Today is John Winston Lennon’s birthday. He would have turned 79 on this date but for a truly crazed assassin. Imagine stalking someone because of Catcher in the Rye! Lennon wrote many marvelous songs (we especially like his early stuff, such as “Hard Day’s Night,” “If I Fell,” and “Help”). But since this is the Drug and Device Law blog, it feels almost obligatory to supply a list of Lennon’s top ten drug songs. Here they are (feel free to send us your own lists):
1. Dr. Robert
2. Tomorrow Never Knows
3. She Said She Said
4. Day Tripper
5. Lucy In the Sky with Diamonds
6. A Day in the Life
7. Everybody’s Got Something to Hide Except Me and My Monkey
8. Happiness is a Warm Gun
9. Cold Turkey
10. #9 Dream
(Bexis is lobbying to include “With a Little Help from My Friends.”)
And thus we have discharged our duty.
Speaking of duty and speaking of drugs, let’s take a look at Franklin v. Wal-Mart, Inc., 2019 WL 2744624 (D. Md. July 1, 2019), where the plaintiff sued a pharmacist and the pharmacist’s employers because the pharmacists failed to obtain her informed consent to the use of hydrochlorothiazide by not warning her of the risks associated with taking it and lithium at the same time. The result of this failure, according to the plaintiff, was that she ended up suffering from lithium toxicity and pancreatitis. As part of her claim against the pharmacist, the plaintiff alleged that the pharmaceutical warnings for hydrochlorothiazide include that it should not be taken in combination with lithium due to the combination causing increased lithium levels. She also alleged that the warnings indicate that patients should be closely monitored for toxicities if the two medications are administered together.
The defendants moved to dismiss the claims because pharmacists, unlike doctors, have no duty to obtain informed consent. Maryland law controlled, and Maryland law said that the defendants were right.
Specifically, the Franklin case turned on the language of the Maryland Pharmacy Act, which provides that “pharmaceutical care” “may include patient counseling and providing information to licensed and certified health care providers.” That “may” is permissive, as opposed to mandatory, language. It does not create an obligation to provide patient counseling. (Note this theme. It comes up frequently in this case.)
The plaintiff also relied on the definition of “practice pharmacy,” which includes, inter alia, the following activities:
(iv) Monitoring prescriptions for prescription and nonprescription drugs or devices;
(v) Providing information, explanation, or recommendations to patients and health care practitioners about the safe and effective use of prescription or nonprescription drugs or devices; or
(vi) Identifying and appraising problems concerning the use or monitoring of therapy with drugs or devices.
The Franklin court reasoned that “to engage in an activity, however, does not mean that one is required to do so.”
The plaintiff also argued that “because pharmacists, like physicians, must be licensed, pass an exam, and maintain continuing education requirements, the doctrine of informed consent should apply to them.” The problem with that argument is that licensure and continuing education requirements “are common to many professions” and it seems a bit much to leap from those general requirements to the imposition of a duty on pharmacists to obtain informed consent. (Phew! For a moment there, we were wondering whether we, as mere hack attorneys who somehow passed the bar and now pay outrageous amounts for continuing legal education, are on the hook for informed consent.)
The plaintiff was still not out of arguments. Under Maryland law, pharmacists may refuse to fill a prescription based on their professional judgment. But that “authorization is inapposite to the situation here where the pharmacist did fill the patient’s prescription.” The plaintiff next referred to the section of the Maryland Pharmacy Act stating that “only a licensed pharmacist…may provide information to the public or a health care practitioner concerning prescription or nonprescription drugs or devices including information as to their therapeutic values, potential side effects, and use in the treatment and prevention of diseases.” But this is another instance where the word “may” connotes permissive authority rather than mandatory action. The court held that pharmacists “are thus not required to provide information about potential side effects pursuant to this section.”
Similarly, the Maryland Pharmacy Act, contains another may-not-must when it says that pharmacists shall offer to discuss “any matter which, in the exercise of the pharmacist’s professional judgment, the pharmacist deems significant,” and such matters “may include…[c]ommon severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur.” But as the Franklin court held, “an offer to discuss and a duty to inform are two distinct obligations. Moreover, the passive means through which pharmacists can satisfy their duty pursuant to Section 12-507(b) stand in stark contrast to what is required of physicians to obtain informed consent.”
The Franklin case was in federal court. No Maryland court had been presented with this precise same issue. There were cases discussing a physician’s duty to obtain informed consent, and even one rejecting an argument that a “pharmacist is per se unqualified to testify in an informed consent action when a physician has been sued.” But no Maryland case has ever come close to holding that pharmacists have a duty to obtain informed consent. Rather, Maryland courts have imposed such a duty on “health care providers.” Guess what? Pharmacists are not included in the statutory definition of “health care providers.” Accordingly, the federal court in Franklin held “that pharmacists are under no obligation to secure informed consent.”