Tag Archives: FDA

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Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker’s recent recall of two metal hip implant components, the Rejuvenate Modular and ABG II modular-neck hip stems, may have dealt a serious blow to one of the key arguments medical device manufacturers have made to defend their metal-on-metal hip replacements. Facing thousands of lawsuits, the makers of ...

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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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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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Decision on Pradaxa Bleeding Lawsuit Multidistrict Litigation Expected Soon

Victims of alleged Pradaxa injuries are awaiting word on whether their lawsuits will be consolidated in a multidistrict litigation. According to a report from The Madison Record, so far just over two dozen Pradaxa bleeding lawsuits have been filed in federal courts throughout the U.S.

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Transvaginal Mesh a Nightmare for Thousands of Women

Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim ...

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Research Study Confirms Fracking Cause of Ohio Earthquakes

Research Study Confirms Fracking as Cause of Ohio Earthquakes

Fracking operation near Poland Township, Ohio, activated a previously unknown fault in the, causing 77 earthquakes with magnitudes ranging from 1.0 to 3.0 in March 2014.

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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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FDA Questions Device Makers about Duodenoscope Cleaning Procedures

Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures

In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...

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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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Government Reports Careless Oversight of Gynecologic Device

Government Finds Careless Oversight of Gynecologic Device

Lax Oversight Put Women at Risk of Cancer: A recently released governmental investigative report has found that for more than 20 years, the U.S. Food and Drug Administration (FDA) has approved 25 surgical devices that may spread undiagnosed cancer in … Continue reading

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

Risperdal Litigation is Second Largest Mass Tort in Philadelphia

Risperdal Litigation is Second Largest Mass Tort in PA

Mass Tort Contains Risperdal Gynecomastia Lawsuits Lawsuits alleging the antipsychotic drug Risperdal caused gynecomastia continue to mount against Johnson & Johnson’s Janssen unit. In fact, Risperdal litigation accounts for most of the mass tort growth in Philadelphia’s Complex Litigation Center. … Continue reading

Posted in Pharmaceuticals | Tagged , , , , |

Catheter Recalls due to Serious Complications and Injuries

Catheter Recalls due to Serious Complications and Injuries

The benefits and usefulness of catheters are not in question, when the broad scope of applications and indications for which the devices are used are examined. Catheters are used for administering medications, injecting contrast dye for angiogram procedures, and removing … Continue reading

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IVC Filter Medical Device Risks May Outweigh Benefits

IVC Filter Medical Device Risks May Outweigh Benefits

An inferior vena cava (IVC) filter is a small cage-like device designed to catch and dissolve blood clots. These devices are implanted in patients who have a higher risk of blood clots but for various reasons, cannot take anticoagulants. An … Continue reading

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Invega Linked to Serious Side Effects Such As Gynecomastia

Invega Linked to Serious Side Effects Such As Gynecomastia

Invega is a popular antipsychotic medication increasingly associated with serious side effects such as gynecomastia, or male breast growth. Invega, known also by its generic name, paliperidone, is manufactured and distributed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson … Continue reading

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Depakote Anti-Epilepsy Medication Linked to Birth Defects

Depakote Anti-Epilepsy Medication Linked to Birth Defects

The family of a 12-year-old child has filed a lawsuit on behalf of the young girl who underwent an extremely difficult operation, along with her mother, while she was still in the womb. The highly complicated open fetal surgery took … Continue reading

Posted in Depakote, Pharmaceuticals | Tagged , , , , |

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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Controversial Diabetes Drug Actos Still on the Market

Controversial Diabetes Drug Actos Still on the Market

Though research has shown an association between the type 2 diabetes drug Actos and serious side effects including bladder cancer, heart failure, liver failure, and bone fractures, the Food and Drug Administration (FDA) has stopped short of recalling Actos. Actos … Continue reading

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Clash Over Regulation of “Off-Label” Promotion of Drugs and Devices

Clash Over “Off-Label” Promotion of Drugs and Devices

A 2012 decision from the U.S. Court of Appeals for the Second Circuit that reversed the conviction of Alfred Caronia, a drug representative accused of conspiring to promote the drug Xyrem for unapproved uses set up a clash between the … 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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