Rite Aid Corp. v. Levy-Gray

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. 1 ⁶⁷⁹ 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. Laffer-man).

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 “[m]ore so than I used to, I guess because I know that the pharmacies typically give out pretty broad information sheets at the time of the prescriptions. Probably years ago I would have maybe taken more time going through that.

But ... I do assume to some extent that the pharmacy will provide that 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. ⁶⁸⁰ 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), ie., a pamphlet, entitled “Rite ADVICE.” The “Rite ADVICE” PPI was prepared and customized for Rite Ad by a non-party to this action, First Databank — The Hearst Corporation.

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 ... or more.... 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 2-8 hours of taking ⁶⁸¹ this medication. These products bind with the medicine 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.” (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: “[Bjecause [her newborn] was nursed, I was eating a very well-balanced diet, high in nutrition, a lot of fruit, a lot of vegetables, a lot of dairy products because it was important that I maintain a high nutritional level of milk products because ... that is very important for ... nursed children. I would eat cheese several times a day, and I would drink between eight and ten glasses of milk ... a day along with water and fruit juices.” 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 Doxy-cycline.” 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 ⁶⁸² 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 “didn’t see any reason to [contact her doctor] because the pamphlet itself said what to do....

I trusted the directions. I didn’t see any reason to call the doctor on it.” Rather than improving as a result of the doxycycline treatment, Plaintiffs 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 doxycy-cline 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 measurably] 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 Plaintiffs symptoms, Dr. Haile diagnosed her with post-Lyme syndrome.

PosNLyme 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 ⁶⁸³ each party. The medical theory of Plaintiffs 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 doxycy-cline 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 pharmacists to warn patients of any risks involved in consuming dairy products while taking doxycycline. The court, however, instructed that, by its having furnished the Rite ADVICE pamphlet, Rite Aid could be found to have assumed “a duty” with the concomitant responsibility of performing that duty with reasonable care.

The circuit court did not further refine or illustrate the duty. The court also allowed the jury to consider whether the Rite ADVICE pamphlet made an express warranty, as defined by the court. As to both theories of the case, the court left to the argument of counsel how the evidence applied to the instructions. The arguments of counsel are not reproduced in the record.

The jury found in favor of Rite Aid on the negligence claim, and it found in favor of Plaintiff on the breach of express warranty claim. Following the denial of post-judgment motions filed by Rite Aid, this appeal and cross-appeal were timely noted. Additional facts will be stated in the course of this opinion as necessary to the resolution of the questions presented. Rite Aid presents the following questions: “1) Whether Rite Aid was entitled to judgment because a) the law does not recognize a cause of action against pharmacists for breach of express warranty, b) the Rite Aid ⁶⁸⁴ patient brochure made no promise concerning the performance of doxycycline, and c) the brochure was not part of the basis of the bargain between the parties. “2) Whether Rite Aid was entitled to judgment because [Ms.] Levy-Gray’s claim is preempted because it relies on the assertion that Rite Aid should have provided instructions on the taking of doxycycline contrary to those approved by the FDA. “3) Whether Rite Aid was entitled to judgment because [Ms.] Levy-Gray did not provide rehable expert testimony to establish that Rite Aid caused her injuries. “4) Whether the trial court’s admission of medical opinion evidence that was not rendered to a reasonable degree of medical certainty unduly prejudiced Rite Aid. “5) Whether the trial court erred in failing to instruct the jury a) on the effect of having alternative potential causes of [Ms.] Levy-Gray’s injuries, b) that Rite Aid had no obligation to warn of hazards associated with [Ms.] Levy-Gray’s unique susceptibility to injury, and c) that a defendant is hable only for the exacerbation of a pre-existing condition.” Plaintiff, by cross-appeal, raises the following additional issue: “Whether or not the Trial Court clearly erred and/or abused its discretion by faihng to give the jury the product hability failure to warn jury instruction based upon Rite Aid’s failure to warn [Ms.] Levy-Gray about the contraindications of Doxycycline and calcium products in hght of Mazda Motor of America Inc. v. Rogowski, 105 Md.App. 318 , 659 A.2d 391 , cert. denied, 340 Md. 501 , 667 A.2d 342 (1995).” I. Express Warranty Maryland Code (1975, 2002 Repl.

VoL), § 2-313 of the Commercial Law Article (CL) governs “[e]xpress warranties by affirmation, promise, description, [or] sample.” It provides: ⁶⁸⁵ “(1) Express warranties by the seller are created as follows: “(a) 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 creates an express warranty that the goods shall conform to the affirmation or promise. “(b) Any description of the goods which is made part of the basis of the bargain creates an express warranty that the goods shall conform to the description. “(2) It is not necessary to the creation of an express warranty that the seller use formal words such as ‘warrant’ or ‘guarantee’ or that he have a specific intention to make a warranty, but an affirmation merely of the value of the goods or a statement purporting to be merely the seller’s opinion or commendation of the goods does not create a warranty.” Official Comment 3 to CL § 2-313 furnishes the following elaboration: “3. The present section deals with affirmations of fact by the seller, descriptions of the goods or exhibitions of samples, exactly as any other part of a negotiation which ends in a contract is dealt with. No specific intention to make a warranty is necessary if any of these factors is made part of the basis of the bargain. In actual practice affirmations of fact made by the seller about the goods during a bargain are regarded as part of the description of those goods; hence no particular reliance on such statements need be shown in order to weave them into the fabric of the agreement.

Rather, any fact which is to take such affirmations, once made, out of the agreement requires clear affirmative proof. The issue normally is one of fact.” (Emphasis added). “Bargain” is not a defined term in the Uniform Commercial Code, but it is a term used to define “agreement” in CL § 1-201(3), in relevant part reading: ⁶⁸⁶ “ ‘Agreement’ means the bargain of the parties in fact as found in their language or by implication from other circumstances including course of dealing or usage of trade or course of performance as provided in Titles 1 through 10 of this article[.]” In the UCC, “Agreement,” or “bargain of the parties in fact,” is to be contrasted with “ ‘Contract’ [which] means the total legal obligation which results from the parties’ agreement as affected by Titles 1 through 10 of this article and any other applicable rules of law.” CL § 1-201(11). A. Reliance Understanding Rite Aid’s first argument, that there can be no express warranty by a pharmacist dispensing prescription drugs, requires that we review the law applicable to the prescription drug manufacturer-physician-patient relationship. Rite Aid’s argument is based on an offshoot of the “learned intermediar/’ doctrine which governs that relationship.

We explain. “[T]he traditional rules [are] that drug and medical-device manufacturers are liable only when their products contain manufacturing defects or are sold without adequate instructions and warnings to prescribing and other health-care providers.” Restatement (Third) of Torts: Products Liability § 6, “Liability Of Commercial Seller Or Distributor For Harm Caused By Defective Prescription Drugs And Medical Devices,” cmt. a. The rationale for the traditional rule is stated in comment b, reading, in relevant part, as follows: “The obligation of a manufacturer to warn about risks attendant to the use of drugs and medical devices that may be sold only pursuant to a health-care provider’s prescription traditionally has required warnings directed to healthcare providers and not to patients. The rationale supporting this ‘learned intermediary’ rule is that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy. The duty then devolves on the health-care provid ⁶⁸⁷ er to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy.

Subsection (d)(1) retains the ‘learned intermediary’ rule.” Courts have developed a corollary to the learned intermediary rule that extends the defense to pharmacies and pharmacists. Because physicians, possessing knowledge of the range of possible choices among prescription drugs and of the patient’s particular condition, have the duty to warn of potential adverse consequences, there are cases that hold that the duty of pharmacists is to dispense the drug in accordance with physicians’ prescriptions, generally without injecting themselves into the physician-patient relationship. The Court of Appeals applied this reasoning in People’s Sen). Drug Stores, Inc. v. Somerville, 161 Md. 662 , 158 A. 12 (1932).

That was a negligence action against a pharmacy that had filled a prescription for capsules, each containing one-fourth grain of strychnine, with other ingredients. The theory of the plaintiff’s claim was that the pharmacist should have refused to fill the prescription because the strychnine content was too large. Reversing, without a new trial, a judgment for the plaintiff, the Court reasoned: “[I]t does not follow, because a physician in a given case is liable, that the druggist who filled the prescription is also liable. It would be a dangerous principle to establish that a druggist cannot safely fill a prescription merely because it is out of the ordinary.

If that were done, many patients might die from being denied unusual remedies in extreme cases. Of course this does not mean that pharmacists can safely fill prescriptions calling for doses that are obviously fatal; or that where the doses prescribed appear to be unusual the prescription can be safely filled without inquiry of the physician to make sure there has been no error. There is no evidence that this precaution was not taken in the present case; but, even if it was not, that would be immaterial here, because the result of such inquiry would have ⁶⁸⁸ been to confirm the prescription, as the physician who wrote it testified that it was his usual prescription in such cases.” Id. at 666-67 , 158 A. at 13-14 . Federal courts have applied the rule of People’s Serv.

Drug Stores in negligent failure to warn cases brought against pharmacies that are governed by Maryland law. See Hofherr v. Dart Indus., Inc., 853 F.2d 259, 263-64 (4th Cir.1988); Moore v. Wyeth-Ayerst Laboratories, 236 F.Supp.2d 509, 512-13 (D.Md.2002). Other cases holding that the pharmacist-patient relationship ordinarily does not give rise to a duty imposed by law (as contrasted with an assumed duty) to warn of potential adverse consequences of prescribed drugs include Ramirez v. Richardson-Merrell, Inc., 628 F.Supp. 85 (E.D.Pa.1986); Walker v. Jack Eckerd Corp., 209 Ga.App. 517 , 434 S.E.2d 63 (1993); Fakhouri v. Taylor, 248 Ill.App.3d 328 , 187 Ill.Dec. 927 , 618 N.E.2d 518 , cert. denied, 152 Ill.2d 557 , 190 Ill.Dec. 887 , 622 N.E.2d 1204 (1993); Leesley v. West, 165 Ill.App.3d 135 , 116 Ill.Dec. 136 , 518 N.E.2d 758 (1988); Ingram v. Hook’s Drugs, Inc., 476 N.E.2d 881 (Ind.App.1985); Nichols v. Central Merchandise, Inc., 16 Kan.App.2d 65 , 817 P.2d 1131 (1991); Kinney v. Hutchinson, 449 So.2d 696 (La. App.), cert. denied, 452 So.2d 170 (La.1984); Adkins v. Mong, 168 Mich.App. 726 , 425 N.W.2d 151 (1988); Moore v. Memorial Hosp. of Gulfport, 825 So.2d 658 (Miss.2002); Batiste v. American Home Prods.

Corp., 32 N.C.App. 1 , 231 S.E.2d 269 , cert. denied, 292 N.C. 466 , 233 S.E.2d 921 (1977); Griffith v. Blatt, 158 Or.App. 204 , 973 P.2d 385 (1999), rev’d, 334 Or. 456 , 51 P.3d 1256 (2002); 2 Laws v. Johnson, 799 S.W.2d 249 . (Tenn.App.1990); McKee v. American Home Prods. Corp., 113 Wash.2d 701 , 782 P.2d 1045 (1989) (en banc); and Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455 (Tex.App.2000). Contra Horner v. Spalitto, 1 S.W.3d 519 (Mo.App.1999).

Rite Aid’s initial argument against any express warranty in the instant matter combines the above-described corollary to ⁶⁸⁹ the learned intermediary doctrine with Rite Aid’s assumption that, in Maryland, under CL § 2-313, there must be reliance on the pharmacist in order for the latter’s affirmation of fact to be an express warranty. “Whether or not reliance is an essential element of ‘basis of the bargain,’ [as used in U.C.C. § 2-313(1 )(a),] is a question answered differently by the various jurisdictions.” 3 Williston on Sales § 17-8, at 18 (5th ed. 1996). The Court of Appeals has not had occasion to speak to that issue. 3 The analysis relied upon by Rite Aid was articulated and applied in In re Rezulin Prods. Liability Litigation, 133 F.Supp.2d 272 (S.D.N.Y.2001). Rezulin is a prescription diabetes medication, the use of which prompted hundreds of suits against its manufacturer.

These suits were consolidated in the Southern District of New York by the Judicial Panel on Multidistrict Litigation. The issue in the reported opinion was whether sixteen cases should be remanded from the consolidation to state courts in Mississippi, Texas, West Virginia, and Louisiana or whether the pharmacies that had dispensed Rezulin to those plaintiffs were “fraudulently” joined as defendants, thereby preserving federal diversity jurisdiction. The test applied by the court for “fraudulent” joinder was whether the plaintiffs could state a legally sufficient and factually arguable claim against the pharmacies. Among the claims asserted against the pharmacies was breach of express warranty.

Under the law of each of the states involved, a pharmacy was not liable to the patient for failure to warn because those states either applied, or were predicted to apply, to pharmacies the above-described corollary to the learned intermediary doctrine. The court concluded that, ⁶⁹⁰ because patients rely on physicians in purchasing a prescription drug, and not on pharmacists, there could be no express warranty. This reasoning of the Rezulin multidistrict litigation court is most fully set forth in its discussion of the cases from Mississippi. The court said: “Patients who purchase prescription drugs from pharmacists do not negotiate or bargain with the pharmacists about the suitability of the product.

Even assuming a pharmacist were to make a representation about the safety of a particular drug, the representation would not form ‘part of the basis of the bargain’ as required by the Mississippi UCC because the patient purchases the drug on the basis of discussions with his or her physician. Unlike the buyer-seller relationship in normal sales transactions, the relationship between the patient and pharmacist is a function of a regulatory system requiring that certain drugs be sold solely by prescription of a physician. It is through the pharmacy that the patient purchases the drug, but in only this sense does the pharmacy function as a ‘seller.’ The only representations regarding the intrinsic properties of the drug that form the basis of the buyer’s purchase are those of the physician. It is precisely for this reason that the learned intermediary doctrine focuses on communications between the manufacturer and physicians, rather than patients or pharmacies; it is the physicians who make the ultimate decision on whether to prescribe the drug.” Id. at 291-92 .

Accord Salisbury v. Purdue Pharma, L.P., 166 F.Supp.2d 546 (E.D.Ky.2001); In re Baycol Prods. Litigation, 2004 WL 1118642 (D.Minn.2004). These cases, utilizing the learned intermediary rule in concluding, as a matter of law, that there can be no reliance on an alleged express warranty by the pharmacy, do not involve PPIs that were prepared, or caused to be prepared, by the pharmacy and distributed in its name. 4 ⁶⁹¹ In the instant matter, we shall assume, arguendo, that, in order to find an express warranty under CL § 2-313, Maryland law requires the buyer’s reliance on a statement made by the seller. Nevertheless, under the facts of the instant matter, we cannot hold as a matter of law that Ms. Levy-Gray relied solely on Dr. Geckler to describe for her the characteristics of doxycycline, because he did not advise her of the drug’s characteristics or how it should be taken.

Rather, Dr. Geckler relied on the dispensing pharmacist to furnish that information to the patient and, perforce, Plaintiff also relied on the dispensing pharmacist. Indeed, the PPI furnished to Ms. Levy-Gray invited her reliance and evidences Rite Aid’s intent that she rely on the affirmations of fact about doxycycline contained in the PPL Its cover informed her that “[ijnside is everything you need to know about your prescription.” Our conclusion that Plaintiff relied on Rite Aid is reinforced by evidence that Ms. Levy-Gray had had prescriptions filled by Rite Aid in the past and, inferentially, had received PPIs from the pharmacy. This evidence tends to show a course of dealing, CL § 1-201(3), under which Plaintiff, who had no instructions regarding the usage of doxycycline from the ⁶⁹² prescribing physician, relied upon Rite Aid to furnish that information. B. Is There Sufficient Evidence of a Warranty?

Whether the Rite ADVICE pamphlet contains an express warranty under CL § 2-313 is a much closer question on which there is a dearth of authority. Most of the reported cases dealing with the liability of a pharmacist who is dispensing a prescription drug address a negligence theory of liability. This is consistent with Restatement (Third) of Torts: Products Liability § 6(e), which states the following rule: “A retail seller or other distributor of a prescription drug ... is subject to liability for harm caused by the drug ... if: “(2) at or before the time of sale or other distribution of the drug ... the retail seller or other distributor fails to exercise reasonable care and such failure causes harm to persons.” In the matter before us, the jury exonerated Rite Aid of negligence. Under CL § 2-313, in order to have an express warranty there must be an affirmative statement of fact by the seller about the goods.

A claim that there is a warranty by omission is at odds with the UCC definition of an express warranty. See Witherspoon v. Philip Morris Inc., 964 F.Supp. 455, 465 (D.D.C.1997). Here, the manufacturer’s package insert that accompanied the doxycycline shipped by Watson to Rite Aid contained, inter alia, the following statement: “All patients taking doxycycline should be advised: “• That the absorption of tetracyclines is reduced when taken with foods, especially those which contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.” ⁶⁹³ The omission of this statement, which was relevant to the negligence claim asserted by Plaintiff, and is of some relevance to the medical causation issues, is not relevant to the creation of an express warranty.

Rite Aid, drawing on cases in which manufacturers were claimed to have made an express warranty, contends that, in order to create an express warranty, there must be a promise concerning the performance or safety of the drug involved. Rite Aid’s lead citation is to Basko v. Sterling Drug, Inc., 416 F.2d 417 (2d Cir.1969). That decision reversed a judgment on verdict for the defendant in a products liability failure to warn case for error in the instructions on causation. The appellate court, however, agreed with the trial court’s refusal to submit a breach of express warranty theory to the jury, because the “defendant did not represent either (1) that its drugs were free from all harmful side effects or (2) that its drugs were absolutely harmless.” Id. at 428 .

These two alternatives do not exhaust the potential universe of affirmations of fact about a prescription drug for the purpose of CL § 2-313 express warranties. These two alternatives do not include an affirmative statement as to other substances with which the drug compatibly may be ingested. Rite Aid also argues that the instructions in the Rite ADVICE pamphlet are analogous to the instruction manual for the snowblower that was involved in Shreve v. Sears, Roebuck & Co., 166 F.Supp.2d 378 (D.Md.2001). There, the plaintiff was injured when he lost his balance and his hand went into the chute of the snowblower.

The blades of the machine were still rotating, although the dead man lever had been released, which should have stopped the rotation of the blades. The court entered summary judgment dismissing an express warranty claim because the facts were more consistent with a breach of an implied warranty of merchantability and because the owner’s manual, describing the operation of the machine, had not been furnished to the plaintiff until after the sale had been completed. Here, the PPI was delivered simultaneously with the sale, so Shreve is not directly on ⁶⁹⁴ point. 5 Plaintiff, similarly off point, seeks to expand the express warranty concept. Ms. Levy-Gray emphasizes the cover of the Rite ADVICE pamphlet where it states: “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.” These statements are not affirmations of fact about doxyeycline. They may be descriptive of the information provided as a service by Rite Aid, or of the service provided by any of its pharmacists, but the statements contain no affirmation of fact about doxyey-cline. By their nature, express warranties are case specific.

Courts may conclude in appropriate cases that a statement by a seller of goods does not create, as a matter of law, an express warranty. Illustrative is Jones v. Walter Kidde Portable Equip., Inc., 183 F.3d 67 (1st Cir.1999). In that case the plaintiff suffered nerve damage to her arm during surgery caused by undue pressure from a malfunctioning, automatic tourniquet manufactured by the defendant. An expert opined that “the malfunction was due to a foreign particle temporarily holding open the gas supply valve and another blocking the safety relief valve,” and that both particles ultimately blew away under pressure.

Id. at 69 . The manufacturer’s statements about the product included the following: “‘IMPORTANT! MONITOR CUFF PRESSURE CONTINUOUSLY DURING USE. ‘“Pressure will remain at the selected setting during the entire procedure unless manually changed. “ ‘[Directions for changing] “ ‘NOTE: SHOULD A LEAK EVER DEVELOP IN THE TOURNIQUET VALVE DURING USE, THE SET PRES ⁶⁹⁵ SURE WILL RISE AT LEAST 150 MM HG. BEFORE PRESSURE RELIEF OPERATES. “ ‘INSTRUCTIONS IN THIS MANUAL FOR MAINTENANCE MUST BE FOLLOWED TO MINIMIZE LEAK POTENTIALS.’ “In addition, an instruction on the side of the tourniquet’s metal shell sa[id], similarly, ‘[djuring use monitor pressure gauge continuously for pressure stability.’ ” Id. at 70 .

The plaintiff contended that an express warranty was created by the statement, “Pressure will remain at the selected setting[.]” Affirming a judgment NOV for the defendant, the court said: “Where the relied on statement is flanked with another, IMPORTANT advice that something may go wrong and instructions how to guard against it, we hold as a matter of law that the combination cannot be read as warranty that the event will not happen.” Id. In the case before us, any express warranty rests on the statement: “Take [doxycycline] with food or milk if stomach upset occurs unless your doctor directs you otherwise.” This statement is sufficient for a jury reasonably to conclude that Rite Aid represented to Plaintiff that a characteristic or quality of doxycycline was that it was compatible with food or milk. The closest that the Rite ADVICE pamphlet comes to the characteristic of absorption is in the next sentence which reads: “Avoid taking antacids containing magnesium, aluminum or calcium, sucralfate, iron preparations or vitamin (zinc) products within 2-3 hours of taking this medication.” Reasonable persons certainly could read this sentence as limited to over-the-counter or prescription antacids, including those containing calcium, that are ingested within two to three hours of the doxycycline dosage. There is no evidence that Plaintiff was taking antacids.

It is true that the Rite ADVICE pamphlet states, in bold type, that “it should not be construed to indicate that use ⁶⁹⁶ of the drug is safe, appropriate, or effective for you.” 6 This statement must be read in the context of the Rite ADVICE pamphlet as a whole. To hold that that general disclaimer precludes any express warranty in this case requires a judicial finding that no reasonable person could read the Rite ADVICE pamphlet without concluding that the general statement negated the more particular description of doxycycline, i.e., that it could be taken with food or milk. The instant matter, we hold, is one in which comment 3 to § 2-313 is appropriately applied. Whether the disclaimer took the statement of the compatibility characteristic of doxycycline out of the bargain was a question of fact for the jury.

C. Timing of the Affirmation of Fact Rite Aid’s third argument for precluding, as a matter of law, a finding of express warranty rests on the requirement of CL § 2-313(l)(a) that the affirmation of fact become “part of the basis of the bargain.” This, Rite Aid submits, means that the affirmation must be a negotiated term of the agreement, or at least there must be proof that the plaintiff “ ‘read, heard, saw or knew of the advertisement containing the affirmation of fact or promise’ before the purchase.” Parkinson v. Guidant Corp., 315 F.Supp.2d 741, 752 (W.D.Pa.2004). See also Williams v. Dow Chem. Co., 255 F.Supp.2d 219, 230 (S.D.N.Y.2003); Boyd v. Johnson & Johnson, 2002 WL 372959 , ³ (Pa.Com.Pl.2002). These cases involve claims of express warranty based on advertisements.

In such cases the requirement that the plaintiff must have seen the advertisement prior to the sale is imposed to prevent fraud, if for no other reason. It proves too much, however, to apply to written warranties a requirement of pre-sale knowledge by the buyer of the affirmation of fact. We agree with the analysis of the court in ⁶⁹⁷ Murphy v. Mallard Coach Co., 179 A.D.2d 187 , 582 N.Y.S.2d 528 (N.Y.App.Div.1992), affirming a judgment for the plaintiff on a breach of express written warranty. Rejecting the argument presented here by Rite Aid, the appellate division said: “[Wjhile the warranty was technically handed over after plaintiffs paid the purchase price, the fact that it was given to plaintiffs at the time they took delivery of the motor home renders it sufficiently proximate in time so as to fairly be said to be part of the basis of the bargain (compare, UCC [§ ]2-313, comment 7; 1 White and Summers, Uniform Commercial Code, § 9-5, at 448-455 [3d ed.]).

To accept the manufacturer’s argument that in order to be part of the basis of the bargain the warranty must actually be handed over during the negotiation process so as to be said to be an actual procuring cause of the contract, is to ignore the practical realities of consumer transactions wherein the warranty card generally comes with the goods, packed in the box of boxed items or handed over after purchase of larger, non-boxed goods and, accordingly, is not available to be read by the consumer until after the item is actually purchased and brought home. Indeed, such interpretation would, in effect, render almost all consumer warranties an absolute nullity.” Id. at 531 (some citations omitted). See also In re Bridgestone/Firestone, Inc. Tires Prods. Liability Litigation, 205 F.R.D. 503, 527 (S.D.Ind.2001), rev. on other grounds, 288 F.3d 1012 (7th Cir.2002) (“Whether the consumer was aware of the terms of the written warranty before the purchase or not, it was certainly part of the bargain, in that the warranty was part of what the seller sold to the buyer”).

The Fourth Circuit, applying Virginia law, in Martin v. American, Med. Sys., Inc., 116 F.3d 102 (4th Cir.1997), considered a breach of express warranty claim involving a penile prosthesis, which the plaintiff asserted caused infection. The plaintiff had the product inserted in a hospital, and documents accompanying the delivery of the product stated in part that it was “ ‘delivered to the hospital prefilled and sterile.’ ” Id. at 103 . The plaintiff did not learn of this representation until the ⁶⁹⁸ litigation began.

Nevertheless, the court held that “[t]he express warranty inquiry focuses on what it is that the seller agreed to sell, and, absent clear proof that the parties did not intend their bargain to include the seller’s description of the goods, that description is an express warranty.” Id. at 105 . For all the foregoing reasons we hold that Rite Aid expressly warranted that doxycycline could be taken with milk or other dairy products.

II

Preemption We now address Rite Aid’s argument based on the Supremacy Clause of the United States Constitution. The submission contains two steps. Rite Aid first assumes that the Congress of the United States, by enacting the labeling provisions of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et. seq., intended to preempt state law causes of action against prescription drug manufacturers that are based on representations in, or omissions from, the product’s “label,” as approved by the FDA. 7 From that premise Rite Aid next argues that the immunity from that class of actions under state law should be extended to pharmacies that choose, although not legally compelled to do so, to furnish to their customers information concerning prescription drugs that is substantially the same as in the manufacturer’s label. Rite Aid does not contend that express preemption applies to the prescription drug here.

The silence of Congress concerning preemption of state law with respect to prescription drugs may be contrasted with 21 U.S.C. § 379r(a), prohibiting any state or political subdivision thereof from establishing any “requirement” for nonprescription drugs “that is different from or in addition to, or that is otherwise not identical with, a requirement under,” inter alia, the FDCA. This express preemption provision barred a state law express warranty action involving an over-the-counter product for head lice in Kanter ⁶⁹⁹ v. Warner-Lambert Co., 99 Cal.App.4th 780 , 122 Cal.Rptr.2d 72 (2002). Nor do we deal with preemption by occupation of the field. In Hillsborough County, Fla. v. Automated Med.

Laboratories, Inc., 471 U.S. 707 , 105 S.Ct. 2371 , 85 L.Ed.2d 714 (1985), the local government regulated blood plasma collection centers by requirements additional to those federally imposed. Sustaining the local regulation, the Court said: “To infer pre-emption whenever an agency deals with a problem comprehensively is virtually tantamount to saying that whenever a federal agency decides to step into a field, its regulations will be exclusive. Such a rule, of course, would be inconsistent with the federal-state balance embodied in our Supremacy Clause jurisprudence.” Id. at 717 , 105 S.Ct. at 2377 . Further, this is not a case of direct conflict, as illustrated by Dowhal v. SmithKline Beecham Consumer Healthcare, 32 Cal.4th 910 , 12 Cal.Rptr.3d 262 , 88 P.3d 1 (2004), on which Rite Aid relies.

In that case, as a result of a California initiative requiring warnings on products containing chemicals known to the state to cause reproductive toxicity, the California health authorities mandated a warning for products containing nicotine, including nicotine replacement therapies. It read, “ ‘WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.’ ” Id. at 3. The FDA-approved warning, which is set forth in the margin, “serve[d] a nuanced goal — to inform pregnant women of the risks of [nicotine replacement therapy] products, but in a way that will not lead some women, overly concerned about those risks, to continue smoking.” Id. at 15. 8 No such direct conflict is presented here. ⁷⁰⁰ The conflict, as Rite Aid perceives it, is that, in order to avoid the state law warranty liability that the jury found, Rite Aid must depart from the FDA approved language of the Watson label. Such a result, Rite Aid submits, compels preemption; otherwise, Rite Aid would be subjected to criminal penalties for misbranding under 21 U.S.C. § 331 (a), (b), and (k).

We disagree with the argument both factually and legally. Under the instructions of the court, the jury’s finding of express warranty is based upon the text of the Rite ADVICE pamphlet, not of the Watson label. The variations between the Watson approved label and the Rite ADVICE pamphlet apparently result from decisions made by the editors of the PPI at First Databank, and not from a requirement of Maryland law. The Rite ADVICE pamphlet omits precautions concerning which “[a]ll patients taking doxycycline should be advised[.]” The Rite ADVICE pamphlet omits the statement, presented in the label, that “the absorption of tetracyclines is reduced when taken with foods, especially those which contain calcium.” The Rite ADVICE pamphlet omits the statement in the label: “However, the absorption of doxycycline is not markedly influenced by