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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

81-year-old Port Jefferson Station man was killed in a crash at 4:57 a.m.. He lost control of the vehicle traveling west on Northern State Pkwy, on exit 42, Dix Hills.

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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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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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FDA Urged to Ban Powdered Caffeine

FDA Urged to Ban Powdered Caffeine

Pennsylvania Senator Robert Casey has written to the Food and Drug Administration (FDA) to urge the agency to ban powdered caffeine, a dietary supplement.

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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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Lawsuit Alleges Plavix Caused Oklahoma Man to Suffer Multiple Stomach Bleeds

Another lawsuit has been filed over adverse Plavix side effects. The lawsuit, filed by national law firm Parker Waichman LLP, alleges that the blood thinner, Plavix (clopidogrel), caused an Oklahoma man to suffer from multiple stomach bleeds.

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J.J. Fuds, Inc. Pet Food Recalled - Listeria Contamination

J.J. Fuds, Inc. Pet Food Recalled Over Potential Listeria Contamination

J.J. Fuds, has recalled a specific lot of its J.J. Fuds Chicken Tender Chunks Pet Food over potential contamination with the dangerous, Listeria monocytogenes pathogen.

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Retailers Accused of Selling Fraudulent Herbal Supplements

Major Retailers Accused of Selling Fraudulent Herbal Supplements

The NYS attorney general’s office has accused four national retailers of selling fraudulent dietary supplements.

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Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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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.

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

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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

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

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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

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

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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

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

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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Endoscopy Device May Spread Drug-Resistant Bacterial Infections

 Endoscopy Device May Spread Bacterial Infections


Endoscopy Device May Spread Bacterial Infections


The Food And Drug Administration (FDA) issued a safety alert warning that the complex design of the ERCP endoscope may impede effective cleaning and sterilizing of the reusable device.

There are reports of multidrug-resistant bacterial infections in patients who have undergone ERCP (endoscopic retrograde cholangiopancreatography) with reprocessed dueodenoscopes, even when the reprocessing instructions are followed correctly. From January 2013 through December 2014, the FDA received 75 medical device reports for approximately 135 patients relating to possible microbial transmission from reprocessed dueodenoscopes. The New York Times reports that the FDA alert cam a day after California officials reported that seven patients became ill and two had died from what officials said were improperly sterilized endoscopes at Ronald Reagan UCLA Medical Center. Continue reading

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

Retired Police Officer who Developed Fibromyalgia, Other Conditions after Working at Ground Zero to Receive Enhanced Disability Pension

Retired Police Officer who to Receive Enhanced Disability

Retired Police Officer who to Receive Enhanced Disability


A retired police officer has won her five-year legal battle and will receive enhanced disability pension; she was diagnosed with fibromyalgia and various other conditions after working at Ground Zero. She was represented by Jeffrey Goldberg, an attorney with the national law firm of Parker Waichman LLP. The firm has been actively fighting for the rights of 9/11 rescue workers and first responders for many years and has worked to ensure passage of the Zadroga Act.

New York Daily News reports that the police officer joined the force in 1998. After the September 11th attacks, she worked a security post at Ground Zero for two months; she suffered from dizziness, shortness of breath, nausea and chest pains. In 2002, she was diagnosed with having toxic levels of heavy metals, including cadmium, lead and mercury. She was also diagnosed with fibromyalgia, asthma, chronic fatigue syndrome and acid reflux. The Police Pension Fund argued that the disease was not caused by her exposure to the conditions of Ground Zero and a lower court ruling sided with the city. The Appellate Division in Manhattan, however, has overturned the lower court’s ruling. Continue reading

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