Rite Aid Corp. v. Levy-Gray
| Citation | 876 A.2d 115,162 Md. App. 673 |
| Decision Date | 03 June 2005 |
| Docket Number | No. 0133,0133 |
| Parties | RITE AID CORPORATION v. Ellen R. LEVY-GRAY. |
| Court | Court of Special Appeals of Maryland |
Eric Lasker (Spriggs & Hollingsworth, on the brief), Washington, DC, James Rothschild (Michael J. Carlson, Anderson, Coe & King, L.L.P., on the brief), Baltimore, MD, for Appellant.
Craig Franco (Odin, Feldman & Pittleman, P.C., on the brief), Fairfax, VA, Loyd Byron Hopkins, Fredrick, MD, for Appellee.
Panel: MURPHY, C.J., KENNEY, LAWRENCE F. RODOWSKY (retired, specially assigned), JJ.
LAWRENCE F. RODOWSKY, Judge (retired, specially assigned).
The principal issue here is whether, under the circumstances of this case, the appellant and cross-appellee, Rite Aid Corporation (Rite Aid), made an express warranty when it sold the prescription drug, doxycycline, to the appellee and cross-appellant, Ellen R. Levy-Gray (Ms. Levy-Gray or Plaintiff). A jury in the Circuit Court for Baltimore County, finding the elements of an action for breach of express warranty, entered a verdict in favor of Plaintiff for $250,000.1
Ms. Levy-Gray awoke on October 6, 2000, experiencing severe pain in her back, and with a fever. When these symptoms persisted for a full week, she sought treatment from her internist, Dr. Christine Bell-Lafferman (Dr. Lafferman). Blood samples taken during the visit were tested, and, on October 25, 2000, Dr. Lafferman contacted Ms. Levy-Gray to inform her that her blood had tested positive for Lyme disease. Dr. Lafferman referred Ms. Levy-Gray to Dr. Ronald W. Geckler (Dr. Geckler), an infectious diseases specialist, who saw Ms. Levy-Gray that day. Dr. Geckler confirmed the Lyme disease diagnosis and prescribed doxycycline, an antibiotic in the tetracycline family. Ms. Levy-Gray was breast feeding her baby at the time, and Dr. Geckler advised her to discontinue breast feeding while she was on the medication.
Dr. Geckler prescribed a 100 mg dosage twice a day, generally to be taken twelve hours apart. He did not provide Ms. Levy-Gray with any other specific information on how to take doxycycline. At trial he acknowledged that he relied on pharmacies to provide patients with pharmaceutical information Dr. Geckler is not a party to this action.
Plaintiff filled her doxycycline prescription at Rite Aid Pharmacy # 4465, located off Padonia Road in Timonium. The doxycycline purchased by her from Rite Aid was purchased by Rite Aid from a non-party to this action, Watson Laboratories, Inc. of Corona, California (Watson), for whom the doxycycline, in turn, was manufactured by Halsey Drug Co., Inc. of Rockford, Illinois, also not a party to this action. Watson shipped the doxycycline in bottles containing 500 capsules, each of 100 mg strength. Included with the package from Watson was an eight-page pamphlet which the manufacturer had submitted to the Food and Drug Administration (FDA) and which had been approved by that agency as "labeling" for that prescription drug.
The labeling contains a chemical description of doxycycline, its "clinical pharmacology," its "indications and usage," "contraindications," "warnings," "precautions," and "adverse reactions." It further contains sections headed, "overdosage," "dosage and administration," "how supplied," and "animal pharmacology and animal toxicology." This manufacturer's insert was not intended to be, and was not, delivered to Plaintiff. It was intended for prescribing physicians and made available to them by publication in, inter alia, the Physicians' Desk Reference.
Along with her prescription, Ms. Levy-Gray received from Rite Aid a "patient package insert" (PPI), i.e., a pamphlet, entitled "Rite ADVICE." The "Rite ADVICE" PPI was prepared and customized for Rite Aid by a non-party to this action, First Databank—The Hearst Corporation. The cover page of the pamphlet informed readers: The inside of the pamphlet stated, in part:
(Emphasis added).
Ms. Levy-Gray testified that she ate a high volume of dairy products when she initiated her doxycycline treatment because of her desire to breast-feed her younger child and because she was experiencing an upset stomach due to the doxycycline. She said:
Plaintiff experienced stomach irritation as a result of taking doxycycline approximately eight times within a week-long period of fourteen doses. She stated that she would take the medication "with a full glass of water and ... there are also times where I would follow it with a glass of milk." She also described eating dairy-product-containing foods during this period, including macaroni and cheese, grilled cheese sandwiches, yogurt, ice cream, and cottage cheese.
Ms. Levy-Gray ate a snack in the evening before going to bed "because [she] wanted to make sure that [she] went to bed with something in [her] stomach so that [she] wouldn't get a stomach upset[,] as had been described[,] by taking the Doxycycline." She had ice cream three or four nights a week, and then cookies or cereal on the other nights. This snack was eaten within two hours of her evening doxycycline dose. The PPI said to take doxycycline with food or milk if stomach upset occurs, "unless your doctor directs you otherwise." Neither Dr. Geckler nor Dr. Lafferman had directed her otherwise. She
Rather than improving as a result of the doxycycline treatment, Plaintiff's symptoms worsened. On November 8, 2000, she had a telephone conversation with her brother, Dr. David Levy (Dr. Levy), a urological oncologist living in Seattle, Washington. Dr. Levy informed his sister that the calcium contained in milk products impeded the absorption of doxycycline by the body. Based on her brother's advice, Plaintiff returned to Dr. Lafferman on November 18, informed her of the milk problem, and was given a replacement prescription of doxycycline. According to Dr. Lafferman, Ms. Levy-Gray's condition "began to measurabl[y] improve" within two to three days of discontinuing consumption of milk products with the doxycycline.
Although Ms. Levy-Gray's condition was somewhat improved, it did not return to baseline, and she was referred by Dr. Lafferman to Dr. Charles A. Haile, the Chief of Medical Staff and Chief of the Division of Infectious Diseases at Greater Baltimore Medical Center. Dr. Haile is board certified in internal medicine and infectious diseases, and he treats roughly thirty to forty Lyme disease patients each year.
Dr. Haile first saw Ms. Levy-Gray on December 28, 2000. At this time, she had been taking doxycycline for over a month, but was not recovering. He saw her four times thereafter, to June 21, 2001. When another six-week course of doxycycline had not alleviated Plaintiff's symptoms, Dr. Haile diagnosed her with post-Lyme syndrome. Post-Lyme syndrome is a chronic autoimmune response, in which patients experience symptoms that can mimic Lyme disease in the absence of an active bacterial infection.
Ms. Levy-Gray sued Rite Aid. At a seven day trial the jury heard considerable expert opinion from witnesses called by each party. The medical theory of Plaintiff's case was that her ingestion of milk and other dairy products, while taking doxycycline, reduced the absorption of that drug and prevented it from operating as efficaciously as it otherwise would have, thereby proximately causing the post-Lyme syndrome. Experts called by Rite Aid opined that absorption of doxycycline is reduced by up to twenty percent when ingested with milk or other dairy products containing calcium, but that that reduction is clinically insignificant because of the dosage recommended.
From the legal standpoint, the circuit court permitted the case to go to the jury on two theories, negligence and breach of express warranty. There was no expert testimony that there was a general duty of care legally imposed on...
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