by Sterling Anthony, CPP, expert in packaging, marketing, logistics, and human-factors.
Synopsis:
A woman incurred an unwanted pregnancy as a result of errors with her contraceptive pills.
The packaging presented the pills out-of-sequence. Week-4 pills and week-1 pills were inverted on the calendar card, thereby reversing the presentation of ingredient-active pills and placebos.
The woman filled a personal injury suit, alleging defective packaging and failure-to-warn.
I was retained by the attorney for Plaintiff.
My opinions:
Given the purpose of contraception and the consequences of failure, the manufacturer owed a standard-of-care; however, that standard-of-care was breached.
The packaging had a design defect, because when made to specification, it allowed the pills to be presented in inverted order.
There were alternative designs, technologically and financially feasible, that would have prevented the possibility of an inverted order.
The packaging had a marketing defect, because it failed to warn the consumer of the correct presentation order and failed to instruct the consumer to check for same.
There were ways to have designed effective warnings, consistent with warnings theory and regulatory dictates.
The contract packager chosen by the manufacturer of the pills, lacked the experience, process controls, and quality assurance necessary for the assignment.
There were contract packagers that had the requisite experience, process controls, and quality assurance that would have prevented the errors-at-issue, or, at least, would have caught them in time to prevent a defective product from entering the stream of commerce.
Result:
The case settled.
Sterling Anthony’s contact information is: 100 Renaissance Center-Box 176, Detroit, MI 48243; 313-531-1875; thepackagingexpertwitness@gmail.com; www.thepackagingexpertwitness.com