United States: Should The Learned Intermediary Rule Apply To Prescription Marijuana?

Last Updated: June 18 2019
Article by James Beck

This year's annual DRI Drug & Medical Device Seminar marked a milestone of sorts, with a separate section on medical marijuana being offered for the first time. Regrettably, no free samples were on offer, although since the seminar was in Washington, DC it would have been perfectly legal (at least in terms of DC law) to augment the usual conference swag.

According to a source that appears to be accurate and unbiased, currently 33 states and DC have legalized the prescription of marijuana for medical purposes, and those states have well more than enough electoral votes to win a presidential election. This got us to thinking. Sooner or later somebody is going to sue some producer of medical pot alleging that some harmful effect caused by this "prescription drug" caused some sort of injury. What that injury might be, we have no idea. It's not addictive, and there is practically zero chance of overdose. But plaintiffs sue drug companies all the time, even if they haven't actually used the defendant's product. We call that "multidistrict litigation." So eventually we think it's inevitable that pot product liability will happen.

Which leads us to the question posed by this post: should the learned intermediary rule apply to marijuana when sold as a prescription drug?

We start with the purposes of the learned intermediary rule. Bexis' book, at §2.03[1] does as good a job as any at identifying them:

  • Warnings for prescription drugs are intended for the physician, whose duty it is to balance the risks against the benefits of various drugs and treatments and to prescribe them and supervise their effects.
  • The learned intermediary rule also ensures that product liability law respects the restricted distribution system imposed by federal law, under which prescription medical products may be obtained legally only through a prescribing physician.
  • Requiring that language used in prescription drug labeling be tailored to a lay audience, rather than learned intermediary physicians, would result in a loss of the clarity and precision needed to effectively communicate to practitioners. Patients are usually unable to evaluate the kind of technical information that doctors use to make prescription decisions.
  • The learned intermediary rule recognizes that physicians, not patients, make most prescription decisions in the context of a physician/patient relationship, so the rule preserves the physician/patient relationship from disruption by tort duties.
  • The medical decision to prescribe a particular product for a particular patient is individualized and requires an understanding of both the product being prescribed and the patient's medical history. Thus physicians are in the best position to exercise independent medical judgment that weighs the relative risks and benefits of prescription medical products, and then to explain those decisions to their patients.
  • In many instances manufacturers would find it impractical, or even impossible, to provide direct warnings to patients whose identities are unknown to them.

Id. at at pp. 2.03-1 to -14 & nn. 4-23.

Any discussion of the applicability of the learned intermediary rule to prescription pot must consider the extent to which these reasons – collectively sufficient to convince just about every court in the country in the context of ordinary prescription medical products – are applicable to medical marijuana.

The key difference, at least at the present time, is that medical marijuana is authorized only by the laws of the various states that have legalized it, and is not regulated by the FDA. The FDA's position is succinct, "The FDA has not approved marijuana as a safe and effective drug for any indication." As for state-licensed prescription pot:

The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards.

FDA, "FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers," available here. Perhaps at some point in the future, the FDA's role will change, but for present purposes we're considering only existing regulatory scheme, which is based entirely on state law.

The absence of the FDA has several implications for the learned intermediary rule. It immediately eliminates one of the rationales for the rule – conformance of the common law to the federally organized distribution system for prescription drugs – but that is probably the least salient issue. After all, if the states that have legalized prescription pot require a physician's prescription before anyone may acquire it, then the argument remains the same, simply with "state" replacing "federal."

The more important aspect of the FDA's absence from the equation has to do with what we consider the heart of the learned intermediary rule – that the intended audience for the warnings and most other information accompanying a prescription medical product consists of physicians and other professional health care providers. Given the professional level of the audience to which prescription medical product warnings are directed, they necessarily contain technical explanations that lay people would (at best) have trouble deciphering.

Well, what about prescription pot? What kind of warnings come with it? For us, that's the $64K question when it comes to the learned intermediary rule. If the states don't require a scientifically rigorous package insert for medical marijuana, then the learned intermediary rule is unlikely to apply. There would be no need for an intermediary, learned or otherwise, in that situation. So it comes down to what individual states actually require. There certainly could be warnings – we think, anyway – since we found this article, "Expert-Recommended Warnings for Medical Marijuana," online (though we didn't spend the $43 they wanted to buy it). There's another decent set of warnings at rxlist. However, we've seen no indication that any state requires warnings like this for their medical marijuana.

We Googled "warnings on medical marijuana" to get a feel for what warnings are actually given and came across statements like this: "[T]here are significant health risks associated with using cannabis and cannabinoids[, y]et none of the 33 states that have legalized medical marijuana, or the 10 states that have legalized recreational use, gives adequate warnings of those risks." Or this: "state politicians have given in to populism and the weed industry by ignoring science and allowing the sale of marijuana products with only the weakest of warning labels." Indeed, you can buy rolls of prescription pot "warning labels" on Amazon, with none of them being more than one paragraph long. That appears to be because most state-required warnings are minimal. In Pennsylvania, for example:

(c) The dispensary shall inspect the label to ensure that the label:

* * * *

(5) Contains the following warning stating:

This product is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except on the advice of the practitioner who issued the certification and, in the case of breastfeeding, the infant's pediatrician. This product might impair the ability to drive or operate heavy machinery. Keep out of reach of children.

28 Pa. C.S.A. §1161.28. Other states mandate even less. See 8 Ill. Admin. C. §1000.420.

Another thing to consider in the learned intermediary rule context is the so-called "mass immunization" exception. See Bexis' book, at §2.03[3][b]. While created in response to the mass polio vaccinations of the 1960s, it extends beyond that precise set of facts. The Third Restatement requires, for the rule to apply, that there be "prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings." Restatement (Third) of Torts, Products Liability §6(d)(2).

Subsection (d)(2) recognizes that direct warnings and instructions to patients are warranted for drugs that are dispensed or administered to patients without the personal intervention or evaluation of a health-care provider. . . . When a manufacturer supplies prescription drugs for distribution to patients in this type of unsupervised environment, if a direct warning to patients is feasible and can be effective, the law requires measures to that effect.

Id., comment e. Thus, another criterion to consider is how a particular patient was actually prescribed purportedly harmful marijuana. Was the patient actually seen by a doctor? If so, what was the quality of their interaction? When a patient can obtain prescription pot "in a matter of minutes," as is apparently the case in California, then the chances of the manufacturer of the weed being able to rely on the learned intermediary rule goes down substantially.

Based on what we've seen to date, we don't think that it is likely that the learned intermediary rule will apply to medical marijuana, at least as long as the only product warnings appear to be directed primarily to consumers rather than health care providers. Further, where prescriptions are given out like candy (or, at least like Alice B. Toklas brownies) then the Restatement §6(d)(2) exception to the rule is likely to apply.

That is as it should be. The learned intermediary rule is for bona fide prescription medical products. Unless and until medical marijuana is treated – and labeled − as such, the rule doesn't apply. Further, attempts to assert it in the context of medical marijuana would probably do harm to the rule's current wide acceptance.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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