Articles related to LEGAL MATTERS

Join us as we explore the dynamic world of compounding pharmacies tackling the challenging semaglutide shortages head-on. Compounding pharmacies have stepped up to address the shortage of two semaglutide products, Ozempic and Wegovy. Consequently, they’re facing increased scrutiny from federal and state regulators, as well as Novo Nordisk, the manufacturer of these products. Novo Nordisk is actively monitoring and taking action against entities unlawfully selling compounded semaglutide. The company has sent cease-and-desist letters to some 503A pharmacy compounders. This move is seen as the first step towards potential legal actions. The Alliance for Pharmacy Compounding has defended the rights of 503A pharmacies to compound active pharmaceutical ingredients (APIs) in brand-name medications for specific patients, as long as the brands are on the FDA’s “currently in shortage” list. However, the distinction between legitimate 503A pharmacy compounders and shady operators has been blurred. These operators have rushed to fill the semaglutide gap without proper oversight of their compounding safety processes, source of APIs, or marketing techniques. This negligence could potentially cause serious patient harm. Kristina Bryowsky, PharmD, MBA, Vice President of Pharmacy Services for SSM Health Care, Missouri Region, believes that 503A compounding pharmacies should be allowed to make a product for […]

The case involves a 73-year-old patient, Ms. B, who had a history of rheumatoid arthritis and was taking prednisone for adrenal insufficiency caused by a pituitary tumor. She was treated by an internist, Dr. R, for various ailments over a period of four years. In November 2016, Ms. B was diagnosed with severe community-acquired pneumonia and admitted to the hospital, where she was treated with levofloxacin. After being discharged, she continued taking levofloxacin and suffered an acute rupture of the gluteus medius tendon, resulting in significant disabilities. Ms. B filed a lawsuit against Dr. R, alleging negligence and failure to inform her about the risks and contraindications of the medication. Dr. R sought a summary judgment to have the case dismissed but was denied by the court. The court ruled that a Boxed Warning on a medication, such as the one associated with levofloxacin, can create a triable issue of fact regarding a physician’s departure from accepted medical practice. Dr. R claimed he was unaware of the risks and relied on the hospitalists’ choice of medication, but the court found that he should have been knowledgeable about the specific risks and suitability of the medication for his patient. The case […]

Community oncologists in the United States are at risk of violating the Stark Law if they continue to mail or use delivery services to ensure their patients have access to essential oral medications, after the COVID-19 public health emergency (PHE) ends on May 11th. The Stark Law is a federal law that prohibits healthcare providers from referring patients to entities with which they have a financial relationship, unless certain exceptions apply. The FAQ document published by the Centers for Medicare & Medicaid Services (CMS) in September 2021 suggests that mailing oral drugs could violate the Stark Law, even if the practice does not receive any financial benefit from the delivery. This interpretation is so broad that it could also bar relatives or caregivers from picking up patients’ medications. As a result, practices are facing a difficult choice: require patients to pick up medications in person or refer them to third-party mail-order pharmacies. The latter could lead to delays, denials, or sometimes errors because of a lack of direct communication between the pharmacy and physician.

An Idaho man received $13.5 million after a nearby hospital missed his stroke diagnosis by more than 12 hours. The jury’s finding that the emergency physician engaged in “reckless misconduct” allowed this case to exceed the usual Idaho cap on judgments for cases of this nature of $400,000.00.

A patient requests a letter from the psychiatrist advocating for a service animal or an emotional support animal. What is the distinction between them? What is the psychiatrist’s responsibility when such a request is made?

An appeals court determined that in this instance, Dr. K had a physician-patient relationship with the patient, based on the phone call between Dr. K and the patient’s doctor. “A doctor who gives an informal opinion at the request of a treating physician does not owe a duty of care to the patient whose case was discussed.” The court held that wasn’t the case in this instance. See why in the linked article.