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.”[1] The plaintiff’s claim, a products liability and medical malpractice action, arose out of a shortage of the drug Fabrazyme®, which Genzyme manufactures.[2] Plaintiff Janet Schubert, the widow of Dr. William Schubert, alleges that the Fabrazyme shortage caused her husband’s death.[3] Schubert asserts, among others, a claim for “negligent manufacturing,”[4] based on her allegation that Genzyme negligently allowed a virus contamination in a manufacturing facility, which resulted in an ongoing shortage.[5]
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.[6] 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”[7] 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,[8] the court discussed a Florida case in which the court held that no such duty existed.[9] In Lacognata v. Hospira, Inc., the plaintiff sued a pharmaceutical manufacturer for its failure to provide the plaintiff with injectable vitamin A.[10] 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.”[11] In Schubert, the district court found “no legal or factual distinction”[12] between Schubert’s claim and Lacognata and, like the Florida court, declined to expand state jurisprudence to create such a duty.[13]
The district court for Utah also found that “public policy considerations would weigh heavily against finding a duty.”[14] 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.[15] This “onerous” rule would create a disincentive to manufacturers entering the market and developing new drugs, contrary to the public interest.[16]
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”[17] nor any “regulation imposing a duty to continue manufacturing.”[18] The court suggested that “if such a duty was deemed necessary, the governing regulators would have imposed it.”[19] Thus, the court concluded, “Genzyme’s failure to produce enough Fabrazyme . . . does not give rise to a duty under Utah law.”[20]
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.[21] Though the Court appeared “troubled”[22] by the tort protections afforded to pharmaceutical manufacturers in light of the “dreadful injuries”[23] involved in products liability cases, the majority was nonetheless confined by its prior ruling in PLIVA v. Mensing,[24] a 2011 case involving the federal law prohibiting generic drug manufacturers from independently altering their drugs’ labels.[25]
Laura Anne is a Law & Bioscience fellow with the Center and is a member of the Class of 2014.
[1] Schubert v. Genzyme Corp., No. 2:12CV587DAK, 2012 WL 3292940, at *1 (D. Utah Sept. 4, 2013).
[2] Id.
[3] Id.
[4] Id.
[5] Id.
[6] Id. at *2.
[7] Id.
[8] Id. at *3.
[9] Lacognata, et al. v. Hospira, Inc., 2012 WL 6962884, at *4 (M.D. Fla. July 2, 2012).
[10] Id. at *2.
[11] Id.
[12] Schubert, 2012 WL 3292940, at *6.
[13] Id. at *7.
[14] Id. at *6.
[15] Id. at *7.
[16] Id.
[17] Id. at *6.
[18] Id.
[19] Id.
[20] Id. at *7.
[21] Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2470, 186 L.Ed.2d 607 (2013).
[22] 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.
[23] Bartlett, 133 S. Ct. at 2478.
[24] PLIVA, Inc. v. Mensing, 564 U.S. ___, 131 S. Ct. 2567, 180 L.Ed.2d 580 (2011).
[25] Bartlett, 133 S. Ct. at 2470.