Summer 2025

PERSPECTIVE: THE SCOPE OF THE ENVIRONMENTAL PROTECTION AGENCY’S AUTHORITY UNDER §1311 OF THE CLEAN WATER ACT

The question presented in City and County of San Francisco v. Environmental Protection Agency (2025) is whether “the challenged limitations violate the Clean Water Act, by failing to identify specific limits to which petitioner’s pollutant discharges must conform[1].”

The Supreme Court’s ruling in this case addressed the Environmental Protection Agency’s (EPA) regulatory authority under the Clean Water Act; a comprehensive water quality statute that generally prohibits “the discharge of any pollutant by any person[2].”

The Clean Water Act states:

It is the policy of Congress to recognize, preserve, and protect the primary responsibilities and rights of States to prevent, reduce, and eliminate pollution to plan the development and use of land and water resources…[3].

The Act defines the term discharge of a pollutant to include “any addition of any pollutant to navigable waters from any point source,” and defines the term “pollutant” to mean, among other things, solid waste, sewage, garbage, chemical waste, biological materials, industrial, municipal, and agricultural waste discharged into surface waters[4].

The Clean Water Act requires cities to acquire a National Pollutant Discharge Elimination System (NPDES) for such discharges. The EPA established the National Pollutant Discharge Elimination System as a national approach to maintaining water quality standards. This permitting framework allows the discharge of pollutants as an exception to the above-mentioned prohibitions. Under this program, the EPA may issue permits for discharges of pollutants that meet certain regulatory requirements.

The facts presented in this case established that the city of San Francisco has a sewage system that when the system exceeds its capacity discharges pollutants; thus requiring a permit. In 2019, the Petitioner was issued a new NPDES permit for their Oceanside treatment plant. The Petitioner asserted that the EPA’s criteria for the new permit lacked precise definitions and quantifiable standards for the discharge of pollutants and explained that this ambiguity leads to challenges in compliance and enforcement.

The petition for writ of certiorari was filed on January 8, 2024, and granted on May 28, 2024.

The Petitioner argued the only permit conditions the EPA may impose under §1311 (b)(1)(C) of the Clean Water Act are those that fall within the Clean Water Act’s precise statutory definition of “effluent limitations” – not any other type of permit condition; however, the Court recognized that §1311 authorizes the EPA to impose limitations that do not fall within this definition[5].   The Supreme Court has previously recognized that water-quality prohibitions can supplement effluent limitations “so that numerous point sources, despite individual compliance with effluent limitations, may be further regulated to prevent water quality standards from falling below acceptable levels[6].”

The Court reasoned Congress used more extensive language, authorizing EPA to impose “any more stringent limitation, including those necessary to meet water quality standards” or “required to implement any applicable water quality standard[7].”  The Court further reasoned that the EPA exceeded its authority in imposing “end-result” requirements in NPDES permits and reaffirmed the Clean Water Act by emphasizing that the statute requires the EPA to specify clear, quantifiable effluent limitations in permits, rather than vague conditions tied to water quality outcomes.

In a joint statement by San Francisco City Attorney David Chiu and San Francisco Public Utilities Commission (SFPUC) General Manager Dennis Herrera, they indicated “[w]e are very pleased the Court issued the narrow decision San Francisco sought. This decision upholds the Clean Water Act’s critical role in protecting water quality and simply requires the EPA to fulfill its obligations under the Clean Water Act, as intended by Congress [8].”

The significance of this case is that it limits the scope of federal agency regulatory authority and shifts away from deferring to agency interpretation toward judicial review.  Although not mentioned in this case the Chevron doctrine is implicated. The Chevron doctrine’s long-standing precedent of deferring to a federal agency’s statutory interpretation in determining whether an agency has exceeded its authority was recently overturned on the grounds it conflicts with the Administrative Procedure Act [9]. Federal courts are encouraged to use their judgment in deciding a federal agency’s scope of authority.  

[1] City and County of San Francisco v. EPA, 601 U.S. 753 (2025). 

[2] Id. 

[3] 33 U.S.C. §1251 et seq. 

[4] City and County of San Francisco v. EPA, 601 U.S. 753 (2025). 

[5] Id. 

[6] Id. 

[7] Id. 

[8] City and County of San Francisco (202, March 4).  SCOTUS issues decision in San Francisco’s favor in water quality permitting case [Press release].  SCOTUS issues decision in San Francisco’s favor in water quality permitting case – City Attorney of San Francisco

[9] Loper Bright Enterprises v Raimondo, 603 U.S. 369 (2024).  

Standard
Spring 2025

PERSPECTIVE: ENFORCING THE FALSE CLAIMS ACT TO DETER THE PRACTICE OF HEALTH CARE FRAUD

The False Claims Act (FCA) of 1863 is a federal law that penalizes individuals or entities who defraud governmental programs. It allows civil remedies when a party knowingly makes a false statement or has the intent to defraud that is material and causes the government to lose money.

The FCA enables the federal government to recover in litigation for fraud committed against the government. The statute includes a qui tam provision that allows people who are not affiliated with the government to sue an organization on behalf of the government. This is informally called “whistleblowing”.  The Supreme Court case Vermont Agency of Natural Resources v. United States ex rel. Stevens (2000) presented the question of whether states or state agencies could be held liable under the FCA. The case involved a qui tam lawsuit against the Vermont Agency of Natural Resources, alleging that false claims were sent to the Environmental Protection Agency (EPA) in exchange for federal grants.

The Court ruled that states and state agencies are not “persons” subject to liability under the FCA. This decision was based on the interpretive presumption that the term “person” does not include sovereign entities like states. The ruling also emphasized the Eleventh Amendment, which bars private individuals from suing states in federal court without their consent. In addition to a qui tam lawsuit, enforcement of the statute allows government agencies to take enforcement action against people or entities who knowingly submit false claims. For example, The Department of Justice (DOJ) has been instrumental in recovering billions lost to fraudulent claims. Within the DOJ, settlements and judgments under the False Claims Act exceeded $2.9 billion in the fiscal year ending Sept. 30, 2024 and over $1.67 billion related to matters that involved the health care industry [1]. Once recovered the money is allocated back to the defrauded federal programs, restoring the government’s objective in providing those funds.

The FCA prohibits the filing of fraudulent claims from services received for federal funding. The FCA defines a “claim” as any request or demand for money or property made directly or indirectly to the Federal Government.  The Supreme Court case Allison Engine Co. v. United States ex rel. Sander (2008) underscored the intent requirement under the FCA. The Court ruled that to establish liability under the FCA, plaintiffs must prove that the defendant intended the false statement to be material to the government’s decision to pay a claim. It was not enough to show that government funds were used; there also had to be an intent to defraud the government.  The Fraud Enforcement and Recovery Act of 2009 broadened the scope of the FCA by clarifying that the FCA applies not just to fraudulent claims submitted directly to the government but also to fraudulent claims made indirectly to the government by third parties.

The FCA is designed to protect the government from being overcharged or sold poor-quality goods or services. The Supreme Court case Universal Health Services, Inc. v. United States ex rel. Escobar (2016) explains the “implied false certification” theory under the FCA. The Court held that a defendant could be liable under the FCA if they submitted claims that made specific representations about goods or services provided but failed to disclose noncompliance with material statutory, regulatory, or contractual requirements [2].

The Court reasoned the failure to disclose noncompliance rendered the claims misleading. The decision emphasized the importance of materiality, requiring that the undisclosed violations be significant enough to influence the government’s payment decision. Under the FCA a person does not violate the False Claims Act by simply submitting a fraudulent claim to the government; to violate the FCA a person must have submitted, or caused the submission of, the false claim (or made a false statement or record) with knowledge of the falsity [3].

The basis for establishing intent under the FCA is outlined in §3729(b)(1).  This section defines “knowledge” in the context of false claims. It states that a person acts with knowledge if they have either (1) actual knowledge of the information’s falsity, (2) deliberate ignorance of the truth or falsity of the information, or (3) reckless disregard for the truth or falsity of the information [4]. This regulation ensures that liability under the FCA applies only to those who knowingly engage in fraudulent activities, even if they avoid confirming the truth of their claims. 

The case United States ex rel. Schutte v. SuperValu Inc. (2023) emphasized the knowledge requirement under the FCA. The plaintiffs accused SuperValu of defrauding federal health care programs by misreporting drug prices. SuperValu offered discounted prices through a price-matching program but reported higher retail prices as their “usual and customary” charges for reimbursement. The plaintiff insisted this discrepancy led to false claims being submitted to the government. The Supreme Court ruled that the FCA’s scienter (knowledge) requirement focuses on the defendant’s subjective knowledge and beliefs at the time of the alleged violation, rather than on an objectively reasonable interpretation of the law [5].  This decision highlights the fact that people could be held liable if they knowingly submitted false claims, even if their actions seem reasonable under an objective standard.

The FCA has been very effective in recoveries for fraud committed in the health care industry. The FCA makes it illegal to submit false or fraudulent claims to Medicare or Medicaid. Examples of health care fraud include billing for services never rendered; billing for more expensive services than rendered and billing for services that are not considered medically necessary. The FCA protects the integrity of the health care industry by preserving the capability to provide affordable quality care.

[1] “False Claims Act Settlements and Judgments Exceed $2.9 Billion in Fiscal Year 2024,” U.S. Department of Justice, Office of Public Affairs, March 8, 2025.

[2] Universal Health Services, Inc. v. United States ex rel. Escobar, 579 U.S. 176 (2016).

[3] Id.

[4] 31 U.S.C. §§ 3729–3733.

[5] United States ex rel. Schutte v. Supervalu Inc., 598 U.S. 739 (2023).

Standard
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.

Standard
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).

Standard
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.

Standard