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Fracking Releasing Hazardous Chemicals into Local Waterways

Fracking Releasing Hazardous Chemicals into Local Waterways

Study shows two hazardous chemicals—ammonium & iodide—are being released & spilled into Pennsylvania and W.Virginia waterways from fracking operations in Marcellus shale.

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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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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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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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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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Two Men Found Dead of Carbon Monoxide Poisoning

Two Men Found Dead of Carbon Monoxide Poisoning at Long Island, New York Auto Shop

Two men were found dead of apparent carbon monoxide poisoning in a Holbrook, New York, auto-detailing shop Thursday night, Suffolk County police say.

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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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64 More Plavix Patients File Suit Over Bleeding Side Effects

Another Plavix lawsuit has been filed on behalf of 64 Plavix patients who allege bleeding side effects. Plavix (clopidogrel) is a blood thinner prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, such as the heart attacks and strokes it is ...

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MTA Bus Crash and Two Cars Injures 23 at Utica Ave. & Clarendon Rd

Crash Involving MTA Bus and Two Cars Injures 23

Police are investigating an accident in Brooklyn on Wednesday afternoon that injured 23 people, 3 of them critically, when a car was knocked into the path of an MTA bus.

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Image Source: saidaonline.com

Sleep Aids Can Increase Alzheimer’s Risk

A new study has found that over-the-counter sleeping aids and anti-allergy medicines can increase the risk of Alzheimer’s disease.

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OtisMed CEO Receives Prison Sentence in Distribution of Defective Knee Devices Scheme

OtisMed CEO Receives Prison Sentence

OtisMed CEO Receives Prison Sentence


The U.S. District Court of the District of New Jersey sentenced former OtisMed Corporation chief executive officer, Charlie Chi, to 24 months in prison for his involvement in the distribution of “adulterated” medical devices.

In December 2014, OtisMed agreed to pay more than $80 million to resolve criminal and civil liability related to distributing adulterated medical devices with intent to defraud and mislead. At that time, Chi pleaded guilty to introducing adulterated medical devices into interstate commerce. Chi will also serve one year of supervised release and pay a $75,000 fine, the Imperial Valley News reports. Continue reading

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

Fireworks Safety Tips and Spray Sunscreen Warning Offered for 4th of July

Fireworks Safety Tips & Spray Sunscreen Warning

Fireworks Safety Tips & Spray Sunscreen Warning


As families prepare to enjoy 4th of July festivities, federal agencies have issued safety alerts about spray-on sunscreens and fireworks.

The Consumer Product Safety Commission (CPSC) issued its annual list of tips for safe use of fireworks and the Food and Drug Administration (FDA) was warned about spray-on sunscreens. Continue reading

Posted in Accident, Health Concerns | Tagged , , , , |

Drug Dispenser have 4 More Months to Comply with DSCSA Regulations

Drug Dispenser have 4 Months to Comply with DSCSA

Drug Dispenser have 4 Months to Comply with DSCSA


Pharmacies have an additional four months to meet track and trace requirements under the Drug Supply Chain Security Act (DSCSA), Regulatory Affairs Professionals Society (RAPS) reports. The DSCSA is under the Drug Quality and Security Act (DQSA) signed into law in 2013 and seeks to keep track of drug products in the supply chain nationwide. The U.S. Food and Drug Administration (FDA) has extended the deadline from July 2, 2015 to November 1, 2015 in response drug dispensers’ requests. The agency said it would use its “enforcement discretion” to allow more time even though the statutory date of compliance remains the same.

The DSCA requires drug packages to carry a unique serial number so that they can easily be tracked by federal regulators. This allows the FDA to more easily pinpoint the source of a problem and reduce the risk of counterfeit products. Every entity in the supply chain must keep track of the packages through this system. Continue reading

Posted in Legal News | Tagged , , , |

In DaVita Whistleblower Case, Doctor and Nurse May Receive Over $110 Million

DaVita Whistleblower Doctor & Nurse to Receive Over $110M

DaVita Whistleblower Doctor & Nurse to Receive Over $110M


Two whistleblowers, a doctor and nurse in Atlanta, could receive more than $110 million for exposing alleged fraud by DaVita Healthcare Partners, the largest dialysis provider in the country. According to their lawsuit, the company intentionally wasted drugs in order to receive reimbursements from the federal government. Before 2011, the Centers for Medicare and Medicaid Services reimbursed dialysis providers for drug wastage from single-use vials. The whistleblowers alleged that DaVita instructed staff to use unnecessarily large vials of the vitamin D supplement Zemplar and the iron drug Vanofer. The scheme allegedly cost taxpayers hundreds of millions.

According to a Department of Justice (DOJ) press release dated June 24th, DaVita paid $450 million to resolve the allegations. The release noted that DaVita reduced its wastage substantially after the Centers for Medicare and Medicaid Services changed its reimbursement policy in 2011 and “wastage derived from single-use vials was no longer profitable “ Continue reading

Posted in Legal News | Tagged , , , |

Advocacy Groups Sue for Release of Clinical Trial Data for Hepatitis C Drugs

Advocacy Groups Sue for Release of Clinical Trial Data

Advocacy Groups Sue for Release of Clinical Trial Data


Two public health advocacy organizations have filed a lawsuit against the Food and Drug Administration (FDA) for release of clinical trial data for Gilead Sciences hepatitis C treatments.

Researchers and patient advocates have long fought with drug makers and regulators over access to such information, the Wall Street Journal reports. Continue reading

Posted in Health Concerns, Legal News, Pharmaceuticals | Tagged , , , , |

Study Shows Energy Drinks Can Lead to Caffeine Intoxication

Energy Drinks Can Lead to Caffeine Intoxication

Energy Drinks Can Lead to Caffeine Intoxication


The fact that energy drinks contain excessive amounts of caffeine comes as no surprise. But what are the chances that these popular beverages present real health risks? A study published in the journal Drug and Alcohol Dependence investigated this; the authors found that energy drinks may lead to caffeine intoxication, a clinical condition that could lead to death in rare instances. Signs of caffeine intoxication include nervousness, anxiety, insomnia restlessness, tremor, rapid heartbeat, pacing and gastrointestinal distress.

Caffeine is regulated by the U.S. Food and Drug Administration (FDA), but only for food products. A regular 12-ounce soda is allowed to contain a maximum of 71 milligrams of caffeine, but only has about 35 milligrams. Energy drinks manage to circumvent rules because they are considered dietary supplements, which fall outside of the agency’s jurisdiction. Furthermore, these beverages do not have to have warning labels as required of over-the-counter products. Continue reading

Posted in Legal News, Toxic Substances | Tagged , , , , |

ADHD Treatment May Cause Permanent Skin Discoloration, FDA Warns

ADHD Treatment May Cause Permanent Skin Discoloration

ADHD Treatment May Cause Permanent Skin Discoloration


The Daytrana patch, a daily treatment for attention deficit hyperactivity disorder (ADHD), may cause permanent skin color changes, the Food and Drug Administration (FDA) warns.

The FDA added a new warning to the drug label to describe this skin condition, known as chemical leukoderma. The agency says patients and caregivers should watch for areas of lighter skin, especially under the drug patch, and immediately report changes to a health care professional. Patients should not stop using the Daytrana patch without first talking to a doctor. Continue reading

Posted in Defective Products, Pharmaceuticals | Tagged , , , , , |

UK Regulators Issue Updated Guidance for Smith & Nephew Metal-on-Metal Hip Implants

UK Regulators Issue Updated for Smith & Nephew Hip Implants

UK Regulators Issue Updated for Smith & Nephew Hip Implants


The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has issued updated guidance for Smith & Nephew Orthopaedics Birmingham Hip Resurfacing (BHR) system due to a higher than expected failure rate. According to a medical device alert posted on the regulators’ website on June 25th, the device should not be implanted in women or patients who need a femoral head sized 46 mm or less. The notification also states to “Only use 48mm BHR heads in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measured 48mm at the time of surgery”.

The notification instructs customers to return all devices that have femoral head sizes 46 mm and smaller. The respective acetabular and dysplasia cups should also be returned. The alert affects patients who are symptomatic, female, or patients with head sizes 46 mm or smaller. Smith & Nephew used recent data from the National Joint Registry (NJR) for England, Wales and Northern Ireland to identify these groups of high-risk patients. The device alert also gave recommendations for affected patients, including the need for blood metal ion testing. Continue reading

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

Thousands of Complaints Prompt FDA Panel Meeting about Essure Birth Control

Complaints Prompt FDA Panel Meeting about Essure

Complaints Prompt FDA Panel Meeting about Essure


In response to more than 5,000 reports of adverse events and side effects of the Essure birth control implant, the Food and Drug Administration (FDA) has scheduled a hearing for September 24 to evaluate the safety and effectiveness device.

The FDA said it has received 5,093 reports of adverse events—including deaths—among women who received the Essure permanent birth control implant. In the twelve years since Essure’s approval, the agency has received reports of four deaths of women who used the device, as well as five reports of deaths of fetuses in women who became pregnant despite the implant, the Wall Street Journal reports. The device has been on the market since 2002. Continue reading

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

FDA Says Partially Hydrogenated Oils, Source of Trans Fat, Must be Removed from Food

FDA Says Hydrogenated Oils Must be Removed

FDA Says Hydrogenated Oils Must be Removed


In a press release issued last Tuesday, the U.S. Food and Drug Administration (FDA) announced that partially hydrogenated oils (PHO), the main source of trans fat in processed foods, must be removed from food products over the next three years. PHOs will no longer be “generally recognized as safe” or GRAS in human food, the agency said. The FDA first made about PHOs not being GRAS in 2013; the agency has just now finalized it.

Trans fat is created when hydrogen is added to vegetable oil, changing the shape of the fat so that it becomes solid at room temperature. The food industry also uses partially hydrogenated oil because it extends the shelf life of a product. However, trans fats are shown to have a detrimental affect on health; these types of fats increases your LDL (bad cholesterol) and lower your LDL (good cholesterol). “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.” said FDA’s Acting Commissioner Stephen Ostroff, M.D. Continue reading

Posted in Legal News, Toxic Substances | Tagged , , , |

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