GOP Confusion Over Stem Cell Research

Bill of Health Contributor Dov Fox has a new article up on the Huffington Post:

Republican candidates convened last night for the first debates of the 2016 campaign. The presidential hopefuls disagreed on every topic they faced — immigration, health care, foreign policy, gay rights, the economy — all but one, that is. Their differences of opinion disappeared each time they were asked about the controversy over the recent release of an undercover video with Planned Parenthood. On the issue raised by that edited film clip, the candidates came together in a rare consensus.

All 17 — from Ted Cruz to Carly Fiorina — staunchly opposed research that uses tissue cells from aborted or miscarried fetuses. The candidates unanimously called for Congress to end its support of Planned Parenthood over its contribution to that research, with some like Louisiana Gov. Bobby Jindal joining party leaders who would force a government shutdown over that issue. This, after Senate Republicans earlier this week failed to clear a procedural vote to defund. […]

Read the full article here.

Reproductive Malpractice and the U.S. Military

Check out the new op-ed at HuffPo by Bill of Health bloggers Dov Fox and Alex Stein on the unfair treatment of American servicewomen (and their children) under the Feres doctrine should they fall victim to medical malpractice during their pregnancy or delivery. Fox and Stein call for SCOTUS to fix the loophole it left open in the 1950 case, or for Congress to “set up a fund for compensating children whose disabilities were caused by substandard care at military medical facilities.”  Take a look at the full post here.

Are Egg Donors like Miners and Boxers?

By Dov Fox

The U.S. tax court has just issued its long-awaited decision in Perez v. Commissioner, 144 T.C. No. 4 (Jan. 22, 2015). (Hat tip to Richard Carpenter, who represented Perez.) The case decided whether the $20,000 a woman called Nichelle Perez received to provide her eggs is, for IRS purposes, taxable income, or, instead, recovery for physical damages, which would make that payment tax-free. An introduction to this case is available in my earlier Bill of Health post: Can you be taxed for selling your eggs?, and at greater length in last year’s Taxing Eggs: A Mini Symposium, over at the Faculty Lounge. And the opinion cites thoughtful articles by Professors Kim Krawiec, Bridget Crawford, and Lisa Milot.)

The legal question presented was whether the payments Perez received are tax-exempt “damages” under Section 104 of the Internal Revenue Code. The court held they did not, and thus could be taxed. Judge Holmes observed that the contracts had characterized those payments as consideration for pain and suffering rather than the eggs themselves. He explained that “the injury here, as painful as it was to Perez, was exactly within the scope of the medical procedures to which she contractually consented.” Accordingly, “the payments were made not to compensate her for some unwanted invasion against her bodily integrity but to compensate her for services rendered.” Despite the pain and danger Perez incurred through the process of egg retrieval, Judge Holmes affirmed that “the money she received was not ‘damages'” because “she voluntarily signed a contract to be paid to endure” those risks. I’d be interested to learn whether readers find persuasive the Court’s provocative analogies to egg “donation”: Continue reading

Dov Fox on Racial Sorting in Family Formation

Check out Dov Fox‘s new op-ed on racial sorting in family formation over at Huffington Post: Reproducing Race.

The piece was prompted by this week’s news of the white lesbian mother who sued a sperm bank for mixing up the sample she ordered with that from a black donor. The impulse to call one’s mixed-race child a “wrongful birth” gives reason, Dov argues, to rethink the racial preferences that we tend to accept without question; race-matching should be resisted for expressing the divisive notion that single-race families should be preferred to multiracial ones and that families should be set apart by race.

The Expressive Dimension of Donor Deferral

By Dov Fox

The Guardian and L.A. Times are the latest major news organizations to decry trans-Atlantic restrictions on blood donation by men who have sex with men (MSM). The case against such categorical bans has been reignited by an influential piece that Bill of Health editor Glenn Cohen recently published with co-authors Jeremy Feigenbaum and Eli Adashi in the Journal of the American Medical Association. Cohen, Feigenbaum, and Adashi make a powerful case why sexual orientation should be just one component among others used to assess the risk that blood donors might spread HIV.[i]

But their argument elides exactly what is—and isn’t—wrong with excluding men who have sex with men from donating blood. At times they suggest the longstanding U.S. ban reflects “outdated homophobic perceptions.” Yet they acknowledge that it was “well-intentioned and guided by a need to protect the integrity of the national blood supply.” Indeed, the Food and Drug Administration that enacted the lifetime MSM ban solicited guidance from the National Gay Task Force whose recommendations were adopted into Red Cross blood collection procedures.[ii] It’s unlikely the policy was motivated by animus as opposed to concern for public health.

Elsewhere, the authors imply the policy’s chief offense is that it deprives MSM of a crucial “civic opportunity.” But giving blood, even if it shares the life-saving potential of military service and registration as an organ donor, is not typically regarded as a duty of citizenship tantamount to voting or jury service.[iii] So it’s not its effects on those it excludes that makes the donor ban so bad.

The best reason to let low-risk gay men give blood lies in the demeaning message that excluding them expresses, what I’ve called the expressive dimension of donor deferralContinue reading

The U.S. Supreme Court vs. The American Psychological Association

by Dov Fox

The U.S. Supreme Court has not in recent years held the views of the American Psychological Association (APA) in so high regard as it did this week.

In 2012, the Court set aside the APA’s arguments for why due process requires the exclusion of eyewitness testimony obtained under suggestive circumstances that rendered it especially likely to be unreliable.

And in 2011, when the Court struck down on free speech grounds a state regulation on violent video games, it gave short shrift to the APA’s warnings about those games’ connection to violent behavior in young boys.

But in its recent death penalty decision, Florida v. Hall, the Court relied heavily on important APA insights in declaring it unconstitutional for states to set an IQ cutoff to determine whether a prisoner is eligible to receive capital punishment. Continue reading

Michael Jackson and Emotional Damages

by Dov Fox

You know the King of Pop died in 2009 while rehearsing for a comeback tour in London. Here’s a twist you may not have heard about: Michael Jackson fan club members sued Conrad Murray, the doctor who administered the lethal overdose of anesthesia. And the celebrity enthusiasts won. A French court recently awarded five of the grieving fans economic damages (albeit just a euro each) to compensate for their emotional suffering.

The case highlights a neglected problem in our own law, not just medical malpractice, but constitutional and common law too. It’s this: Supreme Court rules and policies about harm, compulsion, and intentionality rely on the flawed assumption that operations of the mind are meaningfully distinct from those of the body. In our new essay on Dualism and Doctrine, Alex Stein and I (1) demonstrate just how this fiction distorts the law, (2) argue that the reasons for its persistence cannot save it, and (3) identify the ways in which courts should uproot dualism’s pernicious influence on our legal system. Continue reading

On Patents, Patients and the Public Interest

By Michael Young

Earlier this month, a U.S. District Court in Delaware issued an injunction to bar sales of a minimally invasive Medtronic replacement heart valve that putatively infringed on competitor’s Edwards Lifesciences valve system patent.  After this ruling was issued, Medtronic filed an emergency motion requesting stay and expedited appeal of this injunction, contending that that “if the injunction were permitted to go into effect, treatable patients [with aortic annuli larger than 25mm for whom Edwards’ valve is not suited] may unnecessarily die in the name of already expired patent rights. Put simply, the calamity to public health that would result from the injunction is premised on a legally improper extension of patent rights” (Medtronic v. Edwards, 08-CV-0091, 2014).  Shortly thereafter, The Federal Court Circuit of Appeals agreed to postpone the injunction and to expedite Medtronic’s appeal.

While still unraveling, this case offers unique insights into the important yet often overlooked dialectic between patient safety and patent rights.

Continue reading

Genetic Mugshots

Dov Fox

New technologies can put pressure on the logic of the law. Consider the well-settled legal conclusion that equal protection rights don’t apply when police use race-based descriptions to look for suspects. An emerging forensic technique called DNA phenotyping makes it hard to defend this reliance on racial proxies–rather than appearance itself–in the investigation of crime.

Phenotyping promises to use a piece of hair or skin left at a crime scene to infer an unknown person’s physical characteristics like eye color, nose shape, and cheekbone width. A groundbreaking new study — featured in last week’s NatureNew Scientist, and Time Magazine — used high-resolution 3D images and facial recognition software to approximate the facial features of almost 600 people of mixed ancestry from their DNA.

I consider the scientific, constitutional, and criminological implications of this technology in The Second Generation of Racial Profiling. I argue that reliable DNA phenotyping would force us to rethink whether race-based suspect descriptions are the kind of racially classifying state action subject to strict scrutiny–and it would lean on the narrow tailoring requirement that the state use race-neutral alternatives when possible. I summarized my replies to the best policy objections in a short piece on The Future of Genetic Privacy:

Critics of the forensic technique argue that its adoption would imperil individual privacy and facilitate racial profiling. These objections are important, but they’re overstated. What “a person knowingly exposes to the public,” the Supreme Court has held, “is not a subject of Fourth Amendment protection” against unreasonable searches and seizures. And statutory safeguards could be afforded for sensitive external traits about whether a suspect has changed genders, for example, or had plastic surgery.

Racial profiling is another concern. That the technology could be used to target minorities at disproportionate rates, however, gives no reason to think that such misuse is probable or any more likely than DNA dragnets or stop-and-question sweeps based on race-based suspect descriptions. The adoption of more precise physical markers in place of notoriously unreliable eyewitness observation would improve arrest accuracy and enhance police legitimacy.

The more serious worry is that DNA phenotyping might resurrect discredited conceptions of racial biology. If the [National Institute of Justice-funded] technology works as well as the government is banking it will, however, then replacing race-based suspect designations with the colors and shapes of facial features could, to the contrary, loosen the hold that race has on the way that people think about crime. Today’s all-points-bulletin for a “black man” could give way to tomorrow’s search for a suspect with dimples, copper complexion, and green eyes.

Wouldn’t police just filter these markers into racial terms? Maybe not, if they’re trained like clerks at a makeup counter are to trade in racial identifiers for face shapes and color tones. Besides, measures short of prohibition would likely soften whatever risk the adoption of DNA phenotyping would pose to egalitarian norms — for example, requiring higher burdens for investigatory use, or racial impact assessments of the kind that gained national prominence after the Supreme Court struck down a key provision of the Voting Rights Act.

Dov Fox quoted on pre-natal DNA testing

Dov Fox is quoted in a story in this morning’s Boston Globe on a new study recommending pre-natal DNA testing as a superior method for detecting chromosomal abnormalities in a fetus. 

“This technology is certainly only in its infancy as the range of testable conditions expands, physical conditions, cognitive conditions, even behavioral ones,” said Dov Fox, an assistant professor of law at the University of San Diego School of Law. “That will only further complicate how parents decide what counts as healthy or acceptable in the children that they have.”

Read the full article.

 

Dov Fox on the FDA’s ruling on 23andMe

Dov Fox has a new piece up at the Huffington Post on the 23andMe controversy: “Genetic Testing Needs a Nudge.” From the article:

Mail-away genetic testing promises to revolutionize the way that people learn about and manage their health. Already half a million Americans have sent their saliva to find out their risk of genetic disease — no doctors needed.

Splashed across TV sets nationwide this past summer was 23andMe’s invitation to discover “hundreds of things about your health,” including that you “might have an increased risk of heart disease, arthritis, [or] gallstones.”

Since the company’s inception in 2007, the government had allowed it to market and sell its at-home genetic tests free of regulation. For $99 and the click of a mouse, 23andMe promised a “first step in prevention” to “mitigate[e] serious diseases.”

But this winter, the Food and Drug Administration issued a letter forbidding sales of the test to diagnose health conditions unless there is evidence that it works for that purpose. Shortly after 23andMe announced that it had “suspended” all sales of its “health-related genetic tests to comply” with the FDA directive, consumers brought aclass action lawsuit against the company, alleging that it “falsely and misleadingly advertises” the genetic test “as providing ‘health reports on 240+ conditions'” in the absence of “analytical or clinical validation.”

The 23andMe controversy illustrates a stalemate over the role of direct-to-consumer genetic testing in American health care.

You can read the full piece here.

Can you be taxed for selling your eggs?

Dov Fox

Those who deal in alternative ways of making families use euphemisms that obscure the market mechanisms at work when individuals ‘‘donate’’ their eggs or sperm, couples ‘‘contribute’’ their embryos, surrogates ‘‘offer’’ their wombs, and orphans are ‘‘matched’’ to adoptive parents. Make no mistake, family formation is big business. The question of first impression before a San Diego Tax Court judge is whether that business is taxable.

Nichelle Perez, like almost 17,000 other women every year in the U.S. alone, received payment (in her case $20,000) for providing her eggs to the infertile through an invasive and risky process of ‘‘superovulation.’’ When the IRS sought to tax that payment as business earnings from self-employment, Perez objected that it ought to be exempted, lest she ‘‘be[] penalized for doing something good for another person.”

Should the sale of eggs that have grown inside a woman’s body be taxed like property that’s subject to a long-term capital gain? Or does the pain and suffering that the transaction involves make it more like a settlement from a personal-injury lawsuit? Does the answer turn on the legal (or moral) status of human eggs? Or on whether the conditions under which a woman agrees to their extraction are meaningfully ‘‘voluntary’’?

Continue reading

Fox interviewed on NPR about FDA’s Ban on Direct-to-Consumer Genetic Testing

Bill of Health Contributor Dov Fox was interviewed today on NPR’s “Marketplace” about the FDA’s decision to ban all sales of direct-to-consumer genetic testing by 23andMe.

23andMe provides information about genetic health risks to people who buy at-home “DNA spit kits.” The company seeks to inform consumers about their susceptibility to more than 250 diseases. But the FDA now says the company hasn’t proved the tests are accurate enough, and the agency is worried Americans are relying on the results instead of visiting their doctor. The FDA exercised its jurisdiction under the Food Drug & Cosmetic Act to regulate the DNA spit kits as a genetic device used in the diagnosis or treatment of disease.

“This field of personalized medicine is really in its infancy,” said Fox, “and its terrifically exciting what we might learn one day, but its just not there yet. 23andMe hasn’t shown that their reports about your health from your genes alone are all that useful. They’re just not accurate at this time in the way that the FDA requires.”

Critics say regulators are standing in the way of consumers having the convenience of obtaining information about their own health at a reasonable price point without an expensive trip to the doctor.  According to Fox, it’s a powerful argument that is often made by genetic testing companies such as 23andMe. The problem is the public’s understanding of genetics is very low. “These tests,” he argued, “come not only with limited accuracy, but also without the benefit of genetic counseling.”

Continue reading

Dov Fox on Roe v. Wade

In a new piece at the Huffington Post, Bill of Health Contributor Dov Fox explores “The Forgotten Holding of Roe v. Wade — that states have a valid reason to regulate reproductive conduct because of an interest in “potential life.”

That “the State may [legitimately] assert” that interest, Roe held, “as long as at leastpotential life is involved,” explains why the government may, as a constitutional matter, restrict stem cell research that destroys human embryos, for example, whether or not those frozen embryos might otherwise be brought to term. That the fetus “represents only thepotentiality of life,” on the other hand, and accordingly lacks any interests of its own under the Constitution, explains why states may not, as many have tried, accord the legal status of personhood to human life beginning at conception.

The potential-life holding helps to resolve these and many other disputes over embryo contracts, fetal pain, and sex selection, for example, as I show in a forthcoming article. Arecent lawsuit exemplifies the enduring significance of Roe‘s potential-life holding. The case marks the first-ever federal challenge to fetal protection laws that punish women for using drugs during pregnancy.

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Dov Fox on screening sperm donors’ DNA

In “Company seeks to make sperm banks safer,” a recent article in the Boston Globe, Bill of Health blogger Dov Fox recently weighed in on new companies that propose to screen sperm donor DNA in an effort to reduce the chance that children conceived with donated sperm will have childhood genetic diseases:

Dov Fox, an assistant professor at the University of San Diego School of Law who studies bioethics, said it is unclear whether genomic understanding will evolve to allow testing such as GenePeeks offers to ever be informative for common diseases caused by a blend of genetic and environmental risk factors. And he, like others, worries that one day such technology will be extended to not just avoiding disease, but selecting the babies parents want. GenePeeks will not cross that line, Morriss said.

Read the full article here.

Dov Fox on the question of “designer babies”

Bill of Health blogger Dov Fox was quoted in the recent article “Genetic-testing patent raises concerns about ‘designer babies’.”

“‘Some people might say this is in some respects similar to dating websites to the extent you look for traits in somebody you want to have children with,’ said Dov Fox, a law professor at the University of San Diego. But the important question, he said, is whether the accuracy from the genetic testing, albeit imperfect, makes 23andMe’s service more troubling.”

View the full article here.

Fox on 23andMe’s Designer Baby Patent

Check out blogger Dov Fox‘s new op-ed over at HuffPo discussing 23andMe’s Designer Baby Patent.  Here’s a quick taste: 

Even if 23andMe doesn’t bring its donor selection technique to market, there’s still reason to resist granting such patents in the first place. Patents do more, after all, than incentive innovators to disclose their inventions to the public. When the government confers a patent for a particular invention, it implicitly approves of that invention as an object worthy of exclusive rights. A patent award sends the message that this is an invention whose development should be protected and promoted.

The utility standard in patent law requires that a patented invention be “socially beneficial.” That requirement once contained a morality condition that rendered ineligible for patent protection inventions whose sole use was deemed “injurious to the well-being, good policy, or sound morals of society.” But this morals dimension of patent law’s utility requirement has more recently fallen out of favor. The PTO expressly rejected the argument that “patents should not issue for [human] genes because the sequence of the human genome is at the core of what it means to be human,” and the Supreme Court declined even to consider such morality-based arguments in last summer’s gene patenting case of Myriad Genetics.

Congress should consider amending the patent law to appoint ethical representatives to the PTO. Its present staff, given their alternative professional backgrounds and competing professional responsibilities, cannot reasonably be expected to account for the relevant methodology and literature. But qualified experts could equip the PTO to enlarge the range of arguments that it draws upon to determine whether an invention serves social utility.

Dov Fox on Genetics and “The End of Family Secrets”

Bill of Health blogger Dov Fox was featured in a recent National Geographic article on genetics and genealogy.

Dov Fox, an assistant professor of law at the University of San Diego who specializes in genetic and bioethical issues, told me that it’s only a matter of time before genetic genealogy leads to lawsuits regarding fidelity, paternity, and inheritance. But it’s unclear, for now, how the law will handle those cases.

Here in the U.S., there aren’t any federal privacy statutes that would apply, Fox says. The U.S. Genetic Information Nondiscrimination Act (GINA), passed in 2008, says that health insurers and employers cannot use an individual’s genetic information to deny medical coverage or to make employment decisions. But genetic genealogy doesn’t have anything to do with medical risks. That means lawyers will have to get creative in how they present their cases.

“What happens often with advances in science and technology is that we try to shoehorn new advances into ill-fitting existing statutes,” Fox says. So genetic genealogy cases might hinge upon laws originally written for blackmail, libel, or even peeping Tom violations.

For more, read the full article here.

Does Individuality Save Eugenics?

Dov Fox

So asks medical historian Nathaniel Comfort in today’s Scientific America, echoing Ross Douthat’s New York Times inquiry into Eugenics, Past and Future. Comfort and Douthat are skeptical of the view, articulated by an emerging class of academics, that individual parents should use reproductive technologies to select or enhance certain genetic traits in their children.

“Hitler gave eugenics a bad name,” is how I expressed this view in the first scholarly examination of that ideal, “but there is nothing objectionable as such about the eugenic ambition to produce people of a particular type.” Comfort illuminates two centuries of developments in the medicine, society, and culture of “eugenics.” But he offers little analysis of why individuality fails to “save” the new eugenics, beyond his two assertions, heard often in these debates, that it risks “unforeseeable consequences” and might “dissolve into a species of collective eugenics.” What more might be said in support of this second suggestion, that a political theory that privileges freedom, equality, and fairness cannot accommodate individual choice about offspring characteristics?

Continue reading

Dov Fox on the Future of Genetic Privacy

Bill of Health contributor Dov Fox has a new op-ed at the Huffington Post on “junk” DNA and the future of genetic privacy in the aftermath of the Supreme Court’s ruling, in Maryland v. King, that police may collect DNA from people under arrest. Fox argues,

The next great controversy over forensic DNA won’t have anything to do with whether police can test “junk” DNA from people whose identity they already know. It will be about whether police can look “more broadly” at the “other stuff” that genetic information can reveal from people who aren’t yet known to them. That our DNA could serve as an eyewitness has powerful implications, beyond individual privacy, for the pervasive role of race in the investigation of crime.

Read the full piece here.