Kirkland, WA / USA - circa March 2020: Street view of the Life Care Center of Kirkland building, ground zero of the coronavirus outbreak in Kirkland.

The PREP Act and Nursing Homes’ Fight to Move COVID Claims to Federal Court

By Kaitlynn Milvert

As nursing homes face wrongful death claims amid the COVID-19 pandemic, they increasingly have pursued a common litigation strategy: attempting to reroute state tort lawsuits to federal court.

A recent ruling in the Third Circuit Court of Appeals rejected this tactic. As the first court of appeals ruling on this issue, the decision avoids extending a federal statute limiting pandemic liability into unprecedented areas and defines at least some limits on the statute’s effect on state tort suits. Read More

America divided concept, american flag on cracked background.

COVID-19 Unmasks Issues Around Public Health Preemption

By Jessica Amoroso and Sarah Winston

States across the U.S. are using preemption to stifle local authority aimed at mitigating the spread of COVID-19, resulting in confusion and a fragmented response.

Historically, local governments have played an important role in providing direct and indirect services to their communities, as they have a heightened awareness of their needs compared to state governments. This has proven especially true during the COVID-19 pandemic, as city and municipal initiatives often have been the initial access point for virus-related services.

But state preemption is increasingly being used as a legal tool to prevent cities and municipalities from legislating on issues of importance to public health.

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Gloved hand holding medical rapid test labeled COVID-19 over sheet of paper listing the test result as negative.

Federal COVID-19 Response Unlawfully Blocks State Public Health Efforts

By Barbara J. Evans and Ellen Wright Clayton

The federal government recently used preemption unlawfully to prevent state public health efforts to protect vulnerable people from COVID-19.

As 1,000 current and former CDC epidemiologists noted in an open letter, the federal government has failed to use legal powers it does have to manage the crisis, leaving states to “invent their own differing systems” to manage COVID-19. We add that the federal government is now asserting emergency powers it does not have to disable state public health responses.

Early this month, Nevada officials halted the use of two rapid coronavirus tests that produced high false-positive rates when used for screening vulnerable people in Nevada’s nursing homes, assisted-living, long-term care, and other congregate facilities. More than half the positive test results were false.

On October 8, the U.S. Department of Health and Human Services (HHS) sent a letter threatening that the Nevada officials’ action was “inconsistent with and preempted by federal law and, as such, must cease immediately or appropriate action will be taken against those involved.” Nevada yielded to this threat and, on October 9, removed its directive to stop using the tests.

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Preemption, Paid Leave, and the Health of America

As the United States continues its response to a seemingly inevitable coronavirus epidemic, experts in law and public health are stressing the importance of supportive social safety nets to ensure an equitable and fair response to the virus’s spread.

If you are one of the nearly two million Americans who works for minimum wage, for much of the service industry, or in the contingent labor force, a situation that forces you to stay home from work – because of illness, or government- or self-imposed quarantine or social distancing measures – could create dire financial circumstances and inhibit measures to mitigate the impact of an infectious disease like COVID-19.

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Pom Wonderful v. Coca-Cola: Will the Supreme Court’s Decision Have Implications Beyond “Pomegranate Blueberry Flavored Blend of 5 Juices”?

By Kate Greenwood

Cross-Posted at Health Reform Watch

On April 21st, the Supreme Court will hear oral argument in Pom Wonderful v. The Coca-Cola Company, a case in which Pom sued Coke under Section 43(a) of the Lanham Act arguing that Coke’s product “Pomegranate Blueberry Flavored Blend of 5 Juices” was misleadingly named.  Coke countered that the suit should be dismissed because the name was specifically authorized by the Food and Drug Administration’s regulations governing flavored juice blends, and both the District Court and the Ninth Circuit Court of Appeals agreed.

In its opening brief filed last week, Pom argues that neither the provisions of the Food, Drug and Cosmetic Act governing food and beverage labeling generally, nor the regulations that specifically address juice blends, precludes the application of the Lanham Act to Coke’s misleading juice label.  This conclusion, per Pom,

“follows inexorably from this Court’s holding in Wyeth v. Levine … that FDA’s approval of a drug label does not displace state failure-to-warn suits challenging the adequacy of the warning. … Following Wyeth, there can be no serious argument that the provisions of the FDCA are in ‘irreconcilable conflict’ with the Lanham Act.  FDA does not even generally review—much less approve—particular food labels; nothing even arguably prevented Coca-Cola from designing its label to avoid misleading consumers; and FDA has given no indication that its juice-naming rules set the outer bounds of labeling regulation.” 

In its brief opposing Pom’s petition for certiorari, Coke distinguished Wyeth, noting that the provisions of the FDCA governing drug labeling do not expressly preempt state regulation.  The provisions of the FDCA governing food and beverage labels, by contrast, “expressly supplant State laws—including those that imposed more ‘stringent’ requirements[.]”  This, Coke argued, shows that the food and beverage statutory provisions and their implementing regulations “were not intended as a ‘floor’ but rather as the exclusive body of regulation to which food and beverage labels would be subject.”

In her latest article, The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, Diana Winters decries the time and money courts deciding food and beverage labeling cases must spend “negotiating the interaction between federal and state law, with inconsistent outcomes”.  Read More