Mid-Atlantic Health Law TOPICS

In Rite Aid v. Levy-Gray, Maryland's highest court recently ruled that a pharmacy may be held liable for breach of warranty on the basis of statements it makes in package inserts for prescriptions that it fills. In doing so, the Maryland Court of Appeals became the first state appellate court to reach such a conclusion.

A. Levy-Gray's Complications

Ellen Levy-Gray's physician diagnosed her with Lyme disease and prescribed the antibiotic doxycycline. She filled the prescription at a Rite Aid Pharmacy. Rite Aid inserted an information package that directed Ms. Levy-Gray to take each dose with a glass of water or "with food or milk if stomach upset occurs unless your doctor directs you otherwise."

Although Ms. Levy-Gray took the first dose of doxycycline with water, the following day she started taking the medicine with milk because she had experienced an upset stomach. In fact, since she hoped to resume breastfeeding her newborn after her course of treatment, Ms. Levy-Gray consumed 8-10 glasses of milk per day plus many other dairy products. Her symptoms improved, but she never fully recovered.

Ms. Levy-Gray was subsequently diagnosed with post-Lyme syndrome, a chronic autoimmune response in which patients experience symptoms that mimic Lyme disease, but without an active bacterial infection. Ms. Levy-Gray alleged that her consumption of milk and other dairy products while taking doxycycline, consistent with the information provided by Rite Aid, reduced the absorption of the drug, and prevented its effective operation, thereby causing her post-Lyme syndrome.

B. Breach of Warranty

A breach of express warranty claim provides a remedy for consumers who are injured by products that fail to conform to representations made about them by their manufacturers or sellers. In such cases, it is unnecessary for the injured party to prove that the representation was negligently made, which was significant in this case because the Rite Aid insert was derived from FDA approved language that was developed by the drug's manufacturer.

Ms. Levy-Gray sued Rite Aid alleging that the statement in the Rite Aid package insert that doxycycline could be taken with food or milk in the event of an upset stomach constituted an express warranty that she could consume dairy products without altering the drug's effectiveness. She argued that she developed post-Lyme syndrome because she relied on that statement and consumed dairy products while she was taking the medication. By its verdict in favor of Ms. Levy-Gray with respect to her breach of warranty claim, the jury evidently agreed with her, and the Maryland Court of Appeals upheld that verdict.

C. Learned Intermediary Doctrine

One of the arguments Rite Aid made on appeal was that the learned intermediary doctrine should bar Ms. Levy-Gray from recovering damages from Rite Aid under an express warranty theory. That doctrine was originally developed as a defense for drug and medical device manufacturers. The defense obliges manufacturers to warn health care providers, but not their patients, about risks attendant to the use of prescription drugs.

The doctrine assumes that only health care providers are in a position to understand the risks of prescription based therapies. Accordingly, as long as the manufacturer provides good information to the prescribing doctors, patients cannot successfully sue the manufacturer.

A number of courts have extended the learned intermediary doctrine to provide a defense to pharmacies and pharmacists. In those jurisdictions, the physician, and not the pharmacy, has a duty to supply the patient with appropriate information so that the patient can make an informed choice as to whether to proceed with recommended therapy. Therefore, pharmacists cannot be held liable for their failure to warn their customers about prescription medication's operative properties.

In the Rite Aid matter, the Maryland Court of Appeals acknowledged that it had adopted a form of the learned intermediary doctrine in a previous case. In that earlier case, the court overturned a verdict against a pharmacist who had filled a prescription as ordered by the physician. The prescription allegedly contained unsafe levels of strychnine.

However, the court declined Rite Aid's invitation to extend the learned intermediary doctrine to cases in which pharmacies disseminate information concerning the properties and effectiveness of a prescription drug. Insofar as a patient relies to his or her detriment on the pharmacy's representation, the learned intermediary defense is no bar to an express warranty claim in Maryland.

D. Conclusion

In Levy-Gray v. Rite Aid, the court did not impose a duty on pharmacies to provide warnings or instructions to its customers. However, once a pharmacy does so, those instructions can create an express warranty under Maryland law, and the pharmacy can be held liable if that warranty is breached.