Monthly Archives: May 2015
National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat
A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...
FDA Gives 7 Companies Go Ahead To Market Generic Plavix
The U.S. Food & Drug Administration (FDA) just gave seven companies the go-ahead to market generic Plavix. Plavix is a blood thinner prescribed for the prevention of blood clots, heart attacks, and which has been linked to serious side effects such as the heart attacks and strokes it is supposed to ...
Government Penalizes 721 Hospitals for High Rates of Infections, Injuries
Medicare is reducing payments to 721 hospitals, one out of every seven hospitals in the nation, for having high rates of “hospital-acquired” conditions (HAC.
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.
Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit
A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...
New York Property Owners Challenge Binghamton Fracking Ban
According to a Reuters report, the landowners believe the Binghamton, N.Y., city council and Mayor acted against proper protocol when voting to ban fracking drilling the the city. Instead, they feel the city should have consulted with the Broome County Planning Commission before approving the ban.
Decision on Pradaxa Bleeding Lawsuit Multidistrict Litigation Expected Soon
Victims of alleged Pradaxa injuries are awaiting word on whether their lawsuits will be consolidated in a multidistrict litigation. According to a report from The Madison Record, so far just over two dozen Pradaxa bleeding lawsuits have been filed in federal courts throughout the U.S.
First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January
The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...
Louisiana Whistleblower Lawsuit Revived
A state appeals court in Louisiana has ruled that a former employee of Rapides Parish Coliseum can proceed with a whistleblower lawsuit against the Coliseum Authority.
Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors
Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.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
