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Law360 (March 18, 2021, 5:23 PM EDT) --

The first two dozen of what may be tens of thousands of cases have already been filed by the families of long-term care residents who contracted COVID-19. The plaintiffs typically allege that the facilities were negligent or otherwise violated various state law duties of care in their response to the COVID-19 pandemic. And the plaintiffs almost universally file suit in state court.

The initial battle in these cases is now clear: whether the cases will be litigated in state or federal courts.

Long-term care facilitieshave wisely been attempting to remove these cases to federal court. They've faced mixed success.

The U.S. District Court for the Central District of California recently found one suit,Compare Garcia v. Welltower OpCo Group LLC,entirely preempted by federal law and the facility entitled to immunity, whereas other district courts have remanded cases back to state court.[1] The issue is now heading to the federal courts of appeals, which will begin to settle the law in their respective circuits.

They should find in favor of federal jurisdiction.Long-term care facilities were at the center of an all-hands-on-deck federal response to the COVID-19 threat, and their conduct cannot be judged independent of the federal direction they received. That makes a federal forum the proper forum under two different doctrines: federal officer removal and complete preemption.

Federal Officer Removal

Congress established a broad standard for federal officer removal to ensure a federal forum not just for federal officials, but for those who assist them.

To successfully invoke federal officer removal, a defendant must be (1) acting under a federal officer and (2) the suit must be one relating to any act under color of such federal office. The defendant also must have a colorable federal defense.

Suits against long-term care facilities participating in Medicare and Medicaid programs that raise claims related to the COVID-19 mitigation and prevention precautions undertaken by those facilities are such suits and therefore belong in federal court.

Long-term care facilities participating in Medicare or Medicaid acted under federal officials because officials at the Centers for Medicare and Medicaid Services, working to ensure that the Centers for Disease Control and Prevention's public health guidance was being implemented, conscribed thosefacilities into the federal response to COVID-19.[2]

Because they house the most vulnerable population in the country, long-term care facilities were at the very front lines of the government's efforts to prevent COVID-19 deaths.

From day one, CMS directed a response that, to use the words of the U.S. Supreme Court in Watson v. Philip Morris Cos. in 2007, went "beyond simple compliance with the law" but rather required long-term care facilities to help "officers fulfill [the] basic governmental task" of protecting a vulnerable population during a pandemic.[3]

CMS dictated the standards for infection prevention and control believed necessary to provide safe, high-quality care.[4] CMS issued, and then continuously modified, guidance on visitor access, personal protective equipment use, testing frequency, monitoring of staff and dealing with residents with COVID-19.[5]

CMS also ordered compliance checks to ensure long-term care facilities complied with the federal direction.[6] CMS' frequent and pervasive direction to achieve the federal function of protecting a vulnerable population means long-term care facilitiesacted under those federal officials.

The suits also relate to such acts. To qualify for removal, only the circumstances that gave rise to the suit need relate to the federally directed acts.[7]

Given the pervasiveness of CMS' direction, in all but the rarest case, a suit challenging a long-term care facility'sCOVID-19 response will relate to the acts directed by federal officials.

And, as discussed next, many of these cases will turn on whether long-term care facilities are immune under the federal Public Readiness and Emergency Preparedness Act, which establishes a federal immunity defense in times of public health emergencies that should be resolved in federal court.

Complete Preemption

The second basis for removal is complete preemption based on the PREP Act. When a federal statute "displace[s] entirely any state cause of action," federal jurisdiction is proper because the only possible claim is a federal one.[8]

The PREP Act is such a statute. When the secretary of the U.S. Department of Health and Human Services declares a public health emergency, the PREP Act confers immunity "from suit and liability under Federal and State law" for any "covered person with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure."[9]

The sole exception to a covered person's immunity is in cases of willfulness and, even there, the remedy is an exclusive federal cause of action before a three-judge court in the U.S. District Court for the District of Columbia. This structure pairing preemption with a sole federal cause of action is the defining feature of statutory schemes that completely preempt state causes of action.[10]

Many claims against long-term care facilities will fall within the PREP Act's preemptive scope. The secretary has designated masks, respirators and COVID-19 tests as covered countermeasures, meaning the PREP Act applies to any claims against covered persons relating to the administration or use of those countermeasures.[11]

The secretary has also made explicit that this immunity broadly applies to claims concerning both the use and the failure to provide countermeasures, such as when limited supplies lead to prioritizing certain uses at the expense of others.[12]

Because Congress afforded the secretary unreviewable discretion to designate such countermeasures, this determination should receive significant judicial deference. And it is beyond dispute that long-term care facilities are covered persons entitled to the act's protection they administer and dispense such countermeasures, and provide a facility where countermeasures are administered or used.[13]

Indeed, the office of the secretary has taken the position that the PREP Act completely preempts claims in this area.[14]

Federal jurisdiction makes good sense. Federal officer removal exists in part to protect those who work with the federal government from anti-federal government bias in state courts. It ensures those with colorable federal defenses will receive fair treatment of those federal defenses by ensuring they are adjudicated in federal court.

Long-term care facilitieswarrant that protection for actions they took in conjunction with the federal government's national response to the COVID-19 public health emergency.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] Compare Garcia v. Welltower OpCo Grp. LLC , 2021 WL 492581 (C.D. Cal. Feb. 10, 2021), with Lyons v. Cucumber Holdings, LLC , 2021 WL 364640 (C.D. Cal. Feb. 3, 2021), and Dupervil v. All. Health Operations, LCC , 2021 WL 355137 (E.D.N.Y. Feb. 2, 2021).

[2] See Watson v. Philip Morris Cos ., 551 U.S. 142, 152 (2007) (private party is "acting under" a federal officer when it is "involve[d in] an effort to assist, or to help carry out, the duties or tasks of the federal superior"); Jacks v. Meridian Res. Co., 701 F.3d 1224, 1232-33 (8th Cir. 2012) (Congress's decision to "establish a health benefits program for federal employees" by "set[ting] up a partnership between [the federal government] and private carriers" meant private carriers rendering services were "acting under" federal officers for removal purposes).

[3] Watson, 551 U.S. at 153.

[4] Ctrs. for Medicare & Medicaid Servs., CMS Prepares Nation's Healthcare Facilities for Coronavirus Threat (Feb. 6, 2020), https://www.cms.gov/newsroom/press-releases/cms-prepares-nations-healthcare-facilities-coronavirus-threat.

[5] Id.; Ctrs. for Medicare & Medicaid Servs., Mem. from Director, Quality, Safety & Oversight Grp. to State Survey Agency Directors, Guidance for Use of Certain Industrial Respirators by Health Care Personnel, No. QSO-20-17-ALL (Mar. 10, 2020), https://www.cms.gov/files/document/qso-20-17-all.pdf; 42 C.F.R. 483.80.

[6] Ctrs. for Medicare & Medicaid Servs., Mem. from Director, Quality, Safety & Oversight Grp. to State Survey Agency Directors, Prioritization of Survey Activities, No. QSO-20-20-All (Mar. 20, 2020), https://www.cms.gov/files/document/qso-20-20-allpdf.pdf.

[7] See Maryland v. Soper , 270 U.S. 9, 33 (1926) (suit need not "be for the very acts which the [defendant] admits to have been done under federal authority"); Latiolais v. Huntington Ingalls, Inc., 951 F.3d 286, 292 (5th Cir. 2020) ("a civil action relating to an act under color of federal office may be removed").

[8] Metro. Life Ins. Co. v. Taylor , 481 U.S. 58, 64 (1987).

[9] 42 U.S.C. 247d-6d(a)(1).

[10] See Avco Corp. v. Aero Lodge No. 735, Int'l Ass'n of Machinists & Aerospace Workers , 390 U.S. 557, 559 (1968) (NLRA); Metro. Life Ins. Co. v. Taylor, 481 U.S. 58 (1987) (ERISA); In re WTC Disaster Site, 414 F.3d 352, 375 (2d Cir. 2005) (Air Transportation Safety and System Stability Act).

[11] Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15,198, 15,202 (Mar. 17, 2020); Dep't of Health & Human Servs., Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration (Dec. 3, 2020), https://www.phe.gov/Preparedness/legal/prepact/Pages/4-PREP-Act.aspx; see also 247d-6d(i)(1)(D), as amended by Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. No. 116-136, 3103, 134 Stat. 281, 361 (2020).

[12] Dep't of Health & Human Servs., Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act, supra.

[13] 42 U.S.C. 247d-6d(d)(1), (i)(6).

[14] Dep't of Health & Human Servs., Office of the Secretary, General Counsel, Advisory Opinion 21-01 on the Public Readiness and Emergency Preparedness Act and the Scope of Preemption Provision (Jan, 8, 2021), https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/2101081078-jo-advisory-opinion-prep-act-complete-preemption-01-08-2021-final-hhs-web.pdf.

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COVID Suits Against Nursing Homes Belong In Federal Court - Law360

On March 12, 2021, ALJ Clark Cheney issued the public version of Order No. 22 (dated January 7, 2021) denying Respondent Regeneron Pharmaceuticals (Regeneron) motion to terminate the investigation for lack of standing in Certain Pre-Filled Syringes for Intravitreal Injection and Components Thereof (Inv. No. 337-TA-1207).

By way background, this investigation is based on a June 19, 2020 complaint filed by Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, Novartis) alleging a violation of Section 337 by Regeneron in the importation and/or sale of certain pre-filled syringes for intravitreal injection and components thereof by reason of infringement of claims 1-6 and 11-26 of U.S. Patent No. 9,220,631 (the 631 patent). Regeneron filed a motion to terminate the investigation for lack of standing on the grounds that Novartis does not have a statutory cause of action to assert the 631 patent without adding non-party Vetter Pharma International GmbH (Vetter) as a complainant.

According to the Order, the relationship between Novartis and Vetter dates back to 2009 and was memorialized in an agreement dated January 27, 2009. Novartis was involved in the manufacture and sale of pharmaceutical products and Vetter supplied Novartis with pre-filled pharmaceutical products. On February 14, 2013, Vetter informed Novartis that pursuant to the terms of the 2009 agreement, Vetter owned certain intellectual property claimed in Novartis patent applications. Specifically, Vetter asserted ownership in a German patent application filed by Novartis (DE 20 2012 011 016 U), one of the foreign priority applications identified on the face of the 631 patent asserted in this investigation. The 2013 dispute led the parties to execute a fourth amendment to the 2009 agreement acknowledging a dispute as to the ownership of, and the rights of and the use related to, the intellectual property, including the 631 patent. On December 19, 2019, the parties executed a seventh amendment (the 2019 Amendment) to the 2009 agreement.

Regenerons motion to terminate focused on the scope of patent rights granted to Vetter in the 2019 Amendment. In particular, Regeneron argued that the 2019 Amendment granted Vetter such substantial rights in the 631 patent that Vetter must be joined as a co-complainant in this investigation, relying on language from the 2019 Amendment granting Vetter a co-exclusive license. ALJ Cheney disagreed, and found that the co-exclusive license to the 631 patent was limited and not enough to confer standing on Vetter. The ALJ noted that the assignment history of the 631 patent demonstrated that the inventors assigned their rights in the 631 patent to Novartis, and that Regeneron did not dispute that Novartis owns the 631 patent. ALJ Cheney then determined that Vetter was not granted exclusionary rights regarding the 631 patent sufficient to confer standing, stating that Vetters rights to exclude others from using the claimed invention are wholly contingent on the actions of Novartis and are limited and illusory. For example, the ALJ pointed to Vetters limited right to sublicense the 631 patent under the 2019 Amendment.

Regeneron also argued that the potential for serial litigation weighs in favor of making Vetter a party to this investigation. But ALJ Cheney found that the provisions of the 2019 Amendment demonstrate that Vetter has no right to re-litigate the investigation as complainant after the investigation is terminated. For example, Regeneron asserted that, when litigation between Novartis and Regeneron concludes, there is nothing in the [2019] amendment to the Agreement to prevent Vetter from providing a notice of infringement and, after six months, filing a lawsuit against Regeneron in its own name and under its own direction and control. The ALJ, however, stated that Regenerons argument seems predicated on the assumption that Vetter would notify Novartis of the same allegedly infringing acts at issue in this investigation, i.e., the importation into the United States of the EYLEA pre-filled syringe, and observed that that infringement (as defined in the 2019 Amendment) is in fact being litigated by Novartis in this investigation and that [t]he 2019 Amendment does not permit Vetter to bring suit regarding that act of alleged infringement once Novartis has done so.

Excerpt from:
ALJ Cheney Denies Motion to Terminate Investigation in Certain Pre-Filled Syringes (337-TA-1207) - Lexology

As debates about policing pervade the public conversation, Professor Rachel Harmon of the University of Virginia School of Law has written the first casebook to look at the laws that govern police conduct in the United States.

The Law of the Police, published by Wolters Kluwer and available now, takes on the question of how the law shapes police-citizen encounters and how the law might be leveraged to make policing serve the public better.

Harmon, a former federal prosecutor who directs the Law Schools Center for Criminal Justice, has taught a course on the laws governing police for 15 years. She came to UVA Law in 2006 after spending eight years as a federal prosecutor in the U.S. Department of Justices Civil Rights Division.

Throughout her time in academia, she has wrestled with what role, if any, policing should have in peoples lives, and how best to prevent misconduct.

I came to the Law School from practice, where I spent years prosecuting civil rights cases, including against police officers, she said. Over time, I got frustrated with criminal prosecution as a response to police misconduct. Prosecuting illegal police violence can be important, but I knew there had to be better ways to prevent problems in policing.

Among her goals for the book, she said, was to look at how different laws and legal rules make policing more or less harmful.

The book is a reaction to the traditional approach to policing the police, which is rights-focused. For example, a common police practice she considers problematic is selectively asking drivers, based on a gut feeling, to open their trunks during a traffic stop with all of the officers conscious and unconscious biases in tow.

Lawyers have typically looked at such problems and argued that they violate Fourth Amendment doctrine or, if they dont, that the doctrine should be changed, she said. I see things differently.

In the evolution of her thoughts, Harmon first looked at how existing rights and remedies might be applied to curb policing that works against the public interest.

I spent my first couple of years as an academic looking at legal remedies to see whether they could be used to prevent problems in policing and tossing them over my shoulder, Harmon said. So civil rights damages actions, is that going to work? No, thats not going to work a lot of the time. Justice Department investigations of police departments, is that going to work? No, that wont work well enough either.

She then suggested enhancements to these existing tools, before going another way.

I wrote a couple of articles trying to improve rights and remedies before I started to write about how to think more broadly about police misconduct as a regulatory problem. The question is not only how to remedy police misconduct, but how to use law to get the public safety we want, both through policing and through other means.

Focusing on that question led Harmon to study the harms of policing and how the law overlooks them or contributes to them.

Moreover, studying the vast array of legal rules that shape policing and police departments led Harmon to realize how little of it lawyers and law students may know, she said.

Hopefully, the book can be a resource, not just for law students, but for academics, lawyers, police chiefs, journalists, activists, judges or just about anyone interested in how the law actually governs policing and how it might do so differently, whether thats reforming police departments or turning public safety over to nonpolice actors, she said.

She noted that the book is different than a criminal procedure textbook, which specifically prepares lawyers for the concepts they will need to know as future prosecutors or defenders. Her book is organized by police practices, such as stopping traffic, using force, maintaining order, and policing resistance and protests, rather than legal categories dictated by Fourth and Fifth Amendment law. The book covers departmental policies and local and state law, as well as federal statutes and cases. It also addresses topics law students rarely study and on which there are few resources for lawyers and commentators, such as asset forfeiture, protest policing, video recording the police, and criminal investigations and prosecutions of police officers.

Even so, that hasnt stopped some professors who have given her book a test run from using it in their criminal procedure courses. Harmon said that the book was not conceived with that purpose in mind, but she has grown more comfortable with the idea that it can be used to teach an alternative version of criminal procedure, one in which the police are front and center.

Harmon is a member of the American Law Institute and serves as an associate reporter for ALIs project on Principles of the Law of Policing. She advises nonprofits and government actors on issues of policing and the law, and served as a policing expert for the independent review of the white supremacist events of Aug. 11-12, 2017, in Charlottesville, Virginia.

In December she co-authored a report, Policing Priorities for the New Administration, advocating for a stronger regulatory approach. The report, in collaboration with Barry Friedman and the Policing Project at the New York University School of Law, urged the White House to appoint a policing czar and require that all of the more than 80 federal law enforcement agencies meet basic standards for transparency, among other clear and actionable measures.

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Harmon's New Casebook Is First to Look at Law of the Police - UVA Law

In 2017, a high school student (referred to as B.L.) expressed her frustration with having not made the varsity cheerleading team through a private Snapchat post. The image showed her making an obscene gesture and was captioned, f- school f- softball f- cheer f- everything.

A friend saved the snap and showed it to school authorities, resulting in B.L.s expulsion from the junior varsity team. She was reinstated to the team a few months later as litigation ensued.

Ultimately, the case reached a federal appeals court, which ruled in the students favor on the grounds that the school districts punishment violated the First Amendment; however obscene it may have been, the snap was between friends, off campus and outside of school grounds.

But this was not the end of the story. Mahanoy Area School District appealed the decision to the Supreme Court, which heard arguments in January.

The justices should affirm the lower courts decision in favor of free speech for high school and college students, especially off-campus. Moreover, there is a need to clarify those protections in the modern social media landscape.

First of all, there is a judicial precedent to take into consideration: that of the case of Tinker v. Des Moines in 1969. The ruling of that case was that unless it threatened to disrupt the academic environment, freedom of expression could not be infringed upon on school grounds. If schools have less power over expression on-campus, what, then, gives them power to punish students for things they said off-campus?

B.L.s speech did not fit the criteria established by Tinker v. Des Moines, as there was no call to disrupt academic activity. Rather, she was momentarily expressing her frustration in a temporary post.

Moreover, B.L. expressed herself in private, which ought to be considered outside of the school districts jurisdiction. Not only did the district infringe on her First Amendment rights to freedom of speech and expression, but also her Fourth Amendment right to privacy.

Now, a right to privacy is not explicitly written in the Constitution, but it is implied: The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated Because her speech was non-disruptive, it was not reasonable for B.L. to be punished for a statement she made in a private circle.

Although ruling in favor of rights to privacy and free speech and expression is the higher road for the Supreme Court to take, Mahanoy Area School Districts concerns must be taken into account. Officials there worry that if they have no jurisdiction over what is said by students off-campus, they will be unable to intervene in cases of cyberbullying and other such behavior outside of school.

Even taking that concern into account, the Supreme Court should rule in favor of First Amendment rights for students off-campus and their privacy. They should also uphold Tinker v. Des Moines with an additional provision for social media that being that it lies outside of school district authority with the exceptions of the use of school-owned handles and speech that disrupts academics or threatens or intimidates faculty, staff, or other students. Only in such exceptional cases should schools have jurisdiction over speech.

First Amendment rights are crucial to a students ability to communicate their thoughts and ideas with their peers and superiors. To quote the majority opinion in Tinker v. Des Moines, students do not shed their constitutional rights to freedom of speech or expression at the schoolhouse gate and certainly not outside of it.

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The precedent of free speech on campus | The Record - The Record

Judge Merrick Garland, U.S. President-elect Joe Biden's nominee to be U.S. Attorney General, speaks as Biden listens while announcing his Justice Department nominees at his transition headquarters in Wilmington, Delaware, January 7, 2021.

Kevin Lamarque | Reuters

Merrick Garland is finally getting his day before the Senate.

Garland, President Joe Biden's pick to be attorney general, will appear before the Senate Judiciary Committee on Monday for the first day of his confirmation hearings, scheduled to continue through the week.

The hearings were delayed amid some partisan squabbling while Democrats and Republicans struggled to come to a power-sharing agreement in the evenly divided Senate.

Those delays came after Garland was denied any hearings at all in 2016, when former President Barack Obama nominated the centrist judge to the Supreme Court following the death of Justice Antonin Scalia, the conservative stalwart.

The federal appeals court judge is expected to be confirmed swiftly likely by the start of March though he may face some uncomfortable grilling, primarily from the panel's Republicans.

Sen. Chuck Grassley, R-Iowa, the judiciary committee's ranking Republican, has indicated that Garland will be quizzed about how he will handle the federal probe into Biden's son, Hunter Biden, related to the younger Biden's finances. Hunter Biden has disclosed that federal prosecutors are examining his "tax affairs."

All-in-all, though, the hearings are likely to be low-drama. In a statement, Democratic Committee Chairman Sen. Dick Durbin of Illinois called Garland "a consensus pick who should be confirmed swiftly on his merits."

Garland has been a judge on the D.C Circuit U.S. Court of Appeals since 1997 and served as the chief judge on the court, considered the most important except the Supreme Court, from 2013 until 2020.

The 68-year-old, if confirmed, will lead the Department of Justice, which will be crucial to Biden's agenda for criminal justice reform. Biden has also said that he hopes that, by choosing Garland, he will be able to demonstrate a contrast from President Donald Trump's use of the department for self-serving aims.

"We need to restore the honor, the integrity, the independence of the DOJ of this nation that has been so badly damaged," Biden said during a January speech introducing Garland.

"I want to be clear to those who lead this department who you will serve: You won't work for me. You are not the president's or the vice president's lawyer," Biden added. "Your loyalty is not to me. It's to the law, the Constitution, the people of this nation."

Trump's four-year tenure was marked by controversy in the Justice Department.

His first attorney general, Jeff Sessions, was ultimately forced to resign in 2018 after Trump attacked him for months over his decision to recuse himself from former special counsel Robert Mueller's Russia probe.

William Barr, Trump's final attorney general, was accused of tampering in the prosecutions of Trump allies Roger Stone and Michael Flynn, and of issuing misleading statements related to Mueller's final report.

Garland has pledged to maintain his independence.

"The essence of the rule of law is that like cases are treated alike: That there not be one rule for Democrats and another for Republicans, one rule for friends, another for foes, one rule for the powerful, and another for the powerless," he said last month.

It is likely that Democrats will push Garland to address how his views on criminal justice align with Biden's pledge to boost racial equity in the legal system. Civil rights groups have noted that in his rulings as a judge, Garland has demonstrated a conservative bent.

"Judge Garland very rarely ruled in favor of defendants in Fourth Amendment cases and has generally found law enforcement action to be reasonable under the circumstances," the American Civil Liberties Union wrote in a 2016 report while Garland was under Supreme Court consideration.

The report also found that Garland's "notable sentencing decisions similarly demonstrate a pro-prosecution perspective."

During his campaign, Biden pledged to reduce the number of people incarcerated in the U.S. and to root out inequities in sentencing.

In his first days in office, he ordered the Justice Department to limit its contracting with private prisons and made other promises related to racial equity in the department. While the administration has been in place for a month, rights groups have been pushing it to do more.

An early test for Garland could come as a result of the Jan. 6 riot on the Capitol, which has led to increasing calls for a new domestic terrorism law to help the Federal Bureau of Investigation a part of the DOJ go after members of the pro-Trump mob that waged the attack.

Federal prosecutors have said the investigation into the attack is likely unprecedented in DOJ history, and that more than 200 people have already been charged.

While law enforcement associations have come out in support of such legislation, civil liberties groups have suggested that such bills tend to fall hardest on already persecuted communities, like Black and Muslim people.

Garland is expected to draw on his work in 1995 overseeing the prosecutions stemming from the Oklahoma City bombing, which was perpetrated by White supremacists.

In addition to assembling the trial team in that case, Garland drafted the Justice Department's critical incident response plan and "oversaw the United States Marshals Service's vulnerability assessment of federal facilities," according to paperwork he filed with the Senate as part of his confirmation process.

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Merrick Garland will finally face the Senate: Attorney general confirmation hearings start Monday - CNBC