Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA
The U.S. Food & Drug Administration (FDA) is reviewing a new study that reported an increased risk of sudden, heart-related deaths among people using the antibiotic Zithromax (azithromycin), known popularly as Z-Pak. In a statement issued late yesterday, the FDA said patients being treated with Zithromax should not stop taking ...
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 ...
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, ...
Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation
A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.
Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise
Having already spent around $3 billion on its DePuy Orthopaedics ASR hip implant recall, Johnson & Johnson is facing another potential debacle involving a metal-on-metal version of its Pinnacle Hip Replacement System. According to a report from Reuters, Johnson & Johnson and its DePuy unit already face some 1,600 metal-on-metal ...
Research Suggest Fracking Chemicals Can Pollute Aquifers
A new study suggests fluids used during the hydraulic fracturing (fracking) process could migrate through underground fractures and contaminate water aquifers.
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.
Canadian Study Finds Actos Raises Bladder Cancer Risk by 22 Percent
Yet another study is confirming the association between the diabetes drug, Actos, and bladder cancer. This latest research, published today in the Canadian Medical Association Journal, found that taking Actos raised the risk of bladder cancer among diabetics by about one-fifth.
Fracking Should be Kept 600m From Aquifers, Study Says
New research on the safety of hydraulic fracturing (fracking) suggests new wells should not be dug within 600 meters of a water aquifer because underground fractures can extend about that far from a dug well. According to a report from UK’s The Guardian newspaper, researchers and geologists at Durham University have ...
Medtronic Infuse Studies Faulted for Downplaying Side Effects
Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...Jurors Told Intuitive Surgical Ran Like a Car Dealership
In a case involving the safety of Intuitive Surgical’s da Vinci robotic system, the jury was told that the company acted “just like a car dealership” in training doctors to use the equipment.
In addition, jurors heard that the plaintiff, Fred Taylor, had died because of the company’s practices, and that Intuitive should pay more than $8 million in damages to his estate. These remarks were part of the plaintiff’s attorney’s closing arguments in a Port Orchard, Washington state court, Bloomberg News reports. Continue reading
End in Sight for Water-Contamination Cleanup at Camp Lejeune
At Camp Lejeune, the North Carolina Marine Corps base, cleanup continues of the decades-long drinking-water contamination problem that began in the 1950s.
More than 600 polluted sites are scattered around the 170-square-mile Marine base, located at the mouth of the New River. About five-dozen sites remain to be cleaned up, according to The Associated Press (AP). The contamination comes from a variety of pollutants – leaking gasoline from the base’s fuel storage farm, and chemicals including carcinogenic pesticides, benzene, and dry-cleaning solvents, some of which were intentionally dumped at Lejeune. Continue reading
Pharmacists Distributed Cheap Drug Substitutes to Kidney Dialysis Patients, Faces Four Years in Prison
A Tennessee pharmacist just pleaded guilty to swapping a cheaper drug substitute for the U.S. Food and Drug Administration (FDA) approved iron sucrose drug for kidney dialysis patients.
The pharmacist, Robert Harshbarger, 53, substituted a cheaper version of the drug from China, which was administered to kidney dialysis patients in Kansas, according to Kansas First News. Harshbarger was conducting business as American Inhalation Medication Specialists, Inc. and pleaded guilty to one count of distributing a misbranded drug and one count of health care fraud. Continue reading
Experimental Sleep Drug, Suvorexant, Raises FDA Concerns
The U.S. Food and Drug Administration (FDA) says that experimental insomnia drug, suvorexant, manufactured by Merck & Co. Inc., may be associated with dangerous side effects.
The experimental insomnia medication was found to be effective at helping patients sleep; however, suvorexant was found to have some significant side effects, such as daytime drowsiness and suicidal ideation, the agency’s advisory committee warned, according to CBS/The Associated Press (CBS/AP). The FDA released a review of suvorexant this week, in advance of today’s public meeting. Continue reading
Hidden Camera Reveals Horrifying Abuse of Canadian Nursing Home Patient
Shocking video footage taken by hidden camera at an Ontario, Canada, nursing home shows an elderly woman being subjected to horrific abuse at the hands of nursing home employees.
Four employees at St Joseph’s at Fleming long-term care home have been suspended pending investigation, the (U.K.) Daily Mail reports, after a patient’s son documented repeated abuse with a hidden camera he placed in his mother’s room. The Ontario Ministry of Health is investigating the case. While Alan Cavell, CEO of St Joseph’s at Fleming, stopped short of calling the treatment seen on camera abuse, “I would think that most people would say that it was,” he told CTV News. Continue reading
Metal-on-Metal Hip Device Tissue Damage Appears Before Symptoms
Metal-on-metal hip implant devices can cause synovitis—inflammation of the joint lining—and this significant adverse side effect can appear long before patients experience symptoms, according to a new study.
The study also found that magnetic resonance imaging (MRI) can be used to identify synovitis, said researchers at the Hospital for Special Surgery, wrote Health Canal. The research appears in an upcoming issue of the Journal of Bone & Joint Surgery. Continue reading
Man Alleges Taking Actos for Two Years Caused Bladder Cancer
A South Dakota man is the latest to bring a lawsuit against Takeda Pharmaceuticals, the maker of Type 2 diabetes drug, Actos (pioglitazone). The plaintiff alleges that taking Actos for two years caused him to develop bladder cancer.
Actos was approved by the U.S. Food and Drug Administration (FDA) in 1999.
According to the complaint, the man began taking Actos in January 2009; he developed bladder cancer in May 2011, allegedly due to his having taken Actos. At the time of his diagnosis, he stopped taking the medication. The lawsuit alleges that the defendants were aware that taking Actos could lead to an increased risk of bladder cancer, but failed to disclose this information to the man, his doctor, and consumers. The plaintiff is suing for extensive pain and suffering and severe emotional distress. Continue reading
Parker Waichman LLP Takes on Credit Card Companies, Fights for Small Business
National law firm, Parker Waichman LLP, and co-counsel just filed an objection to the passage of a proposed $7.25 billion settlement of a price-fixing case brought against Visa Inc. and MasterCard Inc. over credit card transaction fees. Co-counsel—both based in Little Rock, Arkansas—are Duncan Firm P.A. and Thrash Law Firm P.A.
The settlement has drawn criticism from trade associations and retailers that argue that the settlement grants credit card companies too much leeway to raise future rates, according to Bloomberg News. Continue reading
GranuFlo, NaturaLyte Maker Faces Center Closure Following Patient Deaths, Poor Infection Control Standards
A dialysis center owned by Fresenius Medical Care North America has shut down following infection-related deaths and hospitalizations.
The Bessemer Kidney Center is one of one dozen dialysis centers in Alabama that are owned by Fresenius Medical Care. This center was shut down earlier this month following two patient deaths and other patient hospitalizations that occurred over a matter of days, according to AL.com. The U.S. Centers for Disease Control and Prevention (CDC) and the Alabama Department of Public Health are investigating. Continue reading
DEP Drilling Review Reveals Water Damage, Questionable Testing Methods
A recently released drilling review found water damage and questionable testing methods in many cases when oil and gas activity were involved.
State environmental regulators found, according to a Times-Tribune/The Sunday Times report, that between 2008 – 2012, oil and gas development activity harmed water supplies for some 161 Pennsylvania homes, farms, churches, and businesses based on nearly 1,000 determination letters and enforcement orders written by Department of Environmental Protection (DEP) officials and obtained by the media outlet. Determination letters are sent to water supply owners who seek state inspections into whether or not oil and gas drilling activities polluted their well water or impacted the water flow to their wells, according to the Times-Tribune. Continue reading
