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British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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Study Links Liquid in E-Cigarette to Viral Infections

Study Links Liquid in Electronic Cigarette to Increased Risk of Viral Infections

The National Jewish Health study, links the liquid used in e-cigarettes to a higher risk of respiratory viral infections, whether the liquid contains nicotine or not.

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New York Property Owners Challenge Binghamton Fracking Ban

According to a Reuters report, the landowners believe the Binghamton, N.Y., city council and Mayor acted against proper protocol when voting to ban fracking drilling the the city. Instead, they feel the city should have consulted with the Broome County Planning Commission before approving the ban.

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Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...

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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 ...

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Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.

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Parker Waichman Representing Another Louisiana Plaintiff in Actos Bladder Cancer Lawsuit

A Louisiana man has become the latest to claim that his taking the type 2 diabetes drug Actos resulted in developing bladder cancer. He has filed a lawsuit against the Japanese manufacturer of the drug and the marketer of it in the U.S., claiming they failed to warn about this ...

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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. ...

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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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Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.

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Study: Antibiotics Associated with Increased Risk of Juvenile Arthritis

The use of antibiotics was linked to an increased risk of cancer in a study conducted by researchers from Rutgers University, University of Pennsylvania and Nemours A.I. duPont Hospital for Children. Findings showed that children who were exposed to antibiotics were twice as likely to develop juvenile arthritis compared to those who were not. As additional courses of antibiotics were taken, the risk increased; the risk was strongest within one year of taking antibiotics. The study was published in the journal Pediatrics.

Researchers conducted the study in light of evidence suggesting that children may be more likely to develop chronic diseases, including inflammatory bowel disease, when exposed to antibiotics. “Antibiotics are one of the better known disruptors of human microbial communities,” said lead author Daniel Horton, a postdoctoral research fellow working in the Department of Pediatrics at Rutgers Robert Wood Johnson Medical School and biomedical informatics master’s degree candidate in the Rutgers School of Health Related Profession. Continue reading

Posted in Legal News |

Class 2 Recall Issued for Nearly 2,000 Medtronic MiniMed Insulin Pumps

Medtronic has recalled nearly 2,000 units of its MiniMed 640G insulin pumps, according to a notification posted on the U.S. Food and Drug Administration’s (FDA’s) website. The device was distributed in the following 10 European countries: Australia, Czech Republic, Denmark, Finland, France, Ireland, the Netherlands, Norway, Sweden and the United Kingdom. Medtronic intends to submit the pump for PMA submission later this year, Fierce Medical Devices reports.

According to the recall notice, there may be instances where “the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.” The recall was designated as Class 2 by the FDA, meaning that exposure to the recalled device might lead to temporary or reversible adverse events or that there is a low risk of serious events. Continue reading

Posted in Legal News |

Chrysler Agrees to Record Fines and Penalties and Must Buy Back Defective Vehicles

Chrysler Agrees to Record Fines & Penalties

Chrysler Agrees to Record Fines & Penalties


Fiat Chrysler Automobiles could pay up to $105 million in fines and penalties and must buy back defective vehicles in an agreement with the federal government that will also require an independent monitor to oversee future vehicle recalls.

The automaker may have to buy back more than half a million vehicles with defective suspension parts if owners wish to sell those vehicles back to Chrysler, Fortune reports. Continue reading

Posted in Defective Products, Motor Vehicles | Tagged , , , , |

Woman’s Eyesight Endangered by Serious Side Effect of Tylenol

Woman’s Eyesight Endangered by Tylenol Side Effect

Woman’s Eyesight Endangered by Tylenol Side Effect


After taking Tylenol when she felt sick on vacation, an Indiana woman suffered a serious skin reaction like burns, over 40 percent of her body, and doctors are fighting to save her eyesight.

Stricken while vacationing near Bowling Green, Kentucky, Donna Emley, of Fort Wayne, Indiana, was diagnosed with Stevens-Johnson syndrome, a serious disorder of the skin and mucous membranes. Stevens-Johnson is usually a reaction to medication or an infection, according to the Mayo Clinic. Emley was sent to the burn unit at Vanderbilt University Medical Center in Nashville for treatment. Continue reading

Posted in Health Concerns, Pharmaceuticals | Tagged , , , , |

Ikea Warns of Dangers with 27 Million Dressers Following 2 Fatalities

Ikea Warns of Dangers with 27M Dressers Following 2 Fatalities

Ikea Warns of Dangers with 27M Dressers Following 2 Fatalities


Following the tragic deaths of two toddlers, Ikea is warning of the risks with its chests and dressers. Associated Press reports that Ikea chests resulted in fatal injuries when they tipped over and fell on two boys last year. The Swedish company is warning that the 27 million chests and dressers should be kept away from children if they are not mounted to a wall. CPSC spokesman Scott Wolfson said “They are unstable when built and used without a wall anchoring device,” according to AP. Consumers who have the furniture can obtain a free kit from Ikea for mounting to a wall; the kit will be available for consumers who purchased chests and dressers above specific heights.

In February 2014, a Malm six-drawer chest fell on a two-year-old boy in West Chester, Pennsylvania; he was fatally pinned against his bed. A three-drawer Malm chest fatally injured a 23-month old boy from Snohomish, Washington when it fell over. Continue reading

Posted in Health Concerns, Legal News | Tagged , , , , |

Legislation Before Congress Would Weaken Testing and Regulation of Medical Devices

Legislation Would Weaken Regulation of Medical Devices

Legislation Would Weaken Regulation of Medical Devices


In a time when ever-increasing numbers of Americans rely on medical devices, legislation currently before Congress could weaken the standards the Food and Drug Administration (FDA) uses to determine a device’s safety and efficacy.

The 21st Century Cures Act would allow devices to reach the market using case-study evidence rather than clinical trial results to demonstrate the device’s safety and effectiveness. Current approval process requires one clinical trial (new drugs, in contrast, usually require two trials). Writing in an op-ed piece in the New York Times, cardiologists Rita Redberg and Sanket S. Dhruva warn that medical devices, some of which are permanently implanted in the patient’s body, should have stricter approval requirements. Only a small minority of medical devices undergo randomized, controlled, blinded clinical studies—considered the gold standard in trials. Continue reading

Posted in Defective Medical Devices, Health Concerns | Tagged , , , , |

FDA Convening Panel to Reconsider Safety of Essure Birth Control System

FDA Convening Panel to Reconsider Safety of Essure

FDA Convening Panel to Reconsider Safety of Essure


On September 24, 2015, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the Food and Drug Administration (FDA) will meet to discuss the risks and benefits of Bayer HealthCare’s Essure birth control system.

The panel will seek expert scientific and clinical opinion on the risks and benefits of the Essure, a method for nonsurgical permanent female sterilization, and will hear testimony from doctors and scientists, as well as from women who have had the device implanted. The committee will evaluate scientific evidence about the safety and effectiveness of the Essure System, including perforation/migration of the device, device removal, chronic pain, allergic reactions, unintended pregnancy, and ectopic pregnancy. The committee will provide recommendations to the FDA about appropriate use of the device, product labeling, and the potential need for additional postmarket clinical studies. Continue reading

Posted in Defective Medical Devices, Health Concerns | Tagged , , , , |

Data Breach for Ashley Madison, Dating Site that Promotes Affairs

Data Breach for Ashley Madison, Dating Site

Data Breach for Ashley Madison, Dating Site


Ashley Madison, an online dating service with the slogan “Life is Short. Have an Affair,” reports that the site has been breached and hackers have obtained personal data about the service’s millions of members.

The Impact Team, the name given by the group behind the attack, said they had stolen information on Ashley Madison’s 37 million members. The group has leaked a portion of the data and said it will release all if the site is not shut down, the New York Times reports. Continue reading

Posted in Consumer Fraud | Tagged , , , , |

Studies Show Increased Melanoma Risk in Men Who Use Viagra

Increased Melanoma Risk in Men Who Use Viagra

Increased Melanoma Risk in Men Who Use Viagra


A study published in the Journal of the American Medical Association shows an increased risk of melanoma for men who use the erectile dysfunction drug Viagra.

Men who use Viagra have almost twice the melanoma risk, according to a study, CBSMiami reports. Researchers followed 25,000 thousand male health care professionals were followed for ten years as part of the research, tracking which men developed melanoma and whether they used Viagra (sildenafil). Continue reading

Posted in Health Concerns, Pharmaceuticals | Tagged , , , |

Study Shows Increased Hospitalization Rates Among Those Living Near Fracking Sites

Increased Hospitalization Among Those Near Fracking Sites

Increased Hospitalization Among Those Near Fracking Sites


A study by researchers from the University of Pennsylvania and Columbia University indicates that people who live near hydraulic fracturing drilling sites have a higher rate of hospitalizations for such issues as heart conditions, neurological illnesses, and cancer.

The research team was drawn from Columbia University’s Mailman School of Public Health, the Lamont-Doherty Earth Observatory, and the University of Pennsylvania’s Perelman School of Medicine. Their findings were based on analyses of hospitalization data for three Pennsylvania counties, and the article was published online last week in the journal PLOS One. Continue reading

Posted in Health Concerns, Hydraulic Fracturing / Fracking, Toxic Substances | Tagged , , , |

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