894 A.2d 563 (Md. 2006)
On October 25, 2000, Dr. Ronald Geckler diagnosed Ellen Levy-Gray with Lyme disease and prescribed doxycycline without providing instructions on administration with food or milk.1
Ms. Levy-Gray filled the prescription at Rite Aid Pharmacy #4465 in Timonium, Maryland, selecting that location due to prior dealings and its status as a national chain.2 Rite Aid obtained the doxycycline at issue from Watson Laboratories, Inc. of Corona, California, which is not a party to this action.3
Watson shipped the doxycycline in bottles containing 500 capsules and included an eight-page pamphlet.4 The pamphlet from Watson provided in pertinent part that if gastric irritation occurs, it is recommended that doxycycline be given with food or milk.5 The doxycycline came with Rite Aid's Rite Advice patient package insert, which directed to take each dose with a full glass of water and to take with food or milk if stomach upset occurs unless otherwise directed by a doctor, while also including a general disclaimer.6
Ms. Levy-Gray began taking the first dose with water on October 26, 2000, but switched to milk the following day due to upset stomach and consumed large quantities of dairy products daily, including eight to ten glasses of milk, in an effort to maintain her breast milk supply.7 Her symptoms did not improve during this period.8 Upon advice from her brother, she discontinued dairy consumption with the medication, after which her symptoms improved within two to three days.9
She later received a diagnosis of post-Lyme syndrome from Dr. Charles Haile following a failed second course of treatment.10 On November 2, 2001, Ms. Levy-Gray filed suit against Rite Aid in the Circuit Court for Baltimore County alleging multiple claims including breach of express warranty, with her husband asserting loss of consortium.11 After motions to dismiss and for summary judgment were resolved, a seven-day trial commenced on May 20, 2003, during which experts testified on both sides regarding the effect of dairy on doxycycline absorption.12
The jury found for Rite Aid on negligence but awarded Ms. Levy-Gray $250,000 on the express warranty claim.13 Rite Aid appealed to the Court of Special Appeals, which affirmed.14 On July 18, 2005, Rite Aid filed a petition for writ of certiorari with this Court.15 On September 8, 2005, the Court of Appeals of Maryland granted the petition and issued the writ.16
Whether a pharmacy can be held liable on a theory of express warranty for information and advice furnished with a prescription drug?17
Maryland Code (1975, 2002 Repl.Vol.), Section 2-313 of the Commercial Law Article provides that express warranties by the seller are created by any affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain.18 Prescription drugs qualify as goods under Section 2-105.19 The learned intermediary doctrine does not preclude liability when the pharmacy disseminates its own patient package insert.20
Yes. Rite Aid furnished the Rite Advice pamphlet with the doxycycline prescription filled for Ms. Levy-Gray at Rite Aid Pharmacy #4465.21 The pamphlet's direction to take with food or milk if upset stomach occurs constitutes an affirmation of fact relating to the compatibility of the drug with dairy products.22 This affirmation became part of the basis of the bargain because Ms. Levy-Gray selected Rite Aid based on prior dealings and relied on the pamphlet after Dr. Geckler provided no administration instructions.23
The learned intermediary doctrine, as applied in People's Serv. Drug Stores, Inc. v. Somerville for ordinary prescription filling, does not extend to a pharmacy's affirmative provision of information in a package insert.24
Related opinions on this issue
Joined by Raker, J.
Judge Harrell dissents.27 He maintains that the instruction for taking doxycycline with milk if upset stomach occurs was not part of the basis of the bargain.28 Ms. Levy-Gray purchased the drug on her physician's advice, not based on any representation from Rite Aid.29
In his view, prescription drug sales differ fundamentally from ordinary consumer transactions.30 Patients rely on physicians rather than pharmacists.31 Breach of express warranty is an inappropriate theory.32
Negligence would be the proper avenue instead.33
Whether instructions on how to use a product delivered to the customer after the product is paid for, of which the customer is unaware prior to the sale, fulfill the requirements for an express warranty under Section 2-313 of Maryland's Commercial Law Article?34
Maryland Code (1975, 2002 Repl.Vol.), Section 2-313 provides that an affirmation of fact relating to goods creates an express warranty if it becomes part of the basis of the bargain.35 Official Comment 7 clarifies that the precise time when the affirmation is made is not material.36 The sole question is whether the language is fairly to be regarded as part of the contract.37 Post-sale affirmations can constitute warranties or modifications.38
Yes. The Rite Advice pamphlet was delivered to Ms. Levy-Gray with the doxycycline after the purchase at Rite Aid Pharmacy #4465.39 The instruction to take with food or milk if stomach upset occurs is an affirmation of fact relating to the goods by stating compatibility with milk.40 Although Ms. Levy-Gray was unaware of the pamphlet prior to the sale, Official Comment 7 to Section 2-313 establishes that timing is not material.41
The jury could find it part of the basis of the bargain due to her course of dealing with Rite Aid and the pamphlet's cover statement that it contained everything needed to know about the prescription.42 The general disclaimer did not negate the specific instruction as a matter of law.43
Related opinions on this issue
Joined by Raker, J.
Judge Harrell dissents on this issue as well.47 The medication instruction could not have been part of the basis of the bargain.48 It was neither a dickered term nor part of the contract.49
The precise time when words of description or affirmation are made is not material under Official Comment 7.50 Yet it would not be fair to regard the instructions for use of a prescription medication as part of the contract.51 The patient would need to return to the prescribing physician to discuss any concerns.52