Tag: medical error

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

by Sterling Anthony, CPP, expert witness, packaging, warnings, patent infringement, cargo loading & securement, insurance claims  

Case synopsis:

 A man at a country club experienced a severe allergic reaction to a bee sting.  An ambulance team, consisting of a paramedic and a technician, arrived.  During the on-site treatment, the ambulance workers administered the wrong drug.  The medical error sent the man into respiratory distress.  He was rushed to the hospital but died shortly thereafter.

The mistaken drug had been packaged in a clear IV (intravenous) bag and had a see-through overwrap.

Litigation for wrongful death was filed against the ambulance company and against the manufacturer of the drug that had been mistakenly administered.  The allegations against the drug manufacturer were defective packaging and failure-to-warn, the theory being that the mistaken drug was packaged in a manner that facilitated the medical error and that there should have been warnings.

I was retained by the attorney for the Defendant drug manufacturer.

My opinions:

The direct and proximate cause of the medical error was the failure by the ambulance team to read the labeling .  The sequence disclosed in their depositions was: the paramedic asked for a saline solution; the technician retrieved a drug named lidocaine, without confirming his believed choice; the paramedic administered the lidocaine, without checking what he’d been handed.

There was nothing about the packaging that prevented nor even hampered the reading of the labeling.  The word, lidocaine, was in such bold, large print, that it was the most prominent feature of the labeling.  The labeling also incorporated red markings, known in the medical field as indication that the drug is therapeutically-active, which, saline solution is not.

The Complaint alleged that the packaging for the lidocaine should have been more distinguishable, in terms of size, shape, and overall tactile feel, from those of the saline solution.  There is a  reason for such standardization: it facilitates the procedure for hanging an IV bag, connecting the tubing, and starting the IV drip.

The Complaint alleged that, since lidocaine is a clear liquid, as are various other drugs, the packaging for lidocaine should have been color-coded.   Color-coding, however, quickly can become counterproductive.  In the midst of corporate colors and other design elements——with their possible hues, tones, shades, and tints——an attempt to assign meaning via colors would overwhelm the memory. Besides, the lidocaine incorporated red coloring, signaling that it’s therapeutically-active.

The Complaint alleged that ambulance workers operate under severe time restraints, and failing to read the labeling is a foreseeable consequence; and, therefore, there should have been warnings.  Rather than being an excuse for not having read the labeling, the conditions under which ambulance work is performed make reading the labeling essential; after all, lives are at risk.  Additionally, since the ambulance team didn’t read the labeling, including the most salient elements of same, a warning would not have been read under those same circumstances.

The conduct of the ambulance team was indefensible and contrary to their expected levels of knowledge, education, and training.

Result:

The case settled.

Sterling Anthony, CPP, is a consultant to the industrial, institutional, and government sectors and an expert to the legal community.  He is a former manager at Fortune 100 companies and a former instructor at two major universities.  His contact information is: 100 Renaissance Center-Box 43176, Detroit, MI 48243; (office) 313-531-1875; (cell) 313-623-0522; (fax) 313-531-1972; thepackagingexpertwitness@gmail; www.thepackagingexpertwitness.com