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 ...
Transvaginal Mesh a Nightmare for Thousands of Women
Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim ...
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 ...
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.
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 ...
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 ...
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 ...
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 ...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 ...
Actos, Avandia May Up Risk for Diabetic Macular Edema
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 ...Class Action Lawsuit: Goodman and Amana Air Conditioners Allegedly Violated Consumer Warranties
Since 2007, Goodman and Amana manufactured and sold central air conditioners that are both defective and breach warranties that were not honored, according to a recently filed class action lawsuit.
The complaint indicates that defective evaporator coils cause the air conditioners to work improperly. In fact, the defective evaporator coils “improperly and prematurely leak refrigerant under normal use.” The complaint also states that, “As the air conditioners leak refrigerant, they are unable to function properly and are thus unfit for their ordinary and intended purpose.” Continue reading
Many Popular Medications Contain Cancer-Causing Compounds, May Increase Cancer Risks
Cancer is devastating, killing about 600,000 people every year. Cancer is, in fact, the second-leading cause of death in the United States. Yet, despite consumers’ proactive measures to avoid cancer-causing products, some pharmaceuticals might contain carcinogens, ameliorating the best consumer efforts.
Medications we routinely take may contain dangerous ingredients. Consider that the U.S. Food and Drug Administration (FDA) does mandate that pharmaceutical companies test their products for so-called “carcinogenicity” in animals, yet even if the drugs test positive for increased tumor risks, that does not automatically get those drugs rejected, according to The Gazette. In fact, those very drugs may end up making their way to market. Continue reading
Supreme Court Decision Allows Regulators to Sue Over Generic-Drug Deals
In a decision handed down on Monday, the U.S. Supreme Court ruled that pharmaceutical companies that pay rivals to keep less-costly generic versions of best-selling drugs off the market can be sued by the Federal Trade Commission (FTC) for potential antitrust violations.
The justices, in a 5 to 3 vote, threw out lower-court rulings that said such agreements, called pay-for-delay agreements, are legal, provided they did not keep a generic drug off the market beyond the term of the brand-name drug’s patent, The New York Times reports. Continue reading
InFuse® Bone Graft No Better than Traditional Graft, Review Finds
An independent, dual review, found that Medtronic’s InFuse® product provided limited benefits. The bone graft product was also found to cause potential harm, including a small increased risk of cancer and works no better than traditional bone grafts, according to the review.
The U.S. Food and Drug Administration (FDA) approved InFuse® in 2002 for use in fusing damaged vertebrae in the lower spine; InFuse® was not approved for use on the upper, or cervical, spine, where it is now widely used, according to Bloomberg Businessweek. In fact, the FDA released a July 1, 2008 notification warning that the InFuse® bone graft had been associated with serious complications, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing, and nerve damage, when used in cervical spinal fusions. Continue reading
Asbestos Continues to Cause Significant Mesothelioma Risks
One case of mesothelioma is proving to be an example of what new generation asbestos lawsuits are looking like.
In one case, the plaintiff suffered from chest pain, traveled nationwide for major surgery, underwent chemotherapy, had to manage debilitating pain, and was dealing with a lawsuit that had not been finalized at the time of his death, according to The Wall Street Journal. His attorneys are suing an array of firms they believe exposed the now-deceased plaintiff to asbestos at some point during his life. Continue reading
European Drug Regulator Urges Caution in Use of Painkiller Diclofenac
The European Medicines Agency (EMA), Europe’s drug regulator, warned on Friday that the painkiller diclofenac, especially in high doses, carries extra heart attack risks, which should be taken into consideration by doctors prescribing the drug.
“Patients who have serious underlying heart or circulatory conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke, should not use diclofenac,” the EMA said in a statement. The EMA’s warning comes after a large international study showed that long-term, high-dose use of non-steroidal anti-inflammatory (NSAID) painkillers such as diclofenac and ibuprofen increases the risk of a major vascular event—heart attack, stroke, or death from cardiovascular disease—by around a third, Reuters reports. Continue reading
How Safe is Robotic Surgery?
Personal injury lawsuits allege that the da Vinci robotic surgical system marketed by Intuitive Surgical has caused severe internal injuries, including burns, tears, and other complications, some of which have resulted in death or chronic pain and disability. da Vinci lawsuits fault aggressive marketing tactics used by Intuitive Surgical to convince hospitals to purchase the expensive surgical robot, and allege that a combination of design flaws inherent in the robot, coupled with poor physician training on the device, have resulted in serious injuries.
In fact, some 89 deaths have been linked to the robotic surgical systems since 2009. According to the U.S. Food and Drug Administration (FDA), it has received more than 200 reports of burns, cuts, and infections, since 2007, according to NBC News. Continue reading
FDA Warning Letter Issued to Edwards Lifesciences
Following a month-long U.S. Food and Drug Administration (FDA) inspection of the Edward’s Lifescience manufacturing facility in Draper, Utah, the agency issued a detailed warning letter to the medical device maker. The inspection also prompted a couple of recalls and a letter to investors.
In its letter, the agency cited seven manufacturing violations. Some, according to a MassDevice.com report, led to recalls. Violations included “failure to validate” manufacturing processes that the FDA said, “cannot be fully verified by subsequent inspection and test.” The inspectors also noted six customer complaints concerning Edwards’ QuickDraw cannulae, which broke during cardiac procedures. The inspectors pointed out that Edward’s Lifesciences does not appropriately validate its ovens’ temperatures, which is critical to maintain proper manufacturing bonding, MassDevice.com wrote. Continue reading
FDA Calls for Cybersecurity Safeguards for Medical Devices
The U.S. Food and Drug Administration (FDA) issued a safety alert on Thursday recommending that medical device manufacturers and health care facilities take steps to secure implantable medical devices and hospital equipment against cyberattacks, which could threaten patient lives and safety.
Cybersecurity experts largely focus on the vulnerability of hospital equipment such as CT scanners and heart monitors, whose functions can be disrupted by viruses and malware that travel over hospital networks, the Wall Street Journal reports. But device experts warn that individual implantable devices – defibrillators, pacemakers, and insulin pumps – are also vulnerable. Because “medical devices are increasingly interconnected, via the Internet, hospital networks, other medical devices, and smartphones,” the FDA alert explains, “there is an increased risk of cybersecurity breaches, which could affect how a medical device operates. Continue reading
NHTSA Calls for Research on Risks of Hands-Free Texting While Driving
National Highway Traffic Safety Administration (NHTSA) administrator David Strickland has called for more research to determine whether the government should impose regulations on hands-free messaging behind the wheel.
Strickland spoke this week in response to a study released by the Automobile Association of America (AAA) that suggested using voice-activated technology while driving an automobile may be more dangerous than using hand-held devices, the Detroit News reports. Automakers have spent hundreds of millions of dollars developing systems that use voice commands to allow drivers not only to make calls but also send emails and texts while driving. Automakers claim this is safer because drivers can keep their eyes on the road and their hands on the wheel. But the AAA study suggests that driver distraction is actually greater with voice-activated technologies because drivers are attempting tasks that require a higher degree of concentration. Continue reading
