Featured Stories
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.

Read More

Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.

Read More

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 ...

Read More

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.

Read More

Actos Bladder Cancer Lawsuits Continue, New Complaint Filed by Tennessee Resident

Actos bladder cancer lawsuits continue, with a new complaint filed by a resident of Tennessee. The national law firm, Parker Waichman LLP, represents the Tennessee man who alleges that Actos caused his bladder cancer.

Read More

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, ...

Read More

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.

Read More

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.

Read More

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.

Read More

Failing DePuy ASR Hip Implants Sending Hundreds of Australians Back to the OR

Roughly 1,000 people in Australia have had to undergo revision surgeries because of failed DePuy ASR hip implants. According to TheAge.com, DePuy Orthopaedics has heard from more than 4,000 people in Australia and New Zealand seeking help with the recalled metal-on-metal hip replacement devices.

Read More

Emails Show FDA Was Warned of Duodenoscope Infection Risks Six Years Ago

 Emails Show FDA Was Warned of Duodenoscope Infection

Emails Show FDA Was Warned of Duodenoscope Infection


The Food and Drug Administration (FDA) received warnings nearly six years ago about the risk of “superbug” infection from specialized medical scopes. The devices have been tied to a series of deadly superbug outbreaks.

In 2009, after duodenoscopes were linked numerous drug-resistant infections in Florida hospital patients (and to 15 deaths), epidemiologists at the Florida Department of Health and the Centers for Disease Control and Prevention (CDC) warned that the infections occurred because hospitals were having trouble properly cleaning the scopes, USA Today reports. Continue reading

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

Lumber Liquidators CEO Unexpectedly Resigns Amid Product Safety Concerns

Lumber Liquidators CEO Unexpectedly Resigns

Lumber Liquidators CEO Unexpectedly Resigns


Lumber Liquidators CEO Robert Lynch unexpectedly resigned Thursday following weeks of struggles over safety concerns related to its flooring products.

The Toano, Va.-based company will search nationally for a replacement, the company said. Thomas Sullivan, Lumber Liquidators founder, will serve as acting CEO, USA Today reports. Lynch also stepped down from the board of directors. John Presley, its lead independent director, will be non-executive chairman of the board effective immediately. CFO Dan Terrell will leave the company in June. Continue reading

Posted in Defective Products, Health Concerns, Toxic Substances | Tagged , , , |

Indian Food Inspectors Order Instant Noodle Recall over Dangerous Levels of Lead

Indian Food Inspectors Order Instant Noodle Recall

Indian Food Inspectors Order Instant Noodle Recall


Food inspectors in the northern Indian state of Uttar Pradesh have ordered Nestle India to recall a batch of Maggi instant noodles from stores across the country because the product contained dangerous levels of lead.

India’s Food Safety and Drug Administration (FDA) said high lead content was found during routine tests on two dozen packets of instant noodles, manufactured by Nestle in India, Reuters reports. Continue reading

Posted in Health Concerns, Toxic Substances | Tagged , , , , |

Takata Air Bag Recall Expands to Nearly 34 Million Vehicles

Takata Air Bag Recall Expands to Nearly 34 Million Vehicles

Takata Air Bag Recall Expands to Nearly 34 Million Vehicles


Takata Corp., under pressure from safety regulators, has agreed to declare 33.8 million air bags defective, doubling the number of cars and trucks affected and making this the largest auto recall in U.S. history.

The problem is that the chemical that inflates the air bags can explode with great force, blowing apart a metal inflator and sending shrapnel into the passenger compartment, Newsday reports. Thus far, the faulty air bags are responsible for six deaths and more than 100 injuries worldwide. Continue reading

Posted in Defective Products, Motor Vehicles, Product Recalls, Recalled Vehicles | Tagged , , |

Study Shows Link between Volume of Robotic Prostate Surgery and Complication Rate

Study Links between Robotic Prostate Surgery & Complications

Study Links between Robotic Prostate Surgery & Complications


Research presented at the meeting of the American Urological Association suggests an association between the volume of robot-assisted prostate surgery at a hospital and complication rates for the procedures.

Hospitals with the fewest robot-assisted radical prostatectomy (RARP) procedures had a 14.7% complication rate, while complications occurred in about 5.7% of cases at the highest-volume hospitals, MedPage Today reports. Continue reading

Posted in Health Concerns | Tagged , , , |

FDA Expects to Issue Near-Total Ban on Trans Fats

FDA Expects to Issue Near-Total Ban on Trans Fats

FDA Expects to Issue Near-Total Ban on Trans Fats


The U.S. Food and Drug Administration (FDA) may issue a near-total ban on trans fats as early as this week, Politico reports. Foods contain trans fats if they list “partially hydrogenated oils” as an ingredient. It has been widely used in recent decades because it increases shelf life, enhances texture and helps food keep its color. However, it has been shown cause significant health problems. According to the American Heart Association, trans fats increase the risk fo heart disease, stroke and type 2 diabetes; they raise the levels of bad cholesterol (LDL) and lower good cholesterol (HDL).

The move to ban almost all trans fats stems from the Obama administration’s efforts to promote a healthier American diet. The ban may include very select exemptions, but most uses of trans fat as in ingredient will no longer be valid. The use of trans fat in food products has been reduced 85 percent over the past decade, and the ruling could reduce it even more. Continue reading

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

Patient Experiences to Become Part of Medical Device Reviews

Patient Experiences to Become Part of Medical Device Reviews

Patient Experiences to Become Part of Medical Device Reviews


The Food and Drug Administration (FDA) is developing guidelines that will incorporate patients’ experiences with medical devices into the regulatory review process.

Working together, the Medical Device Innovation Consortium, a collaboration of the device industry, the FDA, and the National Institutes of Health, released a draft framework for device makers as they collect patient-preference information and submit the data to the FDA when seeking device approvals, Roll Call reports. The draft calls for the FDA to incorporate patient input in reviewing new device applications. The House Energy and Commerce Committee will consider this issue as it works on legislation called 21st Century Cures. Continue reading

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

Following Whistleblower Allegations, Congressional Hearing Probes Allegations of Improper Use of Federal Charge Cards

Allegations of Improper Use of Federal Charge Cards

Allegations of Improper Use of Federal Charge Cards


On Thursday, a congressional hearing was held to investigate whether or not federal charge cards were improperly used at the Department of Veterans Affairs. KUSA reports that the hearing stems from a whistleblower’s letter stating that purchase cards were used without proper contracts, alleging that the VA illegally spent as much as $6 billion a year. The practice of using the purchase cards without contracts had been ongoing for years, the whistleblower said. Continue reading

Posted in Legal News | Tagged , , , , |

FDA Warns Newer Type 2 Diabetes Drugs May Cause Ketoacidosis

FDA Warns Newer Type 2 Diabetes Drugs May Cause Ketoacidosis

FDA Warns Newer Type 2 Diabetes Drugs May Cause Ketoacidosis


The Food and Drug Administration (FDA) is warning that some of the newer Type 2 diabetes medicines—canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance)—may cause ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones. Patients with ketoacidosis may require hospitalization.

The FDA is continuing to investigate the issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Continue reading

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

CVS Agrees to $22 Million Settlement in Florida Painkiller Case

CVS Agrees to $22M Settlement in Florida Painkiller Case

CVS Agrees to $22M Settlement in Florida Painkiller Case


CVS Health Corp. has agreed to a $22 million settlement with the federal government over allegations that two of its retail stores located in Sanford, Florida distributed controlled substances based on prescriptions that had not been issued for legitimate medical purposes by a health care provider.

A.D. Wright, Special Agent in Charge, Drug Enforcement Administration (DEA), Miami Field Division, and A. Lee Bentley, III, United States Attorney for the Middle District of Florida, announced the settlement. The settlement resolves all civil matters between CVS, the Drug Enforcement Administration (DEA), and the state of Florida, the company revealed in a regulatory filing. CVS said the funds for the payment were accrued in previous fiscal periods, the Wall Street Journal reports. Continue reading

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

© 2005-2014 Parker Waichman LLP ®. All Rights Reserved.