Covid-19 is not over. Per doctor advice (namely, that geezers whose primary form of exercise consists of removing Meursault corks should do their best to avoid Covid) we recently received yet another Covid-19 jab.  We’re not up to double digits yet, but cannot be far from it.    For those of you who would gleefully castigate us for not being a “pure blood,” our only response is: d’uh; there has never been anything pure about us.

Covid-19 litigation is not over, either.  Two weeks ago we dropped a post about a court permitting a plaintiff to circumvent immunity under the Public Readiness and Preparedness (PREP) Act by alleging a constitutional, rather than tort, claim.  Today’s case, DN v. Gilead Sciences, Inc., 2025 Mich. App. LEXIS 2672 (Mich. Ct. App. April 8, 2025), offers a very different result. DN is a PREP Act preemption win for the defendants in what would otherwise be a straight manufacturing defect case.  DN was an 83 year old man who had been diagnosed with Covid-19.  He received two doses of remdesivir.  He later suffered two strokes, had a leg amputated, became bed-ridden and required around-the-clock care.  It is a sad story. The claim was that glass particles in the remdesivir caused those injuries.  (Being Churchill fans, we cannot help but think of the old story about  Lady Astor telling Churchill that if she were his wife, she’d put glass in his coffee.  He responded that if she were his wife, he’d drink it.) (Yes, in most versions, it is poison, not glass.) (Being inveterate defense cranks, we also cannot help pointing out that there was no allegation of glass ever being found in DN’s body.)  The plaintiffs filed a complaint in Michigan state court on behalf of DN, asserting claims for breach of express warranty, negligence, gross negligence, intentional misrepresentation, and loss of consortium. 

The case was removed to federal court. That ended up being a detour. The federal court determined that the only claim over which it had original jurisdiction was the claim for intentional misrepresentation, but that even that claim must be dismissed because the plaintiff had not exhausted administrative remedies.  So the case bounced back to state court.  The defendants (the remdesivir manufacturer and the hospital) moved for summary judgment based on complete PREP Act preemption.  The trial court denied the motion for summary judgment.  It bought the plaintiffs’ batty theory that “because the FDA did not approve or license remdesivir in a form that contained glass particles, the allegedly contaminated remdesivir doses did not constitute covered countermeasure.” Put another way – and this really does seem to fit into the category of being too clever by half – the plaintiffs maintained “that it is the glass particles, and not the remdesivir itself, that caused DN’s lasting injuries.”

The defendants in DN then appealed the denial of their summary judgment motion.  That sort of thing is not appealable in most jurisdictions, but apparently it is available in Michigan.  Along with Motown, Barry Sanders, Sleeping Bear Dunes, the longest freshwater coastline in the country, the Mackinac Bridge, and the Joe Louis Fist sculpture, the ability to appeal denials of summary judgment has to be one of the best arguments for Michigan being America’s best state.   

The appellate court reversed the trial court’s decision in a decision that is solidly reasoned and artfully written.  The opinion begins with a discussion of the Spanish flu pandemic of 1918 and the Covid-19 pandemic of 2020-21 as “two devastating global health crises.”  (As Philadelphia lawyers, we feel duty-bound to mention that Philadelphia’s refusal to cancel a parade in 1918 resulted in the city being particularly hard-hit. Some of our old, old relatives talk about uncles, aunts, etc. who succumbed to the Spanish flu in Philly. Bad times.) The DN appellate court set about the task of de novo statutory interpretation.  Put plainly, the plain language of the PREP Act grants immunity to any “covered person” (and the manufacturer and hospital were clearly covered persons) against “any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.”  That is broad language.  Congress passed the PREP Act to prevent suits like this in the face of a serious public health emergency.  And there is the word “manufacture” sitting right in the middle of that broad language as a statutorily protected activity. 

The appellate court was won over by the defendant manufacturer’s argument that “Congress’ explicit extension of PREP Act immunity to claims involving a covered countermeasure’s ‘manufacture’ would be rendered meaningless if, as Plaintiffs suggest, the presence of a manufacturing defect prevented the product from being a covered countermeasure in the first place.” To accept the plaintiffs’ position that “manufacturing defects prevent products from being considered ‘covered countermeasures’ under the PREP Act,” the court “would have to render some of the language of the PREP Act nugatory, in violation of our principles of statutory interpretation.”

It turns out that the plaintiffs in DN did not attempt to bring the only claim that the PREP Act allows.  The DN court concluded that the plain language of the PREP Act clearly granted the defendants “immunity from all liability for injuries that were not caused by willful misconduct.”  That is hardly surprising.  “Willful misconduct” is defined in the PREP Act as “an act or omission that is taken – (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.” The court did not see how the defendants’ conduct, even assuming the presence of glass in the medicine, rose (sank?) to the level of willful misconduct.  We do not see it, either.  It looks like the plaintiffs did not, either.