Hansen v. Brandywine Nursing & Rehab. Ctr.
| Decision Date | 23 January 2023 |
| Docket Number | C. A. N21C-03-233 CEB |
| Parties | TERRI HANSEN, Personal Representative of the Estate of CHARLES SECREST, Plaintiff, v. BRANDYWINE NURSING AND REHABILITATION CENTER, INC., A Delaware Corporation, Defendant. And BEVERLY SHINNEN, Personal Representative of the Estate of SOPHIE STAR SAKEWICZ, Plaintiff, |
| Court | Delaware Superior Court |
Submitted: January 9, 2023
Upon Consideration of Defendant Brandywine Nursing and Rehabilitation Center, Inc. 's Motion to Dismiss, DENIED.
Neil R. Lapinski, Esquire, Phillip A. Giordano, Esquire, and Madeline R. Silverman, Esquire, GORDON, FOURNARIS &MAMMARELLA, P.A., Wilmington, Delaware; Michael P Minuti, Esquire, MCCAN DILLON JAFFE &LAMB, LLC Wilmington, Delaware. Counsel to Terri Hansen, Personal Representative of the Estate of Charles Secrest, and Beverly Shinnin, Personal Representative of the Estate of Sophie Star Sakewicz.
Stephen J. Milewski, Esquire, and Roopa Sabesan, Esquire, WHITE AND WILLIAMS LLP, Wilmington, Delaware. Attorneys for Defendant Brandywine Nursing and Rehabilitation Center, Inc.
Charles E. Butler, Resident Judge Plaintiffs Charles Secrest and Sophie Star Sakewicz (the "Plaintiffs") were elderly residents of Brandywine Nursing and Rehabilitation Center, Inc. ("BNR"). While in the care of BNR, the Plaintiffs fell ill with COVID-19 and subsequently died. This action is brought by the Plaintiffs' personal representatives and seeks damages for negligence surrounding their deaths. BNR now argues that the immunity provision of the PREP Act requires the Court to dismiss the action against it. The Court finds to the contrary. Accordingly, BNR's motion to dismiss will be denied.
BNR is a private, skilled nursing facility located in New Castle County.[1] It operates an authorized 169 beds and accepts Medicaid/Medicare as payment.[2] It is heavily regulated at both the state and federal levels.
The Plaintiffs were both residents of BNR. Charles Secrest was 82 years old and suffering from dementia.[3] Sophie Star Sakewicz was 95 years old.[4] The Plaintiffs died while in the care of BNR and this action is brought by their personal representatives. Most of the factual allegations in the Complaint are made "[u]pon information and belief" of the personal representatives.[5]
The Plaintiffs both allegedly died of complications from COVID-19 in April 2020, shortly after the beginning of what is now called "the Pandemic."[6] The Plaintiffs claim that BNR failed to properly hire, train, or direct staff as to the proper protocols to be followed in the face of the Pandemic.[7] The Plaintiffs further allege that BNR failed to follow emergent CDC guidelines concerning hygiene, segregation and visitation, and were "negligent in other respects that may be uncovered during discovery."[8]
The Complaint contains five counts: (1) Count I is for wrongful death under 10 Del. C. § 3724; (2) Count II is the corollary survival action under 10 Del. C. § 3704; (3) Count III alleges BNR was grossly negligent; (4) Count IV alleges BNR engaged in willful and wanton misconduct; and (5) Count V alleges BNR is liable under the doctrine of respondeat superior.
A basic understanding of the Public Readiness and Emergency Preparedness ("PREP") Act of 20 05[9] is important to grasp the arguments before the Court. The Court therefore considers a very brief history of the PREP Act.
In 1918, an estimated 500 million people around the world were infected during an influenza epidemic, sometimes called "the Spanish Flu."[10] In the United States, the epidemic claimed some 675,000 lives.[11] The culprit in this tragedy was finally determined to be the H1N1 virus, to which there was no pharmaceutical intervention available at the time.[12]
So, in 1976, when two soldiers at Fort Dix, New Jersey tested positive for the H1N1 virus, public health officials had ample reason for alarm.[13] In response, President Gerald Ford announced the National Influenza Immunization Program ("NIIP"), and Congress budgeted $135 million to produce enough vaccine to inoculate the entire U.S. population against H1N1.[14]
Pursuant to the NIIP, drug manufacturers were enlisted to produce the vaccine. But the insurers for the manufacturers balked; they were unwilling to take on the potentially ruinous liability if the vaccines produced unanticipated, harmful results or side effects.[15] Given the breadth of the potential liability, the manufacturers demanded that the government agree to protect them from such lawsuits.[16] The government obliged, immunizing the manufacturers from tort liability for the vaccine. Further, to ensure some level of protection for U.S. citizens injured by the vaccine, the government agreed to waive sovereign immunity and assume any liabilities.[17] The manufacturers thereupon undertook mass production, and the government undertook mass vaccination.[18]
Some 4,000 lawsuits were subsequently filed concerning side effects from the NIIP vaccine.[19] Most suits claimed that patients developed Guillain-Barre Syndrome from taking the vaccine.[20] The resulting government litigation costs amounted to approximately $90 million, nearly doubling what was spent on the vaccination program itself.[21]
i. The Project Bioshield Act
While other public health emergencies have come along since 1976, none have had such a profound effect on law and public health policy as the 9/11 terrorist attacks and coincident anthrax scares. In addition to the Homeland Security Act of 2002,[22] Congress passed the Project Bioshield Act of 2004.[23] The Project Bioshield Act was an "ambitious [project aimed at] creat[ing] a new biodefense industry for the expeditious development and production of medical countermeasures and related products and services to secure the U.S. homeland against bioterrorism."[24] The Act authorized the Secretary of Health and Human Services ("HHS") to permit distribution of products approved on an "emergency use authorization" in response to a biological, chemical, radiological or nuclear attack, or other "material threat" to the health and safety of American citizens.[25] in permanent nerve damage. In some cases, Guillain-Barre Syndrome has led to death. See Guillain-Barre Syndrome, Ctr. for Disease &Control Prevention (June 27, 2022), https://www.cdc.gov/campylobacter/guillain-barre.html. Problems arose with developing and stockpiling vaccines and antidotes. First, there was but one customer-the U.S. government-which would have to remain committed to buying and storing the supply.[26] Next, very expensive, first-line research was needed because not all known pathogens had known antidotes.[27] Then there was the problem lingering from the NIIP debacle: how to protect manufacturers from liability claims over a drug created only at the behest of the government.[28]Finally, there was the question how to administer and pay for the claims of citizens who were harmed by the vaccines or antidotes themselves.[29]
This very simplified history of how the PREP Act came to be demonstrates that the immunity provided for in the Act exists to guarantee a supply of vaccines and related countermeasures in the event of a public health emergency.[30] The immunity ensures that drug manufacturers will not be sued should the vaccine or other government-ordered countermeasure turn out to be defective or harmful.
The PREP Act provides immunity for "covered countermeasures" undertaken by "covered persons" in response to a declared state of emergency.[31] On March 10, 2020, the Secretary of HHS declared COVID-19 a public health emergency with an effective date of February 4, 2020.[32] The Plaintiffs concede that BNR is a "covered person" under the statute, leaving the Court to consider whether BNR was engaged in "covered countermeasures" with respect to the activities alleged in the complaint.[33]
The Plaintiffs filed their Complaint with this Court in March 2021. BNR filed a notice of removal to the U.S. District Court for the District of Delaware in May 2021. In the district court, BNR took the position that the dispute may only be heard in federal court because (1) the PREP Act is a "complete preemption" statute which supplants all state causes of action; and (2) the Secretary of HHS has declared that all claims involving the PREP Act were removable to federal court.[34] Those issues were fully briefed in the district court.
While the matter was pending in the district court, the Third Circuit Court of Appeals decided the case of Maglioli v. Alliance HC Holdings LLC.[35] Maglioli was brought by the estates of residents of a nursing home in New Jersey.[36] Those residents contracted COVID-19 and died while in the care of said nursing home.[37]As here, the nursing home removed the case to federal court, essentially making the same "complete preemption" arguments that BNR raised in the District Court of Delaware.[38]
In affirming the district court's remand to state court in Maglioli, the Third Circuit held that the doctrine of complete preemption does not apply to the PREP Act.[39] The Court further ruled that HHS could not expand or contract federal court jurisdiction by issuance of an Advisory Opinion and that any attempt to do so was not entitled to "Chevron deference."[40] Thus, the Third Circuit's ruling was that the defendant in a state court tort claim concerning COVID-19 contracted in a nursing home could not remove the action to federal court.[41] In light of Maglioli, it is no surprise that the district court in this action remanded this matter to state court.
Following the remand to this Court, BNR filed the instant ...
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