U.S. Supreme Court

The Supreme Court’s Rulings on COVID-19 Vaccine Mandates, Explained

By Kaitlynn Milvert

In a pair of rulings issued January 13, the Supreme Court put on hold the federal vaccine-or-test requirements for large employers, but allowed federal vaccination requirements for health care workers to take effect while they are litigated in the lower federal courts.

The Court decisions each addressed questions of whether federal agencies — the Occupational Safety and Health Administration (OSHA) and the Centers for Medicare and Medicaid Services (CMS) — have authority to set these vaccination-related requirements.

In doing so, the Court drew new and unprecedented lines between the kinds of risks that agencies operating outside of the health care context — such as OSHA — have power to address through federal regulations. The Court’s decisions on these issues are likely to loom large in future litigation as federal vaccine requirements continue to be litigated in the lower courts.

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Person filling syringe from vial.

The Beginning of the End of Federalism As We Know It Here on Earth One and Earth 616?

By Jennifer Bard

Friday’s emergency hearing by the Supreme Court regarding the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate was extraordinary both in that it happened at all and what took place.

The hearing came in a response to a petition by a coalition of states and the National Federation of Independent Business (NFIB) to halt an Emergency Temporary Standard (ETS) issued by OSHA mandating that all employers with over 100 employees “establish minimum vaccination standards” including “vaccination verification, face covering, and testing requirements.”

That the Court heard the case on an emergency basis signaled their concern that OSHA, in issuing the ETS, was overreaching its authority, as they ruled the Centers for Disease Control and Prevention had done in issuing an eviction moratorium.

But what made the colloquies particularly unsettling is that the ETS was carefully crafted to be, as Professors Larry Gostin and Dorit Rubinstein Reiss explain lucidly, well within contemporary standards for an exercise of federal power affecting a health matter usually within the jurisdiction of a state. It applies only to employers already obligated to follow OSHA workplace standards and fell far short of a vaccine mandate. Moreover, however severe the risk of COVID when this was drafted six months ago, the risk from the Omicron variant is many times greater.

Yet the sympathetic ear given by the majority of the Justices to the arguments made by the lawyers seeking a stay made it possible to wonder if the whole thing was happening in either one of DC or the MCU’s multiverse. This is because the questioning, directly and by implication, calls into doubt what past Courts have identified as the framework of federalism — a nickname for the Constitution’s balancing of a strong federal government against the rights of individual states. We cannot know the extent to which the Justices will adopt any of the arguments offered them for limiting federal agency power, but from this hearing we can anticipate substantial strengthening of an individual state’s ability to resist federal regulation.

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U.S. Supreme Court

Major Questions about Vaccine Mandates, the Supreme Court, and the Major Questions Doctrine

By Wendy Parmet and Dorit Reiss

This Friday, the Supreme Court will hear arguments about two federal vaccine mandates: the Centers for Medicare and Medicaid Services’ (CMS) mandate for health care workers, and the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate for employers with over 100 workers. In each case, a key question will be whether the Court should apply the so-called “major questions doctrine.” The Court’s adoption of this approach in the mandate cases would not only remove an important tool for combating the pandemic; it also would severely limit the federal government’s capacity to address many other health threats, while expanding the Court’s ability to substitute its judgment for Congress’.

Although not fully defined or delineated, the major questions doctrine bars administrative agencies from using broad grants of statutory authorities in new and “major” ways. A type of clear statement rule, it requires courts to presume that in the absence of specific Congressional authorization, agencies lack the power to issue new regulations that could be seen as “major.”

In theory, the rule allows courts to avoid federalism and separation of powers concerns. In practice, it empowers courts to resurrect long-discarded approaches to federalism and separation of powers without saying so. It also enables courts to disregard explicit grants of statutory authority (so much for textualism!).

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Close up of a Doctor making a vaccination in the shoulder of patient.

The CMS Vaccine Mandate: The Nationwide Injunction and What It Means

By Kaitlynn Milvert

On November 30, 2021, a federal district court issued a nationwide preliminary injunction to block the Centers for Medicare and Medicaid Services (CMS) vaccine requirements for health care workers.

This ruling comes mere days before the December 6 deadline for employees of CMS-funded facilities to receive their first dose of a COVID-19 vaccine, and it casts uncertainty over upcoming deadlines for vaccination compliance.

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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

Photograph of Purdue Pharma headquarters

The Role of Attorneys General in the Opioid Litigation

By Daniel Aaron

People following the opioid lawsuits might have noticed some strange headlines as of late. Virtually every state’s attorney general (AG) is suing Purdue Pharmaceuticals, maker of the blockbuster drug OxyContin. Purdue filed for bankruptcy and is hoping to settle for “$10 billion.” However, the deal only includes $4.4 billion in cash, which is less than the Sackler family, owners of Purdue, transferred to personal accounts over the past decade. In other words, the amount of money the Sacklers made from the opioid epidemic is more than what they will pay more than forty states to help abate the crisis. Is anyone supporting this deal?

Yes, in fact, and this is where the plot thickens. With several exceptions, support for the deal falls along party lines: Republican AGs support the deal, and Democratic AGs oppose it. Why does a decision about settling with an opioid company appear to be political? What is the role of an attorney general? And are they supposed to defend public health?

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Contracting to counter gene patents – a 21st Century solution to access and innovation

By Sarah Ali-Khan and E. Richard Gold

As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013 Supreme Court of the United States decision in Myriad v AMP spelled the end of these patents, but the number of gene patents has actually increased since that decision. This is because, while limiting the availability of patents over genomic DNA, the court decision was narrow, leaving substantial grey zones such as over cDNA or where the patent covers a sequence of DNA used in a particular way. Patent agents have been assiduous in exploiting these grey zones to file for and obtain patents over molecular tests. This development points to continued adverse consequences of gene patents not only in the US, but around the world. Our recently published GIM article Gene patents still alive and kicking: their impact on provision of genetic testing for Long QT syndrome in the Canadian public health-care system’, not only examines the impact of gene patents in one country, Canada, but shows how 21st Century contracting can provide a nuanced and pragmatic means to enabling both access and innovation around patented genetic tests.

In Nov 2014, in the first Canadian instance of a public interest ‘test case’ in intellectual property and public health, The Children’s Hospital of Eastern Ontario (CHEO) challenged five patents held by Transgenomic Inc. over a genetic test for Long QT Syndrome (LQTS), a potentially fatal cardiac disorder most commonly striking in children and youth. Widely reported, settled in March 2016, and named as one of the year’s cases having the most impact on intellectual property, the case produced the CHEO Public Health Access Agreement. The Agreement does not itself alter law– gene patents remain valid in Canada. Rather, it constitutes a contractual agreement between parties to the litigation, allowing for efficient, no-cost test implementation. The Agreement explicitly states that Transgenomic will freely grant a license to test the LQTS-associated genes to any entity providing services within Canada’s public healthcare system. That is, except for a marginal private market, all LQTS in Canada can now be provided free. Read More

Violations of federal antifraud provisions alleged against two hepatitis B treatment producers

By Wendy S. Salkin

Two investor class-action suits have been filed within days of one another against two different California-based pharmaceutical companies both of which produce hepatitis B treatments, Dynavax Technologies and Arrowhead Pharmaceuticals. The named plaintiffs in both shareholder class-action suits, David Soontjens and Yaki J. Meller, are represented by counsel at Pomerantz, LLP.[1]

Meller v. Arrowhead Pharmaceuticals, Inc., et al., complaint filed (C. D. Cal. Nov. 15, 2016)

On November 15th, named plaintiff Yaki J. Meller filed a Class Action Complaint in the United States District Court for the Central District of California against Pasadena-based Arrowhead Pharmaceuticals, Inc., its President and CEO (Christopher Anzalone), and its CFO (Kenneth Myszkowski). Arrowhead is a biopharmaceutical company that, according to its website, “develops medicines that treat intractable diseases by silencing the genes that cause them.”

Among its clinical stage drugs are ARC-520 and ARC-521, which “are designed to treat chronic hepatitis B virus infection by reducing the expression and release of new viral particles and key viral proteins with the goal of achieving a functional cure.” ARC-520 is the drug at issue. According to the Complaint, Arrowhead knew but failed to disclose that ARC-520 “could be fatal at its higher doses and that the FDA was unlikely to approve the treatment as a result.”[2] In particular, the Complaint alleges that Arrowhead:

made false and/or misleading statements and/or failed to disclose that: (i) the Company’s ARC-520 was unsafe at certain doses and caused deaths in an ongoing primate toxicology study; and (ii) as a result, Arrowhead’s public statements were materially false and misleading at all relevant times.

According to Meller’s Complaint, in so doing, Arrowhead violated Sections 10(b) (“Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting.”) and 20(a) (“Liability to contemporaneous traders for insider trading.”) of the Securities Exchange Act of 1934, “Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting” and “Liability to contemporaneous traders for insider trading,” respectively, and Securities and Exchange Commission Rule 10b-5, “Employment of manipulative and deceptive devices.”

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Upcoming Fairness Hearing in NFL Concussion Litigation

By Christine Baugh

On November 19, Judge Anita Brody will hold a fairness hearing in the class action lawsuit of National Football League (NFL) Players v. NFL re: concussion injury. This is one of the final steps toward final approval (or rejection) of the settlement in the case. Before final approval Judge Brody must determine that the settlement is fair, reasonable, and adequate for the over 20,000 retired NFL players who are included in the class. A variety of concerns have been brought forth publicly regarding the proposed settlement, which received preliminary approval from Brody earlier this year. Around 140 retired NFL players filed objections to the proposed settlement and around 200 have opted out of the class. This blog post provides a brief overview of the settlement and objections to it.

Settlement terms (summarized):

  • Monetary Awards for those with a qualifying diagnosis. Award amount is determined based on a sliding scale that factors in diagnosis, age, and years played in the NFL.
  • Baseline Assessment Program. Class members who are Retired NFL Players have the option to participate in a baseline assessment and medical monitoring program.
  • Education Fund will be established to promote safety and injury prevention in football.

The long-form settlement document can be viewed here.

Concerns (summarized, non-exhaustive): 

A variety of concerns regarding the preliminarily approved settlement have been brought forth through the media and other channels. These are the types of issues that will likely be discussed at the fairness hearing and that Judge Brody will have to weigh in her determination of whether the settlement is fair, adequate, and reasonable for the class as a whole.

Many concerns regard the categories of diagnosis that are eligible for compensation.

Compensable categories are too restrictive: Under the current settlement agreement, former players can be compensated if they have a qualifying diagnosis of Alzheimer’s disease, Parkinson’s disease, Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s disease), death with chronic traumatic encephalopathy (between January 1, 2006 and July 7, 2014), and what are called Level 2 and Level 1.5 Impairment (these categories represent a pattern of performance on a battery of neurocognitive tests that is 2 or 1.7-1.8 standard deviations below normal, respectively). Some have argued that, although the categories included are important to compensate, there are other prevalent problems such as pituitary dysfunctiondepression, and mood and behavioral disorders that are associated with repetitive head trauma and should also be covered by the settlement agreement. Others are concerned that there are characteristics about the existing categories that are problematic (see next two points below).  Read More