Rite Aid v. Levy-Gray

Decision Date13 March 2006
Docket NumberNo. 61, September Term, 2005.,61, September Term, 2005.
Citation894 A.2d 563,391 Md. 608
PartiesRITE AID CORPORATION v. Ellen R. LEVY-GRAY.
CourtCourt of Special Appeals of Maryland

Melvin J. Sykes (James A. Rothschild, Michael J. Carlson, Anderson, Coe & King, LLP, Baltimore, on brief), for petitioner.

Craig Franco (Odin, Feldman & Pittleman, P.C., Fairvax, VA), Loyd Byron Hopkins (Loyd Byron Hopkins, P.C., Frederick), all on brief, for respondent.

Steven P. Benson, O'Brien, Butler, McConihe & Schaefer, Washington, DC, Susan C. Winckler, American Pharmacists Assn., Washington, DC, amicus brief for Nat. Assn. of Chain Drug Stores, Inc. & American Pharmacists Assn. in support of petitioner.

Mary Ellen Fleck, Don L. Bell, Nat. Assn. of Chain Drug Stores, Inc., Alexandria, VA, of counsel.

Argued before BELL, C.J., RAKER, WILNER, CATHELL, HARRELL, BATTAGLIA and GREENE, JJ.

BATTAGLIA, J.

In the case sub judice, a jury returned a verdict against Rite Aid Corporation, the petitioner, for breach of express warranty based on a package insert that it generated and provided with a prescription pharmaceutical, doxycycline, directing the respondent, Ellen Levy-Gray, to "take with food or milk if upset stomach occurs." Because, based on the facts of the instant case, we determine that the jury reasonably could infer that the language "take with food or milk if upset stomach occurs" constitutes an express warranty under Maryland Code (1975, 2002 Repl.Vol.), Section 2-313 of the Commercial Law Article, we affirm the judgment of the Court of Special Appeals.

Background

On October 25, 2000, Dr. Ronald Geckler, the head of Infectious Diseases at Mercy Medical Center, diagnosed Ms. Levy-Gray with Lyme disease and gave her a prescription for doxycycline, a drug that is part of the group of Tetracycline-based drugs.1 Dr. Geckler informed Ms. Levy-Gray that while taking doxycycline she could not continue nursing her son, but provided no other instructions as to how she should take the doxycycline. Ms. Levy-Gray filled her prescription at the Rite Aid Pharmacy # 4465, located at 12224 Tullamore Road, in Timonium, Maryland, which she stated she chose because of prior dealings with that store as well as the fact that Rite Aid was a national chain of pharmacies. Rite Aid obtained the doxycycline at issue from Watson Laboratories, Inc. of Corona, California (Watson), which is not a party to this action. Watson shipped the doxycycline in bottles containing 500 capsules and included an eight-page pamphlet which the manufacturer had submitted to the United States Food and Drug Administration (FDA) and which had been approved by that agency as "labeling" for that prescription drug. The pamphlet from Watson provided in pertinent part:

If gastric irritation occurs, it is recommended that doxycycline be given with food or milk.

The doxycycline received by Ms. Levy-Gray was accompanied by an instruction and information pamphlet, known as a "patient package insert" (PPI), entitled "Rite Advice." The "Rite Advice" pamphlet was drafted for Rite Aid by First Data Bank Corporation, which is not a party to the case sub judice. The cover page of the pamphlet informed readers: "Inside is everything you need to know about your prescription. It covers everything in writing from dosage to side effects. If you have any questions, just ask your pharmacist." The inside of the pamphlet stated, in part:

IMPORTANT NOTE: THE FOLLOWING INFORMATION IS INTENDED TO SUPPLEMENT, NOT SUBSTITUTE FOR, THE EXPERTISE AND JUDGMENT OF YOUR PHYSICIAN, PHARMACIST OR OTHER HEALTHCARE PROFESSIONAL.

IT SHOULD NOT BE CONSTRUED TO INDICATE THAT USE OF THE DRUG IS SAFE, APPROPRIATE, OR EFFECTIVE FOR YOU.

CONSULT YOUR HEALTHCARE PROFESSIONAL BEFORE USING THIS DRUG.

* * *

HOW TO TAKE THIS MEDICATION: Take each dose with a full glass of water (4 oz. or 120 ml) or more. Do not lie down for at least 1 hour after taking this drug. Take with food or milk if stomach upset occurs unless your doctor directs you otherwise. Avoid taking antacids, containing magnesium, aluminum or calcium, sucralfate, iron preparations or vitamin (zinc) products within 2-3 hours of taking this medication. These products bind with the medication preventing its absorption . . . .

* * *

The information in this leaflet may be used as an educational aid. This information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. This information is not intended as medical advice for individual problems[.]

Ms. Levy-Gray took the first dose of doxycycline on October 26 with water. According to Ms. Levy-Gray's testimony, the following day she started taking the medication with milk because she had experienced an upset stomach. While continuing to take the drug, Ms. Levy-Gray also consumed a large quantity of dairy products including eight to ten glasses of milk per day, macaroni and cheese, grilled cheese sandwiches, yogurt, ice cream, and cottage cheese, as she testified, in an effort to maintain her breast milk to resume nursing her son after her treatment ended. During this time, according to Ms. Levy-Gray's testimony, she experienced no alleviation of her symptoms from Lyme disease.

Upon advice from her brother, a urological oncologist, Ms. Levy-Gray stopped taking the doxycyline with dairy products. Although Ms. Levy-Gray's symptoms improved within two or three days of discontinuing consumption of dairy products in conjunction with the doxycycline, she did not fully recover and was referred by Dr. Christine Lafferman, her internist, to Dr. Charles A. Haile, the Chief of Medical Staff and Chief of the Division of Infectious Diseases at Greater Baltimore Medical Center, who is board certified in internal medicine and infectious diseases. Ms. Levy-Gray met with Dr. Haile on December 28, 2000. When a second six-week course of doxycycline failed to ameliorate Ms. Levy-Gray's symptoms, Dr. Haile diagnosed her with post-Lyme syndrome, which is a chronic autoimmune response in which patients experience symptoms that mimic Lyme disease without an active bacterial infection.

On November 2, 2001, Ms. Levy-Gray filed a complaint in the Circuit Court for Baltimore County against Rite Aid seeking relief based on the theories of negligence, product liability, failure to warn, negligent misrepresentation, and breach of express warranty. Her husband asserted a claim for loss of consortium.2 Ms. Levy-Gray alleged that her consumption of milk and other various dairy products while taking the doxycycline, consistent with the information provided by Rite Aid, reduced the absorption of the drug and prevented it from operating as effectively as possible, thereby proximately causing her post-Lyme syndrome.

On December 10, 2001, Rite Aid filed a motion to dismiss the complaint for failure to state a claim upon which relief could be granted because the statements contained in the "Rite Advice" pamphlet did not constitute an express warranty and the fact that the particular Rite Aid store involved in the case was not a proper party to the suit. The court granted the motion with respect to the Rite Aid store and denied the motion regarding the express warranty issue on February 25, 2002. Rite Aid thereafter filed a motion for summary judgment arguing that it could not be held liable under negligence, strict liability or breach of express warranty under the facts of the case sub judice. On January 10, 2003, the trial judge denied the motion. Ms. Levy-Gray subsequently filed an amended complaint, which increased the ad damnum clause for compensatory damages to $2,500,000 and added a claim for $8,000,000 in punitive damages.

On May 20, 2003, the trial in the Circuit Court of Baltimore County before Judge John F. Fader II commenced and lasted seven days, wherein the jury heard copious testimony from expert witnesses called by both parties. Rite Aid's experts testified that the absorption of doxycycline might have been reduced by up to twenty percent when taken with milk or other dairy products, but that the reduction was clinically insignificant because the recommended dosage provided more of the drug than was necessary to treat the infection. Conversely, Ms. Levy-Gray's experts testified that doxycycline should not have been taken with dairy products and that Ms. Levy-Gray's consumption of milk with her medication caused her continued Lyme disease symptoms.

At the close of evidence, Judge Fader permitted the case to go to the jury on the theories of negligence and breach of express warranty and dismissed the remainder of the claims. The court presented the jury with the following instructions:

An individual or an entity may only be sued for negligence if that individual or entity had a duty to another person which the defendant breached. That duty may be imposed by statute: automobile negligence case, follow the rules of the road; or by case law, or by volunteering to assume a duty. It is the Plaintiffs' contention in this case that Rite Aid had a duty to her because it assumed that duty by giving prescription advice to her. One who volunteers to assist or aid another must exercise the same degree of case a reasonable person would exercise under the same or similar circumstances.

Rite Aid gave her that pamphlet. The law says that a volunteer who assumes a duty has a responsibility to use reasonable care in fulfilling that duty. Negligence is what she alleges, saying that they had a duty because they volunteered, they breached that duty. Rite Aid says we did not breach that duty. The conflict in the evidence is for you to resolve.

Negligence is doing something that a person using reasonable care would not do or not doing something that a person using reasonable care would do. Reasonable care means that caution, attention, or skill a reasonable person would use under similar circumstances.

Thus the first question alleging negligence. Do you find in favor of Rite Aid, do you find...

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