FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say
The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.
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.
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).
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 ...
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 ...
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, ...
Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery
DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...
Study Finds SSRI Antidepressant Side Effects Outweigh Their Benefits
A new study is raising more concerns about the safety of commonly used antidepressants, including selective serotonin reuptake (SSRI) inhibitor antidepressants. Investigators who conducted the study, which is published in the journal Frontiers in Psychology, posit that increased knowledge of the negative effects of SSRIs and other antidepressants could reduce ...
Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings
Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.
Indiana Woman Alleges Serious Injuries From Transvaginal Mesh Products
Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a woman who suffered injuries after receiving transvaginal mesh implants. The lawsuit suit alleges that the transvaginal mesh created an unreasonable risk and directly caused her injuries.Zyprexa Gets FDA Attention Following Two Patient Deaths
Zyprexa is an antipsychotic medication manufactured by Eli Lilly used to treat disorders such as schizophrenia and bipolar disorder. This drug, however, has caught the attention of the U.S. Food and Drug Administration (FDA) when two patients died after receiving the injections. The FDA is now investigating Zyprexa, which is manufactured by Eli Lilly. Continue reading
Despite Prior Objections, Chrysler to Recall 2.7 Million Jeeps
Despite intense objections last week, Chrysler Group has agreed to recall 2.7 million Jeeps. The announcement was made hours before a government deadline on the issue.
In a rare move, Chrysler had defied a National Highway Traffic Safety Administration (NHTSA) recall request maintaining its Jeeps were safe and challenging the regulator’s collision data analysis. The NHTSA said that the rear-mounted gas tanks in 1993-2004 Jeep Grand Cherokees and 2002-2007 Jeep Liberty vehicles are too vulnerable to leaking and could catch on fire in a rear-end crash, according to ABC News previously. Although the NHTSA can call for a recall, the agency requires a court order to enforce that demand. Continue reading
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
