State-Level Solutions to Discrimination in Organ Transplants 

By Emily Largent

organ transplant
Doctors in North Dakota perform a kidney transplant. (Photo by ndguard/Flickr)

In recent years, alleged instances of discrimination against people with disabilities in organ transplantation have captured public attention.

In 2012, for example, the parents of Amelia Rivera, a child with Wolf-Hirschhorn syndrome, alleged that they were told their daughter was not a candidate for a kidney transplant because of her “mental retardation.” The Children’s Hospital of Philadelphia denied “disqualify[ing] transplant patients on the basis of intellectual ability.” Nevertheless, more than 51,000 individuals signed a change.org petition demanding that the hospital “allow the life saving [sic] transplant four-year-old Amelia Rivera needs to survive.”  Ultimately, Rivera received a living donor kidney transplant from her mother.

Read More

Remembering Alan Wertheimer

By Emily Largent

A week ago, I received the sad news that Alan Wertheimer had passed away. Alan made many important contributions to the philosophical literature, including Coercion and Exploitation. And while Alan would tell you that he did not identify as a bioethicist, he made significant contributions to the bioethics literature as well. I am certain his work will continue to be influential in many areas.

On a personal note, Alan was a mentor and friend. I truly appreciated his intellectual generosity and his many kindnesses toward me.

I met Alan while I was a pre-doctoral fellow in the Department of Bioethics at the NIH. My initial impressions of him were shaped by the vivid and incisive hypotheticals he offered for our consideration; the pointed questions he asked in the Department’s Works in Progress sessions (which have a reputation for “combative collegiality”); the thoughtful and rapid comments he made on manuscripts; and a surprisingly competitive bowling outing that Alan took with the Department of Bioethics fellows. Read More

Pay Disparities in Nursing

By Emily Largent

I’ve mentioned on this blog before that I had a past life as a nurse.  Therefore, I wanted to call attention to an important new study that has just come out in JAMA: Salary Differences Between Male and Female Registered Nurses in the United States.  The study found that “[m]ale RNs outearned female RNs across settings, specialties, and positions.”  On average, male nurses make $5,150 more per year than female colleagues in similar positions.  This salary gap affects 2.5 million female RNs.

There is speculation that a male nurse may be perceived as more expert simply because he is a man. This explanation is deeply ironic.  Decades  of legal barriers kept men out of the field, and historically, some nursing schools refused to admit men due to sex stereotypes that categorized caring as a feminine trait.  The Supreme Court deemed this practice unconstitutional in Mississippi University for Women v. Hogan.  While that decision came down in 1982, research suggests that men continue to face pervasive barriers in nursing school (e.g., hearing anti-male remarks from faculty).

Ongoing identification of nursing as “women’s work” and the presence of gender bias in nursing can affect male nurses in different, seemingly contradictory ways.  On the one hand, the 2000 National Sample Survey of Registered Nurses found that men leave nursing at a higher rate in their first four years of practice.  Some have attributed that attrition to the harmful effects of gender bias.  On the other hand, it has been observed that–unlike women who enter male-dominated professions–male nurses who enter this female-dominated profession typically encounter structural advantages that tend to enhance their careers.

There is a need for more nurses.  According to the Bureau of Labor Statistics’s Employment Projections, the RN workforce is expected to grow to 3.24 million in 2022.  That is a 19% increase.  Nursing is a context that highlights how gender stereotyping hurts everyone–men who encounter discrimination, women who earn less than their male counterparts, and patients who benefit most when nursing recruits and retains excellent people.

I personally found nursing to be very rewarding.  I hope this study motivates employers to scrutinize their pay structures but also to appreciate and address the broader effects of gender bias on the profession.

M.C. v. Aaronson – Update

By Emily Largent

In 2013, M.C. (a minor child), by and through his adoptive parents, filed a complaint in federal district court against the physicians who recommended and performed M.C.’s sex assignment surgery and the South Carolina Department of Social Services (SCDSS) officials who authorized it.  This was the first lawsuit of its kind filed on behalf an intersex child who was given sex assignment surgery while too young to give informed consent.

By way of background, M.C. was born with ovotesticular difference/disorder of sexual development (DSD).  Ovotesticular DSD is a condition in which an infant is born with the internal reproductive organs of both sexes; the external genitalia are usually ambiguous but can range from normal female to normal male.  Shortly after birth, M.C.’s biological parents expressed their desire to relinquish their parental rights, and M.C. was placed in the custody of SCDSS.  A team of physicians subsequently evaluated M.C’s condition and recommended to SCDSS officials that M.C. undergo sex assignment surgery in order to make his body appear female.  SCDSS consented to the surgery, which was performed in April 2006.

M.C. was adopted in December 2006.  Initially, his adoptive parents raised M.C. as a female in accordance with his assigned gender.  M.C., however, refused to be identified as a girl.  His adoptive mother has described being “really sad that that decision [regarding surgery] had been made for him. . . . And it’s becoming more and more difficult just as his identity has become more clearly male.”  M.C. is now living as a boy with the support of his family, friends, school, and others.

Read More

UCLA, CREA, and FDA

By Emily Largent

Before law school, I worked as a nurse at Ronald Reagan UCLA Medical Center.  The work was interesting, as was the news.  I was there when the Los Angeles Times published an investigation revealing that Japanese gang figures received liver transplants at UCLA and when the Times reported on UCLA employees illegally viewing medical records of celebrities.

This week, UCLA made headlines once again when officials announced that nearly 180 patients may have been exposed to a potentially deadly superbug from contaminated duodenoscopes.  Seven UCLA patients–two of whom died–were infected with carbapenem-resistant Enterobacteriaceae (CRE) after a procedure known as endoscopic retrograde cholangiopancreatography (ERCP).  CRE are a family of germs that are difficult to treat because they have high levels of antibiotic resistance, and CRE can lead to death in up to 50% of patients who become infected.

This problem is not unique to UCLA.  The University of Pittsburgh Medical Center had a duodenoscope-related outbreak in 2012. Last month, Virginia Mason Medical Center in Seattle acknowledged that 32 patients were sickened by contaminated endoscopes from 2012 to 2014.  Eleven of those patients died.  From January 2013 to December 2014, the FDA received 75 Medical Device Reports (MDRs) related to possible microbial transmission from duodenoscopes.

The FDA issued a safety communication yesterday, February 19th, which warned doctors that the complex design of duodenoscopes may impede effective reprocessing.  Reprocessing is a multi-step process to clean and disinfect or sterilize reusable devices.  The FDA noted that multi-drug resistant infections have been associated with reprocessed duodenoscopes “even when manufacturer reprocessing instructions are followed correctly.” (UCLA stated that its scopes had been sterilized in line with the manufacturer’s standards.)  Nevertheless, the FDA urged medical providers to carefully follow manufacturers’ cleaning instructions and talk to patients about the benefits and risks of undergoing procedures involving duodenoscopes.

Some have argued that this did not go far enough.  What other options are available to the FDA?

Read More

Vaccines and the Presidential Campaign

By Emily Largent

The 2016 Presidential race is gathering steam, and this has led me to wonder what–if any–effect the recent measles outbreak might have on campaigns.  While a majority of the public holds the view that vaccinating kids is the right thing to do, a growing number of people are eschewing vaccinations.  Moreover, it has been said that skepticism about inoculations is “one of those issues that . . . grab people across the political spectrum.”

I was, therefore, interested to see that New Jersey Governor Chris Christie, who launched a political action committee last month ahead of a likely run for the GOP presidential nomination, said on Monday that parents “need to have some measure of choice” about vaccinating their children.  See also here. Read More

Caffeine and the Law

By Emily Largent

Generally speaking, law school goes more smoothly when the law student is caffeinated.  Consider that Justice Elena Kagan was known at Harvard Law School as the “coffee dean” for instituting free coffee for students (and, as an aside, expects to be known as the “frozen yogurt justice” for bringing frozen yogurt to the SCOTUS cafeteria).

Last year, the deaths of Logan Stiner and James Wade Sweatt drew attention to another place where caffeine intersects with the law: the regulation (or lack thereof) of powdered caffeine by the FDA.  Both men died after ingesting powdered caffeine.  One teaspoon of powdered pure caffeine is roughly equivalent to 25 cups of coffee.  Manufacturers encourage consumers to take between 1/16 and 1/64 teaspoon (see, e.g., here), though measuring such minute amounts with common kitchen tools may be impossible.  On it’s blog, FDA observes that the people most drawn to powdered pure caffeine are “children, teenagers, and young adults.”  It is not clear how common it is for individuals to overdose on caffeine powder, as the cause of death may be listed as “heart attack” in many cases.

Read More

FDA Updates System for Explaining Risks of Meds in Pregnancy

By Emily Largent

On Wednesday, the FDA published the “Pregnancy and Lactation Labeling Rule” (PLLR), which “requires changes to the content and format for information presented in prescription drug labeling . . . to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thus allowing them to make informed and educated decisions for themselves and their children.”  The FDA also issued draft guidance for industry to assist drug manufacturers in complying with the new labeling and format requirements.

The current system, which was developed in the 1970s, uses letters of the alphabet–A, B, C, D, and X–to denote risk, with X being the most dangerous.  The PLLR removes pregnancy letter categories from all prescription drug and biological product labeling.  The new system breaks the risk into three categories: Pregnancy, Lactation, and Females and Males of Reproductive Potential.  Companies will be required to provide a summary of risks, a discussion of the data supporting that summary, and relevant information to help clinicians make prescribing decisions.  The changes go into effect on June 30, 2015.  Labeling for over-the-counter medications will not change.

The PLLR should help many women, as there are more than 6 million pregnancies in the U.S. each year.  Research suggests that over 90% of women use at least one medicine during pregnancy, and about 70% use at least one prescription medicine.  I think the PLLR is a wonderful step to enhance patient education and decision-making.  It will not, however, address our limited current knowledge of the safety of medication use during pregnancy.  About 98% of medicines approved for use in the United States between 2000 and 2010 had limited data to assess the risk for birth defects, for example.  More research is urgently needed, and it’s unfortunate that the rule stops short of requiring companies to conduct studies if none exist.

The Civil Rights Movement and the Blood Supply

By Emily Largent

This year marks the 50th anniversary of the Civil Rights Act of 1964, and this semester, I have been fortunate enough to take a class on the Civil Rights Movement with Professor Randall Kennedy.  This has prompted me to examine the influence of race on healthcare delivery in the 1940s, ’50s, and ’60s.  Racism infected all aspects of the healthcare system, including medical schools and schools of nursing, residencies and post-graduate training, professional societies for doctors and nurses, ambulance services, outpatient clinics, staff privileges at hospitals, hospital admissions, and medical research.  Doubtlessly, the color line in medicine compounded physical ills with emotional and dignitary harms.

I find the stories related to the segregation of the American blood supply during World War II to be particularly interesting because they show that discrimination was a national (i.e., not just a Southern) problem, and there is a small connection to Harvard Law School.  Speak Now Against the Day: The Generation Before the Civil Rights Movement in the South by John Egerton has proven to be an excellent source of information on this topic.

Blacks made contributions to the war effort in many capacities.  William H. Hastie, a graduate of Harvard Law School, took leave from his position as Dean at Howard University School of Law (HUSL) to accept an appointment as civilian aide to Secretary of War Stimson.  Charles R. Drew, a physician who had conducted pioneering research on typing, preserving, and storing blood for later transfusion, helped both Britain and the United States establish blood programs to support military operations. In February 1941, Drew was made medical director of the American Red Cross blood bank program.

Late in 1941, the surgeons general of the United States Army and Navy informed the Red Cross that only blood from white donors would be accepted for military use.  Although it had been conclusively proven that there were no racial differences in blood, the military yielded to prevailing social bias and heavy political pressure.  In January 1942, the War Department revised its position, agreeing to accept blood from black donors, though also insisting on rigid adherence to segregation of the blood supply.  The Red Cross not only accepted that decision but declared that it had no interest in trying to settle racial-social controversies.  Later, Red Cross officials “suggested that those who persisted in criticizing the policy were unpatriotically attempting to cripple the blood donor service and thus harm the war effort itself.”  Read More

Update: Proposition 46

By Emily Largent

I previously wrote about California Proposition 46–which proposed to raise the cap on pain and suffering awards in malpractice cases from $250,000 to $1.1 million, require doctors to check a statewide database of drug prescriptions before prescribing some narcotics, and require doctors to undergo random drug and alcohol testing–here.

What happened?  On Tuesday, voters “soundly defeated a proposal to lift a decades-old cap on courtroom damages for medical negligence, after a multimillion-dollar political duel pitting trial lawyers against doctors and insurers.”  Proposition 46 was defeated by a 2-to-1 margin, with 67% of voters rejecting it. (There is some speculation that an error in translation for voter materials could have affected the way Vietnamese-speaking voters voted on Tuesday; however, there is no suggestion this would have changed the outcome.)

Proposition 46 was the most expensive race in California this election.  The No side spent close to $60 million in its efforts to see the Proposition defeated, almost seven times the spending on the Yes side.