Tag Archives: superbug

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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.

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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 ...

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Actos, Avandia May Up Risk for Diabetic Macular Edema

A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...

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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.

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National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

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Newly-Filed Plavix Lawsuits Claim Drug Caused Gastrointestinal Bleeds, Cerebral Hemorrhage, and TTP

The manufacturer of Plavix continues to be named in lawsuits alleging the blood thinner caused some patients to suffer from serious bleeding side effects. Most recently, the national law firm of Parker Waichman LLP filed nine Plavix bleeding lawsuits in state court in New York.

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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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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Sleep Aids Can Increase Alzheimer’s Risk

A new study has found that over-the-counter sleeping aids and anti-allergy medicines can increase the risk of Alzheimer’s disease.

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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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Senate Report Critical of Medical Device Makers’ Failure to Report Infections

duodenoscopes

A Senate report released on January 13, 2016 finds that superbug infections linked to poorly cleaned medical devices have been more widespread than previously known. The reports places blame on hospitals, device makers, and the Food and Drug Administration (FDA). … Continue reading

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

Olympus Faces Wrongful Death Lawsuit over Contaminated Duodenoscope

Olympus Faces Wrongful Death Lawsuit over Duodenoscope

A wrongful death lawsuit against Olympus America, Olympus Medical Systems Corp. and Custom Ultrasonics has been filed over the use of an allegedly contaminated medical scope. The suit was filed on behalf of a woman whose husband died of an … Continue reading

Posted in Defective Medical Devices, Duodenoscope, Legal News | Tagged , , , , |

Following Superbug Outbreaks, FDA Mandates Safety Studies from Scope Manufacturers

FDA Mandates Safety Studies from Scope Manufacturers

The U.S. Food and Drug Administration (FDA) is ordering duodenoscope manufacturers to study how the devices are cleaned. The safety studies are prompted by a series of antibiotic-resistant bacterial infection outbreaks in the United States linked to contaminated scopes. The … Continue reading

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Medical Scope Makers Warned in the Wake of Superbug Outbreaks

Three manufacturers of duodenoscopes—specialized medical scopes—have received Food and Drug Administration (FDA) warning letters because the scopes have been linked to outbreaks of a deadly “superbug.” The FDA says the companies failed to adequately report problems with the devices and, in … Continue reading

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

Gastrointestinal Scope Makers Receive FDA Warning Letters

Gastrointestinal Scope Makers Receive FDA Warning Letters

The Food and Drug Administration (FDA) sent warning letters to the three makers of a specialized gastrointestinal scope that has been linked to outbreaks of superbug infections at U.S. hospitals. In the spring, the FDA conducted inspections of the manufacturing … Continue reading

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

Olympus Receives FDA Warning Letter for Failing to Notify Agency about Superbug Infections in Required Time

Olympus Receives FDA Warning to Notify about Superbug

Gastrointestinal scope maker Olympus Corp. waited three years to alert federal regulators about 16 patient superbug infections the company learned about in 2012. The Food and Drug Administration (FDA) cited that lapse in reporting and other safety-related violations in warning … Continue reading

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

Emails Show FDA Was Warned of Duodenoscope Infection Risks Six Years Ago

Emails Show FDA Was Warned of Duodenoscope Infection

The Food and Drug Administration (FDA) received warnings nearly six years ago about the risk of “superbug” infection from specialized medical scopes. The devices have been tied to a series of deadly superbug outbreaks. In 2009, after duodenoscopes were linked … Continue reading

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

FDA Knew Medical Devices Can Transmit Superbugs but Did Not Act

FDA Knew Medical Devices Transmit Superbugs but Did Not Act

Experts in hospital-acquired infections say that health regulators have known since at least 2009 that certain reusable medical devices can transmit lethal infections but have not recommended any new safety requirements. The latest outbreak involving duodenoscopes may have exposed 179 … Continue reading

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

Warning to UCLA Hospital Patients Exposed to Drug-Resistant Superbug

Warning to UCLA Hospital Patients Exposed to Superbug

One hundred seventy-nine patients at UCLA Ronald Reagan Medical Center have been told they may have been exposed to a drug-resistant “superbug” during endoscopy procedures that infected seven patients and may have contributed to two deaths. Patients who may have … Continue reading

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

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