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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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Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...

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Boston Scientific Transvaginal Mesh

Tennessee Woman Alleges Boston Scientific Transvaginal Mesh Product Caused Painful Injuries

More reports of painful injuries are being linked to transvaginal mesh. This time, a Tennessee woman has filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System.

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Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...

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Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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Dozens Receive Nonsterile Simulated Saline Solution

Dozens-Receive-Nonsterile-Simulated-Saline-Solution

The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.

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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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Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda

A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...

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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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Research Links Tylenol Use during Pregnancy to Increased Risk of 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

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.

The research team includes UMass Amherst biologist Thomas Zoeller, an expert in endocrine-disrupting chemicals, epidemiologist Sue Hankinson, and biostatistician Carol Bigelow, who, along with Reeves, will analyze levels of 11 phthalate metabolites in urine samples from 500 women diagnosed with invasive beast cancer after Year 3 of follow-up and in 1,000 healthy matched controls in a prospective study within the Women’s Health Initiative, the Recorder reports. Because the samples “were given many years before any sign of disease appeared,” this study will give “much stronger evidence in terms of causality than studies using another design,” Reeves says. Researchers will have three stored urine samples—from baseline, Year 1 and Year 3—for analysis, and they will be able to address variation in phthalate exposure. They will be able to get an idea of a woman’s typical or average exposure to phthalates.

At this point, the scientific evidence on phthalate exposure risk is unclear and Reeves says with this study the researchers hope to provide either “reassurance or solid evidence of cause for concern,” according to the Recorder.

The Environmental Protection Agency (EPA) is concerned about phthalates because of their toxicity and the evidence of pervasive human and environmental exposure to these chemicals. Phthalates are used in a wide variety of industrial and consumer products, many of which pose potentially high exposure. Phthalates have been detected in food (they are used in coatings in food packaging) and also measured in humans. Studies have shown adverse effects on the development of the reproductive system in male laboratory animals. According to the EPA, several studies have shown associations between phthalate exposures and human health, although no causal link has been established. Recent scientific attention has focused on whether the cumulative effect of several phthalates may multiply the reproductive effects in the organism exposed.

 

 

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 , , , |

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 , , , |

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