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Sloppy Prescribing and “Unlearned Intermediary” Law

Posted on | December 8, 2016 | No Comments

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Mike Magee

The term “learned intermediary” is a legal term, first used in 1966, and defined by the Fifth Circuit Court as follows: “Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect.  As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient.  His is the task of weighing the benefits of any medication against its potential dangers.  The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.  Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a ‘learned intermediary’ between manufacturer and consumer.”

Grounding for this definition of responsibility, and potential liability, is the fact that consumers are unable to purchase prescription drugs without a physician encounter and physician consent to prescribe. Over the past half century, physicians have jealously guarded the near exclusive privilege of prescribing, more than willing to accept liability in return for market power. In short, patients want drugs, and in order to get them, they must pay for an office visit.

But this is not 1966. For one thing, in 1985, the FDA opened a crack in the door to allow pharmaceutical companies to market products directly to consumers through Direct-To-Consumer (DTC) advertising. The law was further liberalized in 1997, and drug company ads are now ubiquitous on television and the Internet, providing for medicalization of normal behavior and a constant “consumer push” to the doctor’s office.

The consumers have grown up as well, with study after study showing they are doing their own primary research from diagnosis through therapeutics, and increasingly double-checking physician recommendations rather than reflexly “following orders”.

And then there is the physician, whose “sloppy prescribing” for drugs like Oxycontin, with huckster prodding by bought and paid for “pain is the 5th vital sign” thought leaders, has managed to reverse the survival curve for Americans for the first time in 100 years. But it’s not just opioids. A 2016 report in JAMA of 58 Emergency Departments across the US identified nearly 43,000 cases of adverse drug reactions between 2013 and 2014. Over a quarter of the cases required hospitalization, with those over 65 requiring admission 43.6% of the time. For elders, anticoagulants, antibiotics, and diabetes medications were the major offenders, along with opioids.

Transparent databases are rapidly revealing that, in many cases, the physician’s prescribing habits reveal an “unlearned intermediary”. But it would be a mistake to single this group out either on the basis of ignorance, naivete, poor judgement, or carelessness. The truth is physicians are a relatively easy mark for the pharmaceutical industry, especially when the industry is enabled by paid academic physician “thought leaders”, and when AMA endorsed “specialty societies” which, once they gain Federation status without any rigorous quality control levers, are able to generate publications and CME activities as marketing arms of their industry benefactors.

One would think that, with the Purdue Pharma man-made opioid epidemic, the AMA and others would have gotten the message that, by allowing their “learned intermediaries” to become increasingly compromised, they are putting their prescribing franchise, and physicians future earning power, at risk. They have endorsed the stop gap measure of requiring physicians to check state prescribing databases before writing for opioids. But the prescribing problem is much bigger than opioids. There is no indication of increasing oversight, caution, or correction of the collusive behaviors of the Medical Industrial Complex, of which the AMA is a major marketing pillar.

Rather, the organization has focused on medicalizing “opioid addiction”, which is indeed compassionate for these victims, but does little to get to the heart of the problem. The drug industry is similarly unrepentant, instead doubling down on the sale of buprenorphine and naloxone here, there, and everywhere, and creating a new treatable disease entity, opioid induced constipation or OID. The creation of “new markets” and the selling into them is deliberate, insidious, and escalates day by day. Consumers addiction to poly-pharmacy is now firmly established in the culture, and physicians are historically compliant.

Leaders at the AMA should by now be able to read the tea leaves. Way back in 1999, in Perez v. Wyeth Laboratories, Inc, in a case involving the “learned intermediary” shield of liability on Norplant implants gone bad, (a product heavily DTC marketed), the New Jersey Supreme Court ruled that the companies aggressive marketing to consumers “alters the calculus of the learned intermediary doctrine.”

A Harvard Law expert characterized the result this way:

“The 5-2 majority relied on a novel understanding of the learned intermediary rule to justify its exception. It suggested that since the learned intermediary rule was announced in a Norman Rockwell setting where physicians still made house calls, the shift to managed care had rendered the rule less appropriate.[2] The majority also employed great creativity in locating the so-called premises of the learned intermediary doctrine in: (1) a reluctance to undermine the doctor-patient relationship; (2) an absence in the era of “doctor knows best” of the need for the patient’s informed consent; (3) the inability of the drug manufacturer to communicate with patients; and (4) the complexity of the subject.[3] This unique characterization of the rule enabled the majority to declare these four premises invalid in the context of DTC advertising and therefore to find the learned intermediary rule inapplicable in this context.”

But, of course, this is a two way street with potential bad outcomes for the House of Medicine. 1) “Unlearned intermediaries”, if they persist in this age of consumer empowerment and discoverable databases, will be increasingly vulnerable to liability. 2) The growing discovery that physicians, as a result of sloppy prescribing may be labeled “unlearned”, may well ignite expansion of the scope of practice of non-physician health professionals.

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