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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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Federal DePuy ASR Hip Implant Trials Likely to Start This Year

It looks as though the first trials in the DePuy ASR hip implant multidistrict litigation could begin sometime later this year. According to a report from Bloomberg News, during a status conference held yesterday in Florida, attorneys for both plaintiffs and the defense told U.S. District Judge David Katz that ...

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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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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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E-cigarettes Could Increase Risk of Lung Infections

E-cigarettes Could Increase Risk of Lung Infections

New research suggests the liquid used in electronic cigarettes could increase the risk of viral lung infections, regardless of whether it contains nicotine.

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Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System

Medical device maker Smith & Nephew has reported a drop in sales of its metal-on-metal hip implant devices. According to the company, hip implant sales were down 2 percent during the first quarter of 2012, largely because its Birmingham Hip Resurfacing System suffered from an association with other metal-on-metal hip ...

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Estate of Kentucky Man Alleges Wrongful Death Due to Actos Bladder Cancer

National law firm, Parker Waichman LLP, just filed a lawsuit on behalf of the estate of a Kentucky man who developed bladder cancer and subsequently died, allegedly due to the use of diabetes drug, Actos. The lawsuit names Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceuticals North America, ...

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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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$15 Million in Damages Awarded to Child for Birth Defects Linked to Depakote

$15M Awarded to Child for Defects Linked to Depakote

$15M Awarded to Child for Defects Linked to Depakote


This week a St. Louis jury found that a Minnesota girl’s birth defects were caused by the epilepsy medication Depakote her mother took during pregnancy and the jury awarded the child $15 million in damages.

The jury returned the unanimous verdict on Tuesday and is now considering whether to award punitive damages as well, the St. Louis Post Dispatch reports. Continue reading

Posted in Birth Defects, Depakote, Legal News, Pharmaceuticals |

Research Links Tylenol Use during Pregnancy to Increased Risk of Male Sterility

Tylenol Use during Pregnancy linked to Male Sterility

Tylenol Use during Pregnancy linked to Male Sterility


New research suggests that males may have a higher risk of infertility if their mothers took Tylenol for extended periods during pregnancy. A study conducted by researchers at the University of Edinburgh and published in the journal Science Translational Medicine found that acetaminophen, the main active ingredient in Tylenol and Paracetamol, may inhibit production of testosterone. Researchers said that men have a higher risk of infertility, undescended testicles and testicular cancer when exposed to lower levels of prenatal testosterone. Continue reading

Posted in Legal News |

UMass Epidemiologist to Lead Study of Possible Link Between Phthalates and Breast Cancer Risk

Possible Link Between Phthalates and Breast Cancer Risk

Possible Link Between Phthalates and Breast Cancer Risk


An epidemiologist at the University of Massachusetts Amherst has received a $1.5 million grant from the National Institute of Environmental Health Sciences to study whether phthalates affect human breast cancer risk.

Prof. Katherine Reeves of the UMass School of Public Health will lead the three-year grant to investigate a possible relationship between phthalates—widely used plasticizing and solvent chemicals—and breast cancer risk, the (Greenfield, Mass.) Recorder reports.

Phthalates are found in such products as cosmetics, shampoo, flooring and medical tubing, plastic packaging (including food and blood-storage containers), and some children’s toys. They are added to products increase flexibility, transparency, durability, and longevity. Reeves and her colleagues will study phthalate metabolites, products found in urine samples after the chemicals have passed through the body. Measurable phthalate levels are found in nearly 100 percent of the United States population though the levels vary widely, according to the Recorder. Phthalate metabolites have been reported in human breast milk. Until now, only a handful of small studies have looked at whether phthalates affect human breast cancer risk and none have measured phthalate metabolites before a cancer diagnosis.
Continue reading

Posted in Health Concerns, Toxic Substances |

Health Authorities Investigate Multistate Salmonella Outbreak Possibly Linked to Raw Tuna in Sushi

Health Authorities Investigate Salmonella Outbreak

Health Authorities Investigate Salmonella Outbreak


The Food and Drug Administration, the Centers for Disease Control and Prevention (CDC), and state and local health officials are investigating a multistate outbreak of Salmonella Paratyphi B variant L(+) tartrate(+) infections, possibly linked to sushi made from raw tuna.

The FDA said it “recognize[s] that people will be concerned about these illnesses,” and is moving as quickly as possible in its investigation to prevent additional illnesses. Continue reading

Posted in Food Poisoning, Salmonella | Tagged , , , , |

Acetaminophen Use in Pregnancy Could Affect Son’s Fertility

Acetaminophen Use in Pregnancy Could Affect Son’s Fertility

Acetaminophen Use in Pregnancy Could Affect Son’s Fertility


New research in mice suggests that long-term exposure to acetaminophen during pregnancy could lower a male’s production of testosterone, possibly affecting his fertility.

The results suggest that if a pregnant woman takes acetaminophen for several days it could affect her unborn boy. The boy’s future sperm could be lowered, Medical News Today (MNT) reports. Continue reading

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

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 , , , |

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