Maryland Lyme Disease Case: Pharmacy Held Responsible For Improper Doxycycline Instructions

On October 25, 2000, an infectious disease specialist diagnosed his patient with Lyme disease and gave her a prescription for doxycycline, a Tetracycline-based drug commonly prescribed for the treatment of Lyme disease. The specialist informed the patient that while taking doxycycline she could not continue nursing her son, but gave her no other instructions as to how she should take the doxycycline. The patient filled her prescription at a local pharmacy that was part of a national pharmacy chain. The company that manufactured the doxycycline provided the pharmacy with a pamphlet that stated, “If gastric irritation occurs, it is recommended that doxycycline be given with food or milk.”

The pharmacy provided the patient with its own instruction and information pamphlet (“patient package insert”) that stated on its cover page, “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.” Inside the pamphlet were instructions on how to take the medication which stated, in part, “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 . . . .” (emphasis added)

The patient took her first dose of doxycycline with water on October 26, 2000. Beginning on October 27th, she started taking the medication with milk because she had experienced an upset stomach. While continuing to take the drug, she also consumed a large quantity of dairy products in an effort to maintain her breast milk to resume nursing her baby after her treatment ended. During this time, she did not experience alleviation of her Lyme disease symptoms.

The patient’s brother, who is a physician, advised her to stop taking the doxycyline with dairy products. Although her symptoms improved within two or three days of discontinuing consumption of dairy products in conjunction with the doxycycline, she did not fully recover. When a second six-week course of doxycycline failed to resolve her Lyme disease symptoms, her physician 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, the patient filed a case against the pharmacy and its parent pharmacy chain, alleging negligence, product liability, failure to warn, negligent misrepresentation, and breach of express warranty. Her lawsuit alleged that her consumption of milk and other various dairy products while taking the doxycycline, consistent with the information provided by the pharmacy, reduced the absorption and effectiveness of the doxycycline, thereby proximately causing her post-Lyme syndrome.

After a seven-day trial in May, 2003, the jury found in favor of the pharmacy chain on the negligence claim but found in favor of  the patient with respect to the breach of express warranty claim, awarding the patient $250,000. Both parties appealed to the Maryland intermediate appellate court and subsequently appealed to the highest appellate court, which held that under the circumstances of this case, the jury reasonably could infer that the instruction “take with food or milk if upset stomach occurs” in the pharmacy pamphlet given to the patient constitutes an express warranty under Maryland Code (1975, 2002 Repl. Vol.), Section 2-313 of the Commercial Law Article. The Court of Appeals stated that “the jury could reasonably infer from the evidence introduced that the phrase “take with food or milk if upset stomach occurs,” although not guaranteeing effectiveness, affirmed that milk would not adversely impact the efficacy of the drug.”

Additionally, the Court of Appeals declined to hold that a general disclaimer would preclude any express warranty in this case as a matter of law, because a reasonable consumer could conclude that the general statement did not negate the effect of the more specific assertion as to the administration of the doxycycline when the entire document is read as a whole. The Court of Appeals held that the issue of fact concerning the interplay between the general disclaimer and the administration instruction was properly before the jury and that deference must be given ‘to the inferences a fact-finder may draw.’” [The pamphlet given to the patient contained the following general disclaimer: “IMPORTANT NOTE: THE FOLLOWING INFORMATION IS INTENDED TO SUPPLEMENT, NOT SUBSTITUTE FOR, THE EXPERTISE AND JUDGMENT OF YOUR PHYSICIAN, PHARMACIST OR OTHER HEALTH CARE 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.]

Source  Rite Aid Corporation v. Ellen R. Levy-Gray

If you or a loved one were injured as a result of the failure to timely diagnose Lyme disease or a drug injury, you should promptly contact a local medical malpractice attorney or drug claim attorney to assist you with your claim.

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This entry was posted on Tuesday, December 11th, 2012 at 10:57 am. Both comments and pings are currently closed.

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