Tag Archives: superbug

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Cancer Groups Call for E-cigarettes Regulation/Research

Two Leading Cancer Groups Issue Call for Regulation of E-cigarettes and Research on Health Risks

In a joint statement, the American Society of Clinical Oncology and the American Association for Cancer Research have called on the federal government to move quickly to regulate e-cigarettes and increase research on their health effects. These leading research and treatment organizations asked the Food and Drug Administration (FDA) to make ...

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Soda Consumption Causes Early Puberty & Girls’ Cancer Risk

Soda Consumption Causes Early Puberty and Increases Girls’ Cancer Risk

Drinking just one-and-a-half cans of sugar-sweetened soda a day can bring on early puberty in girls and increase their breast cancer risk.

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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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FDA Questions Device Makers about Duodenoscope Cleaning Procedures

Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures

In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...

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Western Pennsylvania Familes File Suit Over Alleged Fracking Pollution

Three families in western Pennsylvania believe a leading hydraulic fracturing (fracking) company and two water testing labs are conspiring to produce false results that show natural gas drilling is not contaminating their private water wells.

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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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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 ...

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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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Medtronic Settles Charges Over Kickbacks To Doctors

Medical device giant, Medtronic Inc., is settling charges over kickbacks to doctors. The firms just agreed to pay $23.5 million to settle claims it paid physicians kickbacks in exchange for their use of its pacemakers and defibrillators, according to a U.S. Justice Department announcement yesterday. The company was accused of seeking ...

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Tentative Ohio Fracking Regulations Criticized as too Lax

Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.

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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

Posted in Legal News | Tagged , , , , |

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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