A spree of remarkable rulings has already made 2022 a jaw-dropping year for health care and pharmaceutical law, where the U.S. Supreme Court reshaped abortion rights, opioid crisis prosecutions, Medicare's rulemaking powers and vital sources of hospital income. At the midyear mark, Law360 recaps the rulings and analyzes their implications.
Abortion Rights Suddenly Changing at 'Incredible Pace'
In one of the most consequential and controversial rulings in Supreme Court history, right-leaning justices on June 24 overturned another of the high court's most consequential and controversial rulings — Roe v. Wade — and thereby eliminated the half-century-old constitutional right to abortion.
Within weeks of the 5-4 decision in Dobbs v. Jackson Women's Health Organization, highly restrictive abortion laws took effect in roughly a dozen states, and enforcement of similar statutes is anticipated soon in roughly a dozen more. In some states, the availability of abortion care has been changing by the day amid a flurry of court rulings. …
In addition to affecting patient access, the fluctuating legal landscape is complicating the everyday delivery of health care services. Doctors and pharmacists have reported concerns about legal exposure in connection with procedures and pills that could, at least in theory, facilitate an unlawful abortion.
"Providers have struggled to keep up with the rapidly changing state laws and to understand how those laws — often drafted by non-clinicians — are to be applied to the care being provided to patients," Jennifer Nelson Carney, an Epstein Becker Green lawyer, told Law360. …
'Major Questions Doctrine' Clouds HHS Rulemaking
The first half of 2022 ended with a bang on June 30 when the Supreme Court — in a 6-3 decision along ideological lines — invoked the "major questions doctrine" in West Virginia v. U.S. Environmental Protection Agency. The invocation carried big implications for climate change, but even bigger implications for executive branch rulemaking, much of which emanates from the U.S. Department of Health and Human Services.
Although the high court had previously applied versions of the doctrine, it had not done so explicitly. As described by the majority in the EPA case, regulations with vast "economic and political significance" can qualify as "major questions," and agencies must identify "clear congressional authorization" for such regulations.
Given that HHS oversees more than $1.5 trillion in annual spending, focuses on life-or-death topics and publishes thousands of pages of regulations per year, its policymaking could be especially vulnerable. Lobbyists and litigators might increasingly argue that disfavored HHS regulations present "major questions" and exceed congressional authorization. …
Epstein Becker Green member Stuart M. Gerson echoed that prediction, saying, "You would find me, as a litigator who represents all sorts of health care providers, attempting to do it in an appropriate case. ... West Virginia v. EPA offers something that litigators like myself are going to look at seriously."
Gerson cautioned, however, that corporate health lawyers should "temper any alacrity with a realistic judgment" of whether something is truly major. …
As in the EPA case, Chevron deference is seemingly being diluted via neglect; the Supreme Court even avoided the Chevron framework when deciding two HHS cases this year — the ones involving 340B and disproportionate share hospital payments — even though deference was a central theme at oral arguments.
In an interview, Gerson predicted that "Chevron is not going to die," and that "agencies will get deference in [cases that] involve technical matters that courts are not competent to decide." But generally speaking, he added, judges "have read Chevron out of the game — they're just ignoring it."