Category Archives: Defective Medical Devices

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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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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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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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New York City Council Calls for Zadroga Act to be Renewed

New York City Council Calls for Zadroga Act to be Renewed

New York City Council members are calling for the Zadroga Act, which provides compensation and medical treatment to 9/11 victims, to be renewed.

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FDA Warning for Bone Graft Products in Patients Under 18

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.

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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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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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Research Suggest Fracking Chemicals Can Pollute Aquifers

A new study suggests fluids used during the hydraulic fracturing (fracking) process could migrate through underground fractures and contaminate water aquifers.

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J.J. Fuds, Inc. Pet Food Recalled - Listeria Contamination

J.J. Fuds, Inc. Pet Food Recalled Over Potential Listeria Contamination

J.J. Fuds, has recalled a specific lot of its J.J. Fuds Chicken Tender Chunks Pet Food over potential contamination with the dangerous, Listeria monocytogenes pathogen.

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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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Sorin 3T Heater-Cooler System Linked to Lung Infections

Sorin 3T Heater-Cooler System Linked to Lung Infections

A woman whose husband was exposed to non-tuberculous mycobacteria during cardiac surgery has filed a lawsuit against LivaNova and Sorin Group alleging the Sorin 3T Heater-Cooler System used during her husband’s surgery ultimately led to his death. The plaintiff’s husband … Continue reading

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Stryker Faces Mounting Defective Hip Implant Lawsuits

Medical device maker Stryker and other leading manufacturers of metal-on-metal hip implants have received thousands of complaints from both doctors and patients that their devices, including the Stryker LFIT, are defective and prone to high rates of failure. According to … Continue reading

Posted in Defective Medical Devices, Metal Hip Implants |

Stryker LFIT Metal-on-Metal Hip Component Safety Concerns

Stryker LFIT Metal-on-Metal Hip Component Safety Concerns

Stryker LFIT CoCr V40 Femoral Heads Recalled in Canada, “Hazard Alert” Issued in Australia Regulators in Canada and Australia recently took action regarding a metal-on-metal hip implant component, the LFIT CoCr V40 Femoral Heads. Metal-on-metal hip implants have been the … Continue reading

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Johnson & Johnson’s Ethicon Recalls Physiomesh Hernia Mesh

J&J’s Ethicon Recalls Physiomesh Hernia Mesh

Physiomesh Recalled Due to High Failure Rates Ethicon, a Johnson & Johnson unit, is recalling its Physiomesh because studies show that patients are undergoing higher rates of revision surgery compared to other mesh devices. Physiomesh flexible composite hernia mesh is … Continue reading

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DePuy Recalls Battery Adaptors Over Potential Explosion Risk

DePuy Recalls Battery Adaptors Over Potential Explosion Risk

A Class 1 recall for the DePuy Synthes’ Small Battery Drive and the Small Battery Drive II adaptor and light adaptor has been announced by the U.S. Food and Drug Administration (FDA). The adaptors potentially produce extreme internal pressure that … Continue reading

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After Fixing Battery Defect, St. Jude Continued to Sell Older Pacemakers

Early Battery Depletion with St. Jude Medical ICDs & CRT-Ds

St. Jude Medical is facing criticism regarding certain models of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). These heart devices deliver electrical shocks or pacing in patients. Recently, certain models of the Fortify, Unify and Assura … Continue reading

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LivaNova Faces Class Action Lawsuit over Sorin 3T Heater-Cooler System

LivaNova Faces Lawsuit over Sorin 3T Heater-Cooler System

A class action lawsuit has been filed against LivaNova over its Sorin 3T Heater-Cooler system. The suit, which represents two plaintiffs so far, alleges that the Sorin 3T Heater-Cooler introduced nontuberculous mycobacterium when the device was used during heart surgeries. … Continue reading

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More than 800 Bair Hugger Lawsuits Pending in Federal MDL

More than 800 Bair Hugger Lawsuits Pending in Federal MDL

A recent update by the U.S. Judicial Panel on Multidistrict Litigation (JPML) indicates that as of October 17, 2016, there were 809 pending Bair Hugger infection cases, an increase of 116 filings since September 15th. The plaintiffs in these cases … Continue reading

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FDA Investigation Finds Underreporting of Medical Device Problems

FDA Finds Underreporting of Medical Device Problems

Under federal law, hospitals must report adverse events related to medical devices to the U.S. Food and Drug Administration (FDA), but an FDA investigation has revealed that many hospitals are likely underreporting these events. This reporting helps the FDA identify … Continue reading

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St. Jude ICD Recall Is Deemed a Class I by Federal Regulators

St. Jude ICD Recall Is Deemed a Class I

St. Jude recently reported two patient deaths tied to early depletion of lithium batteries in St. Jude Medical Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D). The U.S. Food and Drug Administration (FDA) and St. Jude issued an … Continue reading

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