Medical Risk Law Weekly News

Week of: March 25, 2019

IN THE NEWS


New Generic Blood Pressure Drug to Relieve Shortages

On March 12, 2019, the FDA granted Alkem Laboratories Limited approval to market a new generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The FDA prioritized the review of this drug application to help relieve the shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers. Click title to continue reading...


 
MEDICAL ALERTS


New Indication for Heart Valve Repair Device

On March 14, 2019, the FDA granted Abbott Vascular Inc. approval to market the MitraClip Clip Delivery System (MitraClip) for a new indication. The device reduces moderate-to-severe or severe mitral regurgitation, a leakage of blood backward through the mitral valve into the heart’s left atrium that can cause heart failure symptoms such as shortness of breath, fatigue, and swelling in the legs. Click title to continue reading...



Consent Decree Entered Against Compounding Pharmacy

On March 12, 2019, the United States District Court for the Northern District of Texas entered a consent decree of permanent injunction against JMA Partners, Inc., doing business as Guardian Pharmacy Services, in Dallas, Texas, as well as the company’s owner. The district court ordered the company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FDCA) and other requirements. Despite previous warnings from the FDA, Guardian Pharmacy Services continued to violate the law, putting patients at risk. Click title to continue reading...



HIV Testing and Treatment Gaps Hinder Efforts to Stop New Infections

On March 18, 2019, the CDC published a report that found that the vast majority of new HIV infections in the U.S. in 2016 were transmitted from people with HIV who either did not know they had HIV or who received a diagnosis but were not receiving HIV care. Click title to continue reading...


  CASE ALERTS


Failure to Monitor Vital Signs in Pediatric ICU; Motion to Dismiss

An infant patient was admitted to the hospital after falling headfirst into a bucket that held a cleaning solution containing bleach. A diagnostic procedure revealed mild irritation of the patient’s stomach and esophagus. Two days later, while the patient had some vomiting, the patient was eating and drinking satisfactorily. The hospital discharged the patient. Click title to continue reading...



Claim Against Unidentified Attending Physician Time-Barred

A patient who had been involved in a motor vehicle accident was admitted to the trauma intensive care unit of a hospital with multiple injuries, including six fractured ribs and injuries to the right knee and right foot. Click title to continue reading...



Out-Of-Network Claims for Covered Services; Medical Loss Ratio

The Patient Protection and Affordable Care Act’s (ACA’s) medical loss ratio provision requires an insurer to pay a rebate to insureds if the ratio between what the insurer pays out in claims for medical services is less than 80 percent of the revenue the insurer takes in. Health insurance companies that did not spend at least 80 percent of their premium income on healthcare claims (“incurred claims”) and health quality improvement are required to refund to their insureds the difference between the amount actually spent and the 80 percent figure. The instructions for calculating the ratio were provided under the statute and further explained in federal regulations. The regulations defined “incurred claims” to include payments made by an insurer for clinical services and to exclude administrative expenses or work unrelated to clinical services. Click title to continue reading...


FEATURE


Damages Checklist: Malpractice for Failure to Warn of IUD Risks

As a special feature for our Premium subscribers, we have included this damages checklist as guidance for counsel in a medical malpractice action involving an intrauterine device (IUD) complication. This checklist can also be used by health care facility risk managers to assess potential liability and damages associated with IUD complications and create policies to prevent liability and mitigate damages. Click title to continue reading...