Tag Archives: Medical device

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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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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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British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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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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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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Study Finds SSRI Antidepressant Side Effects Outweigh Their Benefits

A new study is raising more concerns about the safety of commonly used antidepressants, including selective serotonin reuptake (SSRI) inhibitor antidepressants. Investigators who conducted the study, which is published in the journal Frontiers in Psychology, posit that increased knowledge of the negative effects of SSRIs and other antidepressants could reduce ...

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FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety

An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...

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Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Lawsuits filed by alleged victims of DePuy Orthopaedics’ recalled ASR hip replacement devices continue to pile up in the multidistrict litigation currently underway in U.S. District Court, Northern District of Ohio. Most recently, a woman from Pryor, Oklahoma, filed suit alleging complications caused by a DePuy ASR hip implant ...

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DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).

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Medtronic Uses Preemption in Medtronic Infuse Case, Again

Medtronic Uses Preemption in Medtronic Infuse Case, Again

The denial of review by the United States Supreme Court today in the case of Caplinger v. Medtronic, Inc., Docket No. 15-321, though it might appear to be a victory for medical device manufacturer, Medtronic, Inc., it was not. While … Continue reading

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

New Legislation Outsources Medical Device Safety Reviews

Medical-Device-Safety-Reviews

Consumer groups and health advocates are concerned about legislation just passed by the House of Representatives that would make it easier for medical devices to reach the market and would put safety determinations in the hands of subcontractors paid by … Continue reading

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

FDA Warns of Possible Patient Injury if Coating Separates from Intravascular Medical Device

Coating on Medical Devices Can Cause Patient Injuries

The Food and Drug Administration (FDA) has issued a safety communication warning of the possibility of patient injury if the hydrophilic and/or hydrophobic coatings on medical devices separate—peel, flake, shed, delaminate, slough off—during use. A number of factors can cause … Continue reading

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

European Medicines Agency Seeks Market Suspension of Medtronic InductOs

Euro Medicines Agency Seeks Suspension of Medtronic InductOs

The European Union’s medical device regulator has recommended suspension of the marketing authorization for Medtronic’s InductOs bone growth device until issues at a U.S. plant that makes a component of the device are resolved. The European Medicines Agency (EMA) launched … Continue reading

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Device Used During Surgery Linked to 8 Infections, 4 Deaths at PA Hospital

Device Used During Surgery Linked to 8 Infections, 4 Deaths

A device used to heat and cool a patient’s blood during heart surgery has been linked to infections in 8 patients at a Pennsylvania hospital. The New York Times reports that four of those patients have died, but it is … Continue reading

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

Newly Launched FDA Website Tracks Medical Devices

Newly Launched FDA Website Tracks Medical Devices

The U.S. Food and Drug Administration (FDA) has announced the launch of its online Global Unique Device Identification Database, AccessGUDID, which allows the public to track medical devices through unique identifiers. Through this site, company-submitted information can now be looked … Continue reading

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Justice Department Fines Medical Device Makers over $110 Million

Justice Department Fines Medical Device Makers

The U.S. Department of Justice and U.S. Department of Health and Human Services released their joint annual report on health care fraud and abuse control on March 19th. According to the report, the federal government won or negotiated roughly $3.3 … Continue reading

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Justice Department Settles False Claims Case with Medtronic for $4.4 Million

Justice Department Settles False Claims w/Medtronic

In an announcement last week, the U.S. Department of Justice said it had reached an agreement with medical device maker Medtronic for violations of the False Claims Act. The announced settlement is $4.4 million. The Justice Department brought action against … Continue reading

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