring rules to its own policy considerations.

Gunnerbot

AI-powered case assistant

Loaded: Freeman v. Hoffman-La Roche, Inc. (2000)

Try: "What was the holding?" or "Explain the dissent"

Premium Feature