Monthly Archives: May 2015
Johnson & Johnson Marketing of Gynecare Prolift Transvaginal Mesh Raises More Questions
Johnson & Johnson and its Ethicon unit are again coming under scrutiny for the way it marketed its Gynecare ProLift transvaginal mesh product. According to a new report from Bloomberg News, Johnson & Johnson continued marketing the Gynecare ProLift device for months after it received a warning from the ...
FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say
The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.
Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man
81-year-old Port Jefferson Station man was killed in a crash at 4:57 a.m.. He lost control of the vehicle traveling west on Northern State Pkwy, on exit 42, Dix Hills.
Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch
Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.
What Action Will the FDA Take on E-cigarettes?
As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.
Two-Leading-Cancer-Groups-Issue-Call-for-Regulation-of-E-cigarettes-and-Research-on-Health-Risks
The American Society of Clinical Oncology & the American Association for Cancer Research called for government regulation & research of e-cigarettes on health effects.
Lawsuits over DePuy ASR Metal-on-Metal Hip Implants Continue to Mount
DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be hit with lawsuits over recalled metal-on-metal DePuy ASR hip implants. Just yesterday, the national law firm of Parker Waichman LLP announced it had filed yet another DePuy ASR hip implant lawsuit, this time on behalf of a Virginia resident ...
Newly-Filed Plavix Lawsuits Claim Drug Caused Gastrointestinal Bleeds, Cerebral Hemorrhage, and TTP
The manufacturer of Plavix continues to be named in lawsuits alleging the blood thinner caused some patients to suffer from serious bleeding side effects. Most recently, the national law firm of Parker Waichman LLP filed nine Plavix bleeding lawsuits in state court in New York.
Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings
Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.FDA Inspection Results in Warning Letter to Smith & Nephew
A March inspection of the Andover, Massachusetts manufacturing facilities of medical device maker Smith & Nephew has resulted in a Food and Drug Administration (FDA) warning letter to the company based on problems uncovered the inspection. The inspection took place … Continue reading
Update on CareFusion Recall of AVEA Ventilators
This week, medical device maker CareFusion provided an update on a global voluntary recall that was initiated on April 21, 2015 to address an issue with certain units of AVEA ventilators. The AVEA ventilator is used in hospitals and health … Continue reading
$15 Million in Damages Awarded to Child for Birth Defects Linked to Depakote
This week a St. Louis jury found that a Minnesota girl’s birth defects were caused by the epilepsy medication Depakote her mother took during pregnancy and the jury awarded the child $15 million in damages. The jury returned the unanimous … Continue reading
Research Links Tylenol Use during Pregnancy to Increased Risk of Male Sterility
New research suggests that males may have a higher risk of infertility if their mothers took Tylenol for extended periods during pregnancy. A study conducted by researchers at the University of Edinburgh and published in the journal Science Translational Medicine … Continue reading
UMass Epidemiologist to Lead Study of Possible Link Between Phthalates and Breast Cancer Risk
An epidemiologist at the University of Massachusetts Amherst has received a $1.5 million grant from the National Institute of Environmental Health Sciences to study whether phthalates affect human breast cancer risk. Prof. Katherine Reeves of the UMass School of Public … Continue reading
Health Authorities Investigate Multistate Salmonella Outbreak Possibly Linked to Raw Tuna in Sushi
The Food and Drug Administration, the Centers for Disease Control and Prevention (CDC), and state and local health officials are investigating a multistate outbreak of Salmonella Paratyphi B variant L(+) tartrate(+) infections, possibly linked to sushi made from raw tuna. … Continue reading
Acetaminophen Use in Pregnancy Could Affect Son’s Fertility
New research in mice suggests that long-term exposure to acetaminophen during pregnancy could lower a male’s production of testosterone, possibly affecting his fertility. The results suggest that if a pregnant woman takes acetaminophen for several days it could affect her … Continue reading
Emails Show FDA Was Warned of Duodenoscope Infection Risks Six Years Ago
The Food and Drug Administration (FDA) received warnings nearly six years ago about the risk of “superbug” infection from specialized medical scopes. The devices have been tied to a series of deadly superbug outbreaks. In 2009, after duodenoscopes were linked … Continue reading
Lumber Liquidators CEO Unexpectedly Resigns Amid Product Safety Concerns
Lumber Liquidators CEO Robert Lynch unexpectedly resigned Thursday following weeks of struggles over safety concerns related to its flooring products. The Toano, Va.-based company will search nationally for a replacement, the company said. Thomas Sullivan, Lumber Liquidators founder, will serve … Continue reading
Indian Food Inspectors Order Instant Noodle Recall over Dangerous Levels of Lead
Food inspectors in the northern Indian state of Uttar Pradesh have ordered Nestle India to recall a batch of Maggi instant noodles from stores across the country because the product contained dangerous levels of lead. India’s Food Safety and Drug … Continue reading
