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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

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 ...

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Knee Replacement Patients Should Consider Nickel Allergies before Surgery

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 ...

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Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

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 ...

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Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise

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 ...
Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

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, ...

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Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Lawsuits filed by alleged victims of DePuy Orthopaedics’ recalled ASR hip replacement devices continue to pile up in the multidistrict litigation currently underway in U.S. District Court, Northern District of Ohio. Most recently, a woman from Pryor, Oklahoma, filed suit alleging complications caused by a DePuy ASR hip implant ...

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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also ...

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Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

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 ...

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Smokers More Vulnerable to Joint Replacement Failures

Smokers More Vulnerable to Joint Replacement Failures

People who smoke cigarettes before and after receiving a total joint replacement, such as a hip replacement device or knee implant, are far more likely to endure revision surgeries on those implants than people who don’t smoke.

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More Than 2,500 Cancer Cases in Ground Zero Responders

2500-Cancer-Cases-in-Ground-Zero-RespondersThe number of cancers diagnosed in Ground Zero responders more than doubled this past year.

The World Trade Center Health Program counted 1,655 responders with cancer, bringing the total to 2,518, the New York Post reports. This number includes police, firefighters, EMTs, construction and sanitation workers, and volunteers. Many, including construction worker John Vobecky, fear the cancer numbers will continue to rise “in the next 5 or even 10 years.” There have been 1,145 compensation claims listing cancer, but according to the Post only 115 claims have been awarded. Some ailing first responders fear compensation won’t come until after they die, WPIX-11 reports. Continue reading

Posted in Health Concerns, Legal News, Toxic Substances, Zadroga Act Claims |

Nitrogen Spiking Scams Protein Supplement Customers

Nitrogen-Spiking-Scams-in-protein-powdersSome protein powder manufacturers are scamming their customers by cutting their protein supplements with non-protein ingredients; this is called “nitrogen spiking” or “protein spiking.”

Gene Bruno, a dietary supplement scientist, reported on protein spiking in the April 2014 issue of Natural Products Insider. Bruno says that, according to NSF senior research scientist John Travis, reduced nitrogen can be liberated as ammonia in a protein test. By adding cheaper ingredients that contain nitrogen, manufacturers can manipulate the test to artificially inflate the amount of protein in their product. Protein spiking has prompted the American Herbal Products Association (AHPA) to propose a “defined standard” when measuring protein.

Amino acids are used because they contain nitrogen and are less expensive than complete proteins such as whey protein, casein protein and egg protein. Bruno’s report notes that “Although amino acids are the building blocks of protein, they do not have the same beneficial effects of whole protein.” because they are absorbed differently. The report also quotes Tim Ziegenfuss, CEO of the Center for Applied Health Sciences as saying “Arginine has approximately three times more nitrogen than whey protein, and creatine has approximately one and a half times more nitrogen at less than half the price. Spiking protein with these nutraceuticals is a cheap way to drive up the nitrogen level of a protein powder without adding more high-quality protein.”

Brands that may be guilty of protein spiking include: Body Fortress, ProSupps, MusclePharm Arnold series, 4 Dimension Nutrition, Designer Whey, Mutant Nutrition, Top Secret Nutrition, Gaspari Nutrition, Giant Sports Nutrition, Infinite Labs, and Beast Sports Nutrition.

Consumers looking to buy protein supplements should read the label to avoid a product that has been spiked; ingredients to look out for are arginine, glycine, creatine and taurine. According to General Nutrition Centers (GNC), these ingredients should not be counted in a protein test, even though some of them may have health benefits.

Dietary supplements are not subject to the same regulations as other health items. The U.S. Food and Drug Administration (FDA) can only take action against the manufacturer once the product is already on the market, and shown to be adulterated or misbranded. The FDA has taken action against companies in the past for being dishonest about what was in their product.

Posted in Legal News |

Higher Risk of Gynecomastia in Risperdal Users, New Research Suggests

Higher-Risk-of-Gynecomastia-in-Risperdal-UsersNew research presented at the American Association for Geriatric Psychiatry 2014 Annual Meeting suggests that there is a higher risk of gynecomastia with Risperdal (risperidone) users than non-users. Researchers found that older men taking the antipsychotic drug were 69 percent more likely to have breast enlargement compared to those who did not. The researchers also found evidence that there is a higher risk of gynecomastia with Risperdal compared to other antipsychotics.

“This is the first and largest epidemiologic study on this question using data from 1 million men in the United States,” said lead author Mahyar Etminan, PharmD. Dr. Etminan is a drug safety researcher in the Therapeutic Evaluation Unit at Provincial Health Services Authority of British Columbia and an assistant professor at the University of British Columbia, Vancouver.

The researchers looked at data from the IMS LifeLink Health Plan claims database. Among 1 million men in the United States between the ages of 45 and 80 who made the claims between 2001 and 2011, 8,285 were identified as having gynecomastia. Ten men who did not have the condition were matched to each man who did as a control group. The mean age of both groups was 65.5 years.

“There has been a lot of interest on the risk of gynecosmastia with Risperdal, mainly in adolescent boys but also in older men. There have been reports to the FDA [US Food and Drug Administration] and case reports from academics,”  Dr. Etminan said.  “So we wanted to see if there was actually a risk with Risperdal that is over and beyond the other antipsychotics. We do know that these drugs in general can cause gynecomastia because of the way they change the hormones in the body. But we weren’t really sure whether Risperdal does it more than the others.”

There was a trend in the data suggests that Risperdal increased the risk of gynecomastia compared with paliperidone or quetiapine. Etminan noted that “Statistically, this wasn’t significant, which means we didn’t have enough power or enough people in this study. But the trend was definitely there,”

Although the study was only done on older men, Dr. Etminan emphasized that the condition can occur in younger boys. This factor may be especially important if the drugs are equal in efficacy, he says, because the psychological effects may be more problematic in younger men, say VendorsBay.

There are hundreds of lawsuits alleging that Risperdal caused gynecomastia. In 2012, Johnson & Johnson reached the first settlement; the lawsuit was filed on behalf of a 21-year old man alleging that the drug led to breast enlargement and subsequent surgical removal. Shortly afterwards, five more lawsuits were settled.

Posted in Legal News |

Surgeon General Issues Warnings About Skin Cancer, Tanning Beds

FDA-skin-cancer-warning-on_tanning_bedsExperts agree that tanning—whether from natural sunlight or from tanning salons—is creating a major health issue in the United States and is increasing risks for certain cancers, some deadly.

The U.S. Surgeon General, Borish Lushniak, just warned that, when outside, people should remain in the shade and should wear sunscreen. Tanning booths, said Lushniak, should be avoided, wrote News Ledge.

The Surgeon General told The Washington Post that, “Right now we’re seeing kind of a bad trend developing when it comes to skin cancers. Skin cancers—melanoma and non-melanoma skin cancer—are increasing. It got to the point for us, right now, to be able to say, ‘We need to have this call to action.’” Continue reading

Posted in Consumer Fraud |

Safety Concerns Prompt FDA to Evaluate OTC Antiseptics

FDA-to-Evaluate-OTC-AntisepticsJust months after raising concerns to manufacturers, the U.S. Food and Drug Administration (FDA) will be holding a meeting to discuss whether or not non-prescription antiseptic products are safe and effective, RAPS reports.

Over-the-counter antiseptics are used to reduce the risk of infection during an injection. They are distributed in both single-use form and multiple-use packages; with the latter, the product is available in a package such as a tube that allows users to apply more antiseptic later. Continue reading

Posted in Legal News |

FDA Warns that OTC Acne Products May Cause Dangerous Side Effects

Acne-Products-May-Cause-Dangerous-Side-EffectsIn a recent consumer warning, the Food and Drug Administration (FDA) said over-the-counter acne products that contain benzoyl peroxide or salicylic acid can cause serious and potentially life-threatening allergic reactions or severe irritation.

These products come in a variety of forms: gels, lotions, facial washes, cleansing pads, and facial scrubs. The FDA received 131 reports of serious allergic reactions from these products, according to Health Hub (of the Cleveland Clinic). Consumers and manufacturers made the reports between 1969 and January 2013. Those reports included such severe symptoms as

  • Throat tightness
  • Shortness of breath
  • Wheezing
  • Low blood pressure
  • Fainting
  • Collapse Continue reading
Posted in Pharmaceuticals |

FDA: Unique Pharmaceuticals’ Sterile Drugs Recalled Over Insanitary Conditions

Unique-PharmaceuticalsUnique Pharmaceuticals, Ltd. just announced a nationwide recall of all of its sterile compounded preparations within those preparations’ expiry period over a potential lack of sterility assurance, the U.S. Food and Drug Administration (FDA) just revealed.

The sterile drug preparations compounded by the outsourcing facility have not reached the expiration date listed on the products. Unique Pharmaceuticals indicated that it initiated the recall following FDA concerns with Unique Pharmaceuticals’ compounding facilities and processes. According to the agency, the facilities and processes present a lack of sterility assurance and were also observed during recent inspections conducted by the FDA. Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals |

Researchers: Liver Failure, Transplant Tied to Weight-Loss Supplement

Liver-Failure-Tied-to-Weight-Loss-SupplementA woman who had been taking a weight loss supplement suffered liver failure and needed a liver transplant, according to a recent report of her case.

The woman, 35, had taken three Saba Appetite Control and Energy (ACE) pills in a two-day period. Two weeks later, she developed jaundice, suffered from liver failure and required a liver transplant, according to Live Science, citing a report from researchers at the University of Kentucky in Lexington, who treated her. Continue reading

Posted in Defective Products, Health Concerns |

“National Whistleblower Appreciation Day” Founded by Senate

National-Whistleblower-Appreciation-DayThe United States Senate declared July 30, 2013 as “National Whistleblower Appreciation Day” in an effort to support and commend the actions of individuals refused to accept fraud, misconduct and other wrongdoing. According to National Whistleblowers Center, a non-profit organization, the decision to establish “National Whistleblower Appreciation Day” was a unanimous one made by the Senate on July 31, 2013. Continue reading

Posted in Legal News |

GM’s Best Selling Pickup Trucks Recalled Six Times this Year

GM-Best-Selling-Pickup-Trucks-RecalledGeneral Motors (GM) has recalled its 2014 Chevrolet Silverado and GMC Sierra six times this year so far, making them the most frequently recalled vehicles. And unfortunately for GM, that is not the end of the pickups’ recall history, they have been recalled a total of nine times since they were introduced one year ago, according to CNNMoney. Continue reading

Posted in Legal News |