Author

Jennifer Walker-Journey

3945 posts

Jennifer Walker-Journey is a professional writer whose 20-year career spans from newspapers and magazines to Ezines and business blogs. Her primary focus is corporate and business writing, though she relishes any opportunity to write features. In her limited free time, Jennifer strives to finish the novel she is writing. She lives in Birmingham with her husband, Rick, and their insatiably curious son, Truman.

Tracheotomy humidifiers recalled for cracks

Two recalls have been issued for Teleflex Medical’s MAQUET Servo Humidifier 163 for connector cracks and cracks in connector tubes that may result in serious health consequences including death to patients. Some connector cracks were found when preparing patients for support with a ventilator. These cracks could cause oxygen and other gasses to leak from the ventilator and not deliver sufficient treatment to patients. Cracks were also found in the connector tubes during the manufacturing process and some devices were distributed before the problem was identified. The MAQUET Servo Humidifier is a heat and moisture condenser that is placed over ... Read More

FDA issues injury warning about MRI units

MRI recall - FDA image

The Food and Drug Administration (FDA) is warning health care professionals that some MRI units may have been modified to disable the Magnet Rundown Unit (MRU), which is one method to shut off the magnet field of the MRI in case of emergency, such as when a metal (ferrous) object is brought into the magnet field. In the event of an emergency, a delay in shut off can result in life-threatening injuries. At least two hospital employees have been injured when they entered the MRI room carrying a metal container. The recall is being issued because this defect may cause ... Read More

Antibiotic, antibacterial injections recalled for sterility concerns

Syringe

The Food and Drug Administration (FDA) has ordered the recall of 10 lots of the antibiotic colistimethate and three lots of antibacterial drug Rifampin manufactured by Emcure Pharmaceuticals and distributed by Heritage because of manufacturing practices that put the injectable drugs’ sterility in question. Intravenous administration of non-sterile injection products may result in a site-specific or systemic infection, which may lead to hospitalization, significant morbidity (such as organ damage), or death. To date, Heritage has not received any reports of adverse events in patients resulting from use of the injections affected by the recall. Affected products include 10 lots of colistimethate ... Read More

Bard on verge of settlement in transvaginal mesh case

transvaginal mesh

C.R. Bard and a woman who claims she was injured by the medical device maker’s defective transvaginal mesh are on the verge of a settlement, just days before the lawsuit was scheduled to go to trial. Debra Wise’s lawsuit was part of a federal multidistrict litigation in West Virginia. The “pending settlement” was signed off on by U.S. District Judge Joseph Goodwin, and the case was ordered off the active docket in the litigation. Wise’s lawsuit was originally filed in West Virginia state court in the Circuit Court of Cabell County before it was transferred to the federal multidistrict litigation. ... Read More

Congressman pushes for hearing on FDA’s role in superbug outbreak

duodenoscope

A congressman whose district includes the UCLA hospital where more than 100 patients were exposed to a drug-resistant superbug is calling for the House Committee on Oversight and Government Reform to hold the Food and Drug Administration (FDA) accountable for not taking action sooner when it learned that certain medical devices could spread the dangerous bacteria from patient to patient. Rep. Ted Lieu, D-Calif., who also serves on the House Committee on Oversight and Government Reform, urged his fellow committee members to hold a hearing on the matter, adding that the agency’s recent safety alert failed to adequately provide health care ... Read More

FDA aims to improve medical device oversight

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The Food and Drug Administration (FDA) has issued an extensive report on how the agency aims to modernize is surveillance of medical devices to help ensure patient safety and increase manufacturer liability. The report comes in the wake of litigation over injuries caused by faulty medical devices from metal-on-metal hip implants to transvaginal mesh. The report, commissioned by the FDA and prepared by an expert panel of representatives from agencies, organizations and corporations, involves the implementation of the agency’s new unique device identifiers, or UDIs. The system is intended to assign a unique identifier to medical devices by the year ... Read More

DePuy increases fund for victims of defective hip implants

DePuy-ASR-hip-recall

Johnson & Johnson subsidiary DePuy Orthopaedics has agreed to add up to $350 million to a $2.5 billion settlement involving its defective hip implants. The original settlement, penned in November 2013, awarded up to $250,000 to about 8,000 patients who had undergone revision surgery to have their ASR hip replacement system removed prior to Sept. 1, 2013. Patients received less than the full $250,000 based on factors such as if they smoked or had a high body mass index. The original settlement also included $475 million in supplemental awards for patients who suffered further injuries from the revision surgery. About ... Read More

Injectable muscle relaxer recalled for sterility risk

Syringe

Two lots of the injectable muscle relaxer atracurium besylate manufactured by Emcure Pharmaceuticals and distributed by Sagent Pharmaceuticals are being recalled because the Food and Drug Administration (FDA) has observed activities during manufacturing that put into question the drug’s sterility. Non-sterility of a drug administered intravenously can result in infections, which could be fatal, especially in patients with compromised immune systems. Atracurium besylate is used along with anesthesia to facilitate endotracheal intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation. The drug is listed on the World Health Organization’s List of Essential Medicines, a list of the most important ... Read More

Jury awards $2.5 million in Risperdal gynecomastia lawsuit

risperdal

Johnson & Johnson subsidiary Janssen Pharmaceutical was ordered to pay $2.5 million in damages to the parents of an autistic boy who claimed the drug company covered up risks associated with its antipsychotic drug Risperdal, leading their son to grow female breasts, a condition known as gynecomastia. The lawsuit was filed by the family of Austin Pledger, now 20. They claimed their son took Risperdal for five years beginning at age 7, during which he developed gynecomastia. At the time, Risperdal was not approved to treat children but the drug company actively promoted the drug to physicians for pediatric use. Doctors can prescribe ... Read More

Risperdal lawsuit claims long-term emotional injury

risperdal

A Texas man has filed a lawsuit against the makers of the antipsychotic drug Risperdal claiming he suffered long-term emotional problems after the drug caused him to grow female breasts. Jacoby Moore filed his Risperdal lawsuit in Jefferon County District Court against Ortho-McNeil-Janssen Pharmaceuticals Inc., formerly known as Janssen Pharmaceuticals Inc., Johnson & Johnson Company, Johnson & Johnson Research and Development, and Dr. Ravikumar Kanneganti both individually and doing business as Child Guidance Center. Moore says he was prescribed Risperdal by Kanneganti when he was 7 to treat attention deficit disorder (ADHD). Risperdal, known generically as risperidone, is approved to ... Read More