A public health analyst at the CDC’s Public Health Law Program compiled legal sources and described principles that impact responses to unsafe injection practices that result in infection and injury. In particular, the article aimed to inform healthcare providers and healthcare facility leaders about the statutory, administrative, criminal, and tort law implications related to preventable harms from unsafe injection practices.
Infection and injury due to unsafe injection practices in healthcare settings are considered preventable harms, and as such, may provide grounds for legal disputes. The law can be a deterrent and thereby a tool for prevention, providing options to prosecutors and the public under existing legal sources. The legal framework consists of statutes, regulations, and case law that affect the responsibilities of public health and healthcare practitioners to address unsafe practices that result in preventable harms.
The Supreme Court has long upheld the authority of states and localities to promote public health goals by enforcing their police powers, specifically empowering state agencies to regulate the behaviors and activities of private entities and the public. Many public health responsibilities dictated in state statutes and regulations therefore sit with state and local health-related boards and agencies. Agencies may promote best practices, license health professionals and facilities, and levy fines or report criminal conduct for certain actions or inactions.
Injection safety and, more broadly, unsafe practices related to needle, syringe, and medication vial use remains a vitally important issue to today’s healthcare and public health fields. Although public health interventions are designed to improve provider practices, preventable harms related to unsafe practices occur through numerous procedures and in a variety of settings. Researchers estimate that unsafe injection practices resulted in the notification of potential exposure to infections of over 130,000 patients in the US from 2001 to 2011.
The harms resulting from unsafe injection practices are preventable. The CDC is a source of evidence-based guidelines for safe injection practices in all healthcare settings. Provider and patient education campaigns conducted in partnership with state health departments support the single use of needles and syringes and have influenced best practices and policies. Patient safety advocates also call for transparency in the information disseminated about the preventable harm histories of providers and facilities. Although attention and resources have been devoted to injection safety for years, reports of unsafe practices continue to surface as the scope of practice for facilities and providers changes in response to healthcare advances and financial incentives, including reimbursements through Medicare and Medicaid.
Healthcare practitioners should be aware of legal actions brought in the states in which they practice, but several foundational cases related to injection safety events directly exemplify the principles discussed in this review and remain standards for new cases brought today. A pair of cases from New Jersey from 1963 show the simultaneous criminal prosecution (State v. Weiner, 41 N.J. 21 (1963)) and a licensure action (State Bd. of Medical Examiners v. Weiner, 41 N.J. 56 (1963)) against a physician who was convicted on 12 counts of involuntary manslaughter for the infection and resulting death of 12 patients with hepatitis B. The state supreme court took the case on appeal and decided that the prosecution did not establish a causal connection “by expert proof” between the deaths and a specific act or omission of the physician, or even identify all the acts of omissions which could have caused the disease to be transmitted. The criminal prosecution eventually was reversed on appeal and the charges dropped due to insufficient causation, and the licensure revocation “based on crimes of moral turpitude” was also reversed.
A series of civil negligence cases brought for actions related to a hepatitis C outbreak in New York provides an example where the full range of legal actions was available to try a physician and facility leadership (Von Stackelberg v. Goldweber, 33 Misc. 3d 1229(A) (2011); Bernard v. Goldweber, 34 Misc.3d 1223(A) (2012); Doe v. Goldweber, 112 A.D.3d 446 (2013)). The New York City Department of Health and Mental Hygiene found a number of probable outbreak-associated cases of hepatitis B and C among patients who had received injections from medication vials from a single physician between 2003 and 2007. Concurrent with the outbreak investigation, the state Office of Professional Medical Conduct suspended and later revoked the physician’s medical license, charging him with “gross incompetence, gross negligence, and failure to comply with provisions governing the practice of medicine, as a result of his violation of infection control practices and for allowing his infection control certification to lapse.” While the physician filed bankruptcy, plaintiffs, some deceased, sued the group practices that retained him to provide services in several ambulatory surgery centers. Because the failure to investigate the physician’s licensure and supervise and monitor his actions did not rise to vicarious liability, willful behavior, or negligent hiring by the group practice physicians, complaints against them were dismissed.
Cases related to hepatitis C transmission by one physician in New Jersey illustrate both state action against the physician and individual action against the physician and his medical malpractice insurer. In Matter of DeMarco, 83 N.J. 25 (1980), the New Jersey State Board of Medical Examiners petitioned the Supreme Court of New Jersey to review its authority to sanction a physician who caused 92 counts of hepatitis C. The Board sought to levy administrative penalties on the physician after revoking his license to practice. The court allowed the Board to interpret the civil strict liability of the physician for statutory violations to impose multiple penalties upon finding multiple violations. In a recent civil case, DeMarco v. Stoddard, 2014 WL 237823 (Jan. 22, 2014), a patient sued the same physician and the physician’s medical malpractice insurer for indemnification of his claims. The insurer had previously rescinded the physician’s malpractice policy, and a prior court judgment against the physician voided the policy, but the court required the insurer to indemnify the patient and awarded the patient attorney’s fees.
Courts may allow patients to seek relief from a variety of parties in order to best assign responsibility for an injection safety episode. For example, in a Nevada outbreak of hepatitis C from an endoscopy clinic, plaintiffs sued the physician involved, his clinic manager, a nurse anesthetist, and even the pharmaceutical corporation that manufactured the anesthetic in question. Grosshans v. Endoscopy Center of Southern Nevada, 2011 WL 4448940 (Sept. 23, 2011). The physician also faced criminal charges of second degree felony murder, and was convicted and sentenced to life in prison. Desai v. Nevada, 2013 WL 1092451 (Mar. 13, 2013). Public reaction to the outbreak resulted in changes to Nevada laws and regulations to prevent future incidents and patient harm.
Injection safety can also be promoted through state statutes and regulations that follow the latest trends and information in public health. For example, Nevada and North Carolina, guided by public health principles, recently promulgated state regulations that expressly promote injection safety. Following the conviction of a Michigan physician who reused needles, sutures, and other instruments for fraud, patient advocacy resulted in the passage of state legislation that prohibits the reuse of medical devices designed for single use with criminal and administrative penalties.
By providing resources to the public and allocating responsibility to the full roster of actors, the law can promote better injection safety practices going forward. Changes to law and policy that seek to improve healthcare delivery may impose additional requirements on healthcare providers and facility leadership while also requiring attention from state and local health and regulatory officials. Although each state’s provisions are unique, the law serves as a tool to promote public health and prevention throughout the nation.
See the CDC Report
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks