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.
Plaintiff Receives Drug Pamphlet. 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.
Plaintiff Sues Rite Aid. 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.
Doctor, Patient Both Rely on Pharmacy. 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."
Representation of Drug's Compatibility With Milk. 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.
Expert Causation Testimony Sufficient. 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.
lymednva
Frequent Contributor (1K+ posts)
Member # 9098
posted
This is great!
quote: post-Lyme syndrome, a chronic autoimmune response in which patients experience symptoms that can mimic Lyme disease even in the absence of active infection.
-------------------- Lymednva Posts: 2407 | From over the river and through the woods | Registered: Apr 2006
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lymebytes
Frequent Contributor (1K+ posts)
Member # 11830
posted
Ok...does post lyme syndrome exist or not? Basically this proves she won her case on a bogus diagnosis called Post Lyme Syndrome!
The illiteracy of the IDSA stating that Lyme bacteria dies within a few weeks of antibiotic treatment and any remaining symptoms are "post lyme syndrome" isn't even true, so Rite Aid paid the price.
As we know LLMD's say to stay on antibiotics until symptom-free and I have never heard any of them even mention this autoimmune response or disorder called Post lyme syndrome.
The truth is really Doxy with milk or not, she very likely would have not have responded to the medication anyway and been "cured" even if she has taken it correctly.
I am sure many here have taken Doxy correctly and here we are still in treatment months/years later. So the question this brings up, do we have post lyme sydrome, does it really exist?
You think that if someone who was lyme literate had spoken in the case she would have lost, arguing that Doxy taken correctly was no guarantee of a resolving the disease for her anyway, that lyme disease can be become chronic and Doxy is not always the answer.
She really lucked out that this world is so illiterate to this disease and that apparently no one brought up that if she now continues with long term antibiotic treatment her "post lyme syndrome" can resolve.
Amazing- any I can't find a lawyer willing to take my case!
Boomerang
Frequent Contributor (1K+ posts)
Member # 7979
posted
Well, isn't that interesting? Wish we had an old doxy bottle I could check.
Posts: 1366 | From Southeast | Registered: Sep 2005
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Geneal
Frequent Contributor (5K+ posts)
Member # 10375
posted
Great article.
Wonder why a nursing mom would take doxy anyways....
Couldn't it pass through the breast milk and discolor baby's teeth?
Hugs,
Geneal
Posts: 6250 | From Louisiana | Registered: Oct 2006
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groovy2
Frequent Contributor (1K+ posts)
Member # 6304
posted
Hi All
Dairy makes Doxi perty much useless --
For the first 3 months that I took Doxi I was taking with yogurt --OuCh -
I figured it out from reading not to take doxi with calcium--
Dairy --Has lots of calcium in it --
Once I quit eating Dairy the doxi worked Much Better--
It dose not surprise me that you got miss labeled meds--
Over the last 4 years I only found one pharmacy that dose a Good Job here in Austin
All the others Screw Up my order over half the time --
The Good pharmacy is Very Well run- and is Also Cheaper by over 50% the price of the others --
Take care--Jay--
Posts: 2999 | From Austin tx USA | Registered: Oct 2004
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Tincup
Honored Contributor (10K+ posts)
Member # 5829
posted
Yes.. the case has a number of flaws. But in Maryland they are SOOOOOOOOO Lyme illiterate that his can easily happen.
As Lymebytes said.. "The truth is really Doxy with milk or not, she very likely would have not have responded to the medication anyway and been "cured" even if she has taken it correctly."
You are absolutely right.
The IDSA, drug companies and insurance companies can't have it BOTH ways. They can't testify that she would NOT have been cured anyway... as this would go against their theory that Lyme IS cured easily with short term treatment. If they did they would blow it for all other cases against us!
So they had to suck it up and pay. You can see they have fought this case against her for a LONG while and the lady has gotten nothing to date. Maybe now she will?
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G....
My understanding is that it shouldn't be used.. however.. I think they do?
Another one of those "debatable" things associated with Lyme.
posted
So, I realized I've been taking Doxy with dairy.
I take it with meals & for breakfast i usually eat bagel w/ butter, egg & cheese,. Wash it down with coffee & cream.
People on Doxy - are you cutting out dairy entirely, or just not eating it within 2 hours of taking abx?
Does Tasti D-Lite count as dairy? Posts: 32 | From New York, NY | Registered: Jun 2007
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charlie
Frequent Contributor (1K+ posts)
Member # 25
posted
2 hrs away is fine...but I guess I just thought everybody knew no dairy or metals with doxy....no metals also means besides supplements, no baking soda or pepto bismol.
If taking tetracycline it's even worse....all of the above plus empty stomach for 2 hours before...this is why tetra often doesn't work IMO, how can you even plan for that 3 or 4 times a day?
Charlie
Posts: 2804 | From Texas | Registered: Oct 2000
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mojo
Frequent Contributor (1K+ posts)
Member # 9309
posted
When I got my Doxy last year from CVS it said OK to take with food or milk if stomach upset. I learned on the Lyme Boards to space dairy 2 hours.
I did some research on it and the makers of Doxy (can't remember who?) determined that in only interfered with the Doxy's effectiveness by 22% (22%!!!) so they felt the warning wasn't necessary. duh Going on memory but this was so upsetting that even after a year I feel I remember this pretty well.
Posts: 1761 | From USA | Registered: May 2006
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posted
I found that article pretty amazing-Dr Lafferman was my doctor-the one that told me I didn't have lyme-I came in with the tick the day after my bite. Now, a year later I am still on the boards
Posts: 561 | From eastcoast | Registered: Aug 2006
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Keebler
Honored Contributor (25K+ posts)
Member # 12673
posted
don't some vegetables also contain calcium . . . ?
I don't eat dairy and rely on green leafy stuff for it.
Too bad about the "post lyme syndrome label" as it may prevent her from further treatment. "Syndrome" sounds not so bad and partly like it's a behavior thing but mostly like it's just the way it is.
that article is TWO years old, and doxy still says to take with milk ??
I wonder what kind of treatment she's gotten over time and how she is doing today.
Posts: 48021 | From Tree House | Registered: Jul 2007
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Cobweb
Unregistered
posted
Kudos to my LLMD for not relying on second hand info from pharmacist by instructing me directly NOT to do dairy and doxy.
I think prescribing doc holds some responsibility in this.
My old Doxy bottle-not from Rite Aid-says to take it with crackers or piece of bread if stomach is upset and plenty of water. No mention of milk either way.
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