Shook Attorneys Examine "Drug Waste" Allegations Posed by BMJ Study

Shook, Hardy & Bacon Pharmaceutical and Medical Device Litigation attorneys Jim Muehlberger, Lori McGroder and Iain Kennedy have authored a March 10, 2016, Law360 article about a recent British Medical Journal (BMJ) study allegedly linking $2.8 billion in waste to single-dose drug vial sizes. Titled “Overspending Driven by Oversized Single Dose Vials of Cancer Drugs,” the BMJ report claims that packaging oncology drugs in single-dose vials based on patient weight or body size leads to leftover medication and makes it possible for prescription drug manufacturers to "artificially increase the amount of drug they sell per treated patient."

Describing flaws in the study's methodology, which assumes that pricing is linear to dosing, the Law360 article argues that "decreasing the dosing volume by a certain percentage" would not necessarily result "in proportional cost savings to patients." As the authors explain, "There is no requirement that pharmaceutical manufacturers price their products in exact proportion to the volume in the bottle. And there are various important reasons that manufacturers offer some extra volume of medication in their dosing options. Moreover, in setting prices for their products, drug manufacturers take into account all of the expenditures that go into bringing products to market, not just the marginal cost of producing another milliliter of medicine."

The article also notes that in Thompson v. Allergan USA, Inc., 993 F. Supp. 2d 1007, 1014 (E.D. Mo. 2014), the court dismissed litigation targeting so-called "drug waste," finding that the U.S. Food and Drug Administration (FDA) approved the single-use vial "exactly as it was being sold," to ensure proper dosing and product stability. "The FDA gives careful thought and consideration to the drugs it approves and regulates," concludes the article. "Unused product may be there for a variety of reasons—promoting product stability, aiding efficient dosing, or even assisting in simplifying hospital inventory complexity. Moreover, drug packaging is a complex area in which patient safety is always the primary concern."