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Pennsylvania Health System Proposes Comprehensive Fracking Study

A proposed study would examine the health effects of hydraulic fracturing (fracking) drilling on the people living closest to active natural gas wells.

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National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

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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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Three Injured, Long Island Railroad Train Hits Car on Tracks

Three Injured When Long Island Railroad Train Hits Car on Tracks

Three people, including a train engineer, were injured on Wednesday when a Long Island Rail Road train hit a livery cab on the tracks west of Wyandanch station, LIRR officials said. LIRR spokesman Salvatore Arena said the driver of the Lincoln Town Car was taken to Good Samaritan Hospital Medical Center ...

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Zadroga Act Cancer Decision Expected This Week

The federal official tasked with determining what ailments should be covered by the federal Zadroga Act is expected to decide by Saturday if certain cancers will be eligible for compensation. The decision is being eagerly awaited by thousands of first responders who believe they developed cancer due to exposure ...

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Geodon the antipsychotic drug can Cause Deadly Skin Reaction

Geodon can Cause Deadly Skin Reaction, FDA Warns

The FDA has required a new warning label for the antipsychotic drug Geodon (ziprasidone) to include the risk of a potentially fatal skin reaction.

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Study Finds Plavix May Only Benefit Smokers

An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, ...

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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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British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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New York’s Anti-Subrogation Law is Not Preempted by ERISA, Supreme Court Rules

A recent decision by the Supreme Court is expected to stop several insurers from attempting to cite the legal notion of subrogation, which is when insurance companies seek reimbursement for benefits paid for the insured.

Last July, the U.S. Court of Appeals for the Second Circuit ruled that New York’s anti-subrogation law is not preempted by the Employee Retirement Income Security Act (ERISA). The court ruled that the law, which prevents private health insurers from seeking reimbursement for medical benefits paid out of a tort settlement, is applicable to health insurers providing ERISA coverage. The litigation stems from a class action lawsuit originally filed in New York State Supreme Court. The case was moved to federal court when the District Court granted the defendants’ motion to dismiss for failure to state a claim based on ERISA preemption. The case was remanded to the District Court on appeal by the Court of Appeals for the Second Circuit; the court found that the plaintiffs’ claims were not subject to complete ERISA preemption. Continue reading

Posted in Legal News |

FDA Cautions Consumers Against Buying Oxy Elite Pro

Consumers should think twice before purchasing weight loss supplements, particularly Oxy Elite Pro, the U.S. Food and Drug Administration (FDA) warned on Friday. According to Youth Health, a sample of Oxy Elite Pro shipped from a different country was found to have fluoxetine.

Oxy Elite Pro, like many weight loss supplements, is a type of thermogenic. This means that it tries to boost the body’s metabolism and burn fat by increasing the body’s internal heat. Continue reading

Posted in Legal News |

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

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