Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke
The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...
Colorado Woman Sues American Medical Systems Over Transvaginal Mesh Injuries
Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a Colorado woman allegedly injured by transvaginal mesh products manufactured by American Medical Systems, Inc. The suit was filed on May 21, 2012 in the U.S. District Court for the Northern District of California (Case No. ...
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 ...
FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety
An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...
Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices
Stryker’s recent recall of two metal hip implant components, the Rejuvenate Modular and ABG II modular-neck hip stems, may have dealt a serious blow to one of the key arguments medical device manufacturers have made to defend their metal-on-metal hip replacements. Facing thousands of lawsuits, the makers of ...
DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds
A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).
Majority of Metal-on-Metal Hip Implant Failures Occur within Two Years, Study Finds
A newly published metal-on-metal hip replacement study is reporting that the majority of failures occur early, within two years of surgery. The study, published in the journal Orthopedics, is just the latest to indicate that close follow-up of metal-on-metal hip implant patients is warranted.
West Virginia Man Claims Metal-on-Metal DePuy Pinnacle Hip Replacement Led to Pain, Elevated Cobalt Levels
A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...
Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks
According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...da Vinci Robotic Surgery Case With Jury
Jury deliberations are scheduled in the first of some 26 lawsuits brought over Intuitive’s da Vinci robotic surgical system and involve allegations of injuries associated with the controversial robotic system.
Kitsap County Superior Court Judge Jay Roof (Port Orchard, Washington), just handed the case to the 12-member jury after a five-week trial, according to Bloomberg News. Deliberations being this week.
Personal injury lawsuits have alleged that the da Vinci system has caused patients to suffer from a variety of adverse events, including internal injuries. Many of these injuries are the result of burns, tears, and other complications. In some cases, patients have died or suffer from chronic pain, even disability. da Vinci lawsuits fault aggressive Intuitive marketing positioned to induce hospitals to buy the costly system. Lawsuits also allege that a collaboration of design flaws and poor physician training on the da Vinci led to the injuries alleged in the litigation. At last count, some 70 deaths have been tied to the system since 2009. Continue reading
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
