September 27, 2013
by Laura Anne Taylor
On September 4, 2013, a United States District Court for the District of Utah dismissed a negligence claim against the pharmaceutical manufacturer Genzyme Corporation (“Genzyme”), holding that a drug manufacturer has no legal duty “to manufacture a pharmaceutical in quantities sufficient to meet market demand.” The plaintiff’s claim, a products liability and medical malpractice action, arose out of a shortage of the drug Fabrazyme®, which Genzyme manufactures. Plaintiff Janet Schubert, the widow of Dr. William Schubert, alleges that the Fabrazyme shortage caused her husband’s death. Schubert asserts, among others, a claim for “negligent manufacturing,” based on her allegation that Genzyme negligently allowed a virus contamination in a manufacturing facility, which resulted in an ongoing shortage.
To state a claim for negligence under Utah law, a plaintiff must assert that (1) the defendant owes the plaintiff a duty of reasonable care, (2) the defendant breached that duty, (3) the breach caused the plaintiff’s injury, and (4) the plaintiff suffered damages. In this case, Schubert asserts that Genzyme owed a duty to her husband and to others patients taking Fabrazyme “to use reasonable care to ensure a continuous supply” of the drug.
Though no Utah court had previously addressed the issue of whether a drug manufacturer has an affirmative duty to manufacture sufficient quantities of a drug, the court discussed a Florida case in which the court held that no such duty existed. In Lacognata v. Hospira, Inc., the plaintiff sued a pharmaceutical manufacturer for its failure to provide the plaintiff with injectable vitamin A. The Florida court agreed with the defendant that “no authority” supported the plaintiff’s claim that a drug manufacturer “has a duty to continue supplying a patient with a drug that it knows the patient relies upon for his or her medical health.” In Schubert, the district court found “no legal or factual distinction” between Schubert’s claim and Lacognata and, like the Florida court, declined to expand state jurisprudence to create such a duty.
The district court for Utah also found that “public policy considerations would weigh heavily against finding a duty.” Imposing such a duty, the court reasoned, would prevent pharmaceutical manufacturers from ever ceasing production, force them to predict market demand, and require them to retain large stockpiles to ensure availability. This “onerous” rule would create a disincentive to manufacturers entering the market and developing new drugs, contrary to the public interest.
Finally, the court pointed out that although pharmaceutical manufacturing is a heavily regulated industry, there is no statutory duty placed on manufacturers “to ensure a continued supply of any given pharmaceutical” nor any “regulation imposing a duty to continue manufacturing.” The court suggested that “if such a duty was deemed necessary, the governing regulators would have imposed it.” Thus, the court concluded, “Genzyme’s failure to produce enough Fabrazyme . . . does not give rise to a duty under Utah law.”
In another recent case involving a plaintiff’s negligence claim against a pharmaceutical manufacturer, the Supreme Court reaffirmed tort protections for generic pharmaceutical manufacturers by holding that the plaintiff’s negligence claim was pre-empted by federal law. Though the Court appeared “troubled” by the tort protections afforded to pharmaceutical manufacturers in light of the “dreadful injuries” involved in products liability cases, the majority was nonetheless confined by its prior ruling in PLIVA v. Mensing, a 2011 case involving the federal law prohibiting generic drug manufacturers from independently altering their drugs’ labels.
Laura Anne is a Law & Bioscience fellow with the Center and is a member of the Class of 2014.
 Schubert v. Genzyme Corp., No. 2:12CV587DAK, 2012 WL 3292940, at *1 (D. Utah Sept. 4, 2013).
 Id. at *2.
 Id. at *3.
 Lacognata, et al. v. Hospira, Inc., 2012 WL 6962884, at *4 (M.D. Fla. July 2, 2012).
 Id. at *2.
 Schubert, 2012 WL 3292940, at *6.
 Id. at *7.
 Id. at *6.
 Id. at *7.
 Id. at *6.
 Id. at *7.
 Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2470, 186 L.Ed.2d 607 (2013).
 Ronald Mann, Argument recap: Court troubled by tort protections for generic pharmaceutical manufacturers, Scotusblog (Mar. 27, 2013, 9:00 A.M.), http://www.scotusblog.com/?p=161862.
 Bartlett, 133 S. Ct. at 2478.
 PLIVA, Inc. v. Mensing, 564 U.S. ___, 131 S. Ct. 2567, 180 L.Ed.2d 580 (2011).
 Bartlett, 133 S. Ct. at 2470.