## Facts

- Robert I. Larkin, a 69-year-old Indiana resident and long-time paraplegic, was treated by Dr. Jeffrey Reynolds in Louisville, Kentucky.
- Dr. Reynolds had prescribed various nonsteroidal anti-inflammatory drugs for Larkin’s pain over many years.
- In August 1998, during a visit for sinusitis and shoulder pain, Dr. Reynolds provided Larkin a sample of Zithromax (Pfizer) and instructed a dosing regimen; the sample contained no written instructions or warnings, and Larkin recalled no additional discussion.
- At the same visit, Dr. Reynolds switched Larkin’s anti-inflammatory medication to Daypro (G.D. Searle); Larkin filled the prescription and did not recall receiving warning literature.
- In late September 1998, Larkin developed a worsening rash and extensive blistering with skin sloughing.
- In early October, Dr. Reynolds diagnosed toxic epidermal necrolysis and Stevens-Johnson syndrome and attributed the conditions to Daypro, Zithromax, or both.
- Larkin was hospitalized in a burn unit for about ten days and thereafter experienced significant deterioration, including confinement to a wheelchair.
- The Larkins sued the manufacturers in federal court, including on a theory that the manufacturers failed to warn the ultimate consumer of relevant risks.

## Issues

1. Whether Kentucky applies the learned intermediary doctrine so that a prescription-drug manufacturer satisfies its duty to warn by providing adequate warnings to the prescribing physician, without a separate duty to warn the patient directly, where the physician was informed of the risks.

## Decision

- The Kentucky Supreme Court answered the certified question “yes.”
- Kentucky adopted the learned intermediary doctrine for prescription drugs.
- A prescription-drug manufacturer generally discharges its duty to warn by adequately warning the prescribing physician, who acts as the intermediary between manufacturer and patient.
- The court did not decide whether the warnings given for the specific drugs were adequate; that issue remained for the federal courts on remand.

## Legal Principles

- For prescription drugs, the manufacturer’s duty to warn ordinarily runs to the prescribing physician rather than directly to the patient.
- The physician is treated as a “learned intermediary” because the physician is positioned to assess the patient’s condition, weigh risks and benefits, and communicate appropriate warnings.
- Adoption of the doctrine does not remove the duty to warn; it defines the proper recipient of the warning in the prescription-drug setting.
- Manufacturers remain potentially liable if warnings to the prescribing physician are inadequate as to known or reasonably knowable risks.
- The decision rejected a general rule requiring manufacturers to provide direct-to-consumer warnings in the circumstances presented.

## Conclusion

Kentucky recognized the learned intermediary doctrine in prescription-drug failure-to-warn cases, holding that adequate warnings to the prescribing physician generally satisfy the manufacturer’s duty and that no additional duty to warn the patient directly was imposed on the facts presented by the certified question.


Larkin v. Pfizer, Inc., 153 S.W.3d 758 (Ky. 2004)