April 2017

A Different Kind of Egg For Easter: Scientific Proof of Fetal Pain and the Legal Right to Choose Abortion

Angela Fralish, MJLST Invited Blogger

On January 3, 2017 Congressman Trent Franks from Arizona suggested a major change in the law which could overturn precedent of more than 30 years. He introduced the “Pain-Capable Unborn Child Protection Act” which generally prohibits abortions after 20 weeks. Fueling this highly controversial legislation is a complex scientific and legal debate as to whether or not the fetus can feel pain at 20 weeks, and if that proof should result in a change in the law.

Advocates on both sides of the Act include physicians, legislators, constitutional law experts, policy interest groups, philosophers and neuroscientists. Supporters of non-interference prior to viability advocate that proof of fetal pain is not substantiated. One the other side, fetal pain protestors argue that a fetus can in fact feel pain at 20 weeks, and abortions should be proscribed between after that time.

The Supreme Court ruled in watershed cases Roe v. Wade (1973), and Planned Parenthood v. Casey (1992), that a woman’s right to elect an abortion prior to viability, which is usually 23 to 24 weeks, is a constitutionally protected “fundamental right.” Time and time again, the Supreme Court has upheld that precedent, and prevented the right to interfere with a woman’s choice prior to viability. However, new medical technology advances call the old law into question. As Supreme Court Justice Sandra Day O’Connor noted in Roe, medical science will reduce the point of viability and “Roe is clearly on a collision course with itself.”

Scientifically speaking, both parties have referenced the anatomical makeup for fetal pain to support their arguments. Studies show that the thalamus and pain sensor receptors, usually developed by 20 weeks, are used to process pain. The counter argument is that the anatomical capability to feel pain does not equate to actually feeling pain: fetuses at 20 weeks lack the necessary pain pathways, or physiological ability to communicate pain, even if the thalamus and receptors are available. Legislative findings of the Pain-Capable Unborn Child Protection Act argue that fetuses at 20 weeks not only respond to touch, but also emit stress hormones and recoil at painful stimuli. Thus, some have concluded that fetuses are indeed “capable” of feeling pain and abortion should be proscribed at that time.

So where should the court draw the line? One past example of legislation related to medical uncertainty related to fetal pain was the Partial Birth Abortion Act of 2003. After much controversy, this act was upheld by Gonzalez v. Carhart  (2007) noting that “medical uncertainty does not foreclose the exercise of legislative power in the abortion context any more than it does in other contexts.” In this sense, Congressman Trent Franks’ bill could potentially pass, despite long held precedent, because the courts retain legislative power within the abortion context when there is medical uncertainty. However, much like the Partial Birth Abortion Act, if Congress passes this legislation, it will be up to the state courts and modern day legal advocates to reinforce or discredit it on a case-by-case basis.

Only time will tell how this intricately webbed science-law issue will play out. Judith Munson quoted as early as 1975 in her article Fetal Research: A View from Right to Life to Wrongful Birth, “The controversy has become a contest between the state of the art and the state of the law.” Constitutional lawyers, physicians and the general public certainly have their work cut out for them in understanding how medical science impacts the law. As O.D. Jones remarks, “Law and neuroscience seem strange bedfellows. But the engagement of law with neuroscientific evidence was inevitable.” This holds especially true in relation to mother chicks and decisions regarding their “eggs.”


Recalling History with The FDA’s Safety Alerts

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: MJLST is pleased to welcome back Tommy Tobin for another series on Food and FDA law. This is #1 of 3 in April. You can find his earlier posts here.]

The FDA’s Safety Alerts for Human Medical Products provide insight on how the agency is protecting the American consumer. For example, through the agency’s online list of alerts, consumers are warned against using suppositories that claim that they can cure cancer. Such alerts harken back to the agency’s origins at the turn of the twentieth century.

While Dr. Harvey Washington Wiley is not a household name to most Americans today, his legacy is felt each day in our households. Dr. Wiley spent decades calling for increased protections for consumer safety. His “Poison Squad” experiments pitted healthy young volunteers against food additives to determine the effects on health. With the passage of federal legislation in 1906, the organization that was to become the FDA was on its way to its modern-day role.

One of Wiley’s remarkably prescient articles was his 1914 co-authored piece “Swindled Getting Slim,” which he wrote after leaving government service. Even at that time, Dr. Wiley found that “the whole list of obesity-cures would strain credulity to the breaking point.” Rallying against fakes, frauds, and fad diets, the piece warned the public about purveyors of weight-loss remedies that presented “simple old-time frauds under new names and new auspices, with marvelous scientific explanations of how they do the work.”

One of the products that Dr. Wiley had in his cross-hairs was the titular “Get Slim.” In his article, Wiley wrote that “Pink lemonade costs five cents a glass at the circus, but when you buy it in the form of ‘Get Slim,’ $1 is the price of a ‘twelve days’ dose.’” Not only was “Get Slim” expensive, it was also dangerous. A 1916 issue of Good Housekeeping updated readers about the story:

In the January, 1914 Good Housekeeping was published an article by Dr. Wiley and Anne Lewis Pierce entitled “Swindled Getting Slim.” In it the true character of several so-called obesity-cures was made plain, among them “Get Slim,” manufactured by Jean Downs, of New York City. The demand for “Get Slim” rapidly fell off, and the manufacturer, convinced that Good Housekeeping had caused it by calling her “cure” a fake, brought suit for $50,000. After various delays…the case was brought to trial…December 15th, 1915. Two days were spent in taking testimony, Jean Downs telling how she made the stuff and several chemists and biologists testifying that, if made as she said she made it, it was more dangerous than Dr. Wiley had said. In his charge to the jury Justice Lehman said that a magazine was within its rights in criticizing a preparation offered to the public and that unless they thought the publication of the article was inspired by malice they must find in favor of the defendant. The jury so found. Thus endeth “Get Slim.”

One of the ways the modern-day FDA carries on the work of Dr. Wiley is to warn the public against dangers lurking in their household products. For example, the FDA has issued numerous Safety Alerts against products with undisclosed drug ingredients—including several weight loss products—in recent years.

“Pink Bikini” and “Shorts on the Beach” were capsules marketed by Texas-based Lucy’s Weight Loss System. These weight loss products were the subject of a nationwide recall in 2016 when the FDA found that their ingredients included several active, undisclosed pharmaceutical ingredients. These included Sibutramine, an appetite suppressant withdrawn from the American market years earlier because it created cardiovascular risks, and Phenolphthalein, a known carcinogen which also had been disallowed due to serious health concerns. In its safety alert, the FDA noted that the offending pills should “not be consumed.”

In 2014 alone, the FDA noted over 35 public notices and recalls for products with undeclared drug ingredients. This is in addition to warnings and recalls related to consumer dangers with bacterial contaminations, glass particles, and other issues with dozens of nutritional, drug, and medical device products.

To date this year, the FDA has warned the public that certain injectable products labeled “latex free” contained latex, which could be life-threatening for those with allergies. In addition, the FDA issued a Safety Alert for certain male sexual enhancement supplements, including one with the name XtraHRD, for containing active drug ingredients. Without proper identification, consumers may take such products without knowing they contained drugs.  As such, consumers are advised not to take these capsules and to return any in their possession to the company for a refund. In considering the danger to the public, the Safety Alert noted “Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. [Erectile dysfunction] is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.”

Public health and safety is at the core of the FDA’s mission. The FDA’s modern-day efforts toward this mission honor its roots as well as the work of Dr. Wiley and others.