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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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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...

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Actos, Avandia May Up Risk for Diabetic Macular Edema

A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...

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Crash on N.State Pkwy Kills Port Jefferson Station Man

Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man

A Port Jefferson Station man was killed on Wednesday due to a single-vehicle crash on the Northern State Parkway in Dix Hills. Police are investigating the accident, Newsday reports. According to Newsday, the 81-year-old man was driving a Nissan Altima west in the right lane, west of Exit 42. He ...

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Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer AG reported yesterday that it continues to settle Yaz and Yasmin birth control pill lawsuits. According to a report from Bloomberg News, the company said in its latest Stockholder Newsletter that it has settled 651 Yaz and Yasmin blood clot lawsuits for a total of $147 million. The average ...

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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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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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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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Hip Replacement, Knee Implant Patients with Diabetes, Other Health Problems May Face Difficult Recoveries

Patients receiving hip replacement devices or knee implants may face a more complicated recovery if they are obese, or suffer from diabetes or other health woes. According to a new study published online in the journal Anesthesiology, at least 3% of all total hip or knee replacement patients will ...

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Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...

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FDA Warns L’Oréal about Improper Marketing of Skin Care Products

FDA-Warns L’Oreal - Improper Marketing of Skin Care Products

FDA-Warns L’Oréal – Improper Marketing of Skin Care Products


The Food and Drug Administration (FDA) has warned cosmetic giant L’Oréal, for the second time in three years, about improper marketing of skin care products.

Cosmetic products are not subject to the same scrutiny and regulation as drugs, but cosmetics are limited in the types of claims they can make to consumers, according to Regulatory Focus (from Regulatory Affairs Professionals Society). Federal law describes cosmetics as products “intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness or altering the appearance.” Cosmetics are not intended to heal, cure or otherwise affect the body’s structure or function. But if a product is marketed for a therapeutic use, such as treating or preventing disease, it is a drug under the law. Continue reading

Posted in Consumer Fraud | Tagged , , , , |

3 Injured in Hauppauge Crash

3 Injured in Hauppauge Crash

3 Injured in Hauppauge Crash


A two-car crash involving the SUV of a Long Island fire chief in Hauppauge leaves three people injured. According to Associated Press, a car headed south on Route 111 hit an SUV belonging to the Stony Brook Fire Department chief. Parts of Routes 111 and 347 were subsequently closed. The car was driven by a man with one passenger, who suffered serious injuries and was taken to the hospital. The driver did not have any life-threatening injuries. Continue reading

Posted in Legal News | Tagged , , , , |

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

Posted in Legal News | Tagged , , , , |

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

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

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.

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

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

Posted in Legal News | Tagged , , , , , , |

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

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

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

Posted in Legal News | Tagged , , , , |

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

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

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

Posted in Legal News | Tagged , , , , , |

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