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YOUR LEGAL RIGHTS | Do drug-makers have immunity while creating COVID-19 cures?

As we all know, circumstances in a world turned upside down by the deadly virus that has now killed 60,000 in the U.S. are anything but normal. We believe the extraordinary danger posed by COVID-19 warrants extraordinary measures. 
davidbetras032020
Attorney David Betras

In America and across the globe, scientists are working furiously to develop vaccines and treatments that will end the COVID-19 pandemic. 

Their efforts are already bearing fruit. Earlier this week, a team of researchers at the Jenner Institute in Oxford, England announced that they were ready to conduct human trials of a new coronavirus vaccine. If it is proven effective and receives emergency approval from regulators millions of doses could be available by September.

Along with that good news, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, announced Thursday that results from a clinical trial conducted by the National Institute of Allergy and Infectious Diseases show that the experimental drug remdesivir may be the first effective coronavirus treatment. He compared it to the discovery of the first HIV medication.

Under normal circumstances, it takes years for new drugs to be tested and judged safe for use. But as we all know, circumstances in a world turned upside down by the deadly virus that has now killed 60,000 in the U.S. are anything but normal. According to reports, the U.S. Food and Drug Administration will grant emergency-use authorization for remdesivir, next week. The prospect that the Oxford vaccine may be ready by September is even more amazing — experts had speculated that it would take at least 18 months to begin vaccinating people against the disease.

Along with relaxing the regulations that add years to the drug approval process, the federal government recently took another step designed to encourage the rapid development and deployment of COVID-19 therapies by granting drugmakers, researchers, physicians, and others involved in the manufacture and distribution of coronavirus “countermeasures” immunity from state and federal product liability lawsuits. The immunity was granted by the Secretary of Health and Human Services on March 17 under the provisions of the Public Readiness and Preparedness (PREP) Act.

As attorneys who regularly represent clients severely injured or killed as a result of medical malpractice, faulty devices, and dangerous drugs, we would typically be uncomfortable with this blanket grant of immunity. But in this instance, and only in this instance, we believe the extraordinary danger posed by COVID-19 warrants extraordinary measures. 

We are relatively comfortable taking this position because individuals or their survivors/estate that are seriously injured or die “as a direct result of the administration or use of a Covered Countermeasure” may be able to obtain benefits from the Countermeasures Injury Compensation Program established under the provisions of the PREP Declaration.

While we believe this grant of immunity is necessary, we don’t believe it can be allowed to set a precedent for the future. 

For decades, lawsuits brought by our firm and others have protected the public from incompetent health care practitioners and deadly devices and drugs. For years “Big Pharma,” billion-dollar insurance companies and industry trade groups have waged a war on the civil justice system. 

We won’t sit back and allow that system to become another victim of the pandemic. 

Because so many people have so many questions, BKH will continue to provide answers via Mahoning Matters and the free COVID-19 legal clinics we broadcast on Facebook Live each Wednesday. We’ll be here to help for the duration of the crisis. If you have questions, send them to news@mahoningmatters.com.

—  Attorney David Betras, a senior partner at Betras, Kopp & Harshman LLC., directs the firm’s non-litigation activities and practices criminal defense law in both the state and federal courts. He has practiced law for 35 years.