Winter 2024

PERSPECTIVE: EMPHASIZING THE FUNCTION OF THE FEDERAL DRUG ADMINISTRATION (FDA) IN WYTHE v. DIANA LEVINE

The Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of drugs sold in the United States [1]. The FDA plays a crucial role in ensuring drug safety in the United States by issuing recalls of unsafe drugs and label changes. The Federal Food and Drug Act was enacted in 1906 and “prohibited the manufacture or interstate shipment of adulterated or misbranded drugs, supplemented the protection for consumers already provided by state regulation and common-law liability [2]. “In 1938 Congress enacted the Federal Food, Drug, and Cosmetic Act (FDCA) that included a provision requiring premarket approval of new drugs. It required every manufacturer to submit a new drug application to the FDA for review [3].”  Before 1962, the FDA had the burden of proof in proving harm to keep a drug out of the market; however, Congress amended the (FDCA) to shift the burden of proof from the FDA to the manufacturer. Now the manufacturer is required to demonstrate that its drug is “safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling” before distribution of the drug [4].

The case of Wythe v. Diana Levine raised the question of whether federal preemption can be used as a defense to state regulation of drug safety. The issue presented to the Supreme Court is whether petitioner Wyeth, a drug manufacturer, should be held liable for strict product liability and/or negligence state law claims for failure to provide adequate warning labels despite FDA approval of their drug labeling. A strict product liability (failure-to-warn) cause of action governs most legal claims for injury caused by dangerous or defective products. 

Respondent, Diana Levine, was treated for a medical condition with the drug Phenergan, which is manufactured by the petitioner Wythe. According to the drug label the drug can be administered either through the (1) IV push method or (2) IV drip method.

The facts show the respondent was treated with the IV push method. The respondent received a greater dose than the label prescribed and the drug may have been inadvertently injected into an artery rather than a vein, causing gangrene which ultimately led to amputation of her forearm.

State claims were filed in Vermont state court. “Wyeth was found negligent as well as strictly liable, the jury also determined that Levine’s injury was foreseeable; the inadequate label was both a but-for and proximate cause of Levine’s injury,” awarding damages [5].

The Vermont Supreme Court affirmed the state court’s verdict rejecting Wythe’s preemption defense. Wythe appealed and the Supreme Court granted Wythe’s petition for certiorari.

Respondent argues the labeling of the drug by the drug company was defective because there was an inadequate warning of the IV push method being of higher risk than the IV drip method. The petitioner filed a motion for summary judgment as a matter of law. The Supreme Court held that federal law does not preempt the respondent’s state law claim shielding petitioner from liability and affirmed the judgment of the Vermont State Court.

The Court reasoned that drug manufacturers are always responsible for the content of their labels when new risks emerge. They reasoned “[t]here was no direct conflict between FDA regulations and respondent’s state-law claims because those regulations permit strengthened warnings before FDA approval on an interim basis so long as it later submits the revised warning for review and approval [6].” The Court’s reasoning is based on the 1962 amendments of the FDCA that added a saving clause, indicating that a provision of state law would only be invalidated upon a “direct and positive conflict” with the FDCA [7]. This amendment set a high standard for federal preemption of state law. In short, the Supreme Court concluded the respondent’s state law claims do not obstruct the federal objectives of the FDCA.

The FDA provides an essential function in ensuring the drug market is safe and effective.   Wythe v. Diane Levine reiterates that this function is done with auxiliary help from common law and state regulation to ensure optimal compliance.

[1] CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul.

[2] Wythe v Levine, 555 U.S. 555 (2009).

[3] Id.

[4] Id. 

[5] Id.

[6] Id.

[7] Id.

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Fall 2024

PERSPECTIVE: UNDERSTANDING THE LEGISLATIVE INTENT OF THE EMPLOYEE RETIREMENT INCOME SECURITY ACT (ERISA)

The Employee Retirement Income Security Act of 1974 (ERISA) is a federal statute designed to protect the well-being of employees and their beneficiaries in employee benefit plans. The term “employee benefit plan” is defined as one which provides to employees “medical, surgical, or hospital care or benefits, or benefits in the event of sickness, accident, disability [or] death [1]. 

ERISA is a uniform federal regulatory scheme; however, ERISA does not regulate the substantive content of benefit plans. ERISA also created a course of action for employees to file claims and set standards for remedies available under the statute. 

The case of Pilot Life Insurance v. Dedeaux reinforced the significance of ERISA.  In Pilot Life Insurance, the employee filed a claim for health benefits that were ultimately terminated by the employer. The benefits the employee received were regulated by ERISA.

“Under the civil enforcement provisions of §502(a) of ERISA a plan participant or beneficiary may sue to recover benefits due under the plan, to enforce the participant’s rights under the plan, or to clarify rights to future benefits [2].” The cause of action created under this provision is a breach of fiduciary duty.

The employee in Pilot Life Insurance filed on two counts (1) a common law tort claim and (2)a contract claim asserting the employer violated a “bad faith” state law in terminating employee’s benefits; however, the employee did not bring forward any claims created under the ERISA statute.  The District Court granted summary judgement citing the pre-emption clause of ERISA.

Section §514(a) of ERISA provides, with enumerated exceptions, that ERISA shall supersede “any and all state laws insofar as they may now or hereafter relate to any employee benefit plan” covered by ERISA. This section is better known as the pre-emption doctrine.

In Shaw v. Delta Airlines, the Supreme Court noted: 

The limited legislative history dealing with §514 is entirely consistent with Congress’ goal of ensuring that employers would not face “conflicting or inconsistent State and local regulation of employee benefit plans [3].  Congress applied the principle of pre-emption “in its broadest sense to foreclose any non-Federal regulation of employee benefit plans,” creating only very limited exceptions to preemption [4].   “The question of whether a certain state action is pre-empted by state law is one of congressional intent; the purpose of Congress is the ultimate touchstone [5].”

The employee in Pilot Life Insurance filed an appeal from the District Court’s decision.  The question presented to the Court of Appeals is whether the saving clause, that exempts the pre-emption clause, applies to the employee’s claim.  The saving clause delineated in §514(b) referred to as the deemer clause states no employee benefit plan “shall be deemed to be an insurance company for purposes of any law of any State purporting to regulate insurance companies.

The Court of Appeals recognized that the saving clause is applied if the state law “regulates insurance” meaning “a law must not just have an impact on the insurance industry but must be specifically directed toward that industry [6].” 

The Court of Appeals upheld employee’s claim citing the saving clause of ERISA and reversed the District Court’s decision based upon Metropolitan Life. 

The Supreme Court acknowledged Metropolitan Life’s guidance in determining whether the saving clause applies either by (1) a “common sense view or by (2) interpreting the phrase “business of insurance” under the McCarran-Ferguson Act.

The common sense view of the understanding of the meaning of the state law is that the law “which regulates insurance” is within the plain language of §514(b)(2)(A) and is therefore saved from pre-emption of §514(a) [7]. 

The McCarran-Ferguson Act states: “The business of insurance, and every person engaged therein, shall be subject to the laws of the several States which relate to the regulation or taxation of such business.” The Supreme Court noted the term “business of insurance” under the McCarran-Ferguson Act is determined by:   “First, whether the practice has the effect of transferring or spreading a policyholder’s risk; second, whether the practice is an integral part of the policy relationship between the insurer and the insured; and third, whether the practice is limited to entities within the insurance industry [8].” 

The Supreme Court noted, “our understanding of the saving clause must be informed by the legislative intent concerning the civil enforcement provisions provided by ERISA.”  

The Supreme Court does not agree with the Court of Appeals interpretation of “business of insurance” as applied to this case and determined the state law cited in this case is one of “bad faith” not interpreted as regulating insurance and therefore not supported by the saving clause. 

The Supreme Court emphasized Congress’s intent in interpreting the ERISA doctrine by stating:        

“The policy choices reflected in the inclusion of certain remedies and the exclusion of others in the federal scheme would be completely undermined if ERISA-plan participants and beneficiaries were free to obtain remedies under state law that Congress rejected in ERISA [9].”

The predictability of the ERISA doctrine is reflected by the legislative history of Congress in creating a regulation with provisions that are explicitly stated with narrow exceptions. Understanding congressional intent also helps to ensure the regulation is being interpreted in a way that aligns with its original purpose. The case law reinforces the objective of the ERISA doctrine in protecting and promoting employee benefit plans.

[1] Metropolitan Life v. Massachusetts, 471 U.S. 724 (1985).

[2] Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41 (1987).

[3] Shaw v. Delta Air Lines, Inc., 463 U. S. 85 (1983).

[4] Id. 

[5] Id.

[6] Metropolitan Life v. Massachusetts, 471 U.S. 724 (1985).

[7] Id.

[8] Id.

[9] Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41 (1987).

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Summer 2024

PERSPECTIVE: THE IMPORTANCE OF VACCINES AND IMMUNIZATION

The Covid pandemic reinforced the significance of vaccinations. Vaccines are the most effective public health measure for eliminating disease and preventing disease outbreaks. Vaccination, along with sanitation and clean drinking water, are public health interventions that are undeniably responsible for improved health outcomes globally[1]. Immunization has led to the elimination and control of various infectious diseases; hence the practice of vaccination is vastly valued and protected within the health care community[2]. The added value of vaccination, on a population level, is the potential to generate herd immunity. Where a sufficiently high proportion of the population are vaccinated, transmission of the infecting agent is halted thereby protecting the unvaccinated, who may be those too young, too vulnerable, or too immunosuppressed to receive vaccines[3].

In the United States, the most significant impact of vaccines has been to prevent morbidity and mortality from serious infections that disproportionately affect children[4]. The Vaccines for Children Program was implemented in the United States to fund vaccinations for children after a measles epidemic revealed half the children were shown to be unvaccinated. The program is an entitlement program (a right granted by law) for eligible children, ages 18 and younger[5] . 

The schedule for childhood vaccination ages 0-6 is shown below:

Source: CDC

Vaccination in this country is state-mandated, meaning that to go to school or be considered fit to participate in certain activities, the administration of a vaccine is required. Safeguards are in place to ensure vaccines are developed in a safe, efficient, and effective manner. The National Vaccine Program Office and the Food and Drug Administration coordinate vaccine-related activities and regulate vaccines as a means of ensuring safe and effective delivery of vaccines[6]. The National Childhood Vaccine Injury Act (NCVIA) of 1986 is a no-fault alternative to the tort system and was implemented in response to the overuse of the civil liability system as a means of resolving injury claims related to a vaccine’s adverse effects. Optimal success in vaccination development is attained when vaccine manufacturers are reassured their efforts will not be stifled by repeated litigation. The Act created a no-fault compensation program designed to alleviate litigation resulting from a defective vaccine and provides tort liability protection for manufacturing companies. 

In recent years, much debate has surfaced about whether adverse effects from the diphtheria, tetanus, and pertussis (DTP) vaccines correlate with the development of autism. Concerns are focused on thimerosal, a mercury-containing preservative that is used in vaccines [7]. Claims filed through NCVIA have proven to be unsubstantiated in finding a link between autism and childhood vaccinations. However, one such claim made it to the United States Supreme Court. In Bruesewitz et al. v. Wyeth LLC, FKA Wyeth, Inc. et. al, the plaintiff, sued Wyeth LLC, a vaccine manufacturing company, on a legal theory of strict liability for the physical injury their daughter suffered after being administered a vaccine manufactured by the company.

The issue is whether Wyeth LLC, a vaccine manufacture, should be held strictly liable for the injury and resulting disabilities sustained by Hannah Bruesewitz after receiving a defective vaccine manufactured by the defendant. The Supreme Court affirmed the Third Circuit Court’s ruling. The applicable rule of law, in this case, is grounded in 42 U.S.C. §300aa-22(b)(1). The statute states,

“[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings [8].”

Based on this statute, the court reasoned that state-law design-defect claims rooted in products liability law are preempted, further suggesting the design in and of itself taken into consideration with safe manufacturing and adequate warnings is not subject to tort action[9]. Thus, the Supreme Court ruling reaffirmed the application of the National Childhood Vaccine Injury Act of 1986 as a means of delineating liability from the result of any adverse effects related to vaccine injury. Consequently, the most effective public policies directed at addressing the issue of adverse effects related to the vaccine are rooted in comprehensive vaccine-preventable disease surveillance systems. The Department of Health and Human Services funds vaccine surveillance programs that collect data from patients, clinicians, and manufacturers concerning vaccine-related injury. In 1990, the Vaccine Adverse Event Reporting System (VAERS) was established to monitor the adverse effects of vaccines[10]. The data from VAERS is utilized in myriad ways such as detecting new, unusual, or rare adverse effects from vaccines and identifying potential risk factors[11].

Case law supports a state’s enforcement of vaccination as a public health measure. In Jacobson v Massachusetts, the Supreme Court rejected a Fourteenth Amendment Due Process challenge to a state law mandating smallpox vaccination by an inhabitant who argued the state law violated his liberty rights. Ultimately, the Court ruled that the state of Massachusetts acted constitutionally within its police powers by implementing a mandatory vaccination law during an epidemic to protect the health and safety of the public and that Jacobson’s liberty interest must give way to the “common good.”In Zucht v. King, the Supreme Court reinforced this precedent of compulsory vaccination by not allowing unvaccinated children attend school even when there is no epidemic.

In Laurel Hill Cemetery v San Franciso, the court ruled that whatever the tribunal, in questions of this kind, great caution must be used in overruling the decision of the local authorities or in allowing it to be overruled…the Court is reluctant to interfere with the deliberate decisions of the highest court of the state whose people are directly concerned. The plaintiff must wait until there is a change in practice, or at least an established consensus of civilized opinion, before it can expect this Court to overthrow the rules that the lawmakers and the court of his own state uphold. [12].

The end of the 20th century marked a revolution in vaccine development as mRNA vaccines emerged as promising alternative platforms to conventional vaccines[13].  The interest in mRNA stems from its simple and inexpensive production, its transient activity and natural degradation in the human body, and its safety advantages compared to DNA therapeutics[14].

The importance of vaccines cannot be understated in terms of preventing disease and lowering health care costs. Claims of adverse effects help to reinforce the development of safe and efficacious vaccines as an ongoing process in providing quality care.

[1] Rodrigues CMC and Plotkin SA (2020) Impact of Vaccines; Health, Economic and Social Perspectives.

[2] Rosenthal, Ken S. & Zimmerman, Daniel H. (2006).  Vaccines All Things Considered.  Clinical and Vaccine Immunology, 13(8).

[3] Rodrigues CMC and Plotkin SA (2020) Impact of Vaccines; Health, Economic and Social Perspectives.

[4] Ibid.

[5] Centers for Disease Control (2023, December 19). About the Vaccines for Children program CDC. Retrieved June 14, 2024, from https://www.cdc.gov/vaccines/programs/vfc/about/index.htmlCopy Citation

[6] Rosenthal, Ken S. & Zimmerman, Daniel H. (2006).  Vaccines All Things Considered.  Clinical and Vaccine Immunology, 13(8).

[7] Vaccine Policy Issues.  CRS Report for Congress.  May 19, 2005.  <http://www.fas.org/sgp/crs/misc/RL31793.pdf>.

[8] Bruesewitz et al. v. Wyeth LLC, FKA Wyeth, Inc., et. al., 562 U.S. (2011).

[9] Id.

[10] United States.  Centers for Disease Control & Prevention.  Manual for the Surveillance of Vaccine-Preventable Diseases.  Atlanta: Centers for Disease Control & Prevention, 2012. Print.

[11] Ibid.

[12] Laurel Hill Cemetery v San Franciso, 216 US. 358 (1910).

[13] Karam, M., & Daoud, G. (2022). mRNA vaccines: Past, present, future. Asian Journal of Pharmaceutical Sciences, 17 (4), 491–522.

[14] Ibid.

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Spring 2024

PERSPECTIVE: REVIEW OF NATIONAL ASSOCIATION FOR HOME CARE & HOSPICE V. BECERRA

In 2020, over 3 million people received home health care services in the United States [1]. Home health care services are covered under the Medicare program and administered by the Centers for Medicare & Medicaid Services.  Section 1395 of U.S.C. 42 outlines the process of how Medicare pays for home health services through the Home Health Prospective Payment System. At issue is a final rule that will implement revisions to the payment system.

The National Association for Home Care & Hospice (“NAHC”) filed a complaint in the in the U.S. District Court for the District of Columbia against the Secretary of the United States Dept. of Health & Human Services because Medicare payments provided by the Centers for Medicare and Medicaid Services under the final rule were not budget neutral and improperly calculated per the Bipartisan Budget Act of 2018, resulting in a decrease in payments.

In the complaint, the plaintiff challenges the final rule stating: “… the rule violates the Medicare statute’s plain language and arbitrarily and capriciously sets payment rates at a level that will result in substantial financial harm to numerous home health agencies across the country [2].” The plaintiff also notes “Congress instructed the Secretary to compute a standard prospective payment amount for the unit of service to be based on aggregate home health agency costs as reflected in the most recently audited home health costs reports at that time [3].”

05 U.S.C § 551 of the Administrative Procedure Act permits judicial review of agency actions, findings, and conclusions that are not in accordance with law or are in excess of statutory jurisdiction, authority, or limitations. As a form of redress, the plaintiff requests an injunction that directs the Secretary to withdraw or suspend the final rule and withhold applying the new payment system until the rule has been revised [4].”


[1] National Center for Health Statistics. Home Health Care, Hyattsville, MD. 2023

[2] National Association for Home Care & Hospice v. Becerra, 23-cv-01942

[3] Id.

[4] Id.

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Winter 2023

PERSPECTIVE: PRESERVING TITLE X OF THE PUBLIC HEALTH SERVICES ACT

Title X of the Public Health Services (PHS) Act is a family planning program enacted in 1970 that requires physicians to recommend family planning services and related preventative health services to low-income and uninsured individuals. In 2016, more than four million patients, almost 90% of whom were poor or low-income, obtained care through the Title X program[1]. Per the Health & Human Services, Title X is intended to (1) advance health equity through the delivery of Title X services (2) improve and expand access to Title X services and (3) ensure health care delivery of the highest quality (cite)…..

The fiscal year (FY) 2018 Funding Opportunity Announcement (FOA) altered the criteria for the grant-making process of Title X. National Family Planning & Reproductive Health Association (NFPRHA), a non-profit organization that provides Title X-funded services, filed a motion in federal court requesting injunctive relief because the 2018 FOA undermines the objectives of Title X. The plaintiff argues the “requirement of directive counseling, the lack of any reference to biomedical family planning methods, the elimination of any mention of the recognized clinical guidelines, the minimizing of the importance of direct medical care, and other changes made by the 2018 FOA mainly favor grant applicants with little or no experience in providing high-quality family planning care[2].” The plaintiff’s claim is “unless defendants are enjoined from the 2018 FOA by this Court, NFPRHA’s physicians and the millions of patients they serve each year will suffer irreparable harm” because “Title X became, and remains, the only dedicated source of federal funding for family planning services in this country[3].”

Challenges by Planned Parenthood to the 2018 FOA were reviewed with this claim. The district court ruled against the plaintiffs citing the claim was not “reviewable” by the Administrative Procedure Act (APA). An appeal was filed and the United States Court of Appeals ruled because “the 2018 grant process has long since concluded, superseded by an amended 2019 FOA, no meaningful injunctive relief could be provided making the case moot and any declaration that the 2018 FOA was unlawful would amount to an advisory opinion.

The American Medical Association (AMA) contends the 2019 gag rule stemming from the 2018 FOA violates a code of medical ethics. The AMA states open and frank communication of what family planning services physicians can discuss with their patients is a tenant of quality care and any limitation to that rule diminishes medical standards. New motions for a preliminary injunction were filed by several states to block the 2019 gag rule from taking effect after being published in the Federal Register on March 4, 2019. The outcome of these legal challenges resulted in conflicting conclusions of the 2019 gag rule with no uniform consensus on the legality of the rule. Ultimately, a petition for certiorari was filed and the Supreme Court dismissed plaintiffs’ legal challenges to the gag rule because an amendment to the 2019 gag rule was enacted in 2021 allowing physicians more autonomy of what family planning services can be recommended or discussed with their patients.

[1] National Family Planning & Reproductive Health Association v. Azar, No. 1:18-cv-00756 (D.D.C. filed Apr. 19, 2018).

[2] Id.

[3] Id.

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