Medical Risk Law Weekly News

Week of: September 17, 2018

IN THE NEWS


New Dosage of Maintenance Treatment for Opioid Dependence

On September 7, 2018, the FDA granted Teva Pharmaceuticals USA Inc. approval to market Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths. Click title to continue reading...


 
MEDICAL ALERTS


Staggering Number of Heart Disease, Stroke Deaths in 2016

On September 6, 2018, the CDC published a report that found that, despite being largely preventable, heart attacks, strokes, heart failure, and other related conditions caused 2.2 million hospitalizations in 2016, resulting in $32.7 billion in costs and 415,000 deaths. Many of these events were in adults between the ages of 35 and 64, with more than 775,000 hospitalizations and 75,000 deaths occurring within this group in 2016. If every state reduced these life-changing events by six percent every year, one million cardiac events could be prevented by 2022. Click title to continue reading...



Enteral Feeding Tube Misconnections; Serious Injuries

On September 7, 2018, the FDA issued a letter to manufacturers of enteral feeding tubes, health care professionals, and hospital purchasing departments and distributors to communicate the FDA’s concerns about continued reports of misconnections with enteral devices. Enteral access feeding devices are placed in patients who have a functional and accessible gastrointestinal tract, but are not able to consume or absorb enough nutrients to sustain adequate nutrition and hydration. To reduce the risk of misconnections and patient injury, the FDA recommended hospitals and clinicians use enteral devices with connectors that meet the International Organization for Standardization (ISO) 80369-1 or ISO 80369-3 standard, or that are otherwise designed to reduce the risk of misconnections. Click title to continue reading...



Subglottic Suction System Recall, Risk of Device Breakage; Lungs

On September 4, 2018, Vyaire Medical, Inc., recalled the Tri-Flo Subglottic Suction System because there is a risk that the distal soft tip of the catheter may break off and enter the patient's lungs. This may result in serious adverse health consequences including choking, wheezing, additional surgery to remove the tip from the patient’s lungs, irritation and reddening of the skin (erythema), infections, or death. Click title to continue reading...


  CASE ALERTS


Error to Deny Motion to Compel without Requiring Privilege Log; Nutrition Infection

A patient was admitted to the hospital complaining of nausea; vomiting; and gastritis, inflammation, irritation, or erosion of the lining of the stomach. The patient was ordered to undergo full bowel rest by having Trans-Peritoneal Nutrition (TPN) administered through a Peripherally Inserted Central Catheter (PICC line). A PICC line was inserted into the patient’s right arm. The PICC line was used to administer a daily dose of TPN, which came in a sterile bag. Despite the treatment, the patient’s symptoms did not subside. Click title to continue reading...



Expert Had Not Done Surgery for Years before Spine Surgery Case

A surgeon performed spinal surgery on a patient using a medical device. The device employed locking screws, couplers, and rods to fuse the lower spine. One of the locking screws on the implanted device failed or was not properly secured, resulting in only partial fusion of the patient’s spine. The surgeon performed an additional surgery three years later to remove loose hardware and fuse an additional portion of the patient’s spine. Click title to continue reading...



Penalty Equal to Medical Expenses for COBRA Notice Violation

After an employer terminated an employee, the employee obtained continuation coverage under the employer’s health care plan through the Consolidated Omnibus Budget Recovery Act (COBRA). COBRA allows a former employee to continue receiving health insurance through the former employer’s Employee Retirement Income Security Act (ERISA) health insurance plan. The employer was the plan administrator. Click title to continue reading...


FEATURE


Plaintiff’s Interrogatories: Chiropractic Malpractice

As a special feature for our Premium subscribers, we have included this feature containing illustrative interrogatories to be served on the defendant in an action for chiropractic malpractice. In this illustrative situation, a man sought treatment from a chiropractor due to a stiff neck. In the course of the chiropractic treatment, the man suffered a stroke, which left him partially paralyzed and unable to speak. The man sued the chiropractor for malpractice. Party identifying information has been redacted to protect privacy. Click title to continue reading...