American Journal of Law & Medicine

A "Duty" to Continue Selling Medicines

III. SOURCES OF A "DUTY" TO CONTINUE SELLING MEDICINES

Plaintiffs have proved quite inventive in postulating why a "duty" ought to exist for pharmaceutical manufacturers to continue supplying their medicines to patients. Mrs. Schubert in Utah and Mrs. Lacognata in Florida have added new chapters to this endeavor, extending it (for the first time) to FDA-approved medicines facing product shortages. The various litigation strategies are a veritable march through tort and contract law theory, implicating common law principles that have long remained buried in those dusty volumes of the Restatement of the Law where few dare to venture. Neither the court in Utah nor the court in Florida provided this effort any encouragement. (279) The labor of the experimental drug clinical trial plaintiffs shows the same lack of success, as they, too, journeyed to the outer reaches of constitutional law, statutory law, and common law for relief. The paths staked in these various litigations illustrate how the current state of the law resists a snug fit with this type of "duty."

Over time, these litigations have explored ten different candidates as the possible source of a duty to continue supplying medicines. None has proven successful. An independent assessment of these ten potential analytical sources for a litigation remedy tends toward the same conclusion. Existing law, however creatively repackaged, does not impose upon pharmaceutical manufacturers a "duty" to keep selling their medicines.

A. CURRENT FEDERAL PHARMACEUTICAL LAWS

The most probable source of any legal duty imposed on medicine manufacturers to avoid supply interruptions and to continue selling their medicines is federal law. "The pharmaceutical drug industry has been heavily regulated [by federal law] since 1906," with a web of laws that today constitutes a "comprehensive regulatory regime." (280) If a duty to keep selling exists, somewhere within that sprawling body of law would seem its most likely source. In none of the litigations summarized above, however, did any court unearth such an obligation.

The requirement that any new drug be approved prior to distribution is readily found. (281) Other laws appear plainly. The new drug laws, for example, authorize FDA to withdraw, (282) or encourage the manufacturer's voluntary withdrawal (283) of, a drug's approval under certain circumstances. Those laws also permit FDA to withdraw a drug's approval upon the applicant's own request. (284) Where that applicant is the medicine's sole manufacturer, and the drug is "life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition," the laws impose on the applicant a further obligation to notify FDA in writing at least six months prior to the medicine's temporary or permanent discontinuance. (285) (If that length of prior notice is not possible, the applicant is allowed to make that notification "as soon as possible." (286)) Upon receiving notice of such a temporary or permanent discontinuance, FDA is authorized to expedite review of certain new drug applications or expedite facility inspections or reinspections, if doing so "could help mitigate or prevent [a medicine] shortage." (287) Drug withdrawals from sale must be followed up, within fifteen days, by a report to FDA supplying various information concerning the withdrawn drug. (288) On that report, "[i]t is requested but not required that the reason for withdrawal of the drug product from sale be included." (289) Finally, these laws permit, and sometimes require, FDA to independently determine whether a drug's voluntary withdrawal was due to safety or effectiveness concerns. (290)

Fairly read, these federal laws do not appear in any respect to bar a medicine manufacturer from ceasing to sell its drugs. On the contrary, the laws seem to anticipate just that, and then set in place procedures to be followed once such a cessation occurs. (291) Both Mrs. Schubert and Mrs. Lacognata argued that federal law forbade their drug manufacturers from refusing to supply the medicines. (292) After checking, neither court found such an obligation grounded in enacted federal law. (293) An independent review of those laws supports that conclusion.

Even were the federal pharmaceutical laws susceptible to such a reading, a further obstacle would stand in the way of a patient using them in civil litigation. The federal pharmaceutical laws permit only the federal government to sue to vindicate those legal mandates; no private right of action exists. (294)

For much the same reason, the intimation that the federal patent laws can offer a compelled-access remedy is also unlikely to succeed. Mrs. Schubert, for example, had argued that the manufacturer of her husband's medicine was liable in negligence "for non-use of the invention by banning the publicly funded invention from being given in therapeutic doses to Fabry Disease patients." (295) She is correct that a federal agency that funds an invention may "march-in" to take back the invention's license and re-grant it to another if the person or entity entitled to make use of the invention "has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in such field of use" or to "alleviate health or safety needs which are not reasonably satisfied by the contractor, assignee, or their licensees." (296) Like the federal pharmaceutical laws, however, this "march-in" provision grants rights to the federal government and its agencies, but nowhere purports to invest citizens with private rights to sue. (297) More telling still, it appears that no federal agency has ever exercised its own "march-in" authority; (298) indeed, a "march-in" petition for this very biologic--Fabrazyme--was considered and denied by the National Institutes of Health. (299)

For all of these reasons, it is unlikely that current federal statutory or regulatory law supports imposing a "duty" on manufacturers to continue selling medicines.

B. Substantive Due Process

As the fountain of protection for many personal liberties, the Constitution has been cited as a potential source for a "right to survive" or "right to save one's life," an enshrinement that could implicate so fundamental a personal liberty interest that its encroachment by a medicine manufacturer might entitle a plaintiff to a remedy under the Reconstitution Civil Rights Act of 1871. (300) Neither Mrs. Schubert nor Mrs. Lacognata pressed such an argument, and when experimental drug patients attempted it, they were turned away. (301)

Many impediments greet such a contention. The Supreme Court has had a controversial past in its struggle to give meaning to the doctrine of substantive due process, a principle that forbids certain governmental actions, "regardless of the fairness of the procedures used to implement them ... [so as] to prevent governmental power from being 'used for purposes of oppression."" (302) Consequently, the Court now admonishes great restraint and "the utmost care whenever we are asked to break new ground in this field" because the "guideposts for responsible decision-making in this unchartered area are scarce and open-ended." (303) The concern, mulled the Court, is to guard against "the liberty protected by the Due Process Clause [being] subtly transformed into the policy preferences of the Members of this Court." (304)

Consequently, to prevail on a substantive due process claim, litigants must establish as a threshold matter that the liberty interest sought to be vindicated--here, the right to compel access to a medicine--is "deeply rooted in this Nation's history and tradition and implicit in the concept of ordered liberty," and, further, that the interest is capable of careful description. (305) Litigants have, to date, most often foundered on the first inquiry. (306) The courts that have considered the issue have found that, contrary to a national history and tradition of unrestricted access to pharmaceuticals, the historical record recounts instead a pattern of aggressive regulatory oversight and sharply constrained access to drugs. (307)

Moreover, the guarantee of substantive due process is a safeguard against untoward action by (or fairly attributable to) the government. (308) Although a private actor's conduct could, in an appropriate context, trigger a substantive due process constitutional violation, to do so it must be "fairly attributable to the State." (309) This, in turn, requires that the private actor's conduct cause a deprivation through "the exercise of some right or privilege created by the State or by a rule of conduct imposed by the State or by a person for whom the State is responsible," and that the private actor "may fairly be said to be a state actor" because "he is a state official, because he has acted together with or has obtained significant aid from state officials, or because his conduct is otherwise chargeable to the State." (310) Absent such a limit on liability, cautioned the Court, "private parties could face constitutional litigation whenever they seek to rely on some state rule governing their interactions with the community surrounding them." (311)

Here, too, drug-access litigants have failed. Neither FDA nor other governmental entities are typically implicated in the private actor's decision not to supply medicines (especially in a manufacturing shortage circumstance), nor is the patient's claimed injury (denial of medicine access) caused by the regulator's conduct or decision-making. (312) To the contrary, in most drug supply interruption scenarios one might envision, the decision to interrupt a supply of medicines is entirely one made by the private actor (or as a necessary consequence of external circumstances--like viral contaminations, power failures, and the like--over which FDA had no control). (313) Indeed, an FDA-approved medicine's supply interruption decision, when made, likely clashes with, rather than advances, the national health policy objectives FDA is charged with pursuing. (314)

This precise barrier defeated Mrs. Cacchillo's federal constitutional claim to her muscular dystrophy medicine. (315) The court there wrote that "[it] is not enough ... for a plaintiff to plead state involvement in some activity of the institution alleged to have inflicted injury upon a plaintiff; rather, the plaintiff must allege that the state was involved with the activity that caused the injury giving rise to the action." (316) Therefore, because Mrs. Cacchillo made no allegation "that any federal or state agency or actor had any involvement in Insmed's decision to decline its support for [her] compassionate use application," the court concluded that "there is no plausible basis upon which to find state or federal action sufficient to support" a constitutional injury. (317)

These impediments--the lack of a constitutionally recognizable liberty interest in uninterrupted medicine access and the lack of causal involvement by government in the access interruption--portends poorly for a successful substantive due process claim by patients against medicine manufacturers. This constitutional guarantee is unlikely to be a source for a "duty" on drug makers to continue selling their medicines.

C. Conventional Products Liability Theory

Prototypical products liability law is similarly unlikely to be the wellspring from which a "duty" to continue selling medicines will come. Classically litigated, products liability theory is formulated to mediate personal and property losses caused by encountering a product that contained a defect in its design, defect in its manufacture, or defect in its warnings or instructions. (318) Liability grounded on an absence of such an encounter turns products theory on its head.

Design defects are "hazards lurking in a product's engineering or scientific conception that may reasonably be avoided by a different design or formula." (319) Lying "at the heart of products liability law," design liability "rests fundamentally on the premise that manufacturers are fairly held to answer in courts for the basic safety of their products' designs." (320)

Manufacturing defects are "unintended physical irregularities that occur during the production process," (321) resulting in a "flawed condition" of the product which "may lead to its failure during use, to an accident, and possibly to an injury to the user or another." (322) Considered a "first pillar of modern products liability law," it is "now quite settled" that "manufacturers and other suppliers are liable for injuries caused by manufacturing defects in products that they sell." (323)

Warning defects are "the absence[s] of information needed by users to avoid product hazards." (324) These "informational obligations" are two-fold: the duty "to inform buyers and users of hidden dangers in a product" (the warning duty) and the duty "to inform buyers on how to avoid a product's dangers in order to use it safely" (the instruction duty). (325) When a user is injured by a product "because such danger or safety information was not provided, the manufacturer is subject to liability for the harm." (326)

Each of these three classic products claims necessarily contemplates that the product at issue will have contained an actual defect that rendered the product, upon its encounter with the litigating plaintiff, in a "condition unreasonably dangerous to the user." (327) More simply stated, plaintiffs will be arguing that the product that injured them (or otherwise caused them a loss) would not have done so had it been more properly designed, more properly manufactured, or more properly warned about. At their irreducible core, then, these claims all hinge on an injury (or loss) suffered by exposure to the allegedly defective product. This, in turn, presupposes that the product at issue has, in point of fact, been sold to or otherwise conveyed to the litigating plaintiff, thereby facilitating the injurious encounter which brings him or her to court in the first place. (328) In other words, the import of conventional products liability theory is holding product sellers and suppliers accountable for injuries caused when contact with their products' defects, existing at the moment of sale, causes injury or loss. (329)

This model is ill-suited as a source for a "duty" on a manufacturer to continue selling medicines. In a supply-interruption context, there is no encounter between the manufacturer's product and the plaintiff. Indeed, it is this very absence of an encounter that forms the gravamen of the complaint. The patient's allegation isn't that the product is defective (in design, manufacture, or warning), but that the product's attributes are quite to the contrary highly desirable, useful, and (at least at this point in the contention) safe. (330) The manufacturer's claimed misdeed is not an errant supplying of a defective product--what classic products liability theory aims to vindicate. Rather, the misdeed is the errant failure to supply a non-defective product to someone who wanted to, but was refused the right to, encounter it. The very essence of products liability theory is missing. In short, none of the foundational requisites for conventional products liability will exist in a claim a supply-interruption patient is likely to bring. Accordingly, conventional products law is not a probable source for this "duty".

D. Contract, Quasi Contract, and Warranty Law

Litigants have also attempted to ground a right to continued drug access on common law contract and warranty theories. The framing of such claims is illustrative as to why contract and warranty theory, too, are unlikely to represent credible sources for a "duty" on manufacturers to keep selling.

A claim of breach of express contract was pressed by the asbestosis experimental drug patients in Vinion v. Amgen, Inc., where the plaintiffs alleged that, as participants in the clinical drug trial, they were assured of continued access to Enbrel. (331) Similarly, the Parkinson's patients in Abney v. Amgen, Inc, (332) and Suthers v. Amgen Inc, (333) alleged that, in accordance with the terms of a written informed consent form, the manufacturer committed to providing them with post-trial access to GDNF. Likewise, the muscular dystrophy patient in Cacchillo v. Insmed Inc. contended that the manufacturer induced her to participate in a clinical trial to study the drug IPLEX with the false promise of assisting her in obtaining compassionate use access to the drug after the trial had closed. (334) None of those contract claims survived.

The necessary predicate for success on these claims--as with any express contract claim--is, of course, the existence of a legally enforceable promise. (335) Thus, to support a contract-based duty to avoid shortages or supply interruptions, a contract--an affirmative promise--must have committed the manufacturer to a continued, uninterrupted patient supply of the drug at issue. Contracting parties can agree freely on such terms as they may choose, (336) and it is certainly not impossible that a medicine manufacturer could draw up a contract committing to continuously supplying a patient with uninterrupted access to a drug. Not impossible, but as this case law bears out, certainly improbable. (337)

Furthermore, what a patient understood a manufacturer's commitment to be, no matter how emotionally compelling that conclusion might be, is never solely dispositive on contract formation. It is now generally clear that "unilateral understandings of one party, no matter how subjectively reasonable, are insufficient to form the basis of a contractual promise." (338) What instead, the patient will be obligated to show are the terms of an agreement sufficiently definite to constitute an enforceable promise, a standard that vague, imprecise ruminations or intimations cannot meet. (339) Moreover, if the claimed promise was not reduced to writing, the allegation may also run aground on statute of frauds principles. (340)

Allegations of promissory estoppel have proven similarly unavailing for continued-access claims. The common law generally enforces promises made, even in the absence of consideration, if they are reasonably and detrimentally relied upon by the promisee. (341) Such was the claim asserted by Mrs. Lacognata in Florida (342) and Jacob Gunvalson in New Jersey. (343) Mrs. Lacognata contended that her manufacturer had breached an implied contract when, after representing to her that Aquasol A would be backordered until September 2011, it failed to provide her with Aquasol A in September 2011. (344) Jacob alleged that his manufacturer had promised him access to the experimental drug PTC-124, prompting him to forego enrolling in a clinical study to otherwise obtain access to that drug. (345)

Neither claim prevailed. Both courts found that the asserted promises (critical for sustaining any promissory estoppel claim) lacked the required specificity, clarity, and conclusiveness to be enforced. (346) Thus, the same essential missing element that doomed the express breach of contract claims--an enforceable promise--defeated the promissory estoppel contentions.

One final observation about Jacob Gunvalson's litigation merits mention. Although later reversed by the Third Circuit, Jacob's claim had originally succeeded before the trial judge, at least to the extent of a grant of preliminary injunctive relief. (347) Even there, though, the trial judge took great pains to avoid the impression that his ruling stood as any broad precedent. In the judge's opinion, Jacob should prevail, but only because his mother's special access and intimacy with the drug manufacturer through her role as a prominent patient advocate had placed the promise-making event in a "unique situation." (348) "The Court strongly doubts," continued the opinion, "that many--if any--other parents of DMD children have this kind of relationship with PTC (or other drug companies)." (349) Indeed, the judge explained that he "believes PTC's claim that it normally takes care to refrain from promising any parent access to PTC 124 and that it attempted to do so in this case." (350) Nonetheless, the judge "also [found] that Plaintiffs' unusually close relationship with PTC likely muddied this otherwise clear message." (351) Then, with a forebodingly worded closing admonition, the judge cautioned: "Thus, the Court's ruling today should not in any way suggest that PTC has a general obligation to provide PTC 124-or any experimental drug-to sick persons. Indeed, the Court appreciates that sound scientific and medicinal practices may disfavor a drug company from doing so." (352) The judge's sentiment could hardly be clearer: Jacob wins here, but only because of extraordinarily peculiar circumstances unique to him and his family; no other patient should expect the same result.

Finally, in her complaint against Genzyme Corporation, Mrs. Schubert alleged that the manufacturer had breached an express warranty, an implied warranty of merchantability, and an implied warranty of fitness for a particular purpose by selling her husband reduced doses of Fabrazyme when, at those reduced volumes, the medicine was not therapeutic in treating his disease. (353) It is telling that the drug manufacturer did not attack this claim in its motion to dismiss. (354) Such claims are highly promise-specific. They contend that the manufacturer's act of supplying a partial dose implied that the as-supplied dose was not merchantable or fit because the reduced dose rendered it non-therapeutic, and thus the supplying of the partial-dose of the medicine was actionable. Whatever fate such a claim may meet in the course of Mrs. Schubert's litigation, this much is plain: the claim is not one vindicating a "duty" to supply something, but rather a fairly traditional "duty" to avoid supplying something improper.

The lesson from this journey through continued-access claims pressed under contract theory tends to confirm that the source of a broad "duty" to avoid interrupting a supply of medicines is unlikely to be grounded in contract. True, manufacturers could make promises to patients, enforceable in contract theory, that a supply of medicine will never be interrupted, and, if made, such promises are subject to being enforced. As this review makes plain, such promises are unlikely. Or, in the belief expressed by Jacob Gunvalson's judge, manufacturers are far more prone to "take[] care to refrain from promising any ... access to" medicines. (355) Mindful of the meticulously enforced requirement that agreements be definite, clear, and conclusive to support a legal remedy, it seems very improbable that a contractually enforceable "duty" to continue selling medicines will arise from some non-specific, penumbral-like ether emanating from the law of promises.

E. Common Law Duty to Initiate a Rescue

The common law does not generally impose a duty to attempt a rescue of someone known to be in danger. (356) This principle is understood to apply "irrespective of the gravity of the danger to which the other is subjected and the insignificance of the trouble, effort, or expense of giving him aid or protection." (357) Indeed, the principle is said to apply even when the actor's failure to act "is due to a desire that the other shall be harmed." (358) Although the principle has been decried "as revolting to any moral sense," it "thus far ... remain[s] the law." (359)

The principle recognizes two caveats. First, it applies "only where the peril in which the actor knows that the other is placed is not due to any active force which is under the actor's control;" if it is, then "his failure to control it is treated as though he were actively directing it." (360) The Restatement offers this illustration:

   A, a factory owner, sees B, a young child or a blind man who has
   wandered into his factory, about to approach a piece of moving
   machinery. A is negligent if he permits the machinery to continue
   in motion when by the exercise of reasonable care he could stop it
   before B comes in contact with it. (361)

Second, it does not apply when a special relationship exists between the actor and the person in need of rescue (such as common carrier to passengers, innkeeper to guests, possessor of land to invitees, and legal or voluntary custodian to charges), which imposes independently

a duty to aid. (362)

Mrs. Lacognata argued, at least implicitly, that both these caveats triggered a tort duty on the part of Hospira to continue to supply her with Aquasol A. (363) She reasoned that the manufacturer's conduct "(and no one else's) placed [her] at a foreseeable risk of harm when Hospira negligently transferred manufacturing facilities without properly securing the supply chain of Aquasol A and ... by creating an inadequate stockpile and otherwise deprioritizing remediation of the injuries to" her. (364) Hospira, she insisted, "was not a bystander to the Aquasol A shortage because Hospira's conduct (not someone else's) created the zone of risk." (365) Thus, "because Hospira's conduct placed the Plaintiffs at a foreseeable risk for injury, it also had a duty to exercise care." (366)

The court blithely dismissed this proposition. "There is no authority that supports Plaintiffs argument that a drug manufacturer, like Hospira, has a duty to continue supplying a patient with a drug that it knows the patient relies upon for his or her medical health. …

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