Scalpel Weekly News

Week of: December 19, 2016

IN THE NEWS


Hearing Aid Accessibility

On December 7, 2016, the FDA announced important steps to better support consumer access to hearing aids. The agency issued a guidance document explaining that it does not intend to enforce the requirement that individuals 18 years or more old receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. The FDA also announced that it will consider creating a category of over-the-counter (OTC) hearing aids that could deliver new, innovative, and lower-cost products to millions of consumers. Click title to continue reading...


 
MEDICAL ALERTS


Excess Material May Split, Separate from Multi-Med Single Lumen Catheters in Kits

On December 9, 2016, Centurian recalled convenience kits containing Multi-Med Single Lumen Catheters. Centurian indicated that there is the potential for excess material to remain at the tip of the catheter during the manufacturing process. 



EU and FDA Reliance Regarding Drug Manufacturer Inspections

On December 7, 2016, Dara Corrigan, J.D., the FDA’s Associate Commissioner for Global Regulatory Policy, introduced the Mutual Reliance Initiative (MRI). Click title to continue reading...



Microcephaly Risk High When Infected Early in Pregnancy

A report published by the CDC on December 9, 2016, offered important new evidence about the geographic breadth, impact, and timing of Zika virus disease and microcephaly (a smaller than expected infant head size). Click title to continue reading...


  CASE ALERTS


Internist’s Report Sufficient for Deficient Infection Control Claim against Dermatologist

A woman sought treatment for swelling and lower leg pain at a dermatology practice group. There, a dermatologist diagnosed her with erythema nodosum, a skin condition marked by red or violet subcutaneous nodules. Erythema nodosum can ordinarily be diagnosed clinically, but biopsies may be ordered in atypical cases. Click title to continue reading...



J-Tube Punctured Intestine, In-Home Nurse Not Liable

A woman requiring 24 hour care had a jejunostomy tube (J-tube) through which medications and nutrients were administered. A licensed practical nurse (LPN) employed by a home health care provider cared for the woman daily from 11 PM to 7 AM. Click title to continue reading...



Survival Act Claims; Wrongful Death Act Limitations; Prostate Cancer Death

A man presented to his primary care physician complaining of migraine headaches. As part of the examination, blood samples were taken and sent for testing. The man’s prostate-specific antigen (PSA) level was 15.4, significantly higher than normal. Click title to continue reading...


FEATURE


Glaucoma Expert Preclusion Motion

As a special feature for our Premium subscribers we have included this feature containing an illustrative Plaintiffs Opposition to Defendants Motion In Limine to Preclude Testimony by [Expert], M.D., Regarding Causation and Plaintiff’s Complaints of Glaucoma. In this illustration, the plaintiff is attempting to keep the plaintiff’s expert testimony on the causation of the plaintiff’s glaucoma in the trial, while the defendant is attempting, by its motion in limine, to have the expert’s testimony precluded. Click title to continue reading...