Daily Archives: August 4, 2016

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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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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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Boston Scientific Transvaginal Mesh

Tennessee Woman Alleges Boston Scientific Transvaginal Mesh Product Caused Painful Injuries

More reports of painful injuries are being linked to transvaginal mesh. This time, a Tennessee woman has filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System.

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Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.

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Whistleblower Wins Retaliation - Canaveral National Seashore

Whistleblower Wins Retaliation Lawsuit

A whistleblower who reported misconduct at Canaveral National Seashore has won a retaliation ruling against the U.S. Department of Interior, Florida Today reports.

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Trial over Ethicon Transvaginal Mesh Begins in California

Pelvic mesh devices have become the subject of safety concerns in recent years amidst reports that they can cause serious, sometimes permanent injuries.

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Study Finds Plavix May Only Benefit Smokers

An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, ...

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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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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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Invokana’s Link to Ketoacidosis Allegedly Hidden by Janssen and J&J

Invokana’s Link to Ketoacidosis Hidden by Janssen and J&J

A Florida woman alleges, in a recent lawsuit brought against the makers of Invokana–Janssen Pharmaceuticals, and its parent company Johnson & Johnson (J&J)–, that the drug makers neglected to issue a proper warning about the connection between Invokana and ketoacidosis, … Continue reading

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Lawsuit Alleges Eliquis Caused Fatal Hemorrhaging, Drug Makers Failed to Warn

Pfizer and Bristol-Myers Squibb are facing a wrongful death lawsuit alleging that the companies failed to warn about the risk of irreversible bleeding with Eliquis (apixaban), an anticoagulant. The lawsuit was filed on behalf of a woman whose husband began … Continue reading

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Cerebellar Atrophy Reported in Dilantin Patients

Cerebellar Atrophy Reported in Dilantin Patients

The U.S. Food and Drug Administration (FDA) has approved labeling changes stating that cerebellar atrophy has been reported in patients taking phenytoin. This nervous system adverse reaction appears to occur more frequently when drug levels are elevated or when it … Continue reading

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Janssen Failed to Warn of Ketoacidosis Risk with Invokana Diabetes Drug, Suit Alleges

Janssen Failed to Warn of Issue with Invokana Diabetes Drug

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is accused of failing to warn about the risk of ketoacidosis with its type 2 diabetes drug Invokana. Diabetic ketoacidosis is a serious condition caused by the build up of ketone bodies, … Continue reading

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