Gavel And Medical Stethoscope

Does DOJ Actually Reward Cooperation by Health Care Organizations? New Data Raises Questions

By Jacob Elberg

For decades, even as the Department of Justice has pressed for corporate cooperation and self-disclosure, the health care industry and the white-collar defense bar have expressed skepticism regarding the actual impact of engaging in those behaviors. When it comes to the resolution of civil False Claims Act (FCA) cases – the primary tool for government action in response to corporate misconduct in the health care industry, through which the Department of Justice generates more than $2 billion annually – DOJ’s response has been a series of public statements amounting to, “trust us, we reward those things.”

Until now, the health care industry has been without any mechanism to test those assurances. Read More

Don’t Ask What Money Can Do For the Opioid Plaintiffs, Ask What Pharma Can Do For Them

Jennifer Oliva’s insightful commentary on Oklahoma’s settlement with Purdue Pharma and the Sackler family detailed the settlement terms and posed important questions about the sufficiency of the agreed damages. I’d like to push a little further on a couple of fronts.

First, what does the journey from Cleveland, Ohio to Norman, Oklahoma tell us about the opioid litigation and the multi-district (MDL) process, some aspects of which I have addressed elsewhere. Second, while dollar figures (expressed in profits, harms, and even philanthropy) have dominated the headlines, should we be paying more attention to non-monetary remedies?

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Dov Fox on BYU Radio

dov fox headshotBill of Health contributor Dov Fox joined BYU radio’s Top of Mind with Julie Rose to discuss his new book, “Birth Rights and Wrongs: How Medicine and Technology are Remaking Reproduction and the Law,” and the implications of the largely unregulated U.S. fertility industry.

Across the country, more and more Americans choose to put off starting families, with many relying on the lucrative U.S. fertility industry for family planning when the time comes. Though a booming enterprise, the industry remains distinct from other medical practices: it offers patients little recourse for medical mistakes and misconduct. Read More

Image of Normal blood cells next to a sickle blood cell, colored scanning electron microscope image.

Recharting the Course of Sickle Cell Disease – Who will Benefit?

By Vence L. Bonham and Anitra Persaud

Scientific advancements in gene therapy and the implications of leveraging this technology to develop new curative therapies are at the forefront of medical research. Sickle cell disease (SCD), the most common genetic blood disorder, stands center stage. Last month, 60 Minutes aired a segment showcasing the story of a patient at the NIH Clinical Center who is on her journey to a cure of sickle cell disease (SCD) with the help of an experimental gene therapy.

Preliminary clinical trial findings suggest that gene therapy has an acceptable level of safety and can help individuals with the disease produce normal red blood cells instead of the sickle-shaped ones that underlie the physiological basis of the disease and its complications. Given these promising results, there is hope that gene therapy may catalyze a turning point for the SCD population, a community that has long suffered the debilitating effects of not only their disease, but of longstanding neglect within the medical system and research enterprise. Read More

Illustration of mitochondrial donation

Time to Revisit the Prohibition on So-Called “Three-Parent IVF”?

In an editorial appropriately titled, “This Editorial Is Not About Designer Babies,” the New York Times supported efforts by the Petrie-Flom Center and suggested it was time for Congress to consider lifting the effective ban on mitochondrial replacement therapies — sometimes colloquially but inaccurately referred to as “three-parent IVF.”

The piece referred to the Petrie-Flom Center’s upcoming public event and Roundtable, where experts will have a general conversation about the state of the law in the U.S. and elsewhere and to, as a group, discuss whether the prohibition against MRT might be lifted and, if so, how that might be accomplished.

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Of Risk and Gene Drives

A few weeks ago, I attended a panel on gene editing at Harvard Medical School that covered some aspects of the science, ethics, and law of the practice. It was an interesting talk, in part because it largely covered the ethical issues of gene editing for human medicine and in other species as two sides of the same coin, rather than as fundamentally different conversations, as they are often treated.

Indeed, one member of the audience asked why there is so much focus on the safety and ethics of human gene editing, when the stakes, he argued, are much higher in the use of gene editing for environmental engineering. A botched human germline edit could harm a family; a botched gene drive could kill us all. It’s an interesting point. And because it suggests that we may want to be less than sanguine on the use of gene drives to eradicate malaria, on which I have previously been extremely sanguine, it is a point worth responding to. Read More

a pile of vaccine vials and a needle

Where Calls for Overturning Bruesewitz v. Wyeth Go Wrong

This week, legislators in Minnesota proposed a resolution calling on Congress and the President to legislate to overturn the Supreme Court’s decision in Bruesewitz v. Wyeth, 562 U.S. 223 (2011). Similar resolutions have been proposed in other states – and like them, this resolution is supported by legislators who are not anti-vaccine. You could support vaccines and yet have concerned about limits on access to courts and support broadening them. However, the phrasing of this specific resolution strongly suggests that its supporters suffer from misconceptions about our vaccine compensation scheme.

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Regulating Human Subject Research: Like Being an Unwilling Participant in a Very Nerdy Version of Groundhog Day

This is the first in a series of blog posts highlighting how I am developing an overview of some of the significant gaps in regulation of human subject research. I will be looking at the use of living human beings as participants in experiments conducted by academics to advance knowledge, as well as by biomedical companies to test new products.

My goal is two-fold: I hope to develop the first Nutshell in Human Subject Regulation as a valuable handbook for those studying and working in this field. In addition, I hope to bring together two issues that are often separate: providing greater protection to people who participate in research as subjects, and increasing the quality of the information generated. Read More