Category: Blog

            The U.S. Public Health Emergency (PHE) that began at the start of the COVID-19 pandemic concluded on May 11, 2023, ending the temporary policies started in response to the pandemic. These changes have affected the American public in different ways. For those with Medicare, over-the-counter COVID-19 tests are no longer free, and coverage regarding COVID-19 testing and treatment will change depending on the insurance plan. Another change that comes with the termination of the PHE is that COVID-19 vaccines and boosters will continue to be free, but only until the federal stockpile lasts. While these changes might seem obvious as COVID is not as prominent as it once used to be, there are some changes that have negatively impacted underserving a community’s way beyond COVID-19 coverage.

            One of these changes includes Medicaid redeterminations restarting. Continued Medicaid enrollment ended March 31, 2023, and states have restarted Medicaid and Children’s Health Insurance Program (CHIP) edibility reviews. Some patients that usually do not qualify for Medicaid, did qualify during the PHE period. This means that these patients have the dreadful task of finding and transitioning to another type of insurance. Unfortunately, the only insurance option was Medicaid for some of these patients, as they could not afford anything else.

            A direct consequence of the end of the PHE will be the looming loss of Medicaid eligibility for the millions of Americans who come from low-income households. There could be as many as eighteen million enrollees without coverage as a result of the new eligibility requirements. The U.S. Department of Health and Human Services predicts that people of color will lose coverage because of administrative barriers, not because they don’t qualify in many instances. 

The end of PHE will affect more Black and Hispanic communities since they are twice as likely to be Medicaid recipients. This sudden cut in coverage will only worsen an already failing healthcare system for people of color; this is because the cut in coverage will reduce access to screenings and preventive care for chronic diseases that are more common in people of color, overload already overburdened hospitals with emergency care, and cripple low-income families with medical debt.

 To avoid or lessen all of these inequalities in the healthcare system, states must act as soon as possible. For example, states can market campaigns to encourage citizens to sign up for alternative care that has COVID-19 benefits, as well as communicate with Medicare enrollees so that they at least know their coverage is coming to an end. The state of Colorado has already taken a proactive approach to healthcare insurance by opening enrollment for a program called OmniSalud that assists undocumented residents and individuals with protections through the Deferred Action for Childhood Arrivals program in obtaining affordable healthcare insurance. Communities that lack these kinds of programs should follow suit and protect their most vulnerable residents.

  It is an overstatement to say that COVID has ended when it has not. It is important to remember that moving out of an emergency state does not mean the impact on vulnerable communities has concluded. It is imperative that states enact policies that prevent the worsening of COVID-induced inequities in the most vulnerable communities.

Spooky season is upon us, but what do you do when you get the kind of jump scare you do not want?  On October 4^th, Walmart shopper Veronica allegedly experienced exactly that when she opened a package of Reese’s cups to find that mealworms and maggots had breached the batch. In the PSA video that Veronica posted to TikTok, she opened several Reese’s Cups on camera, demonstrating that she didn’t plant the worms herself. Comments on the video pose several questions: could it be last year’s leftover candy? Could there have been a packaging defect? The latter, of course, leads to the inevitable question: is this a Walmart problem, a Hershey problem, or will this become a mass consumer problem?

Calls for a product defect recall against Reese’s Peanut Butter Cups circulated the internet for the first time in 2014, when two men posted a video on Twitter alleging similar circumstances as Veronica’s. The same year, Fact-Checker David Mikkelson pointed out the indeterminable veracity of the video. Global insect-eating enthusiasts, on the other hand, find no problem mixing a little protein with their candy. In Bon Appetite magazine’s 2014 publication, Larry Peterman discloses not only that his company, Hotlix, creates exclusively insect-filled candies, but also that the Food and Drug Administration told him that he doesn’t have to clip the stingers off scorpions before adding them to lollipops! This, however, does not distract from the reality that in the average consumer’s preferred candy-to-insect ratio, there is such a thing as much too much, and the FDA is inclined to agree.

The FDA’s stance on insect contamination in food is that in order to be permissible, it must also be “natural or unavoidable.” The natural and unavoidable ratio of insect-to-chocolate is on average sixty or more fragments to 100 grams of chocolate, introduced or unfiltered during the processing stage of production. That’s more than a hundred bug fragments in every Hershey’s Candy Bar—and that’s before it even hits the shelves. Yet, these candy bars are still considered safe for consumption. Meanwhile, Trader Joe’s has pulled almond cookies and broccoli cheddar soup off the shelves due to insect contamination possibly too high for even the apparently insect-loving FDA. Most consumers are also unsurprised to find wasp heads in figs, as they play an essential role in pollination. So, could the line between “too much” and “much too much” be drawn depending on expectations? And what do consumers do when confronted with creepy-crawly tricks in their Halloween treats this October 31^st?

Products liability may have an answer. The Civil Jury Instructions for products liability offer a consumer expectations test, which states that in order to prove a product is defective—or, in this case, too defective to eat—”a plaintiff must prove that the product failed to perform as safely as an ordinary user or consumer of the product would expect when used in an intended or reasonably foreseeable manner, including reasonably foreseeable misuse.” Thus, companies like Walmart and Hershey may not be liable if candy is improperly stored, is beyond its expiration, or contains maggots. In a case arising from Texas, plaintiff Peables Fowls experienced a shock upon finding maggots in the Almond Joy she purchased and popped into her mouth while sitting in the Walmart parking lot. Not only did she launch herself from the truck, but she also left it in reverse and nearly lost her car to oncoming traffic. Upon review of Ms. Fowls’ tort case, The District Court found that a vendor has no duty to inspect or test a product manufactured by another for latent defects like maggots or mealworms. On a wider scope, companies may conduct food recalls voluntarily or the FDA may request a recall. So, between FDA regulations, company candidness, and products liability, the message to candy consumers this Halloween seems be: if you don’t want to risk getting tricked, the safest bet is to avoid the treat.

In a bold move, California Governor Gavin Newsom recently enacted legislation banning four commonly used additives, including Red Dye No. 3. As the Golden State takes this proactive stance to protect public health, the Food and Drug Administration (FDA) is facing pressure to take similar action on a national scale.

            The four additives at issue in the legislation, which are all commonly used in United States food and beverage production, are brominated vegetable oil, potassium bromate, propylparaben, and Red No. 3. Red No. 3 is a dye used for coloring in foods such as Nerds, Peeps, and many Halloween treats.

            The bill put forth by Governor Newsom, titled The California Food Safety Act, prohibits the use of these four additives in California beginning in 2027. Newsom notes that the four additives in the bill “are already banned in various other countries;” Newsom also cited the  European Union’s near-complete ban on Red No. 3. By delaying the bill’s implementation until 2027, Newsom stated in the bill that he intends to give brands significant time to revise their recipes to avoid these harmful chemicals. Newsom also pressured the FDA to review and establish updated national safety levels for these additives.

            Given the pressure from Governor Newsom and consumer advocacy groups to ban the use of Red No. 3 and other additives in foods, the FDA may take action. The definition of food additives in the Federal Food, Drug, and Cosmetic (FD&C) Act contains a provision for the use of ingredients that are “Generally Recognized as Safe” (GRAS) without pre-market approval from the FDA. There is no GRAS exception for Red No. 3 and other color additives, as they are not included in the definition of food additives. Instead, Red No. 3 and other synthetic dyes are subject to a formal FDA certification process based on safety and purpose to be listed. Should the FDA wish to reverse its certification and ban the use of Red No. 3 for all purposes, it could easily do so via the same regulatory action it took to restrict its use in 1990.

The FDA restricted Red No. 3 in 1990 by banning its use in cosmetics and externally applied drugs, citing their own studies that determined that FD&C Red No. 3 is an animal carcinogen. By banning Red No. 3 from being used in cosmetics and externally applied drugs but not banning its use in food, the FDA implicitly stated that Red No. 3 was somehow safe enough to be ingested, despite not being safe enough to be applied to the skin.

The FDA still has not banned the dye from being used in foods, despite its website reading, “The FDA does not approve the use of a color additive that is found to induce cancer in people or animals.” This language stems from the Delaney Clause of the FD&C Act, which forbids any additives in food shown to be carcinogenic in any species of animal or in humans. Despite their studies determining it to be carcinogenic, the FDA currently allows Red No. 3 to be used in food and drugs. This policy contradicts the Delaney Clause and the FDA’s stance of not approving carcinogenic color additives.

            California can use its economic strength to influence the FDA’s decision-making regarding the fate of Red No. 3. Because California contributes significantly more to the U.S. GDP than any other state, corporations heavily consider California’s regulations. The FDA should proactively promote a state of uniformity by banning Red No. 3 nationwide because national food companies currently using Red No. 3 will likely have to adjust their formulas to accommodate California law anyway.

In addition to its influence on corporations, the California Food Safety Act could serve as model legislation for other states seeking to ban additives including Red No. 3. This would lead to an industry-wide state of disarray, where every state allows its own different set of additives. The FDA can and should prevent this chaos by implementing a national ban on Red No. 3.

            It’s been more than a year since the passage of the Inflation Reduction Act (IRA), which made over $393 million in investments towards reinforcing existing energy infrastructure, furthering R&D on clean energy sources, and strengthening the Internal Revenue Service’s collections efficacy. One of the IRA’s blockbuster provisions has increasingly made waves in the news and courthouses nationwide: the Medicare Drug Price Negotiation Program. Before the IRA’s enactment, the Health and Human Services (HHS) Secretary was prohibited from involvement in negotiations between pharmacies, drug manufacturers, and prescription drug plan sponsors under the “noninterference” clause. The IRA inserted an exception to the clause that now mandates the Secretary to negotiate prices directly with manufacturers for a select number of expensive “single-source” branded drugs or biologics without generic or biosimilar counterparts.

In response to the Program, drug companies and trade groups have filed ten complaints across seven federal forums around the country (Astellas dropped their complaint as their drug did not appear on the first round of negotiations). The plaintiffs include Merck, U.S. Chamber of Commerce (through its Dayton chapter), BMS, PhRMA, Janssen, Boehringer, AstraZeneca, Novartis, and Novo Nordisk. Interestingly, the root of many of the plaintiffs’ novel constitutional claims are the consequences if any of the ten manufacturers choose not to participate in the Program.

All manufacturers of the first ten branded drugs up for negotiation were required to begin the negotiations by October 1, 2023. Any manufacturer that fails to negotiate with Centers for Medicare & Medicaid Services (CMS) will be required to either pay an excise tax amounting up to 95% of the medication’s sales or cease its participation altogether in Medicare and Medicaid. Since Medicare held a 30% share of U.S. retail prescription drug spending in 2017, nonparticipation or nonagreement to the negotiations would be a huge deal for several manufacturers.

While it is too early to tell whether the courts will validate some of the constitutional claims, we at least know that there is some skepticism regarding some of the plaintiffs’ due process arguments: such is so in the U.S. Chamber of Commerce complaint. In a disappointment to the Chamber and its members, Judge Michael J. Newman not only denied the Chamber’s motion for a preliminary injunction on the program but expressed disapproval of their due process claims, one of which is that the negotiated prices were confiscatory and thus violated the Fifth Amendment. Judge Newman stated that the negotiated prices were not confiscatory because participation in Medicare was voluntary for drug manufacturers, whether it was a wise business sense or not. Given that the order also cites plenty of Sixth Circuit precedent supporting the notion that participation in Medicare is voluntary, it will be interesting to see whether this impacts other constitutional arguments throughout the litigation’s lifecycle. This is especially so since the present Supreme Court is exceedingly suspicious of Fifth Amendment violation matters.

            The Chamber of Commerce suit is just the tip of the Medicare Negotiations Program litigation iceberg. There are also First, Fifth, and Eight Amendment concerns raised by many of the plaintiffs’ complaints (e.g. the 95% excise tax can be considered an “excessive fine” under Eighth Amendment). Some even expect the disagreement across the circuits to result in a fast track to the Supreme Court, which casts much uncertainty on the legal survival of a program that would yield $98.5 billion in savings for Medicare over ten years – only time will tell.

            Between one to three million cases of domestic violence are reported nationally every year; however, there are an estimated ten million victims when including unreported cases. Historically, domestic violence was considered a familial matter that should be dealt with in the home, not in the courtroom. Slowly but steadily, the Battered Women’s Movement created the beginning of domestic and family violence concerns in the legal sphere. The movement, with a slogan of “we will not be beaten,” sought to raise public awareness of domestic violence and advocate for better policy. The movement focused on battered women’s syndrome as a way to psychologically describe the effect of long-term trauma in abusive relationships, and was used as an expanded self-defense argument in court. Continuing into the 1960’s, the first cases of domestic violence were transferred from criminal courts into family courts in New York. With the prominence of domestic violence as a national concern, the advocates began to debate the best approach to minimize the violence.

            The Victim of Crime Act (VOCA), passed by Congress in 1984 and amended in 1988, was established to provide funding to states for victim assistance and compensation programs for victims of violent crimes. However, it was not until 1994 that the first federal law was created directed towards domestic violence. The Violence Against Women’s Act (VAWA), which recognized domestic violence and sexual assault as a national crime, highlighted that the creation of federal law can help relieve state and local criminal justice systems that are overburdened with family violence matters through much needed funding and large scale resources.

In further effort to decrease violence, on March 20, 2023, the Department of Health and Human Services (DHHS) announced a new office under the Administration for Children and Families (ACF): the Office of Family Violence Prevention and Services (OFVPS). The office was created with the goal of prioritizing domestic violence prevention and educating the intersections of preventative work throughout the federal government. OFVPS has 3 main goals: to develop an AFC-wide action plan regarding domestic violence within social service programs, coordinate and collaborate efforts with agency partners, and prioritize continued implementation of appropriations.

Most notably under this department, Representative Lucy McBath reintroduced the Family Violence Prevention and Services Improvement Act (FVPSA), which will reauthorize and expand funding for survivor support programs and preventative family violence programs.

FVPSA was originally introduced in 1984 and was again reauthorized on April 13, 2023. The FVPSA is now the primary stream of funding for emergency shelters and victim assistance programs for domestic violence survivors and their children. Compared to VOCA and VAWA, it is the only federal source that is specifically dedicated to funding domestic violence services. The domestic violence programs provide survivors with vital resources such as shelters, safety planning, crisis counseling, legal advocacy routes, and other support services to leave their abusive partners. 

Funding under VAWA, VOCA, and FVPSA has shown to improve nationwide responses to domestic violence and other forms of sexual violence at both the federal, state, and local level.

FVPSA alone currently provides to over 1.3 million victims and their families every year. Through this Act, funding for domestic violence has been federally increased to roughly two hundred and fifty million dollars. Culturally specific programs will be expanded for larger access, and in combination with the VAWA Reauthorization Act of 2022, Indian Tribes have a stronger capacity to exercise their sovereignty over cases of domestic violence within tribal land. However, despite these resources, domestic violence remains rampant.

Domestic violence is a silent epidemic in America, and since the COVID-19 pandemic, demand for domestic violence services has only increased. Unfortunately, domestic and sexual violence services face continual budget deficiencies with the continual increasing demand. Federal funding should be increased and allocated towards preventative measures to decrease victimization, in addition to the continual focus on remedial support for victims and their families. As of May 25, 2023, the Biden Administration has released a national strategy plan to end gender-based violence. This plan includes elevating the office FVPS, establishing new FVPSA grants, and allocating increased funds to Department of Justice VAWA programs. If continued into the next administration, federal funding shows a positive step towards combatting domestic violence.

            The coronavirus pandemic has had far-reaching effects in various sectors of health law, including medical malpractice. Within the malpractice sector, there have been changes to how claims are litigated because ofemergency statutes changing liability, and there will likely be an increase in claims due to an increase in hospital-acquired infections. As a result, hospital systems are being forced to respond with higher-than-expected costs of litigating these malpractice claims and are passing on these cost issues to future patients through decreased available capital.

            The U.S. has mirrored an international model limiting liability in response to the pandemic. Italy, after seeing its first wave of COVID-19 cases, limited the legal responsibility of hospital professionals to gross negligence. An Italian study of medical malpractice in a COVID-19 setting identified two critical points that were subsequently addressed with U.S. liability statutes: the pandemic had a heavy burden on healthcare resources, and because of limited understanding, treatment and preventative measures were limited.

Statutes enacted during the pandemic limited the ability of some patients to seek out medical malpractice claims surrounding COVID-19 care and hospitalizations. The federal government responded with §3215 of The Coronavirus Aid, Relief, and Economic Security (CARES) Act, which immunized volunteer healthcare workers from liability when providing COVID-19 services during the emergency response.

States also responded with liability limitations protecting healthcare workers which are now starting to see claims being brought. New York, for example, enacted the Emergency Disaster Treatment Protection Act (EDTPA) which immunized hospitals from liability for COVID-19 related services with the exceptions of “willful or intentional criminal misconduct, gross negligence, recklessness, or intentional infliction of harm.” The act has since been repealed, but it was enacted at the time of a patient’s 2020 death. In the subsequent lawsuit, the healthcare workers were found to not be liable since they were not grossly negligent. Similar cases are likely to follow, but the costs of litigating these claims will remain for both parties.

            Despite liability limits, malpractice claims may continue to rise in the ongoing fight against COVID-19. As hospitals faced workforce shortages and health worker burnout and trauma, many had to restructure their floors and create new COVID units with ever-limited staff. As a result, the number of hospital-associated infections (HAIs) understandably increased. During 2020 and 2021, following the initial start of the U.S. based pandemic response, central line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), and methicillin-resistant Staphylococcus aureus (MRSA) bacteremia all increased over 2019 data. From 2019 to the third quarter of 2021, ventilator-associated events increased by 60%. These numbers suggest even more claims will arise out of the pandemic as patients recover and seek out remedies for their unnecessarily long and traumatic hospital stays resulting from their HAIs.

            These changes are resulting in higher than anticipated litigation costs to hospitals. This is impacting their ability to budget on top of a decrease in operating margins from the pandemic. Together, these limits on projected income and increased output for litigation costs are negatively impacting patients further; break-even margins force hospitals to restrict spending and limit investments in patient futures. As the number of HAIs has increased, so have claims, and therefore the cost of litigating has increased. This cost is being passed off to patients in the form of decreased future health expenditures and may create even more malpractice claims in the future as hospitals struggle to keep up.