Tag Archives: Medical device

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Post -Tonsillectomy Morphine Life-Threatening in Children

Post -Tonsillectomy Morphine can be Life-Threatening in Children, Study Finds

A new study published in Pediatrics suggests that morphine can result in life-threatening respiratory problems when given to children after a tonsillectomy.

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Crash on N.State Pkwy Kills Port Jefferson Station Man

Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man

A Port Jefferson Station man was killed on Wednesday due to a single-vehicle crash on the Northern State Parkway in Dix Hills. Police are investigating the accident, Newsday reports. According to Newsday, the 81-year-old man was driving a Nissan Altima west in the right lane, west of Exit 42. He ...

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DeflateGate’s Effects Impact Legal Gambling and the Economy

DeflateGate’s Effects Impact Legal Gambling and the Economy

The NFL has initiated a probe into the New England Patriots following allegations that the team intentionally used overly deflated footballs.

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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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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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Actos, Avandia May Up Risk for Diabetic Macular Edema

A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...

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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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Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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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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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

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

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

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

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