Last month, He Jiankui, a Chinese researcher, announced the birth of the world’s first gene-edited babies, whose DNA had been edited to reduce the risk of HIV infection. While the claim has not yet been verified, Chinese authorities have launched an investigation and ordered this researcher’s work to stop. In the discussion that follows, Stanford Law Professor Hank Greely, an expert in the ethical, legal, and social implications of new biomedical technologies, and a Stanford Health Policy Fellow, discusses the legal and ethical questions surrounding the new world of gene-editing.

First, can you explain what the Chinese researcher, He Jiankui, did?

I’ll try but, first, we don’t know whether He Jiankui** did anything except make YouTube videos and give a talk. There has been no independent verification that these babies exist, let alone that he edited their genes. It would be a very bold fraud, but bold frauds have been carried out before in bioscience, including, notably, Hwang Woo-Suk’s false claim in 2004-05 that he had successfully cloned human embryos.

Assuming He Jiankui did what he said he did, he used a fantastic new DNA editing tool called CRISPR (“Clustered Regularly Interspaced Short Palindromic Repeats”) in human embryos very shortly after the eggs were fertilized. His goal was to change a gene called CCR5. This gene makes a protein that sits on the outside of some our white blood cells, crucial to the immune system, called T cells. There is good evidence that T cells that lack CCR5 cannot be (or cannot easily be) infected with HIV; about 1% of Northern Europeans (and a smaller percentage of people elsewhere) have a particular change in their CCR5 gene that deleted 32 base pairs (“letters”) in the DNA sequence and they do not seem to get HIV infections. So, his stated goal was to provide these embryos (and the babies, teenagers, and adults they turn into) with immunity from HIV infection. The data he released, however, shows that one of the twins only had half of her cells modified. If half of her T cells have CCR5, she could still be HIV infected. The other twin had all of her cells changed but not in the way He Jiankui intended, and not in the way found in people. We have no idea whether she will be immune, wholly or partially, from HIV infection.

Is it legal in the U.S.—or anywhere? If not, why?

It is not legal in the U.S. The FDA takes the position, which I think courts would most likely uphold, that genetically altered human embryos are either drugs or biological products (or both) and so under its jurisdiction. It is illegal—a federal crime—to distribute a new drug without FDA approval. The FDA has not approved genome editing for embryos for clinical use. For research uses only, you can get FDA permission more easily. You need to submit an application to the FDA for what’s called an Investigation New Drug (IND) exemption. You need to show the FDA that there is good reason, based on non-human research, that this will not be too risky for the research participants and that there is a reasonable chance it will be effective. His work would not satisfy either side of this and so would not get an IND.

But that’s not relevant right now because since December 2015 Congress has regularly added an amendment to the FDA’s funding bill, prohibiting it from even considering any application, of any kind, for human germline editing. So, if you did this in the US now, you’d be doing it without FDA approval, which would make your use an illegal distribution of a new drug.

In many other countries, particularly in Europe, any germline human genome editing is illegal by specific statute (which it is not in the U.S.). In most countries there is no law on this—many poor countries have other things to worry about—so it is legal (at least, not specifically illegal) in most countries.

What are the dangers? What are the potential benefits?

One danger to the children is that CRISPR might have caused damage to other parts of their DNA. These so-called off-target effects are fairly common when CRISPR is used. In addition to changes in other parts of the genome, we know that He Jiankui did not accurately make the changes he aimed for in the CCR5 gene; it’s possible that the He Jiankui-modified gene would not only be ineffective at preventing HIV but affirmatively harmful.

A second danger is that life without a working CCR5 gene may have its own problems. The Northern Europeans without it include adults and appear healthy but they haven’t been closely followed to see if they are at higher risk for other problems. There is some early evidence, for example, that they might be more susceptible to West Nile Virus and influenza.

The potential benefit to the babies is HIV immunity but it is of very little weight. One twin cannot be immune because half of her cells have CCR5. The other may not be immune. And both are “saved” from the possibility, probably small, that they would become infected after being exposed to HIV (probably several decades in the future). HIV is already a manageable disease (though certainly not fun); we have no idea how easily preventable or treatable it may be in 20 years.

The potential benefit to science/medicine is showing that CRISPR’d babies can be born but if that is worth establishing, it could and should be done in a different setting, with an embryo with a very serious disease for which no good alternative exists.

When might it become legal? 

It could become legal any time Congress lets the appropriations rider lapse (next fall) and FDA decided there was enough safety information to allow it to proceed. I expect that neither of those will happen anytime soon.

When/if it does, would it be governed or overseen by an international organization? How might it be regulated? 

Highly unlikely. In the U.S. it will be overseen by FDA and local IRBs. Not perfect but not terrible.

What are the ethical challenges we’ll face when it does become legal?

For me, really not much. The safety issues for the kids are key. Apart from that, based on our current knowledge of human genetics, there are very few situations where gene editing in embryos will be better than embryo selection. We don’t know enough to make super babies and are unlikely to anytime soon. For some people doing any genetic editing that could pass down to future generations is itself a major ethical issue, a “line in the sand” we should not pass. As I have written elsewhere, I don’t think that’s right. See https://leapsmag.com/much-ado-about-nothing-much-crispr-for-human-embryo-editing/

What legal issues do you anticipate?

If this is tried before it is legal, I would expect federal criminal charges against the clinics/scientists. That might raise the question of whether a gene-modified human embryo really is a drug or biological device for purposes of FDA law. If this is tried after it is legal and it goes wrong, big malpractice suits. If it gets used under appropriate regulation, not much.

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Hank Greely is the Deane F. and Kate Edelman Johnson Professor of Law at Stanford Law School, Director of the Center for Law and the Biosciences, Professor (by courtesy) of Genetics, Stanford School of Medicine, Chair of the Steering Committee of the Center for Biomedical Ethics. And Director of the Stanford Program in Neuroscience and Society.

** He Jiankui was a postdoctoral scholar at Stanford in the laboratory of Prof. Stephen Quake from January 2011 to January 2012. His work in the Quake lab focused on computational analysis and was in no way related to gene-editing.

The Trump administration has proposed a new rule that would require direct-to-consumer TV advertisements for prescription drugs to disclose the price of their products.

The Centers for Medicare & Medicaid Services (CMS) said the disclosures would help consumers “make informed decisions that minimize not only their out-of-pocket costs, but also expenditures borne by Medicare and Medicaid, both of which are significant problems.”

The idea enjoys broad public support, since medical care and drug costs continue to skyrocket.  A U.S. Senate report earlier this year revealed that the cost of the 20 most commonly prescribed brand-name drugs have risen tenfold in the past five years.

In a June 2018 poll, 76 percent of Americans favored required drug advertisements to include a statement about how much the drugs cost.

But Michelle Mello, a Stanford Law School professor and Stanford Medicine professor of health research and policy, writes in this New England Journal of Medicine perspective that the proposed rule raises substantial public health and legal concerns.

A potential unintended consequence of price disclosure may be to dissuade patients from seeking care, writes Mello and her co-author, Stacie B. Dusetzina of Vanderbilt University School of Medicine, because of the perception that they cannot afford treatment. For example, Trulicity, a widely advertised drug for type 2 diabetes has a list price of $730 a month.

“Patients who could benefit from diabetes treatment may assume that they cannot afford it, when in fact insured patients’ costs for Trulicity may be much lower, and cheaper treatment options available,” they write. Metformin, for instance, costs $4 per month for patients who pay cash.

CMS would demand drug makers use the list prices from the Wholesale Acquisition Cost (WAC) in their television ads, including that costs “may be different” for those who are insured.

“This wording doesn’t communicate that costs to patients are probably much lower than the WAC,” writes Mello, a core faculty member at Stanford Health Policy.

This could have important legal implications as well, as compelled disclosures in advertising impinge on commercial speech protected by the First Amendment. Furthermore, they write, “disagreement about whether the WAC accurately represents a drug’s price could affect how courts assess the rule when constitutional challenges are inevitably filed.”

The researchers say three aspects of the proposed rule undercut the government’s ability to argue that it would improve patient decision-making and reduce drug spending: 

1. Price information does little to inform consumer decisions if it inaccurately represents actual cost.
2. Consumers can already obtain information on cash prices online and their own cost from their insurer.
3. The rule contains no meaningful enforcement mechanism; CMS plans only to list violators on its website, calling into question whether companies will comply.

“We think that a better alternative would be making patient-specific cost information accessible at the point of prescribing, “ the authors write. 

The cost of prescription drugs should become a routine part of clinician-patient discussions, although they acknowledge that this would put more time constraints on medical practices.

“Providing salient cost information at the right time could help reduce drug spending while preserving patient choice, but we believe that direct-to-consumer advertising is the wrong vehicle,” they write.

A national panel of medical experts is recommending for the first time that clinicians offer daily preventive medication to patients who are at high risk of acquiring HIV/AIDS.

The U.S. Preventive Services Task Force estimates that 1.1 million Americans are currently living with HIV. More than 700,000 people have died from AIDS in the United States since the first cases were reported in 1981 and some 40,000 Americans are diagnosed with the virus each year.

Though HIV is treatable, there is still no vaccine and it has significant health consequences.

But the Task Force said in a published draft recommendation on Tuesday that it found “convincing evidence” that taking a daily pre-exposure prophylaxis, known as PrEP, provides a substantial benefit in decreasing the risk of HIV infection in people at high risk. 

PrEP is a combination of two drugs, tenofovir disoproxil fumarate and emtricitabine, taken in one daily pill. The Centers for Disease Control and Prevention says that PrEP reduces the risk of getting HIV from sex by more than 90 percent and by 70 percent for intravenous drug users.

“Unfortunately, HIV is still a major problem in the United States,” said Stanford Health Policy’s Douglas K. Owens, vice-chairman of the Task Force, an independent, voluntary panel of experts in prevention and evidence-based medicine. “But the evidence on this daily treatment is that, if you take it properly, it’s very effective.”

The Task Force, whose recommendations are followed by primary care physicians and clinical practices across the country, gave the recommendation its highest grade, an A. But it noted that PrEP currently is not being used in many persons at high risk of HIV infection. 

“We hope our recommendation will bring attention to a very effective preventative service,” Owens said. “We want clinicians to be aware that for patients at high risk of HIV, PrEP is an important preventive strategy to discuss.”

The global AIDS epidemic has slowed in recent year. AIDS-related deaths have been reduced by more than 50 percent since the peak of the AIDS crisis in 2004. In 2017, 940,000 people died from AIDS-related illnesses worldwide, compared to 1.4 million in 2010 and 1.9 million in 2004.

But many people remain at risk, including sex workers and people who have been trafficked.

The Task Force recommendation is only for those Americans who remain at high risk for contracting the virus, including:

1. Sexually active men whose male partners are already living with HIV, or have a recent sexually transmitted infection (STI) such as syphilis, gonorrhea, or chlamydia;
2. Heterosexual women and men who are sexually active and have an STI or partner living with HIV or who are inconsistent in their use of condoms with a partner at high risk of HIV;
3. People who inject drugs and either share drug injection equipment.

The Task Force reaffirmed its 2013 recommendation that people ages 15 to 65 and all pregnant women also be screened for HIV in an additional draft recommendation. Both recommendations are open for public comment until December 26.

Research by Stanford Health Policy’s Michelle Mello looks at what happens when a group of hospitals started systematically acknowledging adverse outcomes in care by apologizing and proactively offering compensation where substandard care caused serious harm. 

Hospitals have traditionally “crouched in a deny-and-defend posture when things go wrong in medical care,” said Mello, a professor of law at Stanford Law School and a professor of health research and policy. The new approach, called “a communication-and-resolution program,” or CRP, is being adopted by an increasing number of health-care facilities.

“None of the hospitals experienced worsening liability or trends after CRP implementation, which suggests that transparency, apology, and proactive compensation can be pursued without adverse financial consequences,” Mello and her co-authors write in the study published Monday in Health Affairs. However, despite the growing consensus that CRPs are the right thing to do, concerns over liability risks remain.”

Stanford Health Policy asked Mello some questions about the research:

Could this new approach to resolving patient conflict be a thing of the future?

Hospitals that adopt CRPs believe they will help improve patient safety and are consistent with the ethical obligation to disclose medical errors; they also hope they will reduce liability costs. However, there is a lot of uncertainty about their effects on costs. On the one hand, being honest with patients could avoid the anger that prompts patients to sue, and compensating injured patients early on saves on litigation expenses. On the other hand, in the traditional system, very few patients injured by substandard care ever get compensated. Offering up admissions of error and early compensation could mean a lot more patients receive payment, raising total costs. Uncertainty about this issue continues to be a barrier to widespread adoption of the CRP approach.

What were the key findings in your study?

We evaluated the liability effects of CRP implementation at four Massachusetts hospitals by examining before-and-after trends in malpractice claims, volume, cost, and time to resolution. We then compared those to trends among similar hospitals in the state that did not adopt CRPs. We found that CRP implementation was associated with improved trends in the rate of new claims and legal defense costs at the two big hospitals that implemented these programs — favorable developments that were not seen at comparison hospitals with no communication-and-resolution programs in place. CRP implementation was not associated with significant changes upward or downward in trends of new claims receiving compensation, compensation costs, total liability costs, or average compensation per paid claim, nor was it associated with a significant change in time to resolution.

So then why are the findings important?

The study helps resolve uncertainty about the liability effects of admitting and compensating medical errors, especially since the study design was much stronger than that of previous studies. We found that the CRP approach does not expand liability risk and may, in fact, improve some liability outcomes. Therefore, hospitals can “do the right thing” — be honest about errors, apologize, and compensate patients who are injured by negligence — without adverse financial consequences.

Who began the CRP approach and what is the average payment proactively made to patients who did not receive proper care?

The approach dates to the late 1990s and was first publicized by a Veterans Affairs hospital in Kentucky and then by the University of Michigan Health System, both of which reported very positive outcomes.  Stanford was also an early adopter.

The model calls for patients to be compensated at about what the hospital estimates their claim would be worth in traditional litigation. In our study in Massachusetts, the median payment to patients was $75,000. That’s a lot lower than the median payment in the tort system, but the mix of injuries is different. In traditional litigation, 85 percent of claims involve very serious injuries or deaths, because smaller claims aren’t attractive to plaintiff attorneys. They just go uncompensated. In CRPs, it’s easier for patients with moderate-severity injuries to have access to justice.

U.S. social insurance programs traditionally have been paid out to beneficiaries directly by the federal government. But the last two decades have seen an accelerated effort to subsidize private health insurance plans to provide Medicare and Medicaid benefits.

The United States has a large private health insurance sector — accounting for more than $1.1 trillion of health-care spending in 2016. Yet the taxpayer-funded Medicare and Medicaid (including special insurance for children ) account for even more than that, about $1.2 trillion, or some 40 percent of overall health-care spending in this country.

In Medicaid, which provides health care to low-income Americans, as many as 80 percent of beneficiaries are enrolled in publicly-funded, but privately-run managed care plans. That figure for Medicare, which covers the elderly and disabled, stands at more than 30 percent for their medical coverage, and many more for their drug coverage.

Over the past decade, the share of subsidization of privately run insurance plans as opposed to direct reimbursement of providers in public spending on Medicare and Medicaid has almost doubled, increasing from 22 percent to 40 percent.

“These changes raise very different policy questions, as this moves us from thinking about how, for example, Medicare should reimburse health-care providers, to how it should pay private insurers,” said Stanford Health Policy health economist, Maria Polyakova.

With the growing overlap between the public and private sources of health insurance, Polyakova worries that there is too much room for costly mistakes, or outright shenanigans.

“There’s a lot of confusion among Medicare beneficiaries about who pays how much for their benefits, as subsidies to private insurers are complex and not transparent,” said Polyakova, an assistant professor of Health Research and Policy at the School of Medicine and faculty fellow at the Stanford Institute for Economic Policy Research.

“Similarly, for policymakers, figuring out how to pay insurers rather than health-care providers raises complicated policy design questions,” Polyakova said. “We have to set up subsidies in a way that benefits patients and a competitive market, but also be aware that the private firms operating in these markets are very sophisticated and will take any advantage of any design loopholes.”

Polyakova and colleagues set out to find a formula that could benefit all sides. To do so, they focused on the private provision of prescription drug benefit in Medicare Part D. Their findings were recently released in a working paper by the National Bureau of Economic Research. 

More than 50 million individuals benefit from Medicare, which accounts for $500 billion in annual budgetary outlays by the federal government. Once enrolled in Medicare, consumers have a choice of more than a dozen Prescription Drug Plans (PDP) under what is known as the Medicare Part D program. This drug program launched in 2006 is a rapidly growing market that accounts for about a fifth of overall federal spending in Medicare, about $100 billion.

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“Beyond its sheer economic size, this market further plays an important role in policymaking, as it has become the role model for private provision of publicly funded social insurance,” wrote Polyakova and her co-authors.

Consumers of Part D bear only a small portion of the program’s cost. A consumer pays on average a $40 monthly premium, although premiums vary widely. For each consumer, the government is sending on average an additional $55 to the plan in which the consumer is enrolled, with much higher subsidies for consumers with greater health problems. The government pays the full premium for low-income beneficiaries.

The independent insurance firms are quite satisfied with the 50-percent-or-higher subsidy that comes from Washington and attracts more consumers into the market.

But is that the best use of our tax dollars?

Polyakova and her colleagues used a dataset that contains detailed information about plan prices and characteristics for all Part D plans in all markets from 2007 to 2010. The data also includes information on individual enrollment in prescription drug plans and records of drug purchases that consumers make after enrolling in a plan

They created a model that focused on two things: 

1. They first developed and estimated a model of supply and demand for drug plans. With the model, they could compute how much of government dollars benefit consumers and how much ends up being captured by insurers.
2. With this supply-and-demand model, they could simulate whatever market structure they wanted, imagining what would happen if the government gave each Medicare Part D consumer a voucher of, for example, $700 to pay for their prescription medications.

What they found is that, at least for Part D, the current mechanisms do a surprisingly good job at keeping costs low.

“On the supply-side, we find, perhaps surprisingly, that the current structure of the program mutes insurers’ ability to strategically raise subsidies, and hence positively affects total program efficiency,” they wrote.

At the same time, they also find that taxpayer dollars could be spent even more efficiently. 

Currently, the subsidy is found through a formula that uses prices set by insurers. Their simulation suggests that setting a fixed voucher-like subsidy would encourage insurers to lower prices for their plans even more. If insurers knew the fixed subsidy level in advance, then they would have a strong incentive to price as close as possible to this subsidy. Any difference between the subsidy and the premium would have to be paid by consumers, so costlier insurers may lose customers. 

Under the current system, the ultimate subsidy is linked to insurer prices and is not known in advance of insurers submitting their price bids, which makes the incentives to reduce prices slightly less strong. Great caution is required when setting such voucher-like subsidies, however. If they are set too low, insurers may be forced to quit the market or provide poor quality products.

Even more return on the taxpayer’s dollar could be achieved by setting higher vouchers for more economically efficient (but not lower quality) plans and lower vouchers for plans that have higher operating costs. Improving the return on the dollar could allow the government to spend less and still allow the same number of consumers to purchase coverage. 

“Most of our government health-care dollars are increasingly spent through this indirect mechanism of giving money to private firms and simply hoping that things will somehow work out,” Polyakova said. “But the way we design these mechanisms are hugely important: You may be wasting billions of dollars if these are not set up properly — and there are not that many people working on this, as these rules are incredibly involved.”

Some 450 million patient visits to primary care clinics occur in the United States each year. And as the shortage of doctors grows larger each year, primary care teams face increasing pressure both during patient encounters and outside the examining room.

The growing time constraints on primary care clinics — conducting patient consults faster, logging results in EMRs sooner, keeping up with regulatory changes — are worrying patients and physicians alike. 

Stanford Health Policy’s Kathryn M. McDonald and colleagues wanted to better understand the organizational influences of time stressors and the impact they are having on patients.

“Patients get interrupted often when doctors and their care teams are rushed,” said McDonald, MM, PhD, executive director of the Center for Health Policy and Center for Primary Care and Outcomes Research. “They worry about whether their concerns and needs will be addressed adequately. Getting the right diagnosis, treatment and support are all important to patients, so any risk of experiencing suboptimal care due to time stressors is worth understanding better.”

In a study published in the American Public Health Association journal, Medical Care, McDonald and her colleagues wrote that despite concern about the impact time pressure has on the delivery of health care, “scant evidence exists about types of time stress, the organizational factors that shape such stressors in routine care settings, and consequences for patients and practitioners alike.” 

So the researchers analyzed cross-sectional survey data collected from January to August 2016 from primary care teams at 16 randomly selected primary care practices associated with two large Accountable Care Organizations (ACOs) and their patients with cardiovascular disease, diabetes, or both. Through April 2016, they gathered data from 353 physicians and staff members of the clinics.

Then from May to August 2016, the researchers surveyed 1,291 patients by mail and telephone follow-up calls to ask about their concerns.

They determined that the responses translated into two types of stressors related to the lack of time: practice-level time pressure and encounter-level time pressure.

“The stressor condition is similar to the weather—determined by both barometric pressure and temperature — in potentially different way,” they posited.

They found that different organizational factors are associated with each form of time pressure. A patient-centered culture, for example, may include specific patient engagement initiatives, and is associated with reductions in encounter-level time pressure. Similarly, health information systems that provide true support for clinical workflow and good teamwork also corresponded with less encounter-level time pressure. A different organizational influence — leaders that are responsive to the clinic teams — was associated with reductions in practice-level time pressure.

The potential consequences for patients are missed opportunities in patient care and inadequate chronic care support — two very important factors behind successful health care.

“The findings underscore the importance of linking all levels and aspects of physician practice organizations to mitigate  the negative effects of time pressure on patient care” said Stephen Shortell, principal investigator of the Patient Centered Outcomes Research Institute (PCORI) grant that funded the study.  Their other co-author is Hector Rodriguez at the UC Berkeley School of Public Health.

They discovered that one-third of medical team respondents indicated they work in a chaotic practice atmosphere, juggling patient calls, documentation, quality reporting, and many other tasks. The more senior the staff member was, reports of working in a chaotic environment lessened.

Only 31 percent of those respondents said that during patient visits, it was very unlikely for the team to miss all seven specific opportunities related to screening, diagnosis or treatments. 

“Doctors’ offices may increase their chances of preventing adverse effects of time stressors by becoming more patient-centered, coordinating care among team members better and assuring that information technologies make work easier,” McDonald said in an interview about how the results might lead to some solutions. 

“I was struck by the importance of leadership’s responsiveness to their frontline team’s input about changes needed when doctor’s offices are more chaotic,” she said. “Likewise, for clinics that are part of larger groups, like Accountable Care Organizations, the corporate office’s decisions seem to play a role in the perception of time stressors at the practice level.”

The United States is in the grip of an opioid epidemic, which is affecting millions of Americans and claiming thousands of lives. Many trace their opioid dependence back to their doctor’s office, the drugs prescribed for pain after an injury, surgery, or dental procedure. Were these painkillers over prescribed? Did drug manufacturers exaggerate opioids’ effectiveness while deliberately underplaying their danger? Did drug distributors and retailers take necessary steps to ensure that pills weren’t falling in to the wrong hands?  

In this Q&A, Stanford Law Professors Michelle Mello, an expert in health law and core faculty member at Stanford Health Policy, and Nora Freeman Engstrom, an expert in tort law and complex litigation, explain the scope of the opioid problem and discuss the latest cases and legal challenges.

Just how big of a problem is the opioid crisis in the United States? Can you describe the problem’s scope and seriousness? 

Engstrom: The opioid problem is monstrous. Some 2.4 million Americans have an opioid use disorder, and the epidemic has already claimed 300,000 American lives, including 42,000 in 2016 alone. Worse, if the problem isn’t addressed, death tolls will rise: opioids are on track to claim the lives of another half-million Americans within the next decade. That’s like wiping out the entire city of Atlanta. The economic cost is also astronomical. The Council of Economic Advisors has estimated that, in 2015, “the economic cost of the opioid crisis was $504.0 billion, or 2.8 percent of GDP.”

Mello: If there’s one picture that brings home the shocking toll, it’s this one, showing trends in U.S. deaths based on data from the Centers for Disease Control and Prevention.  Nearly all of the “Poisoning” deaths shown here are opioid related. In terms of what’s killing Americans, opioids dwarf car crashes and guns.

Opioid lawsuits are now making news . Some of the actions are criminal, pursued by the states and federal government. Others of those suits are being initiated by cities, counties, and even states. What do those latter suits allege and what damages are the public plaintiffs trying to recover?

Engstrom: In the past four years, roughly 400 cities, counties, and states have initiated lawsuits seeking recovery for their additional public spending traceable to the opioid epidemic. The governmental entities claim they have been injured because defendants—typically, opioid manufacturers, distributors, and big retail pharmacies—have pumped opioids into the hands of their citizens and, in so doing, increased their spending for governmental services. Everything from policing, education, foster care, the provision of health care, even the operation of coroner’s officers, have all been made more expensive because, as compared to a healthy citizenry, an opioid-addicted populace is far less productive and needs much more by way of government help. Facing these spiraling costs, the governmental plaintiffs contend that the opioid defendants—who, they contend, caused and profited from this crisis—should foot the bill.

So, the typical defendants in these cases are opioid manufacturers, distributors, and big retail pharmacies. What is it that the plaintiffs are alleging these defendants did wrong?

Mello: There are some variations state to state, but for manufacturers, plaintiffs are typically claiming that they made false statements to prescribers and others that the drugs were safer and less addictive than alternatives, even when mounting evidence showed otherwise; that they failed to warn physicians and patients about the risks; and that the products were defectively designed—for example, because manufacturers didn’t make the pills tamper-resistant. For distributors and retailers, the claims are that these defendants failed to monitor, detect, investigate, and report suspicious orders of prescription drugs, even though reasonably prudent suppliers would have done so and the federal Controlled Substances Act requires suppliers to maintain effective controls against diversion of controlled substances to illicit markets.

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