We haven’t had a word to say on the Blog about the biggest health story in the world.  That was because, until now, there wasn’t a product liability angle to it.  That’s now changed.  On March 17, 2020, the U.S. Department of Health and Human Services (“HHS”) published in the Federal Register a “notice of declaration” conferring broad-based immunity from tort (including product liability) litigation for those engaging in “activities related to medical countermeasures against COVID-19.  This declaration is now published at 85 Fed. Reg. 15198 (HHS March 17, 2020)

HHS is conferring tort immunity pursuant to 42 U.S.C. §247d-6d (the Public Readiness & Emergency Preparedness Act) and 21 U.S.C. §§564A-B (the Pandemic and All-Hazards Preparedness Reauthorization Act), and the immunity grant will be accompanied by a “compensation program.”  85 Fed. Reg. at 15198.  The immunity extends to “any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures.”  Id. (emphasis added).  The immunity extends not only to COVID-19-fighting drugs, but also to “products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic.”  Id.  The only exception is for “willful misconduct.”  Id.

The immunity being conferred shoves other federal laws aside as well as preempting state law.

[A] covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure.

85 Fed. Reg. at 15199.

The “covered persons” – those entitled to claim immunity – includes “manufacturers” and “distributors,” which are defined as:

A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.

A distributor means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to:  manufacturers; re-packers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.

Id.  The immunity extends to other defined entities, “program planners, and qualified persons, and their officials, agents, and employees, and the United States,” falling outside of traditional product liability defendants.  Id.  We’re not addressing that aspect of the immunity declaration.

The “covered countermeasures” – what the immunity applies to – are  “qualified pandemic or epidemic product[s],” “security countermeasure[s],” and “a drug, biological product or device authorized for emergency use.”  Id.  These countermeasures are also defined:

A “qualified pandemic or epidemic product means a drug or device . . . or a biological product . . ., that is

  • manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause;

  • manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device;

  • or a product or technology intended to enhance the use or effect of such a drug, biological product, or device.

85 Fed. Reg. at 15199.  One “example” is “liability claims alleging negligence by a manufacturer in creating a vaccine.”  Id. at 12.

A “security countermeasure” is:

a drug or device . . . or a biological product . . . that (i)(a) The Secretary determines to be a priority to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat . . ., or (b) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; and (ii) is determined . . . to be a necessary countermeasure to protect public health.

Id.  These “countermeasures” must be FDA “approved or cleared,” “investigational” under the FDCA or else “licensed” or “authorized for emergency use.”  Id.  They include “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19” and “any device used in the administration of any such product, and all components and constituent materials of any such product.”  Id. at 15202.

The universe of immunized claims extends to those brought by anyone “who should be vaccinated or take a drug or other countermeasure” or “who uses or who is administered a Covered Countermeasure.”  Id. at 15200, 15202.  Beyond that, “liability immunity is afforded . . . [t]o manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population.”  Id. at 15200.  Further, “liability immunity is afforded . . . to manufacturers and distributors without regard to whether the countermeasure is used by or administered to individuals in [any particular] geographic areas.”  Id. at 15201, 15202.

For now (extension is possible), immunity “extends . . . through October 1, 2024 – over 4½ years, and even longer if any given product is “obtained for the Strategic National Stockpile.”  Id. at 15201, 15202.  Immunity from liability extends to claims by persons not eligible for the corresponding compensation program.  Id. at 15201 (“requirements for compensation . . . may not align with the requirements for liability immunity”), 15202 (“immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population”).

The HHS declaration is couched in a lot of administrative word salad, but we think that the prime takeaway is that the scope of tort immunity being conferred by the HHS declaration is quite broad.  It is also very important, since our clients have already been authorized to cut regulatory corners to develop new products and are being asked to do all of this, possibly (it’s hard to tell from one day to the next) at cost or close to it.

The clear import of the declaration is to clear the way for science-based organizations and public health professionals to take control of the situation immunized from legal second-guessing.  We hope this declaration is an indicator of a new direction for the federal government’s, and the country’s, response to COVID-19.