American Journal of Law & Medicine

A "Duty" to Continue Selling Medicines

With disappointing frequency, shortages occur in the supply of prescription pharmaceuticals. Sometimes, those shortages persist for months (even years), and can implicate the only known medicine to treat a life-threatening medical condition. Sometimes, those shortages may also be due to avoidably negligent decisions in manufacture. Twice in the past two years, seriously ill patients--confronting just such medicine supply shortages--have resorted to the courts, demanding a judicial remedy for negligently caused supply interruptions to critically needed medicines. In doing so, they have asserted a bold litigating position: the law ought to impose upon drug manufacturers a legal duty to continue selling their medicines. In other words, once a pharmaceutical manufacturer enters a medicine market, it is obligated by law to remain there and preserve perpetually its medicine's supply. This claim of compelled-access-to-pharmaceuticals pushes to the very frontier of drug law in America.

This Article begins by tracing the two cases (one in Utah, the other in Florida) that confronted these creative compelled-access-to-medicines arguments. Earlier cases, resolving a distinctive but thematically similar compelled-access argument in the context of experimental drugs, are introduced as well. The discussion explains how each claim lost in court. The Article next performs an independent survey of a wide range of legal theories--in constitutional principle, enacted law, regulatory law, and case law--that could be cited as alternative potential sources for imposing a duty on manufacturers to continue selling their drugs. It demonstrates that none is likely to be a credible source for that duty. Finally, the Article examines the competing policy considerations that would be implicated by "inventing " such a duty, finds that a judicial invention is unwise, but offers a potential statutory amendment designed to strike a sound balance between the legitimate proprietary and autonomy interests of manufacturers and the health and survival interests of critically ill patients.

I.   Introduction
II.  Alleging A "Duty" To Continue Selling Medicines
     A. Dr. Schubert and Continued Access to Fabrazyme
        1. Dr. Schubert's Story
        2. Mrs. Schubert's Claims
        3. Mrs. Schubert's Claim Is Rejected
     B. Ms. Lacognata and Continued Access to Aquasol A
        1. Jennifer Lacognata's Story
        2. The Lacognata Lawsuit and Ruling
     C. Clinical Trial Patients and Continued Access to Experimental
        Drugs
        1. The Experimental Drug Landscape
        2. The Experimental Drug Rulings
           a. Parkinson's Disease Patients
           b. Duchenne Muscular Dystrophy Patients
           c. Type 1 Myotonic Muscular Dystrophy Patients
           d. Asbestosis Patients
           e. Patients Suing FDA
III. Sources of a "Duty" To Continue Selling Medicines
     A. Current Federal Pharmaceutical Laws
     B. Substantive Due Process
     C. Conventional Products Liability Theory
     D. Contract, Quasi Contract, and Warranty Law
     E. Common Law Duty to Initiate a Rescue
     F. Common Law Duty to Continue a Rescue Once Initiated
     G. Common Law Duty to Avoid a Negligent Rescue
     H. Common Law Duty to Avoid Interfering With a Rescue
     I. Common Law Doctrines of "Necessity" and Self-Defense
     J. Sui Generis Tort
III. Inventing a "Duty" To Continue Selling Medicines
IV.  A Statutory Proposal for Enhanced Market
      INCENTIVIZATION OF ALTERNATE SOURCING
V.   Conclusion

I. INTRODUCTION

The Panic of 1983 reached its climax in late December. With the winter holiday season bearing ever closer, citizens across the Nation were overwrought. Long lines formed in the wee hours of the morning as the anxious braved the winter cold to queue up in the dark. Spontaneous telephone chains emerged, as neighbors called out to one another with gathered (or inferred) reconnaissance. The evening TV news broadcasted stories of brawls in the aisles and terror in the parking lots. Fistfights and hoarding were commonplace. The phone in most parented homes was never far from reach, as nerve-wracked adults waited for the word that would launch them off the family room sofa, dashing out to the car, and careening down the road towards some unassuming shopping center: Cabbage Patch Kids had been spotted.

The culprits of this frenzy were cuddly, all-fabric toy dolls, invented by a 21-year-old art student and later mass-produced by Coleco in 1982.' They became the singular have-to-have toy the next Christmas. So crazed was the country, that the Cabbage Patch Kids made it on the December 12, 1983 cover of Newsweek magazine with the splashy caption, "What a Doll!" (2) In the years that followed, students of economics and consumer behavior would devote all manner of academic energy to exploring the curious phenomenon of "scarcity marketing" and the psychological dynamics in demand-building from a suppressed supply. (3) But back at Christmas 1983, the "panic" triggered by this toy shortage seemed much less academic. Though entertaining to chuckling spectators standing off from the fray in the distance, it was all too real for desperate parents, hell-bent on ensuring their children's happy walk to the tree that approaching Christmas morning. For them, the hunt for a Cabbage Patch Kid seemed like a life-or-death mission. (4)

What if it really had been?

The cute and now legendary tale of the Cabbage Patch Kids craze grows far darker when a supply shortage imperils something more serious than plush toys. Such was the case in 2009 and 2010 when an enzyme replacement therapy, essential to treating a rare but devastating illness, fell into dangerously short supply. (5) What if the maker of that therapy could have done better to protect the integrity of its product supply? What if the supply interruption could be traced back to careless behavior and poor production judgments? What if the product in depleted supply was critical to sustaining human life, and its interruption turned a loving spouse into a widow?

These were the accusations leveled by a woman in Idaho against the biologies company that had produced her late husband's enzyme therapy. She brought a lawsuit contending that tort law imposed upon that company a duty to exercise reasonable care to ensure that its inventory of enzyme replacement medicine would not be interrupted (or, if it was, that the supply be swiftly repaired). (6) She alleged, in short, that drug manufacturers ought to have a civil duty to sell, and continue selling, their medicine products to all needy patients. (7) It is a remarkable contention, and one that presses to the very frontier of pharmaceutical law in America.

This Article explores the contention that medicine makers ought to be held legally responsible, in tort or otherwise, for carelessly caused interruptions in the supply of medicines. Part I of this Article discusses the several litigations that have introduced this argument into contemporary law. Part II examines, claim by claim, various legal principles that might be candidates for the source of such a legal "duty" to be imposed on medicine manufacturers. Finally, Part III considers the wisdom of inventing such a "duty" if none is found elsewhere, the competing policy considerations weighing on that invention, and a statutory solution that may bridge the various interests in a manner that could offer fresh solutions to this recurring dilemma of drug supply shortages.

II. ALLEGING A "DUTY" TO CONTINUE SELLING MEDICINES

The existence of a legal duty on the part of pharmaceutical manufacturers to continue selling their medicines received its most fulsome airing in a Salt Lake City lawsuit brought by an Idaho widow in March 2012. (8) Her complaint was filed, amended three times, tested on a motion to dismiss, and then revisited on a motion for reconsideration. (9)

But this plaintiff's contention in Utah, though novel, was not wholly unprecedented. At about the same time, lawyers in Florida were raising a similar claim on behalf of a Pinellas County woman. That case was also litigated in the trial court, appealed to the federal court of appeals, and denied review by the United States Supreme Court. (10)

Along the way, lawyers in various other jurisdictions have been pressing similar claims on behalf of clinical drug trial participants who sought continued access to experimental drugs after their clinical trials (and access to the experimental therapies) terminated. (11) All of these litigations champion one common theme: medicine manufacturers ought to have a legal duty to keep manufacturing and selling their goods.

What emerges from this body of case precedent is a captivating tale of tragically ill patients innovating with fascinatingly crafted arguments in support of bold claims that a private commercial actor owes them, as buyers, a duty to sell. It is a riveting tale well worth recounting in depth.

A. Dr. Schubert and Continued Access to Fabrazyme

1. Dr. Schubert's Story

Dr. William Schubert was an obstetrician and gynecologist practicing medicine in southeastern Idaho until his death in March 2010 at the age of 63. (12) By reported accounts, he was a father of seven, a stepfather to three, and the compassionate deliverer of nearly 6,500 babies during his career. (13) About six years prior to his death, Dr. Schubert was diagnosed with Fabry Disease, a rare, inherited, life-threatening medical condition caused by the malfunctioning of an enzyme essential to metabolize lipids. (14) It is estimated that the disease afflicts 1 in 40,000 to 60,000 males, and less frequently in females, (15) or about 5,000 to 10,000 people. (16)

To treat his Fabry Disease, Dr. Schubert was prescribed Fabrazyme, an enzyme replacement therapy. This substance is classified as a "biologic" (or "biological product") because, unlike more conventional drugs which have a known structure and are chemically synthesized, biological therapies are complex mixtures, usually isolated from human, animal, or microorganism sources, and may be composed of sugars, proteins, nucleic acids, or living material like cells and tissues. (17) Producing biologies is often a complex process, with unique manufacturing challenges-- including susceptibility to microbial contamination. (18) Nonetheless, "biologies" may also "represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available." (19) Fabrazyme was evaluated and approved as a "biologic". (20) Manufactured by Genzyme Corporation at its plant in Allston, Massachusetts, Fabrazyme is prepared using recombinant DNA technology in a Chinese Flamster Ovary mammalian cell expression system to create a recombinant human replacement enzyme having the same amino acid sequence as the native enzyme. (21)

During most of the time Dr. Schubert was treating with Fabrazyme, this Genzyme product was the only enzyme replacement therapy approved in the United States for Fabry Disease. (22) Because (presumably) so few patients treat with Fabrazyme (fewer than 1,000 patients in 2010) and because the product preparation technology is so lengthy and complex, (23) the therapy was exceptionally expensive-- about $200,000 per year. (24) Nonetheless, with little other choice, Dr. Schubert and his wife downsized to a smaller home in order to afford their insurance premiums for the Fabrazyme treatments (nearly $4,000 per month). (25) Once his biweekly intravenous treatments of Fabrazyme began, Dr. Schubert "thrived" (26) with "improved" health. (27)

Given the small patient populations this and its other enzyme replacement therapies treat, the manufacturer came to know most of its Fabrazyme patients by name. …

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