## Facts

- Pfizer manufactured Cardura (doxazosin), an FDA-approved prescription drug for hypertension.
- A large NIH clinical trial (ALLHAT) compared doxazosin with a diuretic (chlorthalidone) and raised concerns about doxazosin’s comparative outcomes for certain cardiovascular endpoints.
- After public release of the trial findings, two Cardura users sued Pfizer asserting state-law product-liability theories.
- Plaintiffs did not seek damages; they sought injunctive relief compelling Pfizer to:
  - notify Cardura users and physicians about the NIH findings, and
  - implement notice through label changes and “Dear Doctor” letters not required by the FDA.
- Plaintiffs pursued this relief through a motion for judgment on the pleadings under Federal Rule of Civil Procedure 12(c).
- The FDA submitted an amicus filing expressing concern that the requested injunction would interfere with federal control of prescription-drug labeling and physician communications.

## Issues

1. Whether a court should, under the doctrine of primary jurisdiction, decline to order state-law injunctive relief requiring changes to FDA-approved prescription-drug labeling and physician notification letters based on new clinical-trial data.
2. Whether judicially compelled warnings and “Dear Doctor” letters risk conflict with the FDA’s regulatory authority over labeling and drug-risk communications.

## Decision

- The court denied plaintiffs’ request for injunctive relief.
- The court held that decisions about whether, and how, newly published scientific information should be reflected in prescription-drug labeling and mass communications to health-care professionals fall within the FDA’s primary jurisdiction.
- The court reasoned that evaluating the clinical significance of the NIH trial results and crafting appropriate warnings required scientific and medical judgments within the FDA’s expertise.
- The court emphasized the risk of inconsistent obligations if a court ordered warnings or letters that the FDA could later modify, contradict, or decline to require.

## Legal Principles

- Under primary jurisdiction, a court may defer or decline to act when resolution of a dispute requires the specialized expertise of an administrative agency charged with regulatory duties.
- Prescription-drug labeling and formal safety communications to health-care professionals are matters committed in the first instance to FDA oversight, and courts should avoid issuing state-law injunctions that effectively dictate labeling content.
- When requested relief would create a substantial risk of conflict between judicial mandates and subsequent agency action, primary jurisdiction supports deference to the agency.

## Conclusion

The court refused to compel Pfizer, under state-law injunctive theories, to change Cardura’s FDA-approved labeling or issue “Dear Doctor” letters based on NIH trial findings, concluding that the FDA is the proper decisionmaker on whether such warnings or communications are warranted.


Bernhardt v. Pfizer, Inc., No. 00 Civ. 4042, 2000 WL 1738645 (S.D.N.Y. Nov. 22, 2000)