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.
Zadroga Act Cancer Decision Expected This Week
The federal official tasked with determining what ailments should be covered by the federal Zadroga Act is expected to decide by Saturday if certain cancers will be eligible for compensation. The decision is being eagerly awaited by thousands of first responders who believe they developed cancer due to exposure ...
Fracking Boom Changing Way of Life in Pennsylvania's Northern Tier
In just a few years, the impact of hydraulic fracturing (fracking) drilling on northeastern Pennsylvania is hard to miss. Thousands of natural gas wells have been opened in that area specifically in the last five years as companies look to exploit the vast Marcellus shale formation about two miles below the ...
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 ...
First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL
The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...
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).
Western Pennsylvania Familes File Suit Over Alleged Fracking Pollution
Three families in western Pennsylvania believe a leading hydraulic fracturing (fracking) company and two water testing labs are conspiring to produce false results that show natural gas drilling is not contaminating their private water wells.
Knee Replacement Patients Should Consider Nickel Allergies before Surgery
Individuals considering undergoing knee replacement surgery should ask their doctors to run a test to determine if they have a nickel allergy. Determining if a patient suffers from a nickel allergy will ensure the right knee implant is chosen for their surgery, and possibly save them from considerable pain and ...
Study Finds Plavix May Only Benefit Smokers
An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, ...
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 ...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
Type 2 Diabetes Medication Risks Examined in Journal Review
Incretin mimetics, a class of Type 2 diabetes drugs, are sparking debate and renewing concerns about health risks, especially to the pancreas. In fact, a piece published in the journal BMJ, states that the drugs, which include Byetta and Januvia, might be riskier than initially believed.
According to the journal,drug companies have withheld data on the potentially dangerous effects of incretin mimetics. BMJ analyzed thousands of pages of regulatory documents it obtained under Freedom of Information rules, locating unpublished data indicating, “unwanted proliferative or inflammatory pancreatic effects,” according to MedPage Today. “On their own, the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug,” Deborah Cohen, Investigative Editor for BMJ, wrote. Continue reading
New Lawsuit Alleges Actos Caused Arizona Man’s Bladder Cancer
An Arizona man who took the diabetes drug Actos (pioglitazone) for several years has filed a lawsuit alleging that the drug caused his bladder cancer. The lawsuit further alleges that Takeda Pharmaceuticals, the drug’s manufacturer, was aware of the risk but failed to warn consumers.
According to the legal complaint, the plaintiff started taking Actos in March 2003 to treat his Type 2 diabetes and he was diagnosed with bladder cancer in November 2008. He alleges that the cancer is due to the side effects of Actos. The suit further claims that the defendants, Takeda Pharmaceuticals North America, Inc. and Eli Lilly and Company, were aware of the bladder cancer risk but did not disclose this to patients or their doctors in order to protect their financial interests. Bloomberg News reported that peak sales for Actos, in the year ending March 2011, totaled $4.5 billion, which represented 27 percent of the company’s revenues at the time. Continue reading
Timeline Established for Transvaginal Mesh Bellwether Cases
In a pretrial order to American Medical Systems Inc., the U.S. District Court for the Southern District of West Virginia established a timeline for selecting five transvaginal mesh cases that will be bellwether trials in the multidistrict litigation entitled In Re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2325.
Bellwether cases are chosen to represent common claims and theories among a large group of plaintiffs. The verdicts in these trials are useful in the remaining cases and can also serve to guide settlements. Thousands of transvaginal mesh lawsuits have been consolidated into five pending MDLs involving a number of manufacturers of transvaginal mesh. Continue reading
Louisiana Chemical Plant Blast Kills 1, Injures 33
The Geisemar, Louisiana Williams Olefins chemical plant was the site of a blaze that shot a massive fireball and smoke column into the sky today, leaving 33 people injured. One person died in the blast.
People in a two-mile radius were ordered to remain indoors, in part due to smoke, Lester Kenyon, a spokesman for Ascension Parish said, according to Reuters. All of the roads leading into the plant have been closed, the company announced and “Emergency shut-down valves have been closed. The unit is isolated,” parent group Williams Cos. said in a statement. “We are in the process of accounting for all personnel.” Continue reading
