This article is continuing our coverage of the Philips Respironics Ventilator, CPAP and BiPAP recall. If you did not read our first article, you may want to get up to speed before reading our first article at this link.
Our first article address why the Philips Respironics recalls may not have caught the attention of many law firms and why failing to understand the significance of these recalls would be a mistake for any plaintiffs’ law firm.
The “optics” for any defendant in a mass litigation are as important as any matter of law. This article will explain why the “optics” for Philips in the instant matter are, arguably, horrid.
The Problem and the Optics
The problem: Degradation of the polyester-based polyurethane (PE-PUR) sound dampening foam used by Philips Respironics in the design and manufacture, of a series of recalled Ventilator, CPAP and BiPAP devices.
Based on statements made by Philips, the degradation of the PE-PUR foam can lead to the release of several gaseous Volatile Organic Compounds (VOCs), including diethylene glycol, Toluene Diisocyanate, Toluene Diamine, Phenol Dimethyl Diazine as well as potential inhalation of degraded particles of the sound dampening foam.
The Optics: Exposure to diethylene glycol, resulting in 115 deaths in a two-month period in 1937, was the catalyst for the enactment of the Food, Drug and Cosmetic Act of 1938 and the creation of the modern-day FDA. Eighty-three years later, diethylene glycol is included in the list of toxic chemicals users of Philips Respironics Ventilator, CPAP and BiPAP recalled devices may have inhaled in significant doses (See more below on the history of Diethylene glycol and the creation of the FDA after “The Massengill Incident of 1937”).
These VOCs, when released, are likely to be delivered in high doses to the users of the recalled Ventilator, CPAP and BiPAP devices via direct inhalation.
This article will focus on the VOC, diethylene glycol as it was this toxic substance that led to the broad federalization of Food and Drug Law in the United States.
Given the history of diethylene glycol exposure in the United States, the recent exposure of humans to diethylene glycol presents horrible optics for Philips.
It is worth noting that this is not the first time Mass Tort Nexus has covered issues related to Diethylene glycol exposure to humans from FDA-regulated products. See this link.
MTN is currently compiling intake criteria and supporting clinical research, for the injuries known to be caused by the list of Volatile Organic Compounds (VOCs) associated with these devices. MTN members can obtain more detailed information by contacting Barbara Capasso at (954) 383-3932 or firstname.lastname@example.org.
MTN is also working with MTN member case generation companies, record review companies and other service providers to assist those who assist your firm, in your marketing and case work-up for this major emerging litigation.
It is worth noting that qualifying clients, obtaining the required records and record review for this emerging litigation, will be complex and involve contact with medical providers your firm has likely never had reason to interact with.
The Massengill Incident of 1937
In 1937, a pharmaceutical manufacturer, S. E. Massengill Company, developed liquid oral preparation of sulfanilamide using diethylene glycol (DEG) as the solvent and excipient. The company branded the new drug as “Elixir Sulfanilamide”, Elixir Sulfanilamide, which was a liquid version (for oral ingestion) of the common antibiotic Sulfanilamide, commonly referred to as Sulfa. The diethylene glycol in Elixir Sulfanilamide was blamed for the deaths of approximately 100 individuals over the course of several months after its introduction.
Dr. Samuel Evans Massengill, when pressed to admit some measure of culpability, infamously answered, “We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.”
Harold Watkins, the company’s chief pharmacist and chemist primarily responsible for the development of Elixir Sulfanilamide, committed suicide while awaiting trial on charges arising from the 105 deaths in 15 states during the months of September and October of 1937.
There have been numerous other international incidents of mass casualties attributed to the ingestion and inhalation of diethylene glycol since the Massengill Incident.
The Food Drug and Cosmetic Act of 1938
The Massengill Incident of 1937 caused a public outcry and pressure on the federal government to revisit the Pure Food and Drug Act of 1906, which did not require drug makers to test products for safety prior to exposing humans to their products.
Congress responded quickly to public pressure, and enacted the Food Drug and Cosmetic Act of 1938, which was signed into law by President Franklin Roosevelt on June 25th 1938.
Eighty-Three Years Later
Jun 14, 2021: Philips issues recall notification to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices.
Diethylene glycol is listed by Philips as one of the toxic substances emitted by the breakdown of the sound dampening foam used in their recalled BiPAP, CPAP and Ventilator devices.
Eighty-three years (to the month) after the Massengill/ Elixir Sulfanilamide incident led to the passage of the Food Drug and Cosmetic Act of 1938, and the ultimate creation of the modern FDA, we again appear to face an incident of a (now) FDA-regulated group of medical devices exposing humans to diethylene glycol, once again.
From an “optics” perspective, exposing individuals to diethylene glycol presents “optics” for Philips that they should never want to be put before a jury.