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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

A class action lawsuit filed in Australia over DePuy Orthopaedics’ recalled metal-on-metal ASR Hip Implants has signed up more than 1,000 plaintiffs. The attorneys representing the Australian ASR Hip Implant lawsuit plaintiffs recently told The Courier-Mail that damages in the lawsuit are expected to be worth more than $200 million. One ...

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Three Injured, Long Island Railroad Train Hits Car on Tracks

Three Injured When Long Island Railroad Train Hits Car on Tracks

Three people, including a train engineer, were injured on Wednesday when a Long Island Rail Road train hit a livery cab on the tracks west of Wyandanch station, LIRR officials said. LIRR spokesman Salvatore Arena said the driver of the Lincoln Town Car was taken to Good Samaritan Hospital Medical Center ...

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Research Study Confirms Fracking Cause of Ohio Earthquakes

Research Study Confirms Fracking as Cause of Ohio Earthquakes

Fracking operation near Poland Township, Ohio, activated a previously unknown fault in the, causing 77 earthquakes with magnitudes ranging from 1.0 to 3.0 in March 2014.

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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 Finds Plavix May Only Benefit Smokers

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, ...

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Government Penalizes 721 Hospitals for High Rates of Infections, Injuries

Government Penalizes 721 Hospitals for High Rates of Infections, Injuries

Medicare is reducing payments to 721 hospitals, one out of every seven hospitals in the nation, for having high rates of “hospital-acquired” conditions (HAC.

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Medtronic Infuse Studies Faulted for Downplaying Side Effects

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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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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Xarelto Mass Tort Organized in Philadelphia

Xarelto Mass Tort Organized in Philadelphia

Xarelto Mass Tort Organized in Philadelphia


Administrative Judge Kevin Dougherty of the Philadelphia Court of Common Pleas ordered the creation of a mass tort, transferring roughly 75 cases involving the blood thinner Xarelto to the court’s Complex Litigation Center.

The lawsuits are filed against Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer HealthCare Pharmaceuticals. The lawsuits allege that Xarelto (rivaroxaban) causes uncontrollable and sometimes fatal bleeding, the Legal Intelligencer reports. An attorney representing several plaintiffs said Xarelto can cause “bleeding that cannot be stopped because there’s no antidote. The person can bleed to death or sustain serious injuries which could have been controlled in another product.” Continue reading

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

Long Island Car Crash Kills 1 Person, Injures 2 More

Long Island Car Crash Kills 1 Person, Injures 2 More

Long Island Car Crash Kills 1 Person, Injures 2 More


A single-car accident on Long Island left one person dead and two more critically injured, Associated Press reports. The crash occurred at 4:30 a.m. Monday in Deer Park. Suffolk County Police have not yet determined the cause of the crash, but they say it was not a result of the weather.

The three occupants were in a 2003 Infiniti southbound on Straight Path when it swerved off the road and crashed into a tree south of Sagamore Lane. One of the occupants, a 28-year old man of Wyandanch, was ejected from the vehicle and pronounced dead at the scene. The other two occupants were also of Wyandanch. Police do not know who was the driving the car.

Posted in Legal News | Tagged , , , , |

Oil Spill into Yellowstone River Raises Concerns about Nation’s Aging Pipelines

Oil Spill into Yellowstone River Raises Concerns about Aging Pipelines

Oil Spill into Yellowstone River Raises Concerns about Aging Pipelines


As a community downstream from the January 17 Poplar Pipeline oil spill into the Yellowstone River works to treat benzene contamination of its water supply, concerns are being raised about oversight of the nation’s aging pipeline network.

Federal investigators and pipeline company officials were trying to determine the cause of the 40,000-gallon spill, which contaminated downstream water supplies in the city of Glendive, Montana, The Associated Press (AP) reports.  Continue reading

Posted in Benzene, Health Concerns, Oil Spills, Toxic Substances | Tagged , , , , , |

FDA-Approval Does Not Ensure Safety or Effectiveness of Drugs

FDA-Approval Does Not Ensure Safety/Effectiveness of Drugs

FDA-Approval Does Not Ensure Safety/Effectiveness of Drugs


When a drug is approved by the U.S. Food and Drug Administration (FDA), it may give some the impression that it is proven to be safe and effective for a certain condition. An investigation by the Milwaukee Journal Sentinel, however, shows that this is not necessarily true. By focusing on new diabetes drugs that have been on the market, the investigation suggests that FDA approval is no guarantee of safety or efficacy.

Diabetes medications such as Januvia, Byetta and Victoza were linked to 3,000 deaths and about 20,000 hospitalizations in the last decade. Furthermore, the report showed that none of the 30 new diabetes drugs have been shown to decrease the risk of key complications associated with the condition, such as heart attacks, stroke and blindness. Continue reading

Posted in Legal News | Tagged , , , , , |

Study Suggests Hormonal Contraceptives Linked to Increased Brain Tumor Risk

Study Suggests Hormonal Contraceptives Linked to Brain Tumor

Study Suggests Hormonal Contraceptives Linked to Brain Tumor


A study of Danish women of reproductive age suggests that long-term use of hormonal contraceptives is associated with an increased risk of brain tumors.

Hormonal contraceptives, which contain female sex hormones, are commonly prescribed in pill form. “The Pill” first became widely available in the 1960s and gave women all over the world control over childbearing. The new study, which appeared in the British Journal of Clinical Pharmacology, reports that taking a hormonal contraceptive for at least five years is associated with a possible increase in the woman’s risk of developing a rare tumor, glioma of the brain, Science 2.0 reports.   Continue reading

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

British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

British Health Agency Strengthens Warnings about Valproate

British Health Agency Strengthens Warnings about Valproate


The Medicines and Healthcare Products Regulatory Agency (MHRA), Britain’s drug regulatory agency, has issued a statement urging healthcare professionals to give women better information on the risk of birth defects when Depakote and other valproate medicines are used during pregnancy. These medications are used to treat epilepsy and bipolar disorder.

Following a European review last year, which found that up to 40 percent of children born to women who take valproate during pregnancy may have developmental disorders and other birth defects, MHRA moved to strengthen product information. The agency is making informational booklets available to healthcare professionals and patients and the leaflet in the drug packing is being updated with stronger warnings about the risk of developmental disorders in children exposed to valproate during pregnancy. The review found that of 35,000 women prescribed valproate, 375 become pregnant per year while taking it. Continue reading

Posted in Birth Defects, Depakote, Health Concerns, Pharmaceuticals | Tagged , , , , , |

Whistleblower Wins Retaliation Lawsuit

Whistleblower Wins Retaliation - Canaveral National Seashore

Whistleblower Wins Retaliation – Canaveral National Seashore


A whistleblower who reported misconduct at Canaveral National Seashore has won a retaliation ruling against the U.S. Department of Interior, Florida Today reports. The former employee filed a suit in 2011 alleging misconduct, including contracting violations and nepotism. Continue reading

Posted in Legal News | Tagged , , , , |

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

British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System


The British Medicines and Healthcare Products Regulatory Agency (MHRA) has announced the recall of Smith & Nephew Renasys negative pressure wound care devices because of the risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds if there is a blockage in the vacuum system of the affected devices.

A negative pressure wound therapy (NPWT) device is an electric pump system that applies a vacuum to chronic, deep cavity wounds. The systems use disposable components such as foam or gauze dressings and tubing. If a blockage in the system is not detected, fluid from the wound can build up and leak from the dressing, according to the MHRA. The affected devices may not detect blockages and the alarm will not sound even if the dressing has visibly lifted from the wound. Continue reading

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

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA Warning for Bone Graft Products in Patients Under 18

FDA Warning – Bone Graft Products/Patients Under 18


The Food and Drug Administration has issued a safety alert to healthcare providers, patients, and parents and guardians that bone graft devices containing recombinant proteins or synthetic peptides should not be the first treatment considered for patients under age 18.

Certain recombinant proteins and synthetic peptides mimic bone growth substances normally found in the body and may be added to a carrier and then surgically implanted in a patient with a bone defect to promote new bone growth or to replace or heal existing bone. The FDA has approved devices such as Medtronic Infuse for orthopedic and dental use only in patients over the age of 18 who are done growing (skeletal mature). The labeling for each product provides the specific indications for use. The FDA has not evaluated their safety and effectiveness in patients under age 18, who are considered skeletally immature. Any product that affects bone growth has the potential to negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates. Continue reading

Posted in Defective Medical Devices, Medtonic Infuse | Tagged , , , , |

What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?


As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

E-cigarettes, battery-powered devices that heat nicotine liquid into an inhalable vapor, have been touted as a means to wean smokers from traditional cigarettes. They do not produce smoke, and there is no carcinogenic tar produced in burning tobacco in traditional cigarettes. But smokers are not adopting the devices in the numbers expected, The New York Times reports, and some experts argue that e-cigarette manufacturers see them not as a cessation device but as a way to introduce nonsmokers, in particular young people, to smoking. Continue reading

Posted in Health Concerns, Toxic Substances | Tagged , , , , |

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