Bayer’s bold plan to block all future Roundup liability with science panel comes up short

Bayer has been pursuing a bold plan to clear for itself a liability-free way to sell Roundup weed killer in the future despite a series of jury verdicts finding it’s been causing cancer. Bayer had been pushing a settlement that would have wrapped up all future claims — including by people who haven’t gotten cancer yet. That plan is in limbo now after a federal judge overseeing the case expressed skepticism about it on multiple fronts.

Key to the plan was Bayer’s appeal to science. The settlement would have established a panel of scientists who would decide whether Roundup’s key ingredient, glyphosate, causes cancer. On its website, Bayer said the settlement “will return the discussion about the safety and utility of glyphosate-based herbicides back to where it belongs – to the scientific and regulatory arena and to the full body of science.”

It’s not surprising Bayer would say the dispute ought to be kept exclusively in the domain of regulatory agencies and bespoke science panels, because Bayer has been losing badly in the courts.

Judge Vince Chhabria, the federal judge in Northern California who is presiding in the case in which Bayer has been seeking the comprehensive settlement, signaled he was unlikely to give his blessing to the plan. In the context of an order denying a deadline extension, Judge Chhabria expressed doubt the proposed settlement would benefit future victims:

“Thus far, judges have been allowing these cases to go to juries, and juries have been reaching verdicts in favor of the plaintiffs, awarding significant compensatory and punitive damages. Why would a potential class member want to replace a jury trial and the right to seek punitive damages with the process contemplated by the settlement agreement?”

Judge Chhabria also doubted whether it was permissible under the law and constitution to take the fact-finding away from the courts and give that function over to a panel of scientists:

“Even with the consent of both sides, it’s questionable whether it would be constitutional (or otherwise lawful) to delegate the function of deciding the general causation question (that is, whether and at what dose Roundup is capable of causing cancer) from judges and juries to a panel of scientists.”

After the skepticism expressed by the judge, Bayer retreated from the proposed settlement with the aims of reworking it.

The case is In re: Roundup Products Liability Litigation (MDL No. 2741). Court documents can be found on a court webpage maintained for the case.

WIPO responds on COVID

Sean Flynn at the American University Program on Information Justice and Intellectual Property has posted about the World Intellectual Property Organization’s action with regard to coronavirus and intellectual property, some of which is responsive to the open letter I blogged about last month. Flynn writes, “The new initiatives and statement respond to many of the issues raised in an earlier letter from a broad coalition to WIPO’s Director General asking for a clear stance on intellectual property and the COVID pandemic.”

Coronavirus and Civil Liability for Potential Infection: Part I

Guest post by Professor John Culhane

As Congress resumes its ritual squabbling over how best to direct another round of economic relief from COVID-19, one current sticking point is whether to grant sweeping immunity from tort liability to businesses that decide to reopen. Because the reach of the commerce clause isn’t infinite, there is some question about whether such a move would even be constitutional as to local businesses, but the move is a predictable response to an issue that can be expected to gain currency as the pandemic continues to disrupt virtually every aspect of life. In this context, it’s worth examining how transmitting the virus would be analyzed under orthodox negligence principles – or, in rare cases, as meeting the requirements for intentional tort liability. In this first part of a two-part piece, I will take a look at the more straightforward intentional tort cases – battery; assault; and intentional infliction of emotional distress. The second part will attempt to sort through the complexities of possible negligence claims.

We can expect intentional tort cases to be rare. Anyone who purposely coughs or sneezes at someone else, to choose the most likely (if distressing) example, would clearly face liability for battery. The requirement of contact would be met by the airborne particles that would be transported from the miscreant who coughed or sneezed at the other person. Case law has established that blowing smoke in another person’s face is a battery, because of the smoke particles, and because the action is one that a reasonable person would find highly offensive. That’s no less true here: The kind of deliberate, anti-social conduct involved in the cough or sneeze would be, if anything, even more offensive. (The presence of a mask on the victim’s face wouldn’t change the conclusion on “contact,” by the way, because a battery is established when the defendant makes contact with anything that’s in close contact with the plaintiff, including clothing. The mask would clearly qualify as something in “close contact” with the plaintiff.)

There would also be claims for assault (if the victims was aware of the attack just before it happened). Neither battery nor assault claims would require a showing that the defendant actually transmitted COVID-19 to the plaintiff; the torts are complete with the offense, although obviously the damages would be much greater if the plaintiff could prove transmission of the virus and subsequent illness (or death). This will of course be difficult to do, and would likely be successful only in those cases where the plaintiff can reasonably eliminate other possible sources of infection. But juries that hear such cases might be expected to resolve reasonable doubts on this score in favor of the person who comes down with COVID-19 after the attack – or in favor of their estate. 

A more problematic, though still possible, tort is intentional infliction of emotional distress. Most of the requirements would be easily satisfied. The attack certainly meet the tort’s requirement of “extreme and outrageous” behavior. Further, the defendant would readily be found at least reckless in causing emotional distress, and this tort allows recklessness (conscious disregard of a known risk) to substitute for intent. The problem is that many courts have been extremely strict on the emotional distress requirement, requiring that it be serious – not just as a matter of damages, but as a sine qua non for the tort to be cognizable at all. In some states, the distress has to be debilitating, essentially – often meaning there’s been a showing of attendant physical distress. But given the emotional toll of possible exposure to this virus, in the current climate, that usually high hurdle might not prove too high to clear.

As noted above, these claims are – we must hope! – rare. Negligence is the much greater, and thornier, problem. I’ll address this in Part II of this article.

Professor John Culhane is Professor of Law and H. Albert Young Fellow in Constitutional Law and Co-Director of the Family Health Law & Policy Institute at Widener University Delaware Law School. He presented at the April 20, 2020 Mini-Conference on Coronavirus and Law.

Acute Care Hospital Bed Supply in the Time of Pandemic: Just in Time Inventory vs. Pandemic Preparedness

guest post by Ann Marie Marciarille

Thank you to Eric E. Johnson of the University of Oklahoma College of Law for putting together a Second Mini-Conference on Coronavirus and Law on April 15, 2020.  Eric was gracious enough to allow me to choose to talk about Acute Care Hospital Bed Supply in the Time of Pandemic.  All of the other participants were gracious enough to listen and ask questions, in turn. I thank them as well. 

I chose acute care hospital bed supply as my topic because of a string of op eds I noted from around the country faulting earlier hospital merger and acquisition policies that, apparently, created the tight supply of acute care hospital beds laid bare by Coronavirus  emergent hospitalizations.  Commentators in Boston, Chicago, New York, and San Francisco all implied that acute care hospital bed supply was too tight, in light of past decisions to allow mergers or acquisitions or closures.  All of this led me to the question of just how tight we want acute care hospital bed supply to be?

Don’t look in conventional antitrust law on merger analysis for language on leaving some excess acute care bed supply in the system in preparation for surge or pandemic needs, because you won’t find it.  This also made we wonder why we have no way to talk about these things or why we lack the vocabulary to ask these questions.

Practice experience reminds me of a few situations where opponents of mergers had mixed in, along with other grounds, the cry that wringing all the excess acute care bed capacity of the system would leave us ill prepared for another 1918-style flu epidemic or 1908-style earthquake.  Such arguments typically gained little traction, as there was no consensus that surge or pandemic emergency capacity had any role to play in conventional merger analysis’s focus on technical and scale efficiency in acute care hospitals and the goal of greater competition by wringing excess supply out of the system. 

But we are humbled now or as humbled as we may be for some time by the incredible surge in demand the leaking stories of people, particularly people who are low income, being sent home with fever, pneumonia, and instructions to self-monitor which turned into instructions to self-monitor unto death.  Is what was formerly seen as excess capacity really idle capacity necessary for pandemic or mass disaster preparation and ought merger analysis take some cognizance of the interest of the acute care hospital bed consuming public in having some flex in the bed supply?

I am still thinking about this.

[Cross-posted at https://www.marciarille.com]

Prof. Alan Z. Rozenshtein on the Fourth Amendment and Covid

At our Fourth Mini-Conference on Coronavirus and Law, Professor Alan Z. Rozenshtein gave an excellent talk titled “Disease Surveillance and the Fourth Amendment.” Here are the slides from his talk. His key points are that we are going to need disease surveillance, that currently the Fourth Amendment allows almost anything along these lines, and that we therefore will need additional safeguards. Professor Rozenshtein argues these safeguard should be found within the Fourth Amendment itself.

Professor Rozenshtein has been blogging about coronavirus and Fourth Amendment issues at Lawfare blog. His “Disease Surveillance and the Fourth Amendment” post provides a nuanced explanation of the doctrine in this area, and his “Government Surveillance in an Age of Pandemics” post provides useful historical and global context.

Rep. Bill Foster’s letter to HHS and FDA

U.S. Representative Bill Foster (Illinois 11th) is working on the issue of speeding up vaccine approval. Along with former HHS secretary and current member of Congress Rep. Donna Shalala (Florida 27th), Foster is spearheading a letter signed by dozens of members of Congress to HHS Secretary Azar and FDA Commissioner Hahn asking them to consider using human challenge trials to speed up a vaccine. The letter, which is worth reading in its entirety, is here: https://foster.house.gov/hhs-fda.

I believe it is too late to add signatures at this point, but consider calling your representatives to alert this to this effort and to ask them to support it.

“Thinking About the Legal Dimension of the Pandemic”

On Friday, April 10, 2020, I presented at the First Mini-Conference on Coronavirus and Law—held over Zoom.

My talk was “Thinking About the Legal Dimension of the Pandemic,” and it leaned heavily on a forthcoming law review article I co-authored with Ted Bailey. I intended the talk as an introduction to the mini-conferences. In it, tried to make three points.

My first point was that the pandemic is not just a function of biology, it is also a function of law. How transmissible and fatal COVID-19 is depends on various legal inputs (mandated public health measures, regulatory approvals of treatments, etc.). My second point was that many professionals involved in this fight (clinicians, research scientists, etc.) seem to take the law as a given, something that can’t be changed. My third point follows from the first two—since the pandemic is in part a function of law, and since those on the frontlines in the healthcare field are not used to thinking that the law can be used, redirected, or changed, then there is the opportunity to make progress against the coronavirus pandemic by thinking of the law not as a fixed constraint but as a lever we can adjust. To sum it up: Changing the law can fight the pandemic.

Skladany in The Hill on state governors’ power to compel manufacturing pandemic medical supplies

In an opinion piece in The Hill, Penn State Dickinson law professor Martin Skladany argues that governors ought to be threatening to use their general police powers to compel manufacturers in their states to begin manufacturing personal protective equipment (PPE).

“In the absence of a quick and robust federal response,” Skladany writes, “governors need to seize an additional weapon in this fight. Even if they do not compel in-state manufacturers, just the threat of doing so could help them negotiate with companies or push the Trump administration to do more.”

The news is filled with examples of companies jumping in to help with the the fight against the pandemic by repurposing their assets and human resources. Among the many examples are a Chicago pizzeria using its oven to make face masks and a Brooklyn whiskey distillery making hand sanitzer. But to the extent businesses with relevant assets and expertise aren’t helping, Skladany’s plan is worth serious consideration.

Skladany acknowledges, of course, that states vary with regard to governors’ powers. And Skladany acknolwedges that any governors taking action along these lines would probably provoke lawsuits challenging the constitutionality of such moves. But he’s nuanced about this. The mere rattling of the saber may be sufficient to help push businesses in a state into doing more to help.

Indeed, this gets into an important thing that non-lawyers often don’t grasp about the law: Uncertainty in what the law allows doesn’t mean the law in this regard is bad or useless. To the contrary, uncertainty is often a powerful encouragement for opposing parties to meet in the middle. That often—although not always—creates good-for-society solutions where everyone gets at least part of what they want.

by Eric E. Johnson

Speed up the FDA’s vaccine-approval process [full text of WaPo opinion piece]

It seems some users will not be able to see the opinion piece I wrote with Ted Bailey on the WaPo site because of the Washington Post’s paywall. Here is the full text:

Speed up the FDA’s vaccine-approval process

By Eric. E Johnson and Theodore C. Bailey

With the coronavirus pandemic, our challenge is to move faster than a very fast-moving problem. Changing the law could help.

The estimated 12-to-18-month timeframe for getting a vaccine to market is largely because of safety and efficacy testing required by the Food and Drug Administration. Legislation could shorten that timeframe without compromising the science — if the testing process tolerates more risk on volunteer study participants.

The FDA’s long-standing approval process places a premium on keeping human subjects safe. For most problems, this represents a prudent calibration of risks and benefits. For the coronavirus, however, the tradeoffs are different. The general public faces imminent danger from a virus capable of exponential growth.

Over the years, Congress has repeatedly, and rightly, stepped in with legislation to speed the process. Now, Congress should act to sharpen the curve of innovation against covid-19 by pushing the FDA to suspend its rules and practices and navigate according to the judgment of its experts.

Regular FDA approval processes begin human testing with a phase-one trial that must run its course with a small number of subjects — studying safety before enrolling subjects for larger phase-two and phase-three trials to assess a vaccine’s effectiveness. Yet clinical trial phases that are typically sequential could be combined or overlapped.

Collapsing trial phases without compromising scientific standards will require exposing more individuals to uncertain risk. Yet to do otherwise in a rapidly expanding pandemic leaves the global population exposed to a bureaucratically protracted period of pandemic risk without medical mitigation.

In the current crisis, it is ethically defensible to expedite clinical research with the cooperation of well-informed and consenting clinical subjects. There is no “safe” choice; it’s a risk-risk tradeoff — a question of more risk for research subjects or a longer wait for an approved vaccine.

We should respect the will of selfless individuals to knowingly take on the risks of investigational vaccines as an act of service for the sake of ending the pandemic.

Eric. E Johnson is an associate professor of law at University of Oklahoma College of Law. Theodore C. Bailey is chief of the Division of Infectious Disease at Greater Baltimore Medical Center.

My op-ed with Dr. Ted Bailey in the Washington Post on speeding up vaccine approvals

Dr. Theodore Bailey of Greater Baltimore Medical Center and I argue in a Washington Post opinion piece published today that one way the law can help end the pandemic is by speeding up the vaccine approval process at the FDA.