What Is a Manufacturer's Legal Duty to Supply Medications?

Pharmacy Times, April 2015 Respiratory Health, Volume 81, Issue 4

If a pharmaceutical manufacturer markets a medication via interstate commerce and then reduces production and rations availability of the medication, can a lawsuit proceed that alleges negligence?

ISSUE OF THE CASE

If a pharmaceutical manufacturer markets a medication via interstate commerce and then, faced with challenges at the manufacturing facility, reduces production and rations availability of the medication, can a lawsuit, filed by the widow of a patient who had been receiving the full dosage of the medication prior to supplies being limited, proceed that alleges negligence?

FACTS OF THE CASE

A major US pharmaceutical manufacturer secured FDA approval to market a medication used to treat Fabry Disease, a disorder with a genetic basis that results in missing enzymes needed to metabolize lipids and which has many physical manifestations. An FDA inspection of the manufacturing facility uncovered contamination, leading to limitations on production. In response to the reduced supply, the manufacturer imposed rationing with patients younger than 18 years, as it has done in the past, and reduced dosages by as much as 70% for older patients.

A patient who had been diagnosed with the disease had been receiving the full dosage for 4 years, with administration every 2 weeks. Following implementation of rationing for patients in his age range, the patient’s health condition declined, allegedly leading to his death. His widow filed a federal lawsuit in a western state against the manufacturer, alleging negligence, strict liability, and breach of both express and implied warranties in the sales transactions. The negligence portion of the suit, the focus of this discussion, was based on an allegation that the manufacturer “negligently allowed a virus contamination in the manufacturing facility” where the product was made. The plaintiff argued that the manufacturer had a legal duty to “use reasonable care to ensure a continued supply in therapeutic doses.”

The manufacturer, as the defendant, moved to dismiss the negligence claim to the extent it alleged existence of “a duty to manufacture a pharmaceutical in quantities sufficient to meet market demand.”

THE COURT’S RULING

The court dismissed the portion of the lawsuit that focused on “failure to produce a sufficient quantity of the medication” as equating to negligence, concluding that there was no legal duty under either state or federal law to do so.

THE COURT’S REASONING

The first element of a claim for negligence is the existence of a legal duty running from the defendant to the plaintiff. The widow argued that the manufacturer’s duty flowed from its affirmative misfeasance (ie, improperly operating the manufacturing facility led to the shortage), while the manufacturer argued that the shortage was based on nonfeasance (ie, an act of omission) and that the reason for the shortage was irrelevant. The widow advanced the argument by alleging that the manufacturer negligently caused its product to become contaminated.

This court could identify only one earlier case from a southeastern state that presented the identical legal issue. In that case, the manufacturer was the only firm to produce the product, and it completely ceased production. The earlier court’s decision set the precedent that there is no legal authority to support the argument “that a drug manufacturer has a duty to continue supplying a patient with a drug it knows the patient relies upon for his or her medical health.”

The court concluded that applying the law of the state in which the matter arose to the facts presented led to the conclusion that the reason for the shortage was irrelevant. The court also examined whether it made a difference that the manufacturer in the present case had only reduced its supply, whereas the manufacturer from the precedent-setting case had discontinued the product altogether. This court concluded that there was “no distinction between the duty of a company that exits the market altogether and a company that does not supply enough product to meet full market demand.” In both instances, the harm is the shortage of the medication, and it is an act of nonfeasance. The court included the statement that the manufacturer “should not be penalized for producing as much of the product as it could.”

Another allegation in the lawsuit was that the lowered dosage of the medication was more harmful than receiving no medication. This allegation included a claim that the manufacturer knew that a reduced dosage of the pharmaceutical would be more harmful than no medication. The court decided that an issue such as that needs to be fleshed out and explored through pretrial discovery, with possible further exploration during the trial.

The court concluded by emphasizing, “Pharmaceutical manufacturing is heavily regulated by federal law, and there is no statutory duty placed on a manufacturer to ensure a continued supply of any given pharmaceutical.” While federal regulations require a manufacturer to report an interruption or discontinuance to the FDA, there is no regulation imposing a duty to continue manufacturing the product. Moreover, there is no federal law requiring a manufacturer to produce amounts sufficient to meet all potential demand.

Dr. Fink is a professor of pharmacy law and policy and Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington.