Should Pharmaceutical Manufacturers be Forced to Produce a Product Against Their Will?

5th-aAs the beginning of a new administration nears, politicians and pundits have been floating many ideas for regulating the cost and availability of pharmaceuticals and other medical treatments. One of the worst ideas being discussed is the judicial creation of a common-law duty to manufacture. Thankfully, there are significant Constitutional and judicial hurdles preventing this duty from materializing.

In order to develop and produce innovative, life-saving drugs, pharmaceutical manufacturers must go through incredibly expensive and time-consuming clinical trials required by the rigid guidelines of the Food and Drug Administration (FDA). As an incentive to go through this process, these companies receive patents to help them recoup the costs of the clinical trials. In some instances, however, even with market exclusivity, manufacturers are unwilling to continue producing these drugs, often because production ceases to be economically feasible.

When this happens, some consumers have asked the courts to compel continued production, regardless of the cost, claiming that the drugs’ manufacturers have a duty to continue selling. Fortunately, not a single one of these lawsuits has succeeded thus far, and for good reason: the law does not impose on manufacturers a duty to continue producing drugs.

In Schubert v. Genzyme Corp., the plaintiff’s now-deceased husband, Dr. William Schubert, took medication manufactured by Genzyme Corporation. After a series of virus contaminations led to severe shortages in the supply of this medicine, Schubert sought and obtained a bioequivalent drug from a different manufacturer. The plaintiff alleged that the shortages caused delays in her husband’s treatments which ultimately led to his death. She claimed that Genzyme owed a duty to “use reasonable care to ensure a continued supply in therapeutic doses,” and was thus negligent in failing to do so.

In dismissing this action, the Utah district court cited to the only other reported lawsuit to make this exact argument—a Florida case entitled Lacognata v. Hospira, Inc., in which a drug manufacturer was the only maker of a new drug, and it exited the market entirely. Both courts correctly held that there is no statutory or legal obligation for a manufacturer to produce a specific amount of, or to ensure a continued supply of, any given drug. Indeed, FDA has regulations in place requiring a manufacturer to provide six-months’ notice to the government if it anticipates an interruption or discontinuation of production, but this is merely a duty to disclose, not to continue production.

As the Schubert court pointed out, “[i]mposing such a duty would prevent a manufacturer from ever ceasing production, require it to predict all potential demand, and further require it to maintain large stockpiles to prevent any shortages in case of production problems. Such an onerous rule is contrary to public policy because it creates an enormous disincentive for potential providers of pharmaceuticals from entering the market in the first place and could stifle development of new therapies.”

Further, there are several constitutional factors that go against a duty to produce. For example, the Fifth Amendment prohibits the government from taking “private property… for public use, without just compensation.” The so-called duty to manufacture would effect such a taking. Many manufacturers become insolvent awaiting the FDA approval process and are no longer able to finish. In addition, there are many unknown variables that could cause a manufacturer to be unable to sustain production of a given product. By asking the courts to impose a duty to continue production despite the economic or financial hardships, plaintiffs are asking the courts to ensure that manufacturers continue providing drugs to the public regardless of the cost. This would cause manufacturers to expend perhaps millions of dollars to produce drugs at a loss, thus allowing the government to take their property for public use (to the extent that aiding the consumers who need the drugs is a public use) without just compensation.

Furthermore, even if the government were to incentivize or compensate manufacturers for producing these drugs, the Constitution expressly forbids forcing any individual or private corporation to work against its will. The Thirteenth Amendment states that “[n]either slavery nor involuntary servitude… shall exist within the United States.” Forcing a manufacturer to stay in business indefinitely or imposing a legal duty to continue producing a drug is arguably a form of involuntary servitude. No private company or individual employee should be forced to produce a pharmaceutical against its will.

Besides, without Congressional authorization, the courts have no authority to impose this duty on manufacturers. In Youngstown Sheet & Tube Co. v. Sawyer, the President issued an executive order directing the Secretary of Commerce to take possession of and operate most of the steel mills in the country. The employees of the steel companies had organized a nationwide labor strike, and the President was worried that, without an executive order, this would lead to a steel shortage. The courts held that the President did not have Congressional or Constitutional authority to issue this executive order, and thus deemed the order unconstitutional. Similarly, the plaintiffs in Schubert and Lacognata are asking the courts to impose a duty on manufacturers where no Congressional or Constitutional authority has been given to the courts to do so.

Although one cannot help but be moved by the tragic plight of the plaintiffs in these cases who are seeking rare, life-saving treatments, the courts have consistently held that “sympathy for [a party] does not relieve us of the responsibility of following the law.” Even with the plaintiffs’ need in mind, commandeering the property or labor of pharmaceutical manufacturers and their employees is not the answer.

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