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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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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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Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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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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Smokers More Vulnerable to Joint Replacement Failures

People who smoke cigarettes before and after receiving a total joint replacement, such as a hip replacement device or knee implant, are far more likely to endure revision surgeries on those implants than people who don’t smoke.

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Conspiracy Claims in Talcum Powder Case Survive Motion to Dismiss

Conspiracy Claims in Talcum Powder Case Survive Motion to Dismiss

E. District of Missouri denied motion to dismiss conspiracy claims. Lawsuit alleges the defendants conspired to misrepresent true dangers with use of talcum powder.

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FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today

The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.

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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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Canadian Study Confirms Actos Bladder Cancer Risk

A new study conducted by Canadian researchers has found that users of the type 2 diabetes drug, Actos (pioglitazone), may face a higher risk of developing bladder cancer than first thought. The study, published in the British Medical Journal, found that taking Actos for two years doubles the likelihood ...

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

FDA Questions Device Makers about Duodenoscope Cleaning Procedures

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 with drug-resistant bacteria at Ronald Reagan UCLA Medical Center.

A duodenoscope is a long, flexible tube with a tiny camera attached at the end. It is inserted through the throat to help diagnose gastrointestinal tract disorders. According to NYT, these devices have been linked to serious infections at several other hospitals. In 2013, 39 patients at Advocate Lutheran General Hospital in Chicago were infected with carbapenem-resistant Enterobacteriaceae (CRE) after undergoing procedures with duodenoscopes. This is the same bacteria that caused recent infections in Los Angles. In January, Virginia Mason Hospital in Seattle said that from November 2012 to early 2014, 32 patients were infected with CRE through the scopes. Eleven of these patients ultimately died, but it is unknown whether the infections were to blame because they were already critically ill. Continue reading

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HeartWare Recalls Older Ventricular Assist System Controllers

HeartWare Recalls Ventricular Assist System Controllers

HeartWare Recalls Ventricular Assist System Controllers


HeartWare International is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System controllers distributed in the U.S. during the clinical trial period prior to Food and Drug Administration (FDA) approval in 2012.

The company has written to clinicians and patients to inform them that the affected clinical trial controllers are more susceptible to electrostatic discharge (ESD) than newer, commercial controllers. An ESD event could result in the pump stopping, which could cause serious injury or death, according to HeartWare’s news release. HeartWare has improved the design of  newer controllers to improve immunity to ESD. The recall does not affect the newer controllers. Continue reading

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AliveCor Recalls Heart Monitor App Because of Crashes

AliveCor Recalls Heart Monitor App Because of Crashes

AliveCor Recalls Heart Monitor App Because of Crashes


AliveCor has recalled its AliveECG app version 2.1.2 for the Apple iOs operating system because the app crashes on use.

The recall affects 5,600 active users on Apple’s iOS operating system, according to the Food and Drug Administration (FDA) recall notice. The app is used in conjunction with the AliveCor Heart Monitor, a device cleared by the FDA. The AliveECG app records accurate electrocardiogram (ECGs) and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

In January, AliveCor posted information on its website, Facebook Page and Twitter to alert users about the issue. The company pulled the app and quickly released an updated version (2.1.3) on iTunes. This version fixes issues causing a crash when updating from a previous version.

The FDA identified this as a Class III recall. In a Class III recall, the least hazardous recall category, “use of or exposure to a violative product is not likely to cause adverse health consequences.” Such products generally violate FDA labeling or manufacturing laws.

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Malware Comes Preinstalled with Some Lenovo Laptops

Malware Comes Preinstalled with Some Lenovo Laptops

Malware Comes Preinstalled with Some Lenovo Laptops


Lenovo users may be getting more than they bargained for with their new laptops. Mashable reports that some Lenovo products come preinstalled with adware called Superfish, which breaks secure website connections and makes sensitive user information vulnerable to security threats.

Superfish breaks HTTPS, which is meant to provide a secure connection over the internet, in order to better scout for ads. The adware also looks at user data on connections that would not normally be visible. Mashable reports that according to experts, Superfish disrupts encrypted connections in a way that leaves users vulnerable to more malicious hackers; sensitive data, such as banking information, can potentially be stolen. Continue reading

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Johnson & Johnson Hit with $2.5 Million Verdict in Risperdal Case

 Johnson & Johnson Hit with $2.5 Million Verdict in Risperdal Case


Johnson & Johnson Hit with $2.5 Million Verdict in Risperdal Case


A Philadelphia jury hit a Johnson & Johnson unit with $2.5 million in damages in a case accusing the drug maker of failing the parents and doctors of an autistic boy about risks associated with the antipsychotic drug Risperdal.

During the trial in the Philadelphia County Court of Common Pleas, the jury heard testimony that Janssen Pharmaceuticals Inc. had worked for years to hide evidence that the drug was linked to abnormal growth of female breast tissue — gynecomastia — in adolescent boys, Law360 reports. The lawsuit was filed in 2012 by the family of a boy who grew large breasts after taking Risperdal for nearly five years, beginning in 2002, when he was seven. Continue reading

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GE MRI Systems Recalled Due to Disabled Magnet Rundown Units

GE MRI System Recalled Due to Disabled Magnet Rundown Units

GE MRI System Recalled Due to Disabled Magnet Rundown Units


Earlier this month, GE Healthcare recalled 12,968 MRI systems due to a disabled Magnet Rundown Unit (MRU) in India. When this unit is disabled, it can slow the removal of a magnetic object from the scanner. This can lead to life-threatening consequences, prompting a Class I recall.

Class I recalls are reserved for issues that can lead to serious injuries or death. They are the U.S. Food and Drug Administration’s (FDA’s) most serious type of recall. Continue reading

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FDA Knew Medical Devices Can Transmit Superbugs but Did Not Act

FDA Knew Medical Devices Transmit Superbugs but Did Not Act

FDA Knew Medical Devices Transmit Superbugs but Did Not Act


Experts in hospital-acquired infections say that health regulators have known since at least 2009 that certain reusable medical devices can transmit lethal infections but have not recommended any new safety requirements.

The latest outbreak involving duodenoscopes may have exposed 179 patients at UCLA’s Ronald Reagan Medical Center in Los Angeles to drug-resistant bacteria and contributed to two deaths, Reuters reports. This is not the first time the sometimes-fatal infections have been traced to the devices, which are inserted down the throat to diagnose and treat pancreatic and bile duct diseases. Duodenoscopes are manufactured by the medical divisions of Olympus Corp, Pentax, and Fujifilm. The UCLA hospital uses an Olympus model. Continue reading

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More than 12,000 GE MRI Systems Recalled Due to Potentially Life-Threatening Issue

More than 12,000 GE MRI Systems Recalled

More than 12,000 GE MRI Systems Recalled


A Class I recall has been issued for more than 12,000 MRI systems manufactured by General Electric, Modern Healthcare reports. The recall was issued because of a potentially life-threatening problem that can occur when parts are not connected properly. Many GE MRI brands, including Signa and Discovery, are affected by the recall.

Class I recalls are the FDA’s most serious recall status, and are reserved for situations where serious injury or death can occur. In this case, the problem was that the magnet rundown units may not be connected properly. “In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries,” the FDA said in its recall notice, issued Feb. 18. The recall affects a total of 12,968 machines; 5,708 are in the United States and the rest are in other countries. Continue reading

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Warning to UCLA Hospital Patients Exposed to Drug-Resistant Superbug

Warning to UCLA Hospital Patients Exposed to Superbug

Warning to UCLA Hospital Patients Exposed to Superbug


One hundred seventy-nine patients at UCLA Ronald Reagan Medical Center have been told they may have been exposed to a drug-resistant “superbug” during endoscopy procedures that infected seven patients and may have contributed to two deaths.

Patients who may have been infected by the carbapenem-resistant Enterobacteriaceae (CRE) are being offered home testing kits that would be analyzed by the hospital, UCLA officials said. The exposures occurred between October 2014 and January 2015 during which a specialized endoscope is inserted down the throat to diagnose and treat pancreatic and bile duct diseases, Reuters reports. The Food and Drug Administration (FDA) warned that the design of the endoscopes may hinder proper cleaning and disinfection, the FDA warned on Thursday. Continue reading

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Artificial Coloring in Soda Increases Cancer Risk, Study Finds

Artificial Coloring in Soda Increases Cancer Risk

Artificial Coloring in Soda Increases Cancer Risk


A new study has found that drinking at least one can of soda per day may significantly increase the risk of cancer. Research conducted by the Johns Hopkins Bloomberg School of Public Health found that some caramel colorings in soda can produce 4-methylimidazole (4-MEI), a potential carcinogen.

The study, published online in the Public Library of Science journal PLOS One, noted that 44-58 percent of American adults typically consume at least one can of soda daily; these individuals have a higher risk of 4-MEI from soft drinks. In 2014, Consumers Reports published an analysis of 4-MEI concentrations among 110 different soft drinks. This study builds on that analysis, and researchers say that the risk of cancer may increase greatly with lifetime exposure to the substance.

“Soft drink consumers are being exposed to an avoidable and unnecessary cancer risk from an ingredient that is being added to these beverages simply for aesthetic purposes,” said Keeve Nachman, senior author of the study and director of the Food Production and Public Health Program at the CLF, according to Newsmax Health. “This unnecessary exposure poses a threat to public health and raises questions about the continued use of caramel coloring in soda. Continue reading

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