Baltimore Sun
May 30, 2003|By Stephanie Hanes | Stephanie Hanes, SUN STAFF
In what lawyers believe is the first case of its kind in Maryland, a Baltimore County jury ordered the Rite Aid Corp. yesterday to pay $250,000 to a woman who said she became permanently disabled after following incorrect advice on an information pamphlet enclosed with her Lyme disease antibiotic.
Although Baltimore County Circuit Judge John F. Fader II will review many of the lawsuit's complex legal issues at a hearing in August, and although the case will likely go on from there to the Court of Appeals, yesterday's verdict is at least a short-term victory for Ellen Levy Gray, 42, of Owings Mills, a former star athlete who now strains to play with her 3- and 5-year-old children.
"At least there's a monetary value on it," Levy Gray said yesterday. "It's not going to give me two years back. But it's something I can give to my kids."
In October 2000, an infectious disease specialist diagnosed Levy Gray with acute Lyme disease and prescribed her the antibiotic Doxycycline, a drug also used to treat anthrax and syphilis.
Levy Gray filled the prescription at the Rite Aid pharmacy on Tullamore Road in Timonium. Along with the antibiotic, the pharmacy gave Levy Gray patient information literature called a "Rite Advice" pamphlet.
That pamphlet advised Levy Gray to "take with food or milk if stomach upset occurs unless a doctor directs you otherwise," according to court papers. She followed the advice.
It was only after her symptoms persisted - muscle soreness and weakness, nausea, headaches and fatigue - that she spoke to her brother, a doctor, about how she was taking the drug with milk. He was shocked, she said, and told her to stop. Milk, he said, was known to inhibit the effects of Doxycycline.
According to Levy Gray's complaint, she went back to the Rite Aid and spoke with two pharmacists there. The two pharmacists, she said, explained "exactly how milk interferes with the bodily absorption of Doxycycline," agreed that the pamphlet was incorrect and said it should be changed.
But by that time, according to Levy Gray and medical experts who testified on her behalf, long-term damage had been done.
"Much like anthrax, in acute Lyme disease there is a `window' where, to effectively counteract the effects of the disease, the antibiotic must be taken," Levy Gray's attorney Lloyd Byron Hopkins wrote in one motion. "When one falls outside this window, death results in anthrax [cases] and disability and relapsing Lyme disease results with acute Lyme disease."
http://articles.baltimoresun.com/2003-05-30/news/0305300377_1_lyme-levy-antibiotic
Product Safety & Liability Reporter
Volume: 33 Number: 24
June 20, 2005
Pharmacy Created Express Warranty Through Information Pamphlet, Court Says
A pharmacy's information pamphlet expressly warranted that the antibiotic doxycycline could be taken safely with milk, even though calcium lowers the drug's absorption rate, a Maryland appeals court held June 3 (Rite Aid Corp. v. Levy-Gray, Md. Ct. Spec. App., No. 0133, September Term 2004, 6/3/05).
The Maryland Court of Special Appeals upheld a $250,000 verdict to a woman who developed complications of Lyme disease because her diet, high in dairy products, interfered with the effectiveness of the doxycycline.
The court also said the plaintiff presented reliable expert medical testimony addressing the causal link between her diet, the compromised treatment, and her condition.
Ellen Levy-Gray consulted her physician in October 2000 after suffering pain and fever for a week. Dr. Christine Bell-Lafferman referred Levy-Gray to Dr. Ronald W. Geckler, an infectious disease specialist, after blood tests were positive for Lyme Disease. Gecker confirmed the Lyme diagnosis and prescribed doxycycline, an antibiotic in the tetracycline family.
According to the opinion, Geckler did not provide Levy-Gray with any prescribing information other than dose and frequency, explaining that he relied on pharmacies to provide specific information on the characteristics of prescription medications.
Levy-Gray filled her prescription at Rite Aid Pharmacy #4465, in Timonium, Md. Along with her prescription, the plaintiff received from Rite-Aid a "patient package insert," (PPI) entitled "Rite ADVICE." The cover page of the pamphlet informed patients that "Inside is everything you need to know about your prescription. It covers everything from dosage to side effects."
Additionally, the inside of the pamphlet stated, in part, "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 2-3 hours of taking this medication. These products bind with the medicine preventing its absorption."
Levy-Gray testified she consumed a diet high in dairy products because she was nursing a baby and because she was experiencing an upset stomach from the medication. Her Lyme symptoms did not improve with treatment, and in November 2000, she spoke with her brother, a urological oncologist in Seattle, Wash. Dr. David Levy told her that the calcium in dairy products impedes the absorption of the antibiotic.
According to the opinion, Levy-Gray returned to Bell-Lafferman, told her about the milk issue, and received a prescription refill. The plaintiff's condition began to improve several days after she stopped using milk products. However, Levy-Gray's condition never fully returned to normal. She consulted with Dr. Charles A. Haile, a specialist who treats 30 to 40 Lyme disease patients each year. Haile determined that Levy-Gray was suffering from post-Lyme syndrome, a chronic autoimmune response in which patients experience symptoms that can mimic Lyme disease even in the absence of active infection.
Levy-Gray sued Rite Aid. She asserted that her ingestion of dairy products reduced the absorption of the doxycycline, preventing it from operating as effectively as it otherwise would have and proximately causing her post-Lyme syndrome. The trial court permitted the case to go to the jury on two theories, negligence and breach of express warranty. The jury found for Levy-Gray on the warranty claim and found for Rite-Aid on the negligence claim. Cross-appeals were filed.
Rite Aid argued the law does not recognize a cause of action against pharmacists for breach of express warranty, and contended the Rite Aid patient brochure made no promise concerning the performance of doxycycline and was not part of the basis of the bargain between the parties.
Rite Aid's argument is an offshoot of the learned intermediary principle, which holds that a drug manufacturer has a duty to warn physicians about the health effects of prescription medications. Because patients rely on physicians to impart health information regarding prescription drugs, there can be no express warranty from a pharmacist, Rite Aid argued.
But in this case, the court said, "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 court said, "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 PPI."
Whether the Rite ADVICE pamphlet contains an express warranty under Maryland CL Section 2-313 is a much closer question on which there is a dearth of authority, the court said. The statute requires "an affirmative statement of fact by the seller about the goods."
Rite Aid, drawing on cases in which manufacturers were claimed to have made an express warranty, contended that "there must be a promise concerning the performance or safety of the drug involved."
In this case, the express warranty rests on the statement: "Take [doxycycline] with food or milk if stomach upset occurs unless your doctor directs you otherwise." This statement, the court said, is sufficient for a jury reasonably to conclude that Rite Aid represented to the plaintiff that a characteristic or quality of doxycycline was that it was compatible with food or milk.
But the closest the Rite ADVICE pamphlet comes to the characteristic of absorption is the sentence that instructed patients to avoid taking antacids that contained calcium and several other minerals. Reasonable persons certainly could read this sentence as limited to over-the-counter or prescription antacids, including those with calcium, the court said.
It is true that the Rite ADVICE pamphlet states in bold type that "it should not be construed to indicate that use of the drug is safe, appropriate, or effective for you." But this statement must be read in the context of the Rite ADVICE pamphlet as a whole, the court said. "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.
"Whether the disclaimer took the statement of the compatibility characteristic of doxycycline out of the bargain was a question of fact for the jury," the opinion said.
Rite Aid also argued that an express warranty finding rests on the requirement that the affirmation of fact become part of the basis of the bargain. But the court rejected the defendant's contention that there could be no warranty because the plaintiff received the pamphlet after she purchased the drug. "It proves too much, to apply to written warranties a requirement of pre-sale knowledge by the buyer of the affirmation of fact," the court said.
The court also said Levy-Gray's expert testimony on causation was sufficient. Dr. Neil A. Crane, board-certified in internal medicine and infectious diseases, treated two or three cases of Lyme disease annually, for which he prescribed doxycycline. He advised his patients "to avoid food altogether, take it with water, but especially avoid calcium-containing wafers such as antacids … and dairy products that contain calcium."
Based on records from Haile and Bell-Lafferman, Crane reached the conclusion that "milk and dairy products interfered with [Plaintiff's] therapy." He explained that Levy-Gray was cured of Lyme disease, but then had post-infectious complications, which generally does not happen with proper treatment. Records also indicated she began to improve after she stopped using milk products.
Bell-Lafferman, in addition to practicing internal medicine, holds a graduate degree in clinical pharmacology, the court said. She sees some five Lyme disease patients a month. Bell-Lafferman agreed that patients taking doxycycline should avoid dairy products. Based on general knowledge of the tetracycline family of antibiotics and on Levy-Gray's course of treatment, Bell-Lafferman agreed that the plaintiff's post-Lyme disease symptoms resulted from decreased absorption caused by the ingestion of milk products.
Bell-Lafferman explained, "Temporally that shows me medically that she had a decreased effect of the drug before she stopped taking it with milk. We frequently judge efficacy of those kinds of things."
Crane's and Bell-Lafferman's testimony rested on a sufficiently sound basis to be admissible, the court concluded.
The court also rejected Rite-Aid's preemption argument, citing many decisions holding that FDA approval of a prescription drug does not preempt claims against the manufacturer. It is only logical that "approval does not preempt state law claims based on a PPI which a pharmacy, unregulated by the FDA, chooses to cause to be produced and to distribute to customers at the point of sale," the opinion said.
Because of its ruling in the plaintiff's favor on Rite-Aid's cross-appeal, the court did not rule on her cross-appeal.
Retired Judge Lawrence F. Rodowsky wrote the opinion.
Craig Franco of Odin, Feldman & Pittleman in Fairfax, Va., represented Levy-Gray.
Eric Lasker of Spriggs & Hollingsworth in Washington, D.C., represented Rite Aid.
Full article: Click here