Scalpel Weekly News

Week of: July 25, 2016

IN THE NEWS


Anti-Coagulant Testing System Removed from Market

Following a collaborative process with the FDA, Alere Inc. publicly announced its intent to withdraw the Alere INRatio and INRatio2 PT/INR Monitoring System from the market on July 11, 2016. Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution to allow them to continue anti-coagulation monitoring in the least disruptive manner possible. In certain cases, an Alere INRatio PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). Click title to continue reading...


 
MEDICAL ALERTS


Stool Softener Recall; Bacteria Contamination; 5-State Outbreak

On July 16, 2016, the FDA alerted health care professionals that PharmaTech LLC, of Davie, Florida, recalled all non-expired lots of Diocto Liquid, a docusate sodium solution stool softener distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states. Click title to continue reading...



FDA Approves Intraocular Lens for Cataract Patients

On July 15, 2016, the FDA approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision at near, intermediate and far distances. Click title to continue reading...



Tobacco Use and Involuntary Secondhand Smoke Exposure High in Multiunit Housing

Americans living in multiunit housing, such as apartments and condominiums, are more likely to use tobacco products and less likely to have smoke-free home rules than people living in single-family housing, according to a new study by the CDC announced on July 13, 2016. About 80 million people in the U.S. live in multiunit housing. Many who live in public housing are especially affected by secondhand smoke including children, the elderly, and people with disabilities. Click title to continue reading...


  CASE ALERTS


Adding Doctor, Hospital to Claim Time-Barred; Products Liability; Stroke During Surgery

A woman underwent surgery at a hospital. Due to complications that occurred during the procedure, the woman suffered a stroke. The woman filed a complaint against the manufacturer of the medical device used in the procedure, alleging strict products liability. The initial complaint did not name the hospital or doctor as party to the suit nor did it state a claim for medical malpractice. Click title to continue reading...



Patient Coffee Spill During Seizure; Burn Treatment Negligence

A man sought treatment in the emergency room (ER) at a hospital. The man complained of a history of recurrent seizures. After he was placed on an examination table, his father brought him a cup of coffee. The man experienced another seizure and the hot coffee spilled into his lap, burning him. Later that day, the man was admitted to the hospital. Click title to continue reading...



Infant’s Win on Lack of Informed Consent Did Not Preclude Parents’ Wrongful Death Action

A woman suffered a partial placental abruption, her placenta partially peeled away from the inner wall of the uterus, when she was 28 weeks pregnant. Placental abruption is irreversible, can deprive the fetus of oxygen and nutrients, and cause heavy bleeding in the mother. Left untreated, placental abruption puts both mother and fetus at risk of death. The woman was hospitalized. Click title to continue reading...


FEATURE


Excluding Physician Testimony on Multiple Sclerosis Medication Injury

As a special feature for our Premium subscribers we have included this feature containing an illustrative Motion in Limine to exclude the testimony of the defendant treating neurologist in a malpractice action involving a patient with multiple sclerosis and prescribed medications that caused injury and death. Click title to continue reading...