Tag Archives: Medical device

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FDA Gives 7 Companies Go Ahead To Market Generic Plavix

The U.S. Food & Drug Administration (FDA) just gave seven companies the go-ahead to market generic Plavix. Plavix is a blood thinner prescribed for the prevention of blood clots, heart attacks, and which has been linked to serious side effects such as the heart attacks and strokes it is supposed to ...

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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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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E-cigarettes Could Increase Risk of Lung Infections

E-cigarettes Could Increase Risk of Lung Infections

New research suggests the liquid used in electronic cigarettes could increase the risk of viral lung infections, regardless of whether it contains nicotine.

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Bleeding Side Effects of Pradaxa, Xarelto Have Some Doctors Concerned

Some heart doctors are raising concerns about a new class of heart drugs that include Pradaxa. Recently, a number of doctors interviewed by Reuters said they were hesitant to prescribe Pradaxa, as well as another blood thinner called Xarelto, because of concerns regarding the risk of stroke, serious bleeding ...

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National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

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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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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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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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Knee Replacement Patients Should Consider Nickel Allergies before Surgery

Individuals considering undergoing knee replacement surgery should ask their doctors to run a test to determine if they have a nickel allergy. Determining if a patient suffers from a nickel allergy will ensure the right knee implant is chosen for their surgery, and possibly save them from considerable pain and ...

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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

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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

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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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