Scalpel Weekly News

Week of: April 17, 2017

IN THE NEWS


First Direct-to-Consumer Genetic Health Risk Test Allowed by FDA

On April 6, 2017, the FDA allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional. Click title to continue reading...


 
MEDICAL ALERTS


Cerebrospinal Fluid Valve and Shunt Recall; Potential for Under-Drainage

On April 8, 2017, Medtronic recalled all unused units of the StrataMR adjustable valves and shunts. Medtronic is conducting this voluntary recall due to an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid. Click title to continue reading...



Spontaneous Ventilator Reset; Voluntary Corrective Action

On April 5, 2017, Medtronic notified customers worldwide of a voluntary field corrective action for all its Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. Click title to continue reading...



CDC Report: 1 in 10 U.S. Women with Zika had Fetus or Baby with Birth Defects in 2016

On April 4, 2017, the CDC published a report that showed that of the 250 pregnant women who had confirmed Zika infection in 2016, 24 – or about 1 in 10 of them – had a fetus or baby with Zika-related birth defects. This report is the first to provide the analysis of a subgroup of pregnant women in the U.S. with clear, confirmed test results of Zika virus infection. Click title to continue reading...


  CASE ALERTS


Misuse of Retractor Blade Related Back to Negligent Surgery Claim

A man underwent spinal surgery to address problems with the C6 through C7 vertebrae. During the surgery, the surgeon used a skull clamp to secure the man. The surgeon placed a retractor blade, a surgical instrument with which a surgeon can hold back organs and tissues so that body parts may be accessed, on the man’s C3 through C4 vertebrae during the procedure. Click title to continue reading...



Failure to Prescribe Medication In Complaint Against Surgeon

A woman suffered from bone marrow cancer. The woman was under the care of a surgeon. After the woman was discharged from the hospital, the surgeon did not prescribe anticoagulation medicine. Click title to continue reading...



Fraudulent Incorporation Defense; Radiologist’s Professional Corporation

A radiologist formed a professional service corporation to perform MRI scans at three existing MRI facilities. The radiologist’s professional service corporation leased the three MRI facilities and all of the medical and office equipment used at the facilities from companies owned and controlled by one nonparty. Click title to continue reading...


FEATURE


Complaint: Procuring Unauthorized Autopsy

As a special feature for our Premium subscribers we have included this feature containing an illustrative complaint against an insurance company for wrongfully ordering an autopsy without consulting the decedent’s next of kin. In this example, the insurance company ordered the autopsy for use in defeating a prior claim unrelated to the decedent’s death. Click title to continue reading...