The New York Times recently examined how declining drug reimbursement rates and cost pressures from companies managing drug plans for public and private health insurers are creating chaotic workplaces at some of the nation’s biggest retail pharmacy chains, see Ellen Gabler, “How Chaos at Chain Pharmacies Is Putting Patients at Risk,” New York Times, Jan. 31, 2020. The New York Times expose explores how understaffing has led to medication errors with catastrophic, and sometimes fatal, consequences. This is a significant public safety risk with enormous potential for civil liability when dispensing errors result in serious injuries. The article also reports that pharmacists facing unrealistic employment metrics are often pushed to fill prescriptions that are not medically necessary. There may be safety risks associated with this practice and, in some cases, and there is additional potential civil liability exposure in the form of health care fraud whistleblower claims.
Medication Dispensing Errors
As the New York Times reported, staffing cuts have led to longer shifts, minimal break time, and a great deal of distraction from the critical tasks performed by pharmacists. Pharmacists and other employees of understaffed pharmacies are forced to juggle administrative tasks and long lines while maintaining a focus on filling prescriptions accurately and counseling patients adequately. Not only do these issues negatively impact pharmacists, but patients can also suffer serious potential consequences of such hectic workplaces.
For example, one patient learned that he had been taking estrogen-rather than the antidepressant that he was prescribed-after experiencing shortness of breath and extreme dizziness. The man was fortunate to discover his pharmacy’s mistake before suffering serious harm, but others have not been so lucky. A Florida senior citizen, for instance, did not discover that a pharmacy had dispensed a powerful chemotherapy drug-rather than her prescribed antidepressant-until she began to suffer the organ failure that ultimately caused her death.
Circumstances such as these provide a clear basis for a medical malpractice suit. In Pennsylvania, the plaintiff pursuing medical negligence claims bears the burden of establishing a “duty owed by the [health care provider] to the patient, a breach of that duty by the [health care provider], that the breach was the proximate cause of the harm suffered, and the damages suffered were a direct result of the harm.” See Grossman v. Barke, 868 A.2d 561, 566 (Pa. Super Ct. 2005). And while expert testimony is typically required to establish that the treatment rendered was not in accord with acceptable standards of care, there is an exception to this general rule where “‘the matter under investigation is so simple, and the lack of skill or want of care so obvious, as to be within the range of ordinary experience and comprehension of even non-professional persons.'” See Brown v. Philadelphia College of Osteopathic Medicine, 674 A.2d 1130, 1136 (Pa. Super. Ct. 1996) (quoting Brannan v. Lankenau Hospital, 417 A.2d 196, 201 (Pa. 1980)).
A pharmacy’s failure to fulfill its basic obligations to accurately dispense medications constitutes a simple and nontechnical error that likely would not require standard of care expert testimony. To be sure, however, testimony from an expert or treating physician will likely still be required in most cases to prove that the pharmacy’s error did in fact cause a patient’s harm. On top of that, other evidence critical to such cases includes the original dispensed medication (and all packaging and instructions) and documentation of how many doses the person took and when. Patients must be sure to preserve and secure these important items.
Health Care Fraud Whistleblower Claims
A focus on profits and corporate performance metrics, the New York Times exposé explains, has also led to the dispensing of drugs that are not medically necessary. See Ellen Gabler, ” How Chaos at Chain Pharmacies Is Putting Patients at Risk,” New York Times, Jan. 31, 2020. The article states that employment reviews focused on hitting targets and driving revenue put pressure on pharmacy staff to fill as many prescriptions as possible. This has led to a number of practices designed to maximize prescription volume-including cold-calls to patients, automatic fill programs that result in dangerous duplications, and requests to doctors for refills that were never sought by patients nor were medically necessary.
The article described a Pennsylvania rheumatologist who said that he is buried with refill requests for nearly each prescription he writes-even for drugs intended only for a short treatment. In fact, the doctor noted, roughly half of the refill requests that he receives are unwarranted.
Pharmacists or others with inside information about practices that produce a high volume of medically unnecessary prescriptions for Medicare or Medicaid beneficiaries may have a potential whistleblower claim under the United States False Claims Act (FCA). The FCA imposes civil liability (including treble damages and fines) on any private company that “knowingly presents .,, a false or fraudulent claim for payment or approval” to the federal government. Knowingly dispensing medically unnecessary prescriptions to federal health care program beneficiaries violates the FCA because government programs such as Medicare and Medicaid only pay for items and services that are medically necessary.
Procedurally, a private person (called a relator) may bring a FCA action “in the name of the government.” The government may intervene to take over such an action-called a qui tam action-but the relator “shall have the right to conduct the action” if the government opts not to intervene. A relator in a successful qui tam action is entitled to a share of any recovery made by the government, which can amount to anywhere from 15% to 30% of the government’s recovery depending on whether the government intervenes. Such rewards are designed to encourage private individuals to come forward with evidence of fraud perpetrated on the government-including any Medicare and Medicaid fraud committed by pharmacies-and hopefully offset some of risk associated with deciding to blow the whistle.
Zachary Arbitman is a senior associate and trial attorney at Youman & Caputo, where he represents catastrophic injury victims in cases involving medical malpractice, motor vehicle accidents, workplace injuries, premises liability, and product liability. He also dedicates a significant portion of his practice to representing whistleblowers in claims brought under state and federal False Claims Acts, various state whistleblower statutes, and the IRS, SEC, and CFTC whistleblower programs. Contact him at email@example.com