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From Health Law Daily, September 6, 2013

Court declines to create a duty for pharmaceutical manufacturers to meet drug demands

By Danielle H. Capilla, JD

A drug manufacturer’s motion to dismiss a claim that it negligently manufactured a drug by failing to produce quantities sufficient to meet market demand was granted (Schubert v Genzyme, September 4, 2013, Kimball, D). Janet Schubert filed a lawsuit against Genzyme Corporation alleging that a shortage of Fabrazyme®, manufactured by Genzyme, resulted in her husband’s death. The court found that the heavily regulated drug market could have required manufacturers to produce enough product to meet demand, but had not imposed that requirement. Furthermore, no on-point case law or statute exists to create that requirement. The court dismissed Schubert’s claim alleging negligent manufacturing but did not rule on claims of breach of implied warranty or strict liability.

Background. In 2005 Dr. William Schubert was diagnosed with Fabry Disease, caused by a missing enzyme needed to metabolize lipids, and began taking Fabrazyme. Fabrazyme is an enzyme replacement treatment, which Dr. Schubert received every two weeks until late 2009. According to Janet Schubert’s complaint, in 2009 Genzyme negligently allowed a virus contamination in Fabrazyme’s manufacturing facility, leading to a shortage of the drug for all Fabry Disease patients. The shortage worsened in November of 2009 after the FDA discovered additional contamination of Fabrazyme, including doses with glass, steel and rubber particles. Schubert alleged after the secondary shortage, Genzyme began rationing the drug, providing patients under 18 with the full dose, while older patients received as much as a 70 percent reduction in their dose. It was known that less than a full dosage was not effective. Dr. Schubert’s condition began to deteriorate at this time, and while he was eventually given a compassionate exception from the FDA for a Canadian bioequivalent, Dr. Schubert died in March of 2010.

Duty. The court noted that in order to state a claim for negligence under Utah law, a party must assert that the defendant owed the plaintiff a duty of reasonable care, the defendant breached the duty, the breach caused the injury and the plaintiff suffered damages. The court held that Genzyme correctly asserted that Schubert cannot establish a duty of care with respect to manufacturing enough product to meet market demand. The court also held that no Utah case law exists addressing the duty of a drug manufacturer to supply the market fully. Schubert argued that Genzyme had a legal duty of care as established in Jeffs v West, but the court held that the duty established in Jeffs was not relevant to this case.

The court also noted that case law supported Genzyme’s assertion that the reason for the shortage is irrelevant to establishing whether or not a duty is owed. The court held that public policy considerations weighed heavily against finding a duty. No statutory duty exists to ensure a pharmaceutical manufacturer produces an adequate and continued supply of any drug. Manufacturers are required to report disruptions or discontinuances of drugs but nothing more. The court held it would be more appropriate for regulators to create the duty, not the court. Schubert’s claim of negligently failing to manufacturer Fabrazyme was dismissed.

The case number is 2:12CV587DAK.

Attorneys: Francis M. Wikstrom (Parsons Behle & Latimer) for Genzyme and Sanofi. Katherine E. Venti (Parsons Behle & Latimer) for Sanofi Aventis US and Mount Sinai School of Medicine. Terence L. Rooney (Snow Christensen & Martineau) for University of Utah Hospitals And Clinics, University of Utah Health Sciences Center, University Healthcare, and the State of Utah.

Companies: Genzyme; Sanofi; Sanofi Aventis US; Mount Sinai School of Medicine; University of Utah Hospitals And Clinics; University of Utah Health Sciences Center; University Healthcare.

MainStory: TopStory CaseDecisions PrescriptionDrugNews DrugBiologicalNews FDCActNews UtahNews

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