Train tracks interchange leading around a curve as a controlled fire burns on the track during repairs.

COVID-19 and the Problem of Multiple Sufficient Causes

By Nina A. Kohn

Although politicians and pundits warned that businesses would drown in a “tidal wave” of lawsuits seeking to hold them liable for COVID-19 infections, plaintiffs face significant barriers to recovery. Not the least of these is the requirement that a tort plaintiff establish that the defendant was the “actual cause” (or “cause in fact”) of the plaintiff’s injury. This seemingly simple requirement creates a profound barrier to holding even the most negligent, reckless, and bad intentioned actors liable for spreading COVID-19. As others have observed, in a world in which SARS-CoV-2 is increasingly ubiquitous, plaintiffs will often be unable to show that their infections resulted from any particular bad actor’s behavior.

It is in this environment that a seldom used theory of causation — the “multiple sufficient causes” approach — may find new relevance. But it is also in this environment that the American Law Institute (ALI) — an organization comprised of leading lawyers, judges, and academics that publishes influential “Restatements,” or summaries, of common law — is being urged to jettison that theory in the Restatement Third of Torts.

Read More

Gavel lying in a courtroom.

The Impossibility of Legal Accountability for COVID-19 Torts

By Chloe Reichel and Valerie Gutmann Koch

Since the first days of the COVID-19 pandemic, employers, businesses, and other entities have anticipated litigation around tort claims associated with the novel coronavirus. Early in 2020, scholars here began to grapple with questions of tort liability relating to the pandemic response. However, nearly three years later, it appears that the warnings of a “tidal wave” of lawsuits were vastly overstated.

In this symposium, we asked torts scholars to reflect on questions surrounding whether and how individuals and entities might be held liable for the harms associated with SARS-CoV-2 infection, particularly as infection has grown increasingly widespread and COVID mitigations have become more limited or entirely eliminated.

Read More

IRBs Advise Physician Involvement in Informed Consent

By Nadia N. Sawicki

Much has been written about the Supreme Court of Pennsylvania’s recent decision in Shinal v. Toms, in which the court held that a physician’s duty to obtain informed consent, as codified in Pennsylvania’s MCARE Act, is non-delegable. According to the court, a physician faced with an informed consent suit cannot defend himself on the grounds that the patient was adequately informed of the risks and benefits of treatment by a physician assistant, nurse, or other intermediary acting under the physician’s direction. Pennsylvania is not the first state to adopt this view – courts in other jurisdictions (Connecticut, Louisiana, South Dakota, Texas, New Mexico) have similarly held that the duty to secure informed consent rests with the treating physician alone.

The MCARE (Medical Care Availability and Reduction of Error) Act was passed in 2002 to reform Pennsylvania’s medical malpractice laws, and refers to the duties and rights of “physicians” and “patients.” Shinal, likewise, addressed the issue of informed consent in the context of medical treatment. Thus, I was very surprised to learn that some commercial institutional review boards (IRBs), in reliance on the Pennsylvania Supreme Court’s decision, have been advising clinical trial investigators to revise their consent forms and processes to ensure that physician-investigators – and not recruitment coordinators, nurses, or other study staff – secure the consent of research participants.

Schulman, one of the most well-known commercial IRBs, recently posted about the Shinal case on its website; while noting that the case focused on medical malpractice “and does not address consent in the research context,” it advised investigators to “discuss with their legal counsel the impact of this decision on their consent process.” Sterling IRB had a similar post, advising investigators to “consider drafting consent form updates to clearly require that only physician members of the research team may obtain informed consent from a research subject.” In an e-mail that went directly to investigators and study staff, Sterling also suggested that they submit updated consent forms that “make clear that the only person who can obtain consent is the PI/physician.” A recent article in the Journal of Clinical Research Best Practice, titled “What Impact will the Shinal Case have on Informed Consent in Clinical Research?,” offered a more detailed analysis of the case, and concluded that “there is little to suggest that courts would not uniformly apply the same informed consent standards used in the medical practice to clinical research.” Read More