With the urgent need for more ventilators in the past few months due to the COVID-19 pandemic, we have seen the U.S. Automakers answer our country's call for help by shifting their focus from manufacturing vehicles to manufacturing ventilators. This has been an unprecedented move and has included the invocation of the Defense Production Act. Prior to the COVID-19 pandemic, the entire industry of ventilator manufacturing produced approximately 35,000 ventilators on an annual basis. However, at the beginning of this crisis in the United States, New York Governor Andrew Cuomo forecasted that his state alone would require 40,000 more ventilators to deal with the expected surge of patients that would be admitted to New York hospitals for COVID-19 in the coming months. As a result, the COVID-19 pandemic has overwhelmed the ability of the traditional ventilator manufacturers to meet this urgent demand, requiring the FDA to issue an emergency use authorization (EUA) for the manufacture of ventilators from these unlikely sources.
This altruistic move by the auto manufacturers will likely save many lives. Nevertheless, it cannot be ignored that the ventilators currently being manufactured pursuant to an EUA are being manufactured by companies that don't normally make such devices and the FDA has effectively waived any requirement that such devices be manufactured pursuant to federal regulations setting forth good manufacturing practices.
The Public Readiness and Emergency Preparedness (PREP) Act provides immunity to those companies that make medical devices to combat, cure, diagnose or treat a disease that has been declared a public health emergency, also known as "countermeasures," such as ventilators. The immunity provided is quite broad and would protect anyone making the devices or components used in these devices so long as they are approved through the emergency use authorization process and are used to combat, cure, treat or diagnose COVID-19. The Health and Human Services authorization, which triggered the PREP Act for the COVID-19 pandemic, expires in October 2024, unless extended.
While the PREP Act offers broad immunity to those that qualify, it contains significant limitations in both time and scope. Medical devices created to fight COVID-19, which are still in use after October 1, 2024, may not receive this protection. Medical devices created for the purpose of fighting this pandemic, but are used for other medical treatments also may not enjoy this immunity, if the device is used to treat ailments other than COVID-19.
So this begs the question, what will happen to the ventilators manufactured pursuant to the EUA after October 2024? Surely, some of them still may be in use, treating COVID-19 patients and other patients with respiratory illnesses that require treatment through the use of a ventilator. Moreover, what happens if these ventilators are used with a non-COVID-19 patient and something goes wrong and the patient is injured
Under traditional product liability law, the product manufacturer may be liable for any defect in the manufacture of a medical device that causes the injury. If the ventilator is in use with a COVID-19 patient prior to October 2024, there is likely immunity under the PREP Act, a protection that one expects that the manufacturers of these devices are counting on. However, if the ventilators are not used with COVID-19 patients, or used after the PREP Act declaration expires, then there is probably no immunity for the manufacturers in those situations, and they may face the same liability scheme that every other life sciences product manufacturer faces – strict liability for any product defect.
Unlike most life sciences companies, these automakers, for example, will not be able to point to the fact that their manufacture of these devices was cleared or vetted in any meaningful way by the FDA. They also will not be able to demonstrate that they were required by the FDA to manufacture the ventilators pursuant to strictly regulated good manufacturing practices compliance. This means that some of the best defenses that most life sciences companies enjoy when defending themselves from product liability lawsuits – FDA approval and FDA regulatory compliance – effectively will not be available to these unconventional ventilator manufacturers. A good plaintiff's lawyer is going to be able to take full advantage of this fact in depositions and at trial, if representing a patient claiming an injury from the use of one of these devices.
The limitations of the PREP Act and the future risk of liability for claimed product defects is something to consider for companies engaged in manufacturing medical devices pursuant to an EUA and for the noble purpose of helping our medical professionals to fight a global pandemic. If something does go wrong, the old adage "no good deed goes unpunished" may take a future toll on these good Samaritans (and their insurers).
Originally published May 13, 2020
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