Scalpel Weekly News

Week of: November 06, 2017

IN THE NEWS


Lead Testing System Investigation Finds Significant Violations of Law

On October 23, 2017, the FDA issued a warning letter to Magellan Diagnostics Inc. for several violations of federal law, including marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results. Click title to continue reading...


 
MEDICAL ALERTS


Intravenous Immune Globulin Withdrawn from Market

On October 23, 2017, Octapharma USA Inc. withdrew its Octagam [Immune Globulin Intravenous (human)] 10% Liquid Preparation from the market. Octagam (immune globulin intravenous), also referred to as IVIG, is used to treat primary immunodeficiency diseases. Click title to continue reading...



FDA Validates Medical Device Development Tool

On October 24, 2017, FDA Commissioner Scott Gottlieb, M.D., issued a statement regarding additional steps the FDA is taking as part of the Medical Innovation Access Plan he announced earlier in 2017. These steps include the first completion of the validation of a medical device development tool and the release of three new guidance documents related to medical devices. Click title to continue reading...



Fentanyl Involved in Over Half of Opioid Overdose Deaths in 10 States

On October 27, 2017, the CDC published a report that found that more than half of people in 10 states who died of opioid overdoses during the second half of 2016 tested positive for fentanyl. This report described opioid overdose deaths from July through December 2016 that tested positive for fentanyl, fentanyl analogs, or U-47700, an illicit synthetic opioid, in 10 states participating in the CDC’s Enhanced State Opioid Overdose Surveillance (ESOOS) program. Click title to continue reading...


  CASE ALERTS


Peer Reviews by Expert Retained for Litigation Discoverable; Adverse Medical Incidents

A woman developed stomach pain. The woman was diagnosed with gallstones. A laparoscopic cholecystectomy, a minimally invasive surgical procedure in which the gallbladder is removed with the assistance of a video camera and several thin instruments, was scheduled and performed at a hospital. Click title to continue reading...



Oklahoma Overturns Medical Expert Affidavit Requirement

A man underwent decompressive laminectomies at multiple sites along the cervical spine. A decompressive laminectomy is a surgery that creates space by removing the lamina – the back part of the vertebra that covers the spinal canal – to enlarge the spinal canal to relieve pressure on the spinal cord or nerves. Click title to continue reading...



ALJ Fails to Consider Claim under Social Security Fibromyalgia Guidance

A 41-year-old woman suffered from fibromyalgia. The woman worked as a phlebotomist. Over the course of two years of treatment for fibromyalgia, the woman received facet and epidural injections in the neck and back, as well as steroid injections in each hand. Click title to continue reading...


FEATURE


Interrogatories to Plaintiff: Steroid Injection Malpractice

As a special feature for our Premium subscribers we have included this feature containing illustrative interrogatories to be usedas a guide for counsel preparing interrogatories to the plaintiff in a medical malpractice action involving steroid injections. These interrogatories focus on the case of a man who was treated by an anesthesiologist for chronic back pain. Click title to continue reading...