Featured Stories
Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

Read More

Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...

Read More

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

U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

Read More

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 ...

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

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 ...

Read More

Fracking Releasing Hazardous Chemicals into Local Waterways

Fracking Releasing Hazardous Chemicals into Local Waterways

Study shows two hazardous chemicals—ammonium & iodide—are being released & spilled into Pennsylvania and W.Virginia waterways from fracking operations in Marcellus shale.

Read More

Image Source: wisegeek.com

Trial over Ethicon Transvaginal Mesh Begins in California

Pelvic mesh devices have become the subject of safety concerns in recent years amidst reports that they can cause serious, sometimes permanent injuries.

Read More

Indiana Woman Alleges Serious Injuries From Transvaginal Mesh Products

Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a woman who suffered injuries after receiving transvaginal mesh implants. The lawsuit suit alleges that the transvaginal mesh created an unreasonable risk and directly caused her injuries.

Read More

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 , , , |

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 , , , , |

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