• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Electrical Engineering News and Products

Electronics Engineering Resources, Articles, Forums, Tear Down Videos and Technical Electronics How-To's

  • Products / Components
    • Analog ICs
    • Connectors
    • Microcontrollers
    • Power Electronics
    • Sensors
    • Test and Measurement
    • Wire / Cable
  • Applications
    • Automotive/Transportation
    • Industrial
    • IoT
    • Medical
    • Telecommunications
    • Wearables
    • Wireless
  • Resources
    • DesignFast
    • Digital Issues
    • Engineering Week
    • Oscilloscope Product Finder
    • Podcasts
    • Webinars / Digital Events
    • White Papers
    • Women in Engineering
  • Videos
    • Teschler’s Teardown Videos
    • EE Videos and Interviews
  • Learning Center
    • EE Classrooms
    • Design Guides
      • WiFi & the IOT Design Guide
      • Microcontrollers Design Guide
      • State of the Art Inductors Design Guide
    • FAQs
    • Ebooks / Tech Tips
  • EE Forums
    • EDABoard.com
    • Electro-Tech-Online.com
  • 5G

Will your Good Samaritanism in the pandemic buy you a lawsuit?

June 3, 2020 By Lee Teschler

Leland Teschler | Executive Editor
If you are one of the individuals voluntarily spending your time on technology to help abate the COVID 19 pandemic, consider the experience of the vacuum cleaner company Dyson in the U.K. Company founder James Dyson estimates his firm spent about $25 million and about 10 days to develop a respiratory ventilator that would help fill a projected shortage in that country. While waiting for regulatory approval to produce 10,000 of the machines, Dyson got word from the UK government that his ventilators wouldn’t be needed after all.

Dyson has reportedly said he didn’t mind the expense and time put into the project. But he might end up being lucky Lee-Teschlerhis hastily conceived ventilators never reached the market: At least he won’t be sued for his trouble.

As the smoke clears from the initial pandemic battles, federal politicians are now talking about shielding companies from liability stemming from their actions during the crisis. But the discussions so far center on workers at U.S. businesses. Employers fear a wave of litigation when returning workers start getting sick from the coronavirus. So there has been a push for legislative immunity forcing plaintiffs to show that businesses were grossly negligent or reckless in exposing their workers and customers to the virus.

However, none of these discussions extend to manufacturers making health care equipment in war-effort conditions. Some states have proposed expanding liability protections to manufacturers aiding in the crisis, but there has been no real action on that that front.

On the other side of the issue are plaintiffs’ lawyers who claim immunity shields remove incentives to keep employees safe. But there is some dark humor in the legal profession that perhaps expresses their position more succinctly: Every corpse has a lawyer.

Manufacturers have reason to be concerned about legal troubles. The U.S. Food and Drug Administration normally requires that most new medical devices undergo lengthy laboratory and animal testing to answer basic questions about safety. However, the medical devices being devised during the coronavirus pandemic aren’t getting this kind of scrutiny. Late in March, the FDA issued an Emergency Use Authorization (EUA) that eliminated a need for manufacturing facilities to follow current good manufacturing practices (CGMP), including quality system requirements, when making ventilators. Suspending the CGMP practices– which typically involve a significant amount of procedure documentation and record keeping–allowed non-medical manufacturers such as Ford and GM to begin ventilator production. The EUA also allowed commercially available bag resuscitators and other devices to be modified in ways that allow them to fill in as ventilators.

This isn’t the first time the FDA has relaxed its medical device regulations. In the past, it has allowed equipment to forego clinical testing if it could be proved to be “substantially equivalent” to similar devices already commercially available. But the FDA has taken flak for these policies because they have occasionally led to approving equipment for sale that later underwent significant recalls due to various design and production issues.

And when it comes to respiratory ventilators, the evidence is that even equipment manufactured under normal conditions can have problems. That was the reason the UK recently decided not to use ventilators obtained from China which, UK officials said, were prone to providing an unreliable and varying supply of oxygen.

All these factors constitute lawsuit fodder if well-intentioned manufacturers don’t get legal protection. Absent such protection, we may see yet-another example of the old adage that no good deed goes unpunished.

Filed Under: Covid-19, Featured, Test and Measurement Tips Tagged With: covidengineering

Primary Sidebar

EE Training Center Classrooms

EE Classrooms

Featured Resources

  • EE World Online Learning Center
  • CUI Devices – CUI Insights Blog
  • EE Classroom: Power Delivery
  • EE Classroom: Building Automation
  • EE Classroom: Aerospace & Defense
  • EE Classroom: Grid Infrastructure
Search Millions of Parts from Thousands of Suppliers.

Search Now!
design fast globle

R&D World Podcasts

R&D 100 Episode 8
See More >

Current Digital Issue

June 2022 Special Edition: Test & Measurement Handbook

A frequency you can count on There are few constants in life, but what few there are might include death, taxes, and a U.S. grid frequency that doesn’t vary by more than ±0.5 Hz. However, the certainty of the grid frequency is coming into question, thanks to the rising percentage of renewable energy sources that…

Digital Edition Back Issues

Sponsored Content

New Enterprise Solutions for 112 Gbps PAM4 Applications in Development from I-PEX

Positioning in 5G NR – A look at the technology and related test aspects

Radar, NFC, UV Sensors, and Weather Kits are Some of the New RAKwireless Products for IoT

5G Connectors: Enabling the global 5G vision

Control EMI with I-PEX ZenShield™ Connectors

Speed-up time-to-tapeout with the Aprisa digital place-and-route system and Solido Characterization Suite

More Sponsored Content >>

RSS Current EDABoard.com discussions

  • Unusual gap shape of ETD59 ferrite core?
  • Vco cadencd
  • WH-LTE-7S1 GSM module and SIM card problem
  • Effect of variable gain amplifier and LNA on the input RF signal's phase
  • Pic 16f877A Hex file

RSS Current Electro-Tech-Online.com Discussions

  • Very logical explanation on low calue C3
  • HV Diodes
  • intro to PI
  • Need help working with or replacing a ferrite tube
  • Help wanted to power an AC120v induction motor ( edited from Brushless motor - thank you @SHORTBUS= )

Oscilloscopes Product Finder

Footer

EE World Online

EE WORLD ONLINE NETWORK

  • 5G Technology World
  • Analog IC Tips
  • Battery Power Tips
  • Connector Tips
  • DesignFast
  • EDABoard Forums
  • Electro-Tech-Online Forums
  • Engineer's Garage
  • Microcontroller Tips
  • Power Electronic Tips
  • Sensor Tips
  • Test and Measurement Tips
  • Wire & Cable Tips

EE WORLD ONLINE

  • Subscribe to our newsletter
  • Lee's teardown videos
  • Advertise with us
  • Contact us
  • About Us
Follow us on TwitterAdd us on FacebookConnect with us on LinkedIn Follow us on YouTube Add us on Instagram

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy