Category Archives: Defective Medical Devices

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FDA Urged to Ban Powdered Caffeine

FDA Urged to Ban Powdered Caffeine

Pennsylvania Senator Robert Casey has written to the Food and Drug Administration (FDA) to urge the agency to ban powdered caffeine, a dietary supplement.

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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MTA Bus Crash and Two Cars Injures 23 at Utica Ave. & Clarendon Rd

Crash Involving MTA Bus and Two Cars Injures 23

Police are investigating an accident in Brooklyn on Wednesday afternoon that injured 23 people, 3 of them critically, when a car was knocked into the path of an MTA bus.

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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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Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda

A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...

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Failing DePuy ASR Hip Implants Sending Hundreds of Australians Back to the OR

Roughly 1,000 people in Australia have had to undergo revision surgeries because of failed DePuy ASR hip implants. According to TheAge.com, DePuy Orthopaedics has heard from more than 4,000 people in Australia and New Zealand seeking help with the recalled metal-on-metal hip replacement devices.

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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Fracking Releasing Hazardous Chemicals into Local Waterways

Fracking Releasing Hazardous Chemicals into Local Waterways

Study shows two hazardous chemicals—ammonium & iodide—are being released & spilled into Pennsylvania and W.Virginia waterways from fracking operations in Marcellus shale.

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Warning for Medtronic InterStim Neurostimulation Devices

Australian Health Agency Issues Warning for Battery Problem with Medtronic InterStim Neurostimulation Devices

Warning for Medtronic InterStim Neurostimulation DevicesTGA has issued a safety warning for InterStim and InterStim II neurostimulation devices, because of possible early depletion of the battery.

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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

3 people, injured on Wednesday at 1:20 p.m. when a LIRR train hit a livery cab on the tracks west of Wyandanch station. The train engineer, who suffered a shoulder injury.

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Atrium C-Qur Hernia Mesh Complications and Lawsuits

Atrium C-Qur Hernia Mesh Complications and Lawsuits

A woman recently filed a lawsuit against Atrium Medical, the manufacturers of the Atrium C-Qur hernia mesh, alleging severe pain and injury after the mesh was used during an open repair of her ventral (abdominal) hernia in 2011. According to … Continue reading

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

Government Reports Careless Oversight of Gynecologic Device

Government Finds Careless Oversight of Gynecologic Device

Lax Oversight Put Women at Risk of Cancer: A recently released governmental investigative report has found that for more than 20 years, the U.S. Food and Drug Administration (FDA) has approved 25 surgical devices that may spread undiagnosed cancer in … Continue reading

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

Merck’s Implanon Tied to Device Migration

Implanon Migration Leads to Unwanted Pregnancy, Surgery The Implanon (etonogestrel implant) birth control, is a small, thin implantable plastic rod that slowly releases etonogestrel. The device is meant to last three years and received U.S. Food and Drug Administration (FDA) … Continue reading

Posted in Defective Medical Devices |

Allergic Reactions Reported to Atrium C-Qur Hernia Mesh Coating

Atrium C-Qur hernia mesh has been drawing increasing reports of serious injuries and complications. Patients report that they have suffered infection, pain, organ damage, and allergic reactions to the mesh’s fish oil coating. Lawsuits allege Atrium was aware of the … Continue reading

Posted in Defective Medical Devices, Health Concerns |

C.R. Bard Recalls Halo One Guiding Sheath

The FDA Deems Halo One Guiding Sheath Recall a Class I The U.S. Food and Drug Administration (FDA) recently announced a Class 1 recall of C.R. Bard Peripheral Vascular Inc.’s Halo One thin-walled guiding sheaths over issues involving sheath separation, … Continue reading

Posted in Bard IVC Filter Injuries, Defective Medical Devices, Transvaginal mesh |

Catheter Recalls due to Serious Complications and Injuries

Catheter Recalls due to Serious Complications and Injuries

The benefits and usefulness of catheters are not in question, when the broad scope of applications and indications for which the devices are used are examined. Catheters are used for administering medications, injecting contrast dye for angiogram procedures, and removing … Continue reading

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

INRatio Blood Monitoring Device Recalled Due to Inaccurate Readings

Alere INRatio System Recalled The Alere INRatio and INRatio2 PT/INR Monitor System are devices used to measure how fast a patient’s blood is clotting. This system is used in patients taking warfarin, a decades-old anticoagulant used to prevent blood clot … Continue reading

Posted in Defective Medical Devices |

St. Jude Medical Cardiac Devices Recalled Over Life-Threatening Battery Issue

St. Jude Medical Inc. has recalled 400,000 implanted heart devices because of the risk of premature battery depletion. The defect is linked to two deaths in Europe. The devices included in the recall are St. Jude Medical Implantable Cardioverter Defibrillators … Continue reading

Posted in Defective Medical Devices |

Another DePuy Pinnacle MoM Lawsuit Filed

Pinnacle Metallosis Lawsuits Added To Texas MDL A new lawsuit has been filed against DePuy Orthopedics and Johnson & Johnson over an allegedly failed Pinnacle Acetabular Cup system. DePuy Orthopaedics is a unit of Johnson & Johnson. The Pinnacle metal-on-metal … Continue reading

Posted in Defective Medical Devices, Depuy, Metal Hip Implants |

Ethicon Sued over Physiomesh Hernia Mesh, Withdrawn from Market

Physiomesh Withdrawn Due to High Rates of Revision

Physiomesh Withdrawn Due to High Rate of Recurrence, Revision Ethicon, a unit of Johnson & Johnson, is being sued over its Physiomesh Composite Mesh used for hernia repairs. The company withdrew the product from the market in May 2016 due … Continue reading

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

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