Category Archives: Defective Medical Devices

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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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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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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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British Health Agency Strengthens Warnings about Valproate

British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

Statement issued urging healthcare professionals to give women information on birth defects when Depakote and other valproate medicines are used during pregnancy.

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Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

A man in Louisiana has filed suit against Medtronic Inc. over injuries allegedly cause by off-label use of its Infuse Bone Graft product. The plaintiff, who received Infuse during transforaminal spinal lumbar fusion surgery, claims that the bone growth protein caused unwanted bone growth along his spine, worsening the back ...

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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

The American Society of Clinical Oncology & the American Association for Cancer Research called for government regulation & research of e-cigarettes on health effects.

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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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Cancer Groups Issue Statement for Regulation of E-cigarettes

Cancer Groups Issue Statement Calling for Research and Regulation of E-cigarettes

The American Society of Clinical Oncology & the American Association for Cancer Research are calling on the government to regulate e-cigarettes.

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Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise

Having already spent around $3 billion on its DePuy Orthopaedics ASR hip implant recall, Johnson & Johnson is facing another potential debacle involving a metal-on-metal version of its Pinnacle Hip Replacement System. According to a report from Reuters, Johnson & Johnson and its DePuy unit already face some 1,600 metal-on-metal ...

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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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.F. 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

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