AuthorLamparelli, Rachel

CONTENTS INTRODUCTION II. LEARNED INTERMEDIARY DOCTRINE A. Liability Under the Learned Intermediary Doctrine B. Exceptions to the Learned Intermediary Doctrine III. DIRECT-TO-CONSUMER MARKETING A. FDA Regulation of Direct-to-Consumer Marketing B. The Effect of Direct-to-Consumer Marketing on Application of the Learned Intermediary Doctrine IV. OFF-LABEL DRUG USE AND PROMOTION A. FDA Regulation of Off-Label Use 1. FDA Label Approval Process 2. FDA Regulations on the Promotion of Off-Label Uses B. Reasonable Innovation Rule V. RECOMMENDATION A. Patient Registries in the Physician-Patient Relationship B. Patient Registries and the FDA CONCLUSION INTRODUCTION

In June of 2014, James McLeod went to the doctor seeking treatment for his non-life-threatening atrial fibrillation ("AFib") and was prescribed amiodarone tablets. (1) After over a year of treatments, McLeod noticed that he had not only failed to see any improvements in his condition, but instead felt that his symptoms were worsening. (2) He began to feel a shortness of breath, wheezing, and coughing among other physical ailments until he was eventually admitted to a local hospital in March of 2015. (3) It was then that he discovered that his physical condition had deteriorated so drastically due to amiodarone toxicity. (4) After being prescribe amiodarone just two years prior, McLeod developed Chronic Obstructive Pulmonary Disease, known as COPD. (5)

McLeod subsequently discovered that his prescription was for an "off-label" use of amiodarone. (6) In the everyday practice of medicine, physicians are tasked with treating a diverse body of patients. Typically, physicians can follow standard treatment protocols because they are treating the average patient with a given condition. But physicians may also be faced with patients who have unique needs that cannot be treated with ordinary methods. In these circumstances, physicians must use their expertise and discretion to innovatively develop treatment plans for the unique needs of their patients. Often, physicians will do so by prescribing a drug for an off-label use. (7)

When the Food and Drug Administration ("FDA") reviews new drugs for market approval, it only grants approval based on "label" uses, which are specific uses for certain patient populations (among other criteria). (8) When a physician prescribes a drug for an off-label use, the physician is still prescribing an FDA-approved drug, only the FDA did not approve the drug for that specific use. (9) As such, the drug did not go through efficacy trials for the off-label use as it would for an approved, label use, and its prescription does not include information about side effects and risks. (10) As in McLeod's case, physicians often do not tell their patients that they prescribed the drug for an off-label use, partly because off-label drug use is common. (11) It is estimated that as many as one in five prescriptions are for an "off-label" use of a drug. (12)

Here, McLeod's doctors prescribed amiodarone, the generic version of Cordarone. Cordarone is manufactured and distributed by Wyeth as a first line of therapy for ventricular fibrillation. (13) Since amiodarone is the generic version of a brand-name drug, the FDA requires that the label is identical to the label of its brand equivalent. (14) This means that the generic drug manufacturer can only provide label information (e.g., a description of the drug, warnings, adverse side effects) that is consistent with its brand equivalent. (15) Additionally, the label can include only the FDA-approved uses of the drug. (16) Therefore, the brand drug company is prohibited from advertising or distributing information (including risks) about an off-label use of a drug and as a result the generic equivalent is effectively restricted from distributing warnings about any off-label uses.

In this case, the manufacturer of the brand drug, Wyeth, received FDA approval only for Cordarone's use "as a drug of 'last resort' for patients suffering from documented recurrent life-threatening ventricular fibrillation and ventricular tachycardia." (17) But Wyeth used a promotional campaign to market the off-label use of Cordaone as a first line of therapy for anti-arrhythmic benefits. (18) This off-label promotion is how McLeod came to be prescribed amiodarone since, when he first sought treatment, he was able to manage his AFib and did not need amiodarone for the label use of last-resort medical treatment. (19) Instead, McLeod's prescription of amiodarone was for the off-label use as a first line of therapy. (20) As a result of his injuries from the off-label use, McLeod sued the manufacturer of amiodarone for allegedly causing him to develop COPD. (21)

Despite his injuries, McLeod and others similarly situated face an uphill battle when litigating against pharmaceutical manufacturers. Across the country, plaintiffs struggle to hold drug manufacturers liable for injuries either caused by the manufacturer's promotion of a drug for an off-label use or deceptive marketing practices that misled consumers about the risks inherent to the drug. (22) In part, this is because of the learned intermediary doctrine, a decades-old legal doctrine that helps shield drug manufacturers from liability. (23)

The potential holes in liability created by the learned intermediary doctrine illustrate a larger issue in physician prescribing practices for off-label uses. Namely, that physicians are not held accountable for collecting patient data when they use reasonable innovation and prescribe a treatment off-label. (24) This absence of data has multiple implications. First, if the patient suffers an adverse outcome from using the drug off-label, the physician has no risk data that could help the patient substantiate a case against the prescription drug manufacturer. Relatedly, since manufacturers do not have their own risk data for off-label uses available because of FDA requirements, they can escape liability by claiming they had no knowledge of the risks involved. (25) Further, when physicians prescribe a drug off-label for all of their patients with a certain condition without registering with an Institutional Review Board ("IRB") and tracking the results, they are engaged in illegal human experimentation. (26)

To better protect patients, physicians should have access to a coordinated system of data collection for off-label prescriptions. If physicians are going to be prescribing off-label anyway, the best practice is to track information throughout the process. This data collection can be executed by implementing patient registries. To use patient registries, physicians must obtain the patient's informed consent, both to the off-label treatment and to submitting the patient's health information to the registry. This registry can then alert physicians of trends in adverse patient outcomes, which the physicians can then timely disclose to their patients. The registry can also send this patient data to the FDA for label change considerations. Further, the increased reliance on patient registries will diminish a drug manufacturer's ability to circumvent FDA regulations by claiming the risk information was not knowable because the registries are collecting it for them.

This Note will first address the regulatory and legal doctrines at play when a plaintiff attempts to recover from injuries caused by a prescription drug manufacturer: Part II examines the learned intermediary doctrine, Part III considers direct-to-consumer marketing, and Part IV reviews "off-label" drug promotion. In Part V, this Note recommends implementing patient registries whenever physicians are prescribing a drug off-label. The data collected by patient registries can protect patients without disrupting or adding an exception to the learned intermediary doctrine.


    Under the regime for defective products liability, the Restatement (Third) of Torts outlines the potential liability for harm caused by prescription drug manufacturers. "A manufacturer of a prescription drug ... who sells or otherwise distributes a defective drug ... is subject to liability for harm to persons caused by the defect. A prescription drug ... is one that may be legally sold or otherwise distributed only pursuant to a health-care provider's prescription." (27) A prescription drug manufacturer can avoid liability by invoking the learned intermediary doctrine ("LID"). According to the LID, if a manufacturer communicates the risks of a drug to the prescribing physician, then the manufacturer has no duty to warn the patient directly. (28) The healthcare provider is then considered a "learned intermediary" between the manufacturer and the consumer. (29)

    1. Liability Under the Learned Intermediary Doctrine

      The LID is based on the presumption that healthcare providers are the ones best suited to evaluate and weigh the attendant risks and benefits of a given drug for each individual patient. (30) This presumption thereby creates a duty for the healthcare provider to relay relevant information to the patient so the patient can make informed treatment decisions. (31) Through the LID, prescription drug manufacturers effectively discharge their duty to give warnings to the consumer by providing warnings to the healthcare provider. "A prescribing physician who has been adequately warned about a drug's risks breaks 'the causal link between the manufacturer and the plaintiff, thereby insulating the manufacturer from tort liability for harm caused by the drug.'" (32) If a manufacturer fulfills its duty to warn the prescribing physician, then the manufacturer has a strong defense against liability (33) because "[t]he learned intermediary doctrine precludes a tort plaintiff from recovering for any injuries sustained from use of the drug unless she can show that the warnings were inadequate as to prescribing physicians." (34)

      If a plaintiff can persuade a court that her injuries...

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